Summary of Clinical Outcome Measures for Sports … of Clinical Outcome Measures for Sports-Related Knee Injuries . Final Report . ... Patient input . ... Englishⱡ, French, German,

Summary of Clinical Outcome Measures for Sports-Related Knee Injuries

Final Report

June 5, 2012

AOSSM Outcomes Task Force

James Irrgang, PT, PhD, ATC, FAPTA

Table of Contents

AOSSM Outcomes Task Force……………………………………………………………………..…..1

Summary Table for All Clinical Outcome Measures……………………………………………….....2

International Knee Documentation Committee (IKDC) Subjective Knee Form………………………….…....6

Lysholm Knee Score ……………………………………………………....………………………………...........41

Tegner Activity Scale………………………………………………………………………………………….……74

Cincinnati Knee Scale …………………………………..…………………………………………………………87

Knee Injury and Osteoarthritis Outcome Score (KOOS) – Symptoms Subscale………………….…….…104

Knee Injury and Osteoarthritis Outcome Score (KOOS) – Pain Subscale…………………………….…...136

Knee Injury and Osteoarthritis Outcome Score (KOOS) – ADL Subscale………………………….…...….168

Knee Injury and Osteoarthritis Outcome Score (KOOS) – Sport/Rec Subscale…………………….…..…200

Knee Injury and Osteoarthritis Outcome Score (KOOS) – QOL Subscale…………………………….…...232

Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Pain Subscale……….…264

Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Function Subscale….….289

Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Stiffness Subscale…..…314

Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Overall Subscale……....336

Western Ontario Meniscus Evaluation Tool (WOMET)……………………………………………………....356

Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency………………………………….…361

Marx Activity Scale……………………………………………………………………………………………......369

Kujala Knee Score……………………………………………………………………………………………...…374

International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version…..…381

AOSSM Task Force on Clinical Outcome Measures

AOSSM-Affiliated Members: Members External to AOSSM:

• James Irrgang PT PhD

• Allen Anderson MD

• Warren Dunn MD MPH

• Min Kocher MD MPH

• Robert Marx MD MSc

• Bart Mann PhD

• Bruce Miller MD

• Matt Provencher MD

• Bruce Reider MD

• John Richmond MD

• Julie Agel MA ATC

• Mark Clatworthy MD

• Jeffrey Katz MD MSc

• RobRoy Martin PT PhD

• Lori McLeod PhD

• Marc Swiontkowski MD

1

Clinical Outcome Measures Table for All Instruments

IKDC PEDS IKDC Lysholm Cincinnati

Designed to assess

Variety of knee conditions: ACL, PCL, meniscus,

cartilage patellafemoral problems

Knee condition: ACL, PCL, meniscus,

cartilage patellafemoral problems

Initially designed for ACL. Subsequently used for variety of

other knee conditions

ACL, PCL, MCL, Lateral/postlateral knee

ligaments, meniscal repairs and allografts,

high tibial osteomy

How to obtain instrument

http://www.sportsmed.org/Medical-

Professionals/Research/Grants/IKDC-Forms/

http://www.sportsmed.org/Medical-

Professionals/Research/Grants/IKDC-Forms/

Provided in reference: Lysholm, Am J Sports Med 10:150-154, 1982

Provided in reference: Barber-Westin. Am J

Sports Med. 1999 Jul-Aug;27(4):402-16

Permission No No No No

Cost and licensing fees No No No No

Generation and Selection of Items

Clinical expert, Statistical model

Clinical Experts, Patient input Clinical expert Clinical expert

Normative data available Yes Not reported Yes Yes

Number of questions 18 13 8

Symptoms (4), Patient Perception (1), Sports

Activity (4), ADL function (3), Sports function (3),

Occupational (7), Time to administer ~10 minutes Not reported ~5 minutes Not reported

Time to score by hand Not reported Not reported Not reported Not reported

Automated Scoring available

Yes (http://www.sportsmed.org/

Medical-Professionals/Research/Gr

ants/IKDC-Forms/)

Not available Not Available Not Available

Languages available

Brazilianⱡ, Simplified Chineseⱡ, Traditional

Chineseⱡ, Englishⱡ, French, German, Greek, Italianⱡ,

Japanese, Korean, Swedish, Dutchⱡ

English English English

Scale (scoring) 0-100 (100 best) (Verifying) 0 -100 (100 best) 0 – 100 (100 best)

*Various calculations possible

Recall period 4 weeks 4 weeks Present Present

Validity

Demonstrates hypothesized relationships to other similar

measures and to measures of general physical and emotional

function

Demonstrates hypothesized

relationships to measures of general

physical and emotional function

Demonstrates hypothesized relationships to other similar measures and to measures

of general physical and emotional function

Demonstrates hypothesized relationships to other similar

measures and to measures of general physical and emotional

function

Internal consistency α = .77-.97 α = 0.91 α = .65-.72 Not reported

Test-retest reliability ICC = .87-.98 ICC = .91 ICC = .68-.97 ICC= .80 - .98

Responsiveness - Effect Size ES = .76 - 2.11 ES = 1.39 ES = .76 - 1.2 ES = .60 - 3.49 Responsiveness -

Standardized Response Mean SRM = .57 - 1.5 SRM = 1.35 SRM = .73 – 1.14 SRM = .52 - 2.48

Responsiveness - Minimal Detectable Change MCD = 6.7 – 20.5* MCD = 18.3* MCD = 8.9 – 15.8* MCD = 27.5*

Responsiveness- Minimal Clinically Important Difference MCID = 3.19 - 16.7 Not reported MCID = 10.1 14.0 – 26.0

*Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report


KOOS (Symptoms) KOOS (Pain) KOOS (ADL) KOOS (Sports/Rec) KOOS (QOL)

Designed to assess Post traumatic osteoarthritis (OA); i.e. ACL, meniscus, chondral injuries


http://www.koos.nu/

Permission No

Cost and licensing fees No

Generation and Selection of Items Clinical expert, Patient input

Normative data available Yes

Number of questions 7 9 17 5 4

Time to administer ~10 minutes for all 5 scales

Time to score by hand Not reported

Automated Scoring available

Yes (http://www.koos.nu/)

Languages available

Austrian-German, Czech, Chineseⱡ, Croatian, Danish, Dutchⱡ, Estonian, English, Frenchⱡ, German, Italian, Japanese, Latvian, Lithuanian, Norwegian, Persianⱡ, Portuguese, Polish, Russian, Singapore English, Slovakian, Slovenian,

Spanish, Swedishⱡ, Thai, Turkish, Ukranian

Scale (scoring) Total: 0-100 (100 best)

Recall period Last Week

Validity


relationships to other similar measures and

to measures of general physical and emotional

function



to measures of general physical and emotional function


relationships to other similar measures

and to measures of general physical and emotional function


relationships to other similar

measures and to measures of

general physical and emotional

function


relationships to other similar

measures and to measures of

general physical and emotional

function Internal consistency α = .25 - .83 α = .65 - .94 α = .78 - .97 α = .84 - .98 α = .64 - .90

Test-retest reliability ICC= .74 - .95 ICC= .80 - .92 ICC= .73 - .94 ICC= .45 - .89 ICC= .60 - .95

Responsiveness - Effect Size ES = .72 - 1.63 ES = .82 - 2.59 ES = .67 - 2.25 ES = .90 - 1.31 ES = 1.15 - 2.8

Responsiveness - Standardized Response

Mean SRM = .61 - 1.45 SRM = .71 - 1.85 SRM = .75 - 1.8 SRM = .87 - .89 SRM = .76 - 1.93

Responsiveness - Minimal Detectable

Change 9.9 – 24.3* 11.8 - 29.0* 11.9 – 31.5* 12.2 - 70.0* 14.2 – 34.0*

Responsiveness- Minimal Clinically Important

Difference Not reported Not reported Not reported Not reported Not reported


3

http://www.koos.nu/


WOMAC (Pain) WOMAC (Function) WOMAC (Stiffness) WOMAC (overall)

Designed to assess Rheumatoid arthritis, hip/knee OA

Rheumatoid arthritis, hip/knee OA



How to obtain instrument www.womac .org

Permission Yes

Cost and licensing fees Yes

Generation and Selection of Items Clinical experts, Patient input

Normative data available Yes

Number of questions 5 17 2 24

Time to administer ~12 minutes for all 3 scales

Time to score by hand ~5-10 minutes

Automated Scoring available Not Available (Permission required)

Languages available Over 65 including: English, Arabic, Chinese, Dutch, French-Canadian, German, Hebrew, Italian, Thai, Turkishⱡ, Spanishⱡ

Scale (scoring) 5 Point Likert scale: Pain (0-20 pts), Stiffness (0-8 pts), Function (0-68 pts)

VAS scale: Pain (0-500 pts), Stiffness (0-200 pts), Function (0-1700 pts) Composite scores can be converted to 0-100 scale (0 best)

Recall period Current

Validity


relationships to other similar measures and to

measures of general physical and emotional

function




function




function

Demonstrates hypothesized relationships to other similar measures


Internal consistency α = .75 - .82 α = .84 - .96 α = .71-.84 α = .84 - .96

Test-retest reliability ICC= .78 - .85 ICC= .81 - .93 ICC= .67 - .86 ICC= .86 - .93

Responsiveness - Effect Size ES = .74 - 17.7 ES = .18 - 8.7 ES = .07 - 1.0 ES = .50 - 10.0

Responsiveness - Standardized Response Mean SRM = .35 - 1.5 SRM = .23 - 1.3 SRM = .08 - .64 SRM = .24 - 1.13

Responsiveness - Minimal Detectable Change MCD = 14.4 – 16.2* MCD = 10.6 – 15.0* MCD = 22.9-30.6* MCD = 10.7 – 15.3*

Responsiveness- Minimal Clinically Important Difference MCID = 7.5 - 17.5 MCID = 5.89 - 8.1 MCID = 6.3 - 18.8 MCID = 11.5

* – Minimal detectable change ranges reported in article based on 5 point Likert version of the WOMAC

ⱡ Formal assessment of psychometric properties included in this report

4

http://www.womac.org/

`



WOMET Mohtadi Kujala Tegner Marx

Designed to assess Meniscus injury Health related

quality of life due to ACL injury

Patellofemeral disorders

Activity level – competitive sports, recreational sports,

work and activities of daily living

ACL injury


Sharon Griffin - [email protected]

Provided in reference:

Mohtadi. Am J Sports Med.1998

May-Jun;26(3):350-9

Contact author: Kujala UM -

[email protected]

Provided in reference: Tegner, Clin Orthop

198:43-49, 1985.

Provided in reference: Marx,Am J Sports Med. 2001 Mar-Apr;29(2):213-8

Permission No No No No No

Cost and licensing fees No No No No No

Generation and Selection of Items Patient input

Clinical expert, Patient item generation

Clinical Expert Clinical expert Clinical expert, Patient input

Normative data available Not reported Not reported Not reported Yes Not reported

Number of questions 16 31 13 1 (10 levels) 4

Time to administer ~5 - 10 minutes ~10 - 15 minutes ~10 - 15 minutes ~1 - 2 minutes ~1 minute

Time to score by hand Not reported Not reported Not reported Not reported Not reported

Automated Scoring available Not available Not available Not available Not Available Not available

Languages available English English English, Turkishⱡ English English

Scale (scoring) 0-1600 (0 best) 0-100 (100 best) 0-100 (100 best) 0 -10 (10 best) 0 – 16 (16 best)

Recall period 1 week Last 3 months Present Present Past year

Validity



to measures of general physical

function

Not reported



to measures of general physical

function

Demonstrates hypothesized relationships to other similar measures



relationships to similar scales

Internal consistency α = .91 - .92 Not reported α = .82 - .84 Not reported Not reported

Test-retest reliability ICC = .92 Not reported ICC= .86 - .94 ICC = 0.82 - 0.92 ICC = .97

Responsiveness - Effect Size ES = 1.17 Not reported Not reported ES = .61 - 1.1 Not reported

Responsiveness - Standardized

Response Mean SRM = .65 - .90 Not reported Not reported SRM = .60 - 1.0 Not reported

Responsiveness - Minimal Detectable

Change Not reported Not reported Not reported MCD = 1.0 9.9

Responsiveness- Minimal Clinically

Important Difference Not reported Not reported Not reported Not reported Not reported

Shenay

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Typewritten Text

IKDC SUBJECTIVE KNEE FORM

Irrgang (1) Padua (2) Anderson (3)

Study Characteristics

Purpose Reliability, validity Reliability, validity of Italian translation Normative Data

Study Population/Sample (inclusion/exclusion)

Patients with a variety of knee problems

Patients undergoing ACL reconstruction

Random sample representative of general population

Number 533 50 2670

Age range (average ± SD, min-max) 37.5 years ±16.2 (6.2-86.6) 24 (18-42) 39 years ±14 (18-65)

Sex (% female) 47% (identified) 18% 51%

Reliability

Internal consistency α = 0.92 α = 0.91 NA

Test-retest reliability ICC = 0.94 ICC = 0.90 NA

Time interval 50 days 5 days NA

Validity

Correlation to similar scale NA NA NA

Correlation to general measures of Physical function

Fair (25%), Moderate (75%) correlation to general measures of physical function

Little (33%), Moderate (66%) correlation to general measures of physical function

NA

Correlation to general measures of mental function

Little (75%), Fair (25%) correlation to general measures of mental function

Little (66%), Moderate (33%) correlation to general measures of mental function

NA

Responsiveness

ES NA NA NA

SRM NA NA NA

MDC 12.83(calc) 19.98 (calc) NA

MCID NA NA NA

Time Interval NA NA NA

Other

Floor/Ceiling Effect No No No

Normal Distribution NA Yes No

Normal Data NA NA Yes

OA – Osteoarthritis

6


Irrgang (4) Haverkamp (5) Crawford (6)


Purpose Reliability, validity Reliability, validity of Swedish translation Validity, Responsiveness


Patients with a variety of knee problems

Patients with a variety of knee problems Patients with meniscus pathology

Number 207 145 Test re-test = 31, Construct/Content = 246, SF-12 group = 50, Responsiveness = 100

Age range (average ± SD, min-max) 40.5 years ± 16.7 (12.5-81.3) 54.6 (21-84)

Test re-test = 50.6 (19-73); Construct/Content = 45.4 (18-81); Responsiveness = 47.9 (18-81)

Sex (% female) 53% 58% Test re-test = 32%, Construct/Content = 29%, Responsiveness = 29%

Reliability

Internal consistency NA α = 0.9 α = 0.773

Test-retest reliability NA ICC = 0.96 ICC = 0.95

Time interval NA 1 week 4 weeks

Validity

Correlation to similar scale NA Little (66%), Excellent (33%) correlation to similar scales NA

Correlation to general measures of Physical function NA

Moderate (100%) correlation to general measures of physical function


Correlation to general measures of mental function NA

Little(50%), Fair(50%) correlation to general measures of mental function

NA

Responsiveness

ES 1.13 NA 2.11

SRM 0.94 NA 1.5

MDC 11.5 (sens =.82 spec = .64) 20.5 (sens =.84 spec = .64) NA 8.8

MCID 11.5 NA 3.19

Time Interval 19 months NA 12 months

Other

Floor/Ceiling Effect NA No No

Normal Distribution NA Yes Yes

Normal Data NA NA NA

7


Lertwanich (8) Greco (10) Metsavahl (11) Fu (12)


Purpose Validity, Responsiveness of Thai Translation

Reliability, validity Reliability, validity of Brazilian translation

Reliability, validity of Chinese translation


Various knee related complaints

Patients following articular cartilage surgery

Patients with general knee complaints

Patients with various knee injuries

Number 55 Reliability = 17, Responsiveness = 50 117 84

Age range (average ± SD, min-max)

27.6 (18-50)

Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)

46.7 (15-84) 52.6 (16-85)

Sex (% female) 1.8% Reliability = 39%, Responsiveness = 39.2% 50.4% 36%

Reliability

Internal consistency α = 0.92 NA α = .928 ; .935 (test ; retest) α = 0.97

Test-retest reliability ICC = 0.92 ICC 6mo. = 0.91 ICC 12mo. = 0.93 ICC = 0.988 ICC = .87

Time interval 7 days 6 mo. 12 mo. 1 week 10 days

Validity

Correlation to similar scale NA NA Excellent (100%)

correlation to similar scale NA


Fair (25%), Moderate (75%) correlation to general measures of physical function

NA

Moderate (75%), Excellent (25%) correlation to general measures of physical function



Fair (100%) correlation to mental function NA Fair (100%) correlation to

mental function

Little (50%), Fair (50%) correlation to mental function

Responsiveness

ES NA 6mo = .76 12mo = 1.06 NA NA

SRM NA 6mo = 0.57 12mo = 1.0 NA NA

MDC 8.8 11.4 (calc) 6.7 NA

MCID NA 6mo = 6.3 12mo = 16.7 NA NA

Time Interval NA 6 and 12 months Equation NA

Other

Floor/Ceiling Effect No Yes No NA

Normal Distribution NA NA NA NA

Normal Data NA NA NA NA

8


Schmitt (13)


Purpose Validity, Reliability


Variety of knee injuries

Number 673


6 - 18

Sex (% female) 54%

Reliability

Internal consistency α = 0.91

Test-retest reliability NA

Time interval NA

Validity

Correlation to similar scale NA


Excellent (100%) correlation to physical

function


NA

Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Time Interval NA

Other

Floor/Ceiling Effect NA

Normal Distribution NA

Normal Data NA

9

IKDC STUDY CONSOLIDATION

REFERENCES

1) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct; 29(5): 600-13

2) Padua R, Bondi R, Ceccarelli E, Bondi L, Romanini E, Zanoli G, Campi S. Italian version of the International Knee Documentation Committee Subjective Knee Form: cross- cultural adaptation and validation. Arthroscopy. 2004 Oct; 20(8): 819-23

3) Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. 2006 Jan; 34(1): 128-35

4) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct; 34(10): 1567-73

5) Haverkamp D, Sierevelt IN, Breugem SJ, Lohuis K, Blankevoort L, van Dijk CN. Translation and Validation of the

Dutch Version of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct; 34(10):1680-4

6) Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the IKDC score for

meniscus injuries of the Knee. Arthroscopy. 2007 Aug: 23(8): 839-44 8) Lertwanich P, Praphruetkit T, Keyurapan E,Lamsam C, Kulthanan T. Validity and reliability of Thai version of the

International Knee Documentation Committee Subjective Knee Form. J.Med Assoc Thai.2008 Aug; 91(8):1218-25 10) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee

Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. Epub 2009 Dec 31.

11) Metsavaht L, Leporace G, Riberto M, Sposito MM, Batista LA.Translation and Cross-Cultural Adaptation of the

Brazilian Version of the International Knee Documentation Committee Subjective Knee Form: Validity and Reproducibility. Am J Sports Med. 2010 May 14.

12) Fu SN, Chan YH. Translation and validation of Chinese version of International Knee Documentation Committee

Subjective Knee Form. Disabil Rehab. 2011; 33(13-14):1186-9 - Epub 2010 Oct 22 13) Schmitt LC, Paterno MV, Huang S. Validity and internal consistency of the international knee documentation

committee subjective knee evaluation form in children and adolescents. Am J Sports Med. 2010 Dec;38(12):2443-7. Epub 2010 Aug 30. PubMed PMID: 20805408.

10


Ratings

1 Yes 2 No 3 Not evaluated or not reported NA Not applicable

Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Irrgang Title of the Article Development and Validation of the International Knee

Documentation Committee Subjective Knee Form Year 2001 PubMed ID: 11799013 Reviewer’s Name Travis Hamilton Date of Review June 16, 2011

Content Validity

Reported that items were generated by team of experts 1 Reported that items were developed from patient input NA Reported that content was developed from statistical modeling 1 Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2; positively skewed/platykurtic distribution

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: Pearson coefficients PF=.63, RP=.47, BP=.64,

PCS=.66 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: RE=.26, MH=.25, MCS=.16 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity

Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated

Internal Consistency

Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:

.92

Test-Retest Reliability

Evidence for test-retest reliability (eg.. ICC>.70) 1

11

Indicate value: .94 Testing interval (time between repeated measures) 49.7 days ± 24.4 (4-92)

Interrater Reliability

Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:

Responsiveness

Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)

NA

Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA

Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)

NA

Time interval between baseline and follow-up assessments NA

Descriptive Features

Age range of sample 37.5 years ±16.2 (6.2-86.6) Number: 533 Sex

Male 252/479 (patients sex not recorded in 54 cases) Female

Diagnosis Table 2 ACL injury/surgery PCL injury/surgery

Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL

OA PF

General knee pain Combined injury

Sport related Cartilage degeneration or surgery

Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 1

Notes:

12

13


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Padua Title of the Article Italian Version of the International Knee Documentation

Committee Subjective Knee Form: Cross-Cultural Adaptation and Validation

Year 2004 PubMed ID: 15483542 Reviewer’s Name Travis Hamilton Date of Review 6.25.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to

Italian)

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .67, BP = .56, PCS = -.60 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-35: MH = -.65, MCS = -.40 RE = .44 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = 0.91

14


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .90 Testing interval (time between repeated measures) 5 days



Responsiveness


NA


NA


NA



Age range of sample 24 (18-42) Number: 50 (20 Pts. Randomly for reproducibility) Sex

Male 41 Female 9

Diagnosis ACL injury/surgery 100% PCL injury/surgery


OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2

Notes:

Correlation between the Italian IKDC and the SF-36 was calculated using the Spearman correlation (R).

15

16


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Anderson Title of the Article The International Knee Documentation Committee Subjective

Knee Evaluation Form: Normative Data Year 2006 PubMed ID: 16219941 Reviewer’s Name Travis Hamilton Date of Review June 16, 2011

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 3 (was not established for age group <18 years)

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. People experiencing knee problems would score

lower than those without knee problems.

Criterion Validity

Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated NA


Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:


Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)

17



Responsiveness


NA


NA


NA



Age range of sample 39 years ±14 (18-65) Number: 2670 returned, used: 2625 right knee 2621 left knee (5246

Knees) Sex

Male 1285 Female 1385

Diagnosis NA ACL injury/surgery PCL injury/surgery


OA PF



Provide normative data 1 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2

18


Ratings


Outcome Measure IKDC Subjective Knee Form Author’s Last Name Irrgang Title of the Article Responsiveness of International Knee Documentation

Committee Subjective Knee Form Year 2006 PubMed ID: 16870824 Reviewer’s Name Travis H Date of Review June 16, 2011

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity

Correlated with “gold standard” 1 Predictive of a future outcome NA If yes to either of above, report how this was demonstrated Group level analysis of between-groups differences used 7-

level global rating of change scale in comparison to IKDC. ANOVA = 37.1% of change in IKDC was accounted for by global scale.



19





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES = 1.13, SRM = 0.94 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

1

Report statistics: MCID 11.5 Previous data suggests minimal change ±12.8 (from initial study)

Change in measure related to change in external standard 1 Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)

NA

Time interval between baseline and follow-up assessments 19 months ±2.9 (6-28.0)


Age range of sample 40.5 years ± 16.7 (12.5-81.3) Number: 207 Sex

Male 47.1% Female 52.9%



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

Notes:

20

21


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Haverkamp Title of the Article Translation and Validation of the Dutch Version of the

International Knee Documentation Committee Subjective Knee Form


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 (Figure 1) Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to

Dutch)

Construct Validity

Correlated with a generic instrument/scale 1 (Table 1) If yes. Indicate instrument/scale and correlation coefficient SF-36: PF= .71, RP = .55, BP = .69 Correlated with theoretically similar scale 1 (Table 1) If yes. Indicate instrument/scale and correlation coefficient VAS = -0.62, WOMAC = .77, Oxford 12 = -0.77 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: RE = 0.30, MH = 0.21 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = .9

22


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.96; Pearson correlation (r = 0.92, P <.01) Testing interval (time between repeated measures) 1 Week



Responsiveness


NA


NA


NA



Age range of sample 54.6 (21-84) Number: 145 Sex

Male 42% Female 58%

Diagnosis ACL injury/surgery PCL injury/surgery

Other ligament injury/surgery + ACL 13 (9%) Meniscus. Articuler artroscopy +ACL 42 (29%)

OA 90 (62%) PF 17



Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report 1; Dutch Is this the first or primary report about this instrument? 2

Notes:

• Floor and ceiling effects were not investigated after treatment. It is possible that a ceiling effect occurs after treatment of the knee injury; however, this did not occur in the original version of the IKDC.

23

24


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Crawford Title of the Article Reliability, Validity, and Responsiveness of the IDKC Score for

Meniscus Injuries of the Knee Year 2007 PubMed ID: 17681205 Reviewer’s Name Travis Hamilton Date of Review 6.24.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1

Construct Validity

Correlated with a generic instrument/scale 1; If yes. Indicate instrument/scale and correlation coefficient Physical Component of SF-12: P < 0.05; r = 0.60 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner; P < .001 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses were significant (P < .05);

- Pts. with Workers’ Compensation claim had lower IKDC than pts w/o claim – P < .001 - Pts. with more difficulty with ADL had lower IKDc scores than pts with less difficulty – P < .001, r = 0.680 - Pts. w/ difficulty working bc of knee had lower IKDC scores than pts that did not – P < .001, r = 0.645 - Pts. w/ difficulty w/ sports bc of knee had lower IKDC then pts. who did not – P < .001, r = 0.638 - Pts. with abnormal knee assessment had lower IKDC scores than pts. w/ normal assessments of overall function – P < .001 - Pts. with degenerative/complex meniscus tears had lower IKDC scores than pts. w/ simple tears – P = .004

Criterion Validity


25



Cronbach α = 0.773


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.95 Testing interval (time between repeated measures) Within 4 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES = 2.11; SRM = 1.5 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

1

Report statistics: MDC = 8.8; SE = 3.19 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)

NA

Time interval between baseline and follow-up assessments 12 months


Group A Group B Group C Group D Age range of sample 50.6 (19-73) 45.4 (18-81) 47.9 (18-81) Number: 31 264 50 100 Sex

Male 21 186 71 Female 10 78 29

Diagnosis All pts. had meniscus pathology

ACL injury/surgery PCL injury/surgery

Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 100% 100% 100% 100%

OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

26


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Lertwanich Title of the Article Validation and reliability of Thai Version of the International

Knee Documentation Committee Subjective Knee Form Year 2008 PubMed ID: 18788694 Reviewer’s Name Travis Hamilton Date of Review 6.25.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = .75, RP = .37, BP = .76 PCS = .63 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; MH = .29, RE = .34, MCS = .34 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = 0.92

27


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.92 Testing interval (time between repeated measures) 7 days



Responsiveness


NA


NA


NA




Male 54 Female 1

Diagnosis Table 1. ACL injury/surgery PCL injury/surgery


OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4-WEEKS Language(s) of instrument used in this report Thai Is this the first or primary report about this instrument? 2

28

29


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation

Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.

Year 2009 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 17-Jun-11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 (for all instruments except IKDC) If yes. <30% of sample scored at endpoint Data normally distributed NA

Construct Validity


Criterion Validity




30


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: IKCD (6 mo., 12mo.) = 0.91 ; 0.93 Testing interval (time between repeated measures) see above



Responsiveness

Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s IKDC ES (6 mo., 12mo.) = 0.76 ; 1.06

IKDC SRM (6 mo., 12mo.) =0.57 ; 1.00 (table 2)

Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 month: IKDC MCID: 6.3 (Sens = 0.79 ; Spec = 0.74)

MCD: 15.6 12 month: IKDC MCID: 16.7 (Sens = 0.74 ; Spec = 0.8) MCD: 13.7 (table 3)

Change in measure related to change in external standard 1 (global scale) Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months


Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male

Male Female



OA PF


Sport related Cartilage degeneration or surgery 17 50

Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2

31


Ratings


Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Metsavaht Title of the Article Translation and Cross-Cultural Adaptation of the Brazilian

Version of the International Knee Documentation Committee Subjective Knee Form


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to

Portuguese)

Construct Validity

Correlated with a generic instrument/scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient SF-36; PCS = .79, PF = .75, RF = .54, BP = .63 Correlated with theoretically similar scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient Lysholm = .89, WOMAC = .85 Uncorrelated with theoretically distinct scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient SF-36; MCS = .51, MH = .40, RE = .50 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = .928 ; .935 (test ; retest)

32


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.988 P< .001 Testing interval (time between repeated measures) 1 week



Responsiveness


NA


1

Report statistics: MDC = 6.7 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)



Pretest Group (before accepted translation)

Final Testing Group (statistical and correlational analysis)

Age range of sample 48.9 ± 18.6 (20-82) 46.7 (15-84) Number: 32 117 Sex

Male 31.3% 49.6% Female 68.7% 50.4%

Diagnosis ACL injury/surgery 18.8% PCL injury/surgery

Other ligament injury/surgery + ACL Hamstring insetional tendinopathy (2.6%), patellofemoral pain syndrome (7.7%), patellar tendinopathy (1.7%), tibial shaft fracture (1.7%), knee effusion (1.7%), posterior cruciate ligament injury (.9%), adductor bursitis (.9%), knee replacement (.9%)

Meniscus. Articuler artroscopy +ACL 20.5% OA 37.6% PF 2.6%

General knee pain 100% Combined injury


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report 1; Portuguese Is this the first or primary report about this instrument? 2

33

Notes:

• For cultural adaptation, question relating to “skiing” was changed to “surfing”

34

IKDC Subjective Knee form

Ratings


Outcome Measure IKDC Subjective Knee Form Author’s Last Name Fu Title of the Article Translation and validation of Chinese version of International

Knee Documentation Committee Subjective Knee Form Year 2011 PubMed ID: 20969433 Reviewer’s Name Travis Hamilton Date of Review 7.6.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA; (No effects were observed in the 20 pt. cohort

validation) If yes. <30% of sample scored at endpoint Data normally distributed NA Was there a standard for translation? 1 If yes. How? Backward and Forward translation by professionals.

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 (Chinese version): PF = .64; RP = .50; BP = .64 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 (Chinese version): RE - .24; MH = .41 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = 0.97

35


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.87 Testing interval (time between repeated measures) 7 – 10 days



Responsiveness


NA


NA


NA

Time interval between baseline and follow-up assessments



Male 54 Female 30



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4-WEEKS Language(s) of instrument used in this report 1; chinese Is this the first or primary report about this instrument? 2

36

37


Ratings


Outcome Measure IKDC Subjective Knee Form – Pediatric Version Author’s Last Name Schmitt Title of the Article Validity and Internal Consistency of the International Knee

Documentation Committee Subjective Knee Evaluation Form in Children and Adolescents


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient PedsQL PCS: r = 0.83 (pediatric, r = .84; adolescnet, r = .84;

young adult, r = .79) Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity

Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated



α: No deleted items = 0.911; 3 deleted items = 0.934

38





Responsiveness


NA


NA


NA



Age range of sample 6-18 Number: 673 Sex

Male 312 Female 361



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2

Notes:

3 items deleted were questions 2 (pain frequency), 3 (pain severity), and 6 (locking/catching) did not appreciably influence internal consistency. However the data indicate that the items may contribute to measurement error in the age group studied.

39

40

Lysholm Knee Score

Tegner (2) Bengtsson (3) Risberg (4) Marx (5) Paxton (6)


Purpose Reliability, validity Sensitivity, Reliability Sensitivity Reliability, validity, responsiveness Validity, Reliability


ACL injury ACL, MT, PFPS, and LAS injury***

ACL + combined injury Variety of knee injuries Acute patellar dislocation

Number 76 31 120 Reliability = 41, Validity = 133, Responsiveness = 42

Validity = 110, Test=retest = 81


27

ACL = 26.3 ± 7.8; MT = 39.1 ± 13.8; PFPS = 24.1 ± 7.0; LAS 29.8 ± 5.6

27.8

Reliability = 32.6 (16-60), Validity = 31.5 (14-65), Responsiveness = 30.9 (15-61)

Validity =First dislocation: 16 (9-67), Prior dislocation: 18 (8-65) Test-retest= First dislocation: 16 (9-48), Prior dislocation: 22 (8-65)

Sex (% female) 28% NA 47% Reliability = 51%, Validity = 48%, Responsiveness = 54%

NA

Reliability

Internal consistency NA NA NA NA α = 0.71

Test-retest reliability Intrapersonal CC = .97 Interpersonal CC = .90

Days 1-3: t = 0.75; Days 1-14: t = 0.69; Days 3 – 14: t = 0.68 (Kendall's correlation)

NA ICC = 0.95 r = 0.88

Time interval 2 weeks 1-3 days, 1-14 days, 3-14 days NA 5 days 21 days

Validity

Correlation to similar scale

Excellent (100%) correlation to similar scales

NA

Little (29%) Fair (25%), Moderate (29%), Excellent (16%)

Moderate (50%), Excellent (50%) correlation to similar scales

Little (50%), Excellent (50%) correlation to similar scales


NA NA NA

Fair (33.3%), Moderate (66.6%) correlation to general measures of physical function



NA NA NA

Little (50%), Fair (50%) correlation to general measures of mental function

NA

Responsiveness

ES NA NA NA NA NA

SRM NA NA NA 0.9 NA

MDC NA NA NA 11.6 (calc) NA

MCID NA NA NA NA NA

Guyatt NA NA NA NA NA

Time Interval NA NA 3, 6, 12, 24 months (scores) NA NA

Other

Floor/Ceiling Effect NA NA NA No No

Normal Distribution NA NA NA NA No

Normal Data NA NA NA NA NA *** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain

41

Lysholm Knee Score Continued

Kocher (7) Briggs (8) Heintjes (9) Briggs (10)


Purpose Reliability, Responsiveness

Validity, Reliability, Responsiveness

Reliability, validity, responsiveness



Patients with Choldral lesions Meniscal Injury General knee complaints ACL (plus concurrent)

injuries

Number 76 Test-retest group = 122, Validity group 1 = 191, Validity group 2 = 477

314 Reliability = 41, Validity = 133, Responsiveness = 42

Age range (average ± SD, min-max) 27

Test-retest group = 48 (14-76), Validity group 1 = 40 (13-81), Validity group 2 = 39 (18-62)

24.6 ± 7.5 (12-35)

Reliability = 32.6 (16-60), Validity = 31.5 (14-65), Responsiveness = 30.9 (15-61)

Sex (% female) 28% Test-retest group = 36%, Validity group 1 = 32%, Validity group 2 = 23%

44% Reliability = 51%, Validity = 48%, Responsiveness = 54%

Reliability

Internal consistency α = 0.65 α = 0.729 NA α = .72

Test-retest reliability ICC = 0.91 ICC = 0.92 NA ICC = 0.94

Time interval 4 weeks 4 weeks NA 4 weeks

Validity

Correlation to similar scale Little (100%) correlation to similar scales NA

Little (29%) Fair (25%), Moderate (29%), Excellent (16%)

Excellent (100%) correlation to similar scales



Moderate (100%) correlation to measures of physical function

NA Fair (100%) correlation general measures of physical function

Correlation to general measures of mental function NA NA NA

Little (100%)correlation to general measures of mental function

Responsiveness

ES 1.16 Validity Group 1 = 1.2, Validity Group 2 = 1.2

Traumatic pts = 1.15 Nontraumatic pts = 0.76

6mo. = 1.0 , 9mo. = 1.0, 12mo. = 1.1, 24mo. = 1.1

SRM 1.1 Validity Group 1 =0.97, Validity Group 2 = 1.13

Traumatic pts = 1.14 Nontraumatic pts = 0.73

6mo. = 0.925 , 9mo. = 1.1, 12mo. = 1.2, 24mo. = 0.93

MDC 15.8 (calc) 15.2 (calc) NA 8.9

MCID NA 10.1 NA NA

Guyatt NA NA Traumatic pts = 0.94 Nontraumatic pts = 1.11 NA

Time Interval 52 months 12 months 12 months 6, 9, 12, 24 months

Other

Floor/Ceiling Effect No No No No

Normal Distribution NA NA NA Yes

Normal Data NA NA NA NA *** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain

42

Demirdjian (11)


Purpose Normative Data


High School and College Students

Number 246

Age range (average ± SD, min-max) 17.6 (13 – 25)

Sex (% female) 40%

Reliability

Internal consistency NA


Time interval NA

Validity




Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data Yes

43

LYSHOLM STUDY CONSOLIDATION

REFERENCES

2) Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985; 198:43-9

3) Bengtsson J, Mollborg J, Werner S. A study for testing the sensitivity and reliability of the Lysholm knee scoring scale. Knee Surg Sports Traumatol Arthrose 1996; 4: 27-31

4) Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score, and the Cincinnati knee score a prospective study of 120 ACL reconstructed patients with a 2 year follow up Knee Surg Sports Traumatol Arthroscopy 1999 7: 152-59

5) Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewics TL. Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001; 83: 1459-69

6) Paxton EW, Fithian DC, Stone ML, Silvia P. The reliability and validity of knee specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med 2003; 31 : 487-92

7) Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. J Bone Joint Surg AM. 2004; 86: 1139-45

8) Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the Lysholm Knee Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee. J Bone Joint Surg Am. 2006; 88(4): 698-705

9) Heintjes EM, Bierma-Zeinstra SM, Berger MY, Koes BW. Lysholm scale and WOMAC index were responsive in prospective cohort of young general practice patients. J Clin Epidemol. 2008; 61 (5): 481-8

10) Briggs K, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, Validity, and Responsiveness of the Lysholm Knee Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 years later. Am J Sports Med, 2009; 37: 890-897

11) Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51

44

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Tegner Title of the Article Rating System in the Evaluation of Knee Ligament Injuries Year 1985 PubMed ID:

4028566 Reviewer’s Name Travis Hamilton Date of Review 6.29.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Marhall Scoring Scale; ( r = 0.78; p < .001) (r = Pearson

coefficient) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Intrapersonal correlation coefficient = .97 ( 2 weeks)

Interpersonal correlation coefficient. = .90 (same occasion by physician and physiotherapist)

Testing interval (time between repeated measures) 2 weeks

45



Responsiveness


NA


NA


NA

Time interval between baseline and follow-up assessments NA Descriptive Features

Age range of sample 27 Number: 76 Sex

Male 55 Female 21

Diagnosis ACL injury/surgery 100% PCL injury/surgery


OA PF



Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

This a comparative study investigating the differences between the Lysholm score and the Marshall score relative to knee injury. The results suggests that patients who sore higher on the Lysholm scale, have “too-low” values when scored on the Marshall scale. Also, patients who score low on the Lyholms scale are overestimated by the Marshall scale.

The intrapersonal coefficient of variation was estimated by letting the same orthopedic surgeon determine the score of 15 patients twice with an interval of two weeks. To establish the interpersonal variation, an orthopedic surgeon and a physiotherapist determined the score for the same 15 patients on one and the same occasion.

The intrapersonal coefficient of variation = 3%

The interpersonal coefficient of variation = 4%

46

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Bengtsson Title of the Article A study for testing the sensitivity and reliability of the Lysholm

knee scoring scale Year 1996 PubMed ID: 8819060 Reviewer’s Name Travis Hamilton Date of Review 6.30.11

Content Validity


Construct Validity


Criterion Validity




47


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Days 1-3: τ = 0.75, P < .0001; Days 1-14: τ = 0.69, P < .0001;

Days 3 – 14: τ = 0.68, P < .0001 τ = Kendall’s correlation test

Testing interval (time between repeated measures)


Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: NA

Responsiveness


NA


NA


NA

Time interval between baseline and follow-up assessments Descriptive Features

Age range of sample Table 1 Number: 31 Sex

Male Female



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2 NOTES: Patients that have not undergone surgery and have one of four knee/leg related injuries (ACL rupture, MT, PFPS, and LAS) were included in the study. Patients were mailed a copy of the Lysholm scale and were assessed by phone interview their ratings for each category at 1, 3, and 14 day increments. The sensitivity data show that patients in the ACL group scored significantly higher (P<0.01) on the Lysholm scale than for any of the other groups. Therefore, the conclusion can be made that the Lysholm scale is less sensitive for patients with ACL injury as compared to any of the other knee injuries studied. Group comparisons show there were significant differences between the ACL and MT group (P<0.01), as well as the ACL and LAS group (P < 0.05) (table 3.)

48

49

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Risberg Title of the Article Sensitivity to changes over time for the IKDC form, the

Lysholm score, and the Cincinnati knee score Year 1999 PubMed ID: 10401651 Reviewer’s Name Travis Hamilton Date of Review 6.30.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC1-4 and IKDC-final form, Cincinnati – table 3. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: NA Testing interval (time between repeated measures)

50



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s NA; table 2 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 3 mo., 6.mo., 1 year, 2 years


Age range of sample 27.8 Number: 120 Sex

Male 64 Female 56

Diagnosis ACL injury/surgery 58 PCL injury/surgery


OA PF

General knee pain Combined injury 62 (+ACL)


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in this study. Patients were assessed with 3 instruments (IKDC form, Lycholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year, 2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x = Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the Cincinnati. The Lysholm score was sensitive to clinical changes from 3 to 6 moth follow-up only and remained unchanged thereafter.

51

52

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Marx Title of the Article Reliability, validity, and responsiveness of four knee outcome

scales for athletic patients Year 2001 PubMed ID:


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .66,;RP = .49; BP = .57 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Cincinnati scale = .70; Activities of Daily Living Scale = .85 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: RE = .18; MH = .29 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Confirmed Hypotheses:

• The instruments would all correlate better with each other than they would with the physical component scale or the mental component scale and the physical component scale would correlate more strongly with the knee scales.

• The knee-rating scales would correlate better with each other than they would with any of the eight SR-36 scales.

• The knee scales would correlate better with physical function and role-physical than they would with vitality or social function and that they would correlate better with GH, BP, VT, and SF than they would with RE or MH.

• Knee scales would be significantly correlated with clinician-rated and patient-rated severity.

• There would be a difference in the mean scores on the knee specific instruments for patients who had different patient rated severity scores as well as for those who had different clinician-rated severity score.

• There would be no veiling or floor effects.

53

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.95 Testing interval (time between repeated measures) Mean = 5.2 (2-14)



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s SRM = .9 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 3 months minimum


Reliability Validity Responsiveness Age range of sample 32.6 (16-60) 31.5 (14-65) 30.9 (15-61) Number: 41 133 42 Sex

Male 20 69 19 Female 21 64 23

Diagnosis ACL injury/surgery 28 57 12 PCL injury/surgery 1 2

Other ligament injury/surgery + ACL 4 5 (MCL) 4 (OCD), 3 (PT), 3 (PTO), 1 (OSD) , 5(misc)

3

Meniscus. Articuler artroscopy +ACL 2 17 6 OA PF 2 21 15

General knee pain 4 2 Combined injury

Sport related Cartilage degeneration or surgery 6

Provide normative data NA 54

Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

Spearman coefficient was used for all values testing for validity.

55

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health

instruments in assessing acute patellar dislocation outcomes Year 2003 PubMed ID: 12860533 Reviewer’s Name Travis Hamilton Date of Review 7.7.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = 0.57, RP = 0.38, BP = 0.50 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ** Tegner = 0.24, Fulkerson = 0.93, Kujala = 0.86 , Modified

IKDC knee ligament form = -0.51 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α = 0.71


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ** ρ = 0.88 Testing interval (time between repeated measures) Mean 21 (13-42)

56



Responsiveness


NA


NA


NA



Age range of sample TABLE 1. Number: Sex

Male Female



OA PF



Acute patellar dislocation 100% Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.

57

58

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Kocher Title of the Article Reliability, Validity, and Responsiveness of the Lsholm Knee

Scale for Various Chondral Disorders of the Knee Year 2004 PubMed ID: 15173285 Reviewer’s Name Travis Hamilton Date of Review 7.8.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12: PF = 0.537; RP = 0.476; BP = 0.559 (Pearson coeff.) Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient WOMAC: Pain ρ = -0.802; stiffness ρ = -0.657; function ρ = -

0814 (Spearman ρ) : Tegner: = 0.346 (Pearson) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All were confirmed and significant (P<0.05)

1. Patients with lower activity levels would have lower scores on the Lysholm knee scale.

2. Patients with a greater number of chondral surfaces with Outerbridge grade-4 changes would have lower scores on the Lysholm knee scale.

3. Patients with full0thickness chondral defects would have lower scores on the Lysholm Knee scale than would patients with partial-thickness chondral defects.

4. Patients with chondral defects and associated meniscal tears would have lower scores on the lysholm knee scale than would patients with isolated chondral defects.

5. Patients who had more difficulty with activities of daily living would have lower scores on the Lysholm scale than would patients who had les difficulty with the activities of daily living.

6. Patients who had more difficulty working because of the knee would have lower scores on the Lysholm scale than would patents who had les difficulty working because of the knee.

7. Patients who had more difficulty with sports because of the knee would have lower scores on the Lysholm

59

knee scale than would patients who had less difficulty with sports because of the knee.

8. Patients with previous knee surgery would have lower scores on the Lysholm knee scale than would patients without previous knee surgery.

9. Patients with a poorer assessment of overall knee function would have lower scores on the Lysholm knee scales than would patients with a better assessment of overall knee function.

Criterion Validity




α = 0.65


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.91 *component scores Table 1. Testing interval (time between repeated measures) Within 4 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES = 1.16; SRM = 1.10 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 51.2 months (12.5-79.4)


Age range of sample 44 (14-88) Number: 1657 (Group A) Sex


Diagnosis

Traumatic unicompartmental chondral lesions 679 (ligament injury = 230, meniscal injury = 285) Traumatic multicompartmental chondral lesions 249 (ligament injury = 65, meniscal injury = 107)

60

Degenerative chondral lesions 729 (ligament injury = 80, meniscal injury = 277)

Group B (subset of main group - A) 57 Group C (subset of main group - A) 248

Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2 Notes:

Internal consistency and content and construct validity was determined from patients in Group A. Test-retest reliability data was taken from patients included in Group B. Criterion validity and Responsiveness was determined from group C. There were no overall floor and ceiling effects observed. However, for the domains of squatting had a high (>30%) floor effect, and the domains of limp, instability, support, and locking had high (>30%) ceiling effects

61

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Briggs Title of the Article Reliability, Validity, and Responsiveness of the Lysholm Knee

Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12; r = 0.551 (p < 0.05) Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses significant (p< 0.05)

1. Patients with lower activity levels would have lower Lysholm scores.

2. Bc of the pain, swelling, possible use of crutches and overall disability associated with an acute nee injury, patients with such an injury would have a lower mean Lysholm score than would patients with a chronic knee injury.

3. Patients with a Worker’s Compensation claim would have a lower mean Lysholm score than would patients without a Workers’ Compensation claim.

4. Patients with more difficulty with activities of daily living would have lower Lysholm scores than would patients with less difficulty with activities of daily living.

5. Patients with more difficulty working because of problems with knee would have lower Lysholm scores than would patients with less difficulty because of problems with the knee.

6. Patients with more difficulty participating in sports activity because of problems with the knee would have lower Lysholm scores than would patients with less difficulty participating in sports activity because of

62

problems with the knee. 7. Patients who assessed their overall knee function as

abnormal or severely abnormal would have a lower mean Lysholm score than would patients who assessed it as normal or nearly normal.

8. Patients with a degenerative and/or complex mensical tear would have a lower mean Lysholm score than would patients with a simple tear of the meniscus.

Criterion Validity




α = 0.729


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.927 Testing interval (time between repeated measures) 4 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1: ES = 1.2, SRM = 0.97; Group 2 = ES = 1.2, SRM = 1.13

Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

1


NA



Test-retest group

ICC/Content Val./Construct val./ Group 1

ICC/Content Val./Criterion Val. Group 2

Age range of sample 48 (14-76) 40 (13-81) 39 (18-62) Number: 122 191 477 Sex

Male 77 129 367 Female 45 62 110

Diagnosis 63

Test-retest group




Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 1; MML = 59;

LML = 40; MML+LML = 23; IML = 28

MML = 117; LML = 60; MML+LML = 14

Meniscal lesion + associated intra-articular diseases

OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:

NA

Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion. In the Lysholm score, the domain of squatting and a high floor effect and the domains of limp, instability, support, and locking had a high ceiling effect. Thus, these domains may lack the discriminative ability to differentiate the functional status of patients with a meniscal injury of the knee.

64

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Heintjes Title of the Article Lysholm scale and WOMAC index were responsive in

prospective cohort of young general practice patients Year 2008 PubMed ID: 18394542 Reviewer’s Name Travis Hamilton Date of Review 7.8.11 Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Overall hypotheses confirmed (combined groups)

1. Baseline pain and instrument scores should be moderately correlated.

2. Changes in pain and instrument scores should be moderately correlated.

3. The correlation between recovery scores and change scores on the instruments adjusted for baseline scores should be high.

4. Patients with good baseline COOP/WONCA physical fitness scores should have better instrument scores than patients with poor physical fitness scores.

5. Patients refraining from daily duties because of their knee complaints (employment, domestic work, and school) should show lower scores than patients who do not.

6. Patients bothered by their knee complaints during daily duties (employment, domestic work, and school) should show lower scores than patients who are not.

7. Patients reporting moderate to severe pain with at least four our of seven activities (walking stairs, prolonged sitting with flexed knees, running, jumping, squatting, kneeling, and cycling) should show lower scores.

65

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures) NA



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Traumatic patients: ES = 1.15, SRM = 1.14, Guyatt = 0.94; Nontraumatic patients: ES = 0.76, SRM = 0.73, Guyatt = 1.11


NA


NA

Time interval between baseline and follow-up assessments 1 year


Age range of sample 24.6 ± 7.5 years (12-35) Number: 314

Sex Table 1. Male

Female Diagnosis



OA PF

General knee pain Traumatic – 184; Nontraumatic - 117 Combined injury


Provide normative data NA

66

Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

Notes:

• Analyses were performed for all patients combined and stratified per age group (aged 12-17 or 18 – 35) and per type of knee complain (nontraumatic and traumatic). For responsiveness analysis, baseline scores and 1-year follow-up scores as well as perceived recovery scores, which were available for 137 nontraumatic patients and 91 traumatic patients.

• Construct validity was unsatisfactory in the analysis of the nontraumatic young adults. This is in part due to hypothesis 3. The correlation between change scores and recovery (convergent construct validity) was unsatisfactory. However, because the Guyatt’s statistic is high, the clinically important changes can still be detected in young adults.

67

Lysholm Knee Score

Ratings


Outcome Measure Lyscholm Knee Score Author’s Last Name Briggs Title of the Article The Reliability, Validity, and Responsiveness of the Lysholm

Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 Years Later

Year 2009 PubMed ID:


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12: r = .43 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC: r = .78, P > .001 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (mental component): r = .07, P < .05 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All constructs were significant:

• Patients with moderate to severe difficulty running had lower Lysholm scores than patients with none to mild difficulty. (P<.001)

• Patients with more difficulty with activities of daily living (ADL) had lower Lysholm score than patients with less difficulty with ADL. (P<.001)

• Patients with more difficulty working becaue3 of their knee had lower Lysholm scores than patients with less difficulty working because of their knee. (ρ = 0.43; P<.001)

• Patients with more difficulty with sports because of their knee had lower Lysholm scores than patients with less difficulty with sports because of their knee. (ρ = 0.33; P<.001)

• Patients with abnormal or severely abnormal assessment of overall knee function had lower Lysholm scores than patients with a normal or nearly normal assessment of overall knee function. (P<.001)

• Patients with ACL tears with associated complex miniscal injuries requiring suture repair had a lower Lysholm score than patients with isolated tears. (P<.001)

68

Criterion Validity




α = .72


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.94 Testing interval (time between repeated measures) Within 4 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: 6 mo. = 1; 9 mo. = 1; 12 mo. = 1.1; 24 mo. = 1.1 SRM: : 6 mo. = .925; 9 mo. = 1.1; 12 mo. = 1.2; 24 mo. = .93


1


NA

Time interval between baseline and follow-up assessments 6 mo., 9 mo., 12 mo., 24 mo.


Age range of sample 37 (18-77) Number: 1783 (table 1) Sex


Diagnosis ACL injury/surgery 100%; 593 ACL tears, 1190 concurrent injuries (meniscal

and/or cartilage damage) PCL injury/surgery


OA PF



Provide normative data NA 69

Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

70

Lysholm Knee Score

Ratings


Outcome Measure Lysholm Knee Score Author’s Last Name Demirdjian Title of the Article The Outcomes of Two Knee Scoring Questionnaires in a

Normal Population Year 1998 PubMed ID: 9474400

Reviewer’s Name Travis Hamilton Date of Review 2.27.2012

Content Validity


Construct Validity


Criterion Validity




71





Responsiveness


NA


NA


NA



Age range of sample 17.6 (13 – 25) Number: 246 (215 used for study) Sex

Male 131 Female 84

Diagnosis Normal Population 100%

Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2

72

Notes:

The average score for male subject is 99.10 ± 2.73 (77 – 100) and for female subjects is 97.16 ± 5.26 (75 – 100). For all categories of the Lysholm questionnaire, the male subjects reported higher scores than the female subjects except for the Limp and Support categories. The total scores were significantly greater for the male subjects than the female subjects (P = 0.00005)

73

Tegner Activity Scale

Paxton (2) Briggs (3) Briggs (4) Briggs (5)



Validity, Reliability, Responsiveness


Normative data, validity


Acute patellar dislocation

Meniscal injury

ACL (plus concurrent) injuries

Normal Knees

Number Validity = 110, Test-retest = 81

Test-retest group = 122, Validity group 1 = 191, Validity group 2 = 477

1783

488



Test-retest group = 48 (14-76), Validity group 1 = 40 (13-81), Validity group 2 = 39 (18-62)

37 (18-77)

41 ( 18-85)

Sex (% female) NA

Test-retest group = 36%, Validity group 1 = 32%, Validity group 2 = 23%

42%

50.00%

Reliability

Internal consistency NA NA NA NA

Test-retest reliability r = 0.92 ICC = 0.82 ICC = .82 NA

Time interval 21 days 4 weeks 4 weeks NA

Validity

Correlation to similar scale Little (75%), Fair (25%) correlation to similar scales NA Little (100%) correlation to

similar scales Little (100%) correlation to similar scales


Little (66.6%), Fair (33.3%) correlation to general measures of physical function

Fair (100%) correlation to general measures of physical function

Little (100%) correlation to general measures of physical function

NA


NA NA Little (100%) correlation to general measures of mental function

NA

Responsiveness

ES NA Validity Group 1 = .61, Validity Group 2 = .83

6mo = .74 , 9mo. = 1.1, 12mo. = 1.0, 24mo. = 1.1 NA

SRM NA Validity Group 1 = .60, Validity Group 2 = .704

6mo. = 0.61 , 9mo. = .84, 12mo. = .96, 24mo. = 1.0 NA

MDC NA 1 1 NA

MCID NA NA NA NA

Guyatt NA NA NA NA

Time Interval NA 12 months 6 mo., 9 mo., 12 mo., 24 mo. NA

Other

Floor/Ceiling Effect No No No NA

Normal Distribution No NA No No

Normal Data NA NA NA Yes

74

TEGNER STUDY CONSOLIDATION

REFERENCES

2) Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003; 31: 487-92.

3) Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006; 88(4): 698-705

4) Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med, 2009; 37: 890-897

5) Briggs KK, Steadman JR, Hay CJ and Hines SL: Lysholm score and Tegner activity with normal knees. Am J Sports Med, 2009; 37: 898-901

75

Tegner Activity Level

Ratings


Outcome Measure Tegner Activity Level Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = 0.37, RP = 0.22, BP = 0.20 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ** Lysholm = 0.24, Fulkerson = 0.26, Kujala = 0.33 ,

Modified IKDC knee ligament form = -0.54 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




NA

76


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ** ρ = 0.92 Testing interval (time between repeated measures) Mean 21 (13-42)



Responsiveness


NA


NA


NA



Age range of sample TABLE 1. Number: Sex

Male Female



OA PF



Acute patellar dislocation 100% Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.

77

78


Ratings


Outcome Measure Tegner Activity Level Author’s Last Name Briggs Title of the Article Reliability, Validity, and Responsiveness of the Lysholm Knee

Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee

Year 2006 PubMed ID: 16595458 Reviewer’s Name Travis Hamilton Date of Review 7.8.11 Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12; r = .46 ; P < 0.05 ;Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses significant

9. Patients with moderate-to-severe pain with activity would have a lower mean Tegner activity level than would patients with no or mild pain with activity

10. Patients with moderate-to-severe difficulty running would have a lower mean Tegner activity level than would patients with no or mild difficulty running.

11. Patients with more difficulty with activities of daily living would have lower Tegner activity levels than would patients with less difficulty with activities of daily living.

12. Patients with more difficulty working because of problems with knee would have lower Tegner activity levels than would patents with less difficulty working because of problems with the knee.

13. Patients with more difficulty participating in sports activity because of problems with the knee would have lower Tegner activity levels than would patients with less difficulty participating in sports activity because of problems with the knee.

14. Patients who assessed their overall knee function as abnormal or severely abnormal would have a lower mean Tegner activity level than would patients who assessed it as normal or nearly normal.

15. Because of the pain, swelling, possible use of crutches, and overall disability associated with an acute knee

79

injury, patients with such an injury would have a lower mean Tegner activity level than would patients with a chronic knee injury.

16. Patients with a degenerative and/or complex meniscal tear would have a lower mean Tegner activity level than would patients with a simple meniscal tear.

Criterion Validity








Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1: ES = .61, SRM = 0.60; Group 2 = ES = .836, SRM = .704


1

Report statistics: MDC = 1 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)

NA



Test-retest group




Male 77 50 367 Female 45 30 110


80

Test-retest group



Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 1; MML = 59;

LML = 40; MML+LML = 23; IML = 28

MML = 42; LML = 29; MML+LML = 9

Meniscal lesion + associated intra-articular diseases

OA PF




NA

Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion.

81


Ratings


Outcome Measure Tegner Activity Level Author’s Last Name Briggs Title of the Article The Reliability, Validity, and Responsiveness of the Lysholm

Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 Years Later


19261899 Reviewer’s Name Travis Hamilton Date of Review 6.28.11 Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (Physical component): ρ = .2, P<.05 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC: ρ = .22, P > .001 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (mental component): ρ = -0.01, P = .92 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All constructs were significant:

• Patients with moderate to severe pain with activity had lower Tegner activity levels than patients with none to mild pain with activity. (P < .05)

• Patients with moderate to severe difficulty running had lower Tegner activity levels than patients with none to mild difficulty. (P < .01)

• Patients with more difficulty with activities of daily living had lower Tegner activity levels than patients with less difficulty with activities of daily living. (ρ = 0.37, P < .01)

• Patients with more difficulty working because of their knee had lower Tegner activity levels than patients with less difficulty working because of their knee. (ρ = 0.38, P < .01)

• Patients with more difficulty with sports because of their knee had lower Tegner activity levels than patients with less difficulty with sports because of their knee. (ρ = 0.35, P < .01)

• Patients with abnormal or severely abnormal assessment of overall knee function had lower Tegner activity levels than patients with a normal or nearly normal assessment of overall knee function. (P < .01)

82

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .82 Testing interval (time between repeated measures) Within 4 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: 6 mo. = .74; 9 mo. = 1.1; 12 mo. = 1.0; 24 mo. = 1.0 SRM: : 6 mo. = .61; 9 mo. = .84; 12 mo. = .96; 24 mo. = 1.0


1

Report statistics: MDC = 1 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)

NA

Time interval between baseline and follow-up assessments 6 mo., 9 mo., 12 mo., 24 mo.


Age range of sample 37 (18-77) Number: 1783 (table 1) Sex


Diagnosis ACL injury/surgery 100%; 593 ACL tears, 1190 concurrent injuries (meniscal

and/or cartilage damage)0. PCL injury/surgery


OA PF


Sport related 83

Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

84

Tegner Activity Scale

Ratings


Outcome Measure Tegner Activity Scale Author’s Last Name Briggs Title of the Article Lysholm Score and Tegner Activity Level in Individuals with

Normal Knees Year 2009 PubMed ID: 19307332 Reviewer’s Name Travis Hamilton Date of Review 7.12.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed 2

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient NA Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm: ρ = .07; P = .17 (not correlated) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? Criterion Validity

Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated Internal Consistency




85



Responsiveness


NA


NA


NA



Age range of sample 41 (18-85) Number: 488 Sex

Male 244 Female 244

Diagnosis Normal Knees 100%



OA PF



Provide normative data 1 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? NA

Notes:

Tegner activity level was inversely correlated with age (ρ = -.40, P = .001). This was consistent for both men (ρ = -.48, P = .001) and women (ρ = -.34, P = .001).

86

Cincinnati Knee Scale

Barber-Westin (1) Risberg (2) Marx (3) Greco (5)


Purpose Reliability, Responsiveness, Validity Validity Reliability, Responsiveness,

Validity Reliability,

Responsiveness


Normal, Injured, ACL reconstruction

ACL injury, combined injury Various injuries Patients following articular

cartilage surgery

Number

Validity/Responsiveness Groupn1 = 250, Test-retest Group 2 = 50, Test-retest

Group 3 = 50

120 Reliability group = 41, Validity group = 133, Responsiveness

group = 42

Reliability = 17, Responsiveness = 50


Validity/Responsiveness Groupn1 = 29 (14-58),

Test-retest Group 2 = 36 (13-65), Test-retest Group

3 = 34 (20-59)

27.8

Reliability group = 32.6 (16-60), Validity group = 31.5 (14-65), Responsiveness group = 30.9

(15-61)

Reliability = 43.8 years ± 10.4 (21-60),

Responsiveness = 36.6 years±9.7 (15-56)

Sex (% female)

Validity/Responsiveness Groupn1 = 29%, Test-retest Group 2 = 44%, Test-retest

Group 3 = 56%

46%

Reliability group = 52%, Validity group = 46%,

Responsiveness group = 54%

Reliability = 39%, Responsiveness = 39.2%

Reliability

Internal consistency NA NA NA NA

Test-retest reliability

ICC: Sports activity = .98 (uninjured), .98 (patients) Occupational rating = .87 (uninjured), .97 (patients)

NA ICC = 0.88 6mo = 0.91, 12mo = 0.80

Time interval 7 days NA 5.2 days 6 mo, 12 mo

Validity


Little(29%), Fair (13%), Moderate (33%), Excellent

(25%) correlation to similar scales

Moderate (50%), Excellent (50%) correlation to similar

scales NA


NA NA Moderate (100%) correlation to general measures of physical

function NA


NA NA

Little (100%) correlation between general measures of

mental function

NA

Responsiveness

ES 3.49 NA NA 6mo = 0.60, 12mo = 1.09

SRM 2.48 NA 0.8 6mo = 0.52, 12mo = 0.76

MDC NA NA 27.5 (calc)

(1.96)*(sqrt(2))*((28.7)*sqrt(1-.88))

NA

MCID NA Na NA

6mo = 14.0 (Sens = 0.64 ; Spec = 0.70), 12mo = 26.0

(Sens = 0.55 ; Spec = 0.85)

Guyatt NA NA NA NA

Time Interval 27 months NA 3 months 6, 12 months

Other

Floor/Ceiling Effect No NA No Yes



Subscales used All subscales Symptoms and Function

Symptoms, function, and daily activities

Sports activity, symptoms, and overall rating scale

87

Demirdjian (6)




High School and College Students

Number 246

Age range (average ± SD, min-max) 17.6 (13 – 25)

Sex (% female) 40%

Reliability



Time interval NA

Validity




Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data Yes

Subscales used Symptoms, Sports activity, Function, and Overall

88

CINCINNATI KNEE SCALE CONSOLIDATION

REFERENCES

1) Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16

2) Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score, and the Cincinnati knee score. A prospective study of 120 ACL reconstructed patients with a 2-year follow-up. Knee Surg, Sports Traumatol, Arthroscophy (1999) 7:152-159

3) Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewicz TL.

Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001;83:1459-69

5) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International

Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31

6) Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51

89

Cincinnati Knee Scale (all subscales)

Ratings


Outcome Measure Cincinnati Knee Scale Author’s Last Name Barber-Westin (all subscales) Title of the Article Rigorous Statistical Reliability, Validity, and Responsiveness

Testing of the Cincinnati Knee Rating System in 350 Subjects with Uninjured, Injured, or Anterior Cruciate Ligament-Reconstructed Knees

Year 1999 PubMed ID: 10424208


Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? For those who had ACL injuries, there would be lower

results in the following: 1. Chronic injuries 2. Deteriorated articular cartilage 3. Prior failed ACL reconstructions 4. Poor or fair overall patient perception scores 5. (Not confirmed) Concurrent major operative

procedures such as a meniscus repairs or other ligament reconstructions

6. Operative complications 7. Symptoms with sports or work at follow up 8. Inability to return to work or sports because of the

knee condition 9. Work related injuries

Criterion Validity

90





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Table 1. Testing interval (time between repeated measures) 7 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Overall ES = 3.49 Overall SRM = 2.48


NA


NA



Group 1 (Validity and Responsiveness)

Group 2 (test-retest)

Group 3 (test-retest)


Male 177 28 22 Female 73 22 28


Other ligament injury/surgery + ACL 1 Meniscus. Articuler artroscopy +ACL 1

OA PF 1



Other 1 No Knee related problems 1

91


1

Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? NA

Notes:

92

Cincinnati Knee Scale – Symptoms and Function subscales

Ratings


Outcome Measure Cincinnati Knee Scale (Symptoms and Function subscales) Author’s Last Name Risberg Title of the Article Sensitivity to changes over time for the IKDC form, the

Lysholm score, and the Cincinnati knee score Year 1999 PubMed ID: 10401651 Reviewer’s Name Travis Hamilton Date of Review 6.30.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC1-4 and IKDC-final form, Lysholm – table 3. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




93


Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: NA Testing interval (time between repeated measures)



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s NA; table 2 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 3 mo., 6.mo., 1 year, 2 years


Age range of sample 27.8 Number: 120 Sex

Male 64 Female 56



OA PF

General knee pain Combined injury 62 (+ACL)


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

The Symptoms and Function Subscales were used as described by Noyes in 1984

120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in this study. Patients were assessed with 3 instruments (IKDC form, Lysholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year, 2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x = Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the Cincinnati. The Cincinnati scale was the only outcome measurement sensitive enough to measure significant changes between all follow-up

94

intervals. This score has previously been found to be a sensitive outcome measurement both early and during long term follow up after ACL reconstruction.

The papers cites the Cincinnati Scale used in the reference: “Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture,” By Noyers et al. Which is indicative of the Sports Activity subscale.

95

Cincinnati Knee Scale – Sports Activity subscale

Ratings


Outcome Measure Cincinnati Knee Scale (Symptoms, Daily Activities, Sports Function subscales)

Author’s Last Name Marx Title of the Article Reliability, validity, and responsiveness of four knee outcome

scales for athletic patients Year 2001 PubMed ID:


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .68,;RP = .52; BP = .51 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm scale = .70; Activities of Daily Living Scale = .80 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: RE = .18; MH = .24 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Confirmed Hypotheses:

• The instruments would all correlate better with each other than they would with the physical component scale or the mental component scale and the physical component scale would correlate more strongly with the knee scales.

• The knee-rating scales would correlate better with each other than they would with any of the eight SR-36 scales.

• The knee scales would correlate better with physical function and role-physical than they would with vitality or social function and that they would correlate better with GH, BP, VT, and SF than they would with RE or MH.

• Knee scales would be significantly correlated with clinician-rated and patient-rated severity.

• There would be a difference in the mean scores on the knee specific instruments for patients who had different patient rated severity scores as well as for those who had different clinician-rated severity score.

• There would be no veiling or floor effects. 96

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.88 Testing interval (time between repeated measures) Mean = 5.2 (2-14)



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s SRM = 0.8 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 3 month minimum


Reliability Validity Responsiveness Age range of sample 32.6 (16-60) 31.5 (14-65) 30.9 (15-61) Number: 41 133 42 Sex

Male 20 69 19 Female 21 64 23

Diagnosis ACL injury/surgery 28 57 12 PCL injury/surgery 1 2

Other ligament injury/surgery + ACL 4 5 (MCL) 4 (OCD), 3 (PT), 3 (PTO), 1 (OSD) , 5(misc)

3

Meniscus. Articuler artroscopy +ACL 2 17 6 OA PF 2 21 15

General knee pain 4 2

97

Reliability Validity Responsiveness Combined injury


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2

Notes:

The Symptoms, Daily Activities, and Sports function subscales were used as described by Barber-Westin (ref 1)

98

Cincinnati Knee Scale – (Sports activity, symptoms, and overall rating scale)

Ratings


Outcome Measure Cincinnati Knee Scale – (Sports activity, symptoms, and overall rating scale)

Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation



Content Validity


Construct Validity


Criterion Validity




99


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: CKRS (6 mo., 12mo.) = 0.91 ; 0.80 Testing interval (time between repeated measures) 6 mo, 12 mo



Responsiveness

Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s CKRS ES (6 mo., 12mo.) = 0.60 ; 1.09

CKRS SRM (6 mo., 12mo.) =0.52 ; 0.76 (table 2)

Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 month: CKRS MCID: 14.0 (Sens = 0.64 ; Spec = 0.70)

12 month: CKRS MCID: 26.0 (Sens = 0.55 ; Spec = 0.85) (table 3)

Change in measure related to change in external standard 1 (global scale) Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) NA Time interval between baseline and follow-up assessments 6 months and 12 months



Male Female



OA PF



Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2

100

Cincinnati Knee Score – (Cincinnati Knee Score (Symptoms, Sports activity, Function, and Overall subscales)

Ratings


Outcome Measure Cincinnati Knee Score (Symptoms, Sports activity, Function, and Overall subscales)

Author’s Last Name Demirdjian Title of the Article The Outcomes of Two Knee Scoring Questionnaires in a

Normal Population Year 1998 PubMed ID: 9474400


Content Validity


Construct Validity


Criterion Validity



101






Responsiveness


NA


NA


NA



Age range of sample 17.6 (13 – 25) Number: 246 Sex

Male 131 Female 84

Diagnosis Normal Population 100%

Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2

102

Notes:

The scores for the Cincinnati are based on the Symptoms, Sports activity, Function, and Overall subscales as described by Noyes in 1990.

The average score for male subject is 99.10 ± 3.77 (68 – 100) and for female subjects is 97.82 ± 4.97 (72 – 100). For all categories of the Cincinnati questionnaire, the male subjects reported higher scores than the female subjects except for the walking category. The total scores were significantly greater for the male subjects than the female subjects (P = 0.0051)

103

KOOS- SYMPTOMS SUBSCALE

Roos (1) Roos (2) Xie (4) Ornetti (6)


Purpose Reliability, Responsiveness, Validity

Validity, Reliability of Swedish Version

Validity, Reliability of Singapore English and Chinese Version

Validity, Reliability of French version


ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis Osteoarthritis

Number 21 142 Singapore English = 127 Chinese = 131

Medicine Group = 37, Surgery Group = 30


32 (18-36) 14-89 Singapore English = 65.3 Chinese = 67.8

Medicine Group = 70 10 (45-91), Surgery Group = 71 10 (42-85)

Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%

Medicine Group = 68% Surgery Group = 73%

Reliability

Internal consistency NA α = .74 α:Singapore English = .70 Chinese = .64 α = .76

Test-retest reliability ICC = .93 ICC = .84 ICC: Singapore English = .87 Chinese = .85 ICC = .91

Time interval 9 days 8 days 6 days 2 weeks

Validity

Correlation to similar scale NA Fair (100%) correlation to

similar scale

English: No(100%) Chinese: No (100%) correlation to similar scales

Little (20%), Fair (80%) correlation to similar scales


Little (33%), Fair (66%) correlation to general measures of physical function

Little (33.3%), Fair (66%) correlation to general measures of physical function

English: Little (33.3%),Fair (66.6%) Chinese: Little (33.3%), Fair (66.6%) correlation to general measure of physical function

NA


Litle (100%) correlation to general measures of mental function

Little (100%) correlation to general measures of mental function

English: Little (100%) Chinese: Little (50%), Fair (50%) correlation to general measures of mental function

NA

Responsiveness

ES 0.87 0.93 NA 1.63

SRM NA NA NA 1.45

MDC 9.9 (calc) 21.5 (calc) Singapore English = 19.0 (calc) Chinese = 19.1 (calc)

16.6 (calc)

MCID NA NA NA NA

Guyatt NA NA NA NA

Time Interval 6 month 3 months NA 3 month

Other

Floor/Ceiling Effect NA No No No



104

KOOS- SYMPTOMS SUBSCALE CONTINUED

De Groot (7) Salavati (10) Bekkers (11)


Purpose Validity, Reliability of Dutch version Validity, Reliability of Persian version Validity, reliability


Osteoarthritis Meniscus, ACL, Combined Knee injury Cartilage Degeneration/Surgery

Number Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54

147 40


Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)

31.4 (16 – 59) 35±12 (18-55)

Sex (% female) Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%

11% 30%

Reliability

Internal consistency α: Mild OA = .71 , Moderate OA = .83 , Severe OA = .56 , TKA = .74 , Revision TKA = .78

α = .25 α = 0.74

Test-retest reliability ICC: Mild OA = .74 , Moderate OA = .87 , Revision TKA = .89 ICC = .83 ICC = 0.95

Time interval 3 weeks 8 days 2 days

Validity



Little (20%), Fair(33.3%), Moderate (46.7%) correlation with general measures of physical function

Little (66.6%), Fair (33.3%) correlation with general measures of physical function

NA


Little (50%), Fair (50%) correlation with general measures of mental function

Little (100%) correlation to general measures of mental function NA

Responsiveness

ES NA NA 0.72

SRM NA NA 0.61

MDC ICC: Mild OA = 10.0 , Moderate OA = 24.3 , Revision TKA = 19.7 14.74 (calc) 10.5 (calc)

MCID NA NA NA

Guyatt NA NA NA

Time Interval NA NA 36 months

Other

Floor/Ceiling Effect Yes No No

Normal Distribution NA NA NA


105

Paradowski (12)




General Population

Number 568


568

Sex (% female) 52.0%

Reliability



Time interval NA

Validity



NA


NA

Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other


Normal Distribution No

Normal Data Yes

106

KOOS SYMPTOMS SUBSCALE CONSOLIDATION SUBSCALE

REFERENCES

1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96

2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49

4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30

6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1

7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16

10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14

11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9

12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.

107

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms subscale

Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS

Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11

Content Validity

Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .29 , RP = .27 , BP = .08 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - RE =-.17 , MH = .13 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




108


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: symptoms = .93 Testing interval (time between repeated measures) Within 9 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


Table 4

Time interval between baseline and follow-up assessments 3 and 6 month



Male 9 Female 12



OA PF



Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1

109

110

111


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – symptoms subscale

Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation

of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Table 2. Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .32 , RP = .14 , BP = .29 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - RE =.0 , MH = .04 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α: Symptoms = .74

112


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Symptoms = .84 Testing interval (time between repeated measures) Within 8 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Symptoms = .93 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

na

Report statistics: Change in measure related to change in external standard na Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)



Age range of sample Number: 142 Sex Table 1.

Male Female

Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery


OA PF



Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:

For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).

113

114

115


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms Subscale

Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English

and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate

translators.

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .40 RB = .21 BP = .44/Chinese SF-36 PF =

.31 RB = .18 BP = .43

Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .14 MH = .23/Chinese SF-36 RE = .17 MH

= .29 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA

Criterion Validity


116



α :Singapore English:, Symptoms = .70 Chinese: Symptoms = .64


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; Symptoms = .87

Chinese; Symptoms = .85 Testing interval (time between repeated measures) 6 days



Responsiveness


NA


NA


NA



Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex

Male 30 15 Female 97 116



OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2

117

118

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms Subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms Subscale

Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version

of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. The KOOS symptom, pain, and activity of daily life

domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.

2. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.

3. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.

119

Criterion Validity




α: Symptoms = .76


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Symptoms = .91 Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Symptoms = 1.63 SRM: Symptoms = 1.45


NA


NA

Time interval between baseline and follow-up assessments 3 Months


Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex

Male 32% 27% Female 68% 73%



OA 1 PF




120

Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2

NOTES:

The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.

121


Ratings



Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis

outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11

Content Validity

Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish

to Dutch

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:

1. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.

2. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.

3. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.

4. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:

122

1. All other correlations between the KOOS subscales and the SF-36 should be higher than 0.30 and lower than 0.60

Criterion Validity




Table 2.


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA Symptoms = .74

MODERATE OA Symptoms = .87 REVISION of TKA: Symptoms = .89

Testing interval (time between repeated measures) 3 WEEKS



Responsiveness


NA


NA


NA



Mild OA Moderate OA

Severe OA TKA Revision of TKA

Age range of sample 36 (27-50)

56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)

Number: 36 62 47 63 54 Sex

Male 78 68 48 49 22 Female 22 32 52 51 78



123

OA 1 PF




NA

Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2

Notes:

Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA

From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.

124

125

126


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score- Symptoms subscale

Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and

Osteoarthritis Outcome Score KOOS in Iranians with knee injuries



Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to

Persian)

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .16 , RP = .15 , BP = .34 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.13 , MH = .15 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:

1. The correlations between the KOOS Pain and SF=36 BP subscales should be high.

2. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.

3. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)

127

Criterion Validity

Correlated with “gold standard” NA Predictive of a future outcome A If yes to either of above, report how this was demonstrated



α : Symptoms = .25


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC Symptoms = .83 Testing interval (time between repeated measures) 6 – 8 days



Responsiveness


NA


NA


NA




Male 131 Female 16


Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31

OA PF

General knee pain Combined injury 56


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1

128

Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2

Notes:

The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.

129


Ratings



Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome

Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:


Content Validity


Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:

1. KOOS symptoms with SF-36 physical functioning 2. KOOS pain with SF-36 bodily pain and WE-VAS 3. KOOS ADL with the complete SF-36 questionnaire. 4. KOOS sport and recreation with the Lysholm knee

scoring scale 5. KOOS QOL with EQ-5D

Criterion Validity


130



Symptoms = 0.74


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.95. table 1 Testing interval (time between repeated measures) 2 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Symptoms = .72 SRM: Symptoms = .61


NA


NA

Time interval between baseline and follow-up assessments 36 MONTH


Age range of sample 35±12 (18-55) Number: 40 Sex

Male 70% Female 30%



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

131

132

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult

population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2

Construct Validity

Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




133





Responsiveness


NA


NA


NA



Age range of sample 568 (figure 1) Number: Sex

Male 274 (48%) Female 294 (52%)



OA PF


Sport related General Population 100%

Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2

Notes:

For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.

The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of

134

daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.

135

KOOS - PAIN SUBSCALE

Roos (1) Roos (2) Xie (4)


Purpose Reliability, Responsiveness, Validity Validity, Reliability of Swedish version

Validity, Reliability of Singapore English and Chinese version

Study Population/Sample ACL injury/ Surgery Variety of Knee disorders/injury Osteoarthritis


Age range 32 (18-46) 14-89 Singapore English = 65.3 Chinese = 67.8


Reliability

Internal consistency NA α = .84 α:Singapore English = .79 Chinese = .65

Test-retest reliability ICC = .85 ICC = .91 ICC: Singapore English = .88 Chinese = .87

Time interval 9 days 8 days 6 days

Validity

Correlation to similar scale NA Moderate (100%) correlation to

similar scale English: No(100%) Chinese: No (100%) correlation to similar scales


Little (66%), Fair (33%) correlation to general measures of physical function

Little (33%), Fair (33%), Moderate (33%) correlation to general measures of physical function

English: Little (33%) Fair (66%) Chinese: Little (33%), Fair (66%) correlation to general measure of physical function





Responsiveness

ES 0.84 1.11 NA

SRM NA NA NA


MCID NA NA NA

Guyatt NA NA NA

Time Interval 6 month 3 months NA

Other




136

KOOS - PAIN SUBSCALE CONTINUED

Ornetti (6) DeGroot (7)


Purpose Validity, Reliability of French version Validity, Reliability of Dutch version

Study Population/Sample Osteoarthritis Osteoarthritis

Number Medicine Group = 37, Surgery Group = 30

Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54

Age range Medicine Group = 70 ± 10 (45-91), Surgery Group = 71 ± 10 (42-85)


Sex (% female) Medicine Group = 68% Surgery Group = 73% Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%

Reliability

Internal consistency α = .84 α: Mild OA = .94 , Moderate OA = .93 , Severe OA = .80 , TKA = .92 , Revision TKA = .87

Test-retest reliability ICC = .88 ICC: Mild OA = .80 , Moderate OA = .87 , Revision TKA = .80

Time interval 2 weeks 3 weeks

Validity


Little (20%), Fair (80%) correlation to similar scales NA


NA Little (13.3%), Fair (33.3%), Moderate (53.3%) correlation with general measures of physical function


NA Little (60%), Fair (40%), correlation with general measures of mental function

Responsivenss

ES 2.59 NA

SRM 1.85 NA

MDC 15.3 (calc) (1.96)*(sqrt(2))*((16)*sqrt(1-.88)) ICC: Mild OA = 22.9 (calc) , Moderate OA = 25.6 (calc) , Revision TKA = 29.0 (calc) **used baseline group**

MCID NA NA

Guyatt NA NA

Time Interval 3 month NA

Other

Floor/Ceiling Effect No Yes

Normal Distribution NA NA

Normal Data NA NA

137

KOOS - PAIN SUBSCALE

Salavati (10) Bekkers (11) Paradowski (12)


Purpose Validity, Reliability of Persian version Validity, Reliability Normative Data

Study Population/Sample Meniscus, ACL, Combined Knee injury Cartilage Degeneration/Surgery General Population

Number 147 40 568

Age range 31.4 (16 – 59) 35±12 (18-55) 568

Sex (% female) 11% 30% 52.0%

Reliability

Internal consistency α = .88 α = .88 NA

Test-retest reliability ICC = .91 ICC = .92 NA


Validity



Fair (66.6%), Moderate (33.3%) correlation with general measures of physical function NA NA


Little (50%), Fair (50%) correlation to general measures of mental function NA NA

Responsivenss

ES NA 0.82 NA

SRM NA 0.71 NA

MDC 16.54 (calc) 11.8 (calc) NA

MCID NA NA NA

Guyatt NA NA NA

Time Interval NA 36 months NA

Other

Floor/Ceiling Effect No No NA

Normal Distribution NA NA No


138

KOOS PAIN SUBSCALE CONSOLIDATION

REFRENCES


2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation

of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49




10)Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14

11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis

Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9

12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and

gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.

139

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. PF = .29 , RP = .07 , BP = .46 Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE =-.02 , MH = .09 Tested specific hypothesis to demonstrate construct validity? If yes. What is found?

Criterion Validity




140


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .85 Testing interval (time between repeated measures) Within 9 days



Responsiveness


1


NA


Table 4




Male 9 Female 12



OA PF




141

142

143


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint Table 2. Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .49 , RP = .24 , BP = .65 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4, RE =.15 , MH = .23, Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α: Pain = .84

144


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .86 Testing interval (time between repeated measures) Within 8 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Pain = 1.11 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA




Male Female



OA PF





145

146

147


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English



Content Validity


translators.

Construct Validity


.48 RB = .23 BP = .31

Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = -.01 MH = -.05/Chinese SF-36 RE = .13

MH = .30 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA

Criterion Validity


148



α :Singapore English: Pain = .79 Chinese: Pain = .65


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; Pain = .88

Chinese; Pain = .87 Testing interval (time between repeated measures) 6 days



Responsiveness


NA


NA


NA







OA 1 PF




149

150

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain Subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain Subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version



Content Validity


Construct Validity





Criterion Validity

Correlated with “gold standard” NA

151

Predictive of a future outcome NA If yes to either of above, report how this was demonstrated



α: Pain = .84


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .88 Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Pain = 2.59 SRM: Pain = 1.85


NA


NA




Male 32% 27% Female 68% 73%



OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present

152

Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2

NOTES:


153


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis


Content Validity


to Dutch

Construct Validity






2. All other correlations between the KOOS subscales and

154

the SF-36 should be higher than 0.30 and lower than 0.60

Criterion Validity




Table 2.


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: Pain = .80

MODERATE OA: Pain = .87 REVISION of TKA: Pain = .80




Responsiveness


NA


NA


NA



Mild OA Moderate OA



56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)

Number: 36 62 47 63 54 Sex

Male 78 68 48 49 22 Female 22 32 52 51 78



OA 1 155

PF General knee pain

Combined injury Sport related

Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:

NA


Notes:



156

157

158


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and




Content Validity


Persian)

Construct Validity





Criterion Validity


159



α : Pain = .88


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .91 Testing interval (time between repeated measures) 6 – 8 days



Responsiveness


NA


NA


NA




Male 131 Female 16



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2

160

Notes:


161


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome



Content Validity


Construct Validity




Criterion Validity


162



Pain = 0.88





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Pain = .82 SRM: Pain = .71


NA


NA




Male 70% Female 30%



OA PF




163

164


Ratings





Content Validity


Construct Validity


Criterion Validity




165





Responsiveness


NA


NA


NA




Male 274 (48%) Female 294 (52%)



OA PF




Notes:



166


167

KOOS - ADL SUBSCALE



Purpose Reliability, Responsiveness, Validity Validity, Reliability of Swedish Version Validity, Reliability of Singapore English and Chinese Version

Study Population/Sample ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis


Age range 32 (18-46) 14-89 Singapore English = 65.3 Chinese = 67.8


Reliability

Internal consistency NA α = 0.95 α:Singapore English = .92 Chinese = .82

Test-retest reliability ICC = 0.75 ICC = 0.91 ICC: Singapore English = .91 Chinese = .84


Validity

Correlation to similar scale NA Moderate (100%) correlation to similar

scale English: No (100%) Chinese: No (100%) correlation to similar scales


Fair (66%) , Moderate (33%) correlation to general measures of physical function

Fair (33%), Moderate(66%) correlation to general measures of physical function

English: Fair (66%), Moderate (33%) Chinese Little (33%), Fair (33%), Moderate (33%) correlation to general measure of physical function




English: Little (100%) Chinese: Fair (100%) correlation to general measures of mental function

Responsiveness

ES 0.94 0.67 NA

SRM NA NA NA


MCID NA NA NA

Guyatt NA NA NA


Other




**Used preop SD to calculate MCD 168

KOOS - ADL SUBSCALE

Ornetti (6) DeGroot (7)


Purpose Validity, Reliability of French Version Validity, Reliability of Dutch Version

Study Population/Sample Osteoarthritis Osteoarthritis

Number Medicine Group = 37, Surgery Group = 30 Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54

Age range Medicine Group = 70 10 (45-91), Surgery Group = 71 +/- 10 (42-85)


Sex (% female) Medicine Group = 68% Surgery Group = 73%

Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%

Reliability

Internal consistency α = .93 α: Mild OA = .78 , Moderate OA = .97 , Severe OA = .94 , TKA = .94 , Revision TKA = .93



Validity

Correlation to similar scale Little (20%), Fair (60%), Moderate (20%) correlation to similar scales NA


Little (6.6%), Fair (33.3%), Moderate (53.3%), Excellent (6.6%) correlation to general measures of physical function


Little (30%), Fair (60%), Moderate (10%) correlation to general measures of mental function

Responsiveness

ES 2.25 NA

SRM 1.8 NA

MDC 17.1 (calc) ICC: Mild OA = 16.2 , Moderate OA = 15.0 , Revision TKA = 31.5 (calc) **used baseline group**

MCID NA NA

Guyatt NA NA

Time Interval 3 month NA

Other

Floor/Ceiling Effect No Yes


Normal Data NA NA

**Used preop SD to calculate MCD 169

KOOS - ADL SUBSCALE

Salavati (10) Bekkers (11) Paradowski (12)


Purpose Validity, Reliability of Persian version Validity, reliability Normative Data

Study Population/Sample

Meniscus, ACL, Combined Knee Injury Cartilage Degeneration/Surgery General Population

Number 147 40 568

Age range 31.4 (16 – 59) 35±12 (18-55) 568

Sex (% female) 11% 30.00% 52.0%

Reliability

Internal consistency α = .94 α = 0.95 NA

Test-retest reliability ICC = .90 ICC = 0.87 NA


Validity



Fair (33%), Moderate(66%) correlation to general measures of physical function

NA NA


Little (50%), Fair (50%) correlation to general measures of mental function NA NA

Responsiveness

ES NA 0.7 NA

SRM NA 0.75 NA

MDC 17.3 (calc) 13.9 (calc) NA

MCID NA NA NA

Guyatt NA NA NA

Time Interval NA 36 months NA

Other




**Used preop SD to calculate MCD

170

KOOS ADL SUBSCALE CONSOLIDATION

REFERENCES









171

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. – PF = .57 , RP = .34 , BP = .35 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE = -.05, MH =.22 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




172


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: adl = .75 Testing interval (time between repeated measures) Within 9 days



Responsiveness


1


NA


Table 4




Male 9 Female 12



OA PF




173

174

175


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .68 , RP = .36 , BP = .65 , Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 RE =.18 , MH = .16, Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α: ADL = .95

176


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: ADL = .91 Testing interval (time between repeated measures) Within 8 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: ADL = .67 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)




Male Female



OA PF





177

178

179


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English



Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate

translators.

Construct Validity


.64 RB = .36 BP = .14; Table 4. Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D: Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .10 MH = .14/Chinese SF-36 RE = .33 MH


Criterion Validity


180



α :Singapore English: ADL = .92 Chinese: ADL = .82


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; ADL = .91

Chinese; ADL = .84

Testing interval (time between repeated measures) 6 days



Responsiveness


NA


NA


NA







OA 1 PF




181

182


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version



Content Validity


Construct Validity





183

Criterion Validity




α: ADL = .93


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC ADL = .85 Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ESADL = 2.25 SRMADL = 1.8


NA


NA




Male 32% 27% Female 68% 73%



OA 1 PF




184

Medicine Group Surgery Group Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2

NOTES:


185


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish

to Dutch

Construct Validity







186

Criterion Validity




Table 2.


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: ADL = .85

MODERATE OA ADL = .94 REVISION of TKA: ADL = .73




Responsiveness


NA


NA


NA



Mild OA Moderate OA



56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)

Number: 36 62 47 63 54 Sex

Male 78 68 48 49 22 Female 22 32 52 51 78



OA 1 PF


Sport related 187


NA


Notes:



188

189

190

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL Subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and




Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to

Persian)

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .63 , RP = .38 , BP = .62 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 RE =.34 , MH = .23 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:




Criterion Validity


191



α : ADL = .94


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: ADL = .90 Testing interval (time between repeated measures) 6 – 8 days



Responsiveness


NA


NA


NA




Male 131 Female 16



OA PF




192

Notes:


193


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome



Content Validity


Construct Validity




Criterion Validity


194



ADL = 0.95





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: ADL = .70 SRM: ADL = .75


NA


NA




Male 70% Female 30%



OA PF




195

196


Ratings





Content Validity


Construct Validity


Criterion Validity




197





Responsiveness


NA


NA


NA




Male 274 (48%) Female 294 (52%)



OA PF




Notes:


The decline in function with older age groups was more apparent for the subscales Sport and recreation function comared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of

198


199

KOOS- SPORT/REC SUBSCALE




Validity, Reliability of Swedish version



ACL injury/ Surgery Variety of Knee disorders/injury Osteoarthtis


Age range (average ± SD, min-max) 32 (18-46) 14-89 Singapore English = 65.3

Chinese = 67.8


Reliability

Internal consistency NA α = .85 α:Singapore English = .89 Chinese = .88



Validity

Correlation to similar scale NA Moderate (100%) correlation to similar scale

English: No(100%) Chinese: No (100%) correlation to similar scales


Little (33%), Fair (66.6%) correlation to general measures of physical function


English: Fair (100%) Chinese: Little (100%) correlation to general measure of physical function



Little (50%) to fair (50%) correlation to general measures of mental function

English: Little (100%) Chinese: Little (100%) correlation to general measures of mental function

Responsiveness

ES 1.16 0.9 NA

SRM NA NA NA


MCID NA NA NA

Guyatt NA NA NA

Time Interval 6 months 3 months NA

Other

Floor/Ceiling Effect NA No Yes*



200

KOOS- SPORT/REC SUBSCALE Ornetti (6) DeGroot (7) Salavati (10) Bekkers (11)



Validity, Reliability of Dutch version

Validity, Reliability of Persian version Validity, reliability


Osteoarthtis Osteoarthtis Meniscus, ACL, Combined Knee injury

Cartilage Degeneration/Surgery

Number Medicine Group = 37, Surgery Group = 30


147 40




31.4 (16 – 59) 35±12 (18-55)



11% 30%

Reliability

Internal consistency α = .84

α: Mild OA = .87 , Moderate OA = .95 , Severe OA = .98 , TKA = .88 , Revision TKA = .95

α = .89 α = 0.89


ICC = .61 ICC = 0.89

Time interval 2 weeks 3 weeks 8 days 2 days

Validity


Little (80%), Fair (20%) correlation to similar scales NA NA NA


NA

Little (26.6%), Fair (53.3%), Moderate (20%) correlation with general measures of physical function

Fair (100%)correlation with general measures of physical function

NA


NA Little (70%), Fair (30%) correlation with general measures of mental function


NA

Responsiveness

ES 1.31 NA NA 0.98

SRM 0.89 NA NA 0.87

MDC 23.5 (calc)

ICC: Mild OA = 25.1 , Moderate OA = 31.9 , Revision TKA = 70.0 (calc) **used baseline group**

39.8 (calc) 23.9 (calc)

MCID NA NA NA NA

Guyatt NA NA NA NA

Time Interval 3 month NA NA 36 months

Other

Floor/Ceiling Effect No Yes No No



201

KOOS- SPORT/REC SUBSCALE

Paradowski (12)




General Population

Number 568

Age range (average ± SD, min-max) 568


Reliability



Time interval NA

Validity



NA


NA

Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data Yes

202

KOOS SPORT AND REC SUBSCALE CONSOLIDATION

REFERENCES









203

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score- Sport/Rec subscale

Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .47 , RP = .24 , BP = .27 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - RE =.03 , MH = .23 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




204


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: sport and rec function = .81 Testing interval (time between repeated measures) Within 9 days



Responsiveness


1


NA


Table 4




Male 9 Female 12



OA PF




205

206

207

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec subscale

Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation


Content Validity


Construct Validity


Criterion Validity




α Sport/Rec = .85

208


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Sport and Rec. function = .78 Testing interval (time between repeated measures) Within 8 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Sport/Rec = .90 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)





Male Female



OA PF





209

210

211


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec Subscale

Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English



Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 2. 66.9% - Singapore English; 73.3% - Singapore

Chinese Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate

translators.

Construct Validity


.24 RB = .10 BP = -.04

Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = -.06 MH = -.02/Chinese SF-36 RE = -.01

MH = -.03 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA

Criterion Validity


212



α :Singapore English: Sprt/Rec = .89 Chinese: Sprt/Rec = .88


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English: Sprt/Rec = .65

Chinese; Sprt/Rec = .78 Testing interval (time between repeated measures) 6 days



Responsiveness


NA


NA


NA







OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English

213

Is this the first or primary report about this instrument? 2

214


Ratings



Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version



Content Validity


Construct Validity





Criterion Validity

215




α: Sport/Rec = .84


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Sport/Rec = .82 Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ESSport/Rec = 1.31 SRM: Sport/Rec = .89


NA


NA




Male 32% 27% Female 68% 73%



OA 1 PF




216

Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2

NOTES:


217


Ratings



Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis


Content Validity


to Dutch

Construct Validity







218

Criterion Validity




Table 2.


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: Spt/Rec = .85

MODERATE OA Spt/Rec = .87 REVISION of TKA: Spt/Rec = .45




Responsiveness


NA


NA


NA



Mild OA Moderate OA



56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)

Number: 36 62 47 63 54 Sex

Male 78 68 48 49 22 Female 22 32 52 51 78



OA 1 PF

General knee pain 219



NA


Notes:



220

221

222


Ratings



Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and




Content Validity


Persian)

Construct Validity





223

Criterion Validity




α : Sport/Rec = .89


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC:, Sport/Rec = .61 Testing interval (time between repeated measures) 6 – 8 days



Responsiveness


NA


NA


NA




Male 131 Female 16



OA PF




224

Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2

Notes:


225

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome



Content Validity


Construct Validity




Criterion Validity


226



Sport/Rec. = 0.89





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: Sport/Rec = .98 SRM: Sport/Rec = .87


NA


NA




Male 70% Female 30%



OA PF




227

228


Ratings





Content Validity


Construct Validity


Criterion Validity




229





Responsiveness


NA


NA


NA




Male 274 (48%) Female 294 (52%)



OA PF




Notes:



230


231

KOOS- QOL Subscale



Purpose

Reliability, responsiveness, validity

Validity, Reliability of Swedish version



ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis

Number 21 142 Singapore Englsih = 127 Chinese = 131

Age range (average ± SD, min-max) 32 (18-46) 14-89 Singapore English = 65.3

Chinese = 131


Reliability

Internal consistency NA α = .71 Α:Singapore English = .74 Chinese = .71



Validity

Correlation to similar scale NA Moderate (100%) correlation to similar scale

English: No (100%) Chinese: No (1005) correlation to similar scales




English: Fair (66.6%) Moderate (33.3) Chinese: Fair (100%) correlation to general measure of physical function


Little (50%), Moderate (50%) correlation to general measures of mental function



Responsiveness

ES 1.65 1.15 NA

SRM NA NA NA

MDC 15.4 (calc) (1.96)*(sqrt(2))*((14.9)*sqrt(1-.86))

17.8 (calc) (1.96)*(sqrt(2))*((15.6)*sqrt(1-.83))

Singapore English = 19.5 (calc) (1.96)*(sqrt(2))*((18.8)*sqrt(1-.86)) Chinese = 34.0 (calc) (1.96)*(sqrt(2))*((19.4)*sqrt(1-.60))

MCID NA NA NA

Guyatt NA NA NA


Other




232

KOOS- QOL Subscale Ornetti (6) DeGroot (7) Salavati (10) Bekkers (11)


Purpose Validity, Reliability of French version

Validity, Reliability of Dutch version

Validity, Reliability of Persian version Validity, reliability


Osteoarthritis Osteoarthritis Meniscus, ACL, Combined Knee Injury

Cartilage Degeneration/Surgery

Number Medicine Group = 37 Surgery Group = 30


147 40




31.4 (16 – 59) 35±12 (18-55)



11% 30%

Reliability

Internal consistency α = .83

α: Mild OA = .81 , Moderate OA = .85 , Severe OA = .73 , TKA = .81 , Revision TKA = .90

α = .64 α = 0.90


ICC = .88 ICC = 0.95

Time interval 2 weeks 3 weeks 8 days 2 days

Validity


Little (20%) Fair (60%) Moderate (20%) correlation to similar scales

NA NA NA


NA

Little (6.6%), Fair (53.3%), Moderate (40%) correlation with general measures of physical function

Fair (100%) correlation with general measures of physical function

NA


NA Little (60%), Fair (40%) correlation with general measures of mental function

Little(50%), Fair (50%) correlation to general measures of mental function

NA

Responsiveness

ES 2.8 NA NA 1.32

SRM 1.93 NA NA 0.76

MDC 23.5 (calc) (1.96)*(sqrt(2))*((17)*sqrt(1-.75))

ICC: Mild OA = 20.7 , Moderate OA = 21.8 , Revision TKA = 29.5 (calc) **used baseline group**

16.9 (calc) (1.96)*(sqrt(2))*((17.7)*sqrt(1-.88))

14.2 (calc)

MCID NA NA NA NA

Guyatt NA NA NA NA

Time Interval 3 month NA NA 36 months

Other

Floor/Ceiling Effect No Yes No No



233

KOOS- QOL Subscale

Paradowski (12)




General Population

Number 568


568


Reliability



Time interval NA

Validity



NA


NA

Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data Yes

234

KOOS QOL SUBSCALE CONSOLIDATION

REFERENCE








12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and

gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.

235

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale

Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .19 , RP = .20 , BP = .02 , Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE =-.02 , MH = .33 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity





Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .86 Testing interval (time between repeated measures) Within 9 days

236



Responsiveness


1


NA


Table 4




Male 9 Female 12



OA PF




237

238

239


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation


Content Validity


Construct Validity


Criterion Validity




α: QOL = .71

240


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .83 Testing interval (time between repeated measures) Within 8 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: QOL = 1.15 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA




Male Female



OA PF





241

242

243


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English



Content Validity


translators.

Construct Validity


.41 RB = .34 BP = .38

Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .12 MH = .13/Chinese SF-36 RE = .18 MH


Criterion Validity


244



α :Singapore English: QOL = .74 Chinese:QOL = .71


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; QOL = .86

Chinese; QOL = .60




Responsiveness


NA


NA


NA







OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items

245

Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2

246


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version



Content Validity


Construct Validity





247

Criterion Validity




α: QOL = .83


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .75 Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: QOL = 2.8 SRM: QOL = 1.93


NA


NA




Male 32% 27% Female 68% 73%



OA 1 PF




248

Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2

NOTES:


249


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score- QOL subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish

to Dutch

Construct Validity






5. All other correlations between the KOOS subscales and

250

the SF-36 should be higher than 0.30 and lower than 0.60

Criterion Validity




Table 2.


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: QOL = .88

MODERATE OA: QOL = .91 REVISION of TKA:, QOL = .84




Responsiveness


NA


NA


NA



Mild OA Moderate OA



56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)

Number: 36 62 47 63 54 Sex

Male 78 68 48 49 22 Female 22 32 52 51 78



OA 1 251




NA


Notes:



252

253

254


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and




Content Validity


Persian)

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4- PF = .41 , RP = .37 , BP = .45 , Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.28 , MH = .13 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:




Criterion Validity


255



α : QOL = .64


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .88 Testing interval (time between repeated measures) 6 – 8 days



Responsiveness


NA


NA


NA




Male 131 Female 16



OA PF




256

Notes:


257


Ratings


Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome



Content Validity


Construct Validity




Criterion Validity


258



QOL = 0.90





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES: QOL = 1.32 SRM: Sport/Rec = .76


NA


NA




Male 70% Female 30%



OA PF




259

260


Ratings





Content Validity


Construct Validity


Criterion Validity




261





Responsiveness


NA


NA


NA




Male 274 (48%) Female 294 (52%)



OA PF




Notes:



262


263

WOMAC PAIN SUBSCALE

Davies (1) Angst (2) Escobar (3)


Purpose Responsiveness Responsiveness Validity, Reliability of Spanish translation


Hip/Knee OA Hip/Knee OA Hip/Knee OA

Number Placebo group = 50, Ibuprofen group = 54 223 Hip Group = 100,

Knee Group = 103


Placebo group = 62.1 ± 7.2 (45-79), Ibuprofen group = 61 ± 9.3 (45 – 77)

65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee Group = 70.9 ±6

Sex (% female) Placebo group = 64% Ibuprofen group = 63% 71% Hip Group = 56%

Knee Group = 70%

Reliability


NA α = 0.82

Test-retest reliability NA NA ICC = 0.78

Time interval NA

NA 15 days

Validity




NA Little (100%) correlation to general measures of physical function

Correlation to general measures of mental function NA NA Little (100%) correlation to general

measures of mental function

Responsiveness

ES 7 day = 9.4, 14 day = 6.6, 28 day = 17.7 .33 1.8

SRM NA 0.37 1.5

MDC NA NA NA

MCID NA NA NA

Guyatt NA 0.52 NA

Time Interval 7, 14, 28 days 3 months 6 months

Other

Floor/Ceiling Effect NA No NA




264

WOMAC PAIN SUBSCALE

Salaffi (4) Tuzun (5) Kersten (7)

Study

Purpose Reliability, Validity Reliability, Validity, Responsiveness of Turkish translation

Validity, Responsiveness


Patients following articular cartilage surgery OA Hip/Knee OA

Number Reliability = 17, Responsiveness = 50 72 221



61 ± 9 (41-80) 66.8 ± 8.3

Sex (% female) Reliability = 39%, Responsiveness = 39.2% 86% 58%

Reliability

Internal consistency NA α: Baseline = 0.75, Treatment = 0.81 α = 0.82

Test-retest reliability ICC: 6mo = 0.81, 12mo = 0.85 NA NA

Time interval 10 days NA NA

Validity

Correlation to similar scale Moderate (100%) correlation to similar scales

Moderate (100%) correlation to similar scales NA




NA




NA

Responsiveness

ES NA Group 1 = 0.88, Group 2 = 0.74 NA

SRM NA Group 1 = 1.0 Group 2 = 0.78

Raw score – 0.55 Rasch score = 0.35

MDC 144 (calc) NA NA

MCID NA NA NA

Guyatt NA 0.52 NA

Time Interval 7, 14, 28 days 3 months 6 weeks

Other


Normal Distribution No NA NA


OS - Osteoarthritis

265

WOMAC PAIN SUBSCALE CONTINUED

Greco (8) Bellamy (9)


Purpose Reliability , Responsiveness Normative Data


Patients following articular cartilage surgery General Population

Number Reliability = 17, Responsiveness = 50 7420


Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56) 27-104

Sex (% female) Reliability = 39%, Responsiveness = 39.2% 50%

Reliability

Internal consistency NA NA

Test-retest reliability ICC: 6mo = 0.81, 12mo = 0.85 NA

Time interval 6 month, 12 months NA

Validity

Correlation to similar scale NA NA

Correlation to general measures of Physical function NA NA

Correlation to general measures of mental function NA NA

Responsiveness

ES 6mo = 0.98, 12mo = 1.14 NA

SRM 6mo = 0.91, 12mo = 1.13 NA

MDC 6mo = 16.2, 12mo = 14.4 NA

MCID 6mo = 17.5 (sens = .68, spec = .70), 12mo = 7.5 (sens = .87, spec = .5)

NA

Guyatt NA NA

Time Interval 6, 12 months NA

Other

Floor/Ceiling Effect No NA


Normal Data NA Yes

OA - Osteoarthritis

266

WOMAC PAIN SUBSCALE CONSOLIDATION

REFERENCES

1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9

2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840

3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71

4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.

5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33

7) Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80

8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31

9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5

267

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale

Ratings


Outcome Measure WOMAC – Pain subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of

the WOMAC and Short-Form Medical Outcomes Study Survey in a Randomized, Clinical Trial of Osteoarthritis Patients


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity






268



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES Pain; 7day = 9.4, 14 day = 6.6, 28 day = 17.7 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


TABLE 3

Time interval between baseline and follow-up assessments 7, 14, 28 DAYS


Placebo Ibuprofen Age range of sample 62.1 ± 7.2 (45-79) 61 ± 9.3 (45 – 77) Number: 50 54 Sex

Male 36% 37% Female 64% 63%



OA Hip = 12%, Knee = 70%, Both = 18%

Hip = 5.6%, Knee = 66.7%, Both = 27.8%



Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2 Notes:

Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.

269

270


Ratings


Outcome Measure WOMAC - Pain Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as

compared with the SF-36 in patients with osteoarthritis of the leg undergoing a comprehensive rehabilitation intervention


Content Validity


Construct Validity


Criterion Validity






271



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s 3 month: ES: Pain = .33, SRM : Pain = .37 Guyatt: Pain = .52


NA


End of rehabilitation(3-4 weeks): ES: Pain = .56 SRM : Pain = .72 Guyatt: Pain = .87

Time interval between baseline and follow-up assessments 1 month, 3 month


Age range of sample 65.1 ± 10.0 (37-86) Number: 223 Sex

Male 64 Female 159

Diagnosis Hip 93

Knee 130 ACL injury/surgery PCL injury/surgery


OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2

Notes:

272

273


Ratings


Outcome Measure WOMAC – Pain subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC

Questionnaire for Patients with Hip or Knee Osteoarthritis Year 2002 PubMed ID: 12447629 Reviewer’s Name Travis Hamilton Date of Review 7.28.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 Table 3.

PAIN:BP = -0.6, PF = -0.4, RP = -0.35, Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36

PAIN RE = -0.31, MH = -0.41

Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α: Pain = 0.82

274


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC

Pain = 0.78




Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES Pain = 1.8 SRM Pain = 1.5


NA


NA



Hip Replacement Knee Replacement Age range of sample 68.6 ± 10.3 70.9 ±6 Number: Sex




OA 1 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report Spanish Is this the first or primary report about this instrument? 2

Notes:

275

The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related Quality of Life

276


Ratings


Outcome Measure WOMAC Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster

Universities Osteoarthritis Index in Italian patients with osteoarthritis of the knee


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation (English)

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:

Pain: BP = -0.6, PS = -0.61, SF-36 overall = -.608

Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index

Pain = 0.70

Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: MCS

Pain = -0.58


Criterion Validity


277



α: Pain = 0.91



Pain = 0.86




Responsiveness


NA


NA


NA



Age range of sample 65.7 ± 9.3 (50 – 82) Number: 304 Sex

Male 30% Female 70%



OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2

278


Ratings


Outcome Measure WOMAC – Pain subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the

Turkish version of WOMAC osteoarthritis index Year 2005 PubMed ID: 15639634 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011

Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Pain: PS = -0.55, RP = -0.36, BP = -0.51,


Pain = 0.64

Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:

Pain: RE = -.28, MH = -0.40

Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. Skewness statistics range from -1 to +1.

2. Floor and ceiling effects are less than 20% 3. WOMAC pain and physical function (and lesser extent

stiffness) scores are highly correlated with similar subscale (physical function and bodily pain) scores derived from SF-36.

4. WOMAC index subscales are inadequately or weakly correlated with theoretically unrelated subscale (mental component subscales) scores derived from SF-36.

5. WOMAC total is highly correlated with Lequesne index.

Criterion Validity

Correlated with “gold standard” 279

Predictive of a future outcome If yes to either of above, report how this was demonstrated



α: Time 1 Pain = 0.75

α: Time 2 Pain = 0.81


Evidence for test-retest reliability (eg.. ICC>.70) Indicate value: Testing interval (time between repeated measures)


Evidence for interrater reliability (eg..Kappa > .60) Indicate Value:

Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1 ES: Pain = 0.88 SRM: : Pain = 1.0 Group 2 ES: Pain = 0.74 SRM: : Pain = 0.78


NA


NA

Time interval between baseline and follow-up assessments 2 weeks


Age range of sample 61 ± 9 (41-80) Number: 72 Sex (table 1)

Male 10 Female 62



OA 1 PF


280


Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2

Notes:

Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic exercise).

Time 1: Baseline

Time 2: 3rd day after treatment period (2 WEEKS)

281


Ratings


Outcome Measure WOMAC – Pain subscale Author’s Last Name Kersten Title of the Article The Visual Anologue WOMAC 3.0 scale – internal validity and

responsiveness of the VAS version Year 2010 PubMed ID: 20433732 Reviewer’s Name Travis Hamilton Date of Review 7.28.11

Content Validity


Construct Validity


Criterion Validity




α Pain = 0.82

282





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRM: Pain = 0.55 Interval data (Rasch transformed scores) SRM: Pain = 0.35


NA


NA



Age range of sample 66.8 ± 8.3 Number: 221 Sex

Male 42% Female 58%



OA 40% hip, 60% knee PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2

283


Ratings


Outcome Measure WOMAC – Pain subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation



Content Validity


Construct Validity


Criterion Validity




284


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 6 mo. ICC 12 mo. ICC

Pain = 0.81 Pain = 0.85 Testing interval (time between repeated measures) 6 mo., 12 mo.



Responsiveness

Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s 6 mo. 12 mo.

ES SRM ES SRM

Pain = 0.98, Pain = 0.91, Pain = 1.14,

Pain = 0.94, = 1.13

Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 mo. 12 mo.

MCD MCID MCD MCID

Pain = 16.2,

Pain = 17.5 (sens = .68, spec = .70), Pain = 14.4,

Pain = 7.5 (sens = .87, spec = .5),

Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months



Male Female



OA PF



Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2

285

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Ratings


Outcome Measure WOMAC Author’s Last Name Bellamy Title of the Article Population-Based Normative Values for the Western Ontario

and McMaster (WOMAC) Osteoarthritis Index: Part 1 Year 2011 PubMed ID: 21546065 Reviewer’s Name Travis Hamilton Date of Review 1.2.2012

Content Validity


Construct Validity


Criterion Validity




286





Responsiveness


NA


NA


NA



Age range of sample 27-104 Number: 7420 (respondents) Sex

Male 3707 (~50%) Female 3713 (~50%)



OA PF


Sport related General population 100%

Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1

Notes:

287

288

WOMAC FUNCTION SUBSCALE

Davies (1) Angst (2) Escobar (3)


Purpose Responsiveness Responsiveness Validity, Reliability of Spanish translation


Hip/Knee OA Hip/Knee OA Hip/Knee OA

Number Placebo group = 50, Ibuprofen group = 54 223 Hip Group = 100, Knee Group = 103


Placebo group = 62.1 ± 7.2 (45-79), Ibuprofen group = 61 ± 9.3 (45 – 77)

65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee Group = 70.9 ±6

Sex (% female) Placebo group = 64% Ibuprofen group = 63% 71% Hip Group = 56% Knee Group = 70%

Reliability

Internal consistency NA NA α = 0.93


Time interval NA NA 15 days

Validity







Responsiveness

ES 7 day = 8.7, 14 day = 8.4, 28 day = 7.9 0.18 1.5

SRM NA 0.23 1.3

MDC NA NA NA

MCID NA NA NA

Guyatt NA 0.31 NA

Time Interval 7, 14, 28 days 3 months 6 months

Other

Floor/Ceiling Effect NA No NA




289

WOMAC FUNCTION SUBSCALE CONTINUED

Salaffi (4) Tuzun (5) Kersten (7)


Purpose Reliability, Validity Reliability, Validity, Responsiveness of Turkish translation

Validity, Responsiveness


OA OA Hip/Knee OA

Number 304 72 221

Age range (average ± SD, min-max) 65.7 ± 9.3 (50 – 82) 61 ± 9 (41-80) 66.8 ± 8.3

Sex (% female) 70% 86% 58%

Reliability

Internal consistency α = 0.84 α: Baseline = 0.94, Treatment = 0.96 α = 0.95

Test-retest reliability ICC = 0.89 NA NA

Time interval 10 days NA NA

Validity


Moderate (100%) correlation to similar scales NA




NA




NA

Responsiveness

ES NA Group 1 = 0.79, Group 2 = 0.50 NA

SRM NA Group 1 = 0.94, Group 2 = 0.69 Raw score = 0.49, Rasch score = 0.37

MDC 350.8 (calc) (1.96)*(sqrt(2)) *((381.6)*sqrt(1-.89)) NA NA

MCID NA NA NA

Guyatt NA NA NA

Time Interval NA 2 weeks 6 weeks

Other


Normal Distribution No NA NA

Normal Data NA NA NA OA - Osteoarthritis

290

WOMAC FUNCTION SUBSCALE CONTINUED

Greco (8) Bellamy (9)


Purpose Reliability, Responsiveness Normative Data


Patient’s following articular cartilage surgery General Population

Number Reliability = 17, Responsiveness = 50 7420


Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56) 27-104

Sex (% female) Reliability = 39%, Responsiveness = 39.2% 50%

Reliability


Test-retest reliability ICC: 6mo = 0.93, 12mo = 0.86 NA

Time interval 6 months, 12 months NA

Validity




Responsiveness

ES 6mo = 0.88, 12mo = 1.20 NA

SRM 6mo = 0.86, 12mo = 1.13 NA

MDC 6mo = 10.6, 12mo = 15 NA

MCID 6mo = 8.1(sens = .79, spec = .52), 12mo = 5.89(sens = .94, spec = .50) NA

Guyatt NA NA

Time Interval 6, 12 months NA

Other



Normal Data NA Yes

OA - Osteoarthritis

291

WOMAC FUNCTION SUBSCALE CONSOLIDATION

REFERENCES






7. Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80

8. Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31


292

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale

Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of



Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 0.75 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




293





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES Function; 7day = 8.7, 14 day = 8.4, 28 day = 7.9 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


TABLE 3




Male 36% 37% Female 64% 63%



OA Hip = 12%, Knee = 70%, Both = 18%

Hip = 5.6%, Knee = 66.7%, Both = 27.8%





294

295


Ratings


Outcome Measure WOMAC – function subscale Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as



Content Validity


Construct Validity


Criterion Validity



Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60)

296

Indicate value:





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s 3 month: ES: Function = .18 SRM Function = .23 Guyatt: Function = .31


NA


End of rehabilitation(3-4 weeks): ES Function = .42 SRM Function = .62 Guyatt Function = .73




Male 64 Female 159

Diagnosis Hip 93



OA 1 PF




Notes:

297

298


Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC


Content Validity


Construct Validity


FUNCTION: BP = -0.63, PF = -0.52, RP = -0.43 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36

FUNCTION RE = -0.31, MH = -0.43


Criterion Validity




α: Function = 0.93

299



Function = 0.81




Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES Function = 1.5 SRM Function = 1.3


NA


NA







OA 1 1 PF




Notes:

300


301


Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster



Content Validity


Construct Validity


Function: BP = -0.59, PS = -0.70, SF-36 overall = -.65


Function = 0.75


Function = -0.56


Criterion Validity


302



α: Function = 0.84



Function = 0.89




Responsiveness


NA


NA


NA




Male 30% Female 70%



OA 1 PF




303


Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Function: PS = -0.72, RP = -0.48, BP = -0.54 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index

Function = 0.68


Function: RE = -.40, MH = -0.37






Criterion Validity


304



α: Time 1 Function = 0.94

α: Time 2 Function = 0.96





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1 ES: Function = 0.79 SRM: : Function = 0.94 Group 2 ES: Function = 0.50 SRM: : Function = 0.69


NA


NA




Male 10 Female 62



OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA

305

Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2

Notes:


Time 1: Baseline


306


Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Kersten Title of the Article The Visual Analogue WOMAC 3.0 scale – internal validity and


Content Validity


Construct Validity


Criterion Validity




α Function = 0.95



307



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRMFunction = 0.49 Interval data (Rasch transformed scores) SRM: Function = 0.37


NA


NA




Male 42% Female 58%







308


Ratings


Outcome Measure WOMAC – Function subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation



Content Validity


Construct Validity


Criterion Validity






Function = 0.93 Function = 0.86 Testing interval (time between repeated measures) 6 mo., 12 mo.

309



Responsiveness


ES SRM ES SRM Function = 0.88

Function = 0.86

Function = 1.20

Function = 1.13


MCD MCID MCD MCID

Function = 10.6

Function = 8.1(sens = .79, spec = .52)

Function = 15.0

Function = 5.89(sens = .94, spec = .50)




Male Female



OA PF




310


Ratings




Content Validity


Construct Validity


Criterion Validity




311





Responsiveness


NA


NA


NA




Male 3707 (~50%) Female 3713 (~50%)



OA PF




Notes:

312

313

WOMAC STIFFNESS SUBSCALE

Angst (2) Escobar (3) Salaffi (4)

Study

Purpose Responsiveness Validity, Reliability of Spanish translation Reliability, Validity


Hip/Knee OA Hip/Knee OA OA

Number 223 Hip Group = 100, Knee Group = 103 304

Age range (average ± SD, min-max) 65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee

Group = 70.9 ±6 65.7 ± 9.3 (50 – 82)

Sex (% female) 71% Hip Group = 56% Knee Group = 70% 70%

Reliability

Internal consistency NA α = 0.81 α = 0.84

Test-retest reliability NA ICC = 0.67 ICC = 0.68

Time interval NA 15 days 10 days

Validity

Correlation to similar scale NA NA Moderate (100%) correlation to similar scales







Responsiveness

ES 0.07 1 NA

SRM 0.08 0.8 NA

MDC NA NA 80.2 (calc)

MCID NA NA NA

Guyatt 0.1 NA NA

Time Interval 3 months 6 months NA

Other

Floor/Ceiling Effect No NA No




314

WOMAC STIFFNESS SUBSCALE CONTINUED Tuzun (5) Kersten (7) Greco (8)


Purpose Reliability, Validity, Responsiveness of Turkish translation

Validity, Responsiveness Reliability, Responsiveness


OA Hip/knee OA Patients following articular cartilage surgery

Number 72 221 Reliability = 17, Responsiveness = 50

Age range (average ± SD, min-max) 61 ± 9 (41-80) 66.8 ± 8.3


Sex (% female) 86% 58% Reliability = 39%, Responsiveness = 39.2%

Reliability

Internal consistency α: Baseline = 0.71, Treatment = 0.76 α = 0.80 NA

Test-retest reliability NA NA ICC: 6mo = 0.86, 12mo = 0.75

Time interval NA NA 6 mo, 12 mo

Validity

Correlation to similar scale Moderate (100%) correlation to similar scales NA NA



NA NA



NA NA

Responsiveness

ES Group 1 = 0.44, Group 2 = 0.32 NA 6mo = 0.51, 12mo = 0.72

SRM Group 1 = 0.52, Group 2 = 0.29 6mo = 0.40, 12mo = 0.64

MDC NA NA 6mo = 22.9, 12mo = 30.6

MCID NA NA 6mo = 6.3(sens = .68, spec = .48) , 12mo =18.8(sens = .55, spec = .65)

Guyatt NA NA NA

Time Interval 2 weeks 6 weeks 6, 12 months

Other

Floor/Ceiling Effect No NA No




315

WOMAC STIFFNESS SUBSCALE CONTINUED

Bellamy (9)




General Population

Number 7420

Age range (average ± SD, min-max) 27-104

Sex (% female) 50%

Reliability



Time interval NA

Validity




Responsiveness

ES NA

SRM NA

MDC NA

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data Yes

316

WOMAC STIFFNESS SUBSCALE CONSOLIDATION

REFERENCES





7) Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80

8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31


317

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale

Ratings


Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as



Content Validity


Construct Validity


Criterion Validity




318





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s 3 month: ES:Stiffness = .07 SRM Stiffness = .08, Guyatt: Stiffness = .10


NA


End of rehabilitation(3-4 weeks): ES: Stiffness = .34, SRM Stiffness = .38 Guyatt: Stiffness = .45




Male 64 Female 159

Diagnosis Hip 93



OA 1 PF




Notes:

319

320


Ratings


Outcome Measure WOMAC – stiffness subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC


Content Validity


Construct Validity


STIFFNESS: BP = -0.5, PF = -0.38, RP = -0.33

Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36

STIFFNESS RE = -0.27, MH = -0.33 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




α: Stiffness = 0.81

321



Stiffness = 0.67 Testing interval (time between repeated measures) 15 days



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES Stiffness = 1 SRM Stiffness = 0.8


NA


NA







OA 1 1 PF




Notes:


322

323


Ratings


Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster



Content Validity


Construct Validity


Stiffness: BP = -0.46, PS = -0.54, SF-36 overall = -.51


Stiffness = 0.58


Stiffness = -0.40


Criterion Validity


324



α: Stiffness = 0.84



Stiffness = 0.68 Testing interval (time between repeated measures) 10 days


Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: Responsiveness


NA


NA


NA

Time interval between baseline and follow-up assessments Descriptive Features


Male 30% Female 70%



OA 1 PF




325


Ratings


Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Stiffness: PS = -0.38, RP = -0.47, BP = -0.40


Stiffness = 0.50


Stiffness: RE = -.34, MH = -0.31






Criterion Validity


326



α: Time 1 Stiffness = 0.71

α: Time 2 Stiffness = 0.76





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1 ES: Stiffness = 0.44 SRM: : Stiffness = 0.52 Group 2 ES: Stiffness = 0.32 SRM: : Stiffness = 0.29


NA


NA




Male 10 Female 62



OA 1 PF



327

Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2

Notes:


Time 1: Baseline


328


Ratings


Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Kersten Title of the Article The Visual Analogue WOMAC 3.0 scale – internal validity and


Content Validity


Construct Validity


Criterion Validity




α Stiffness = 0.80

329





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRM: Stiffness = 0.34 Interval data (Rasch transformed scores) SRM: Stiffness = 0.43


NA


NA




Male 42% Female 58%







330


Ratings


Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation



Content Validity


Construct Validity


Criterion Validity




331



Stiffness = 0.86 Stiffness = 0.75 Testing interval (time between repeated measures) 6 mo., 12 mo. Interrater Reliability

Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: Responsiveness


ES SRM ES SRM Stiffness = 0.51,

Stiffness = 0.40,

Stiffness = 0.72

Stiffness = 0.64


MCD MCID MCD MCID

Stiffness = 22.9

Stiffness = 6.3(sens = .68, spec = .48)

Stiffness = 30.6

Stiffness = 18.8(sens = .55, spec = .65)

Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months Descriptive Features


Male Female



OA PF




332


Ratings




Content Validity


Construct Validity


Criterion Validity




333





Responsiveness


NA


NA


NA




Male 3707 (~50%) Female 3713 (~50%)



OA PF




Notes:

334

335

WOMAC OVERALL SUBSCALE

Davies (1) Angst (2) Salaffi (4)


Purpose Reliability, Validity, Responsiveness Reliability, Responsiveness Reliability, Validity


OA Patients following articular cartilage surgery OA

Number 72 Reliability = 17, Responsiveness = 50 304

Age range (average ± SD, min-max) 61 ± 9 (41-80)


65.7 ± 9.3 (50 – 82)

Sex (% female) Placebo group = 64% Ibuprofen group = 63%

Reliability = 39%, Responsiveness = 39.2% 70%

Reliability

Internal consistency NA NA α = 0.84


Time interval NA NA 10 days

Validity

Correlation to similar scale NA NA Moderate (100%) correlation to similar scales






Responsiveness

ES 7 day = 10.0, 14 day = 9.6, 28 day = 9.5 0.18 NA

SRM NA 0.24 NA

MDC NA NA 477.8 (calc) (

MCID NA NA NA

Guyatt NA 0.34 NA

Time Interval 7, 14, 28 days 3 months NA

Other




OA – Osteoarthritis 336

WOMAC – Overall Subscale

Tuzun (5) Greco (8) Bellamy (9)


Purpose Reliability, Validity, Responsiveness of Turkish translation Reliability, Responsiveness Normative Data


OA Patients following articular cartilage surgery General Population

Number 72 Reliability = 17, Responsiveness = 50 7420

Age range (average ± SD, min-max) 61 ± 9 (41-80)


27-104

Sex (% female) 86% Reliability = 39%, Responsiveness = 39.2% 50%

Reliability

Internal consistency α: Baseline = 0.94, Treatment = 0.96 NA NA

Test-retest reliability NA ICC: 6mo = 0.93, 12mo = 0.86 NA

Time interval NA 6 mo, 12 mo NA

Validity

Correlation to similar scale Moderate (100%) correlation to similar scales NA NA


Little (100%) correlation to general measures of physical function NA NA


Little (100%) correlation to general measures of mental function NA NA

Responsiveness

ES Group 1 = 0.79, Group 2 = 0.50 6mo = 0.96, 12mo = 1.19 NA

SRM Group 1 = 0.94, Group 2 = 0.69 6mo = 0.91, 12mo = 1.13 NA

MDC NA 6mo = 10.9, 12mo = 15.3 NA

MCID NA 6mo =11.5 (sens = .79, spec = .57), 12mo = 11.5 (sens = .84, spec = .55) NA

Guyatt NA NA NA

Time Interval 2 weeks 6, 12 months NA

Other




OA - Osteoarthritis

337

WOMAC OVERALL SUBSCALE CONSOLIDATION

REFERENCES


2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared

with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840

4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of

life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.

5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the

Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33 8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee

Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31

9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster

WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5

338

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale

Ratings


Outcome Measure WOMAC – Overall subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of



Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




339





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES overall; 7day = 10.0, 14 day = 9.6, 28 day = 9.5 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


TABLE 3




Male 36% 37% Female 64% 63%



OA Hip = 12%, Knee = 70%, Both = 18%

Hip = 5.6%, Knee = 66.7%, Both = 27.8%





340

341

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall Subscale

Ratings


Outcome Measure WOMAC Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as



Content Validity


Construct Validity


Criterion Validity




342





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s 3 month: ES: global = .18; SRM : global = .24; Guyatt:, global = .34


NA


End of rehabilitation(3-4 weeks): ES: global = .47; SRM : global = .67; Guyatt: global = .82




Male 64 Female 159

Diagnosis Hip 93



OA 1 PF




Notes:

343

344


Ratings


Outcome Measure WOMAC – Overall Subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster



Content Validity


Construct Validity


Overall: BP = -0.60, PS = -0.70, SF-36 overall = -.66 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index

Overall = 0.77 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient Overall = -0.57 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




345





Responsiveness


NA


NA


NA




Male 30% Female 70%



OA 1 PF




346


Ratings


Outcome Measure WOMAC – Overall subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Overall: PS = -0.63, RP = -0.52, BP = -0.55, Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index

Overall = 0.70 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:

Overall: RE = -.40, MH = -0.42 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 16. Skewness statistics range from -1 to +1.





Criterion Validity

Correlated with “gold standard” Predictive of a future outcome If yes to either of above, report how this was demonstrated

347







Responsiveness


1

Report statistics: ES. SRM. Guyatt’s Group 1 ES: Overall = 0.78 SRM: : Overall = 1.02 Group 2 ES: Overall = 0.60 SRM: Overall = 0.70


NA


NA




Male 10 Female 62



OA 1 PF




348

Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2

Notes:


Time 1: Baseline


349


Ratings


Outcome Measure WOMAC – Overall subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation



Content Validity


Construct Validity


Criterion Validity




350



Overall = 0.93 Overall = 0.86 Testing interval (time between repeated measures) 6 mo., 12 mo.



Responsiveness


ES SRM ES SRM Overall = 0.96

Overall = 0.91

Overall = 1.19

Overall = 1.13


MCD MCID MCD MCID

Overall = 10.9

Overall = 11.5 (sens = .79, spec = .57)

Overall = 15.3

Overall = 11.5 (sens = .84, spec = .55)




Male Female



OA PF




351


Ratings




Content Validity


Construct Validity


Criterion Validity




352





Responsiveness


NA


NA


NA




Male 3707 (~50%) Female 3713 (~50%)



OA PF




Notes:

353

354

355

WOMET

Kirkley (1) Sihvonen (2)


Purpose Validity, Reliability Validity, Reliability, Responsiveness

Study Population/Sample (inclusion/exclusion) Meniscus injury Meniscus injury

Number Reliability group = 78, Validity group = 61 485 (100 – validity; 385 – psychometric testing[40 test retest])

Age range (average ± SD, min-max) NA 53 (18 – 81)

Sex (% female) NA 44.7%

Reliability

Internal consistency α = 0.923 α = .917

Test-retest reliability ICC = .92 95% LOA = 20.10 and -20.11


Validity

Correlation to similar scale Fair (50%), Moderate (50%) correlation to similar scales Moderate (100%)

Correlation to general measures of physical function NA Fair (100%)


Responsiveness

ES NA 1.17

SRM 0.65 .90

MDC NA NA

MCID NA NA

Guyatt NA NA

Time Interval 6 months 6 months

Other

Floor/Ceiling Effect No No

Normal DIstribution NA Yes

Normal Data NA NA

WOMET SCALE CONSOLIDATION

REFERENCES

1) Kirkley A, Griffin S, Whelan D. The development and validation of a quality of life-measurement tool for patients

with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med. 2007 Sep; 17(5): 349-56

2) Sihvonen R, Järvelä T, Aho H, Järvinen TL. Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for Patients with a Degenerative Meniscal Tear: A Meniscal Pathology-Specific Quality-of-Life Index. J Bone Joint Surg Am. 2012 May 16;94(10):e651-8.

Western Ontario Meniscal Evaluation Tool (WOMET)

Ratings


Outcome Measure Western Ontario Meniscal Evaluation Tool (WOMET) Author’s Last Name Kirkley Title of the Article The Development and Validation of a Quality of Life

Measurement Tool for Patients with Meniscal Pathology: The Western Ontario Meniscal Evaluation Tool WOMET


Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ACL-QOL, Lysholm TABLE 3 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. WOMET would have positive correlations with both

the Lysholm and ACL-QOL. 2. Because the ACL-QOL was specifically designed assess

HRQOL, the correlation between it and the WOMET was anticipated to be slightly stronger than the correlation between the Lysholm and the WOMET.

Criterion Validity




α = 0.923





Responsiveness


1

Report statistics: ES. SRM. Guyatt’s SRM = 0.65 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA




Reliability Validity Age range of sample Number: 78 61 Sex

Male Female


Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 3 9

OA Subtotal Menisectomy 1

General knee pain Subtotal menisectomy

No surgery 2 Isolated Meniscal Debridement/Partial menisectomy 9 8

Repaired (meniscus pathology) 22 23 Meniscus pathology 36 34

Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 1

Western Ontario Meniscal Evaluation Tool (WOMET)

Ratings


Outcome Measure Western Ontario Meniscal Evaluation Tool (WOMET) Author’s Last Name Sihvonen Title of the Article Validation of the Western Ontario Meniscal Evaluation Tool

(WOMET) for Patients with a Degenerative Meniscal Tear Year 2012 PubMed ID: Reviewer’s Name Travis Date of Review 6.14.2012

Content Validity

Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 Used standard forward and reverse translation process? 1

Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient 15-D = .311 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm = .558 Uncorrelated with theoretically distinct scale If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Table 2 (all were significant and the one discriminate

hypothesis showed no significant difference between the two groups of patients)

Criterion Validity




W/o OA = .913; w/ OA = .931 Overall = .917


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 95% limits of agreement = 20.10 and -20.11 (fig 1) Testing interval (time between repeated measures) 2 weeks



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES = 1.17; SRM = .90 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)


WOMET score was greater for patients who reported knee was better after surgery (31 ± 21) vs same/worse (-3 ± 16) (p < 0.001)



Age range of sample 53 (18 – 81) Number: 485 (100 – validity; 385 – psychometric testing[40 test retset]) Sex

Male 268 Female 217

Diagnosis Arthroscopically verified meniscal tear 100%

Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Finnish/Swedish? Is this the first or primary report about this instrument? 2

Notes:

MOHTADI QOL

Mohtadi(1) Tanner(2)


Purpose Development and validation Development and validation

Study Population/Sample (inclusion/exclusion) ACL injury ACL injury, Meniscal tears, Osteoarthritis

Number Responsiveness = 25, Construct Validity = 50, Test re-test = 25 153

Age range (average ± SD, min-max) Responsiveness = 27.6 years (16-43),

Construct Validity = 27.14 years± (16-43), Test Re-test = NA

44.6 (14-82)

Sex (% female) Responsiveness= 48%, Construct Validity = 40%, Test Re-test = NA 51%

Reliability


Test-retest reliability Average Error = 6% NA

Time interval 2 weeks NA

Validity




Responsiveness

ES NA NA

SRM NA NA

MDC NA NA

MCID NA NA

Guyatt NA NA

Time interval NA NA

Other

Floor/Ceiling effect No NA


Normal Data NA NA

361

MOHTADI QOL CONSOLIDATION QUESTIONNAIRE

REFERENCES

1) Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9.

2) Tanner SM, Dainty KN, Marx RG, Kirkley A. Knee-specific quality-of-life instruments: which ones measure symptoms

and disabilities most important to patients? Am J Sports Med. 2007 5(9):1450-8. Epub 2007 May 14

362

Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency

Ratings


Outcome Measure Mohtadi QOL measure for ACL deficiency Author’s Last Name Mohtadi Title of the Article Development and Validation of the Quality of Life Outcome

Measure (Questionnaire) for Chronic Anterior Cruciate Ligament Deficiency


Content Validity

Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. The ACL-QOL outcome measure should reflect all

severity of chronic ACL deficiency and therefore cover the spectrum of score from 0 – 100.

2. Those patients who were booked for surgery based on clinical evaluation only, independently of the results of the ACL-QOL measure, should have scores lower than 50 and should score lower, on average, than patients not requiring surgery.

Criterion Validity



Evidence for acceptable internal consistency NA

363

(eg.. Cronbach’s α > .60) Indicate value:


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Average error = 6% Testing interval (time between repeated measures) 2 weeks



Responsiveness


NA


NA (NOTES)


NA

Time interval between baseline and follow-up assessments Over a 6 month period


Responsiveness Construct Validity Test Retest Age range of sample 27.6 (16 – 43) 27.14 (16-43) Number: 25 50 25 Sex


Diagnosis ACL injury/surgery 1 1 1 PCL injury/surgery


OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) PRESNENT Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 1

364

Notes:

Responsiveness: 21 out of 25 (84%) had appropriate overall scores on the repeat administration of the ACL-QOL questionnaire based on the clinical changes that had occurred. Of these 21 patients, 9 had clinically improved, 10 remained unchanged, and 2 had deteriorated. Three of the four patients who did not correctly match their overall clinical impression on the second ACL-QOL questionnaire were in the postoperative period after their knee surgery.

365

Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency

Ratings


Outcome Measure Mohtadi QOL measure for ACL deficiency Author’s Last Name Tanner Title of the Article Knee-specific Quality-of-Life Instruments Which Ones

Measure Symptoms and Disabilities Most Important to Patients



Content Validity


Construct Validity


Criterion Validity



Evidence for acceptable internal consistency NA

366






Responsiveness


NA


NA





Male 75 Female 78

Diagnosis Table 3 ACL injury/surgery 1 PCL injury/surgery


OA 1 PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

Notes:

153 patients with ACL, Isolated meniscal tears, or OA were polled to complete a questionnaire of 111 items by combining 222 patient directed questions from 11 knee specific quality of life instruments. The groups were broken down by the type of injury, then group statistics including the mean importance ranking and the frequency importance product (FIP = frequency x mean importance) were calculated. For the population

367

with ACL deficiency, patients endorsed 87 % (27/31) questions on the Mohtadi QOL. The endorsement statistic for the Mohtadi QOL was not reported for patients with Osteoarthritis and Meniscal tears.

368

Marx Activity

Marx (1)




Normal/Sports active

Number 40

Age range (average ± SD, min-max) 33.7 (18-50)

Sex (% female) 32%

Reliability


Test-retest reliability ICC = .97

Time interval 1 year

Validity




Responsiveness

ES NA

SRM NA

MDC 9.9 (calc) (1.96)*(sqrt(2))*((20.8)*sqrt(1-.97))

MCID NA

Guyatt NA

Time Interval NA

Other



Normal Data NA

369

MARX ACTIVITY SCALE CONSOLIDATON

REFERENCES

1) Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am. J Sports Med 2001; 29: 21.3-218

370

MARX ACTIVITY LEVEL

Ratings


Outcome Measure Marx Activity Level Author’s Last Name Marx Title of the Article Development and Evaluation of an Activity Rating Scale for

Disorders of the Knee Year 2001 PubMed ID:


Content Validity

Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA

Construct Validity

Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner = 0.66, Cincinnati = 0.67,Daniel scale = 0.52 ( Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity




371


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.97 Testing interval (time between repeated measures) 1 week



Responsiveness


NA


NA


NA




Male 27 Female 13



OA PF



Participates in sports on a regular basis 28 Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1

Notes:

Items of importance were generated by interviewing 10 orthopaedic surgeons who specialize in sports medicine, 5 physical therapists and athletic trainers who specialize in sports medicine and 10 athletic patients with disorders of the knee. Nine relevant items were generated: getting out of a low chair, going up stairs, going down stairs, running, cutting, pivoting, jumping, decelerating, and doing a deep knee bend/squat. The top 4 items were selected for the scale (Running, cutting, decelerating, and pivoting) depicted in table 1.

372

373

Kujala Activity Level

Paxton (1) Kuru (2)


Purpose Validity, Reliability Validity, Reliability of Turkish translation


Acute patellar dislocation Patellar femoral disorder

Number Validity = 110, Test-retest = 81 40



33 ±12 (17 – 54)

Sex (% female) NA NA

Reliability

Internal consistency α = .82 α = 0.84

Test-retest reliability ICC = .86 MCC** = .94

Time interval 21 days NA

Validity

Correlation to similar scale Demonstrate Little (20%), moderate (20%), excellent (60%) correlation to similar scales

NA


Demonstrates excellent (100%) correlations to similar scales NA


Responsiveness

ES NA NA

SRM NA NA

MDC NA NA

MCID NA NA

Guyatt NA NA

Time Interval NA NA

Other


Normal Distribution No NA

Normal Data NA NA ** MCC = Mean Correlation Coefficient

374

KUJALA CONSOLIDATION

REFERENCES

1) Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee-specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003 Jul-Aug;31(4):487-92.

2) Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6

375

Kujala Knee Score

Ratings


Outcome Measure Kujala Knee Score Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health


Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: PF = .64, RP = .44, BP = .45

MFA: Total = -.52, Mobility = -.1, Leisure = -.51 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner = .33, Fulkerson = .85, Lysholm = .86, IKDC

(modified) = -.54 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?

Criterion Validity



Evidence for acceptable internal consistency 1

376


α = .82


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .86 Testing interval (time between repeated measures) 21 days (13-42)



Responsiveness


NA


NA


NA



Age range of sample Table 1. Number: Sex

Male Female



OA Acute Patellar Dislocation 1



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2

Notes:

377

378

Kujala Knee Score

Ratings


Outcome Measure Kujala Knee Score Author’s Last Name Kuru Title of the Article Validity of the Turkish version of the Kujala patellofemoral

score in patellofemoral pain syndrome Year 2010 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 9.12.11

Content Validity

Reported that items were generated by team of experts NA (Standard forward and reverse translation) Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA

Construct Validity


Criterion Validity




α = 0.84

379


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Mean correlation coefficient = 0.94 Testing interval (time between repeated measures)



Responsiveness


NA


NA


NA



Age range of sample 33 ±12 (17 – 54) Number: 40 Sex

Male 8 Female 32



OA PF 1



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2

380

INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM – PEDIATRIC VERSION

Kocher (1)


Purpose Validity, Reliability, Responsiveness

Study Population/Sample Inclusion/exclusion)

Variety of knee injuries

Number 589


14.6 ± 2.5 (10.0 - 18.9)

Sex (% female) 51%

Reliability

Internal consistency α = 0.91

Test-re-test reliability ICC = .91

Time interval 17 days

Validity Correlation to similar scale NA

Correlation to general measures of physical function

Fair (33%) to Moderate (66%) correlation to physical function

Correlation to general measures of mental function Fair (100%), correlation to mental function

Responsiveness

ES 1.39 SRM 1.35 MDC 18.3 (calc) (1.96)*(sqrt(2))*((22)*sqrt(1-.91)) MCID NA Time interval 7.5 weeks Other Floor/Ceiling effect No Normal Distribution NA

Normal Data NA

381

International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version

REFERENCES

1) Kocher MS, Smith JT, Iversen MD, Brustowicz K, Ogunwole O, Andersen J, Yoo WJ, McFeely ED, Anderson AF, Zurakowski D. Reliability, validity, and responsiveness of a modified International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in children with knee disorders. Am J Sports Med. 2011 May;39(5):933-9. Epub 2010 Nov 10. PubMed PMID: 21068443

382

IKDC SUBJECTIVE KNEE FORM – PEDIATRIC VERSION

Ratings


Outcome Measure IKDC pediatric version Author’s Last Name Kocher Title of the Article Reliability, Validity, and Responsiveness of a Modified

International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in Children With Knee Disorders

Year 2011 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 9.12.11

Content Validity


Construct Validity

Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient **CHQ; PF = .65, RL = .35, BL = .20, PL = .45, BP = .61, GH =

.20, FA = .37, overall = .15, family cohesion = .05 (Bold = used for validity comparisons)

Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient CHQ: EL = .35, MH = .30, SE = .32 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses were confirmed:

1. Patients with greater difficulty walking several blocks or climbing several flights of stairs would have lower pedi-IKDC scores.

2. Patients with greater difficulty getting around their school, neighborhood, or playground would have lower pedi-IKDC scores.

3. Patients with greater difficulty walking 1 block or climbing 1 flight of stairs would have lower pedi-IKDC scores.

4. Patients with greater difficulty doing their tasks around the ouse would have lower pedi-IKDC scores.

5. Patients with greater difficulty bending, lifting, or stooping would have lower pedi-IKDC scores.

6. Patients with greater difficulty doing certain kinds of schoolwork or activities with friends would have lower pedi-IKDC scores.

7. Patients with more severe bodily pain or 383

discomfort during the past 4 weeks would have lower pedi-IKDC scores.

8. Patients with more frequent bodily pain or discomfort would have lower pedi-IKDC scores.

9. Patients who felt worse about their ability to play sports would have lower pedi-IKDC scores.

10. Patients who felt worse about the things they can do would have lower pedi-IKDC scores.

11. Patients whose health or behavior has more regularly limited types of activities that they could do as a family during the past 4 weeks would have lower pedi-IKDC scores.

Criterion Validity




α = 0.91


Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.91 Testing interval (time between repeated measures) 17 days (3-67)



Responsiveness


1

Report statistics: ES. SRM. Guyatt’s ES = 1.39, SRM = 1.35 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)

NA


NA

Time interval between baseline and follow-up assessments 7.5 weeks (.4 – 29.1)

384


Age range of sample 14.6 ± 2.5 (10.0 – 18.9) Number: 589 Sex

Male 288 (48.9%) Female 301 (51.1%)



OA PF



Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) NA Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2

Notes:

Physical functioning (PF), emotional limitations (EM), behavioral limitations (BL), physical limitations (PL), bodily pain (BP), mental health (MH), self esteem (SE), general health perceptions (GHP), and family activities (FA),

385

Documents

Summary of Clinical Outcome Measures for Sports … of Clinical Outcome Measures for Sports-Related Knee Injuries . Final Report . ... Patient input . ... Englishⱡ, French, German,