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ΣΗΜΕΙΩΣΕΙΣ ΕΡΕΥΝΗΤΙΚΗΣ ΜΕΘΟΔΟΛΟΓΙΑΣ Π. Σκαπινάκης

Research Methodology

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Research methodology

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  • .

  • 1.

    ,

    () (Evidence Based Medicine)

    )

    [1] )

    [2].

    ,

    , ,

    .

    ,

    .

    .

    .

    , () . ,

    ( ). ,

    ( ). ,

    .

    2.

    .

    ,

    .

    Feinstein [3]

  • 2

    . (

    , , -

    ) .

    (

    )

    (

    ,

    ). ,

    .

    ( 1)

    , , ,

    .

    (,

    , , )

    ( randomized

    controlled trials) [4].

    -.

    ( 2)

    1:

    -

    ( , ,

    ..)

  • 3

    2:

    ,

    - (screening)

    ,

    - /

    2.1 (Observational Studies)

    .

    :

    .

    2.1.1 (Ecological Studies):

    (association)

    (aggregate) (individual).

    ' ' [1],

    .

    Lewis . [5]

    (Standardised Mortality Rate -

    SMR) .

    .

    .

    .

    ( . )

  • 4

    .

    .

    2.1.2 (Cross-sectional surveys):

    ('' '

    ' - outcome) ('' ' '

    - exposure) .

    ( - )

    -

    . ,

    () .

    ,

    .

    1.

    Skapinakis . [6].

    10000

    +

    -

    + -

    a b

    c d

    : = a/a+c

    b/b+d

    odds ratio (ad/bc)

    1:

  • 5

    .

    ,

    .

    ,

    ,

    .

    2.1.3 (Case control studies):

    , .

    '

    ,

    .

    d

    c

    b

    a

    : Odds Ratio = ad/bc

    2: -

  • 6

    (odds ratios).

    2. ,

    , .. .

    , (.

    ).

    . , Kendell . [7]

    -

    .

    . ,

    [8]

    , .

    ,

    .

    .

  • 7

    2.1.4 (Cohort Studies Longitudinal studies):

    ,

    (..

    ) (..

    ).

    . (..

    ) .

    (relative risks),

    (

    ).

    3. -

    . ,

    .

    .

    . ,

    -

    +

    -

    + (a)

    - (b)

    + (c)

    - (d)

    : a/a+b c/c+d

    3:

    -

  • 8

    ,

    .

    [4]. (

    , )

    .

    , .

    -

    ,

    . Doll

    Hill .

    Framingham [10].

    2.2. (Experimental studies)

    ,

    4:

  • 9

    .

    (randomized controlled trials

    RCTs).

    [11].

    o

    (

    confounding ).

    , .

    [11].

    RCTs (

    )

    .

    RCT , ..

    . ,

    RCT.

    :

    .

    4 RCTs.

    ( )

    .

    .

    (concealment)

    RCT [12].

    .

  • 10

    . RCTs ,

    .

    .

    RCTs

    .

    .

    . ,

    ,

    .

    RCT

    .

    ,

    (intention to treat analysis).

    , ,

    (..

    ).

    ,

    .

    ,

    , .

    RCTs

    ,

    . [13]:

    ) : RCTs

    ( ,

  • 11

    ...),

    [14],

    ) :

    , .

    ,

    ) RCTs:

    RCTs

    .

    ,

    .

    2.3

    , , , ,

    , ,

    - [15]. ,

    .

    ( )

    -,

    .

    -

    ,

    .

    3.

    (publication bias)

    ,

  • 12

    (

    ) [16].

    (funnel plot).

    3: :

    (

    )

    , .

    [17,18].

    .

    Cochrane (Cochrane

    Collaboration)

    -.

    Archie Cochrane,

    Cardiff ,

    . Cochrane

    . 1993

    77 11 Cochrane.

    RCTs

    1948

  • 13

    .

    Internet Cochrane Library (www.cochrane.org

    ,

    ).

    3.

    3.1

    (population)

    , ..

    50-70 .

    (sample) , .

    . ,

    (random) (representative)

    .

    100

    (50% , 50% ),

    55 44 .

    .

    (). (sampling variation).

    ,

    .

    !

    3.2

    :

    ;

  • 14

    ,

    ,

    :

    , H0,

    , H1

    .

    p (p-

    value). p

    , .

    p, .. 0,05,

    ,

    . , p

    . , p

    0,05 ( 5%).

    0,05 ,

    ( , ..

    , p).

    3.3

    ,

    :

    -

    . 5%,

    5%

    .

    .

    -

    . ,

    p

    .

    .

  • 15

    (. )

    .

    3.4

    (power)

    .

    .

    : ) ( 5%),

    )

    ) .

    .

    ,

    .

    80%.

    5%.

    3.5

    5%

    5%.

    4% 6%.

    20 p

    .

    .

    3.6

    (.. ,

    ..) .

    ,

    , .. , .

  • 16

    .

    (standard error)

    .

    ,

    (standard deviation)

    . ,

    .

    :

    95% = (1,96* SE)

    , = SE= .

    ,

    p,

    4.

    ,

    (association)

    . ,

    (exposure) (outcome) [4].

    () ,

    [1].

    .

    .

    .

    ( 5) [19]:

  • 17

    1. (chance) (random

    variation).

    2. (bias).

    3. (confounding).

    4. (reverse causality).

    5. (causality).

    ..

    .

    4. 1.

    .

    . ,

    .

    XY

    YX

    . !

    5:

  • 18

    (.. 5%)

    .

    ,

    .

    .

    .

    4.2

    , .

    ,

    .

    [16,20]:

    (Selection bias) (information or

    measurement bias).

    .

    ,

    ,

    (case-control).

    . ,

    . -

    .

    ,

    [21]. ,

    . ,

    .

  • 19

    [8].

    . , , ,

    . (recall bias)

    [1].

    . ,

    o

    . (..

    ) ,

    . ,

    (randomized controlled trials),

    , .. ,

    (.. )

    ,

    .

    4.3 (Confounding)

    , ,

    [4]. : )

    ) .

    .

    , .

    . ( 6)

    () ().

    .

    .

  • 20

    .

    . ,

    [4].

    4.4 (reverse causality)

    ,

    , ,

    , . ,

    ,

    ,

    .

    , .

    4.5

    ,

    .

    .

    ,

    Bradford Hill ( 7) [20].

    6:

  • 21

    1960 70 [9].

    5.

    . :

    , (outcome)

    , , (..

    )

    .

    5.1 (Health Outcomes)

    ,

    ( )

    (exposure)

    ( )

    ( )

    ( )

    ( )

    ( )

    ( ;)

    ( , )

    ( ;)

    ( )

    7: Hill

  • 22

    . ,

    : )

    (.. ,

    ) )

    . -

    .

    ( )

    ,

    .. ( ).

    ,

    : ) (Death), ) (Disability), )

    (Disease Status), )

    (Dissatisfaction with process of care) )

    (Discomfort about the effects of disease). ,

    five Ds [22].

    5.2 (Measures of Effect)

    (

    )

    . , :

    (relative measures) (absolute measures).

    (relative risk)

    (odds ratio).

    ,

    [2].

    .

    90%,

    30%.

    (relative risk reduction) 66% (90%-30% / 90%

    =66%). (absolute risk reduction) 60% (90% -

    30% = 60%). , 9%,

  • 23

    3%, 66%

    6%.

    ,

    .

    ,

    .

    ( )

    (absolute risk)

    (attributable risk) ,

    (number needed to treat)

    () [2].

    ,

    .

    , NNT

    ,

    .

    90% 30% ,

    60%

    100/60=1,66 . 9% 3% ,

    6% 16,66 .

    NNT

    .

  • 24

    [1] Last JM. A dictionary of Epidemiology 3d edition. Oxford University Press: New York

    1995.

    [2] Sackett B, Straus S, Richardson WS, Rosenberg W, Haynes RB. Evidence Based

    Medicine: How to practice and teach EBM. 2nd Edition. Churchill Livingstone: Edinburgh

    2000.

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    Clinical Pharmacology and Therapeutics 15:97-107.

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    Brown and Company 1996.

    [5] Lewis G, Appleby L, Jarman B. (1994). Suicide and psychiatric services. Lancet 344, 822.

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    unexplained chronic fatigue and psychiatric morbidity: results from a community survey in

    Great Britain. American Journal of Psychiatry 157:1492-1498.

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    case-control study based on standardised obstetric records. British Journal of Psychiatry 168,

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    schizophrenia: two case-control studies based on structured obstetric records. British Journal

    of Psychiatry 176, 516-522.

    [9] Doll R, Hill AB (1964). Mortality in relation to smoking: Ten year's observation of British

    doctors. BMJ 1:1399-1410.

    [10] Dawber TR, Meadors GF, Moore FG (1951). The epidemiological approach to heart

    disease: The Framingham study. American Journal of Public Health 41: 279-286.

    [11] Pocock SJ. Clinical Trials. A practical Approach. John Wiley & Sons: Chichester 1983.

    [12] Kunz R, Oxman AD (1998). The unpredictability paradox: review of empirical

    comparisons of randomised and non-randomised clinical trials.

    BMJ 317, 1185-1190.

    [13] Black, N (1996) Why we need observational studies to evaluate the effectiveness of

    health care BMJ 312, 1215-8

    [14] McKee M, Britton A, Black N, McPherson K, Sanderson C, Bain C (1999). Methods in

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    randomised studies. BMJ 319, 312-5.

    [15] (2001). . 17:232-

    236.

  • 25

    [16] (2001). .

    17:440-445.

    [17] Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated.

    Br Med J 1994, 309, 1351-1355.

    [18] Lau J, Ioannidis JPA, Schmid CH. Summing up evidence: one answer is not always

    enough. Lancet 1998, 351, 123-127.

    [19] Lewis G, Thomas H, Cannon M, Jones P. Epidemiological Methods. In Textbook of

    Community Psychiatry, edited by Thornicroft G and Szmukler G. Oxford University Press:

    Oxford 2001.

    [20] Rothman KJ, Greenland S. Modern Epidemiology 2nd edition. Lippincott Williams and

    Wilkins: Philadelphia 1998.

    [21] Brown GW, Harris T. Social Origins of Depression. Tavistock: London 1978.

    [22] Muir Gray J. Evidence based health care. How to make health policy and management

    decisions. Churchill Livingstone:New York 1997.

  • .

  • , - .1 , ( , , -), -, .2 ,, (evidence-based medicine),3 , , , . -, - , , .

    ; , ; ; -, , - . British Medical Journal , , , Internet (www.bmj.com).

    ( ). 4 -, 1993, , , , - , , . , - 19501997 - , , - -. , , , 1960 .

    .5 , , . -, , . (randomizedcontrolled trial, RCT) - .6

    7 (. 1). , -

    EDITORIAL

  • 17(5), 2000 441

    , , -, -, (.., , ), , , . , - , - - , -. , , .8 -, -. , , -:

    , - ;

    19501997;

    , ;

    , , , , .

    , , , -. , - Murlow,9 , , :

    . (gen-eralisability), (consistency) (inconsistency) . , - - , 4 .6 , -, . , 4 (trend) , , (. 2). , , -, .5

    . (power) (precision) - (effect).

    1 . .

    2 . . -.*

    1 155/1906 187/1900 0,81 (0,651,01) 2 56/2051 84/2030 0,65 (0,460,92) 3 174/3302 248/3293 0,68 (0,560,83) 4 56/3304 96/3301 0,58 (0,410,80) 441/10563 615/10524 0,70 (0,620,79)

    * Pignone et al. Br Med J 2000, 321:15. :

    ( / ) ( / ) ( 9 5 % )

  • (as-sociation), .10 . , ( ) .11 2, - -,6 , , 1906 - , 155 ( 81,3 1000). , 187 1900 ( 98,4 1000). 3800 , 17,1 1000 . , , - 43%!12

    , 6.500 , 80%. , ( ), - , , (chance). , - ( ' ) , , 20.000 , .

    - , -, (precision) . , 95% . - , , - , . , - - (point es-timate) - (odds ratio) -. 95% - , ,

    , (true value) (-, 2, 0,46 0,92 0,620,79).

    - (. 1). , ' - . . (biases), (selection bias).

    , -.13 - (association) . , , (random error) (confounding), . ' , - . - -. , , - .

    , - . (reference population), , - , ,

    442 ARCHIVES OF HELLENIC MEDICINE 17(5), 2000

  • . , , - . -, , - ( ) (eligible population).

    (. 3). , - - -. - ., . - , , (publication/citationbias).14 , .15 , . , - -. - !

    , ; . , , .

    , -.16 () , .. MedLine, Em-base, Cinahl, Psychinfo, Current Contents, () , - - ( 100%). - ' ,() - , , , , , () , () - , () , on-line Cochrane(Cochrane Collaboration), () , .. (gray literature).

    , . , . -, - .( : , - ). , , :4 () 19801996 19791996 , () 19501997,

    17(5), 2000 443

    3 . .

    1. (source population) 2.

    (eligible population)

  • 19751997 , () -, () , , 19701995, () 19601995. ( , !). , . .., , , - .

    , . - (inclusion-exclusion), , . , , . , -, - - , , , :5 () , 65 , . , - . () , , (blind). () ,

    , , , .., - , , , , .., , - (falls) . , . , - 244 . , 29 15 .

    (data extraction) .7 -, , , , , - , -, , , , , , .. , - , -, , . (heterogeneity) .17 ( ), ( ) ( ). -, , .18

    , -. -, : () - , .

    444 ARCHIVES OF HELLENIC MEDICINE 17(5), 2000

  • 17(5), 2000 445

    , , , - , , . () - , . () - , , , x2 . ' , (weight-ed average) .

    . -, , . . . . , , - - . ,, . , , .18 , ,19 , , , , -, - , - .

    .

    ,

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    5. VAN HAASTREGT J, DIEDERIKS J, VAN ROSSUM E, DE WITTE L, CREBOLD-ER H. Effects of preventive home visits to elderly people living inthe community: systematic review. Br Med J 2000, 320:754758

    6. PIGNONE M, PHILLIPS C, MULROW C. Use of lipid lowering drugs forprimary prevention of coronary heart disease: meta-analysis ofrandomised trials. Br Med J 2000, 321:15

    7. McKIBBON A. PDQ Evidence-based Principles and Practice. Hamil -ton, Ontario, BC Decker Inc, 1999:125133

    8. SPASOFF RA. Epidemiologic Methods for Health Policy . New York,Oxford University Press, 1999:128131

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    10. LAST JM (ed). A Dictionary of Epidemiology. 3rd ed. New York, Ox-ford University Press, 1995:128

    11. ALTMAN DG. Practical Statistics for Medical Research . London,Chapman & Hall, 1991:455460

    12. STATA CORPORATION. Stata Version 4.0. Texas, Stata Corporation,College Station, 1995

    13. SACKETT DL . Bias in analytical research. J Chronic Dis 1979, 32:5163

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