Thực Hành Y Học Chứng Cứ trong Y Tế Công Cộng

Thực Hành Y Học Chứng Cứ trong Y Tế Công Cộng

Gs Ts Bs Lê Hoàng Ninh

Thực hành y tế công cộng dựa trên

chứng cứ

Kiến thức/ nghiên cứu

Thực trạng bệnh nhân/

các tham khảo

Kinh nghiêm lâm sàng/ sự

cân nhắc

•“Một trong những khám phá quan trọng nhất, đáng kính ngạc nhất là biết cái mà Ta có thể làm và biết sợ cái mà Ta không thể làm.”

Henry Ford

Mục tiêu

1)Hiểu ý nghĩa về đánh giá các chứng cứ

2) Mô tả mức độ chứng cứ được dùng trong đánh giá các chứng cứ

3) Thăm dò các phương pháp khác như ( thống kê…) có thể dùng trong đánh giá chứng cứ.

4)ứng dụng qui trình nầy trong y tế công cộng.

Thực Hành Y Học Chứng Cứ

•Dùng những hiểu biết có chất lượng cao nhất trong chăm sóc sức khỏe cho cá nhân và cả cộng đồng

Đánh Giá Chứng Cứ

•Là chìa khóa quan trong trong thực hành chứng cứ

•Là kỹ năng cần, cốt lõi trong thực hành y học

Đánh Giá Chứng Cứ

•Phải đảm bảo rằng chứng cứ tìm thấy trên dân số nghiên cứu có thể được thực hiện trên dân số mà các bạn muốn áp dụng

Nội Dung Đánh Giá Chứng Cứ

•1) Định lượng sức / độ mạnh của chứng cứ khoa học

•2) Đánh giá chất lượng và khả năng áp dụng khi ra quyết định chăm sóc sức khỏe

1)Độ Mạnh của Bằng Chứng

•Xếp hạng độ mạnh của chứng cứ cần xem xét kết hợp :

•Chất lượng (Quality)▫Sai lệch hệ thống được giảm thiểu không?,

Như Thế nào? •Số Lượng (Quantity)

▫Độ lớn của ảnh hưởng, tác động, Số nghiên cứu, cỡ mẫu và lực của mẫu.

•Tính hằng định / Ổ định Những nghiên cứu khác, tương tự

cho kết quả giống nhau

1) Độ mạnh của chứng cứ

•Evidence exists on a continuum of rigor•Amount of research attention or maturity

of science varies, therefore evidence varies

•Type of research design reflects the strength of the evidence – known as levels of evidence Stevens & Ledbetter,

2000

Các Mức Độ của Chứng Cứ

•Xếp hạng cao là các chứng cứ từ những nghiên cứu can thiệp lâm sàng

•Độ mạnh của chứng cứ: tin cậy càng lớn khi xác suất áp dụng chứng cứ vào thực hành sẽ mang lại hiệu quả

•Các mức độ chứng cứ : được dựa vào loại thiết kế nghiên cứu

Các Mức Độ Chứng Cứ

•Experts have developed a number of taxonomies to rate strength of evidence

•Most are organized around research designs

Các Mức Độ Chứng Cứ• Theo National Guidelines Clearinghouse• Ia Evidence obtained from meta-analysis or systematic review

of randomized controlled trials• Ib Evidence obtained from at least one randomized controlled

trial

• IIa Evidence obtained from at least one well-designed controlled study without randomization

• IIb Evidence obtained from at least one other type of well-designed quasi-experimental study, without randomization

• III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, and case studies

• IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities

Mức Độ Chứng Cứ• “Rating System for the Hierarchy of Evidence” • Level I: Evidence from a systematic review or meta-

analysis of all relevant randomized controlled trials (RCTs), or evidence based clinical practice guidelines based on systematic reviews of RCTs

• Level II: Evidence obtained from at least one well-designed RCT

• Level III: Evidence obtained from well-designed controlled trials without randomization (quasi-experimental)

• Level IV: Evidence from well-designed case-control and cohort studies (studies of prognosis)

• Level V: Evidence from systematic reviews of descriptive and qualitative studies

• Level VI: Evidence form a single descriptive or qualitative study

• Level VII: Evidence from the opinion of authorities and/or reports of expert committees

(Melnyk & Fineout-Overholt, 2005)

Mức Độ Chứng Cứ• Hê thống xếp hạng mức độ chứng cứ• Type of evidence• I. Meta analysis or comprehensive systematic review of multiple

experimental research studies (Cochrane , National Guidelines Clearinghouse (AHRQ), The Joanna Briggs Institute, Other groups)

• II. Well designed experimental study• III. Well designed quasi-experimental study (Non-randomized controlled,

Single group pre-post design, Cohort, Time series (one group of subjects over time), Matched case-controlled studies (two or more groups are matched on certain variables)

• IV. Well designed non-experimental study (Correlational or comparative descriptive studies, Case study design, Qualitative studies)

• V. Clinical examples and expert opinion (Text books, Non-research journal articles, Verbal report, Non-research based professional standards/guidelines/

• group article) • Strength of evidence• A. Type I evidence or consistent findings from multiple studies from levels II,

III, or IV.• B. Multiple studies with evidence types II, III, or IV that are generally

consistent.• C. Multiple studies with evidence types II, III, or IV that are inconsistent.• D. Limited research evidence or one type II study only.• E. Type IV or V evidence only• • • •

Adapted from Joanna Briggs Institute and AHCPREilers & Heerman, 2005

The U.S. Preventive Services Task Force (2008)

Level of Certainty

Description

High The available evidence usually includes consistent results from well-designed, well conducted studies in representative primary care populations. Thee studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.

Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as:

• The number, size, or quality of individual studies• Inconsistency of findings across individual studies• Limited generalizability of findings to routine primary care practice • Lack of coherence in the chain of evidence

As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.

Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because:

• The limited number or size of studies• Important flaws in study design or methods• Inconsistency of findings across individual studies• Gaps in the chain of evidence• Findings not generalizable to routine primary care practices• Lack of information on important health outcomes

More information may allow estimation of effects on health outcomes

Đánh giá/ xem xét hệ thống (Systematic Reviews)

▫Provides state of the science conclusions about evidence supporting benefits and risks of a given healthcare practice (Stevens, 2001)

▫Most powerful and useful evidence available

▫Tổng hợp các kết quả có giá trị , được sử dụng từ các nghiên cứu nguyên phát vào trong thực hành lâm sàng

Systematic Reviews & Meta Analysis

Phân Tích Meta (Meta-Analysis)

•Cách tiếp cận thống kê để tổng hợp các kết quả từ các nghiên cứu – tóm tắt kết qủa từ các nghiên cứu đưa vào review

•Produces a larger sample size and thus greater power to determine the true magnitude of an effect, yields a summary statistic


Thử Nghiêm có nhóm chứng và phân phối ngẫu nhiên (Randomized Controlled Trial )

▫Experimental studies are the gold standard of research design (randomization of participants to treatment and control, rigorous methods used to minimize bias)

▫Provides most valid, dependable research conclusion about clinical effectiveness of an intervention and establishing cause and effect

▫Allows us to say with a high degree of certainty that the intervention we used was the cause of the outcome


Randomized Controlled Trials

Giả Thực Nghiệm (Quasi-Experimental )

▫Differs from RCT’s only in that participants are NOT randomized to treatment and control groups



Quasi-Experimental

Phi Thực Nghiệm Non-Experimental

▫ Cohort – participants are studied over time, study population shares common characteristics

▫ Case-Control – studies that address questions about harm or causation, investigates why some people develop a disease or behave the way they do vs others who do not

▫ Descriptive – main objective is to describe some phenomena

▫ Qualitative - "any kind of research that produces findings not arrived at by means of statistical procedures or other means of quantification" (Strauss and Corbin, 1990, p. 17).


Randomized Controlled TrialsQuasi-Experimental

Non-Experimental

. Ý Kiến chuyên gia và Thí dụ về lâm sàng(Clinical Examples & Expert Opinion).

▫Expert Opinion – arriving at a value judgement which incorporates the main information available on the subject as well as previous experiences

▫Clinical examples – ▫The “5 rights”



Quasi-Experimental

Non-Experimental

Clinical Examples & Expert Opinion

2) Đánh giá chất lượng và tính ứng dụng (Evaluating Quality & Applicability)

•What are the results?•Are the results valid?•Can the results be applied to the targeted

population and/or public health practice and intervention?

What are the results?

•Kết quả có tương tự với kết quả từ các n.cứu khác không ( nếu có systematic review hay meta-analysis)?

•Kết quả đó là gì?•Kết quả có chính xác

không?•Có thể có sự liên hệ bên

trong từ bộ dữ liệu không?

Kết quả có giá trị không?

•Does this article explicitly address our public health question?

•Was the search for our article detailed and exhaustive? Is it likely that important, relevant studies were missed?

•Does the study selected appear to be of high methodological quality?

•Do you feel the study selected is reproducible?

Kết quả có ứng dụng được không?

•How can the results be interpreted and applied to public health practice and intervention?

•Are study subjects similar to clients to whom care is to be delivered?

•Were all important outcomes considered?

•Are the benefits worth the costs and potential risks?

Search evidence rich resources first

EBP Rich Resources

•Cochrane review http://www.cochrane.org/reviews/

•DARE – Database of Abstracts of Reviews of

•Effectiveness http://www.mrw.interscience.wiley.com/cochrane/cochrane_cldare_articles_fs.html

Agency for Healthcare Research and Quality (AHRQ)

•National Guidelines Clearinghouse www.guidelines.gov

•Guide to Clinical Preventive Services (2008) http://www.ahrq.gov/clinic/pocketgd.htm

•Evidence reports ahrq www.ahrq.gov/clinic/epcix.htm

EBP Rich Resources for P/CHN

•Guide to Community Preventive Services•http://www.thecommunityguide.org/

index.html

Centers for Disease Control & Prevention

•CDC for Public Health Professionalshttp://www.cdc.gov/CDCForYou/

public_health_professionals.html

Association of State and Territorial Health Officials

•Evidence Based Practice•http://www.astho.org/?

template=evidence_based_ph_practice.html

National Association of City and County Public Health Officials

• The Model Practices Database• http://www.naccho.org/topics/modelpractices/• http://archive.naccho.org/modelPractices/

▫ Online searchable collection of practices across public health areas.

▫ Allows you to benefit from colleagues' experiences, to learn what works, and to ensure that resources are used wisely on effective programs that have been implemented with good results.

• The database features practices in the following areas:▫ Community Health ▫ Environmental Health ▫ Public Health Infrastructure ▫ Emergency Preparedness

EBP Rich Resources

•Health Services/Technology Assessment Text (HSTAT)

•http://hstat.nlm.nih.gov•Searchable collection of large, fulltext

practice guidelines, technology assessments and health information

EBP Rich Resources

•Health Policy Guide•http://www.healthpolicyguide.org/▫evidence-based policies to improve the

public’s health▫150 policy topics to support advocacy and

decision making at the state and local levels

EBP Rich Resources

•http://guides.nursinglibrary.yale.edu/content.php?pid=14371&sid=96991

•National Institute for Health & clinNICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.

Application Exercise

•PICO QUESTION:•For the 4 year old

pre-K age group, are there fewer injection site complications with giving the immunizations in the thigh as compared to giving the immunizations in the arm?

Cochrane Review

• Tinnion O, Hanlon M. Acellular vaccines for preventing whooping cough in children. Cochrane Database of Systematic Reviews 1999, Issue 2. Art. No.: CD001478. DOI: 10.1002/14651858.CD001478.pub2

• “…Differences in trial design precluded pooling of the efficacy data and results should be interpreted with caution. Most systemic and local adverse events were significantly less common with acellular than with whole cell pertussis vaccines….”

•Emailed page to print off

National Guidelines Clearinghouse

•1) General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). 2) Update: recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine.

http://www.guidelines.gov/summary/summary.aspx?doc_id=12325&nbr=006390&string=vaccine+AND+administration+AND+site+AND+route


• Injection Route and Injection Site• With the exception of Bacillus Calmette-Guerin

(BCG) vaccine, injectable vaccines are administered by the intramuscular and subcutaneous route. The method of administration of injectable vaccines is determined, in part, by the presence of adjuvants in some vaccines. The term adjuvant refers to a vaccine component distinct from the antigen that enhances the immune response to the antigen. The majority of vaccines containing an adjuvant (e.g., DTaP, DT, Td, Tdap, PCV, Hib, HepA , HepB, and HPV) should be injected into a muscle because administration subcutaneously or intradermally can cause local irritation, induration, skin discoloration, inflammation, and granuloma formation.


•Routes of administration are recommended by the manufacturer for each immunobiologic. Deviation from the recommended route of administration might reduce vaccine efficacy or increase local adverse reactions.

CDC: Advisory Committee on Immunization Practices

•Route •Administering a vaccine by the

recommended route is imperative. Deviation from the recommended route of administration might reduce vaccine efficacy or increase the risk of local reactions. (p. D5)

CDC: Advisory Committee on Immunization Practices• Site • Although there are several IM injection sites

on the body, the recommended IM sites for vaccine administration are the vastus lateralis muscle (anterolateral thigh) and the deltoid muscle (upper arm). The site depends on the age of the individual and the degree of muscle development.

• The usual sites for vaccine administration subcutaneously are the thigh (for infants <12 months of age) and the upper outer triceps of the arm (for persons >12 months of age). If necessary, the upper outer triceps area can be used to administer subcutaneous injections to infants.


•Injectable Vaccine Administration for Children Birth to 6 years

•IM ▫anterolateral thigh or deltoid – Use of

deltoid muscle in children 18 monts and older (if adequate muscle mass) is an option for IM injections (p. D22)

•SC ▫anterolateral thigh or lateral upper arm (p.

D22)

• Schecter, Zempsky, Cohen, McGrath, McMurtry, & Bright (2007). Pain reduction during pediatric immunizations: evidence-based review and recommendations. Pediatrics, 119(5), e1184-98.

• Evidence is limited and somewhat controversial…..▫The limited data available suggests that

intramuscular administration of immunizations should occur in the anterolateral thigh or vastus lateralis for children < 18 months of age and in the upper arm or deltoid for those > 36 months of age.

▫Controversy exists in site selection for 18 to 36 month old children.

Schecter, Zempsky, Cohen, McGrath, McMurtry, & Bright (2007). Pain reduction during pediatric immunizations: evidence-based review and recommendations. Pediatrics, 119(5), e1184-98.

•The shift from thigh to arm should occur when the upper arm has adequate muscle mass to allow injection. This shift is driven by research with 18month old infants that suggests that injection in the thigh is more painful and causes more incapacitation (decreased movement of the extremity, limping) than injection in the arm. However, redness and swelling was found to occur more frequently when given in the arm.

Application Exercise

•PICO QUESTION:•For the 4 year old pre-K age group, are

there fewer injection site complications with giving the immunizations in the thigh as compared to giving the immunizations in the arm?

Source Level of Evidence

Cochrane Review ?


?


?

Evidence Based Review ?

Cochrane Review


CDC: ACIP

Evidence Based Review

Did the Evidence Answer our PICO Question?

Documents

Thực Hành Y Học Chứng Cứ trong Y Tế Công Cộng