Thực Hành Y Học Chứng Cứ trong Y Tế Công Cộng

1. Thực Hành Y Học Chứng Cứ trong Y Tế Công Cộng Gs Ts Bs Lê Hoàng Ninh

2. Thực hành y tế công cộng dựa trên chứng cứ Kinh nghiêm lâm sàng/ sự cân nhắc Thực trạng bệnh nhân/ các tham khảo Kiến thức/ nghiên cứu

4. “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

5. Mục tiêu • Hiểu ý nghĩavềđánhgiácácchứngcứ • Môtảmứcđộchứngcứđượcdùngtrongđánhgiácácchứngcứ • Thămdòcácphươngphápkhácnhư ( thốngkê…) cóthểdùngtrongđánhgiáchứngcứ. • ứngdụng qui trìnhnầytrong y tếcôngcộng.

6. 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

7. 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

8. 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

9. 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

10. 1)ĐộMạnhcủaBằngChứng • Xếphạngđộmạnhcủachứngcứcầnxemxétkếthợp : • Chấtlượng (Quality) • Sailệchhệthốngđượcgiảmthiểukhông?, NhưThếnào? • SốLượng (Quantity) • Độlớncủaảnhhưởng, tácđộng, Sốnghiêncứu, cỡmẫuvàlựccủamẫu. • Tínhhằngđịnh / Ổ định Nhữngnghiêncứukhác, tươngtựchokếtquảgiốngnhau

11. 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

12. 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

13. Các Mức Độ Chứng Cứ • Experts have developed a number of taxonomies to rate strength of evidence • Most are organized around research designs

14. 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

15. 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)

16. MứcĐộChứngCứ • Hêthốngxếphạngmứcđộchứngcứ • 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 AHCPR Eilers & Heerman, 2005

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

19. 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

20. 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 Systematic Reviews & Meta Analysis

21. ThửNghiêmcónhómchứngvàphânphốingẫunhiên (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 Systematic Reviews & Meta Analysis

22. GiảThựcNghiệm(Quasi-Experimental ) • Differs from RCT’s only in that participants are NOT randomized to treatment and control groups Quasi-Experimental Systematic Reviews & Meta Analysis Randomized Controlled Trials

23. Phi ThựcNghiệm 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). Non-Experimental Systematic Reviews & Meta Analysis RandomizedControlledTrials Quasi-Experimental

24. . Ý KiếnchuyêngiavàThídụvềlâmsàng(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” Clinical Examples & Expert Opinion Systematic Reviews & Meta Analysis Non-Experimental Quasi-Experimental Randomized Controlled Trials

25. 2) Đánhgiáchấtlượngvàtínhứngdụng (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?

26. What are the results? • Kếtquảcótươngtựvớikếtquảtừcácn.cứukháckhông ( nếucó systematic review hay meta-analysis)? • Kếtquảđólàgì? • Kếtquảcóchínhxáckhông? • Cóthểcósựliênhệbêntrongtừbộdữliệukhông?

27. Kếtquảcógiátrịkhông? • 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?

28. 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?

29. Search evidence rich resources first

30. 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

31. 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

32. EBP Rich Resources for P/CHN • Guide to Community Preventive Services • http://www.thecommunityguide.org/index.html

33. Centers for Disease Control & Prevention • CDC for Public Health Professionals http://www.cdc.gov/CDCForYou/public_health_professionals.html

34. Association of State and Territorial Health Officials • Evidence Based Practice • http://www.astho.org/?template=evidence_based_ph_practice.html

35. 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

36. 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

37. 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

38. 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.

39. 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?

40. 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

41. 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

42. National Guidelines Clearinghouse • 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.

43. National Guidelines Clearinghouse • 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.

44. 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)

45. 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 vastuslateralis 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.

46. CDC: Advisory Committee on Immunization Practices • 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)

47. 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 vastuslateralis 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.

48. 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.

49. 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?