ọ
ự ứ
ứ ộ
Th c Hành Y H c Ch ng ế C trong Y T Công C ng
Gs Ts Bs Lê Hoàng Ninh
ự
ế
ự
ứ
ứ
Th c hành y t công ộ c ng d a trên ch ng c
ệ
ự
ế
ứ
Ki n th c/ nghiên c uứ
Kinh nghiêm lâm sàng/ s ự cân nh cắ
ạ Th c tr ng b nh nhân/ các tham kh o ả
ữ ọ
ộ ấ đ ế ấ
ể • “M t trong nh ng khám phá quan tr ng ạ nh t, áng kính ng c nh t là bi t cái mà ế ợ ể Ta có th làm và bi t s cái mà Ta không th làm.”
Henry Ford
ụ
M c tiêu
ể ứ
ứ đượ c dùng trong
đ
ề đ ứ ĩ 1)Hi u ý ngh a v ánh giá các ch ng c ứ ả ứ độ ch ng c 2) Mô t m c ứ ứ ánh giá các ch ng c ư ươ ng pháp khác nh 3) Th m dò các ph ể đ
ứ ứ
ụ ế ầ 4) ng d ng qui trình n y trong y t công
ă ố ( th ng kê…) có th dùng trong ánh giá ch ng c . ứ c ng.ộ
ự
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Th c Hành Y H c Ch ng C
ữ
ng cao
ấ ượ ỏ
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ấ
•Dùng nh ng hi u bi t có ch t l ể ă đồ ng
ế nh t trong ch m sóc s c kh e cho cá nhân ả ộ và c c ng
ứ
Đánh Giá Ch ng Cứ
ự
•Là chìa khóa quan trong trong th c hành
ầ
ố
ứ ứ ch ng c ỹ ă
•Là k n ng c n, c t lõi
ự trong th c hành y
h c ọ
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Đánh Giá Ch ng Cứ
ả đả
ả ằ
ấ
•Ph i m b o r ng ố
ứ ch ng c tìm th y ự ể đượ ứ có th c th c ạ
ố
ố
ứ trên dân s nghiên c u hi n ệ trên dân s mà các b n mu n áp d ngụ
ứ
ộ
ứ
N i Dung Đánh Giá Ch ng C
ượ độ ạ ứ ng s c / m nh ứ ứ ủ c a ch ng c
• 1) nh l Đị khoa h cọ
Đ ụ • 2) ánh giá ch t l
ả ă ứ ế đị ấ ượ ng và kh n ng áp d ng ỏ ă khi ra quy t nh ch m sóc s c kh e
ộ ạ
ứ
ủ
ằ
1)Đ M nh c a B ng Ch ng
ả
ệ ố
ứ ầ ủ ứ độ ạ m nh c a ch ng c c n xem xét
ể
▫Sai l ch h th ng
ư c gi m thi u không?, Nh
ng (Quality) đượ
độ
ứ
ố
ng, S nghiên c u,
ng (Quantity) ưở
ươ ự ế ng t cho k t
ố • X p h ng ạ ế ế ợ k t h p : • Ch t l ấ ượ ệ ế Th nào? • S L ố ượ ▫ l n c a nh h Độ ớ ủ ả ng, tác ẫ ự ủ ỡ ẫ c m u và l c c a m u. • Tính h ng nh / Ổ đị đị ằ nh ứ ữ Nh ng nghiên c u khác, t gi ng nhau qu ả
ộ ạ
ủ
ứ
ứ
1) Đ m nh c a ch ng c
• Evidence exists on a continuum of rigor • Amount of research attention or maturity of
science varies, therefore evidence varies
Stevens & Ledbetter, 2000
• Type of research design reflects the strength of the evidence – known as levels of evidence
ứ
ứ
ứ
ộ ủ Các M c Đ c a Ch ng C
ế ứ ừ ữ ứ • X p h ng cao ạ là các ch ng c t nh ng
ứ ệ nghiên c u can thi p lâm sàng
• ủ ứ ậ ớ m nh c a ch ng c :
ự ứ ấ
ạ ả ứ tin c y càng l n Độ ạ ứ ụ khi xác su t áp d ng ch ng c vào th c ệ ẽ hành s mang l i hi u qu
đượ ự • Các m c c d a vào
ứ : ứ ứ độ ứ ch ng c ế ế lo i ạ thi t k nghiên c u
ứ
ứ
ứ
ộ Các M c Đ Ch ng C
• Experts have developed a number of taxonomies to rate strength of evidence
• Most are organized
around research designs
ứ
ứ
ứ
ộ Các M c Đ Ch ng C
• Theo National Guidelines Clearinghouse • Ia Evidence obtained from metaanalysis or systematic review of
randomized controlled trials
• Ib Evidence obtained from at least one randomized controlled trial
• IIa Evidence obtained from at least one welldesigned controlled study
without randomization
• IIb Evidence obtained from at least one other type of welldesigned quasi
experimental study, without randomization
• III Evidence obtained from welldesigned nonexperimental 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
ộ
ứ
M c Đ Ch ng C
ứ ứ • “Rating System for the Hierarchy of Evidence” • Level I: Evidence from a systematic review or metaanalysis 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 welldesigned
RCT
• Level III: Evidence obtained from welldesigned controlled
trials without randomization (quasiexperimental)
• Level IV: Evidence from welldesigned casecontrol 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 & FineoutOverholt, 2005)
ộ
ứ
ứ
ứ
ứ độ ứ
ứ
ạ
ch ng c
M c Đ Ch ng C • Hê th ng x p h ng m c ế ố • 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 quasiexperimental study (Nonrandomized controlled, Single group prepost design, Cohort, Time series (one group of subjects over time), Matched casecontrolled studies (two or more groups are matched on certain variables) • IV. Well designed nonexperimental study (Correlational or comparative
descriptive studies, Case study design, Qualitative studies)
• V. Clinical examples and expert opinion (Text books, Nonresearch journal articles, Verbal report, Nonresearch 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
The U.S. Preventive Services Task Force (2008)
Level of Certainty
Description
High
The available evidence usually includes consistent results from welldesigned, 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
ệ ố
Đánh giá/ xem xét h th ng (Systematic Reviews)
▫Provides state of the science conclusions about
evidence supporting benefits and risks of a given healthcare practice (Stevens, 2001)
ổ
ợ
▫Most powerful and useful evidence available ▫T ng h p các k t qu có giá tr , ị đượ ử ụ ả ế
ứ
ự
ừ c s d ng t các nghiên c u nguyên phát vào trong th c hành lâm sàng
Systematic Reviews & Meta Analysis
Phân Tích Meta (MetaAnalysis)
ế để ổ ố ợ • Cách ti p c n th ng kê ậ ả t ng h p các k t qu
ắ ế ủ ừ
ứ đư ế ứ ừ t các nghiên c u – tóm t t k t q a t các a vào review nghiên c u
• 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
ử
ứ
ẫ
ố
Th Nghiêm có nhóm ch ng và phân ph i ng u 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
Systematic Reviews & Meta Analysis
ả
ự
ệ
Th c Nghi m Gi (QuasiExperimental )
▫Differs from RCT’s only in that participants are NOT randomized to treatment and control groups
Quasi Experimental
Randomized Controlled Trials
Systematic Reviews & Meta Analysis
ự
ệ
Phi Th c Nghi m NonExperimental
▫Cohort – participants are studied over time, study
population shares common characteristics
▫CaseControl – 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).
NonExperimental
QuasiExperimental
Randomized Controlled Trials
Systematic Reviews & Meta Analysis
ế
ụ ề
. Ý Ki n chuyên gia và Thí d v 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”
Clinical Examples & Expert Opinion
Non Experimental
Quasi Experimental
Randomized Controlled Trials
Systematic Reviews & Meta Analysis
ứ
ng và tính ng
ấ ượ Evaluating Quality & Applicability)
2) Đánh giá ch t l ụ d ng ( • 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?
• K t qu có t ng t v i
ế ế ự ớ ứ
ả ả ừ ế
ươ k t qu t các n.c u khác không ( n u có systematic review hay metaanalysis)?
ế ế
• K t qu ó là gì? ả đ • K t qu có chính xác ả không? ể ệ
• Có th có s liên h bên ự ừ ộ ữ ệ trong t b d li u không?
ế
ả
ị
K t qu có giá tr 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?
ụ
ế
ả
ượ
ứ K t qu có ng d ng đ
c 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/coch rane/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 Professionals http://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/
▫evidencebased 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 & clin
NICE 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 preK 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
National Guidelines Clearinghouse
• Injection Route and Injection Site • With the exception of Bacillus CalmetteGuerin
(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.
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.
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.
CDC: Advisory Committee on Immunization Practices
• Injectable Vaccine Administration for Children
Birth to 6 years
▫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)
• IM
▫anterolateral thigh or lateral upper arm (p. D22)
• SC
• Schecter, Zempsky, Cohen, McGrath, McMurtry, & Bright (2007). Pain reduction during pediatric immunizations: evidencebased review and recommendations. Pediatrics, 119(5), e118498.
• 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: evidencebased review and recommendations. Pediatrics, 119(5), e118498.
• 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 preK 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
?
National Guidelines Clearinghouse
?
?
CDC: Advisory Committee on Immunization Practices
Evidence Based Review
?
Cochrane Review
Did the Evidence Answer our PICO Question?
