Bài giảng Thực hành Y học Chứng cứ trong Y tế Công cộng giáo sư thạc sĩ bác sĩ Lê Hoàng Ninh

Bài giảng Thực hành Y học Chứng cứ trong Y tế Công cộng giáo sư thạc sĩ bác sĩ Lê Hoàng Ninh Bài giảng Thực hành Y học Chứng cứ trong Y tế Công cộng giáo sư thạc sĩ bác sĩ Lê Hoàng Ninh Bài giảng Thực hành Y học Chứng cứ trong Y tế Công cộng giáo sư thạc sĩ bác sĩ Lê Hoàng Ninh Bài giảng Thực hành Y học Chứng cứ trong Y tế Công cộng giáo sư thạc sĩ bác sĩ Lê Hoàng Ninh

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

Câu Hỏi

PICO

Tìm kiếm trên y văn

Đánh Giá chứng cứ

Mục tiêu

đánh giá các chứng cứ

kê…) có thể dùng trong đánh giá chứng cứ

Cây hỏi PICO

Tìm y văn

Đánh giá chứng cứ

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

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 chứng cứ

science varies, therefore evidence varies

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

• 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 experimental study, without randomization

quasi-• 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

• 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

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)

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

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

Systematic Reviews & Meta Analysis

Randomized Controlled Trials

Giả Thực Nghiệm

(Quasi-Experimental )

▫ Differs from RCT’s only in

that participants are NOT

randomized to treatment

and control groups

Systematic Reviews & Meta Analysis

Randomized Controlled Trials

Experimental

Quasi-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 )

Systematic Reviews & Meta Analysis

Randomized Controlled Trials Quasi-Experimental

Non-Experimental

Ý Kiến chuyên gia và Thí dụ về lâm sàng

(Clinical Examples & Expert Opinion).

at a value judgement which

incorporates the main

information available on the

subject as well as previous

experiences

▫ The “5 rights”

Systematic Reviews & Meta Analysis

Randomized Controlled Trials

Experimental

Quasi- Experimental

Non-Clinical Examples &

Expert Opinion

2) Đánh giá chất lượng và tính ứng

dụng (Evaluating Quality & Applicability )

population and/or public health practice and intervention?

What are the results?

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

Kết quả có giá trị không?

health question?

exhaustive? Is it likely that important, relevant studies were missed?

• Does the study selected appear to be of high

methodological quality?

Kết quả có ứng dụng được không?

and applied to public health practice

and intervention?

to whom care is to be delivered?

considered?

potential risks?

Search evidence rich resources first

EBP Rich Resources

Agency for Healthcare Research and Quality (AHRQ)

EBP Rich Resources for P/CHN

• http://www.thecommunityguide.org/inde x.html

Centers for Disease Control &

Prevention

http://www.cdc.gov/CDCForYou/public_h ealth_professionals.html

Association of State and Territorial

Health Officials

• http://www.astho.org/?template=evidenc e_based_ph_practice.html

National Association of City and County

Public Health Officials

• The database features practices in the following areas:

▫ Community Health

▫ Environmental Health

▫ Public Health Infrastructure

▫ Emergency Preparedness

EBP Rich Resources

(HSTAT)

• http://hstat.nlm.nih.gov

guidelines, technology assessments and health information

EBP Rich Resources

▫ 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

hp?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:

age group, are there

fewer injection site

Cochrane Review

preventing whooping cough in children Cochrane

Database of Systematic Reviews 1999, Issue 2 Art

No.: CD001478 DOI:

10.1002/14651858.CD001478.pub2

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

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

(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

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

• 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

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:

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

giving the immunizations in the arm?

Source Level of Evidence

Did the Evidence Answer our PICO Question?