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Systematic Review and Meta-Analysis

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Presentation on theme: "Systematic Review and Meta-Analysis"— Presentation transcript:

Critical Reading Strategies: Overview of Research Process

What is a review? An article which looks at a question or subject and seeks to summarise and bring together evidence on a health topic.

Protocol Development.

Introducing... Reproduced and modified from a presentation produced by Zoë Debenham from the original presentation created by Kate Light, Cochrane Trainer.

Critical Appraisal Dr Samira Alsenany Dr SA 2012 Dr Samira alsenany.

Accessing Sources Of Evidence For Practice Introduction To Databases Karen Smith Department of Health Sciences University of York.

Chapter 7. Getting Closer: Grading the Literature and Evaluating the Strength of the Evidence.

Developing Research Proposal Systematic Review Mohammed TA, Omar Ph.D. PT Rehabilitation Health Science.

Their contribution to knowledge Morag Heirs. Research Fellow Centre for Reviews and Dissemination University of York PhD student (NIHR funded) Health.

Reading Scientific Papers Shimae Soheilipour

Evidence Based Practice

THE COCHRANE LIBRARY ON WILEY INTERSCIENCE. Presentation Agenda Brief introduction of Evidence-Based Medicine theories The Cochrane Collaboration – origins,

Systematic Reviews.

Evidence Based Medicine Meta-analysis and systematic reviews Ross Lawrenson.

Introduction to Systematic Reviews Afshin Ostovar Bushehr University of Medical Sciences Bushehr, /9/20151.

COLLEEN KENEFICK, MLS, AHIP HEALTH SCIENCES LIBRARY STONY BROOK UNIVERSITY How to Conduct Literature Searches.

Evidence-Based Public Health Nancy Allee, MLS, MPH University of Michigan November 6, 2004.

This material was developed by Oregon Health & Science University, funded by the Department of Health and Human Services, Office of the National Coordinator.

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Wipanee Phupakdi, MD September 15, Overview  Define EBM  Learn steps in EBM process  Identify parts of a well-built clinical question  Discuss.

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How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses

Affiliations.

• 1 Behavioural Science Centre, Stirling Management School, University of Stirling, Stirling FK9 4LA, United Kingdom; email: [email protected].
• 2 Department of Psychological and Behavioural Science, London School of Economics and Political Science, London WC2A 2AE, United Kingdom.
• 3 Department of Statistics, Northwestern University, Evanston, Illinois 60208, USA; email: [email protected].
• PMID: 30089228
• DOI: 10.1146/annurev-psych-010418-102803

Systematic reviews are characterized by a methodical and replicable methodology and presentation. They involve a comprehensive search to locate all relevant published and unpublished work on a subject; a systematic integration of search results; and a critique of the extent, nature, and quality of evidence in relation to a particular research question. The best reviews synthesize studies to draw broad theoretical conclusions about what a literature means, linking theory to evidence and evidence to theory. This guide describes how to plan, conduct, organize, and present a systematic review of quantitative (meta-analysis) or qualitative (narrative review, meta-synthesis) information. We outline core standards and principles and describe commonly encountered problems. Although this guide targets psychological scientists, its high level of abstraction makes it potentially relevant to any subject area or discipline. We argue that systematic reviews are a key methodology for clarifying whether and how research findings replicate and for explaining possible inconsistencies, and we call for researchers to conduct systematic reviews to help elucidate whether there is a replication crisis.

Keywords: evidence; guide; meta-analysis; meta-synthesis; narrative; systematic review; theory.

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Systematic Review

Oct 12, 2012

970 likes | 2.26k Views

Systematic Review. An Introduction. Review. The general term for all attempts to synthesize the results and conclusions of two or more publications on a given topic. A review may or may not be systematic. Overview=Systematic Review.

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• data extraction
• research findings
• study selection
• inadequate sample size

Presentation Transcript

Systematic Review An Introduction

Review • The general term for all attempts to synthesize the results and conclusions of two or more publications on a given topic. A review may or may not be systematic. R. Heshmat MD; PhD candidate

Overview=Systematic Review • A review of the evidence on a clearly formulated question that uses systematic and explicit methods to identify, select and critically appraise relevant primary research, and to extract and analyze data from the studies that are included in the review. R. Heshmat MD; PhD candidate

Meta-analysis • When an systematic review incorporates a specific statistical strategy for assembling the results of several studies into a single estimate. R. Heshmat MD; PhD candidate

A systematic review may, or may not, include meta-analysis. • Systematic review is always appropriate and desirable, but it may sometime inappropriate to statistically pool results from separate studies. R. Heshmat MD; PhD candidate

A single study may produce a false negative results, due to inadequate sample size. • In the meta-analysis the necessary number of participants can be reached, and small effects can be detected or excluded with confidence. R. Heshmat MD; PhD candidate

Systematic Review:Epidemiology of results Where the findings of an original study replace the individual as the unit of analysis.

Narrative reviews • The classical review is subjective and therefore prone to bias and error. • Selective inclusion of studies that support the author’s view is common. • It ignores sample size, effect size, and research design. • Systematic reviews allow a more objectives appraisal. R. Heshmat MD; PhD candidate

Historical notes • The statistical basis of meta-analysis reaches back to the 17th century in astronomy and geodesy. • In 1976 the psychologist Glass coined the term “meta-analysis”. • In the 1980s meta-analysis became increasingly popular in medicine. R. Heshmat MD; PhD candidate

Finally: • Cochrane Collaboration was held in Oxford in October 1993. The Collaboration aims to help people make well-informed decision about health care by preparing, maintaining and promoting the accessibility of systematic review. R. Heshmat MD; PhD candidate

Principles of and procedures for systematic review Systematic reviews should be as carefully planned as any other research project, with a detailed written protocol in advance.

Stage 1 Planning the review Stage 2 Conducting a review Stage 3 Reporting & dissemination R. Heshmat MD; PhD candidate

Stage 1 Planning the review Phase 0 Identification of the need for a review Phase 1 Preparation of a proposal for a review Phase 2 Development of a review protocol R. Heshmat MD; PhD candidate

Stage 2 Conducting a review Phase 3 Identification of research Phase 4 Selection of studies Phase 5 Study quality assessment Phase 6 Data extraction and monitoring progress Phase 7 Data synthesis R. Heshmat MD; PhD candidate

Stage 3 Reporting & dissemination Phase 8 The report and recommendations Phase 9 Getting evidence into practice R. Heshmat MD; PhD candidate

Developing a Protocol for a Systematic Review

Role of the protocol • A written document that forms the ’plan’ for the review • A protocol helps to avoid or minimise bias • Bias may occur in the retrieval, selection, extraction of data and evaluation of results • A protocol can (and should be) sent for external peer review R. Heshmat MD; PhD candidate

Components of a protocol • Background • Review questions/ Objectives • Search strategy • Study selection criteria and procedures • Study quality assessment checklists and procedures R. Heshmat MD; PhD candidate

Components of a protocol • Data extraction strategy • Data synthesis strategy • Project timetable R. Heshmat MD; PhD candidate

Background section • Patients / disease characteristics • Course of disease • Pathophysiology • Interventions R. Heshmat MD; PhD candidate

Research questions/ objectives • Population/ participants • Interventions • Outcomes • Study designs R. Heshmat MD; PhD candidate

Literature search • Search strategy should specify which databases and other sources will be searched • Based on components of review questions • Do not need to present detailed search strategies in protocol R. Heshmat MD; PhD candidate

Possible sources of literature • Electronic databases • Medline, Embase, PsycLIT, CINAHL • specialist trial registers e.g. CCTR • Handsearching • Checking reference lists • Personal communication • Pharmaceutical companies • Grey literature R. Heshmat MD; PhD candidate

Study selection criteria • Should follow from research questions • i.e. population, interventions, outcomes, study design • Inclusion and exclusion criteria • Details of selection process should be set out here (how many reviewers, how are disagreements resolved?) R. Heshmat MD; PhD candidate

Study quality assessment • Purpose of quality assessment? • For selection? For data synthesis? For implications of results? • Choose appropriate checklist (related to study design) • Details of assessment process (how many reviewers, disagreements etc) R. Heshmat MD; PhD candidate

Data extraction strategy • Think about what data you need to extract from included studies to answer the questions • Pilot a draft data extraction form • Agree process (how many reviewers, disagreements etc) • Any manipulation of study data to be reported here R. Heshmat MD; PhD candidate

Data synthesis • Will results be pooled? How? • How will differences between studies be taken into account? • Proposed sensitivity analyses? Subgroups? • How will results be displayed? • May not be possible to be specific at protocol stage R. Heshmat MD; PhD candidate

Dissemination • How will you publish it? In what format? R. Heshmat MD; PhD candidate

Timescale • Set out key milestones (e.g. searching, study selection, data extraction, draft report to peer review, final report) • Some stages may overlap • An end date for the review is the most important! R. Heshmat MD; PhD candidate

Limitations of Systematic Review • Reporting bias and the inadequate quality of primary research are potentially serious problems for systematic reviews. • The quality of component studies is of crucial importance. • The dissemination of research findings is not a random process; rather it is strongly influenced by the nature and direction of results. R. Heshmat MD; PhD candidate

Publication bias The publication or non-publication of research findings, depending on the nature and direction of the results Type of reporting bias R. Heshmat MD; PhD candidate

Time lag bias The rapid or delayed publication of research finding, depending on the nature and direction of the results R. Heshmat MD; PhD candidate

Multiple (duplicate) publication bias The multiple or singular publication of research finding, depending on the nature and direction of the results R. Heshmat MD; PhD candidate

Citation bias The citation or non-citation of research finding, depending on the nature and direction of the results R. Heshmat MD; PhD candidate

Language bias The publication of research finding in a particular language, depending on the nature and direction of the results R. Heshmat MD; PhD candidate

Outcome reporting bias The selective reporting outcomes but not of others , depending on the nature and direction of the results R. Heshmat MD; PhD candidate

The inclusion of data from unpublished studies can itself introduce bias. • Unpublished studies may be of lower methodological quality than published studies. R. Heshmat MD; PhD candidate

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• Preferences

Systematic Reviews - PowerPoint PPT Presentation

Systematic Reviews

Margaliot, zvi, kevin c. chung. systematic reviews: a primer for plastic surgery research. ... kevin c. chung, md, patricia b. burns, mph, h. myra kim, scd, 'clinical ... – powerpoint ppt presentation.

• An Overview
• A review that is conducted according to clearly stated, scientific research methods, and is designed to minimize biases and errors inherent to traditional, narrative reviews.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007)
• The large amount of medical literature requires clinicians and researchers alike to rely on systematic reviews in order to make an informed decision.
• Systematic Reviews minimize bias. A systematic review is a more scientific method of summarizing literature because specific protocols are used to determine which studies will be included in the review.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD, Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol. 31A No.10 December 2006. p.1671
• The volume of published material makes it impractical for an individual clinician to remain up to date on a variety of common conditions. This is further complicated when individual studies report conflicting conclusions, a problem that is prevalent when small patient samples and retrospective designs are used.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p.1834
• Clearly stated title and objectives
• Comprehensive strategy to search for relevant studies (unpublished and published)
• Explicit and justified criteria for the inclusion or exclusion of any study
• Clear presentation of characteristics of each study included and an analysis of methodological quality
• Comprehensive list of all studies excluded and justification for exclusion
• Linda N. Meurer, MD, MPH Department of Family and Community Medicine. Systematic Synthesis of the Literature Introduction to Meta-analysis. Power Point Presentation.
• Clear analysis of the results of the eligible studies
• statistical synthesis of data (meta-analysis) if appropriate and possible
• or qualitative synthesis
• Structured report of the review clearly stating the aims, describing the methods and materials and reporting the results
• Formulates a Question
• Conducts a Literature Search
• Refines the search by applying predetermined inclusion and exclusion criteria
• Extracts the appropriate data and assess their quality and validity
• Synthesizes, interprets, and reports data
• A systematic review should be based on principles of hypothesis testing, and the hypotheses must be conceived a priori.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p. 1836
• The structured question will determine the inclusion and exclusion criteria
• What is the population of interest?
• What are the interventions?
• What are the outcomes of interest?
• What study designs are appropriate?
• Once the study question is formalized, the authors must compose a comprehensive list of inclusion and exclusion criteria.
• To avoid selection bias, inclusion and exclusion criteria should be agreed upon and formalized before data extraction and analysis.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p.1836
• A comprehensive and reproducible literature search is the foundation of a systematic review.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p.1837
• Database Bias - No single database is likely to contain all published studies on a given subject.
• Publication Bias - selective publication of articles that show positive treatment of effects and statistical significance.
• Hence, it is important to search for unpublished studies through a manual search of conference proceedings, correspondence with experts, and a search of clinical trials registries.
• English-language bias - occurs when reviewers exclude papers published in languages other than English
• Citation bias - occurs when studies with significant or positive results are referenced in other publications, compared with studies with inconclusive or negative findings
• The list of data to be extracted should be agreed upon a priori consensus during the design stage of the study.
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p.1839
• Collected data includes
• Study characteristics
• Sample demographics
• Outcome data
• It is necessary to design a review-specific data extraction form, so that the same data are extracted from each study and missing data are clearly apparent.
• To ensure that data extraction is accurate and reproducible, it should be performed by at least two independent readers.
• The validity of a systematic review ultimately depends on the scientific method of the retrieved studies and the reporting of data.
• Randomized Controlled Trials (RCT)
• RCT are considered to be more rigorous than observational studies
• A review based on well-designed RCT will likely be more valid and accurate than a review based on observational studies or case reports
• The most common way to assess and report study quality has been using a composite, numerical scoring instrument.
• More than 35 different quality assessment instruments have been published in the literature, and most are designed for randomized clinical trials.
• The Jadad score and the T.C. Chalmers score are two examples of quality assessment instruments.
• Randomization (2 points possible)
• 1 point if study described as randomized
• Add 1 point if randomization method described and appropriate (e.g. random numbers generated)
• Deduct 1 point randomization described and inappropriate
• Double-blinding (2 points possible)
• 1 point if study described as double-blinded
• Add 1 point if method of double-blinding described and appropriate
• Deduct 1 point if double-blinding described and inappropriate
• Withdrawals (1 point possible)
• Give 1 point for a description of withdrawals and drop-outs
• Once the data have been extracted and their quality and validity assessed, the outcomes of individual studies within a systematic review may be pooled and presented as summary outcome or effect
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 (2007) p.1840
• The authors summarize heterogeneous data qualitatively
• Data that are very conflicting and widely variable should not, under most circumstances, be combined numerically.
• When data are NOT too sparse, of too low quality or too heterogeneous
• For example the patients, interventions and outcomes in each of the included studies are sufficiently similar
• Meta-analysis is a statistical technique for combining the results of independent, but similar, studies to obtain an overall estimate of treatment effect.
• While all meta-analyses are based on systematic review of literature, not all systematic reviews necessarily include meta-analysis.
• If a meta-analysis is to be included in a systematic review, an experienced statistician or an epidemiologist should be consulted during all phases of the study.
• Protocols for the reporting of meta-analysis results were developed for RCTs (Quality of Reports of Meta-analysis QUOROM and Observational Studies in Epidemiology MOOSE.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol.31A No.10 December 2006. p. 1672
• The purpose of QUOROM and MOOSE guidelines is to provide proper procedures for conducting a meta-analysis and to standardize the methods of reporting a meta-analysis.
• Define the Research Question
• Perform the literature search
• Select the studies
• Extract the data
• Analyze the data
• Report the results
• Common questions addressed in meta-analysis are whether one treatment is more effective than another or if exposure to a certain agent will result in disease.
• The literature search is a critical step in the meta-analysis and often the most difficult part.
• The researcher should search more than just MEDLINE to ensure a comprehensive search.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol.31A No.10 December 2006. p. 1673
• Search for published studies in MEDLINE, EMBASE, and CINAHL.
• Search for unpublished clinical trials in the Cochrane Central Register of Controlled Trials
• The inclusion and exclusion criteria for studies needs to be defined at the beginning, during the design stage of the meta-analysis.
• Factors determining inclusion in the analysis are study design, population characteristics, type of treatment or exposure, and outcome measures.
• Meta-analysis needs to be documented
• One should keep track of the studies included and excluded at each step of the selection process to document the selection process.
• The QUOROM guidelines for reporting a meta-analysis requests that investigators provide a flow diagram of the selection process.
• The validity of a meta-analysis depends on the quality of the studies included, and an assessment of quality is a necessary part of the process.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol.31A No.10 December 2006. p. 1674
• The type of data to be extracted from each study should be determined in the design phase and a standardized form is constructed to record the data.
• What are the examples of data commonly extracted?
• Study design, descriptions of study groups, diagnostic information, treatments, length of follow-up evaluation, and outcome measures.
• The difficulty with data extraction is that studies often use different outcome metrics, which make combining the data awkward. The data should be converted to a uniform metric for pooling.
• There are 2 statistical models used in a meta-analysis
• Fixed effects
• Random effects
• The fixed-effects model assumes that the true effect of treatment is the same for every study.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol.31A No.10 December 2006. p. 1675
• The random effects model assumes that the true effect estimate for each study vary.
• A meta-analysis should include
• A title, abstract, an introduction
• Methods, results, and discussion sections
• The introduction should indicate the clinical question of interest, the hypothesis being tested, the types of treatment or exposure being studied, the study designs to be included, and a description of the study population.
• The methods section should
• describe the literature search, specifically the databases used, and if the search was restricted in any way.
• The selection process for articles, quality assessment, methods of data abstraction, and synthesis.
• The results section should
• Include a flow chart of studies included
• A figure displaying the results from each individual study (forest plot), results of heterogeneity testing, overall summary statistic, and results of a sensitivity analysis and meta-regression, if performed.
• A funnel plot is used as a way to assess publication bias in meta-analysis.
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. Vol.31A No.10 December 2006. p. 1676
• Reading Medical Articles, in Statistics in Medicine. Robert H. Riffenburgh. 2nd edition. Boston Academic Press, 2006.
• Meta-analysis New Developments and Applications in Medical and Social Sciences. Ralph Schulze, Heinz Holling, Dankmar Bohning (eds.) Toronto Hogrefe Huber Publishers, 2003.
• Finding and Using Health Statistics - an online course offered by the National Library of Medicine
• Margaliot, Zvi, Kevin C. Chung. Systematic Reviews A Primer for Plastic Surgery Research. PRS Journal. 120/7 2007 .
• Kevin C. Chung, MD, Patricia B. Burns, MPH, H. Myra Kim, ScD. Clinical Perspective A Practical Guide to Meta-Analysis. The Journal of Hand Surgery. vol. 31A no.10 December 2006.
• Please contact your section instructor
• http//courseinfo.bu.edu/courses/09sprggmsms640_a1 /

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