Systematic Review & Course outline. Lecture (20%) Class discussion & tutorial (30%)
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1 Systematic Review & Meta-analysisanalysis Ammarin Thakkinstian, Ph.D. Section for Clinical Epidemiology and Biostatistics Faculty of Medicine, Ramathibodi Hospital Tel: , Fax: Lecture (20%) Review methods Meta-analysis Course outline Class discussion & tutorial (30%) Review topics Assignments (50%) 1
2 Topics Score Due Date Assignment I: - Initiating review topic - Literature review o Background & rationale, o Formulate a review question & objectives 15% Feb 26, 2009 Assignment II: Locate and select studies - Define inclusion & exclusion criteria 12.5% Mar 6, Search terms and strategies - Identifying studies - Selecting studies Assignment III: - Design o Data extraction forms o Quality or risk of bias assessment 12.5% Mar 13, Perform data extraction & assess quality of studies Assignment IV: - Data analysis plan 15% Mar 20, Dummy tables & figures Assignment V: Data analysis 20% April 17, 2009 Assignment VI: Writing up paper (as a manuscript) - Presentation (verbal) 5% May 7, Submit paper 25% May 8, 2009 Systematic review Review methodology Pooling methods: meta-analysis Dichotomous outcome Continuous outcome 2
3 Systematic review A review that has been prepared using a systematic approach to minimise biases and random error Rationale Tool for health care worker Tool for health care worker, researchers, consumers, and also policy maker who want to keep up with the evidence that is accumulating in their field 3
4 Rationale More objective appraisal of the evidence than traditional narrative reviews - Narrative review: subjective, selection bias, limitation of single or few studies, unhelpful descriptions, e.g., no clear evidence, a weak relationship, a strong relationship. - Systematic review: more transparent appraisal, allow reader to replicate, quantitative conclusion. Meta-analysis: Rationale Estimates treatment effects Leading to reduces probability of false negative results (increase power of test) Potentially to a more timely introduction of effective treatments. 4
5 Rationale Exploratory analyses: subgroups of patients who are likely to respond particularly well to a treatment (or the reverse) may generate promising new research questions to be addressed in future studies. Systematic review may demonstrate the lack of adequate evidence and thus identify area where further studies are needed Terminology Systematic review Overview Meta-analysis Research synthesis Summarizing Pooling 5
6 Review Methodology Good Rationale Clearly state research question Objective Identify relevant studies/locate studies Explicitly describe inclusion & exclusion criteria of studies Data extraction: study factor, outcome Data analysis Results Discussion Review proposal Introduction & background Research question/objective Review methods Locating studies Selecting studies Inclusion/exclusion criteria Data extraction Quality/risk assessment Data analysis Results Discussion 6
7 Rationale Why do we need to perform the review How were results of previous individual and review study (if any) Positive results Negative results Methodologic issues Sample size/power of test Narrative reviews? Selective bias Pooling effect sizes? Quality of the studies 7
8 Good research question Evidence-base Medicine (EBM) Patient Intervention Comparator Outcome PICO 8
9 Research question Is there association between VDR and BMD/osteoporosis in women? To compare rates of osteoporosis in women with BB with bb genotypes Is Rosiglitazone higher risk of developing myocardial infarction compare with Metformin in diabetic patients? To compare incidence of MI between diabetic patients received Rosiglitazone and Metformin Locate studies 1. Defines source of database MEDLINE to present Over 16 million references Since 2005, between 2,000-4,000 completed references are added each day Tuesday through Saturday Cover 5200 worldwide journals in 40 languages - Uses medical subject heading (MeSH) for index - Includes biomedicine and health science journals - English abstracts for 79% on references - 90% are English language articles - 47% of journals covered are published in the US - PubMed available free of charge From 9
10 Defines source of databases EMBASE - Over 12 million records from 1974-present - More than 600,000 records added annually - Covers over 4,800 active peer-reviewed journals published in 70 countries/ 30 languages - uses EMTREE for indexing - includes English abstracts for 80% of references - daily update, within two weeks of receipt of the original journal - Produced by Elsevier, no free version available Defines source of database The Cochrane Controlled Trials Register (CCTR) ClinicalTrials.gov HUGE NET Review Reference lists Hand searching of key journals Personal communication with expert in the field 10
11 Locate studies 2. Define the software & version used for searching - PubMed - OVID version Silver Platter National Center for Biotechnology Information 11
12 National Center for Biotechnology Information 12
13 13
14 3. Defines searching terms Specify period of searching Plan for update searching Combinations of search terms Intervention: treatment/study factor Outcome of interest Comparator* Patient 14
15 Example VDR& BMD/Osteoporosis(J Bone Miner Res. 2004;19(3): ) 1. vitamin D receptor or VDR (MeSH) 2. genotype(s) or allele(s) or polymorphism(s) (MeSH) 3. bone mineral density or BMD or bone density (MeSH) 4. low bone mineral density or low density (textword) 5. osteoporosis (MeSH) 6. fracture (MeSH) 7. 1 and 2 and and 2 and and 2 and and 2 and 6 Selecting studies Clearly define inclusion & exclusion criteria Inclusion criteria Type of subjects Treatment or exposure or gene Comparator (if needed) Outcome Study design randomized controlled trial, observational studies (cohort, case-control, cross-sectional study) Full paper 15
16 Languages English, French, others Restrictions due to sample size or other criteria Multiple publications of the same studies, choose the recent one or the one has provided d more completeness of data Exclusion Incompleteness of information Contact authors at least two times for incomplete data Not the outcome of interest Review studies Narrative review Systematic review Not comparative studies No control group 16
17 Selecting studies Merge studies identified from databases using reference manager (e.g. Endnote) Remove duplicates Two reviewers independently select studies Screen title/abstract to remove non-relevant studies base on eligibility criteria Access full papers Examine other sources of studies Contact t author if needed d Final decision Perform searching every 3 months while doing a review 17
18 Thakkinstian et al. Meta-analysis of molecular association studies: vitamin D receptor gene polymorphisms and BMD as a case study. J Bone Miner Res 2004;19(3): Any observational study (cohort, case-control, and cross-sectional study), regardless of sample size, which determined the difference in mean BMD according to the VDR genotype, or tested t the association between osteoporosis or fracture and the VDR genotypes and which fulfilled the following criteria: 18
19 VDR & BMD/Osteoporosis - The BMD measurements were performed at lumbar spine or hip by Dual Energy X-ray Absorptiometry (DEXA) or Dual Photon Absorptiometry (DPA) method. - sufficient details: mean and SD of BMD, and number of subjects for each VDR genotype, and frequencies of genotype among case and control group were reported for dichotomous outcomes VDR & BMD/Osteoporosis Participants were adult women who were either pre- or post menopausal. Study factor & outcome Bsm/Apa/Taq/Fok BMD/Osteoporosis 19
20 Data extraction (DE) At least two reviewers Design DEF, pilot, & revise DEF The article Study ID, Author, Year & source of publication The study characteristics Type of studies subjects ethnicity, it Adults vs children Postmenopause, premenopause study design (RCT, CS, CC, CrS) Methods used/criteria for measuring outcomes Patients DE (cont.) Demographic and clinical features of study's participants that might affect outcomes mean age, gender, BMI, smoking, underlying diseases T bl f t d f t /i t ti Table of study factors/interventions versus outcomes 20
21 DE (cont.) Dichotomous outcome Frequencies between study factor/intervention vs outcome Group Disease Yes No N I Rx (Exp+) a b n1 a/n1 Placebo (Exp-) c d n2 c/n2 - OR (95% CI), RR (95% CI), HR (95% CI) DE (cont.) Continuous outcome n, mean (95% CI) Group n mean SD A n 1 mean 1 SD 1 B n 2 mean 2 SD 2 21
22 Risk of bias in individual studies Quality Assessment (QA) Consider internal & external validity RCT Risk of bias (cont.) TC Chalmers From Egger M, Smith GD, Altman DG. Systematic reviews in health care: Meta-analysis in context. London: BMJ Books, Jadad s quality assessment scale The Cochrane Collaboration s tool for assessing risk of bias 2009 Preferred reports of items for systematic review and meta-analysis-prisma guideline 22
23 Domain Description Review authors judgement Sequence generation. Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether h it should produce comparable groups. Was the allocation sequence adequately generated? Allocation concealment. Describe the method used Was allocation to conceal the allocation adequately sequence in sufficient concealed? detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Blinding of participants, Describe all measures used, Was knowledge of personnel and outcome if any, to blind study the allocated assessors Assessments should participants and personnel be made for each main outcome from knowledge of which intervention adequately prevented (or class of outcomes). intervention a participant during the study? received. Provide any information relating to whether the intended blinding was effective. Incomplete outcome data Assessments should be made for each main outcome (or class of outcomes). Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any reinclusions in analyses performed by the review authors. Were incomplete outcome data adequately addressed? 23
24 Selective outcome reporting. State how the possibility of selective outcome reporting was examined by the review authors, and what was found. Are reports of the study free of suggestion of selective outcome reporting? Other sources of bias. State any important concerns Was the study about bias not addressed in apparently free of other the other domains in the tool. If particular questions/entries were pre-specified in the review s protocol, responses should be provided for each question/entry. Trial methodology Statistical analysis problems that could put it at a high risk of bias? Premature trial termination Post-randomization exclusion Unbalance baseline characteristics Adequately describe methods of data analysis -use per-protocol analysis, modified ITT Observational studies Thakkinstian A, D'Este DEsteC, Eisman J, Nguyen T, Attia J. Meta-analysis of molecular association studies: vitamin D receptor gene polymorphisms and BMD as a case study. J Bone Miner Res 2004;19:
25 Criteria A. Representativeness of cases - Consecutive/randomly selected from cases population with clearly defined random frame - Consecutive/randomly selected from cases population without clearly defined random frame or with extensively inclusion criteria - Not describe method of selection B. Representativeness of controls - Consecutive/randomly drawn from area (ward/community) as cases with the same criteria - Consecutive/randomly drawn from different area as cases - Not describe Score Criteria C. Ascertainment of osteoporosis/fracture - Clearly described objective criteria of diagnosis of osteoporosis/osteoporotic fracture with proving diagnosis, e.g. measure BMD using DEXA, X-ray for fracture - Diagnosis of osteoporosis/osteoporotic fracture by patients history - Not describe D. Ascertainment of control - Controls were proved that they were not osteoporosis/osteoporotic p fracture, i.e. measured BMD - Only mentioned that controls were subjects who were not osteoporosis/osteoporotic fracture without proving - Not describe Score
26 Criteria E. Ascertainment of VDR examination - Genotyping done under blind condition - Unblind or not mention F. Data analysis HWE: - Checking goodness of fit in control group with appropriate statistics - Checking goodness of fit of HWE in case & control group, or using inappropriate statistics - Not mentioned G. Association assessment: - Appropriate statistic used with adjusting for confounders e.g. logistic regression, or matched case-control design - Appropriate statistic used without adjusting - Inappropriate statistic Score Criteria Score H. Response rate - Response rates for both group are the 2 same or different between groups 5% - Response rates are different between 1 5% - 10% - Response rates are different 10% or 0 more, or not mention about response rates Total 15 26
27 Net work Cochrane collaboration RCT Diagnostic studies 27
28 28
29 29
30 Statistical analysis Unit of analysis is study NOT subject Describe how data will be pooled OR, RR, RD, HR Mean Heterogeneity Test Degree (I 2 ) Explore source(s) of heterogeneity Meta-regression Sub-group analysis Publication bias Graph Test Software P value 30
31 Dummy tables Table 1. study s characteristics Table 2. cross-tabulate table Treatment vs primary outcome Treatment effects & 95% CI Pooled treatment effects Table 3. cross-tabulate table of subgroup Table 4. cross-tabulate table of 2 nd outcome Dummy figures Figure 1. Flow chart of selection of studies Figure 2. Forest plot of 1 st outcome Figure 3. Forest plot of 2 nd outcome 31
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