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Meta-Analysis of Diagnostic Test Accuracy Studies Guideline Final Nov 2014

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Meta-Analysis of Diagnostic Test Accuracy Studies Guideline Final Nov 2014 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 GUIDELINE Meta-analysis of Diagnostic Test Accuracy Studies November 2014 Copyright © EUnetHTA 2013. All Rights Reserved. No part of this document may be reproduced without an explicit acknowledgement of the source and EUnetHTA’s expressed consent. EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 The primary objective of EUnetHTA JA2 WP 7 methodology guidelines is to focus on methodological challenges that are encountered by HTA assessors while performing relative effectiveness assessments of pharmaceuticals or non- pharmaceutical health technologies. As such the guideline represents a consolidated view of non-binding recommendations of EUnetHTA network members and in no case an official opinion of the participating institutions or individuals. Disclaimer: EUnetHTA Joint Action 2 is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the information contained therein. NOV 2014 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 2 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 This guideline on “Meta-analysis of Diagnostic Test Accuracy Studies” has been developed by HIQA – IRELAND, with assistance from draft group members from IQWiG – GERMANY. The guideline was also reviewed and validated by a group of dedicated reviewers from GYEMSZI – HUNGARY, HAS – FRANCE and SBU - SWEDEN. NOV 2014 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 3 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 Table of contents Acronyms - Abbreviations ........................................................................................... 6 Summary and table with main recommendations ....................................................... 7 1. Introduction ......................................................................................................... 10 1.1. Central terms and concepts .............................................................................. 10 1.1.1. Diagnostic test, gold- and reference standards .............................................. 10 1.1.2. Sensitivity and specificity ................................................................................ 10 1.1.3. Likelihood ratios ............................................................................................. 12 1.1.4. Diagnostic odds ratio ...................................................................................... 13 1.1.5. Receiver Operating Characteristic (ROC) curves ........................................... 13 1.1.6. Predictive values ............................................................................................ 15 1.1.7. Diagnostic accuracy ....................................................................................... 15 1.2. Problem statement ........................................................................................... 15 1.3. Objective(s) and scope of the guideline ........................................................... 17 1.4. Related EUnetHTA documents ........................................................................ 17 2. Analysis and discussion of the methodological issue ......................................... 19 2.1. Methods for meta-analysis of diagnostic accuracy studies ............................... 19 2.1.1. Separate random-effects meta-analyses of sensitivity and specificity ............ 19 2.1.2. Separate meta-analyses of positive and negative likelihood ratios ................ 19 2.1.3. Moses-Littenberg summary receiver operating characteristic (SROC) curve . 19 2.1.4. Hierarchical summary ROC (HSROC) model ................................................. 20 2.1.5. Bivariate random-effects meta-analysis for sensitivity and specificity ............ 21 2.1.6. Comparison of methods ................................................................................. 21 2.2. Presentation of results from a meta-analysis of a single diagnostic test .......... 25 2.2.1. Tables ............................................................................................................ 25 2.2.2. Forest plots for sensitivity and specificity ....................................................... 25 2.2.3. Confidence and prediction regions for the summary estimate of sensitivity and specificity ........................................................................................................ 26 2.2.4. Summary ROC curve ..................................................................................... 26 2.2.5. Sensitivity analysis ......................................................................................... 27 NOV 2014 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 4 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 2.3. Comparison of two diagnostic tests with respect to diagnostic accuracy (incorporate non-comparative studies in discussion of heterogeneity) ............. 28 2.4. Sources of bias ................................................................................................. 28 2.4.1. Data gathering and publication bias ............................................................... 28 2.4.2. Heterogeneity in meta-analyses of sensitivity and specificity ......................... 29 2.4.3. Spectrum bias ................................................................................................ 30 2.4.4. Verification/work-up bias and variable gold standard ..................................... 30 2.4.5. Bias resulting from choice of cut-off points ..................................................... 30 2.4.6. Disease prevalence ........................................................................................ 30 2.4.7. Potential for dependence in combined tests ................................................... 31 2.4.8. Missing data/non-evaluable results ................................................................ 31 2.4.9. Individual patient data analysis ...................................................................... 31 2.5. Meta-analysis of the prognostic utility of a diagnostic test ................................ 31 2.6. Assessing the quality of studies and meta-analysis ......................................... 32 2.6.1. STARD ........................................................................................................... 32 2.6.2. QUADAS ........................................................................................................ 32 2.6.3. PRISMA ......................................................................................................... 33 2.6.4. GRADE .......................................................................................................... 33 2.7. Software ........................................................................................................... 33 3. Conclusion and main recommendations ............................................................. 35 Annexe 1. Bibliography ........................................................................................... 37 Annexe 2. Documentation of literature search ........................................................ 41 Annexe 3. Other sources of information .................................................................. 45 NOV 2014 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 5 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 Acronyms - Abbreviations AUC area under the curve DOR diagnostic odds ratio FN false negative FP false positive FPR false positive rate GRADE Grading of Recommendations Applicability, Development and Evaluation HSROC hierarchical summary receiver operator characteristic IPD individual patient data LR- negative likelihood ratio LR+ positive likelihood ratio MESH medical subject headings NPV negative predictive value PPV positive predictive value PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses QUADAS Quality Assessment of Diagnostic Accuracy Studies RCT randomized controlled trial ROC receiver operator characteristic Sn sensitivity Sp specificity SROC summary receiver operator characteristic STARD Standards for Reporting of Diagnostic Accuracy TN true negative TP true positive TPR true positive rate NOV 2014 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 6 EUnetHTA JA2 Guideline ”Meta-analysis of diagnostic test accuracy studies” WP 7 Summary and table with main recommendations Introduction Diagnostic tests are used for a variety of purposes including to: determine whether or not an individual has a particular target condition; provide information on a physiological or pathological state, congenital abnormality, or on a predisposition to a medical condition or disease; predict treatment response or reactions; define or monitor therapeutic measures. Ideally an evaluation should be undertaken to assess the clinical utility of a test. Such an assessment is generally not supported by appropriately designed studies or by long term outcome data. In the absence of clinical utility data, diagnostic tests are evaluated on the basis of
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