Evaluating non-randomised intervention studies - NIHR Health ...

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Abstractcase-mix adjustment methods to compensate forselection bias and our inability to identify nonrandomisedstudies that are free of selection biasindicate that non-randomised studies should only beundertaken when RCTs are infeasible or unethical.Recommendations for further research include: applyingthe resampling methodology in other clinical areas toascertain whether the biases described are typical;developing or refining existing quality assessment toolsfor non-randomised studies; investigating how qualityassessments of non-randomised studies can beincorporated into reviews and the implications ofindividual quality features for interpretation of areview’s results; examination of the reasons for theapparent failure of case-mix adjustment methods; andfurther evaluation of the role of the propensity score.iv
Health Technology Assessment 2003; Vol. 7: No. 27ContentsList of abbreviations ..................................Executive summary ....................................1 Introduction ............................................... 1Types of non-randomised studies .............. 1Sources of bias in non-randomisedstudies ......................................................... 3Case-mix adjustment methods ................... 5Scope of this project ................................... 52 Aims and objectives ................................... 73 Review of empirical comparisons ofthe results of randomised andnon-randomised studies ............................ 9Introduction ............................................... 9Methods ...................................................... 9Results ........................................................ 10Discussion ................................................... 204 Evaluation of checklists and scales forassessing quality of non-randomisedstudies ........................................................ 23Introduction ............................................... 23Methods ...................................................... 24Results ........................................................ 29Discussion ................................................... 415 Use of quality assessment in systematicreviews of non-randomised studies ........... 43Introduction ............................................... 43Methods ...................................................... 43Results ........................................................ 44Discussion ................................................... 476 Empirical estimates of bias associated withnon-random allocation ............................... 49Introduction ............................................... 49Methods ...................................................... 49Results ........................................................ 52Discussion ................................................... 57Conclusions ................................................ 62viiix7 Empirical evaluation of the ability ofcase-mix adjustment methodologies tocontrol for selection bias ........................... 63Introduction ............................................... 63Methods ...................................................... 65Results ........................................................ 71Discussion ................................................... 78Conclusions ................................................ 858 Discussion and conclusions ........................ 87Summary of key findings ........................... 87Discussion ................................................... 88Conclusions ................................................ 91Acknowledgements .................................... 93References .................................................. 95Appendix 1 Search strategy forChapters 3–5 .............................................. 111Appendix 2 Data extraction forms ............ 113Appendix 3 Details of identified qualityassessment tools ......................................... 121Appendix 4 Detailed description of ‘unselected’top 14 quality assessment tools .................... 135Appendix 5 Coverage of core items byselected top tools ........................................ 139Appendix 6 Details of review methods ..... 141Appendix 7 Results of identified systematicreviews ........................................................ 151Appendix 8 Descriptions of the IST andECST .......................................................... 167Health Technology and Assessment reportspublished to date ....................................... 175Health Technology and AssessmentProgramme ................................................ 183v
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