This is an archived version of the Handbook. For the current version, please go to or search for this chapter here.

16.11  References

Abrams 2005  
Abrams KR, Gillies CL, Lambert PC. Meta-analysis of heterogeneously reported trials assessing change from baseline. Statistics in Medicine 2005; 24: 3823-3844.

Bauer 1991  
Bauer P. Multiple testing in clinical trials. Statistics in Medicine 1991; 10: 871-889.

Bender 2001  
Bender R, Lange S. Adjusting for multiple testing – when and how? Journal of Clinical Epidemiology 2001; 54: 343-349.

Bender 2008  
Bender R, Bunce C, Clarke M, Gates S, Lange S, Pace NL, Thorlund K. Attention should be given to multiplicity issues in systematic reviews.
Journal of Clinical Epidemiology 2008; 61: 857-865.

Bradburn 2007  
Bradburn MJ, Deeks JJ, Berlin JA, Russell LA. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Statistics in Medicine 2007; 26: 53-77.

Bucher 1997  
Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta- analysis of randomized controlled trials. Journal of Clinical Epidemiology 1997; 50: 683-691.

Caldwell 2005  
Caldwell DM, Ades AE, Higgins JPT. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005; 331: 897-900.

Campbell 2000  
Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action). Journal of Health Services Research and Policy 2000; 5: 12-16.

Chan 2005  
Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. The Lancet 2005; 365: 1159-1162.

Chen 2005  
Chen T, Hoppe FM. Simultaneous confidence intervals. In: Armitage P, Colton T (editors). Encyclopedia of Biostatistics (2nd edition). Chichester (UK): John Wiley & Sons, 2005.

Cook 2005  
Cook RJ, Dunnett CW. Multiple comparisons. In: Armitage P, Colton T (editors). Encyclopedia of Biostatistics (2nd edition). Chichester (UK): John Wiley & Sons, 2005.

CPMP Working Party on Efficacy of Medicinal Products 1995  
CPMP Working Party on Efficacy of Medicinal Products. Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. Statistics in Medicine 1995; 14: 1659-1682.

Dmitrienko 2006  
Dmitrienko A, Hsu JC. Multiple testing in clinical trials. In: Kotz S, Balakrishnan N, Read CB, Vidakovic B (editors). Encyclopedia of Statistical Sciences (2nd edition). Hoboken (NJ): John Wiley & Sons, 2006.

Donner 1980  
Donner A, Koval JJ. The estimation of intraclass correlation in the analysis of family data. Biometrics 1980; 36: 19-25.

Donner 2000  
Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London (UK): Arnold, 2000.

Donner 2001  
Donner A, Piaggio G, Villar J. Statistical methods for the meta-analysis of cluster randomized trials. Statistical Methods in Medical Research 2001; 10: 325-338.

Donner 2002  
Donner A, Klar N. Issues in the meta-analysis of cluster randomized trials. Statistics in Medicine 2002; 21: 2971-2980.

Elbourne 2002  
Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV, Vaillancourt JM. Meta-analyses involving cross-over trials: methodological issues. International Journal of Epidemiology 2002; 31: 140-149.

Eldridge 2004  
Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clinical Trials 2004; 1: 80-90.

Farrin 2005  
Farrin A, Russell I, Torgerson D, Underwood M, UK BEAM Trial Team. Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, exercise, active management and manipulation (UK BEAM) feasibility study. Clinical Trials 2005; 2: 119-124.

Follmann 1992  
Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. Journal of Clinical Epidemiology 1992; 45: 769-773.

Freeman 1989  
Freeman PR. The performance of the two-stage analysis of two-treatment, two-period cross-over trials. Statistics in Medicine 1989; 8: 1421-1432.

Furukawa 2006  
Furukawa TA, Barbui C, Cipriani A, Brambilla P, Watanabe N. Imputing missing standard deviations in meta-analyses can provide accurate results. Journal of Clinical Epidemiology 2006; 59: 7-10.

Gamble 2005  
Gamble C, Hollis S. Uncertainty method improved on best-worst case analysis in a binary meta-analysis. Journal of Clinical Epidemiology 2005; 58: 579-588.

Glenny 2005  
Glenny AM, Altman DG, Sakarovitch C, Deeks JJ, D'Amico R, Bradburn M, Eastwood AJ. Indirect comparisons of competing interventions. Health Technology Assessment 2005; 9: 26.

Hahn 2005  
Hahn S, Puffer S, Torgerson DJ, Watson J. Methodological bias in cluster randomised trials. BMC Medical Research Methodology 2005; 5: 10.

Hanley 1983  
Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983; 249: 1743-1745.

Health Services Research Unit 2004  
Health Services Research Unit. Database of ICCs: Spreadsheet (Empirical estimates of ICCs from changing professional practice studies) [page last modified 11 Aug 2004]. Available from: (accessed 1 January 2008).

Higgins 2001  
Higgins JPT, Whitehead A, Turner RM, Omar RZ, Thompson SG. Meta-analysis of continuous outcome data from individual patients. Statistics in Medicine 2001; 20: 2219-2241.

Higgins 2002  
Higgins JPT, Spiegelhalter DJ. Being sceptical about meta-analyses: a Bayesian perspective on magnesium trials in myocardial infarction. International Journal of Epidemiology 2002; 31: 96-104.

Higgins 2008  
Higgins JPT, White IR, Wood AM. Imputation methods for missing outcome data in meta-analysis of clinical trials.
Clinical Trials 2008; 5: 225-239.

Hollis 1999
Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999; 319: 670-674.

Hollis 2002  
Hollis S. A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. Statistics in Medicine 2002; 21: 3823-3834.

Juszczak 2003  
Juszczak E, Altman D, Chan AW. A review of the methodology and reporting of multi-arm, parallel group, randomised clinical trials (RCTs).
3rd Joint Meeting of the International Society for Clinical Biostatistics and Society for Clinical Trials, London (UK), 2003.

Khan 1996  
Khan KS, Daya S, Collins JA, Walter SD. Empirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure. Fertility and Sterility 1996; 65: 939-945.

Koch 1996  
Koch GG, Gansky SA. Statistical considerations for multiplicity in confirmatory protocols. Drug Information Journal 1996; 30: 523-534.

Lathyris 2007  
Lathyris DN, Trikalinos TA, Ioannidis JP. Evidence from crossover trials: empirical evaluation and comparison against parallel arm trials. International Journal of Epidemiology 2007; 36: 422-430.

Lee 2005a  
Lee LJ, Thompson SG. Clustering by health professional in individually randomised trials. BMJ 2005; 330: 142-144.

Lee 2005b  
Lee SHH. Use of the two-stage procedure for analysis of cross-over trials in four aspects of medical statistics (PhD thesis). University of London, 2005.

Lewis 1993  
Lewis JA, Machin D. Intention to treat – who should use ITT? British Journal of Cancer 1993; 68: 647-650.

Little 2004  
Little RJA, Rubin DB. Statistical Analysis with Missing Data (2nd edition). Hoboken (NJ): John Wiley & Sons, 2004.

Lunn 2000  
Lunn DJ, Thomas A, Best N, Spiegelhalter D. WinBUGS – a Bayesian modelling framework: concepts, structure, and extensibility. Statistics and Computing 2000; 10: 325-337.

Marinho 2003  
Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride toothpaste for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2003, Issue 1. Art No: CD002278.

McAlister 2003  
McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a systematic review. JAMA 2003; 289: 2545-2553.

Mills 2005  
Mills EJ, Chan AW, Guyatt GH, Altman DG. Design, analysis, and presentation of cross-over trials.
5th Peer Review Congress, Chicago (IL), 2005.

Murray 1995  
Murray DM, Short B. Intraclass correlation among measures related to alcohol-use by young-adults - estimates, correlates and applications in intervention studies. Journal of Studies on Alcohol 1995; 56: 681-694.

Newcombe 2000  
Newcombe RN, Altman DG. Proportions and their differences. In: Altman DG, Machin D, Bryant TN, Gardner MJ (editors). Statistics with Confidence (2nd edition). London (UK): BMJ Books, 2000.

Newell 1992  
Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. International Journal of Epidemiology 1992; 21: 837-841.

Ottenbacher 1998  
Ottenbacher KJ. Quantitative evaluation of multiplicity in epidemiology and public health research. American Journal of Epidemiology 1998; 147: 615-619.

Puffer 2003  
Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ 2003; 327: 785-789.

Qizilbash 1998  
Qizilbash N, Whitehead A, Higgins J, Wilcock G, Schneider L, Farlow M. Cholinesterase inhibition for Alzheimer disease: a meta-analysis of the tacrine trials. JAMA 1998; 280: 1777-1782.

Rao 1992  
Rao JNK, Scott AJ. A simple method for the analysis of clustered binary data. Biometrics 1992; 48: 577-585.

Salanti 2008  
Salanti G, Higgins J, Ades AE, Ioannidis JP. Evaluation of networks of randomized trials. Statistical Methods in Medical Research 2008; 17: 279-301.

Senn 2002  
Senn S. Cross-over Trials in Clinical Research (2nd edition). Chichester (UK): John Wiley & Sons, 2002.

Smith 1995  
Smith TC, Spiegelhalter DJ, Thomas A. Bayesian approaches to random-effects meta-analysis: A comparative study. Statistics in Medicine 1995; 14: 2685-2699.

Song 2003  
Song F, Altman DG, Glenny AM, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003; 325: 472-475.

Spiegelhalter 2004  
Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Chichester (UK): John Wiley & Sons, 2004.

Stewart 1995  
Stewart LA, Clarke MJ. Practical methodology of meta-analyses (overviews) using updated individual patient data. Statistics in Medicine 1995; 14: 2057-2079.

Sutton 2000  
Sutton AJ, Abrams KR, Jones DR, Sheldon TA, Song F. Methods for Meta-analysis in Medical Research. Chichester (UK): John Wiley & Sons, 2000.

Sutton 2001  
Sutton AJ, Abrams KR. Bayesian methods in meta-analysis and evidence synthesis. Statistical Methods in Medical Research 2001; 10: 277-303.

Sweeting 2004  
Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Statistics in Medicine 2004; 23: 1351-1375.

te Velde 1998  
te Velde ER, Cohlen BJ, Looman CW, Habbema JD. Crossover designs versus parallel studies in infertility research. Fertility and Sterility 1998; 69: 357-358.

Thompson 2001  
Thompson SG, Turner RM, Warn DE. Multilevel models for meta-analysis, and their application to absolute risk differences. Statistical Methods in Medical Research 2001; 10: 375-392.

Turner 2000  
Turner RM, Omar RZ, Yang M, Goldstein H, Thompson SG. A multilevel model framework for meta-analysis of clinical trials with binary outcomes. Statistics in Medicine 2000; 19: 3417-3432.

Ukoumunne 1999  
Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG. Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technology Assessment 1999; 3: 5.

Unnebrink 2001  
Unnebrink K, Windeler J. Intention-to-treat: methods for dealing with missing values in clinical trials of progressively deteriorating diseases. Statistics in Medicine 2001; 20: 3931-3946.

White 2005  
White IR, Thomas J. Standardized mean differences in individually-randomized and cluster-randomized trials, with applications to meta-analysis. Clinical Trials 2005; 2: 141-151.

White 2007  
White IR, Carpenter J, Evans S, Schroter S. Eliciting and using expert opinions about dropout bias in randomized controlled trials. Clinical Trials 2007; 4: 125-139.

White 2008a  
White IR, Higgins JPT, Wood A. Allowing for uncertainty due to missing data in meta-analysis. Part 1: Two-stage methods. Statistics in Medicine 2008; 27: 711-727.

White 2008b  
White IR, Welton N, Wood A, Ades AE, Higgins JPT. Allowing for uncertainty due to missing data in meta-analysis. Part 2: Hierarchical models. Statistics in Medicine 2008; 27: 728-745.

Whiting-O'Keefe 1984  
Whiting-O'Keefe QE, Henke C, Simborg DW. Choosing the correct unit of analysis in medical care experiments. Medical Care 1984; 22: 1101-1114.