Reporting missing participant data in randomised trials: Systematic survey of the methodological literature and a proposed guide

BMJ Open

Volumn 5, Issue 12, 2015, Pages

  Akl, Elie A ^a,b   Shawwa, Khaled ^a   Kahale, Lara A ^a   Agoritsas, Thomas ^b   Brignardello Petersen, Romina ^b,c,d   Busse, Jason W ^b,e   Carrasco Labra, Alonso ^b,e   Ebrahim, Shanil ^b,f,g   Johnston, Bradley C ^d,f   Neumann, Ignacio ^b,h   Sola, Ivan ⁱ   Sun, Xin ^b,j   Vandvik, Per ^k,l   Zhang, Yuqing ^b   Alonso Coello, Pablo ⁱ   Guyatt, Gordon H ^b  

^a AMERICAN UNIVERSITY OF BEIRUT   (Lebanon)

^b MCMASTER UNIVERSITY   (Canada)

^c UNIVERSITY OF CHILE   (Chile)

^d UNIVERSITY OF TORONTO   (Canada)

^e MCMASTER UNIVERSITY   (Canada)

^f HOSPITAL FOR SICK CHILDREN   (Canada)

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

ⁱ BIOMEDICAL RESEARCH INSTITUTE SANT PAU IIB SANT PAU   (Spain)

^j SICHUAN UNIVERSITY   (China)

^k NORWEGIAN KNOWLEDGE CENTRE FOR THE HEALTH SERVICES   (Norway)

^l INNLANDET HOSPITAL TRUST   (Norway)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; CONTROLLED CLINICAL TRIAL; HUMAN; HUMAN EXPERIMENT; MEDLINE; RANDOMIZED CONTROLLED TRIAL; SYSTEMATIC REVIEW; MEASUREMENT ACCURACY; METHODOLOGY; PATIENT DROPOUT; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL BIAS; STATISTICS AND NUMERICAL DATA;

BIAS (EPIDEMIOLOGY); DATA ACCURACY; GUIDELINES AS TOPIC; HUMANS; PATIENT DROPOUTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84960089926     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008431     Document Type: Review

References (26)

1. Akl EA, Briel M, You JJ, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ 2012;344:e2809.
2. Sylvestre Y. CONSORT: missing data guidelines, the effects on HTA monograph reporting. Trials 2011;12(Suppl 1):A61.
3. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:834-40.
4. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension JAMA 2013;309:814-22.
5. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
6. Campbell MK, Piaggio G, Elbourne DR, et al., CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661.
7. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159-74.
8. Akl EA, Kahale LA, Agoritsas T, et al. Handling trial participants with missing outcome data when conducting a meta-analysis: a systematic survey of proposed approaches. Syst Rev 2015;4:98.
9. Akl EA, Johnston BC, Alonso-Coello P, et al. Addressing dichotomous data for participants excluded from trial analysis: a guide for systematic reviewers. PLoS ONE 2013;8:e57132.
10. Ebrahim S, Akl EA, Mustafa RA, et al. Addressing continuous data for participants excluded from trial analysis: a guide for systematic reviewers. J Clin Epidemiol 2013;66:1014-21.e1.
11. Ebrahim S, Johnston BC, Akl EA, et al. Addressing continuous data measured with different instruments for participants excluded from trial analysis: a guide for systematic reviewers. J Clin Epidemiol 2014;67:560-70.
12. Bernhard J, Cella DF, Coates AS, et al. Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 1998;17:517-32.
13. Staquet M, Berzon R, Osoba D, et al. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 1996;5:496-502.
14. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
15. Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012;367:1355-60.
16. Little R, Cohen M, Dickersin K, et al. The design and conduct of clinical trials to limit missing data. Stat Med 2012;31:3433-43.
17. O'Neill R, Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. Clin Pharmacol Ther 2012;91:550-4.
18. Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services, Food and Drug Administration, 2009. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM193282 (accessed 13 Jan 2015).
19. Busse JW, Bruno P, Malik K, et al. An efficient strategy allowed English-speaking reviewers to identify foreign-language articles eligible for a systematic review. J Clin Epidemiol 2014;67:547-53.
20. Troxel AB, Fairclough DL, Curran D, et al. Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 1998;17:653-66.
21. Liu M, Wei L, Zhang J. Review of guidelines and literature for handling missing data in longitudinal clinical trials with a case study. Pharm Stat 2006;5:7-18.
22. Amico KR, Harman JJ, O'Grady MA. Attrition and related trends in scientific rigor: a score card for ART adherence intervention research and recommendations for future directions. Curr HIV/AIDS Rep 2008;5:172-85.
23. Sterne JA, White IR, Carlin JB, et al. Multiple imputation for missing data in epidemiological and clinical research: Potential and pitfalls. BMJ 2009;338:b2393.
24. Polit DF, Gillespie BM. Intention-to-treat in randomized controlled trials: recommendations for a total trial strategy. Res Nurs Health 2010;33:355-68.
25. Alshurafa M, Briel M, Akl EA, et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: Systematic review of the methods literature. PloS ONE 2012; 7:e49163.
26. Gewandter JS, McDermott MP, McKeown A, et al. Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations. PAIN 2014;155:1871-7.