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

doi:10.1136/bmjopen-2015-008431

Review

. 2015 Dec 30;5(12):e008431.

doi: 10.1136/bmjopen-2015-008431.

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

Elie A Akl¹, Khaled Shawwa², Lara A Kahale³, Thomas Agoritsas⁴, Romina Brignardello-Petersen⁵, Jason W Busse⁶, Alonso Carrasco-Labra⁷, Shanil Ebrahim⁸, Bradley C Johnston⁹, Ignacio Neumann¹⁰, Ivan Sola¹¹, Xin Sun¹², Per Vandvik¹³, Yuqing Zhang⁴, Pablo Alonso-Coello¹¹, Gordon H Guyatt¹⁴

Affiliations

¹ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
² Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.
³ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon.
⁴ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
⁵ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Evidence Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada.
⁶ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Anesthesia, McMaster University, Hamilton, Canada The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Canada.
⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Evidence Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.
⁸ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Anesthesia, McMaster University, Hamilton, Canada Department of Anesthesia & Pain Medicine, the Hospital for Sick Children, Toronto, Canada Department of Medicine, Stanford Prevention Research Center, Stanford University, Palo Alto, USA.
⁹ Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada Department of Anesthesia & Pain Medicine, the Hospital for Sick Children, Toronto, Canada.
¹⁰ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Internal Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
¹¹ Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau-CIBER of Epidemiology and Public Health (CIBERESP- IIB Sant Pau), Barcelona, Spain.
¹² Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Clinical Research and Evaluation Unit, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
¹³ Norwegian Knowledge Centre for the Health Services, Oslo, Norway Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.
¹⁴ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

PMID: 26719310
PMCID: PMC4710817
DOI: 10.1136/bmjopen-2015-008431

Review

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

Elie A Akl et al. BMJ Open. 2015.

. 2015 Dec 30;5(12):e008431.

doi: 10.1136/bmjopen-2015-008431.

Authors

Affiliations

¹ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
² Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.
³ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon.
⁴ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
⁵ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Evidence Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada.
⁶ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Anesthesia, McMaster University, Hamilton, Canada The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Canada.
⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Evidence Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.
⁸ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Anesthesia, McMaster University, Hamilton, Canada Department of Anesthesia & Pain Medicine, the Hospital for Sick Children, Toronto, Canada Department of Medicine, Stanford Prevention Research Center, Stanford University, Palo Alto, USA.
⁹ Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada Department of Anesthesia & Pain Medicine, the Hospital for Sick Children, Toronto, Canada.
¹⁰ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Internal Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
¹¹ Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau-CIBER of Epidemiology and Public Health (CIBERESP- IIB Sant Pau), Barcelona, Spain.
¹² Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Clinical Research and Evaluation Unit, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
¹³ Norwegian Knowledge Centre for the Health Services, Oslo, Norway Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.
¹⁴ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

PMID: 26719310
PMCID: PMC4710817
DOI: 10.1136/bmjopen-2015-008431

Abstract

Objectives: We conducted a systematic survey of the methodological literature to identify recommended approaches for how and what randomised clinical trial (RCT) authors should report on missing participant data and, on the basis of these approaches, to propose guidance for RCT authors.

Methods: We defined missing participant data (MPD) as missing outcome data for trial participants. We considered both categorical and continuous outcome data. We searched MEDLINE and the Cochrane Methodology Register for articles in which authors proposed approaches to reporting MPD from RCTs. We selected eligible articles independently and in duplicate and extracted data in duplicate. Using an iterative process of discussion and revisions, we used the findings to develop guidance.

Results: Of 10,501 unique citations identified, 13 articles reporting on 10 approaches proved eligible. The identified approaches recommend reporting the following aspects (from most to least frequently recommended): number of participants with MPD (n=10), reasons for MPD (n=7), methods used to handle MPD in the analysis (n=4), flow of participants (n=3), pattern of missingness (eg, whether at random) (n=3), differences in rates of MPD between trial arms (n=2), differences between participants with and without MPD (n=2), results of any sensitivity analyses (n=2), implication of MPD on interpreting the results (n=2) and methods used to prevent missing data (n=1). We propose a guide with nine items related to reporting the number, reasons, patterns, analytical methods and interpretation of MPD.

Conclusions: Most identified approaches invite trial authors to report the extent of MPD and the underlying reasons. Fewer approaches focus on reporting missingness patterns, methods for handling MPD and implications of MPD on results. Our proposed guidance could help RCT authors to better report, and readers to better identify participants with missing data.

Keywords: EPIDEMIOLOGY; Missing participant data; Randomized clinical trials; Systematic reviews.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PubMed Disclaimer

Figures

**Figure 1**
Study flow diagram (MPD, missing participant data).

See this image and copyright information in PMC

Cited by

Performance of oxygenation indices and risk scores to predict invasive mechanical ventilation and mortality in COVID-19.
Bastidas-Goyes AR, Tuta-Quintero E, Aguilar MF, Mora AV, Aponte HC, Villamizar JM, Galeano S, Mejia P, Muñoz M, Paredes S, Pumarejo D, Barragan MDM. Bastidas-Goyes AR, et al. BMC Pulm Med. 2024 Feb 2;24(1):68. doi: 10.1186/s12890-023-02807-8. BMC Pulm Med. 2024. PMID: 38308270 Free PMC article.
Outcomes of Enterococcus faecalis infective endocarditis according to MIC of amoxicillin: a multicentric study.
Do Rego H, Kherabi Y, Corvec S, Plouzeau-Jayle C, Bouchiat C, Macheda G, Meyer S, Cattoir V, Piau C, Guillard T, Zahar JR, Farfour E, Lecomte R, Amara M, Isnard C, Le Monnier A, Pilmis B. Do Rego H, et al. JAC Antimicrob Resist. 2024 Nov 1;6(6):dlae167. doi: 10.1093/jacamr/dlae167. eCollection 2024 Dec. JAC Antimicrob Resist. 2024. PMID: 39493937 Free PMC article.
The ratio of neutrophil-to-lymphocyte and platelet-to-lymphocyte and association with mortality in community-acquired pneumonia: a derivation-validation cohort study.
Enersen CC, Egelund GB, Petersen PT, Andersen S, Ravn P, Rohde G, Lindegaard B, Jensen AV. Enersen CC, et al. Infection. 2023 Oct;51(5):1339-1347. doi: 10.1007/s15010-023-01992-2. Epub 2023 Feb 10. Infection. 2023. PMID: 36763284
Meta-Analyses Proved Inconsistent in How Missing Data Were Handled Across Their Included Primary Trials: A Methodological Survey.
Kahale LA, Khamis AM, Diab B, Chang Y, Lopes LC, Agarwal A, Li L, Mustafa RA, Koujanian S, Waziry R, Busse JW, Dakik A, Hooft L, Guyatt GH, Scholten RJPM, Akl EA. Kahale LA, et al. Clin Epidemiol. 2020 May 27;12:527-535. doi: 10.2147/CLEP.S242080. eCollection 2020. Clin Epidemiol. 2020. PMID: 32547244 Free PMC article.
[Risk of bias in controlled clinical trials].
Schmucker C, Meerpohl JJ, Blümle A. Schmucker C, et al. Radiologe. 2019 Sep;59(9):833-842. doi: 10.1007/s00117-019-0572-z. Radiologe. 2019. PMID: 31346651 Clinical Trial. German.

See all "Cited by" articles

References

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 10.1136/bmj.e2809 - DOI - PubMed
1. Sylvestre Y. CONSORT: missing data guidelines, the effects on HTA monograph reporting. Trials 2011;12(Suppl 1):A61 10.1186/1745-6215-12-S1-A61 - DOI
1. 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. 10.1016/j.jclinepi.2010.02.005 - DOI - PubMed
1. 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. 10.1001/jama.2013.879 - DOI - PubMed
1. 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. 10.7326/0003-4819-141-10-200411160-00009 - DOI - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations

[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 10.1136/bmj.e2809 - DOI - PubMed

[2] 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 10.1136/bmj.e2809 - DOI - PubMed

[3] Sylvestre Y. CONSORT: missing data guidelines, the effects on HTA monograph reporting. Trials 2011;12(Suppl 1):A61 10.1186/1745-6215-12-S1-A61 - DOI

[4] Sylvestre Y. CONSORT: missing data guidelines, the effects on HTA monograph reporting. Trials 2011;12(Suppl 1):A61 10.1186/1745-6215-12-S1-A61 - DOI

[5] 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. 10.1016/j.jclinepi.2010.02.005 - DOI - PubMed

[6] 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. 10.1016/j.jclinepi.2010.02.005 - DOI - PubMed

[7] 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. 10.1001/jama.2013.879 - DOI - PubMed

[8] 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. 10.1001/jama.2013.879 - DOI - PubMed

[9] 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. 10.7326/0003-4819-141-10-200411160-00009 - DOI - PubMed

[10] 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. 10.7326/0003-4819-141-10-200411160-00009 - DOI - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources