Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review

被引：216

作者：

Akl, Elie A. ^{[1
,2
,3
]}

Briel, Matthias ^{[3
,4
]}

You, John J. ^{[3
,5
]}

Sun, Xin ^{[3
,6
]}

Johnston, Bradley C. ^{[3
,7
]}

Busse, Jason W. ^{[3
,8
]}

Mulla, Sohail ^{[3
]}

Lamontagne, Francois ^{[9
]}

Bassler, Dirk ^{[10
,11
]}

Vera, Claudio ^{[12
]}

Alshurafa, Mohamad ^{[3
]}

Katsios, Christina M. ^{[5
]}

Zhou, Qi ^{[3
]}

Cukierman-Yaffe, Tali ^{[5
,13
]}

Gangji, Azim ^{[5
]}

Mills, Edward J. ^{[14
]}

Walter, Stephen D. ^{[3
]}

Cook, Deborah J. ^{[3
,5
]}

Schuenemann, Holger J. ^{[3
,5
,15
]}

Altman, Douglas G. ^{[16
]}

Guyatt, Gordon H. ^{[3
,5
]}

机构：

[1] SUNY Buffalo, Dept Med, ECMC CC 142, Buffalo, NY 14215 USA

[2] SUNY Buffalo, Dept Family Med, Buffalo, NY 14215 USA

[3] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada

[4] Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostatist, CH-4031 Basel, Switzerland

[5] McMaster Univ, Dept Med, Hamilton, ON, Canada

[6] Kaiser Permanente NW, Ctr Hlth Res, Portland, OR USA

[7] Hosp Sick Children, Res Inst, Toronto, ON M5G 1X8, Canada

[8] Inst Work & Hlth, Toronto, ON, Canada

[9] Univ Sherbrooke, Ctr Rech Clin Etienne Le Bel, Sherbrooke, PQ J1K 2R1, Canada

[10] Univ Childrens Hosp Tuebingen, Dept Neonatol, Tubingen, Germany

[11] Univ Childrens Hosp Tuebingen, Ctr Paediat Clin Studies, Tubingen, Germany

[12] Pontificia Univ Catolica Chile, Div Obstet & Gynecol, Santiago, Chile

[13] Tel Aviv Univ, Sackler Sch Med, Sheba Med Ctr,Endocrinl Inst, Gertner Inst Epidemiol & Hlth Policy Res, IL-69978 Tel Aviv, Israel

[14] Univ Ottawa, Fac Hlth Sci, Ottawa, ON, Canada

[15] Univ Freiburg, Inst Med Informat & Biomet, D-79106 Freiburg, Germany

[16] Univ Oxford, Ctr Stat Med, Oxford, England

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2012年 / 344卷

基金：

中国国家自然科学基金;

关键词：

INTENTION-TO-TREAT; ANTIRETROVIRAL TREATMENT; METHODOLOGICAL QUALITY; MISSING-DATA; PROGRAMS; OUTCOMES; BIAS; METAANALYSIS;

D O I：

10.1136/bmj.e2809

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective To assess the reporting, extent, and handling of loss to follow-up and its potential impact on the estimates of the effect of treatment in randomised controlled trials. Design Systematic review. We calculated the percentage of trials for which the relative risk would no longer be significant under a number of assumptions about the outcomes of participants lost to follow-up. Data sources Medline search of five top general medical journals, 2005-07. Eligibility criteria Randomised controlled trials that reported a significant binary primary patient important outcome. Results Of the 235 eligible reports identified, 31 (13%) did not report whether or not loss to follow-up occurred. In reports that did give the relevant information, the median percentage of participants lost to follow-up was 6% (interquartile range 2-14%). The method by which loss to follow-up was handled was unclear in 37 studies (19%); the most commonly used method was survival analysis (66, 35%). When we varied assumptions about loss to follow-up, results of 19% of trials were no longer significant if we assumed no participants lost to follow-up had the event of interest, 17% if we assumed that all participants lost to follow-up had the event, and 58% if we assumed a worst case scenario (all participants lost to follow-up in the treatment group and none of those in the control group had the event). Under more plausible assumptions, in which the incidence of events in those lost to follow-up relative to those followed-up is higher in the intervention than control group, results of 0% to 33% trials were no longer significant. Conclusion Plausible assumptions regarding outcomes of patients lost to follow-up could change the interpretation of results of randomised controlled trials published in top medical journals.

引用

页数：12

共 34 条

[1] Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid [J].

Akl, Elie A. ;

Sun, Xin ;

Busse, Jason W. ;

Johnston, Bradley C. ;

Briel, Matthias ;

Mulla, Sohail ;

You, John J. ;

Bassler, Dirk ;

Lamontagne, Francois ;

Vera, Claudio ;

Alshurafa, Mohamad ;

Katsios, Christina M. ;

Heels-Ansdell, Diane ;

Zhou, Qi ;

Mills, Ed ;

Guyatt, Gordon H. .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2012, 65 (03) :262-267

[2] LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact [J].

Akl, Elie A. ;

Briel, Matthias ;

You, John J. ;

Lamontagne, Francois ;

Gangji, Azim ;

Cukierman-Yaffe, Tali ;

Alshurafa, Mohamad ;

Sun, Xin ;

Nerenberg, Kara A. ;

Johnston, Bradley C. ;

Vera, Claudio ;

Mills, Edward J. ;

Bassler, Dirk ;

Salazar, Arturo ;

Bhatnagar, Neera ;

Busse, Jason W. ;

Khalid, Zara ;

Walter, S. D. ;

Cook, Deborah J. ;

Schuenemann, Holger J. ;

Altman, Douglas G. ;

Guyatt, Gordon H. .

TRIALS, 2009, 10

[3]

[Anonymous], 2009, OPEN MED-WARSAW

[4] Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials [J].

Balk, EM ;

Bonis, PAL ;

Moskowitz, H ;

Schmid, CH ;

Ioannidis, JPA ;

Wang, CC ;

Lau, J .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2002, 287 (22) :2973-2982

[5] Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases [J].

Baron, G ;

Boutron, I ;

Giraudeau, B ;

Ravaud, P .

ARTHRITIS AND RHEUMATISM, 2005, 52 (06) :1858-1865

[6] Mortality of Patients Lost to Follow-Up in Antiretroviral Treatment Programmes in Resource-Limited Settings: Systematic Review and Meta-Analysis [J].

Brinkhof, Martin W. G. ;

Pujades-Rodriguez, Mar ;

Egger, Matthias .

PLOS ONE, 2009, 4 (06)

[7] AN INTRODUCTION TO A BAYESIAN METHOD FOR META-ANALYSIS - THE CONFIDENCE PROFILE METHOD [J].

EDDY, DM ;

HASSELBLAD, V ;

SHACHTER, R .

MEDICAL DECISION MAKING, 1990, 10 (01) :15-23

[8] Post-randomisation exclusions:: the intention to treat principle and excluding patients from analysis [J].

Fergusson, D ;

Aaron, SD ;

Guyatt, G ;

Hébert, P .

BMJ-BRITISH MEDICAL JOURNAL, 2002, 325 (7365) :652-654

[9] Addressing Missing Data in Clinical Trials [J].

Fleming, Thomas R. .

ANNALS OF INTERNAL MEDICINE, 2011, 154 (02) :113-+

[10] Sampling-based approach to determining outcomes of patients lost to follow-up in antiretroviral therapy scale-up programs in Africa [J].

Geng, Elvin H. ;

Emenyonu, Nneka ;

Bwana, Mwebesa Bosco ;

Glidden, David V. ;

Martin, Jeffrey N. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (05) :506-507

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