LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact

被引：66

作者：

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

Briel, Matthias ^{[1
,4
]}

You, John J. ^{[1
,5
]}

Lamontagne, Francois ^{[1
,6
]}

Gangji, Azim ^{[5
]}

Cukierman-Yaffe, Tali ^{[7
]}

Alshurafa, Mohamad ^{[1
]}

Sun, Xin ^{[1
,8
]}

Nerenberg, Kara A. ^{[5
]}

Johnston, Bradley C. ^{[9
]}

Vera, Claudio ^{[10
]}

Mills, Edward J. ^{[11
]}

Bassler, Dirk ^{[12
]}

Salazar, Arturo ^{[13
]}

Bhatnagar, Neera ^{[14
]}

Busse, Jason W. ^{[1
,15
]}

Khalid, Zara ^{[1
]}

Walter, S. D. ^{[1
]}

Cook, Deborah J. ^{[1
,5
]}

Schuenemann, Holger J. ^{[1
,16
]}

Altman, Douglas G. ^{[17
]}

Guyatt, Gordon H. ^{[1
,5
]}

机构：

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

[2] SUNY Buffalo, Dept Med, Buffalo, NY 14260 USA

[3] SUNY Buffalo, Dept Family Med, Buffalo, NY 14260 USA

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

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

[6] Univ Sherbrooke, Dept Med, Sherbrooke, PQ J1K 2R1, Canada

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

[8] Sichuan Univ, Dept Clin Epidemiol, W China Hosp, Chengdu 610064, Peoples R China

[9] Univ Alberta, Dept Med, Edmonton, AB, Canada

[10] Pontificia Univ Catolica Chile, Dept Obstet & Gynecol, Santiago, Chile

[11] Ctr Int Hlth & Human Rights Studies, N York, ON, Canada

[12] Univ Childrens Hosp, Dept Neonatol, Tubingen, Germany

[13] Wayne State Univ, Dept Internal Med, Detroit, MI 48202 USA

[14] McMaster Univ, Hlth Sci Lib, Hamilton, ON, Canada

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

[16] Italian Natl Canc Inst, Dept Epidemiol, Rome, Italy

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

来源：

TRIALS | 2009年 / 10卷

基金：

中国国家自然科学基金; 加拿大健康研究院;

关键词：

RANDOMIZED CONTROLLED-TRIALS; METHODOLOGICAL QUALITY; CONSORT STATEMENT; MISSING DATA; INTENTION; OUTCOMES; BIAS;

D O I：

10.1186/1745-6215-10-40

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Incomplete ascertainment of outcomes in randomized controlled trials (RCTs) is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1) the reporting of loss to follow-up information, (2) the analytic methods used for handling loss to follow-up information, and (3) the extent of reported loss to follow-up. Methods: We will conduct a systematic review of reports of RCTs recently published in five top general medical journals. Eligible RCTs will demonstrate statistically significant effect estimates with respect to primary outcomes that are patient-important and expressed as binary data. Teams of 2 reviewers will independently determine eligibility and extract relevant information from each eligible trial using standardized, pre-piloted forms. To assess the potential impact of loss to follow-up on the estimates of treatment effect we will, for varying assumptions about the outcomes of participants lost to follow-up (LTFU), calculate (1) the percentage of RCTs that lose statistical significance and (2) the mean change in effect estimate across RCTs. The different assumptions we will test are the following: (1) none of the LTFU participants had the event; (2) all LTFU participants had the event; (3) all LTFU participants in the treatment group had the event; none of those in the control group had it (worst case scenario); (4) the event incidence among LTFU participants (relative to observed participants) increased, with a higher relative increase in the intervention group; and (5) the event incidence among LTFU participants (relative to observed participants) increased in the intervention group and decreased in the control group. Discussion: We aim to make our objectives and methods transparent. The results of this study may have important implications for both clinical trialists and users of the medical literature.

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页数：11

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