Division of General Surgery, Department of Surgery, University of Toronto, Toronto, Canada; Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Division of General Surgery, Department of Surgery, University of Toronto, Toronto, Canada.
J Surg Res. 2024 Aug;300:33-42. doi: 10.1016/j.jss.2024.04.054. Epub 2024 May 24.
Loss to follow-up (LTFU) distorts results of randomized controlled trials (RCTs). Understanding trial characteristics that contribute to LTFU may enable investigators to anticipate the extent of LTFU and plan retention strategies. The objective of this systematic review and meta-analysis was to investigate the extent of LTFU in surgical RCTs and evaluate associations between trial characteristics and LTFU.
MEDLINE, Embase, and PubMed Central were searched for surgical RCTs published between January 2002 and December 2021 in the 30 highest impact factor surgical journals. Two-hundred eligible RCTs were randomly selected. The pooled LTFU rate was estimated using random intercept Poisson regression. Associations between trial characteristics and LTFU were assessed using metaregression.
The 200 RCTs included 37,914 participants and 1307 LTFU events. The pooled LTFU rate was 3.10 participants per 100 patient-years (95% confidence interval [CI] 1.85-5.17). Trial characteristics associated with reduced LTFU were standard-of-care outcome assessments (rate ratio [RR] 0.17; 95% CI 0.06-0.48), surgery for transplantation (RR 0.08; 95% CI 0.01-0.43), and surgery for cancer (RR 0.10; 95% CI 0.02-0.53). Increased LTFU was associated with patient-reported outcomes (RR 14.21; 95% CI 4.82-41.91) and follow-up duration ≥ three months (odds ratio 10.09; 95% CI 4.79-21.28).
LTFU in surgical RCTs is uncommon. Participants may be at increased risk of LTFU in trials with outcomes assessed beyond the standard of care, surgical indications other than cancer or transplant, patient-reported outcomes, and longer follow-up. Investigators should consider the impact of design on LTFU and plan retention strategies accordingly.
失访（LTFU）会扭曲随机对照试验（RCT）的结果。了解导致 LTFU 的试验特征，可能使研究人员能够预测 LTFU 的程度，并制定保留策略。本系统评价和荟萃分析的目的是调查外科 RCT 中 LTFU 的程度，并评估试验特征与 LTFU 之间的关联。
在 2002 年 1 月至 2021 年 12 月期间，在影响因子最高的 30 本外科期刊中，我们对已发表的外科 RCT 进行了 MEDLINE、Embase 和 PubMed Central 检索。随机选择了 200 项合格的 RCT。使用随机截距泊松回归估计 LTFU 的汇总发生率。使用荟萃回归评估试验特征与 LTFU 之间的关联。
这 200 项 RCT 共纳入 37914 名参与者和 1307 例 LTFU 事件。汇总 LTFU 发生率为每 100 名患者年 3.10 例（95%置信区间 [CI] 1.85-5.17）。与减少 LTFU 相关的试验特征包括标准护理结局评估（率比 [RR] 0.17；95% CI 0.06-0.48）、移植手术（RR 0.08；95% CI 0.01-0.43）和癌症手术（RR 0.10；95% CI 0.02-0.53）。患者报告结局（RR 14.21；95% CI 4.82-41.91）和随访时间≥3 个月（比值比 10.09；95% CI 4.79-21.28）与 LTFU 增加相关。
外科 RCT 中的 LTFU 并不常见。在结局评估超出标准护理、除癌症或移植外的其他手术适应证、患者报告结局和随访时间较长的试验中，参与者可能面临更高的 LTFU 风险。研究人员应考虑设计对 LTFU 的影响，并相应地制定保留策略。
