School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
College of Medicine and Life Sciences, The University of Toledo, Toledo, Ohio, USA.
Otolaryngol Head Neck Surg. 2023 Oct;169(4):747-754. doi: 10.1002/ohn.312. Epub 2023 Mar 2.
To evaluate the reporting and rates of loss to follow-up (LTFU) in head and neck cancer (HNC) randomized controlled trials based in the United States.
Pubmed/MEDLINE, Cochrane, Scopus databases.
A systematic review of titles in Pubmed/MEDLINE, Scopus, and Cochrane Library was performed. Inclusion criteria were US-based randomized controlled trials focused on the diagnosis, treatment, or prevention of HNC. Retrospective analyses and pilot studies were excluded. The mean age, patients randomized, publication details, trial sites, funding, and LTFU data were recorded. Reporting of participants through each stage of the trial was documented. Binary logistic regression was performed to evaluate associations between study characteristics and reporting LTFU.
A total of 3255 titles were reviewed. Of these, 128 studies met the inclusion criteria for analysis. A total of 22,016 patients were randomized. The mean age of participants was 58.6 years. Overall, 35 studies (27.3%) reported LTFU, and the mean LTFU rate was 4.37%. With the exception of 2 statistical outliers, study characteristics including publication year, number of trial sites, journal discipline, funding source, and intervention type did not predict the odds of reporting LTFU. Compared to 95% of trials reporting participants at eligibility and 100% reporting randomization, only 47% and 57% reported on withdrawal and details of the analysis, respectively.
The majority of clinical trials in HNC in the United States do not report LTFU, which inhibits the evaluation of attrition bias that may impact the interpretation of significant findings. Standardized reporting is needed to evaluate the generalizability of trial results to clinical practice.
评估美国开展的头颈部癌症（HNC）随机对照试验（RCT）的报告和失访（LTFU）率。
PubMed/MEDLINE、Cochrane、Scopus 数据库。
对 PubMed/MEDLINE、Scopus 和 Cochrane Library 的标题进行系统评价。纳入标准为以美国为基础的、聚焦于 HNC 诊断、治疗或预防的 RCT。排除回顾性分析和试点研究。记录平均年龄、随机分组患者、发表详情、试验地点、资金和 LTFU 数据。记录试验各阶段参与者的报告情况。采用二项逻辑回归分析评估研究特征与报告 LTFU 之间的关系。
共查阅了 3255 个标题。其中，有 128 项研究符合分析纳入标准。共有 22016 名患者被随机分组。参与者的平均年龄为 58.6 岁。总体而言，35 项研究（27.3%）报告了 LTFU，平均 LTFU 率为 4.37%。除了 2 个统计学异常值外，研究特征（包括发表年份、试验地点数量、期刊学科、资金来源和干预类型）并不能预测报告 LTFU 的几率。与 95%报告合格参与者和 100%报告随机分组的试验相比，只有 47%和 57%分别报告了退出和分析细节。
美国 HNC 临床试验多数未报告 LTFU，这限制了对可能影响重要发现解释的失访偏倚的评估。需要标准化报告以评估试验结果对临床实践的可推广性。
