前瞻性临床试验入组改善试验内混合研究的基本原理和方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Patrick Lewicki , Sabrina Clark , Elaina Shoemaker , Bingkai Wang , Jerison Ross , Stephanie Daignault-Newton , Noelle Carlozzi , Adam Martin-Schwarze , William Meurer , Anne Sales , Khurshid Ghani , Casey Dauw , Kristian Stensland
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引用次数: 0

摘要

临床试验的入组具有挑战性,并且很少有基于证据的干预措施来改善入组。面向医疗服务提供者的广告活动可能有助于增加注册人数,但这种类型的干预尚未在临床试验中进行前瞻性评估。方法:我们设计了一项随机临床试验来评估为期一个月的电子邮件广告活动对临床试验报名的影响。这项混合实施-有效性的试验研究测试了精确审计和反馈技术的效果,登记有效性结果(登记)和测量实施结果(电子邮件打开,链接点击)。本设计是一项试验中研究(SWAT)的应用,旨在评估旨在提高入组率的干预措施。本研究的目的是为广告宣传和改进SWAT方法提供信息,以评估未来的试验改进干预措施。本试验研究为电子邮件广告活动对提高临床试验入组率的有效性提供了初步数据。此外,通过SWAT建立的基础设施将为临床试验注册改进的未来研究提供信息。该方案可以作为其他研究者寻求评估入组改善干预措施的模板。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial

Introduction

Enrollment to clinical trials is challenging, and few evidence-based interventions to improve enrollment exist. Provider-facing advertising campaigns could help increase enrollment, but this type of intervention has not been prospectively evaluated in a clinical trial.

Methods

We designed a randomized clinical trial to evaluate the effect of a month-long email advertising campaign on enrollment to a clinical trial. This hybrid implementation-effectiveness Study Within a Trial tested the effect of precision audit and feedback techniques enrollment effectiveness outcomes (enrollment) and measured implementation outcomes (email opens, link clicks). This design is an application of a Study Within a Trial (SWAT) to evaluate an intervention intended to improve enrollment. The goal of this study was to inform both this advertising campaign and refine SWAT methods for evaluating future trial improvement interventions.

Discussion

This Study Within a Trial provides preliminary data on the effectiveness of email advertising campaigns for improving clinical trial enrollment. Additionally, the infrastructure built through this SWAT will inform future studies of clinical trial enrollment improvement. This protocol can serve as a template for other investigators seeking to evaluate enrollment improvement interventions.
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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