Lockwood Ishtar, Walker Rachel M, Latimer Sharon, Chaboyer Wendy, Cooke Marie, Gillespie Brigid M
NHMRC Centre of Research Excellence in Wiser Wound Care, Menzies Health Institute Queensland, Australia.
School of Nursing and Midwifery, Griffith University, Brisbane and Gold Coast, Australia.
Contemp Clin Trials Commun. 2022 Jan 20;26:100894. doi: 10.1016/j.conctc.2022.100894. eCollection 2022 Apr.
There is increasing recognition of the importance of undertaking process evaluations alongside implementation of health interventions by examining mechanisms of impact and contextual factors. However, a comprehensive synthesis of process evaluations undertaken alongside clinical trials in hospital settings is lacking. We undertook a scoping review to address this gap.
This review was guided by the methodological framework for scoping studies. Studies were identified using four databases; Ovid Medline, EBSCO CINAHL, EMBASE and Scopus. Two authors independently screened all titles and available abstracts, with a third author available to adjudicate. Studies were eligible for inclusion if they described a process evaluation undertaken alongside a randomised controlled trial in the hospital setting. Data were abstracted by one author and checked by two others and analysed both descriptively and using inductive content analysis.
Data were extracted from 30 articles reporting on 15 trials, most of which were cluster randomised trials (c-RTs) (n = 12). The most common data collection methods used in process evaluations were interviews, questionnaires or surveys, and records or logs. Data analysis revealed three themes relative to how authors: use process data to interpret, understand and explain trial outcomes; evaluate responses to the intervention; and consider the implementation context.
Findings from this review demonstrate the complex nature of intervention implementation in the hospital setting. Overall, there is need for standardised reporting of process evaluations and more explicit descriptions of how authors use frameworks to guide their evaluation.
通过研究影响机制和背景因素，人们越来越认识到在实施健康干预措施的同时进行过程评估的重要性。然而，缺乏对医院环境中与临床试验同时进行的过程评估的全面综合。我们进行了一项范围综述以填补这一空白。
本综述以范围研究的方法框架为指导。使用四个数据库检索研究；Ovid Medline、EBSCO CINAHL、EMBASE和Scopus。两位作者独立筛选所有标题和可用摘要，如有需要第三位作者进行裁决。如果研究描述了在医院环境中与随机对照试验同时进行的过程评估，则有资格纳入。数据由一位作者提取，另外两位作者进行核对，并进行描述性分析和归纳性内容分析。
从30篇报告15项试验的文章中提取数据，其中大多数是整群随机试验（c-RTs）（n = 12）。过程评估中最常用的数据收集方法是访谈、问卷或调查以及记录或日志。数据分析揭示了与作者如何做相关的三个主题：使用过程数据来解释、理解和说明试验结果；评估对干预的反应；以及考虑实施背景。
本综述的结果表明了医院环境中干预实施的复杂性。总体而言，需要对过程评估进行标准化报告，并更明确地描述作者如何使用框架来指导他们的评估。
