卫生服务变革：在随机临床试验评估之前是否需要导入期？

Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?

机构信息

Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG, UK.

出版信息

Trials. 2014 Jan 30;15:41. doi: 10.1186/1745-6215-15-41.

DOI:10.1186/1745-6215-15-41

PMID:24479729

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3933371/

Abstract

BACKGROUND

Most randomised clinical trials (RCTs) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach. Consequently, health professionals involved may feel insufficiently familiar or confident, or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT. This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT.

METHODS

The PhysioDirect trial assessed whether PhysioDirect was as effective as usual care. Prior to the main trial, a run-in of up to 12 weeks was permitted to facilitate physiotherapists to become confident in delivering the new service. Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients' physical function (SF-36v2 questionnaire) and Measure Yourself Medical Outcome Profile v2 collected at baseline and six months. Joinpoint regression determined how long it had taken call times to stabilise. Analysis of covariance determined whether patients' physical function at six months changed from the run-in to the main trial.

RESULTS

Mean PhysioDirect call times (minutes) were higher in the run-in (31 (SD: 12.6)) than in the main trial (25 (SD: 11.6)). Each physiotherapist needed to answer 42 (95% CI: 20,56) calls for their mean call time to stabilise at 25 minutes per call; this took a minimum of seven weeks. For patients' physical function, PhysioDirect was equally clinically effective as usual care during both the run-in (0.17 (95% CI: -0.91,1.24)) and main trial (-0.01 (95% CI: -0.80,0.79)).

CONCLUSIONS

A run-in was not needed in a large trial testing PhysioDirect services in terms of patient outcomes. A learning curve was evident in the process measure of telephone call length. This decreased during the run-in and stabilised prior to commencement of the main trial. Future trials should build in a run-in if it is anticipated that learning would have an effect on patient outcome.

TRIAL REGISTRATION

Current Controlled Trials, ISRCTN55666618.

摘要

背景

大多数测试新医疗服务的随机临床试验 (RCT) 在评估新方法之前不允许进行巩固的导入期。因此，参与的卫生专业人员可能会感到不够熟悉或自信，或者在 RCT 中进行明确评估之前，服务中不可或缺的新流程或系统在常规护理中还没有得到充分嵌入。本研究旨在确定新的物理治疗主导的电话评估和治疗服务 PhysioDirect 的最佳导入期，以及在 RCT 中评估结果之前是否需要导入期。

方法

PhysioDirect 试验评估了 PhysioDirect 是否与常规护理一样有效。在主要试验之前，允许长达 12 周的导入期，以帮助物理治疗师对提供新服务充满信心。从导入期和主要试验中收集的结果包括 PhysioDirect 服务内的电话通话时长以及患者的身体功能（SF-36v2 问卷）和 Measure Yourself Medical Outcome Profile v2，这些结果在基线和六个月时收集。连接点回归确定了通话时间需要多长时间才能稳定。协方差分析确定了患者的身体功能在六个月时从导入期到主要试验是否发生了变化。

结果

导入期（31 分钟（SD：12.6））的 PhysioDirect 通话时间（分钟）平均值高于主要试验（25 分钟（SD：11.6））。每位物理治疗师需要接听 42 次电话，才能使平均通话时间稳定在每次通话 25 分钟；这至少需要七周的时间。对于患者的身体功能，PhysioDirect 在导入期（0.17（95%CI：-0.91，1.24））和主要试验（-0.01（95%CI：-0.80，0.79））中与常规护理一样具有临床疗效。