帕金森病社区管理（PD COMM）试验：一项随机试验的过程评估方案，该试验评估两种类型的言语和语言治疗对帕金森病患者的有效性。
The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.
作者信息
Masterson-Algar Patricia, Burton Christopher R, Brady Marian C, Nicoll Avril, Clarke Carl E, Rick Caroline, Hughes Max, Au Pui, Smith Christina H, Sackley Catherine M
机构信息
Bangor Institute for Health & Medical Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK.
Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
出版信息
Trials. 2017 Aug 29;18(1):397. doi: 10.1186/s13063-017-2130-1.
BACKGROUND
The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why.
METHODS/DESIGN: Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined.
DISCUSSION
To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why.
TRIAL REGISTRATION
ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.
背景
帕金森病言语与沟通（PD COMM）试验是一项III期多中心随机对照试验，旨在评估两种言语和语言治疗（SLT）方法相较于无SLT干预（对照），对自述或由照料者报告存在言语或声音问题的帕金森病患者的有效性和成本效益。我们的方案描述了嵌入在结果评估中的过程评估，其目的是评估PD COMM干预实施时发生了什么，并提供有助于解释PD COMM试验结果的研究发现。此外，PD COMM过程评估的目的是在一个关于试验干预如何能最佳发挥作用以及原因的理论模型内，研究干预的复杂性。
方法/设计：借鉴正常化过程理论和实施保真度框架，将采用混合方法设计来解决过程评估研究问题。将通过深入访谈来调查治疗师和参与者的看法及经历。在PD COMM试验进行期间的相关时间点，还将收集关键事件报告、治疗师的基线调查数据、治疗记录表格和家庭练习日记。过程评估数据将在两组数据合并之前独立于结果评估进行分析。
讨论
迄今为止，已发表的过程评估方案数量有限，且很少与调查康复治疗的试验相关联。我们的过程评估提供了一个强有力的理论框架来支撑设计选择，并针对试验干预的复杂特征进行了调整，有可能为PD COMM中实施的干预措施的哪些组成部分效果最佳（以及哪些效果不佳）、它们如何良好发挥作用以及原因提供有价值的见解。
试验注册
国际标准随机对照试验编号注册库，ISRCTN12421382。于2016年4月18日注册。
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