Department of Clinical Speech and Language Studies, Trinity College Dublin, 7‑9 South Leinster Street, Dublin 2, D02KF66, Ireland.
Speech and Language Therapy Department, Tallaght University Hospital, Dublin 24, Ireland.
Dysphagia. 2022 Apr;37(2):307-317. doi: 10.1007/s00455-021-10279-3. Epub 2021 Mar 15.
Measuring fidelity of delivery and engagement in the methods of a trial helps us to understand whether planned interventions were effective. Treatment fidelity is critical in proving that change in study outcomes is due to the intervention itself and not to variability in its implementation or measurement. Existing reviews of oropharyngeal dysphagia (OD) interventions for Parkinson's disease (PD) have not systematically scrutinized fidelity within clinical trials. This study aimed to examine treatment fidelity in behavioral interventions for OD in PD and provide information about the reliability of existing study findings on behavioral interventions. All published and unpublished randomized controlled trials (RCTs) regarding behavioral interventions for OD in PD were sought. A comprehensive search of eight electronic databases was performed from inception to January 2019 and updated in April 2020. Gray literature was explored to minimize publication bias. No language or date restrictions were applied. Data were extracted by two independent reviewers with a third mediator. The National Institutes of Health Behavior Change Consortium Treatment Fidelity checklist was used to assess fidelity. From the 4998 references identified, eight studies met the inclusion criteria. Behavioral interventions in the included studies varied. The level of treatment fidelity was rated as low across all studies included in the review. The review concluded that low levels of treatment fidelity adherence in RCTs on dysphagia interventions in PD undermine the interpretation of the validity and reliability of study findings along with successful replication of these interventions in research and clinical practice.
评估试验方法的实施和参与度有助于我们了解计划干预措施是否有效。治疗一致性对于证明研究结果的变化是由于干预本身，而不是由于其实施或测量的变异性，至关重要。现有的关于帕金森病（PD）口咽吞咽障碍（OD）干预措施的综述并没有系统地审查临床试验中的一致性。本研究旨在检查 PD 中 OD 的行为干预措施的治疗一致性，并提供有关行为干预措施现有研究结果可靠性的信息。我们检索了所有关于 PD 中 OD 的行为干预的已发表和未发表的随机对照试验（RCT）。从成立到 2019 年 1 月，对 8 个电子数据库进行了全面检索，并于 2020 年 4 月进行了更新。为了最大限度地减少发表偏倚，我们还探索了灰色文献。未对语言或日期进行限制。两名独立评审员提取数据，第三名评审员进行调解。采用美国国立卫生研究院行为改变联盟治疗一致性检查表评估一致性。从确定的 4998 篇参考文献中，有 8 项研究符合纳入标准。纳入研究中的行为干预措施各不相同。在本综述中纳入的所有研究中，治疗一致性的水平均被评为低。本综述得出的结论是，PD 吞咽障碍干预 RCT 中治疗一致性低，影响了对研究结果有效性和可靠性的解释，以及这些干预措施在研究和临床实践中的成功复制。
