李·西尔弗曼嗓音治疗与标准言语和语言治疗及帕金森病对照治疗的比较：一项随机对照试验试点研究（帕金森病沟通试点研究）
Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot).
作者信息
Sackley Catherine M, Smith Christina H, Rick Caroline E, Brady Marian C, Ives Natalie, Patel Smitaa, Woolley Rebecca, Dowling Francis, Patel Ramilla, Roberts Helen, Jowett Sue, Wheatley Keith, Kelly Debbie, Sands Gina, Clarke Carl E
机构信息
1Faculty of Life Sciences and Medicine, King's College London, London, UK.
2Division of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.
出版信息
Pilot Feasibility Stud. 2018 Jan 10;4:30. doi: 10.1186/s40814-017-0222-z. eCollection 2018.
BACKGROUND
Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).
METHODS
The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings.
RESULTS
Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial.
CONCLUSION
Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.
背景
与言语相关的问题在帕金森病（PD）中很常见，但几乎没有证据表明标准言语和语言治疗（SLT）或李·西尔弗曼嗓音治疗（LSVT LOUD®）有效。
方法
PD COMM试点研究是一项三臂、评估者盲法、随机对照试验（RCT），比较LSVT LOUD®、SLT和不干预（比例为1:1:1），以评估可行性并为全面RCT的设计提供信息。符合条件的是患有特发性PD且有言语问题、在过去2年中未接受过针对言语问题的SLT的非痴呆患者。LSVT LOUD®是一种标准化方案（4周内进行16次治疗）。SLT包含每个当地机构的个性化内容（通常每周治疗6 - 8周）。结果包括招募和保留情况、治疗依从性以及数据完整性。在基线、3个月、6个月和12个月收集的结果数据包括患者报告的嗓音和生活质量指标、资源使用情况以及评估者评定的言语录音。
结果
89名患者被随机分组，治疗组的完成率为90%，对照组为100%。各治疗组在所有时间点的嗓音障碍指数（VHI）应答率均≥90%。VHI与其他言语相关结果指标高度相关。LSVT LOUD®组（与对照组相比3个月时差异：-12.5分；95%可信区间-26.2，1.2）和SLT组（与对照组相比3个月时差异：-9.8分；95%可信区间-23.2，3.7）的VHI有改善趋势，这需要在一项有足够效力的试验中得到证实。
结论
随机分组至包括不干预对照组的三臂言语治疗试验是可行且可接受的。两种干预措施的依从性都很好。VHI和其他患者报告的结果是相关指标，并为实质性试验的样本量提供了数据。
试验注册
国际标准随机对照试验编号注册库：ISRCTN75223808。2012年3月22日注册。
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