The effect of two speech and language approaches on speech problems in people with Parkinson's disease: the PD COMM RCT.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Health technology assessment Pub Date : 2024-10-01 DOI:10.3310/ADWP8001
Catherine M Sackley, Caroline Rick, Marian C Brady, Christopher Burton, Sue Jowett, Smitaa Patel, Rebecca Woolley, Patricia Masterson-Algar, Avril Nicoll, Christina H Smith, Zainab Abdali, Natalie Ives, Gillian Beaton, Sylvia Dickson, Ryan Ottridge, Helen Nankervis, Carl E Clarke
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Participants were randomised in a 1 : 1 : 1 ratio to control, National Health Service speech and language therapy or Lee Silverman Voice Treatment LOUD via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Mixed-methods process and health economic evaluations were conducted.</p><p><strong>Setting: </strong>United Kingdom outpatient and home settings.</p><p><strong>Participants: </strong>People with idiopathic Parkinson's disease, with self-reported or carer-reported speech or voice problems. We excluded people with dementia, laryngeal pathology and those within 24 months of previous speech and language therapy.</p><p><strong>Interventions: </strong>The Lee Silverman Voice Treatment LOUD intervention included maximum effort drills and high-effort speech production tasks delivered over four 50-minute therapist-led personalised sessions per week, for 4 weeks with prescribed daily home practice. National Health Service speech and language therapy content and dosage reflected local non-Lee Silverman Voice Treatment speech and language therapy practices, usually 1 hour, once weekly, for 6 weeks. Trained, experienced speech and language therapists or assistants provided interventions. The control was no speech and language therapy until the trial was completed.</p><p><strong>Main outcome measures: </strong>Primary outcome: Voice Handicap Index total score at 3 months. Secondary outcomes: Voice Handicap Index subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICEpop Capabilities Measure for Older Adults; Parkinson's Disease Questionnaire - Carers; resource utilisation; and adverse events. Assessments were completed pre-randomisation and at 3, 6 and 12 months post randomisation.</p><p><strong>Results: </strong>Three hundred and eighty-eight participants were randomised to Lee Silverman Voice Treatment LOUD (<i>n</i> = 130), National Health Service speech and language therapy (<i>n</i> = 129) and control (<i>n</i> = 129). The impact of voice problems at 3 months after randomisation was lower for Lee Silverman Voice Treatment LOUD participants than control [-8.0 (99% confidence interval: -13.3, -2.6); <i>p</i> = 0.001]. There was no evidence of improvement for those with access to National Health Service speech and language therapy when compared to control [1.7 (99% confidence interval: -3.8, 7.1); <i>p</i> = 0.4]. Participants randomised to Lee Silverman Voice Treatment LOUD reported a lower impact of their voice problems than participants randomised to National Health Service speech and language therapy [99% confidence interval: -9.6 (-14.9, -4.4); <i>p</i> < 0.0001]. 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引用次数: 0

Abstract

Background: Speech impairments are common with Parkinson's disease (reported prevalence 68%), increasing conversational demands, reliance on family and social withdrawal.

Objective(s): The PD COMM trial compared the clinical and cost-effectiveness of two speech and language therapy approaches: Lee Silverman Voice Treatment LOUD and National Health Service speech and language therapy for the treatment of speech or voice problems in people with Parkinson's disease to no speech and language therapy (control) and against each other.

Design: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Participants were randomised in a 1 : 1 : 1 ratio to control, National Health Service speech and language therapy or Lee Silverman Voice Treatment LOUD via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Mixed-methods process and health economic evaluations were conducted.

Setting: United Kingdom outpatient and home settings.

Participants: People with idiopathic Parkinson's disease, with self-reported or carer-reported speech or voice problems. We excluded people with dementia, laryngeal pathology and those within 24 months of previous speech and language therapy.

Interventions: The Lee Silverman Voice Treatment LOUD intervention included maximum effort drills and high-effort speech production tasks delivered over four 50-minute therapist-led personalised sessions per week, for 4 weeks with prescribed daily home practice. National Health Service speech and language therapy content and dosage reflected local non-Lee Silverman Voice Treatment speech and language therapy practices, usually 1 hour, once weekly, for 6 weeks. Trained, experienced speech and language therapists or assistants provided interventions. The control was no speech and language therapy until the trial was completed.

Main outcome measures: Primary outcome: Voice Handicap Index total score at 3 months. Secondary outcomes: Voice Handicap Index subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICEpop Capabilities Measure for Older Adults; Parkinson's Disease Questionnaire - Carers; resource utilisation; and adverse events. Assessments were completed pre-randomisation and at 3, 6 and 12 months post randomisation.

Results: Three hundred and eighty-eight participants were randomised to Lee Silverman Voice Treatment LOUD (n = 130), National Health Service speech and language therapy (n = 129) and control (n = 129). The impact of voice problems at 3 months after randomisation was lower for Lee Silverman Voice Treatment LOUD participants than control [-8.0 (99% confidence interval: -13.3, -2.6); p = 0.001]. There was no evidence of improvement for those with access to National Health Service speech and language therapy when compared to control [1.7 (99% confidence interval: -3.8, 7.1); p = 0.4]. Participants randomised to Lee Silverman Voice Treatment LOUD reported a lower impact of their voice problems than participants randomised to National Health Service speech and language therapy [99% confidence interval: -9.6 (-14.9, -4.4); p < 0.0001]. There were no reports of serious adverse events. Staff were confident with the trial interventions; a range of patient and therapist enablers of implementing Lee Silverman Voice Treatment LOUD were identified. The economic evaluation results suggested Lee Silverman Voice Treatment LOUD was more expensive and more effective than control or National Health Service speech and language therapy but was not cost-effective with incremental cost-effectiveness ratios of £197,772 per quality-adjusted life-year gained and £77,017 per quality-adjusted life-year gained, respectively.

Limitations: The number of participants recruited to the trial did not meet the pre-specified power.

Conclusions: People that had access to Lee Silverman Voice Treatment LOUD described a significantly greater reduction in the impact of their Parkinson's disease-related speech problems 3 months after randomisation compared to people that had no speech and language therapy. There was no evidence of a difference between National Health Service speech and language therapy and those that received no speech and language therapy. Lee Silverman Voice Treatment LOUD resulted in a significantly lower impact of voice problems compared to National Health Service speech and language therapy 3 months after randomisation which was still present after 12 months; however, Lee Silverman Voice Treatment LOUD was not found to be cost-effective.

Future work: Implementing Lee Silverman Voice Treatment LOUD in the National Health Service and identifying alternatives to Lee Silverman Voice Treatment LOUD for those who cannot tolerate it. Investigation of less costly alternative options for Lee Silverman Voice Treatment delivery require investigation, with economic evaluation using a preference-based outcome measure that captures improvement in communication.

Study registration: This study is registered as ISRCTN12421382.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 10/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 58. See the NIHR Funding and Awards website for further award information.

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两种言语和语言方法对帕金森病患者言语问题的影响:帕金森病 COMM RCT。
背景:帕金森病患者普遍存在言语障碍(报告发病率为 68%),这增加了患者的对话要求、对家人的依赖以及社交退缩:帕金森病 COMM 试验比较了两种言语治疗方法的临床效果和成本效益:目的:帕金森病 COMM 试验比较了两种言语和语言治疗方法的临床和成本效益:用于治疗帕金森病患者言语或嗓音问题的李-西尔弗曼嗓音治疗 LOUD 方法和国民健康服务言语和语言治疗方法,以及不进行言语和语言治疗的方法(对照组):帕金森病COMM是一项III期、多中心、三臂、无盲、随机对照试验。参与者按1:1:1的比例被随机分配到对照组、国家卫生服务机构的言语和语言治疗组或李-西尔弗曼嗓音治疗LOUD组(通过中央计算机生成的程序进行)。进行了混合方法过程评估和卫生经济评估:英国门诊和家庭环境:特发性帕金森病患者,自述或由护理人员自述有语言或嗓音问题。我们排除了痴呆症患者、喉部病变患者以及之前接受过言语和语言治疗 24 个月内的患者:李-西尔弗曼嗓音治疗 LOUD 干预疗法包括最大努力练习和高努力言语生成任务,每周进行四次,每次 50 分钟,由治疗师指导个性化疗程,为期 4 周,并规定每天在家练习。国民健康服务的言语和语言治疗内容和剂量反映了当地非李-西尔弗曼嗓音治疗的言语和语言治疗实践,通常为每周一次,每次 1 小时,持续 6 周。由训练有素、经验丰富的言语和语言治疗师或助理提供干预。对照组在试验结束前不进行言语和语言治疗:主要结果3 个月后的嗓音障碍指数总分。次要结果嗓音障碍指数分量表、帕金森病问卷-39、获得性言语障碍问卷、EuroQol-5D-5L、ICEpop老年人能力测量、帕金森病问卷-照护者、资源利用率和不良事件。评估在随机前、随机后 3 个月、6 个月和 12 个月完成:三百八十八名参与者被随机分配到李-西尔弗曼嗓音治疗 LOUD(130 人)、国家卫生服务机构的言语和语言治疗(129 人)以及对照组(129 人)。随机分组后 3 个月,李-西尔弗曼嗓音治疗 LOUD 参与者的嗓音问题影响低于对照组 [-8.0 (99% 置信区间:-13.3, -2.6);p = 0.001]。与对照组相比,没有证据表明接受国民健康服务言语和语言治疗的参与者的情况有所改善[1.7(99% 置信区间:-3.8,7.1);p = 0.4]。随机接受李-西尔弗曼嗓音治疗 LOUD 的参与者报告的嗓音问题影响低于随机接受国民健康服务语音和语言治疗的参与者[99% 置信区间:-9.6 (-14.9, -4.4);p 限制:试验招募的参与者人数未达到预先规定的功率:接受过李-西尔弗曼嗓音治疗 LOUD 的患者与未接受过言语和语言治疗的患者相比,在随机分配 3 个月后,帕金森病相关言语问题的影响明显减轻。没有证据表明国家卫生服务机构的言语和语言治疗与未接受言语和语言治疗的患者之间存在差异。与国家医疗服务机构的言语和语言治疗相比,李-西尔弗曼嗓音治疗 LOUD 在随机治疗 3 个月后对嗓音问题的影响明显降低,这种影响在 12 个月后仍然存在;但是,李-西尔弗曼嗓音治疗 LOUD 并不具有成本效益:未来工作:在国民健康服务中实施李-西尔弗曼嗓音治疗 LOUD,并为无法忍受李-西尔弗曼嗓音治疗 LOUD 的患者确定替代方案。研究注册:本研究已注册为 ISRCTN12421382:该奖项由美国国家健康与护理研究所(NIHR)健康技术评估项目资助(NIHR奖项编号:10/135/02),全文发表于《健康技术评估》;第28卷,第58期。更多奖项信息,请参阅 NIHR Funding and Awards 网站。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
期刊最新文献
Diagnostic accuracy of point-of-care tests for acute respiratory infection: a systematic review of reviews. The effect of two speech and language approaches on speech problems in people with Parkinson's disease: the PD COMM RCT. Alitretinoin versus phototherapy as the first-line treatment in adults with severe chronic hand eczema: the ALPHA RCT. Transperineal biopsy devices in people with suspected prostate cancer - a systematic review and economic evaluation. Preventive drug treatments for adults with chronic migraine: a systematic review with economic modelling.
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