Clinical effectiveness, cost-effectiveness and service users' perceptions of early, well-resourced communication therapy following a stroke: a randomised controlled trial (the ACT NoW Study)
Clinical effectiveness, cost-effectiveness and service users' perceptions of early, well-resourced communication therapy following a stroke: a randomised controlled trial (the ACT NoW Study)
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DOI：
10.3310/hta16260
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发表时间：
2012-05-01
影响因子：
3.6
通讯作者：
Tyrrell, P.
中科院分区：
文献类型：
--
作者：
Bowen, A.;Hesketh, A.;Tyrrell, P.
目的：为了确定临床效果，成本效益和服务用户的意见，加强早期沟通治疗的言语和语言（SL）治疗师相比，注意力控制（AC）。设计：成功的可行性研究，其次是一个随机试验与经济评估，和嵌套定性研究，使用32个单独的访谈。设置：12个英国国民保健服务医院和社区中风服务。参与者：2006年12月至2010年1月，170名患有失语症或构音障碍的成人因中风入院。资格由NHS SL治疗师确定。17人拒绝follow-up.Interventions：最佳实践，灵活的干预NHS SL治疗师，每周最多三次接触，长达16周，与受雇visiters.Main结果measures的AC接触人数相似相比：主要结果是盲法，功能性沟通能力6个月后随机化的治疗结果测量活动子量表（TOM）。次要结果是参与者对中风后沟通结果量表（COAST）的看法;照顾者对部分照顾者COAST参与者的看法;欧洲老年人照顾者指数和照顾者COAST生活质量项目的照顾者福祉。记录严重不良事件（SAE）。经济评价：参与者的效用（欧洲生活质量-5维），医疗记录和护理人员的服务使用和成本数据，以及离散选择experiments.Results：干预通常在2周后开始，提供22个联系人。两组都在TOM上有所改善。估计的6个月组间差异[95%置信区间（Cl）]为0.25（-0.19至0.69）分，支持SL治疗。敏感性分析调整基线机会不平衡或不插补死者的值进一步减少了这种差异。符合方案分析排除了拒绝分配和接受NHS SL治疗的对照组的可能稀释治疗。没有证据表明治疗对任何次要结局指标或SAE有额外获益，尽管后者在治疗组中的发生率较低[比值比0.42（95% CI 0.16 - 1.1）]。无论分组如何，受访者都报告说，他们的信心和情绪受到了积极影响，确定了变革的驱动因素，并重视早期和持续的接触。卫生经济学分析表明，不确定性很高。早期加强SL治疗的沟通可能是成本效益只有当决策者准备支付>=25,000磅，以获得一个单位的utility.Conclusions：这些研究结果排除了临床上的TOM上的0.5点显着差异的可能性。没有证据表明，在任何措施，额外的好处，早期沟通治疗以外的AC。目前尚不清楚治疗是否比AC更具成本效益。早期、频繁的接触受到用户的高度重视，并有很好的吸收。两组的功能性沟通都得到了改善，这可能是由于自然恢复以及早期和定期有机会与专业人士（治疗师/来访者）进行日常沟通。没有证据表明建议由合格的SL治疗师在常规护理之上加强提供早期沟通治疗。SL治疗服务重组应考虑在阶梯式护理模式中的技能组合和时间安排，并应在试验背景下进行。
Objective: To determine the clinical effectiveness, cost-effectiveness and service users' views of enhanced early communication therapy by speech and language (SL) therapists compared with attention control (AC).Design: Successful feasibility study followed by a randomised trial with economic evaluation, and nested qualitative study using 32 individual interviews.Setting: Twelve English NHS hospital and community stroke services.Participants: One hundred and seventy adults with aphasia or dysarthria admitted to hospital with stroke, December 2006 to January 2010. Eligibility determined by NHS SL therapists. Seventeen people declined follow-up.Interventions: A best-practice, flexible intervention by NHS SL therapists, up to three contacts per week for up to 16 weeks compared with a similar number of AC contacts by employed visitors.Main outcome measures: Primary outcome was blinded, functional communicative ability 6 months post randomisation on the Therapy Outcome Measure activity subscale (TOM). Secondary outcomes were participants' perceptions on the Communication Outcomes After Stroke scale (COAST); carers' perceptions of participants from part of the Carer COAST; carer well-being on Carers of Older People in Europe Index and quality-of-life items from Carer COAST. Serious adverse events (SAEs) were recorded. Economic evaluation: participants' utility (European Quality of Life-5 Dimensions), service use and cost data from medical records and carers, and a discrete choice experiment.Results: Intervention typically started after 2 weeks, providing 22 contacts. Both groups improved on the TOM. The estimated 6 months' group difference [95% confidence interval (Cl)] was 0.25 (-0.19 to 0.69) points in favour of SL therapy. Sensitivity analyses adjusting for baseline chance imbalance or not imputing values for decedents further reduced this difference. Per-protocol analyses rejected a possible dilution of therapy from controls refusing allocation and receiving NHS SL therapy. There was no evidence of added benefit of therapy on any secondary outcome measure or SAEs, although the latter were less frequent in the therapy group [odds ratio 0.42(95% CI 0.16 to 1.1)]. Regardless of group allocation, interviewed participants reported positive impacts on their confidence and mood, identified drivers for change and valued early and sustained contact. Health economic analysis indicated a high level of uncertainty. Early enhanced SL therapy for communication is likely to be cost-effective only if decision-makers are prepared to pay >=25,000 pound to gain one unit of utility.Conclusions: These findings exclude the possibility of a clinically significant difference of 0.5 points on the TOM. There was no evidence, on any measure, of added benefit of early communication therapy beyond that from AC. It is unclear whether therapy is more or less cost-effective than AC. Early, frequent contact was highly valued by users and had good uptake. Functional communication improved for both groups, plausibly due to natural recovery and early and regular opportunity to practise everyday communication with a professional (therapist/visitor). There is no evidence to recommend enhancing the provision of early communication therapy by a qualified SL therapist over and above usual care. SL therapy service reorganisation should consider skill mix and timing within a stepped care model and should take place within the context of a trial.