Higginson Irene J, Hart Sam, Burman Rachel, Silber Eli, Saleem Tariq, Edmonds Polly
King's College London, School of Medicine, Department of Palliative Care, Policy and Rehabilitation, Denmark Hill, London SE5 9RJ, UK.
BMC Palliat Care. 2008 May 28;7:7. doi: 10.1186/1472-684X-7-7.
Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control) randomised controlled trial of a new palliative care service - a design not previously used to assess palliative care.
METHODS/DESIGN: An innovative palliative care service (comprising a consultant in palliative medicine, a clinical nurse specialist, an administrator and a psychosocial worker) was delivered to people severely affected by multiple sclerosis (MS), and their carers, in southeast London. Our design followed the MRC Framework for the Evaluation of Complex Interventions. In phase II we conducted randomised controlled trial, of immediate referral to the service (fast-track) versus a 12-week wait (standard best practice). Main outcome measures were: compliance (the extent the trial protocol was adhered to), recruitment (target 50 patients), attrition and missing data rates; trial outcomes were Palliative Care Outcome Scale and MS Impact Scale.
69 patients were referred, 52 entered the trial (26 randomised to each arm), 5 refused consent and 12 were excluded from the trial for other reasons, usually illness or urgent needs, achieving our target numbers. 25/26 fast track and 21/26 standard best practice patients completed the trial, resulting in 217/225 (96%) of possible interviews completed, 87% of which took place in the patient's home. Main reasons for failure to interview and/or attrition were death or illness. There were three deaths in the standard best practice group and one in the fast-track group during the trial. At baseline there were no differences between groups. Missing data for individual questionnaire items were small (median 0, mean 1-5 items out of 56+ items per interview), not associated with any patient or carer characteristics or with individual questionnaires, but were associated with interviewer.
This is the first time a fast track (or wait list) randomised trial has been reported in palliative care. We found it achieved good recruitment and is a feasible method to evaluate palliative care services when patients are expected to live longer than 3-6 months. Home interviews are needed for a trial of this kind; interviewers need careful recruitment, training and supervision; and there should be careful separation from the clinical service of the control patients to prevent accidental contamination.
Clinical Trials.Gov NCT00364963.
姑息治疗已被提议用于进展性非癌症疾病，但对服务发展的评估却很少。我们分析了一项新的姑息治疗服务的快速通道（或等待名单对照）随机对照试验的招募、依从性和随访数据——这种设计以前未用于评估姑息治疗。
方法/设计：一项创新的姑息治疗服务（由一名姑息医学顾问、一名临床护理专家、一名管理人员和一名心理社会工作者组成）被提供给伦敦东南部受多发性硬化症（MS）严重影响的患者及其护理人员。我们的设计遵循了医学研究委员会（MRC）复杂干预评估框架。在第二阶段，我们进行了随机对照试验，比较立即转诊至该服务（快速通道）与等待12周（标准最佳实践）的情况。主要结局指标包括：依从性（试验方案的遵守程度）、招募情况（目标为50名患者）、损耗率和缺失数据率；试验结局为姑息治疗结局量表和MS影响量表。
69名患者被转诊，52名进入试验（每组随机分配26名），5名拒绝同意，12名因其他原因被排除在试验之外，通常是疾病或紧急需求，达到了我们的目标人数。25/26名快速通道组和21/26名标准最佳实践组患者完成了试验，导致225次可能的访谈中有217次（96%）完成，其中87%在患者家中进行。未能进行访谈和/或损耗的主要原因是死亡或疾病。试验期间，标准最佳实践组有3人死亡，快速通道组有1人死亡。基线时两组之间无差异。单个问卷项目的缺失数据很少（中位数为0，每次访谈56个以上项目中平均缺失1 - 5个项目），与任何患者或护理人员特征或单个问卷均无关，但与访谈者有关。
这是首次在姑息治疗中报告快速通道（或等待名单）随机试验。我们发现它实现了良好的招募，并且是在预计患者存活时间超过3 - 6个月时评估姑息治疗服务的一种可行方法。对于此类试验需要进行家访；访谈者需要仔细招募、培训和监督；并且对照患者的临床服务应与试验仔细分开，以防止意外污染。
ClinicalTrials.Gov NCT00364963
