Department of Neurology, Radboud University Nijmegen Medical Center, Reinier Postlaan 4, Nijmegen, The Netherlands.
BMC Neurol. 2011 Aug 23;11:106. doi: 10.1186/1471-2377-11-106.
Shared medical appointments are a series of one-to-one doctor-patient contacts, in presence of a group of 6-10 fellow patients. This group visits substitute the annual control visits of patients with the neurologist. The same items attended to in a one-to-one appointment are addressed. The possible advantages of a shared medical appointment could be an added value to the present management of neuromuscular patients. The currently problem-focused one-to-one out-patient visits often leave little time for the patient's psychosocial needs, patient education, and patient empowerment.
METHODS/DESIGN: A randomized, prospective controlled study (RCT) with a follow up of 6 months will be conducted to evaluate the clinical and cost-effectiveness of shared medical appointments compared to usual care for 300 neuromuscular patients and their partners at the Radboud University Nijmegen Medical Center. Every included patient will be randomly allocated to one of the two study arms. This study has been reviewed and approved by the medical ethics committee of the region Arnhem-Nijmegen, The Netherlands. The primary outcome measure is quality of life as measured by the EQ-5D, SF-36 and the Individualized neuromuscular Quality of Life Questionnaire. The primary analysis will be an intention-to-treat analysis on the area under the curve of the quality of life scores. A linear mixed model will be used with random factor group and fixed factors treatment, baseline score and type of neuromuscular disease. For the economic evaluation an incremental cost-effectiveness analysis will be conducted from a societal perspective, relating differences in costs to difference in health outcome. Results are expected in 2012.
This study will be the first randomized controlled trial which evaluates the effect of shared medical appointments versus usual care for neuromuscular patients. This will enable to determine if there is additional value of shared medical appointments to the current therapeutical spectrum. When this study shows that group visits produce the alleged benefits, this may help to increase the acceptance of this innovative and creative way of using one of the most precious resources in health care more efficiently: time.
DutchTrial Register http://www.trialregister.nlNTR1412.
共病门诊是一系列一对一医患接触，在一组 6-10 名同伴患者的存在下进行。该小组替代了神经科医生对患者的年度控制就诊。在一对一预约中处理的相同项目都将得到解决。共病门诊的可能优势可能是对目前神经肌肉患者管理的附加价值。目前以问题为重点的一对一门诊就诊往往几乎没有时间满足患者的心理社会需求、患者教育和患者赋权。
方法/设计：一项随机、前瞻性对照研究（RCT），对 300 名神经肌肉患者及其伴侣在 Radboud 大学奈梅亨医学中心进行共病门诊与常规护理的 6 个月随访，以评估其临床和成本效益。每位纳入的患者将随机分配到两个研究臂之一。该研究已由荷兰奈梅亨地区的医学伦理委员会审查和批准。主要结局指标是生活质量，通过 EQ-5D、SF-36 和个体化神经肌肉生活质量问卷进行测量。主要分析将是对生活质量评分曲线下面积的意向治疗分析。将使用线性混合模型，具有随机因子组和固定因子治疗、基线评分和神经肌肉疾病类型。对于经济评估，将从社会角度进行增量成本效益分析，将成本差异与健康结果差异联系起来。预计结果将于 2012 年公布。
这项研究将是第一项评估共病门诊与神经肌肉患者常规护理相比效果的随机对照试验。这将能够确定共病门诊是否对当前治疗范围有额外的价值。当这项研究表明小组就诊产生了据称的益处时，这可能有助于提高对这种创新和创造性利用医疗保健中最宝贵资源之一的方式的接受程度：时间。
荷兰试验注册中心 http://www.trialregister.nlNTR1412。
