University of Warwick, Clinical Trials Unit, Warwick Medical School, Gibbet Hill Road, Coventry CV47AL, UK.
BMC Musculoskelet Disord. 2011 Feb 25;12:52. doi: 10.1186/1471-2474-12-52.
Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient.
METHODS/DESIGN: Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study.Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research.
Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction.
Current Controlled Trials ISRCTN46035546.
下腰痛是一种常见且代价高昂的疾病。有几种治疗方法可供背痛患者选择，但关于如何改善患者的治疗选择的数据很少。本研究将测试决策支持包（DSP）的效果，该包旨在帮助在物理治疗科寻求背痛治疗的患者对其治疗做出更好、更明智的选择。该套餐将旨在帮助治疗师和患者。
方法/设计：首先，我们将与物理治疗师、患者以及决策支持和决策辅助领域的专家合作，开发 DSP。这项工作将包括：文献和证据回顾；对现有定性数据的二次分析；通过焦点小组探索患者的观点，并通过名义小组技术和德尔菲研究探索专家的观点。其次，我们将在 NHS 考文垂社区物理治疗中心进行一项单中心随机对照试验的试点研究。我们将随机分配物理治疗师接受 DSP 培训或不接受培训。我们将随机分配寻求非特异性下腰痛治疗的患者，要么接受接受决策支持培训的物理治疗师，要么接受常规护理。我们的主要结局测量指标是患者在三个月随访时对治疗的满意度。我们还将评估干预措施的成本效益，并评估进行进一步研究的价值。
知情的共同决策应该是任何临床咨询的重要组成部分，尤其是当有几种潜在具有中等效果的治疗方法时。该试点研究的结果将帮助我们确定改善临床实践中决策过程对患者满意度的益处。
当前对照试验 ISRCTN46035546。
