Moore Helen J, Nixon Catherine, Tariq Anisah, Emery Jon, Hamilton Willie, Hoare Zoë, Kershenbaum Anne, Neal Richard D, Ukoumunne Obioha C, Usher-Smith Juliet, Walter Fiona M, Whyte Sophie, Rubin Greg
School of Medicine, Pharmacy & Health, Durham University, Wolfson Research Institute, Queens Campus, Thornaby, TS17 6BH, UK.
General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton, VIC, 3053, Australia.
Trials. 2016 Apr 4;17:184. doi: 10.1186/s13063-016-1307-3.
For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect.
METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice.
We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected.
ISRCTN Registry, ISRCTN12595588 .
对于大多数癌症而言，仅有少数患者的症状符合英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence）关于紧急转诊的指导标准。对于胃食管癌，仅有32%和8%的患者分别报告有吞咽困难和体重减轻等“警示”症状，且这些症状的出现与疾病晚期相关。尽管电子临床决策支持工具与临床计算机系统集成后在全科医疗中的有效性仍存在不确定性，但此类工具已被开发出来。本试验的目的是优化干预措施，确定干预措施和随机分组的可接受性，确认结局指标的适用性和选择，最终确定III期确定性试验的设计，并获得干预效果的初步估计值。
方法/设计：这是一项双臂、多中心、整群随机对照II期试验设计，为期16个月，涵盖东北和北坎布里亚以及东部地方临床研究网络区域内的60家全科医疗诊所。诊所将被随机分配接受干预措施（电子临床决策支持工具）或作为对照（常规护理）。我们将从这些诊所中招募3000名符合试验纳入标准且因提示胃食管癌症状前来就诊于全科医生的成年人。主要测量指标为过程数据，包括从业者结局、服务结局、诊断间隔、卫生经济结局和患者结局。将对30对患者 - 全科医生二元组的子样本进行一对一访谈，以了解在诊疗过程中使用或不使用电子临床决策支持工具的影响。还将对另外10 - 15名全科医生进行访谈，以识别并了解影响电子临床决策支持工具在实际应用中的促进因素和制约因素。
我们旨在获取关于电子临床决策支持工具在全科医疗中使用的过程指标的新知识，并为后续的确定性III期试验提供信息。还将收集关于支持工具对资源利用和医疗保健成本影响的初步数据。
国际标准随机对照试验编号（ISRCTN Registry），ISRCTN12595588 。
