The MRC ConDuCT-II Hub. COllaboration and iNnovation in DiffiUlt and Complex randomised controlled Trials In Invasive procedures

ConDuCT-II中心位于布里斯托大学的社会和社区医学学院，由外科教授Blazeby教授领导。它将包括一个多学科的学者小组，在开发更好的方法来设计和进行研究以评估医疗干预措施方面有着良好的记录。这项工作将集中在创造新的方法和改进现有的方法，以进行随机对照试验。随机对照试验通常比较两种新的或标准的治疗方法。随机对照试验的重要性在于，参与试验的患者可以通过随机化过程被分配到任何一种接受评价的手术。这意味着患者有平等的机会接受任何一种手术，因此可以对他们每个人的结果进行公平的比较。这些类型的研究是评估医疗保健干预措施的最有效和最可靠的手段，需要更好的方法来进行试验，为卫生政策和实践提供信息。在外科手术和侵入性医疗程序方面特别缺乏设计良好和进行良好的随机对照试验，这意味着实践不是基于证据和外科手术标准，类似的侵入性程序在全国各地和NHS内各不相同。这些主题包括：（1）试验优先顺序和设计，（2）试验招募，（3）可行性研究设计和试验实施，以及（4）结果评估、报告和纳入决策。每个主题都以统计和定性方法的专业知识为基础，与执业临床医生和布里斯托的两个临床试验单位，布里斯托随机试验协作和临床试验和评估单位有密切联系。该中心与区域和国家注册的临床试验单位以及其他MRC中心进行了额外的合作。ConDuCT-II中心将建立在这些关系的基础上，并与英格兰外科手术试验中心（位于布里斯托、牛津、伯明翰和曼彻斯特/利物浦）的皇家外科医学院建立新的关系。ConDuCT-II中心还将通过提供创新方法来优化手术试验的实施和提供专家培训，与世界各地的外科医生和方法学家建立国际联系。ConDuCT-II中心将进行方法学研究，并将创新方法整合到新的可行性研究和手术和侵入性手术的全面试验中。ConDuCT-II Hub还将为临床医生和其他科学家提供研究设计和方法方面的培训计划，以优化复杂医疗干预和手术试验的设计和交付。这些课程也将与公共卫生保健和初级保健干预措施的试验有关。这些类似于外科干预，因为它们在每个干预中包括多个组件，通过共同或单独作用来影响结果。该培训计划将提供学徒培训，以培养新一代了解和实践循证医学的临床医生。新方法将在新的试验中实施，这将为政策和实践层面的医疗决策提供证据。预计ConDuCT-II中心将最终导致研究文化的可持续变化，并将允许开发更多甚至更好的试验，以回答与患者和NHS相关的关键问题。

The ConDuCT-II Hub is based within the School of Social and Community Medicine, at the University of Bristol and is led by Professor Blazeby, Professor of Surgery. It will include a multi-disciplinary group of academics with established track records in the development of better ways for designing and conducting research to evaluate healthcare interventions. The work will focus on creating new methods and improving existing methods to undertake randomised controlled trials. Randomised controlled trials usually compare two new or standard treatments. The importance of a randomised controlled trial is that patients participating in them could be allocated to either of the procedures under evaluation by a process of randomisation. This means that the patients have an equal chance of having either procedure and so a fair comparison of the outcomes of each of them can be made. These types of studies are the most valid and reliable means of evaluating healthcare interventions, and there is a need for better ways of conducting the trials to inform health policy and practice. There is a particular lack of well designed and conducted randomised controlled trials in surgery and invasive healthcare procedures which means that practice is not based on evidence and standards of surgery and similar invasive procedures vary across the country and within the NHS.The research will be undertaken by four interlinked themes. The themes include: (1) trial prioritisation and design, (2) trial recruitment, (3) feasibility study design and trial conduct, and, (4) outcome assessment, reporting and integration into decision-making. Each theme is underpinned by expertise in statistics and qualitative methods and there are close links to practising clinicians and the two clinical trials units in Bristol, the Bristol Randomised Trials Collaboration and the Clinical Trials and Evaluation Unit. The Hub has additional collaborations with the regional and national registered clinical trials units and other MRC Hubs. The ConDuCT-II Hub will build on these relationships and with new relationships with the Royal College of Surgeons of England Surgical Trials Centres (in Bristol, Oxford, Birmingham and Manchester/Liverpool). The ConDuCT-II Hub will also develop international links to surgeons and methodologists worldwide by providing innovative methods to optimise the conduct of trials in surgery and by provision of specialist training. The ConDuCT-II Hub will undertake methodological research and it will integrate innovative methods into new feasibility studies and full trials in surgery and invasive procedures. The ConDuCT-II Hub will also deliver a training programme for clinicians and other scientists in study design and methods to optimise the design and delivery of complex healthcare interventions and trials in surgery. These courses will also be relevant to trials of public healthcare and primary care interventions. These are similar to surgical interventions because they include multiple components within each intervention, that influence outcomes by acting both together and separately. The training programme will provide an apprenticeship to create a new generation of clinicians who understand and practice evidence based medicine. The new methods will be implemented in new trials and this will lead to evidence to inform healthcare decision-making at policy and practice level. It is anticipated that the ConDuCT-II Hub will ultimately lead to a sustainable change in research culture and it will allow more and even better trials to be developed to answer critical questions of relevance to patients and the NHS.