Research Department of Primary Care & Population Health, University College London, Royal Free campus, Rowland Hill St., London NW3 2PF, UK.
BMC Med Res Methodol. 2011 Jan 27;11(1):9. doi: 10.1186/1471-2288-11-9.
To describe the development of a dementia research registry, outlining the conceptual, practical and ethical challenges, and to report initial experiences of recruiting people with dementia to it from primary and secondary care.
Women, the oldest old and ethnic minorities have been under-represented in clinical trials in dementia. Such under-representation biases estimates of absolute effect, absolute harm and cost-effectiveness. Research on dementia should include patient populations that more exactly reflect the population at risk. One of the impediments to this is the lack of a suitable tool for identification of patients suitable for studies. CONSTRUCTION & CONTENTS: A technology development methodology was used to develop a registry of people with dementia and their carers. This involved phases of modelling and prototype creation, 'bench testing' the prototype with experts and then 'field testing' the refined prototype in exemplar sites. The evaluation of the field testing described here is based on a case study methodology. UTILITY: This case study suggests that construction and population of a dementia research registry is feasible, but initial development is complex because of the ethical and organisational difficulties. Recruitment from primary care is particularly costly in terms of staff time and only identifies a very small number of people with dementia who were not already known to specialist services. Recruiting people with dementia through secondary care is a resource intensive process that takes up to six months to complete. Identifying the components of a minimum dataset was easy but its usefulness for pre-screening potential research populations has yet to be established. Acceptance rates are very high in the first clinic to recruit to the registry, but this may reflect the efforts of registry 'champions'.
Easier recruitment may perpetuate potential selection biases and we are not yet able to assess the representativeness of the research-ready population recruited to the registry. The need to recruit from wider populations, through primary and social care, remains. The success of this registry will be measured by the proportion of people from it who are recruited to research projects, and its impact on overall accrual to studies.
描述一个痴呆症研究注册中心的开发过程，概述其在概念、实践和伦理方面所面临的挑战，并报告从初级和二级保健机构招募痴呆症患者加入该中心的初步经验。
在痴呆症临床试验中，女性、最年长的老年人和少数族裔的代表性不足。这种代表性不足会影响绝对疗效、绝对危害和成本效益的估计。痴呆症研究应该包括更准确反映风险人群的患者群体。其中一个障碍是缺乏合适的工具来确定适合研究的患者。
使用技术开发方法来开发痴呆症患者及其照顾者的注册中心。这涉及建模和原型创建阶段、与专家一起对原型进行“基准测试”，然后在示范站点中对经过改进的原型进行“现场测试”。此处描述的现场测试评估基于案例研究方法。
本案例研究表明，痴呆症研究注册中心的构建和人群招募是可行的，但由于伦理和组织方面的困难，初步开发较为复杂。从初级保健中招募需要花费大量的员工时间，并且只能识别出一小部分尚未被专科服务机构知晓的痴呆症患者。通过二级保健招募痴呆症患者是一个资源密集型的过程，需要长达六个月的时间才能完成。确定最小数据集的组成部分很容易，但尚未确定其用于预筛选潜在研究人群的有用性。在第一个加入该注册中心的诊所中，接受率非常高，但这可能反映了注册中心“拥护者”的努力。
更容易的招募可能会延续潜在的选择偏差，我们还无法评估招募到注册中心的有研究准备的人群的代表性。仍然需要通过初级保健和社会保健从更广泛的人群中招募。该注册中心的成功将通过其招募到研究项目的人群比例以及对总体研究入组的影响来衡量。
