Olsen Kirsty, Howel Denise, Barber Robert, Ford Gary A, Gallagher Peter, McAllister-Williams R Hamish, Nilsson Jonna, O'Brien John, Parker Jennie, Thomas Alan
Institute of Neuroscience, Campus for Ageing & Vitality, Newcastle University, Newcastle upon Tyne, NE4 5PL UK.
Institute of Health & Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, NE2 4AX UK.
Pilot Feasibility Stud. 2015 Dec 22;1:44. doi: 10.1186/s40814-015-0042-y. eCollection 2015.
The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. In addition, the relationship between reduced blood pressure and the change in cerebral blood flow and mood was to be investigated.
A single centre pilot randomised controlled trial (RCT), with two parallel groups of intensive or normal treatment for hypertension, recruiting from primary and secondary care and newspaper advert, with an aim of recruiting 66 participants, was observed in this study. At the end of the recruitment period, in order to explore the reasons for failure to recruit to target, surveys were developed and issued to those involved in recruitment.
Recruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant.
Overall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists. To overcome such recruitment difficulties, a prompt commencement of a study after funding so no relevant care changes occur might help prevent similar problems in future studies. In addition, self-referral, in this case via advertisement in papers, may be a useful tool to increase response rate. When recruiting in primary care, direct access to primary care databases, in a secure and anonymised way, may enable more effective screening. Ultimately, the BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study.
ISRCTN 64524251; UKCRN Portfolio No: 13284.
血压快速强化降低与持续性抑郁症情绪及认知的常规治疗（BRILiANT情绪研究）被设计为一项试点研究，旨在调查强化降低血压作为治疗患有重度抑郁症的老年人持续性情绪和认知症状的可行性和安全性，并评估该人群的可招募性。此外，还将研究血压降低与脑血流量变化及情绪之间的关系。
本研究观察了一项单中心试点随机对照试验（RCT），该试验有两个平行组，分别进行高血压的强化治疗或常规治疗，从初级和二级医疗保健机构以及报纸广告中招募，目标是招募66名参与者。在招募期结束时，为了探究未达到招募目标的原因，制定了调查问卷并发放给参与招募的人员。
招募率低于预期，这导致研究扩展到更多地区并通过广告开放自我推荐。然而，由于英国血压治疗质量与结果框架指南的变化导致高血压管理得到改善，几乎没有发现符合条件的患者，研究在招募期结束时关闭，13名参与者同意参与，但12名未通过筛查，最终只有1名参与者被招募。
总体而言，BRILiANT情绪研究被发现不可行，结果表明预期的患者群体已不复存在。为克服此类招募困难，在获得资金后迅速启动研究，以便不发生相关护理变化，这可能有助于防止未来研究出现类似问题。此外，在这种情况下通过报纸广告进行自我推荐可能是提高回应率的有用工具。在初级保健机构进行招募时，以安全且匿名的方式直接访问初级保健数据库可能会实现更有效的筛查。最终，BRILiANT情绪研究被证明不可行；这是该试点研究得出的一个有用结论。
ISRCTN 64524251；英国临床试验注册号：13284。
