Millar Anna N, Daffu-O'Reilly Amrit, Hughes Carmel M, Alldred David P, Barton Garry, Bond Christine M, Desborough James A, Myint Phyo K, Holland Richard, Poland Fiona M, Wright David
School of Pharmacy, Queen's University Belfast, Belfast, UK.
School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.
Trials. 2017 Apr 12;18(1):175. doi: 10.1186/s13063-017-1915-6.
Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS).
A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7-9 and <15% scoring 1-3. Exclusion was defined as ≥70% scoring 1-3 and <15% 7-9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved.
A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS.
We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.
众所周知，为养老院中的老年人开药的情况并不理想。虽然已经发表了一些测试优化该环境下开药干预措施的试验，但结果报告的异质性阻碍了对干预措施的比较，从而限制了证据的综合分析。本研究的目的是制定一个核心结局集（COS），即一份对于所有涉及优化养老院开药的有效性试验都应至少测量和报告的结局清单。该核心结局集是作为养老院独立药剂师开药研究（CHIPPS）的一部分而制定的。
通过对已发表文献的回顾和利益相关者的意见，确定了一长串结局。在进入两轮在线德尔菲法练习之前，对结局进行了审查和完善，然后通过网络链接分发给CHIPPS管理团队，这是一个多学科团队，包括药剂师、医生和患者公众参与代表（以及其他人员），他们组成了德尔菲小组。德尔菲小组成员（n = 19）根据从1（不重要）到9（至关重要）的9点李克特量表对结局的重要性进行评分。结局被纳入核心结局集的共识定义为≥70%的参与者评分为7 - 9且<15%的参与者评分为1 - 3。排除定义为≥70%的参与者评分为1 - 3且<15%的参与者评分为7 - 9。在第二轮问卷中，将个人和小组得分反馈给参与者，第二轮问卷包括尚未达成共识的结局。
确定了一份包含63个潜在结局的长清单。对这份长清单进行完善后得到29个结局，这些结局被纳入德尔菲问卷（第一轮）。经过两轮德尔菲法练习后，13个结局（分为七个总体领域：用药合理性、药物不良事件、处方错误、跌倒、生活质量、全因死亡率和住院（及相关费用））符合纳入最终核心结局集的标准。
我们使用稳健的方法为旨在优化养老院老年人开药的有效性试验制定了一个核心结局集。广泛采用这个核心结局集将有助于试验间证据的综合分析。未来的工作应侧重于评估针对这些关键结局的合适工具，以进一步减少这一背景下结局测量的异质性。
