Table1_Understanding Stakeholder Views Regarding the Design of an Intervention Trial to Reduce Anticholinergic Burden: A Qualitative Study.DOCX

Background: Anticholinergic burden (ACB), is defined as the cumulative effect of anticholinergic medication which are widely prescribed to older adults despite increasing ACB being associated with adverse effects such as: falls, dementia and increased mortality. This research explores the views of health care professionals (HCPs) and patients on a planned trial to reduce ACB by stopping or switching anticholinergic medications. The objectives were to explore the views of key stakeholders (patients, the public, and HCPs) regarding the potential acceptability, design and conduct of an ACB reduction trial.
Materials and Methods: We conducted qualitative interviews and focus groups with 25 HCPs involved in prescribing medication with anticholinergic properties and with 22 members of the public and patients who were prescribed with the medication. Topic guides for the interviews and focus groups explored aspects of feasibility including: 1) views of a trial of de-prescribing/medication switching; 2) how to best communicate information about such a trial; 3) views on who would be best placed and preferred to undertake such medication changes, e.g., pharmacists or General Practitioners (GPs)? 4) perceived barriers and facilitators to trial participation and the smooth conduct of such a trial; 5) HCP views on the future implementability of this approach to reducing ACB and 6) patients’ willingness to be contacted for participation in a future trial. Qualitative data analysis was underpinned by Normalization Process Theory.
Results: The public, patients and HCPs were supportive of an ACB reduction trial. There was consensus among the different groups that key points to consider with such a trial included: 1) ensuring patient engagement throughout to enable concerns/potential pitfalls to be addressed from the beginning; 2) ensuring clear communication to minimise potential misconceptions about the reasons for ACB reduction; and 3) provision of access to a point of contact for patients throughout the life of a trial to address concerns; The HCPs in particular suggested two more key points: 4) minimise the workload implications of any trial; and 5) pharmacists may be best placed to carry out ACB reviews, though overall responsibility for patient medication should remain with GPs.
Conclusion: Patients, the public and HCPs are supportive of trials to reduce ACB. Good communication and patient engagement during design and delivery of a trial are essential as well as safety netting and minimising workload.

背景：抗胆碱能负荷（Anticholinergic burden, ACB）指抗胆碱能药物的累积效应。尽管抗胆碱能负荷升高与跌倒、痴呆、死亡率升高等不良反应相关，但此类药物仍被广泛用于老年人群。本研究旨在探究医疗保健专业人员（Health Care Professionals, HCPs）与患者对一项计划中通过停用或更换抗胆碱能药物以降低ACB的临床试验的看法。研究目标为探索关键利益相关方（患者、公众及HCPs）对该ACB降低临床试验的潜在可接受性、设计与实施的观点。

材料与方法：我们对25名开具过抗胆碱能性质药物的医疗保健专业人员，以及22名曾被开具此类药物的公众与患者开展了定性访谈与焦点小组讨论。访谈及焦点小组的话题指南围绕可行性相关内容展开，具体包括：1）减药/换药临床试验的相关看法；2）如何最佳地传播此类试验的相关信息；3）关于谁最适合且更倾向于开展此类药物调整的观点，例如药师或全科医生（General Practitioners, GPs）？4）试验参与及此类试验顺利实施的感知障碍与促进因素；5）医疗保健专业人员对该ACB降低方案未来可推广性的看法；6）患者是否愿意被联系以参与未来的试验。定性数据分析以正常化过程理论（Normalization Process Theory）为基础。

结果：公众、患者及医疗保健专业人员均对ACB降低临床试验持支持态度。不同群体间达成共识，此类试验需重点考虑的要点包括：1）确保全程让患者参与，以便从初始阶段就解决顾虑与潜在问题；2）确保清晰的沟通，以尽量减少对ACB降低原因的潜在误解；3）为患者提供试验全程的联络渠道，以解决其相关顾虑。医疗保健专业人员还额外提出了两项关键要点：4）尽量降低任何试验带来的工作量影响；5）药师或许最适合开展ACB评估，但患者药物管理的整体责任仍应由全科医生承担。

结论：患者、公众及医疗保健专业人员均支持开展ACB降低相关临床试验。在试验的设计与实施过程中，良好的沟通与患者参与至关重要，同时还需设置安全保障措施并尽量降低工作量负担。