Ekkunagul Thanapon, MacLeod Caitlin Sara, Celnik Anna, Chalmers John, Thomson Ross, Nagy John, Forget Patrice
Epidemiology Group, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.
Aberdeen Royal Infirmary, Aberdeen, UK.
BMJ Open. 2024 Dec 3;14(12):e090289. doi: 10.1136/bmjopen-2024-090289.
Pain surrounding major lower extremity amputations (MLEAs) in the vascular surgical patient can be severe, conferring significant debilitation from the preoperative stage through to the chronic rehabilitation phase. Although there is an evolving understanding of the array of existing analgesic medications and modalities, pain management in this context continues to be challenging. A previous report in the UK revealed that MLEA pain management practices may not be optimal from the perspective of patients. There are also limitations in the comprehensiveness and quality of existing evidence, and existing practices can be heterogeneous. Identifying effective pain management approaches in MLEA has thus been recognised as a key practice and research priority. Therefore, the aim of this study protocol will be to elucidate a multi-specialty view on the perceptions, processes and approaches to perioperative pain management in patients undergoing MLEAs secondary to vascular disease in the UK.
A modified Delphi methodology will be used to gain consensus among a UK-wide multi-specialty panel of clinical experts. At least three iterative rounds of structured anonymous electronic surveys will be circulated to a minimum cohort of 40 participants across relevant specialties. Expert agreement on pre-developed consensus statements pertaining to the approaches and techniques in MLEA pain management will be sought from the first round and quantified by a 5-point Likert scale. Quantitative and qualitative analyses will be performed to evaluate the level of agreement and participant feedback, respectively. A consensus criterion of ≥75% panellist agreement with a ≤10% between-round stability will be used for each statement. The process will be repeated with the results and implementation of feedback highlighted to panellists in each subsequent round.
Ethical approval was not required for this study as the participants and methodology fall outwith the requirements for a National Health Service Research Ethics Committee review. The results will be disseminated in a peer-reviewed publication and presented at relevant conferences.
血管外科患者下肢大截肢（MLEA）周围的疼痛可能很严重，从术前阶段到慢性康复阶段都会导致严重的身体衰弱。尽管对现有镇痛药物和方式的认识不断发展，但在此背景下的疼痛管理仍然具有挑战性。英国此前的一份报告显示，从患者的角度来看，MLEA疼痛管理实践可能并非最佳。现有证据的全面性和质量也存在局限性，而且现有实践可能存在异质性。因此，确定MLEA有效的疼痛管理方法已被视为一项关键的实践和研究重点。因此，本研究方案的目的是阐明英国多专业视角下对因血管疾病接受MLEA患者围手术期疼痛管理的认知、过程和方法。
将采用改良的德尔菲法，在英国范围内的多专业临床专家小组中达成共识。至少三轮结构化匿名电子调查将分发给至少40名相关专业的参与者。第一轮将寻求专家对与MLEA疼痛管理方法和技术相关的预先制定的共识声明的认可，并通过5点李克特量表进行量化。将分别进行定量和定性分析，以评估认可程度和参与者反馈。每条声明将采用≥75%的小组成员认可且轮次间稳定性≤10%的共识标准。每一轮后续调查都将向小组成员突出显示结果及反馈的实施情况，并重复这一过程。
本研究无需伦理批准，因为参与者和方法不属于英国国家医疗服务体系研究伦理委员会审查的要求范围。研究结果将在同行评审的出版物上发表，并在相关会议上展示。
