Kersting Christine, Just Johannes, Piotrowski Alexandra, Schmidt Alexandra, Kufeld Neele, Bisplinghoff Rebecca, Maas Michaela, Bencheva Veronika, Preuß Jordan, Wiese Birgitt, Weckbecker Klaus, Mortsiefer Achim, Thürmann Petra
Chair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Chair of General Practice I and Interprofessional Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Pilot Feasibility Stud. 2024 Nov 1;10(1):132. doi: 10.1186/s40814-024-01564-7.
Chronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation, or withdrawal. A growing body of evidence suggests that sex and gender aspects influence CNCP management as the experience of pain, the emotions associated with it, and the expression of pain may differ between women and men. In addition, doctor-patient communication is known to be influenced by gender stereotypes. Despite there being evidence on such differences, current guidelines do not consider sex- and gender-sensitive approaches. In order to examine how to adequately address the diversity of the experience and processing of pain in patients of differing sex and gender, the GESCO study aims at developing and pilot testing a sex- and gender-sensitive intervention for patients with CNCP receiving long-term opioid therapy (LTOT) in primary care.
The development process is designed in accordance with the first two phases of the UK Medical Research Council. Phase I will iteratively explore, develop, and pilot the intervention's modules using literature searches, interviews, and workshops involving stakeholders and experts. Phase II will pilot-test the novel intervention in a sample of 40 patients with CNCP under LTOT from ten general practices using an effectiveness-implementation hybrid design including a mixed-methods process evaluation focusing on implementation strategy criteria and a single-arm, pre-post comparison to determine preliminary effects in preparation for a larger effectiveness trial. The intervention will combine in-person educational sessions for general practitioners and tools to be used in patient care.
The intervention aims to improve CNCP management in primary care by empowering practitioners to reflect on their attitudes towards pain and stereotypes. Besides sex and gender aspects, awareness of other factors that might affect the care process, such as age, social conditions, or culture, is also promoted. The intention is to develop a comprehensive care concept for CNCP that considers aspects relevant for sex- and gender-sensitive care which are transferrable to other health care fields as well.
German Clinical Trial Register DRKS00029980.
慢性非癌性疼痛（CNCP）在全球范围内是一种常见病症。疾病负担不仅受疼痛本身影响，还受精神共病影响，精神共病会加重症状，通常对治疗产生负面影响，进而可能导致沮丧、顺从或退缩。越来越多的证据表明，性别因素会影响CNCP的管理，因为男性和女性在疼痛体验、与之相关的情绪以及疼痛表达方面可能存在差异。此外，医患沟通已知会受到性别刻板印象的影响。尽管存在关于此类差异的证据，但当前指南并未考虑性别敏感方法。为了研究如何充分应对不同性别患者疼痛体验和处理方式的多样性，GESCO研究旨在为接受初级保健长期阿片类药物治疗（LTOT）的CNCP患者开发并试点测试一种性别敏感干预措施。
开发过程按照英国医学研究理事会的前两个阶段进行设计。第一阶段将通过文献检索、访谈以及涉及利益相关者和专家的研讨会，反复探索、开发并试点干预模块。第二阶段将采用有效性 - 实施混合设计，对来自十个全科诊所的40名接受LTOT的CNCP患者样本进行新干预措施的试点测试，该设计包括一个侧重于实施策略标准的混合方法过程评估以及单组前后比较，以确定初步效果，为更大规模的有效性试验做准备。干预措施将结合针对全科医生的面对面教育课程以及用于患者护理的工具。
该干预措施旨在通过促使从业者反思他们对疼痛的态度和刻板印象，改善初级保健中的CNCP管理。除了性别因素外，还将提高对可能影响护理过程的其他因素的认识，如年龄、社会状况或文化。目的是为CNCP制定一个全面的护理概念，该概念考虑到性别敏感护理的相关方面，并且也可应用于其他医疗保健领域。
德国临床试验注册中心DRKS00029980。
