Murphy Patrick J, Noone Chris, D'Eath Maureen, Casey Dympna, Doherty Sally, Jaarsma Tiny, Murphy Andrew W, O'Donnell Martin, Fallon Noeleen, Gillespie Paddy, Jalali Amirhossein, Sharry Jenny Mc, Newell John, Toomey Elaine, Steinke Elaine E, Byrne Molly
1Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.
2Disciplines of Occupational Therapy and Radiation Therapy, School of Medicine, Trinity College Dublin, Dublin, Ireland.
Pilot Feasibility Stud. 2018 Jul 2;4:88. doi: 10.1186/s40814-018-0278-4. eCollection 2018.
Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland.
The CHARMS intervention, consisting of awareness training and skills development for staff, and education and support for patients, was implemented in two CR centres. Following a repeated measures design, quantitative and qualitative feasibility, fidelity, cost, and outcome data were collected from staff and patients at baseline (T1, pre-intervention), at 3 months post-baseline (T2, post-intervention), and at 6 months post-baseline (T3, post-intervention). Data were organised according to a 14-point reporting framework of methodological issues that should be examined in pilot and feasibility studies. To inform a future definitive trial, potential solutions to identified feasibility issues were generated using the ADePT process for decision-making after pilot and feasibility trials.
Most elements of the study protocol were executed smoothly, and intervention implementation was successful. Patients' ( = 42) responses to the intervention were positive. The reporting framework and the ADePT process facilitated the identification of two overarching feasibility problems, as well as solutions to be implemented in a definitive trial: (1) a high level of patient attrition in the pilot study, to be addressed through the use of financial incentives, reducing the length of the patient questionnaire, and providing a telephone survey option; and (2) negative staff perceptions, to be addressed through an augmented staff intervention, reframing 'sexual counselling' as 'sexual education and support' to fit with professional role perceptions, and reviewing all intervention terminology with a CR staff member to ensure acceptability.
This article reports the successful piloting of a novel sexual counselling implementation intervention in cardiac rehabilitation. The utilisation of an extended reporting framework and the ADePT process facilitated the identification of adaptations necessary to ensure the feasibility of a definitive trial, thereby maximising methodological transparency.
许多心血管疾病（CVD）患者受到与该疾病相关的性问题的影响。国际指南建议所有CVD患者都应接受性咨询，但医疗专业人员很少提供此类咨询。当前研究对心脏健康、关系管理与性（CHARMS）干预措施进行了试点，这是一项复杂的多层次干预措施，旨在提高爱尔兰医院心脏康复（CR）中性咨询指南的实施率。
CHARMS干预措施包括对工作人员的意识培训和技能发展，以及对患者的教育和支持，在两个CR中心实施。采用重复测量设计，从工作人员和患者在基线（T1，干预前）、基线后3个月（T2，干预后）和基线后6个月（T3，干预后）收集定量和定性的可行性、保真度、成本和结果数据。数据根据试点和可行性研究中应检查的14点方法问题报告框架进行整理。为了为未来的确定性试验提供信息，使用试点和可行性试验后的决策ADEPT流程，针对已识别的可行性问题生成了潜在解决方案。
研究方案的大多数要素执行顺利，干预措施实施成功。患者（n = 42）对干预措施的反应是积极的。报告框架和ADEPT流程有助于识别两个总体可行性问题，以及在确定性试验中要实施的解决方案：（1）试点研究中患者流失率高，可通过提供经济激励、缩短患者问卷长度和提供电话调查选项来解决；（2）工作人员的负面看法，可通过加强工作人员干预、将“性咨询”重新表述为“性教育和支持”以符合专业角色认知，以及与CR工作人员一起审查所有干预术语以确保可接受性来解决。
本文报告了在心脏康复中成功试点一种新型性咨询实施干预措施。使用扩展报告框架和ADEPT流程有助于识别确保确定性试验可行性所需的调整，从而最大限度地提高方法透明度。
