Marcilly Romaric, Quindroit Paul, Lemaitre Madleen, Vambergue Anne, Avez Eric, Bubeck Arnaud, Hehn Coline, Beuscart Jean-Baptiste, Grimes Tamasine C
Univ. Lille, CHU Lille, ULR 2694 - METRICS : Évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France, Lille, France
Inserm, CIC-IT 1403, F-59000 Lille, France, Lille, France.
BMJ Open. 2024 Dec 2;14(12):e084475. doi: 10.1136/bmjopen-2024-084475.
Type 2 diabetes is a chronic condition associated with impaired glucose tolerance and a high prevalence of comorbidity, polypharmacy and medication safety incidents. Little is known about the patient work associated with using diabetes management technologies by patients and their informal caregivers at home. This study aims to apply a systems engineering approach to better understand this work.
This is a qualitative focused ethnographic study using interview and photography. Adults, living independently at home, with type 2 diabetes who have been using insulin as part of their treatment regimen for a minimum of 6 months and who are using at least one diabetes management technology without support of a professional at home are eligible for inclusion. Participants will be recruited through advertisements on social media, in diabetes clinics and by contacting associations of persons living with diabetes and diabetes specialists. Participant consent will be taken, interviews will be undertaken in the participant's home, audio-recorded and photographs securely saved. The Systems Engineering Initiative for Patient Safety (SEIPS) model will frame the data coding and we will develop new codes to accommodate data outside the SEIPS model. Results will be interpreted to produce a description of work processes, work system elements and interactions that support or jeopardise the achievement of safety. This protocol will follow the consolidated criteria for reporting qualitative research checklist for the reporting of qualitative research interviews.
This protocol was approved by the University of Lille's Behavioural Sciences Ethics Committee. The study will comply with data protection legislation: the protocol has been declared by the Data Protection Officer of the University of Lille to the National Commission on Informatics and Liberty. We plan to disseminate our findings via presentations at relevant patient/public, professional, academic and scientific meetings, and publish in a peer-reviewed journal.
2型糖尿病是一种慢性病,与糖耐量受损以及高合并症患病率、多种药物联合使用和用药安全事件相关。对于患者及其在家中的非正式照护者使用糖尿病管理技术所涉及的工作,我们知之甚少。本研究旨在应用系统工程方法来更好地理解这项工作。
这是一项采用访谈和摄影的定性聚焦人种学研究。年龄在18岁及以上、独立居住在家、患有2型糖尿病且已将胰岛素作为治疗方案的一部分使用至少6个月、在家中无专业人员支持的情况下使用至少一种糖尿病管理技术的成年人符合纳入条件。参与者将通过社交媒体广告、糖尿病诊所广告以及联系糖尿病患者协会和糖尿病专家进行招募。将获得参与者的同意,在参与者家中进行访谈、录音,并安全保存照片。患者安全系统工程倡议(SEIPS)模型将为数据编码提供框架,我们将开发新的代码以适应SEIPS模型之外的数据。研究结果将被解读,以描述支持或危及安全目标实现的工作流程、工作系统要素及相互作用。本方案将遵循定性研究访谈报告的定性研究报告统一标准清单。
本方案已获得里尔大学行为科学伦理委员会的批准。该研究将遵守数据保护法规:本方案已由里尔大学的数据保护官向国家信息与自由委员会申报。我们计划通过在相关患者/公众、专业、学术和科学会议上进行报告来传播我们的研究结果,并在同行评审期刊上发表。