Short summary

Endometriosis is a chronic disease. It affects up to 10 % of women in the reproductive age and leaves patients in need of continuous contact with the healthcare system. Diagnostic delay of 6.7 years is well known. This project investigates the validity and use of tele-patient-reported outcome measures in outpatient follow-up of patients with endometriosis. The initiative seeks to better treatment, improve patient involvement and satisfaction, and reduce todays waiting time to see a specialist.

Rationale

Endometriosis affects about 10% of all women in their reproductive age. It has no cure and causes frequent and severe abdominal pain, dysmenorrhea, pelvic pain, fatigue, and amongst many patients, infertility. The diagnostic delay is mainly caused by patient- and healthcare provider-related factors. Firstly, normalization of women's menstrual pain and taboo about painful sex contributes to women not seeking professional help. Secondly, the delay may be due to the lack of a clear understanding of endometriosis's etiology and the spectrum of symptoms, which overlap with common diseases in gynecology. Women also report that their experiencing of symptoms are not always taken seriously by the healthcare professional, leaving some women with an average of 7 appointments at their primary care physician before referred to a specialist. Treatment is medical and surgical with a focus on reducing pain. Often, symptoms recur making the condition chronic requiring regular contact with the healthcare system.

Patients experience life with endometriosis as a strain. Pain is one of the most important issues, and insufficient treatment and recognition of symptoms leave patients frustrated. Patients' HRQoL is poorer compared to the general population. Initiatives supporting patient involvement and self-management of symptoms are needed for those living with a chronic condition.

Patients with endometriosis might benefit from Patient Reported Outcomes (PRO) and nurse-led rehabilitation initiated by PRO. PRO include better monitoring of patients' health, tailored dialogue, increased patient participation and symptom management actions, e.g. by self-management strategies. All relevant to patients with endometriosis. In addition, this PhD study will also focus on the use of PRO as a mean to identify those in need of a consultation, and if so, whether the patient needs to see a doctor or a nurse. Nurses will primarily see patients with mild symptoms and focus on rehabilitation of the patient. This is relevant when patients have problems coping with everyday life activities, while at the same time managing chronic symptoms such as pain and tiredness. Doctors will primarily see newly referred patients as well as patients with severe symptoms, which will reduce current waiting times to see a specialist in endometriosis. But for PRO measures to have real impact, the data must be accurate, as inadequate data is a risk for patient safety and treatment outcome. Patients and healthcare professionals must adapt to and accept new methods and work procedures in treatment, hence it is important to explore their perspectives. Therefore, this project seeks to validate telePROM among patients in regard to face- and content validity as well as reliability of measurements. The project will further investigate patients'- and healthcare professionals' perspectives of telePROM, when integrated in outpatient follow-up. Both perspectives must be explored in order to develop a new patient flow and introduce nurse-led rehabilitation based on patients' telePROM.

Description of the cohort

Patients with endometriosis as a main diagnosis, age ≥ 18 years and treated at the outpatient clinic at Odense University Hospital will be invited for this study. Further inclusion criteria are: Danish speaking, as patients must be able to understand and fill in the questionnaire. Newly diagnosed patients are excluded as well as patients with known mental disorders. In sub-study 1 patients with current cysts with need of a physical consultation are also excluded as well as patients in a unstable period of endometriosis, as they are not to experience many differences in symptoms during the test-retest period.

Data and biological material

The study will use both quantitative- and qualitative methods to investigate the use of telePROM in clinical practice. Firstly, validation of the questionnaire will be performed in a sample of 50 patients, where test-retest will be carried out and kappa values will determine items reliability. A sub-sample of 8 patients will be invited for a focus group interview to explore face- and content validity as well as relevance of the questionnaire. Secondly, interpretive descriptive methods will be applied and in-depth interviews with patients' (n=15-20) will be conducted as to explore patients' experiences of using telePROM during follow-up outpatient treatment, being supported by healthcare professionals and ability to manage their condition in everyday life. Next, focus group interviews with healthcare professionals' (n=14) will be conducted as to explore their experiences of telePROM as to its influence on workflow and the patient-clinician relationship. All qualitative data will be analyzed inductively inspired from content analysis and systematic text condensation.

Collaborating researchers and departments

Department of Gynecology and Obstetrics, Odense University Hospital

• Martin Rudnicki Professor, Ph.D, DMSc, M.D.

Steno Diabetes Center, Copenhagen

• Anne Sidenius, Ph.D., cand.scient.anth.

UCL University College, Odense

• Charlotte Nielsen, Ph.D., MScN, RN