Endometriosis and Health Care System Utilization in British Columbia - Trial NCT06217315

Timeline & Enrollment

Primary Outcome

Economic Impact,Prediction Model,Covid pre-post outcomes,Impact of Health Care Utilization

Summary

Purpose & Background Endometriosis is a chronic inflammatory condition believed to affect
 8-10% of reproductive-age women and an unmeasured number of gender-diverse people. It is a
 common cause of pelvic pain and infertility, is now known to be associated with other
 conditions such as heart disease and ovarian cancer and can have a devastating impact on a
 woman's ability to function and achieve their full potential. It has been shown that
 endometriosis and chronic pelvic pain are associated with considerable costs to the
 health-care system in Canada. The in-patient hospital costs for chronic pelvic pain were
 estimated to be $25 million/year and the total societal costs for endometriosis were
 estimated to be 1.8 billion/year.
 
 Standard therapies for endometriosis and pelvic pain include pain medications, hormonal
 suppressive therapies, and surgery. There is a tertiary referral centre of excellence for
 endometriosis at BC Women's Hospital (Centre for Pelvic Pain and Endometriosis), which
 provides advanced surgical treatment of endometriosis and interdisciplinary care for patients
 with endometriosis who have developed other pain comorbidities (e.g. due to central nervous
 system sensitization). Central sensitization responds best to treatments targeted to the
 nervous system, such as Interdisciplinary care includes pain education, physiotherapy, and
 mindfulness-based cognitive therapies. One randomized trial has shown the benefit of an
 interdisciplinary approach compared to standard treatment for the management of chronic
 pelvic pain. At our centre, the investigators reported improvements in pain, mental health,
 quality-of-life, and self-reported reduction in health care utilization, after
 interdisciplinary care, utilizing our ongoing prospective registry. However, a formal
 economic analysis of health care system utilization is required to quantify savings to the
 health care system with an interdisciplinary approach to endometriosis.
 
 Despite surgery being a common treatment of endometriosis, there is variability in outcome
 and a gap is the lack of ability to predict outcomes after endometriosis surgery. For
 example, utilizing self-reported outcomes from our registry, the investigators found that
 poorer outcome after endometriosis surgery was found in patients with evidence of pain
 comorbidities and central sensitization (as surgery is not a direct treatment of these
 factors) (in preparation). Moreover, the investigators have a biobank and have been studying
 biomarkers in surgically excised endometriosis tissue that may predict outcomes after
 surgery. These biomarkers include somatic cancer driver mutations and neuroinflammation. The
 investigators have preliminary data that suggests that these biomarkers may predict rates of
 re-operation at the centre. Beyond self-reported outcomes and re-operation at the centre,
 there is a need to assess health care utilization and re-operation occurring throughout the
 province as additional outcomes that may be associated with our clinical and biomarker
 predictors.
 
 Finally, the SARS-CoV-2 (COVID-19) pandemic has had profound physical and mental health
 effects on populations worldwide. However, there exists limited empirical evidence focusing
 on the wellbeing of patients with endometriosis and/or pelvic pain during the public health
 crisis. Herein, the investigators propose to compare a pre-pandemic cohort to a pandemic
 cohort of subjects with endometriosis and/or chronic pelvic pain, again in terms of health
 care system utilization.
 
 Therefore, the overall purpose of this project is to assess health care utilization patterns
 of patients with endometriosis in British Columbia, and to perform an economic analysis of
 interdisciplinary care, evaluate clinical-biomarker predictors of surgical outcome, and
 assess the impact of the covid pandemic. This will be achieved by linking Population Data BC
 datasets to our ongoing prospective registry (H16-00264) and prospective and retrospective
 biobanks (H14-03040, H17-00329).

ICD-10 Classifications