Acceptability, reliability, and validity of a vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia: a cross-sectional study.

BACKGROUND: Approximately half of people with endometriosis experience deep dyspareunia; however, there is no means of objective self-testing of endometriosis-associated deep dyspareunia. AIM: The aim of this study was to assess the acceptability, test-retest reliability, and validity of a vaginal insert for a self-assessment of endometriosis-associated deep dyspareunia. METHODS: Participants were recruited from a tertiary endometriosis center. Inclusion criteria were: 19 to 49 years of age, self-reported deep dyspareunia of ≥4 of 10, and surgically confirmed endometriosis. Participants completed 2 self-assessments using the vaginal insert to self-assess tenderness at the right and left pelvic floor, bladder, cervix-uterus, and posterior cul-de-sac (vaginal fornix). The participants recorded tenderness at each pelvic site and completed a questionnaire regarding the acceptability of the vaginal insert to assess deep dyspareunia. Test-retest reliability was assessed by correlating the tenderness scores between the 2 assessment dates. Over a 4-week period, the participants also recorded deep dyspareunia severity at each penetrative vaginal sex encounter. Validity was assessed by correlating vaginal insert tenderness to deep dyspareunia severity, and also to tenderness reported on a prior gynecologic pelvic examination. OUTCOMES: The main outcome measures were the acceptability index score, tenderness (0-10) at each pelvic site, and prospective deep dyspareunia scores (0-10) over 4 weeks. RESULTS: There were 19 participants (mean age 34 ± 7 years) who completed the study. The majority identified as female (94.7%), heterosexual (89.5%), and white (89.5%). The median acceptability index score was 0.72 (interquartile range, 0.66-0.81). For test-retest reliability, the intraclass correlation coefficients were 0.79 (P = .001) for the left pelvic floor, 0.82 (P < .001) for the right pelvic floor, 0.54 (P = .07) for the bladder, 0.89 (P < .001) for the cervix-uterus, and 0.77 (P = .003) for the cul-de-sac. The correlation between the highest self-assessed mean tenderness in each participant and self-reported deep dyspareunia over 4 weeks was r = 0.32, but correlations for each pelvic site varied significantly. Tenderness at each site on prior gynecologist pelvic exam was associated with higher self-assessed mean tenderness with the vaginal insert in each participant (effect sizes = 0.42-0.88). CLINICAL IMPLICATIONS: The vaginal insert is acceptable and reliable for the objective self-assessment of endometriosis-associated deep dyspareunia, with initial evidence of validity. STRENGTHS AND LIMITATIONS: A strength was the inclusion of participants who were avoiding sexual activity and a limitation was the small sample size. CONCLUSION: Future studies with larger sample sizes are required to further establish the validity of the vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia.

Negative Sliding Sign during Dynamic Ultrasonography Predicts Low Endometriosis Fertility Index at Laparoscopy.

STUDY OBJECTIVE: Endometriosis fertility index (EFI) is a robust tool to predict the pregnancy rate in patients with endometriosis who are attempting non-in vitro fertilization conception. However, EFI calculation requires laparoscopy. Newly established imaging techniques such as sliding sign, which is used to diagnose pouch of Douglas obliteration, could provide a promising alternative. The objective of this study was to investigate the practicality of using ultrasound data to predict a low EFI (score ≤6). DESIGN: Observational study from a prospective registry (Endometriosis Pelvic Pain Interdisciplinary Cohort, clinicaltrials.gov #NCT02911090). Analyzed data were captured from December 2013 to June 2017. SETTING: Tertiary referral center at British Columbia Women's Hospital. PATIENTS: We analyzed data for 2583 participants from the Endometriosis Pelvic Pain Interdisciplinary Cohort. In this cross-sectional study, we included 86 women aged <40 years. INTERVENTIONS: Dynamic ultrasonography for the sliding sign testing and EFI calculation during laparoscopic surgery. MEASUREMENTS AND MAIN RESULTS: Logistic regression was used to obtain receiver operating characteristic area under the curve (AUC) for the prediction models. Significance was p <.05. Patients with a negative sliding sign were older and had severe endometriosis and longer duration of infertility. Patients with a negative sliding sign had significantly lower total EFI scores and lower surgical factors scores than patients with a positive sliding sign. Logistic regression showed that a negative sliding sign and EFI historic factors score can predict an EFI score ≤6 (sensitivity = 87.9%, specificity = 81.1%, AUC = 0.93 [95% confidence interval, 0.88-0.98]). Adding the diagnosis of endometrioma to the previous prediction model resulted in AUC = 0.95 (95% confidence interval, 0.90-0.995), sensitivity = 84.8%, and specificity = 92.5%. CONCLUSION: The sliding sign could be a potential alternative to the EFI surgical factors, and it could be used in combination with EFI historic factors and the diagnosis of endometrioma to predict an EFI score ≤6 for patients who are not scheduled for immediate surgery.

Hospital-Associated Cost of Endometriosis in Canada: A Population-Based Study.

STUDY OBJECTIVE: To describe the hospital-associated cost of endometriosis in Canada from April 2008 to March 2013. DESIGN: Population-based descriptive study. SETTING: Canada, with the exception of the province of Quebec. PATIENTS: All women aged 15 to 59 years discharged with endometriosis between April 2008 and March 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Over 5 years, 47 021 women were admitted for endometriosis, resulting in a total hospital cost of Canadian dollars (CaD) $152.21 million (US dollars [US $] 147.79 million) and per-case cost of CaD $3237 (US $3143). Uterine endometriosis accounted for 28.29% of cases, ovarian endometriosis 27.44%, and other endometriosis 44.27%. Cost for uterine endometriosis was the highest at CaD $4137 (US $4017) per case, followed by ovarian endometriosis (CaD $3506; US $3404) and other endometriosis (CaD $2495; US $2422). The highest number of cases were in the groups aged 35 to 39 years (20.77%) and 40 to 44 years (20.44%). Hysterectomy accounted for 29.57% of surgical procedures. Encounters with hysterectomy were the costliest at CaD $5062 (US $4915) per case, followed by the ones with other surgical procedures at CaD $2477 (US $2405) per case, and admissions with no surgical procedure at CaD $2164 (US $2101) per case. CONCLUSION: The hospital cost associated with endometriosis was approximately CaD $30 million (US $29.56 million) per year, whereas uterine endometriosis, hysterectomy, and older age were found to have a higher average cost per case. Although this study focuses specifically on hospital admission and does not account for outpatient costs or indirect costs, it nonetheless highlights the economic burden of this debilitating disease on Canadian society during the study period.

Hospital-associated Costs of Chronic Pelvic Pain in Canada: A Population-based Descriptive Study.

OBJECTIVE: To determine the hospital-related costs incurred by women requiring surgery or inpatient admission for chronic pelvic pain in Canada. METHODS: We conducted a population-based, cross-sectional study, focusing on women ages 15-59 with a most responsible International Classification of Diseases diagnosis of pelvic and perineal pain, dysmenorrhea, or dyspareunia who had surgery or inpatient admission with a discharge date between April 1, 2008 and March 31, 2012. This study was based on the Canadian Institute for Health Information Discharge Abstract database and the National Ambulatory Care Reporting System. Clinical diagnoses and interventions and resource intensity weights (RIW) were extracted. Hospital costs were estimated by multiplying cost per weighted case (CPWC) calculated at the national level with respective RIWs. RESULTS: Over four years, there were 34 346 cases of surgery or inpatient admission for chronic pelvic pain amounting to $100.5 million with an average cost of $25 million per year. Pelvic and perineal pain accounted for 61.5% (n = 21 127) of the cases, while dysmenorrhea accounted for 31.8% (n = 10 936), and dyspareunia accounted for 6.6% (n = 2283). The vast majority of the cases (92.9%, n = 31 923) were associated with surgical interventions, with the most common surgeries being hysterectomy (47.1%, n = 16 189), followed by laparoscopy (25.8%, n = 8850), adnexal surgery (6.8%, n = 2349), and other procedures (11.6%, n = 3968). CONCLUSION: While these estimates do not take into account non-hospital related costs, such as outpatient treatment, loss of productivity, and impact on quality of life, this study demonstrates that chronic pelvic pain represents a considerable economic burden to Canada's health care system.