Health economic evaluation of a randomized controlled trial (EMBLA study), an internet-based treatment for provoked vulvodynia

Design

This overall health financial analysis has a health care company point of view and is based on information from the EMBLA study, a multicenter randomized analyze that investigated the results of a 6-7 days guided world-wide-web intervention for provoked vulvodynia²¹. The analyze was accepted by the Ethical Regional Board in Uppsala, Sweden (registration numbers 2015/031 and 2020–07,179), and registered at clinicaltrials.gov (protocol ID EMBLA, ID NCT02809612, 22/06/2016). All experiments ended up done in accordance with the Declaration of Helsinki and General Details Protection Regulation (GDPR). Reporting in the manuscript adopted the recommendations in the CONSORT 2010 pointers.

Members

The sample consisted of 99 women with a analysis of provoked vulvodynia who experienced previously participated in the EMBLA study²². An informed consent was acquired from all provided members in the review. Inclusion criteria were: age more than 18 years, signs or symptoms of provoked vulvodynia for at minimum 6 months just before enrollment in the analyze, accessibility to laptop and internet, and owning a Swedish personal identification number. Likely individuals had been excluded if a diagnosis could not be verified via a screening interview over the telephone, if the participant was going through a health-related investigation or therapy for provoked vulvodynia at the time of recruitment, if the participant was not fluent in the Swedish language or offered serious or acute psychological sickness or compound abuse. Past therapy for provoked vulvodynia was not an exclusion criterium. Participants have been randomized to possibly a guided web intervention (n = 52) or normal treatment (n = 47) by a basic randomization method, employing a computer-generated record of random numbers. Randomization was carried out right until at the very least 26 contributors were being assigned to each and every group in just about every timepoint. A entire description of the analyze protocol is revealed elsewhere²¹.

Participants were being recruited from waiting lists from gynecological clinics in central Sweden or via social media. As formerly described, there were no variances amongst groups in sociodemographic facts or symptoms of provoked vulvodynia at baseline, but the groups diversified drastically with regards to their tries to have intercourse, wherever the intervention group described less tries at intercourse than controls²². The sample consisted of young females (signify age 24.5, SD = 4.4), most of whom ended up in a romance and experienced a greater instruction. In depth details with regards to the history characteristics of the sample is presented elsewhere²².

Intervention

The intervention consisted of a 6-7 days guided internet treatment method delivered throughout the waiting period for medical therapy. The web-based mostly remedy was primarily based on an ACT guide for managing people with chronic agony and tailored for sufferers with provoked vulvodynia by an interdisciplinary staff²⁶. The procedure plan was divided in six modules, one for each 7 days, made up of each information and physical exercises. In every single module, the individuals experienced obtain to affected person education and learning that was shipped created type or throug video clips. The material experienced explanations about the ailment, pelvic floor anatomy and perform, tension, long-term ache, sexuality, conversation with the associate, and ACT. Each and every module contained unique information and facts and exercises associated to ACT. They were also instructed to execute each day pelvic floor workout routines concentrating on leisure, exposure exercise routines, and mindfulness. Exercises primarily based on ACT were being presented in the course of the full treatment method. Guiding was offered by means of weekly prepared responses from eCoaches. The contributors could also speak to the eCoaches by penned concept by way of the system in situation they experienced any concerns. The intervention is explained in entire in other places^21,22.

Sample size calculation

The sample dimensions calculation has been earlier released somewhere else²¹. Those people calculations believed that 26 contributors have been necessary in each individual team at every single timepoint to id a scientific improvement of at least 1.2 units on a visible analogue scale for vulvar suffering. Calculations have been primarily based on a ability of 80{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} for distinctions in between groups, a importance stage of p < 0.05, and a 20{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} dropout rate.

Data collection and outcome measures

Sociodemographic data and self-reported medical history were collected via online assessments at baseline and from medical records.

To analyze healthcare utilization after the internet-based treatment, the number of visits to healthcare related to provoked vulvodynia and the total treatment length were retrieved from medical records from the gynecology clinics that referred the participants to the study. Participants recruited via social media (n = 8), and those who did not reside in the areas included in the multicenter study were invited to answer an online questionnaire with related questions regarding healthcare utilization due to provoked vulvodynia, filled out after the participants had completed the internet-based treatment. Visits to healthcare were further categorized based on the profession visited (gynecologist, midwife, physiotherapist, psychologist/counselor).

Data on quality of life and pain acceptance were collected at three timepoints: baseline (pre-treatment), post-treatment (6 weeks after baseline assessment), and follow-up (9 months after post-treatment assessment). Health-related quality of life was assessed using the questionnaire EQ5-D-3L (EuroQoL 5-dimension, 3-level), which has good construct validity and consists of five questions or domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three possible ratings^27,28.

To estimate costs related to provoked vulvodynia treatment, the operation managers at the gynecology clinics involved in the multicenter randomized study were invited to answer a questionnaire with questions regarding the average time spent per visit for each profession. To estimate the costs for each visit, data on the salary for each profession were retrieved from Statistics Sweden and calculated including social fee.

Costs of the intervention were estimated by adding up the costs for eCoaches, cost for consultation with senior clinicians or researchers, and costs for IT support.

Pain acceptance was assessed with the questionnaire CPAQ-R (chronic pain acceptance questionnaire—revised), with data collected at baseline, post-treatment, and follow-up. The questionnaire has good psychometric properties and is divided into the subscales activity engagement and pain willingness^29,30,31,32. Activity engagement relates to performing activities despite experiencing pain, and pain willingness assesses attempts to control pain. There is no cut-off score for CPAQ-R. Higher scores indicate higher pain acceptance.

Statistical analyses

Patient characteristics at baseline were analyzed with Mann–Whitney’s U test and the chi-square test for differences between groups.

Chi square test was used to analyze differences between groups regarding clinical treatment after the internet intervention (yes/no). Healthcare utilization due to provoked vulvodynia after internet-based treatment (number of visits) and treatment length (in months) were analyzed with Mann–Whitney’s U test as the data were not normally distributed. Analyses were carried out for the total number of healthcare visits and the number of visits by profession (gynecologist, midwife, physiotherapist, psychologist/counselor) due to a discrepancy in resources at different clinics. Due to the variation in the number of visits to midwives and physiotherapists these variables were categorized into groups (0 visits, 1–3 visits, 4–6 visits, and at least 7 visits) and then analyzed with Mann–Whitney’s U test.

Health-related quality of life assessed with EQ5-D-3L was first analyzed for differences between groups at all timepoints using Mann–Whitney’s U test without any imputation. Then, quality-adjusted life-years (QALYs) were calculated by multiplying the individual value for the quality of life index derived from EQ5-D-3L domains by the time (in years) that each participant was part of the study^33,34. The treatment time was adjusted for participants who only completed part of the treatment. For dropouts, data were assumed and imputed as follows: 3 weeks for dropouts before post-treatment assessment and 24 weeks for dropouts between post-treatment and follow-up assessments. A dropout analysis for the randomized study has been previously reported²². The difference between groups regarding QALYs was calculated using Mann–Whitney’s U test.

Costs for treatment were reported in euros. To eliminate differences in price levels between countries, the Purchasing Power Parity for the years 2016–2020 and the mean purchasing power parity over the same period were used as the index for conversion from Swedish kronor to euros, covering the Euro zone as calculated by OECD 36³⁵. Differences between groups in costs were analyzed with Mann–Whitney’s U test, as data distribution was skewed.

Pain acceptance (CPAQ-R) was used as a measure of clinical improvement. Results from CPAQ-R have previously been published elsewhere²², but are in the present study translated into a measure indicating the value to patients, i.e., calculating a reliable change index (RCI) as described by Jacobson & Truax (1991)^36,37. An index higher than 1.96 was considered a clinically meaningful improvement. The differences between groups regarding RCI were calculated with Fisher’s test.

In the cost-effectiveness analysis, it was estimated what additional costs were needed with the treatment in comparison to waiting list for clinical treatment in order to gain one meaningful change in pain acceptance for the patients. The meaningful change in pain acceptance was estimated using RCI, as described above. The ICER was estimated using the equation:

Analyses had been carried out utilizing SPSS IBM Data, model 26.