Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL).Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577.The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC).Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate.National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).
Pelvic organ prolapse affects an estimated 40% of parous women in developed countries, but there is no prevalence data in Samoa. The impacts of pelvic organ prolapse include urinary incontinence and bowel incontinence, with many women being asymptomatic. Samoan women have high prevalence of risk factors for pelvic organ prolapse, such as obesity and parity. There are non-surgical and surgical interventions for pelvic organ prolapse. Limited sexual and reproductive health education in Samoa hinders women's knowledge of the pelvic organs and what is considered normal. This short report describes the process of developing and producing an educational video on pelvic organ prolapse in Samoan and English and the lessons learned from the process.
Background The mean age of presentation for breast cancer among black women is substantially earlier than their white counterparts. Black women also present with adverse prognostic factors that have major clinical implications, including lower survival. To pilot the use of a 6 min DVD on breast cancer in young (under 50 years) black women, to raise awareness and examine the impact of the DVD on increased consultation and referral rates among these women. Methods Two general practices (intervention practices) in the Hackney area were randomised to have the DVD mailed to all black women aged 25–50 years registered with the practices, and two practices to no intervention (control practices). EMIS data was used to compare consultation rates preintervention and postintervention, in the intervention as well as control practices. Interviews with practice staff and focus groups with patients in participating practices provided qualitative data on the study context and DVD effectiveness. Results A trend of declining consultations for breast symptoms was observed (−22% and −31% among non-black women in the control and intervention practices, and −23% among black women in the control practice) except among the target population of black women aged 25–50 years for the DVD in the intervention practices, which saw an increase of 28% in consultations. The qualitative data indicated that the DVD was well received in the target population, and suggested further ways of disseminating awareness messages and overcoming barriers to help-seeking. Conclusions Pilot results suggest that the strategy of distributing the DVD may increase consultations for breast problems.
The protection of fourth dose mRNA vaccination against SARS-CoV-2 is relevant to current global policy decisions regarding ongoing booster roll-out. We aimed to estimate the effect of fourth dose vaccination, prior infection, and duration of PCR positivity in a highly-vaccinated and largely prior-COVID-19 infected cohort of UK healthcare workers.
Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.
The Yamatji people comprise several Aboriginal groups living in the Midwest region of Western Australia. Palliative care remains underutilised among Aboriginal groups, but little is known about Yamatji people's thoughts about and experiences of accessing services.
Background Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women’s quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation. Participants Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking. Intervention The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres’ usual practice. Allocation Remote web-based application; minimisation was by age, pessary user type and centre. Blinding Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat. Results Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference −0.03, 95% confidence interval −9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment. Study registration This study is registered as ISRCTN62510577. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment ; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.
Abstract Background Although Samoan women have a high prevalence of obesity and multiple parity which are risk factors of pelvic organ prolapse, there is no prevalence data on this condition. Aims Translate the Pelvic Organ Prolapse-Symptoms Score (POP-SS) from English into Samoan, Materials and methods Standardised methods for translating questionnaires, individual face to face audio-recorded interviews in which women completed the POP-SS using a Think Aloud method, analysis using a Framework approach. Results The POP-SS was successfully translated in to Samoan, an additional information leaflet was developed to support women’s understanding of what prolapse is, 14 Samoan women were recruited of which 13 were interviewed and completed the POP-SS, results of POP-SS (scores), results of think aloud, results in terms of research experience. Conclusions A Samoan version of the POP-SS is now available for further evaluation of its psychometric properties prior to wider use. The team continue to collaborate on their work on establishing the prevalence of prolapse whilst building local research capacity.
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