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Background Pelvic organ prolapse and dementia are both common conditions which increase in prevalence with age. Women who have prolapse and dementia may have a different clinical presentation from those with prolapse alone. This development study aimed to understand: Which services currently deliver pessary care for women with dementia and how those services manage/support the women and their family supporters, and what women with prolapse and dementia and/or their family supporters would like from services to alleviate the women’s symptoms. Methods Multimethod development study. An anonymous online survey for Health and Social Care Professionals (HSCPs) was circulated via various professional networks. Semistructured interviews were conducted with HSCP, women with a dual diagnosis of prolapse and dementia and their family supporters. Results Survey results ( n = 336) indicated that care was delivered predominantly in secondary care and that HSCPs encounter some challenges in providing best care to women with a dual diagnosis. Two women with prolapse and dementia, two family supporters and six HSCPs were interviewed. Interview data suggested the need for further information about features of prolapse and pessary care directly aimed at family supporters and that care experiences vary for women with a dual diagnosis, especially regarding decision‐making. Conclusions The study demonstrates that the care for women with prolapse and dementia may be different from care for those who do not have a dual diagnosis. Further research is needed to inform clinical practice.

Objective To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL).Design Four-year questionnaire follow-up of trial participants.Setting UK pessary clinics.Sample Responders at 4 years aged >= 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained >= 2 weeks. Exclusions: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.Methods SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat.Outcome Measures The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms.Results Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI -6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI -0.58 to 6.61). At 4-years, SM was cost-effective (INB 2240) pound. There was one potentially related serious adverse event (SM group).Conclusions Pessary self-management is an effective and cost-effective long-term option for women with prolapse.Trial Registration ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577)

Pelvic organ prolapse negatively affects women’s quality of life globally. Vaginal pessaries are a common first-line treatment. The evidence base to support pessary self-management and to understand how it affects women’s lives is poor. This study aimed to identify the acceptability, effectiveness, fidelity to delivery, and adherence for women treated with vaginal pessary for prolapse and the healthcare professionals who treat them and how these differed between self-management and clinic-based care. Multi-method process evaluation embedded within a randomised controlled trial in 21 UK secondary care centres. Data were collected using the following: Recordings of self-management support appointments (n = 21) and 2-week post-support follow-up phone calls (n = 34), healthcare professional completed fidelity checklists of self-management support appointments (n = 156) and 2-week follow-up calls (n = 145), interviews with purposively sampled women randomised to each trial group at baseline (n = 36 total) and 18 months (n = 23), interviews with women who declined randomisation to the trial at baseline (n = 20) and 18 months (n = 18), interviews with healthcare professionals (n = 36), and a free-text response question in the trial questionnaire (n = 77 comments at baseline, n = 136 6 months, n = 127 12 months, n = 98 18 months). Self-management was acceptable with all intervention components perceived as important for women’s self-management ability and to how the intervention worked. Women’s adherence to self-management and clinic-based care varied. Pessary-related complications negatively influenced adherence in both groups. Emotional labour from healthcare professionals in both types of pessary management was a moderator on the pathway to effectiveness. Women’s and healthcare professionals’ positive attitudes were central to successful implementation. Self-managing women expressed self-efficacy differently than those who received clinic-based care in that they were more confident in addressing common pessary problems, and their confidence grew over time. Women in the clinic-based care group had confidence but in paternalistic pessary care. Self-management and clinic-based care were delivered differently, and thus, the trial was a true test of the effectiveness of self-management. This is the first study to provide a programme theory for pessary self-management. Given the acceptability of self-management, the programme theory developed could be used to support the implementation of self-management in clinical practice. Further research is needed to support widespread implementation. ISRCTN62510577 (date of first recruitment was 16th May 2018).

Abstract Background and aims There is evidence to suggest that breast cancer (BC) treatment is associated with an increased risk of developing cardiovascular disease (CVD). Several countries have introduced clinical measures to reduce the impact of breast cancer treatment on cardiovascular function including activated breathing control during radiotherapy, lower radiation doses, and maximum anthracycline doses. The overall aim of this study was therefore to investigate whether breast cancer patients still exhibit higher rates of cardiovascular disease than the general population. Methods We conducted a registry-based cohort study using linked data from four nationwide health registries. Out study population included all Norwegian patients diagnosed with BC between 2013-2020 and matched them by age to 10 controls without BC. Health outcomes were measured from 2008 to 2021. We estimated the cumulative incidence from index date, for ten selected CVDs. For BC patients, the index date was defined as date of BC diagnosis. For controls, the index date was defined as the date of BC diagnosis for the matched BC patient. A wash-out period of 5 years was applied to identify incident cases of CVD. Results The study population included 27,535 patients with BC and 269,9994 matched controls. Median age in both groups was 62 years (IQR: 20). Prior to index date, there were no significant differences in the prevalence of heart valve disease, chronic ischemic heart disease heart failure and peripheral vascular disease in BC patients compared to controls (p>0.05) (Table 1). Hypertensive heart disease, pulmonary embolism, atrial fibrillation, and other cardiac arrythmias were more prevalent in BC patients, while angina pectoris and acute myocardial infarction were more prevalent among controls. After the index date, the incidence proportion for heart valve disease, hypertensive heart disease, pulmonary embolism, atrial fibrillation, other cardiac arrythmias, and heart failure were higher in BC patients compared to controls (p<0.001) (Table 2). No significant differences were found for angina pectoris, acute myocardial infarction, chronic ischemic heart disease, and peripheral vascular disease. Conclusion Breast cancer is still associated with an increased risk of developing several CVDs in current clinical practice, compared to matched controls without breast cancer.Baseline characteristicsIncidence of CVD

Abstract Background Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are recommended as additional lipid-lowering drug treatment for high-risk patients if the low-density lipoprotein cholesterol (LDL-C) targets are not achieved with statins and ezetimibe alone. Nationwide data from clinical practice on the use of PCSK9i are lacking. In 2015, PCSK9i became available in Norway with reimbursement restricted to patients with familial hypercholesterolemia (FH) and/or atherosclerotic cardiovascular disease (ASCVD) with LDL-C above certain levels. Purpose To investigate the use and adherence of lipid lowering drugs among a nationwide cohort of PCSK9i users, utlizing complete pharmacy dispensation data. Methods Information on all PCSK9i users ≤80 years with at least one year of follow-up after the first dispensation were extracted from the Norwegian Prescribed Drug Registry. We evaluated adherence to PCSK9i by calculating the proportion of days covered (PDC) during the initial year of PCSK9i therapy. Poor adherence was defined as PDC <80%, and discontinuation was defined as a gap in treatment ≥180 days during the follow-up period. We analyzed treatment patterns of statins and ezetimibe during the 1-year period before and after PCSK9i initiation by determining the proportion of patients with at least one dispensation of statin and/or ezetimibe treatment. Results A total of 2,997 PCSK9i users were identified. Median age at treatment initiation was 62 (IQR: 13) years and 43% were female. Non-adherence to PCSK9i was observed in 16% of the patients, and 18% discontinued treatment (Table). Non-adherence to PCSK9i was more prevalent in females, and in the lowest and highest age quartiles. No significant difference in non-adherence was found among patients with ASCVD compared to patients with FH. In the year preceding PCSK9i initiation, 74% of patients used statins (including combinations with ezetimibe), 11% used ezetimibe monotherapy, and 15% did not use any statin or ezetimibe treatment (Figure). During the year following PCSK9i initiation, 35% used statins (including combinations), 17% used ezetimibe monotherapy, and 48% did not use any statin or ezetimibe treatment. Among patients with ASCVD, 72% used statins prior to PCSK9i initiation, and 22% used statins after. Among patients with FH, 77% used statins prior to PCSK9i initiation, while 51% used statins after. Conclusion In this nationwide study of incident PCSK9i users, we observed a substantial decrease in usage of statins and ezetimibe following PCSK9i initiation. Further, almost 1 in 5 patients discontinued treatment with PCSK9i. There is a large potential for optimizing treatment and adherence to PCSK9i and conventional lipid-lowering drugs among Norwegian patients with ASCVD and familial hypercholesterolemia.Adherence and discontinuation to PCSK9iUse of statin and ezetimibe

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 selfmanagement 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. vParticipants: 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 pound per quality -adjusted life -year gained, with an estimated incremental net benefit of 564.32 pound 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 selfmanaging 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

What is a process evaluation when used alongside a randomised controlled trial?

BackgroundUrinary incontinence (UI) negatively affects the well-being of women globally. Pelvic Floor Muscle Training (PFMT) is a complex intervention that aims to decrease UI symptoms. Information about how the multiple complex components involved in PFMT achieve and maintain the desired effect are rarely studied as a whole. The evidence base lacks data about how women experience PFMT over time and in the longer-term. This study explored women's experiences of biofeedback-assisted PFMT and PFMT alone, to identify and understand what influenced self-reported adherence to PFMT, and UI outcomes over time.MethodsThis rigorous longitudinal qualitative case study, nested within a randomised controlled trial, recruited forty cases (women with stress or mixed UI; 20 in biofeedback-assisted and 20 in PFMT alone group). A case included up to four semi-structured interviews with each woman (prior to starting PFMT, end of treatment [6 months], 12 months, 24 months). Analysis followed case study analytic traditions, resulting in a Programme Theory about PFMT from the perspectives of women with UI.FindingsThe theory demonstrates factors that motivated women to seek UI treatment, and how these influenced long-term adherence. Therapists who delivered PFMT played a crucial role in supporting women to know how to undertake PFMT (to have capability). Some, but not all, women developed self-efficacy for PFMT. Where women did not have PFMT self-efficacy, adherence tended to be poor. When women had PFMT self-efficacy, the conditions to support adherence were present, but contextual factors could still intercede to inhibit adherence. The intercession of contextual factors was individual to a woman and her life, meaning any particular contextual factor had inconsistent influences on PFMT adherence over time for individual women and exerted varying influences across different women.ConclusionLong term adherence to PFMT is a complex interaction between many different factors. Enquiring about an individual woman's motivation to seek treatment and understanding the contextual factors that affect an individual woman will enable a practitioner to support longer-term adherence.

Women with symptomatic pelvic organ prolapse are offered a choice of conservative and surgical treatment options. Two thirds of women choose a vaginal pessary, a support device inserted in the vagina. This article reports the finding of a randomized controlled trial published in 2023 evaluating the cost-effectiveness of self-management of pessary compared to clinic-based care. Women were recruited in 21 centres across the UK and 340 women were randomized to pessary self-management or clinic-based care. The primary outcome measure was prolapse-specific quality of life and secondary outcomes were generic quality of life, pelvic floor symptoms, sexual function, self-efficacy, pessary complications, pessary use and pessary confidence. Participants’ health care resource use was measured. The trial showed that at 18 month follow-up self-management was not associated with better or worse quality of life than clinic-based care. Women in the self-management group reported fewer pessary complications and lower healthcare resource use.

The study Hagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. eClinicalMedicine 2023;66:102326. To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/pelvic-organ-prolapse-self-management-of-pessaries-can-be-a-good-option/

Objectives: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary selfmanagement (SM) when compared with clinic -based care (CBC). A decision analytic model was developed to extend the economic evaluation. Methods: A randomized controlled trial with health economic evaluation. The SM group received a 30 -minute SM teaching session, information lea flet, 2 -week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality -adjusted life year (QALY), 18 months post -randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5 -year period. Results: There was no signi ficant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (578 pound vs 728) pound. The incremental net bene fit estimated at a willingness to pay of 20 pound 000 per QALY gained was 564 pound, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net bene fit was estimated as 4221 pound, and the probability of SM being cost-effective at 5 years was 69.7%. Conclusions: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.