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ObjectivesThis systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women.DesignA systematic literature review and thematic synthesis of qualitative studies.Data sourcesA search of MEDLINE, CINAHL, Embase and PsycInfo was undertaken using the search terms ‘Women’, ‘Woman’ ‘Female,’ ‘Chronic’, ‘Long-term’, ‘Disease’, ‘Illness’, ‘Condition’ ‘Health,’ ‘Self-management,’ ‘Qualitative,’ ‘Barrier’ and ‘Facilitator’. A hand search for literature was also performed.Eligibility criteriaStudies published before 2005 and those not in English were excluded.Data extraction and synthesisExtracted data were analysed thematically and emerging and recurring themes identified. Themes were mapped to the six components of the COM-B model. Critical appraisal of included publications was undertaken using the CASP (Critical Appraisal Skills Programme) qualitative checklist and finding weighted on quality.ResultsEighty-four publications were identified and eligible for inclusion within the review. Studies were conducted in five continents, with a focus on 20 different chronic conditions and included a total of 1788 women. Barriers and facilitators to physical capability, psychological capability, physical opportunity, social opportunity, autonomic motivation and reflective motivation were identified with a number of recurring themes found. Self-prioritisation, support and culture all had a significant impact on whether women followed self-management recommendations. Certain groups of women such as those living remotely, those with financial difficulties, migrants and those who do not speak the predominant language appear to face additional barriers to self-management.ConclusionsThis review highlights that to self-manage chronic conditions women have to overcome various cultural, financial and social barriers. Self-management programmes should be designed taking into account these factors in order to ensure women are better supported and enabled to improve their health outcomes.

Knowledge, data, and research gaps continue to hinder care

Introduction and hypothesisOur aim was to determine the intraoperative feasibility and complication rate of laparoscopic sacrocolpopexy (LSC) in overweight and obese women compared with women of normal weight.MethodsThis was a retrospective observational cohort study (Canadian Task Force classification II-2) conducted at a tertiary urogyaenocology unit evaluating 119 women who underwent LSC between March 2005 and January 2013.ResultsBody mass index (BMI) was classified as normal (22.89 ± 1.55), overweight (27.12 ± 1.40) and obese (33.47 ± 3.26) according to the World Health Organisation (WHO) classification. There was no difference in intraoperative complication rates for bladder, bowel, ureteric or vascular injury; haemorrhage; conversion to laparotomy; or anaesthetic complications for normal weight, overweight or obese women. Similarly there was no difference in operating time, duration of anaesthetic or hospital stay between BMI class (p = 0.070, p = 0.464, p = 0.898, respectively) postoperative or mesh complication rates. At 6-months’ follow-up, there was no difference in Patient Global Impression of Improvement scale (PGI-I) (defined as very much better or much better) between normal weight, overweight and obese women (76.9, 72 and 65.4%, p = .669) or objective cure using the Pelvic Organ Prolapse Quantification (POP-Q) examination (p = 0.402).ConclusionsLSC is feasible, with equivalent intraoperative complication rates for normal weight, overweight and obese women when performed by experienced laparoscopic urogynaecologists. Given the benefits of a laparoscopic approach in obese women, the authors suggest they should be offered LSC as an option to treat vault prolapse when surgical management is being considered.

IntroductionAn increasing number of women are presenting with symptoms after the placement of mesh implants for prolapse which may be attributable to a mesh implant complication. MRI imaging can be used to evaluate abdominally placed mesh but there is no published research evaluating the use of MRI in this group of women. The objective of our study was to report our experience as a tertiary centre in evaluating abdominal mesh with MR imaging and the agreement of MR reports with surgical findings.Study designA retrospective observational cohort study (Canadian Task Force classification II-2) of all women referred to our tertiary unit who underwent an MR scan for investigation of symptoms of mesh complication following an abdominally placed mesh implant between June 2006 and September 2018 was performed. The reports of MR images were compared with the findings at surgery.ResultsMR scan was performed in 87 with suspected mesh complications. MR scan detected mesh failure in 42.1% of women (37/87), infection in 12.6% (11/87), compression in 2.3% (2/87), exposure in 12.6% (11/88), bowel extrusion in 2.3% (2/87) and inflammation in 11.5% (10/87). Agreement between MR scan report and surgical diagnosis was almost perfect for mesh failure, infection and compression, whilst agreement was only moderate for mesh erosion and signs of inflammation (failure κ = 0.97, infection κ = 0.94, compression κ = 1.0, exposure κ = 0.58 and inflammation κ = 0.24).ConclusionThese data provide information on the role of MR imaging in the investigation of women presenting with suspected intra-abdominal POP mesh complications including recurrence.

IntroductionPelvic organ prolapse (POP) can be effectively managed using a pessary. A scoping review found that pessary self-management appears to benefit women with no increased risk. Despite this, many are unwilling to self-manage their pessary. At present, there is a lack of understanding about what affects willingness to self-manage a pessary. However, there may be relevant, transferable findings from other literature about barriers to the self-management of other chronic conditions. Therefore, this systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women.Methods and analysisThe systematic review will be conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and a guide for the systematic review of qualitative data. A search of MEDLINE, CINAHL, Embase and PsycInfo will be undertaken to identify relevant articles that meet the eligibility criteria using the search terms ‘Women’, ‘Woman’ ‘Female,’ ‘Chronic’, ‘Long-term’, ‘Disease’, ‘Illness’, ‘Condition’ ‘Health,’ ‘Self-management,’ ‘Qualitative,’ ‘Barrier’ and ‘Facilitator’. A hand search of the reference list of non-original research identified during the search but excluded will be conducted for additional publications, which meet the inclusion and exclusion criteria. Studies published before 2005 and those not available in English will be excluded. Data relevant to the topic will be extracted and critical appraisal of all included publications undertaken.Ethics and disseminationNo ethical or Health Research Authority approval is required to undertake the systematic review. The systematic review findings will be disseminated by publication. The findings will also inform subsequent exploratory work regarding pessary self-management.PROSPERO registration numberCRD42022327643.

Background 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. Methods 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). Results 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. Conclusions 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. Trial registration ISRCTN62510577 (date of first recruitment was 16th May 2018).

Background 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. Methods The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura’s social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. Results The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. Conclusions The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. Trial registration ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017

Background Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. Methods This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months’ post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months’ post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women’s quality of life, and of its cost-effectiveness. Trial registration ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Background Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences. Methods The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/ n  = 36), women who declined trial participation but agreed to interview (non-randomised women) ( n  = 20) and healthcare professionals recruiting to the trial ( n  ~ 17) and delivering self-management and clinic-based care ( n  ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n  = 12–18). All participating centres will be asked to record one or two self-management teaching appointments ( n  = 30) and self-management 2-week follow-up telephone calls ( n  = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. Discussion The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. Trial registration ISRCTN62510577 . Registered on 6 October 2017.