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Abstract Background Rapid timescales for the design and delivery of research were common during the COVID-19 pandemic. The recruitment and retention of healthcare workers (HCWs) as participants in research studies are notoriously challenging, but this was exacerbated during the pandemic by the unprecedented demand placed on the workforce. The SARS-CoV-2 Immunity and Reinfection Evaluation (SIREN study) is a prospective multicentre cohort study following HCWs in the UK. This paper discusses the strategies and challenges associated with recruitment and retention of HCW participants in Scotland. Methods There were 44,546 HCWs recruited to the SIREN study, of whom 6,285 were recruited by research teams at ten different research sites in Scotland between October 2020 and March 2021. Information on target and actual sample size, availability of resource, recruitment rate, and recruitment and engagement strategies by site was collated from SIREN study documentation and discussions with local key SIREN site staff. Individual-level data from 6,153 HCW participants with ongoing consent for all data usage were also collated, including socio-demographic data and information on withdrawal (in first year) and opt-in to a study extension after one year. Factors associated with these outcomes were explored in logistic regression analyses. Results Different recruitment strategies were used in each site according to local agreements, protocol and staff capacity, with the recruitment period ranging from 13 to 160 days. The locally-agreed recruitment target was met in four sites. The proportion of participants who withdrew in the first year ranged from 3.1 to 24.8% by site, while subsequent opt-in to a 12-month study extension ranged from 28.6 to 74.8%. The sites with the highest proportions of withdrawals were the same four sites with lowest proportions of opt-in. On an individual level, there was a lower level of retention among younger participants, and those from lower socio-economic backgrounds and minority ethnic groups. Conclusions Site-specific factors including research-readiness likely had a significant influence on recruitment and retention, more so than the specific recruitment or retention strategies employed. Independent of site factors, individual-level variables influenced recruitment and retention, suggesting targeted strategies may be needed to promote research engagement among particular socio-demographic groups.

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. Plain language summary Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women’s quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women’s quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse. Scientific summary Background Pelvic organ prolapse (hereafter prolapse) is the descent of some, or all, of the female pelvic organs from their usual position in the pelvis into the vagina. Prolapse is a common problem, with studies suggesting that up to 65% of women may be affected. Prolapse incidence increases with age. As the population ages, prolapse presents a growing health problem. Women who experience prolapse report bothersome symptoms that negatively affect their quality of life and body image. Symptoms include a feeling of ‘something coming down’ into the vagina; urinary, bowel and sexual symptoms; and pain. Prolapse can be treated conservatively or surgically. Between 10% and 30% of women who have prolapse surgery may need repeat surgery, and the controversy around the use of surgical mesh has brought the focus onto conservative treatment options. One conservative treatment option is vaginal pessary. The pessary is an inexpensive mechanical device that is inserted into the vagina to support the pelvic organs. Pessaries are widely used in the NHS, with two-thirds of women initially choosing a vaginal pessary to treat their prolapse symptoms. The current UK care pathway for women who use a pessary as treatment for prolapse is that the pessary is usually fitted at a gynaecological clinic, or occasionally at a general practitioner surgery, and the woman returns approximately every 6 months to have it removed and replaced with a new one. However, having to return to clinic every 6 months may be inconvenient for women, having a pessary permanently in situ may interfere with sexual intercourse, and the patient may require a review in clinic before 6 months because the pessary has fallen out or because of pessary complications (e.g. vaginal discomfort). An alternative to clinic-based pessary care is pessary self-management, whereby a woman removes and reinserts the pessary herself at home, thus offering her more control over her ability to maintain and improve her own health. Research in other clinical domains suggests that self-management is beneficial because people improve their self-efficacy (confidence) in looking after their own health. To the best of our knowledge, there is no current evidence on the effectiveness of pessary self-management for women with prolapse. The treatment of prolapse with self-care pessary (TOPSY) study aims to fill that evidence gap. Objective The TOPSY trial aimed to evaluate the clinical effectiveness and cost-effectiveness of self-management of a vaginal pessary on the prolapse-specific quality of life of women with pelvic organ prolapse when compared with clinic-based care. Clinic-based care is the standard operating model for many pessary services across the UK. The process evaluation undertaken concurrently with the trial aimed to assess, using a mixed-methods design, intervention acceptability, pathways to effectiveness, adherence to treatment and fidelity. Methods We undertook a parallel-group, multicentre, randomised controlled trial, with individual randomisation, which assessed the superiority of self-management compared with clinic-based pessary care for women who used a pessary for prolapse. Allocation was carried out remotely via a web-based computer system, with minimisation by age (< 65/≥ 65 years), pessary user type (new user/existing user) and centre. A sample size of 330 women (165 per group) was required to provide 90% power to detect a difference of 20 points in the Pelvic Floor Impact Questionnaire-7 score (which measures prolapse-specific quality of life) at 18 months after randomisation, assuming a standard deviation of 50, two-sided alpha of 0.05 and 20% loss to follow-up. Participants were recruited from 21 UK centres where pessary care was routinely provided. Women who were new pessary users (had used a pessary for ≤ 3 months) and existing users (had used a pessary for > 3 months) were identified by centre staff and via patient notes, clinic lists, caseloads and referral letters. Potentially eligible women were sent an invitation letter or approached in clinic by centre staff. Women were eligible for inclusion if they were aged ≥ 18 years, were using a pessary of any material or type (except shelf, Gellhorn or cube pessaries) and had retained the pessary for at least 2 weeks. Women were excluded if they had limited manual dexterity that would affect their ability to remove and replace their pessary; were judged by their healthcare team to have a cognitive deficit such that it was not possible for them to provide informed consent or to self-manage; were pregnant; or had insufficient understanding of the English language (the self-management intervention was only available in English). The primary outcome of effectiveness was prolapse-specific quality of life, measured using the Pelvic Floor Impact Questionnaire-7, and of cost-effectiveness was incremental cost per quality-adjusted life-year at 18 months post randomisation. Interim follow-ups were undertaken at 6 and 12 months. Secondary outcome measures included generic quality of life [measured using the EuroQol-5 Dimensions, five-level (EQ-5D-5L)]; pelvic floor symptoms (measured using the Pelvic Floor Distress Inventory-20); sexual function (measured using the prolapse/incontinence sexual questionnaire-IUGA-Revised); self-efficacy (measured using the General Self-efficacy Scale); pessary complications; pessary use; and pessary confidence. Resource use data were collected using a specifically developed health Resource Use Questionnaire. Study centres received a training visit during which the principles of self-management were explained and the intervention delivery staff were trained in the components of the intervention. Each centre also received a training manual that provided written guidance on the intervention. Women randomised to self-management received: a 30-minute self-management teaching appointment where they were taught to, and given the opportunity to try to, remove, clean and reinsert their own pessary a self-management information leaflet that provided written and diagrammatic information on pessary self-management a 2-week follow-up telephone call to assess if they had been able to remove, clean and reinsert their pessary since the teaching appointment and to assess any difficulties they experienced a telephone helpline number for their local clinical centre. Women in the clinic-based care group received routine appointments at which their pessary was removed and cleaned, or changed for a new one, and replaced by a healthcare professional. The interval between the appointments was determined by the usual practice of the centre. A concurrent mixed-methods process evaluation was undertaken to assess intervention acceptability, pathways to effectiveness, adherence to treatment and fidelity. Recruiting staff at centres were asked to audio-record a sample of their recruitment discussions. Staff delivering the intervention were asked to record a sample of self-management teaching appointments and 2-week follow-up telephone calls and to complete a checklist for every self-management teaching session undertaken to allow assessment of fidelity to the intervention. A subsample of women who were randomised in the trial and consented to take part in an additional interview study were interviewed at baseline and 18 months. Eligible women who declined to be randomised but were willing to take part in an interview study were also interviewed at baseline and 18 months. The Pessary Use Questionnaire included an open question about women’s experiences of their trial group. The interviews and open questions aimed to assess acceptability, adherence and pathways to effectiveness. Finally, recruiting centre staff and healthcare professionals who delivered the intervention were invited to take part in an interview to increase understanding of pathways to effectiveness and fidelity. A within-trial economic evaluation was conducted to compare the costs and benefits, measured in quality-adjusted life-years, of self-management with clinic-based care over the 18 months post randomisation. In addition, a decision-analytic model was developed using the trial data to extend the analysis over a 5-year period. Healthcare resource use data were collected from the clinic visit and telephone support case report forms and from the participant-completed Resource Use Questionnaire. Costs were attached to resource use from published sources. Health state utility values were elicited from responses to the EQ-5D-5L to estimate the difference in quality-adjusted life-years between the trial groups. The trial analysis followed the intention to treat principle, and the analyses of all study elements were documented in prespecified analysis plans. The qualitative analysis for the process evaluation followed framework analysis methods and, where appropriate, case study analytic methods. Results Key results: trial Three hundred and forty women were randomised: 169 to the self-management group and 171 to the clinic-based care group. At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available: 139 (82.2%) in the self-management group and 152 (88.9%) in the clinic-based care group. There was no evidence of a difference between the groups in prolapse-specific quality of life (measured using the Pelvic Floor Impact Questionnaire-7) at 18 months (adjusted mean difference −0.03, 95% confidence interval −9.32 to 9.25). Sensitivity analysis of the primary outcome showed no significant difference between the groups under a range of different assumptions and prespecified sensitivity analyses. A subgroup analysis of the primary outcome showed no significant effect of trial group by subgroup interactions (subgroups were age < 65 vs. ≥ 65 years, new vs. existing pessary user and hysterectomy vs. no hysterectomy at baseline). At the 18-month follow-up, a greater proportion of pessary complications were reported in the clinic-based care group than in the self-management group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no difference between the groups in general self-efficacy, but women in the self-management group were more confident in their ability to manage pessary-related problems and to insert and remove their pessary. An analysis adjusting for clinic-based care appointments cancelled due to the COVID-19 pandemic did not alter the findings. Key results: process evaluation Self-management was reported to be an acceptable intervention to women and to healthcare professionals. Women (whether they received self-management or not) and healthcare professionals reported benefits from pessary self-management to women and the NHS and valued the possibilities provided to women who could self-manage their pessary, such as flexibility and independence in using the pessary as needed. There was fidelity to self-management intervention delivery and there was minimal variance in the delivery of clinic-based care across the study centres. Self-management delivery can be integrated within existing service structures. Interview data demonstrated that women’s adherence to their allocated group ranged from not adherent at all to completely adherent in all aspects, and this was the case in both groups. The COVID-19 pandemic did have an impact on adherence, especially among those in the clinic-based care group when clinic appointments were suspended, which led some women to remove their own pessary. Although the pandemic might have had some effect on adherence, multiple other contextual factors influenced adherence, such as good general health, which influenced it in both groups. Multiple contextual factors impacted on pathways to effectiveness for both trial groups. There was variance in women’s quality of life in both groups across the 18 months’ follow-up. The pessary itself influenced women’s quality of life, regardless of trial group. There was at least the potential for self-management to further enhance that quality of life over and above the influence of the pessary itself. Women in the self-management group had different self-efficacy from those in the clinic-based group. Women in the self-management group felt more confident in addressing common problems with their pessary, such as discharge or slippage, on their own without the need for additional clinic appointments. Key results: economic evaluation The within-trial economic analysis indicated that clinic-based care was dominated by self-management. There was no significant difference in the mean number of quality-adjusted life-years gained between self-management and clinic-based care (0.021), but the mean cost was lower for self-management than for clinic-based care (£578 vs. £728). The incremental net benefit estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained was £564, with an 80.8% probability of cost-effectiveness. The modelling results are consistent with the trial analysis. The incremental net benefit at 5 years was estimated as £4221 and the probability that self-management is a cost-effective intervention was estimated as 69.7%. Key results: synthesis There was no evidence that self-management improved prolapse-specific or general quality of life more than clinic-based care. Although qualitative findings suggested that quality of life had the potential to be improved more in the self-management group, this did not translate beyond participant-level data. The proposed mechanism of action for the intervention was self-efficacy. General self-efficacy did not differ between the groups at 18 months. Women who self-managed were more confident in their abilities to insert and remove their pessary and to manage problems experienced with their pessary than women in the clinic-based care group. There was fidelity to the self-management and clinic-based care intervention delivery, with the groups receiving different interventions, confirming that the trial was a true test. There was variance in adherence to trial group by the women; approximately 40% of the clinic-based care group removed the pessary themselves at least once at some point during follow-up, and 34 women in the self-management group crossed over to clinic-based care. Women in the self-management group reported fewer complications than women in the clinic-based care group. Experience of complications led to a greater likelihood of women discontinuing pessary use. Conclusions Implications for health care Healthcare professionals and policy-makers can be confident that in offering self-management as an option to women who use a vaginal pessary to manage pelvic organ prolapse they are offering an acceptable intervention that will not make women’s quality of life better or worse than clinic-based care. Self-management will, however, reduce the pessary-related complications that women experience and will cost the NHS less to deliver than standard clinic-based care models. Self-management of vaginal pessaries should be offered as part of NHS services from the outset of pessary care and as part of routine, ongoing care. In offering self-management to women, healthcare professionals should explain the lower complication rates experienced by women who self-manage and the possible mechanisms that may lead to that reduction (such as women’s confidence in removing the pessary when experiencing discomfort). Healthcare professionals who deliver self-management training may wish to add further information about options for pessary removal into that training, as women found pessary removal more difficult than pessary insertion. Recommendations for research (in priority order) Future research is needed to identify constructs that are important to women in measuring their prolapse-specific quality of life. This may necessitate the generation of a new measure that has greater sensitivity to quality-of-life constructs beyond the symptomatic changes linked to the pessary itself. Future trials of self-management should test the effectiveness of self-management with a wide range of ethnic groups and with women of different abilities to assess its effectiveness in these populations. This may include the testing of devices that support pessary removal or insertion. Future research is needed that focuses on self-management follow-up. For example, can follow-up be women-initiated, or does it need to be planned at specific intervals? Future research on pessary self-management is needed to look at possible links between pessary continuation and complications, including which specific complications are more likely to lead to discontinuation. 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.

Summary: Background: 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. Methods: Participants underwent fortnightly PCR and regular antibody testing for SARS-CoV-2 and completed symptoms questionnaires. A multi-state model was used to estimate vaccine effectiveness (VE) against infection from a fourth dose compared to a waned third dose, with protection from prior infection and duration of PCR positivity jointly estimated. Findings: 1298 infections were detected among 9560 individuals under active follow-up between September 2022 and March 2023. Compared to a waned third dose, fourth dose VE was 13.1% (95% CI 0.9 to 23.8) overall; 24.0% (95% CI 8.5 to 36.8) in the first 2 months post-vaccination, reducing to 10.3% (95% CI −11.4 to 27.8) and 1.7% (95% CI −17.0 to 17.4) at 2–4 and 4–6 months, respectively. Relative to an infection >2 years ago and controlling for vaccination, 63.6% (95% CI 46.9 to 75.0) and 29.1% (95% CI 3.8 to 43.1) greater protection against infection was estimated for an infection within the past 0–6, and 6–12 months, respectively. A fourth dose was associated with greater protection against asymptomatic infection than symptomatic infection, whilst prior infection independently provided more protection against symptomatic infection, particularly if the infection had occurred within the previous 6 months. Duration of PCR positivity was significantly lower for asymptomatic compared to symptomatic infection. Interpretation: Despite rapid waning of protection, vaccine boosters remain an important tool in responding to the dynamic COVID-19 landscape; boosting population immunity in advance of periods of anticipated pressure, such as surging infection rates or emerging variants of concern. Funding: UK Health Security Agency, Medical Research Council, NIHR HPRU Oxford, Bristol, and others.

Summary: Background: 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). Methods: 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. Findings: 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). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Abstract 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

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.

Abstract Background Up to 50% of women in areas of high socio-economic deprivation are at risk of developing depressive symptoms in pregnancy. Feeling well supported, can facilitate good mental health perinatally. A brief, innovative intervention to facilitate access to support and resources was developed and tested. This included one antenatal and one postnatal session, each with three evidence-based components: i) support from a non-professional peer to enable a woman to identify her needs; ii) information about local community services and signposting; and iii) development of a personalised If–Then plan to access that support. The aims were to evaluate the intervention and research methods for feasibility and acceptability for perinatal women, maternity care providers and peers, and provide preliminary effectiveness indications. Methods Pregnant women living in an area of high deprivation were recruited from community-based antenatal clinics and randomised to intervention or control condition (a booklet about local resources). Outcome measures included women’s use of community services by 34 + weeks gestation and 6 months postnatally; mental health and wellbeing measures, and plan implementation. Interviews and focus groups were conducted with women participants, providers, and peers. Data were analysed using framework analysis. Recruitment and retention of peers and participants, intervention fidelity, and acceptability of outcome measures were recorded. Results Peer facilitators could be recruited, trained, retained and provide the intervention with fidelity. One hundred twenty six women were recruited and randomised, 85% lived in the 1% most deprived UK areas. Recruitment constituted 39% of those eligible, improving to 54% after midwifery liaison. Sixty five percent were retained at 6 months postnatally. Women welcomed the intervention, and found it helpful to plan access to community services. Providers strongly supported the intervention philosophy and integrated this easily into services. The study was not powered to detect significant group differences but there were positive trends in community service use, particularly postnatally. No differences were evident in mental health and wellbeing. Conclusions This intervention was well received and easily integrated into existing services. Women living in highly deprived areas could be recruited, randomised and retained. Measures were acceptable. Peer facilitators were successfully trained and retained. Full effectiveness studies are warranted.

Abstract 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.

Abstract 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.

Abstract Background Antimicrobial resistance (AMR) is high on the UK public health policy agenda, and poses challenges to patient safety and the provision of health services. Widespread prescribing of antibiotics is thought to increase AMR, and mostly takes place in primary medical care. However, prescribing rates vary substantially between general practices. The aim of this study was to understand contextual factors related to general practitioners’ (GPs) antibiotic prescribing behaviour in low, high, and around the mean (medium) prescribing primary care practices. Methods Qualitative semi-structured interviews were conducted with 41 GPs working in North-West England. Participants were purposively sampled from practices with low, medium, and high antibiotic prescribing rates adjusted for the number and characteristics of patients registered in a practice. The interviews were analysed thematically. Results This study found that optimizing antibiotic prescribing creates tensions for GPs, particularly in doctor-patient communication during a consultation. GPs balanced patient expectations and their own decision-making in their communication. When not prescribing antibiotics, GPs reported the need for supportive mechanisms, such as regular practice meetings, within the practice, and in the wider healthcare system (e.g. longer consultation times). In low prescribing practices, GPs reported that increasing dialogue with colleagues, having consistent patterns of prescribing within the practice, supportive practice policies, and enough resources such as consultation time were important supports when not prescribing antibiotics. Conclusions Insight into GPs’ negotiations with patient and public health demands, and consistent and supportive practice-level policies can help support prudent antibiotic prescribing among primary care practices.

Introduction: Poor maternal mental health during the perinatal period has been shown to have potentially long-lasting effects for mother and child. In recognition of this, maternal mental health is receiving increased attention from political and healthcare organizations, with a growing focus on preventing the onset of common mental health disorders. Objective: The objective for this review is to provide an update of randomized controlled trials examining the use of interventions targeted to prevent the onset of postnatal depression and anxiety in nondiagnostic populations with universal or selected samples. Methods: A total of four databases, EBSCO Host, Science Direct, Scopus, and Web of Science, incorporating PsychINFO were searched and papers selected according to clearly specified inclusion criteria. A large Health Technology review was published in 2016, for which the final search was conducted in December 2012. Therefore inclusion criteria were studies published from January 2013 onwards, available in English language, had a focus on prevention of postnatal maternal depression and anxiety, and used psychological interventions. Drug intervention trials were excluded. Findings: 12 studies were identified as examining antenatal or postnatal intervention trials with an aim of preventing maternal postnatal depression and/or anxiety. There continues to be limited evidence to recommend specific prevention strategies for universal samples without further testing. There is evidence to suggest the use of rational-emotive behavioral therapy in an antenatal sample may have some utility, and the use of psychotherapy-based interventions in a postnatal setting is also supported although both require further investigation. Additionally, there is a need to gather information on acceptability, as many trials were hindered by poor adherence to interventions and high attrition that were otherwise unexplained.