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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 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 (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 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.

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.

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.

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.

Since June 2020, the SARS-CoV-2 Immunity and Reinfection Evaluation (SIREN) study has conducted routine PCR testing in UK healthcare workers and sequenced PCR-positive samples. SIREN detected increases in infections and reinfections and delected Omicron subvariant waves emergence contemporaneous with national surveillance. SIREN's sentinel surveillance methods can be used for variant surveillance.