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Background: Dichotomisation of statistical significance, rather than interpretation of effect sizes supported by confidence intervals, is a long-standing problem., Methods: We distributed an online survey to clinical trial statisticians across the UK, Australia and Canada asking about their experiences, perspectives and practices with respect to interpretation of statistical findings from randomised trials. We report a descriptive analysis of the closed-ended questions and a thematic analysis of the open-ended questions., Results: We obtained 101 responses across a broad range of career stages (24% professors; 51% senior lecturers; 22% junior statisticians) and areas of work (28% early phase trials; 44% drug trials; 38% health service trials). The majority (93%) believed that statistical findings should be interpreted by considering (minimal) clinical importance of treatment effects, but many (61%) said quantifying clinically important effect sizes was difficult, and fewer (54%) followed this approach in practice. Thematic analysis identified several barriers to forming a consensus on the statistical interpretation of the study findings, including: the dynamics within teams, lack of knowledge or difficulties in communicating that knowledge, as well as external pressures. External pressures included the pressure to publish definitive findings and statistical review which can sometimes be unhelpful but can at times be a saving grace. However, the concept of the minimally important difference was identified as a particularly poorly defined, even nebulous, construct which lies at the heart of much disagreement and confusion in the field., Conclusion: The majority of participating statisticians believed that it is important to interpret statistical findings based on the clinically important effect size, but report this is difficult to operationalise. Reaching a consensus on the interpretation of a study is a social process involving disparate members of the research team along with editors and reviewers, as well as patients who likely have a role in the elicitation of minimally important differences., (© 2024. The Author(s).)

In recent years, there has been an increase in interest in what environmental sustainability means for healthcare, including oral health and dentistry. To help facilitate discussions among key stakeholders in this area, the Scottish Dental Clinical Effectiveness Programme held a workshop in November 2022. The purpose of this workshop was to explore current thinking on the subject of sustainability as it relates to oral health and to help stakeholders identify how to engage with the sustainability agenda. This paper presents an overview of the presentations and discussions from the workshop and highlights potential avenues for future work and collaboration., (© 2024. The Author(s), under exclusive licence to the British Dental Association.)

Background: Despite the importance of statistical and numerical aspects in key decisions related to clinical trials and their impact in patient's care, patient and public involvement remains underdeveloped in this field. Communication is a barrier to enable successful involvement of patients and the public in numerical aspects. Treatment important differences, a crucial numerical aspect in trials, is considered a priority for patient and public involvement. Creative methods have been proposed to improve communication of technical concepts with members of the public; and to democratise and improve inclusivity in patient and public involvement in health research., Methods: Working with creative professionals, public partners, and statisticians, we aimed to develop, pilot and implement creative workshops to promote a shared understanding of treatment important differences; and co-develop creative prototypes that could be used to communicate the statistical concept to a wider audience in the future. Three 2 to 4 h creative workshops based in the UK were delivered. The first two workshops included 22 participants. They were online and worked as pilots to refine the final in-person workshop via participant feedback and discussion. The final workshop focused on treatment important differences, and we collected information from participants on expectations, subjective numeracy, and experience., Results: The final workshop included 13 participants (5 creative professionals, 4 public partners, and 4 clinical trial statisticians). Participants reported creative workshops helped improve communication of treatment important differences between stakeholders reaching a common understanding of their meaning; and helped democratise knowledge exchange. Each group developed a creative prototype to communicate about treatment important differences with a wider audience, including a song, game, and a cartoon. Participants recommended the format to improve communication of other statistical or complex concepts between stakeholders., Conclusions: Creative workshops can promote shared understanding of complex, statistical concepts and co-development of creative outputs amongst stakeholders. Future work should explore generalisability of the intervention, and what outcomes might be important to consider when implementing creative workshops in patient and public involvement practice., (© 2024. The Author(s).)

Background: Citizen science is a way to democratise science by involving groups of citizens in the research process. Clinical guidelines are used to improve practice, but their implementation can be limited. Involving patients and the public can enhance guideline implementation, but there is uncertainty about the best approaches to achieve this. Citizen science is a potential way to involve patients and the public in improving clinical guideline implementation. We aimed to explore the application of citizen science methods to involve patients and the public in the dissemination and implementation of clinical guidelines in oral health and dentistry., Methods: We developed GUIDE (GUideline Implementation in oral health and DEntistry), a citizen science online platform, using a participatory approach with researchers, oral health professionals, guideline developers and citizens. Recruitment was conducted exclusively online. The platform focused on prespecified challenges related to oral health assessment guidelines, and asked citizens to generate ideas, as well as vote and comment on other citizens' ideas to improve those challenges. Citizens also shared their views via surveys and two online synchronous group meetings. Data were collected on participant's demographics, platform engagement and experience of taking part. The most promising idea category was identified by an advisory group based on engagement, feasibility and relevance. We presented quantitative data using descriptive statistics and analysed qualitative data using inductive and deductive thematic analysis., Results: The platform was open for 6 months and we recruited 189 citizens, from which over 90 citizens actively engaged with the platform. Most citizens were over 34 years (64%), female (58%) and had a university degree (50%). They generated 128 ideas, 146 comments and 248 votes. The challenge that led to most engagement was related to prevention and oral health self-care. To take this challenge forward, citizens generated a further 36 ideas to improve a pre-existing National Health Service oral care prevention leaflet. Citizens discussed motivations to take part in the platform (understanding, values, self-care), reasons to stay engaged (communication and feedback, outputs and impact, and relevance of topics discussed) and suggestions to improve future platforms., Conclusion: Citizen science is an effective approach to generate and prioritise ideas from a group of citizens to improve oral health and dental services. Prevention and oral health self-care were of particular interest to citizens. More research is needed to ensure recruitment of a diverse group of citizens and to improve retention in citizen science projects., Patient or Public Contribution: This project was inherently conducted with the input of public partners (citizen scientists) in all key aspects of its conduct and interpretation. In addition, two public partners were part of the research team and contributed to the design of the project, as well as key decisions related to its conduct, analysis, interpretation and dissemination and are co-authors of this manuscript., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal., Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials., Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist., Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported., Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Importance: Trial protocols outline a trial's objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available., Objective: To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials., Evidence Review: The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist., Findings: This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed., Conclusions and Relevance: In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial's utility and transparency.

Background: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications., Methods: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial., Results: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript., Interpretation: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits., Competing Interests: Competing interests: Charles Weijer reports receiving consulting fees from Cardialen and Eli Lilly & Company. Shelley Vanderhout reports receiving a Postdoctoral Fellowship Award and a System Impact Fellowship Award from the Canadian Institutes of Health Research (in support of the current manuscript). Anne Spinewine reports receiving a Mobility Grant from Fondation Mont-Godinne. No other competing interests were declared., (© 2023 CMA Impact Inc. or its licensors.)

Information graphics or infographics combine visual representations of information or data with text. They have been used in health research to disseminate research findings, translate knowledge and address challenges in health communication to lay audiences. There is emerging evidence of the design of infographics with the involvement of patients and the public in health research. Approaches to involvement include public and patient involvement, patient engagement and participatory research approaches. To date, there has been no comprehensive review of the literature on the design of infographics with patients and the public in health research. This paper presents a protocol and methodological framework for a scoping review to identify and map the available evidence for the involvement of patients and the public in infographics design in health research. It has been informed by preliminary searches and discussions and will guide the conduct and reporting of this review., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Beecher et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Nonmuscle invasive bladder cancer (NMIBC) accounts for 75% of bladder cancers. It is common and costly. Cost and detriment to patient outcomes and quality of life are driven by high recurrence rates and the need for regular invasive surveillance and repeat treatments. There is evidence that the quality of the initial surgical procedure (transurethral resection of bladder tumor [TURBT]) and administration of postoperative bladder chemotherapy significantly reduce cancer recurrence rates and improve outcomes (cancer progression and mortality). There is surgeon-reported evidence that TURBT practice varies significantly across surgeons and sites. There is limited evidence from clinical trials of intravesical chemotherapy that NMIBC recurrence rate varies significantly between sites and that this cannot be accounted for by differences in patient, tumor, or adjuvant treatment factors, suggesting that how the surgery is performed may be a reason for the variation., Objective: This study primarily aims to determine if feedback on and education about surgical quality indicators can improve performance and secondarily if this can reduce cancer recurrence rates. Planned secondary analyses aim to determine what surgeon, operative, perioperative, institutional, and patient factors are associated with better achievement of TURBT quality indicators and NMIBC recurrence rates., Methods: This is an observational, international, multicenter study with an embedded cluster randomized trial of audit, feedback, and education. Sites will be included if they perform TURBT for NMIBC. The study has four phases: (1) site registration and usual practice survey; (2) retrospective audit; (3) randomization to audit, feedback, and education intervention or to no intervention; and (4) prospective audit. Local and national ethical and institutional approvals or exemptions will be obtained at each participating site., Results: The study has 4 coprimary outcomes, which are 4 evidence-based TURBT quality indicators: a surgical performance factor (detrusor muscle resection); an adjuvant treatment factor (intravesical chemotherapy administration); and 2 documentation factors (resection completeness and tumor features). A key secondary outcome is the early cancer recurrence rate. The intervention is a web-based surgical performance feedback dashboard with educational and practical resources for TURBT quality improvement. It will include anonymous site and surgeon-level peer comparison, a performance summary, and targets. The coprimary outcomes will be analyzed at the site level while recurrence rate will be analyzed at the patient level. The study was funded in October 2020 and began data collection in April 2021. As of January 2023, there were 220 hospitals participating and over 15,000 patient records. Projected data collection end date is June 30, 2023., Conclusions: This study aims to use a distributed collaborative model to deliver a site-level web-based performance feedback intervention to improve the quality of endoscopic bladder cancer surgery. The study is funded and projects to complete data collection in June 2023., Trial Registration: ClinicalTrials.org NCT05154084; https://clinicaltrials.gov/ct2/show/NCT05154084., International Registered Report Identifier (irrid): DERR1-10.2196/42254., (©Kevin Gallagher, Nikita Bhatt, Keiran Clement, Eleanor Zimmermann, Sinan Khadhouri, Steven MacLennan, Meghana Kulkarni, Fortis Gaba, Thineskrishna Anbarasan, Aqua Asif, Alexander Light, Alexander Ng, Vinson Chan, Arjun Nathan, David Cooper, Lorna Aucott, Gautier Marcq, Jeremy Yuen-Chun Teoh, Patrick Hensley, Eilidh Duncan, Beatriz Goulao, Tim O'Brien, Matthew Nielsen, Paramananthan Mariappan, Veeru Kasivisvanathan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.06.2023.)

Background: Poor retention in randomised trials can lead to serious consequences to their validity. Studies within trials (SWATs) are used to identify the most effective interventions to increase retention. Many interventions could be applied at any follow-up time point, but SWATs commonly assess interventions at a single time point, which can reduce efficiency., Methods: The re-randomisation design allows participants to be re-enrolled and re-randomised whenever a new retention opportunity occurs (i.e. a new follow-up time point where the intervention could be applied). The main advantages are as follows: (a) it allows the estimation of an average effect across time points, thus increasing generalisability; (b) it can be more efficient than a parallel arm trial due to increased sample size; and (c) it allows subgroup analyses to estimate effectiveness at different time points. We present a case study where the re-randomisation design is used in a SWAT., Results: In our case study, the host trial is a dental trial with two available follow-up points. The Sticker SWAT tests whether adding the trial logo's sticker to the questionnaire's envelope will result in a higher response rate compared with not adding the sticker. The primary outcome is the response rate to postal questionnaires. The re-randomisation design could double the available sample size compared to a parallel arm trial, resulting in the ability to detect an effect size around 28% smaller., Conclusion: The re-randomisation design can increase the efficiency and generalisability of SWATs for trials with multiple follow-up time points., (© 2023. The Author(s).)

Background: Non-inferiority and equivalence trials aim to determine whether a new treatment is good enough (non-inferior) or as good as (equivalent to) another treatment. To inform the decision about non-inferiority or equivalence, a margin is used. We aimed to identify the current methods used to determine non-inferiority or equivalence margins, as well as the main challenges and suggestions from trialists., Methods: We developed an online questionnaire that included both closed and open-ended questions about methods to elicit non-inferiority or equivalence margins, underlying principles, and challenges and suggestions for improvement. We recruited trialists with experience of determining a margin by contacting corresponding authors for non-inferiority or equivalence trials. We used descriptive statistics and content analysis to identify categories in qualitative data., Results: We had forty-one responses, all from non-inferiority trials. More than half of the trials were non-pharmacological (n = 21, 51%), and the most common primary outcome was clinical (n = 29, 71%). The two most used methods to determine the margin were as follows: a review of the evidence base (n = 27, 66%) and opinion seeking methods (n = 24, 59%). From those using reviews, the majority used systematic reviews or reviews of multiple RCTs to determine the margin (n = 17, 63%). From those using opinion seeking methods, the majority involved clinicians with or without other professionals (n = 19, 79%). Respondents reported that patients' opinions on the margin were sought in four trials (16%). Median confidence in overall quality of the margin was 5 out of 7 (maximum confidence); however, around a quarter of the respondents were "completely unconfident" that the margin reflected patient's views. We identified "stakeholder involvement" as the most common category to determine respondent's confidence in the quality of the margins and whether it reflected stakeholder's views. The most common suggestion to improve the definition of margins was "development of methods to involve stakeholders," and the most common challenge identified was "communication of margins.", Conclusions: Responders highlighted the need for clearer guidelines on defining a margin, more and better stakeholder involvement in its selection, and better communication tools that enable discussions about non-inferiority trials with stakeholders. Future research should focus on developing best practice recommendations., (© 2022. The Author(s).)

Background/aims: To evaluate the cost-effectiveness of non-invasive monitoring tests to detect the onset of neovascular age-related macular degeneration (nAMD) in the unaffected second eye of patients receiving treatment for unilateral nAMD in a UK National Health Service (NHS) hospital outpatient setting., Methods: A patient-level state transition model was constructed to simulate the onset, detection, and treatment of nAMD in the second eye. Five index tests were compared: self-reported change in visual function, Amsler test, clinic measured change in visual acuity from baseline, fundus assessment by clinical examination or colour photography, and spectral domain optical coherence tomography (SD-OCT). Diagnosis of nAMD was confirmed by fundus fluorescein angiography (FFA) before prompt initiation of antivascular endothelial growth factor treatment. Quality-adjusted life-years (QALYs) and costs of health and social care were modelled over a 25-year time horizon., Results: SD-OCT generated more QALYs (SD-OCT, 5.830; fundus assessment, 5.787; Amsler grid, 5.736, patient's subjective assessment, 5.630; and visual acuity, 5.600) and lower health and social care costs (SD-OCT, £19 406; fundus assessment, £19 649; Amsler grid, £19 751; patient's subjective assessment, £20 198 and visual acuity, £20 444) per patient compared with other individual monitoring tests. Probabilistic sensitivity analysis indicated a high probability (97%-99%) of SD-OCT being the preferred test across a range of cost-effectiveness thresholds (£13 000-£30 000) applied in the UK NHS., Conclusions: Early treatment of the second eye following FFA confirmation of SD-OCT positive findings is expected to maintain better visual acuity and health-related quality of life and may reduce costs of health and social care over the lifetime of patients., Competing Interests: Competing interests: Grant funding for the study from the NIHR HTA programme (grant number: 12/142/07). SS reports grants and personal fees from Novartis, grants from Allergan, grants and personal fees from Roche, grants and personal fees from Boehringer Ingleheim, personal fees from Apellis, personal fees from Oxurion, personal fees from Heidelberg Engineering, personal fees from Optos, grants and personal fees from Bayer, outside the submitted work. RG reports grants and personal fees from Novartis, grants and personal fees from Bayer, personal fees from Roche, and personal fees from Almeria / allergan, outside the submitted work. CRR is a member of NIHR HTA General Board. UC reports personal fees from Roche, outside the submitted work. GSS reports non-financial support from Merck KGaA, outside the submitted work., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patient factors associated with urinary tract cancer can be used to risk stratify patients referred with haematuria, prioritising those with a higher risk of cancer for prompt investigation., Objective: To develop a prediction model for urinary tract cancer in patients referred with haematuria., Design, Setting, and Participants: A prospective observational study was conducted in 10 282 patients from 110 hospitals across 26 countries, aged ≥16 yr and referred to secondary care with haematuria. Patients with a known or previous urological malignancy were excluded., Outcome Measurements and Statistical Analysis: The primary outcomes were the presence or absence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC], and renal cancer). Mixed-effect multivariable logistic regression was performed with site and country as random effects and clinically important patient-level candidate predictors, chosen a priori, as fixed effects. Predictors were selected primarily using clinical reasoning, in addition to backward stepwise selection. Calibration and discrimination were calculated, and bootstrap validation was performed to calculate optimism., Results and Limitations: The unadjusted prevalence was 17.2% (n = 1763) for bladder cancer, 1.20% (n = 123) for UTUC, and 1.00% (n = 103) for renal cancer. The final model included predictors of increased risk (visible haematuria, age, smoking history, male sex, and family history) and reduced risk (previous haematuria investigations, urinary tract infection, dysuria/suprapubic pain, anticoagulation, catheter use, and previous pelvic radiotherapy). The area under the receiver operating characteristic curve of the final model was 0.86 (95% confidence interval 0.85-0.87). The model is limited to patients without previous urological malignancy., Conclusions: This cancer prediction model is the first to consider established and novel urinary tract cancer diagnostic markers. It can be used in secondary care for risk stratifying patients and aid the clinician's decision-making process in prioritising patients for investigation., Patient Summary: We have developed a tool that uses a person's characteristics to determine the risk of cancer if that person develops blood in the urine (haematuria). This can be used to help prioritise patients for further investigation., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity., Methods: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m 2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies., Discussion: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services., Trial Registration: ISRCTN 91974895 . Registered on 14/04/2021., (© 2022. The Author(s).)

Background: Progression of dental caries can result in irreversible pulpal damage. Partial irreversible pulpitis is the initial stage of this damage, confined to the coronal pulp whilst the radicular pulp shows little or no sign of infection. Preserving the pulp with sustained vitality and developing minimally invasive biologically based therapies are key themes within contemporary clinical practice. However, root canal treatment involving complete removal of the pulp is often the only option (other than extraction) given to patients with irreversible pulpitis, with substantial NHS and patient incurred costs. The European Society of Endodontology's (ESE 2019) recent consensus statement recommends full pulpotomy, where the inflamed coronal pulp is removed with the goal of keeping the radicular pulp vital, as a more minimally invasive technique, potentially avoiding complex root canal treatment. Although this technique may be provided in secondary care, it has not been routinely implemented or evaluated in UK General Dental Practice., Method: This feasibility study aims to identify and assess in a primary care setting the training needs of general dental practitioners and clinical fidelity of the full pulpotomy intervention, estimate likely eligible patient pool and develop recruitment materials ahead of the main randomised controlled trial comparing the clinical and cost-effectiveness of full pulpotomy compared to root canal treatment in pre/molar teeth of adults 16 years and older showing signs indicative of irreversible pulpitis. The feasibility study will recruit and train 10 primary care dentists in the full pulpotomy technique. Dentists will recruit and provide full pulpotomy to 40 participants (four per practice) with indications of partial irreversible pulpitis., Discussion: The Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP) study will address the lack of high-quality evidence in the treatment of irreversible pulpitis, to aid dental practitioners, patients and policymakers in their decision-making. The PIP feasibility study will inform the main study on the practicality of providing both training and provision of the full pulpotomy technique in general dental practice., Trial Registration: ISRCTN Registry, ISRCTN17973604 . Registered on 28 January 2021. Protocol version Protocol version: 1; date: 03.02.2021., (© 2022. The Author(s).)

Purpose: To evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD)., Design: Prospective diagnostic accuracy cohort study conducted in 24 eye clinics in the United Kingdom over 3 years., Participants: Older adults (>50 years) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD., Methods: Self-reported vision, Amsler, clinic-measured visual acuity (VA), fundus assessment, and spectral domain OCT. The reference standard is FFA., Main Outcome Measures: Sensitivity and specificity of the 5 index tests., Results: Of 552 participants monitored for up to 3 years, 145 (26.3%) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Index test positives at nAMD detection in those confirmed by FFA were self-reported vision much worse (5), distortion on Amsler (33), 10-letter decrease in acuity from baseline (36), fundus examination (64), and OCT (110). Percentage index test sensitivities were: self-reported vision 4.2 (95% confidence interval [CI], 1.6-9.8); Amsler 33.7 (95% CI, 25.1-43.5); VA 30.0 (95% CI, 22.5-38.7); fundus examination 53.8 (95% CI, 44.8-62.5); and OCT 91.7 (95% CI, 85.2-95.6). All 5 index test specificities were high at 97.0 (95% CI, 94.6-98.5), 81.4 (95% CI, 76.4-85.5), 66.3 (95% CI, 61.0-71.1), 97.6 (95% CI, 95.3-98.9), and 87.8 (95% CI, 83.8-90.9), respectively. The combination of OCT with one other index test that was a secondary outcome measure increased sensitivity marginally and decreased specificity for all combinations except fundus examination., Conclusions: Tests of self-reported change in vision, unmasking of new distortion, measurements of acuity, and fundus checks to diagnose active nAMD performed poorly in contrast to OCT. Our findings support a change to guidelines in clinical practice to monitor for onset of nAMD., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)

Background: The COVID-19 pandemic forced a UK-wide closure of dental services. An understanding of public concerns about dental care was urgently needed to inform careful resumption of paused dental services., Aim: To describe public concerns about dental care during lockdown., Basic Research Design: Framework analysis of relevant Twitter posts identified collected using the Awario tool., Results: Of 1863 tweets manually screened for eligibility, 285 were relevant, as they contained views expressed by the public. The number of tweets by country were proportionate to the population size. The key views expressed in tweets focused on: 'oral health impact' ('oral health and self-care', 'types of dental problems', 'managing symptoms at home', 'views on consequences of delaying treatment') and 'dental service or care provision' ('views on managing dental care response', 'experiences with access to dental care')., Conclusions: The impact of COVID-19 on dental services raised many physical and mental health concerns for the public, highlighting their importance. Online profiles and social media communication platforms can be used to provide convenient, and timely information on public perceptions of dental care., (Copyright© 2021 Dennis Barber Ltd.)

Introduction The COVID-19 pandemic brought about seismic change for dentistry including the direction to provide remote advice and prescribe analgesia and antimicrobials. The possibilities for care have widened, but the impact of both restrictions and remobilisation on antibiotic prescribing is not known.Aims To report the impact of COVID-19 restrictions and remobilisation on dental antibiotic prescriptions and explore dentists' intentions and attitudes towards antibiotic prescribing.Design and setting Public Health Scotland national prescribing and claims data are reported alongside an online survey of Scottish general and public health service dentists including closed and open-ended questions.Results Antibiotic prescribing rose by 49% following the suspension of routine dental care, to a peak of 34,993 antibiotics (July 2020). The data also show that since the remobilisation of NHS dental care, antibiotic prescribing remains raised at levels around 28% higher than pre-pandemic. The survey highlights dentists' frustrations and concerns about this increased use of antibiotics. Most dentists intend to reduce their prescribing; however, significant challenges to this being realised were raised.Conclusions The previous success within dentistry to protect against the development of antimicrobial resistance has suffered a knock-back during the pandemic. A renewed focus on reducing unnecessary antibiotics within dentistry is required but, crucially, needs to be approached sensitively alongside the current backdrop of challenges within the service., (© 2021. The Author(s).)

Background and Aims: Patient and public involvement is increasingly common in trials, but its quality remains variable in a lot of settings. Many key decisions in trials involve numbers, but patients are rarely involved in those discussions. We aimed to understand patient and public partners' experiences and opinions regarding their involvement in numerical aspects of research and discuss and identify priorities, according to multiple stakeholders, around the most important numerical aspects in trials to involve patients and the public in., Methods: The study had two stages: (1) online focus groups with patient and public partners recruited via online platforms and analysed using inductive thematic analysis and (2) online priority setting meeting with UK- and Ireland-based stakeholders and following James Lind Alliance methodology. Pre-selected numerical aspects were introduced prior to the meeting and discussed and prioritised based on a voting system., Results: In stage 1, we held two focus groups with patient and public partners (n = 9). We identified four themes in the analysis: "Determinants of PPI in numerical aspects", "Identity and roles", "Impact of involving patients and the public in numerical aspects". Patient and public partners believed being involved in numerical aspects of research is important and should be facilitated, but communication about these aspects needs to be clearer. An environment and relationship with researchers that facilitates that will include time for discussion, support to improve knowledge and confidence, clear language and definitions and trust. Patient and public partners perceive their role as bringing an outsider perspective and were mainly interested in involvement in assumptions and dissemination of quantitative research. They believed this can lead to more transparency and improve their experience by making involvement more meaningful. In stage 2, we identified twelve numerical aspects of trials to be prioritised. We held a priority setting meeting with 14 stakeholders, which led to the selection of three priority numerical aspects in patient and public involvement: target differences, interpretation of results and cost-effectiveness. Participants felt all aspects should be considered for involvement and their communication needs to ensure a shared level of understanding to avoid power imbalances., Conclusions: Our work shows the importance of involving patient and public partners in numerical aspects of trials by assessing their experiences and motivations for the first time and discussing and prioritising which numerical aspects of trials are the most important for patients and the public to contribute to. Our research provides a platform for future efforts to improve patient and public involvement in trials and a prioritised set of future research foci., (© 2021. The Author(s).)

Background: Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth., Method: This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes., Discussion: SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN., Trial Registration Number: ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search ., (© 2021. The Author(s).)

Background: Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus., Objective: To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men., Methods: Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two hundred and twenty-two men requiring operative treatment for recurrence of bulbar urethral stricture and having had at least one previous intervention for stricture were recruited. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24 months using a within trial analysis and a Markov model with a 10-year time horizon., Results: In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: - 0.01 [95% CI - 0.17, 0.14)] over 24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data., Conclusions: Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty., Keypoints: Urethrotomy and urethroplasty both led to symptom improvement for men with bulbar urethral stricture-a common cause for urinary symptoms in men; Urethroplasty appeared unlikely to offer good value for money compared to urethrotomy based on current evidence., Trial Registration: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507). Trial protocol: The latest version (1.8) of the full protocol is available at: www.journalslibrary.nihr.ac.uk/programmes/hta/105723/ #/ and a published version is also available: Stephenson R, Carnell S, Johnson N, Brown R, Wilkinson J, Mundy A, et al. Open urethroplasty versus endoscopic urethrotomy-clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial. Trials 2015;16:600. https://doi.org/10.1186/s13063-015-1120-4. Trial main clinical results publication: Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial), European Urology, Volume 78, Issue 4, 2020, Pages 572-580.

Introduction: Unless women start effective contraception after using emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies that are unable to provide ongoing contraception (apart from barrier methods which have high failure rates). This means that women need an appointment with a general practitioner or at a sexual and reproductive health clinic. We conducted a pragmatic cluster randomised cohort crossover trial to determine whether or not pharmacist provision of a bridging supply of a progestogen-only pill plus the invitation to attend a sexual and reproductive health clinic resulted in increased subsequent use of effective contraception (hormonal or intrauterine)., Methods: Twenty-nine pharmacies in three UK cities recruited women receiving emergency contraception (levonorgestrel). In the intervention, women received a 3-month supply of the progestogen-only pill (75 µg of desogestrel) plus a card that provided rapid access to a local sexual and reproductive health clinic. In the control arm, pharmacists advised women to attend their usual contraceptive provider. The primary outcome was reported use of an effective contraception (hormonal and intrauterine methods) at 4 months. Process evaluation was also conducted to inform any future implementation., Results: The study took place December 2017 and June 2019 and recruited 636 women to the intervention ( n  = 316) and control groups ( n  = 320). There were no statistically significant differences in demographic characteristics between the groups. Four-month follow-up data were available for 406 participants: 63% (198/315) of the control group and 65% (208/318) of the intervention group. The proportion of participants reporting use of effective contraception was 20.1% greater (95% confidence interval 5.2% to 35.0%) in the intervention group (58.4%, 95% confidence interval 48.6% to 68.2%) than in the control group (40.5%, 95% confidence interval 29.7% to 51.3%) (adjusted for recruitment period, treatment arm and centre; p  = 0.011). The proportion of women using effective contraception remained statistically significantly larger, when adjusted for age, current sexual relationship and history of past use of effective contraception, and was robust to the missing data. There were no serious adverse events., Conclusion: Provision of a bridging supply of the progestogen-only pill with emergency contraception from a pharmacist and the invitation to a sexual and reproductive health clinic resulted in a significant increase in self-reported subsequent use of effective contraception. This simple intervention has the potential to prevent more unintended pregnancies for women after emergency contraception., Trial Registration: Current Controlled Trials ISRCTN70616901., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 27. See the NIHR Journals Library website for further project information.

Background: Antimicrobial resistance is an increasingly serious threat to global public health and patient safety. Overuse of antibiotics has aggravated this issue. Around 7% of all antibiotics in Scotland are prescribed by dentists. Audit and feedback has been shown to decrease these prescriptions, but there is evidence that dentists still prescribe unnecessarily. Our aim is to compare the effectiveness of a theory-informed in-practice training session (TiPTAP) in addition to individualised audit and feedback, with audit and feedback alone for reducing antibiotic prescribing by NHS dentists working in NHS primary care dental practices., Methods: We will conduct a 2-arm parallel cluster randomised trial: out of 228 practices, 114 will be randomised to the theory-informed in-practice training session targeting antibiotic prescribing and individualised audit and feedback; 114 practices will be randomised to audit and feedback alone. The theory-informed session will include (a) an introductory session including several behaviour change techniques; (b) problem solving discussion, setting and recording action plans; (c) practice-level prescribing feedback discussion. The primary outcome is the number of antibiotic items per 100 NHS treatment claims over a 1-year period post-randomisation for each dentist. Secondary outcomes are the number of amoxicillin 3 g and broad spectrum antibiotics prescribed per 100 NHS treatment claims over a 1-year period; amoxicillin 3 g and broad spectrum antibiotics defined daily doses of antibiotics per 100 claims. Process measures include fidelity, knowledge, and confidence. Primary and secondary outcomes will be obtained using routine data., Discussion: This study provides the opportunity to robustly assess the effect of adding an in-practice training co-intervention to audit and feedback. Its behaviour change theory-informed content will allow replication of the different components and can inform future training interventions., Trial Registration: ISRCTN, ISRCTN12345678 . Registered 18 June 2020.

Objective: We aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it., Design: We developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains., Setting: Online survey targeting UK-based trial units., Participants: Stakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study., Outcome Measures: Trialists' behaviour of involving patients and the public in numerical aspects of trials and its determinants., Results: We included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists' perception of public and patient partners' skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it., Conclusions: More training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners' motivation to be involved. Future research should focus on identifying public and patient partners' motivations and develop strategies to improve the communication of numerical aspects., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective To compare the clinical effectiveness and cost benefit of different frequencies of scale and polish (S&P) treatments in combination with different types of oral hygiene advice (OHA).Design Multi-centre, multi-level cluster randomised factorial open trial with blinded outcome evaluation. UK dental practices were cluster randomised to deliver OHA as usual or personalised. In a separate randomisation, patients were allocated to receive S&P 6-monthly, 12-monthly or never.Setting UK primary dental care.Participants Practices providing NHS care and adults who had received regular dental check-ups.Main outcome measures The percent of sites with bleeding on probing, patient confidence in self-care, incremental net benefits (INB) over three years.Results Sixty-three practices and 1,877 adult patients were randomised and 1,327 analysed (clinical outcome). There was no statistically significant or clinically important difference in gingival bleeding between the three S&P groups (for example, six-monthly versus none: difference 0.87% sites, 95% CI: 1.6 to 3.3, p = 0.48) or between personalised or usual OHA groups (difference -2.5% sites, -95%CI: -8.3 to 3.3, p = 0.39), or oral hygiene self-efficacy (cognitive impact) between either group (for example, six-monthly versus none: difference -0.028, 95% CI -0.119 to 0.063, p = 0.543). The general population place a high value on, and are willing to pay for, S&P services. However, from a dental health perspective, none of the interventions were cost-effective.Conclusion Results suggest S&P treatments and delivering brief personalised OHA provide no clinical benefit and are therefore an inefficient approach to improving dental health (38% of sites were bleeding whatever intervention was received). However, the general population value both interventions.

Objective To compare the clinical effectiveness of different frequencies of dental recall over a four-year period.Design A multi-centre, parallel-group, randomised controlled trial with blinded clinical outcome assessment. Participants were randomised to receive a dental check-up at six-monthly, 24-monthly or risk-based recall intervals. A two-strata trial design was used, with participants randomised within the 24-month stratum if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or six-month recall interval.Setting UK primary dental care.Participants Practices providing NHS care and adults who had received regular dental check-ups.Main outcome measures The percentage of sites with gingival bleeding on probing, oral health-related quality of life (OHRQoL), cost-effectiveness.Results In total, 2,372 participants were recruited from 51 dental practices. Of those, 648 were eligible for the 24-month recall stratum and 1,724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding on probing between intervention arms in any comparison. For those eligible for 24-month recall stratum: the 24-month versus six-month group had an adjusted mean difference of -0.91%, 95% CI (-5.02%, 3.20%); the 24-month group versus risk-based group had an adjusted mean difference of 0.07%, 95% CI (-3.99%, 4.12%). For the overall sample, the risk-based versus six-month adjusted mean difference was 0.78%, 95% CI (-1.17%, 2.72%). There was no evidence of a difference in OHRQoL (0-56 scale, higher score for poorer OHRQoL) between intervention arms in any comparison. For the overall sample, the risk-based versus six-month effect size was -0.35, 95% CI (-1.02, 0.32). There was no evidence of a clinically meaningful difference between the groups in any comparison in either eligibility stratum for any of the secondary clinical or patient-reported outcomes.Conclusion Over a four-year period, we found no evidence of a difference in oral health for participants allocated to a six-month or a risk-based recall interval, nor between a 24-month, six-month or risk-based recall interval for participants eligible for a 24-month recall. However, patients greatly value and are willing to pay for frequent dental check-ups.

Background: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception., Methods: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete)., Findings: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred., Interpretation: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception., Funding: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01)., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health., Objectives: To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period., Design: Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval., Setting: UK primary care dental practices., Participants: Adult, dentate, NHS patients who had visited their dentist in the previous 2 years., Interventions: Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall., Main Outcomes: Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit., Results: A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month ( n  = 138) versus 6-month group ( n  = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based ( n  = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based ( n  = 749) versus 6-month ( n  = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup., Limitations: Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected., Conclusions: Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider., Future Work: Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients., Trial Registration: Current Controlled Trials ISRCTN95933794., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in Health Technology Assessment ; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.

Background: Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking., Objectives: To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men., Design: Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed., Setting: UK NHS with recruitment from 38 hospital sites., Participants: A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture., Interventions: A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group)., Main Outcome Measures: The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence., Results: The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was -0.36 [95% confidence interval (CI) -1.78 to 1.02; p  = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p  = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference -0.01, 95% CI -0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective., Limitations: We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis., Conclusions: The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective., Future Work: Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics., Trial Registration: Current Controlled Trials ISRCTN98009168., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

Background: Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty., Objective: To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture., Design, Setting, and Participants: This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy., Intervention: Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area., Outcome Measurements and Statistical Analysis: The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention., Results and Limitations: The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89])., Conclusions: In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty., Patient Summary: There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions., (Copyright © 2020. Published by Elsevier B.V.)

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose., Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection., Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP., Data Collection and Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome., Main Results: We found no completed studies to include in this review.   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose., Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them., Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients., Data Collection and Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome., Main Results: We found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide - containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo.  AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well., Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection., Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19., Data Collection and Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome., Main Results: We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature).   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Objectives: Our aim was to design and evaluate a novel behavior change approach to increase response rates to an annual postal questionnaire in three randomized studies within a trial (SWAT) and replicate the most promising SWAT., Study Design and Setting: SWAT1 tested a trial logo sticker on questionnaire envelopes vs. no sticker; SWAT2 tested a theoretically informed letter sent with the questionnaire vs. a standard letter; SWAT3 tested a theoretically informed newsletter sent before the questionnaire vs. no newsletter. The SWATs were conducted within a large dental trial (N = 1,877 adults), and SWAT2 replicated in a different trial in a similar setting (N = 2,372)., Results: SWAT1 improved response rates by 1.4%, 95% confidence interval (CI) (-7.2%, 10.0%). SWAT2 improved response rates by 7.0%, 95% CI (1.7%, 12.3%). SWAT3 improved response rates by 0.8%, 95% CI (-5.1%, 6.7%). Replication of SWAT2 as the most promising SWAT showed improvement in response rates of 1.0%, 95% CI (-3.2%, 5.3%). Pooled results from SWAT2 showed an overall improvement in response rates of 3.4%, 95% CI (0.1%, 6.7%)., Conclusion: A theory-based behavioral approach to design interventions to improve trial response rates showed small but meaningful improvements. The approach presented here can be easily implemented and adapted to address other identified barriers to trial retention., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods., Objective: To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness., Design: Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1 : 1 ratio), minimised on the need for concomitant anterior and/or posterior procedure, concomitant incontinence procedure, age and surgeon., Setting: UK hospitals., Participants: Uterine trial - 563 out of 565 randomised women had uterine prolapse surgery. Vault trial - 208 out of 209 randomised women had vault prolapse surgery., Interventions: Uterine trial - uterine preservation or vaginal hysterectomy. Vault trial - abdominal or vaginal vault suspension., Main Outcome Measures: The primary outcome measures were women's prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year)., Results: Uterine trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference -0.05, 95% confidence interval -0.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was £235 (95% confidence interval £6 to £464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference -0.004, 95% confidence interval -0.026 to 0.019). Vault trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference -0.61, 95% confidence interval -2.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was £570 (95% confidence interval £459 to £682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval -0.031 to 0.041)., Conclusions: Uterine trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach., Future Work: Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness., Trial Registration: Current Controlled Trials ISRCTN86784244., Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 13. See the National Institute for Health Research Journals Library website for further project information., Competing Interests: Robert Freeman reports speaker fees [from Bard Medical (Covington, GA, USA), Astellas Pharma Inc. (Tokyo, Japan) and Pfizer Inc. (New York City, NY, USA)] and grants from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. John Norrie reports membership of the following NIHR boards: the Cardiopulmonary Resuscitation Decision-making Committee, HTA Commissioning Board, HTA Commissioning Sub-Board (Expression of Interest), HTA Funding Boards Policy Group, HTA General Board and HTA Post-board Funding Teleconference; the NIHR Clinical Trials Unit Standing Advisory Committee; the NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board; and the Pre-exposure Prophylaxis Impact Review Panel.

Introduction: Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time., Methods and Analysis: Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio., Ethics and Dissemination: Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations., Trial Registration Number: ISRCTN70616901., Competing Interests: Competing interests: AG is a member of HRA Pharma scientific advisory board. PB is a Clinical Director of the not-for profit community interest company SH:24 that provides online sexual health services in partnership with the NHS. AR received research grants, educational grants and consultancy with Gilead Research grants from Roche and BMS Educational grants from Abbvie. JN is Deputy Chair of the NIHR/HTA General Board Committee. NIHR/HTA funded this research., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events., Methods/design: VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation., Discussion: Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally., Trial Registration: Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

Background: Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60% of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment., Methods/design: OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90% with a type I error rate of 5% to detect a 0.1 difference in AUC measured on a 0-1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial., Discussion: The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target., Trial Registration: ISRCTN98009168 Date of registration: 29 November 2012.