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Objectives Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.Design In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.Setting UK stroke services.Participants 3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.Results Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.Conclusion It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.Trial registration number ISRCTN83290762; Post-results.

Abstract Background Psychological safety—speaking up about ideas and concerns, free from interpersonal risk—are essential to the high-risk environment, such as healthcare settings. Psychologically safe working is particularly important in mental health where recovery-oriented approaches rely on collaborative efforts of interprofessional teams to make complex decisions. Much research focuses on antecedents and outcomes associated with psychological safety, but little focus on the practical steps for how to increase psychological safety across and at different levels of a healthcare organisation. Aims We explore how a mental health organisation creates an organisation-wide plan for building the foundations of mental health and how to enhance psychological safety. Methods This review encompasses strategies across psychological safety and organisational culture change to increase psychological safety at an individual, team and organisational level. Summary We set out a comprehensive overview of the types of strategies and interventions for increasing the ethos of psychological safety and setting the foundations for delivering an organisation-wide programme on this topic. We also provide a list of key targeted areas in mental health that would maximally benefit from increasing psychological safety—both in clinical and non-clinical settings. Conclusions Psychological safety is a crucial determinant of safe and effective patient care in mental health services. This paper provides the key steps and considerations, creating a large-scale programme in psychological safety with a focus on mental health and drawing from the current literature, providing concrete steps for how our current understanding of psychological safety into practice.

Objectives: Chronic pelvic pain syndrome (CPPS) in men is a condition associated with significant morbidity which is typically managed in sexual health services. We introduced a modified biopsychosocial approach for managing CPPS in men, reducing use of antibiotics and evaluated its application in a retrospective case review., Methods: Patients attended for a full consultation covering symptomology, onset and social history. Examination included urethral smear and assessment of pelvic floor tension and pain. A focus on pelvic floor relaxation was the mainstay of management with pelvic floor physiotherapy if required. Prescribing of antibiotics being discontinued if no evidence of urethritis at first consultation. The main outcome was change in the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score (which patients completed at each attendance); significant clinical improvement was defined as a NIH-CPSI score reduction of >25% and/or ≥6 points., Results: Among 77 consecutive patients diagnosed with CPPS between April 2017 and December 2018, the mean NIH-CPSI score at the initial visit was 24.1 (11-42). Antibiotics were prescribed to 38/77 (49.4%) and alpha-blockers to 58/77 (75.3%). Overall, 50 (64.9%) patients with a mean initial NIH-CPSI score of 25.4 (11-42) re-attended a CPPS clinic. Among these, the average NIH-CPSI score at the final CPPS clinic appointment declined to 15.9 (0-39) (p<0.001); 34/50 (68%) men experienced significant clinical improvement. Men who attended only one CPPS clinic compared with those who reattended had a shorter duration of symptoms (18 (1-60) vs 36 (1-240) months; p=0.038), a lower initial NIH-CPSI score (21.7 (11-34) vs 25.4 (11-44); p=0.021), but had attended a similar number of clinics prior to referral (2.9 (0-6) vs 3.2 (0-8); p=0.62)., Conclusions: The biopsychosocial approach significantly reduced the NIH-CPSI score in those who re-attended, with 68% of patients having a significant clinical improvement. The first follow-up consultation at 6 weeks is now undertaken by telephone for many patients, if clinically appropriate., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: None declared.

We present an apparent second episode of mpox (monkeypox) genital ulcerative disease in a non-immunosuppressed MSM (man who has sex with men) patient who had completely recovered from a primary mpox infection 4 months previously. The patient had also received a complete two-dose course of smallpox vaccination between the two presentations. This case highlights the importance of continuing to include mpox in the differential diagnoses for individuals presenting with genital or mucosal ulceration, regardless of assumed immunity derived from prior infection or vaccination., Competing Interests: Competing interests: MC received speaker fees from BASHH. PM consulted for and received payment from University Hospital Plymouth & London Medical Laboratory. All other authors declared no competing interests., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To evaluate the impact of a new clinic-based rapid sexually transmitted infection testing, diagnosis and treatment service on healthcare delivery and resource needs in an integrated sexual health service., Design: Controlled interrupted time series study., Setting: Two integrated sexual health services (SHS) in UK: Unity Sexual Health in Bristol, UK (intervention site) and Croydon Sexual Health in London (control site)., Participants: Electronic patient records for all 58 418 attendances during the period 1 year before and 1 year after the intervention., Intervention: Introduction of an in-clinic rapid testing system for gonorrhoea and chlamydia in combination with revised treatment pathways., Outcome Measures: Time-to-test notification, staff capacity, cost per episode of care and overall service costs. We also assessed rates of gonorrhoea culture swabs, follow-up attendances and examinations., Results: Time-to-notification and the rate of gonorrhoea swabs significantly decreased following implementation of the new system. There was no evidence of change in follow-up visits or examination rates for patients seen in clinic related to the new system. Staff capacity in clinics appeared to be maintained across the study period. Overall, the number of episodes per week was unchanged in the intervention site, and the mean cost per episode decreased by 7.5% (95% CI 5.7% to 9.3%)., Conclusions: The clear improvement in time-to-notification, while maintaining activity at a lower overall cost, suggests that the implementation of clinic-based testing had the intended impact, which bolsters the case for more widespread rollout in sexual health services., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To investigate experiences of implementing a new rapid sexual health testing, diagnosis and treatment service., Design: A theory-based qualitative evaluation with a focused ethnographic approach using non-participant observations and interviews with patient and clinic staff. Normalisation process theory was used to structure interview questions and thematic analysis., Setting: A sexual health centre in Bristol, UK., Participants: 26 patients and 21 staff involved in the rapid sexually transmitted infection (STI) service were interviewed. Purposive sampling was aimed for a range of views and experiences and sociodemographics and STI results for patients, job grades and roles for staff. 40 hours of observations were conducted., Results: Implementation of the new service required co-ordinated changes in practice across multiple staff teams. Patients also needed to make changes to how they accessed the service. Multiple small 'pilots' of process changes were necessary to find workable options. For example, the service was introduced in phases beginning with male patients. This responsive operating mode created challenges for delivering comprehensive training and communication in advance to all staff. However, staff worked together to adjust and improve the new service, and morale was buoyed through observing positive impacts on patient care. Patients valued faster results and avoiding unnecessary treatment. Patients reported that they were willing to drop-off self-samples and return for a follow-up appointment, enabling infection-specific treatment in accordance with test results, thus improving antimicrobial stewardship., Conclusions: The new service was acceptable to staff and patients. Implementation of service changes to improve access and delivery of care in the context of stretched resources can pose challenges for staff at all levels. Early evaluation of pilots of process changes played an important role in the success of the service by rapidly feeding back issues for adjustment. Visibility to staff of positive impacts on patient care is important in maintaining morale., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Psychological safety-speaking up about ideas and concerns, free from interpersonal risk-are essential to the high-risk environment, such as healthcare settings. Psychologically safe working is particularly important in mental health where recovery-oriented approaches rely on collaborative efforts of interprofessional teams to make complex decisions. Much research focuses on antecedents and outcomes associated with psychological safety, but little focus on the practical steps for how to increase psychological safety across and at different levels of a healthcare organisation., Aims: We explore how a mental health organisation creates an organisation-wide plan for building the foundations of mental health and how to enhance psychological safety., Methods: This review encompasses strategies across psychological safety and organisational culture change to increase psychological safety at an individual, team and organisational level. We set out a comprehensive overview of the types of strategies and interventions for increasing the ethos of psychological safety and setting the foundations for delivering an organisation-wide programme on this topic. We also provide a list of key targeted areas in mental health that would maximally benefit from increasing psychological safety-both in clinical and non-clinical settings., Conclusions: Psychological safety is a crucial determinant of safe and effective patient care in mental health services. This paper provides the key steps and considerations, creating a large-scale programme in psychological safety with a focus on mental health and drawing from the current literature, providing concrete steps for how our current understanding of psychological safety into practice.

Objectives: Continuous improvement in the delivery of health services is increasingly being demanded in the UK at a time when budgets are being cut. Simulation is one approach used for understanding and assessing the likely impact of changes to the delivery of health services. However, little is known about the usefulness of simulation for analysing the delivery of sexual health services (SHSs). We propose a simulation method to model and evaluate patient flows and resource use within an SHS to inform service redesign., Methods: We developed a discrete event simulation (DES) model to identify the bottlenecks within the Unity SHS (Bristol, UK) and find possible routes for service improvement. Using the example of the introduction of an online service for sexually transmitted infection (STI) and HIV self-sampling for asymptomatic patients, the impact on patient waiting times was examined as the main outcome measure. The model included data such as patient arrival time, staff availability and duration of consultation, examination and treatment. We performed several sensitivity analyses to assess uncertainty in the model parameters., Results: We identified some bottlenecks under the current system, particularly in the consultation and treatment queues for male and female walk-in patients. Introducing the provision of STI and HIV self-sampling alongside existing services decreased the average waiting time (88 vs 128 min) for all patients and reduced the cost of staff time for managing each patient (£72.64 vs £88.74) compared with the current system without online-based self-sampling., Conclusions: The provision of online-based STI and HIV self-sampling for asymptomatic patients could be beneficial in reducing patient waiting times and the model highlights the complexities of using this to cut costs. Attributing recognition for any improvement requires care, but DES modelling can provide valuable insights into the design of SHSs ensuing in quantifiable improvements. Extension of this method with the collection of additional data and the construction of more informed models seems worthwhile., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: UK guidelines recommend a 'routine offer of HIV testing' in primary care where HIV diagnosed prevalence exceeds 2 in 1000. However, current primary care HIV testing rates are low. Efforts to increase primary care HIV testing are needed. To examine how an educational intervention to increase HIV testing in general practice was experienced by healthcare professionals (HCPs) and to understand the perceived impacts on HIV testing., Method: Qualitative interviews with general practitioners (GPs) and nurses 3-months after receiving an educational intervention developed from an adapted version of the Medical Foundation for HIV and Sexual Health (MEDFASH) HIV Testing In Practice (TIPs) online educational tool which included training on HIV associated clinical indicator conditions, why, who, and how to test. The intervention was delivered in 19 high-HIV prevalence general practices in Bristol. 27 semi-structured interviews were conducted across 13 practices with 16 GPs, 10 nurses and the sexual health clinician who delivered the intervention. Transcripts were analysed thematically informed by Normalisation Process Theory., Results: HCPs welcomed the opportunity to update their HIV knowledge through a tailored, interactive session. Post-training, HCPs reported increased awareness of HIV indicator conditions, confidence to offer HIV tests and consideration of HIV tests. Continued testing barriers include perceived lack of opportunity., Conclusions: This qualitative study found that HIV education is perceived as valuable in relation to perceived awareness, confidence, and consideration of HIV testing. However, repetition and support from other strategies are needed to encourage HCPs to offer HIV tests. Future interventions should consider using behaviour change theory to develop a complex intervention that addresses not only HCP capability to offer an HIV test, but also issues of opportunity and motivation.

Background: HIV-infected patients often present to primary care several times with HIV-indicator conditions before diagnosis but the opportunity to test by healthcare professionals (HCPs) is frequently missed. Current HIV testing rates in primary care are low and educational interventions to facilitate HCPs to increase testing and awareness of HIV are needed., Method: We implemented a pilot feasibility stepped-wedged randomised controlled trial of an educational intervention in high HIV prevalence practices in Bristol. The training delivered to HCPs including General Practitioners (GP) aimed to increase HIV testing and included why, who, and how to test. The intervention was adapted from the Medical Foundation for HIV and Sexual Health HIV Testing in Practice (MEDFASH) educational tool. Questionnaires assessed HCP feedback and perceived impacts of the intervention. HIV testing rates were compared between control and intervention practices using 12 monthly laboratory totals., Results: 169 HCPs (from 19 practices) received the educational intervention. 127 (75%) questionnaires were completed. Delivery of the intervention was received positively and was perceived as valuable for increasing awareness, confidence and consideration of testing, with HCPs gaining more awareness of HIV testing guidelines. The main pre-training HIV testing barrier reported by GPs was the patient not considering themselves at risk, whilst for nurses it was a concern about embarrassing or offending the patient. Most HCPs reported the intervention addressed these barriers. The HIV testing rate increased more in the control than in the intervention practices: mean difference 2.6 (95% CI 0.5,4.7) compared with 1.9 (- 0.5,4.3) per 1000 patients, respectively. The number of HIV tests across all practices increased from 1154 in the first 6 months to 1299 in the second 6 months, an annual increase in testing rate of 2.0 (0.7,3.4) from 16.3 to 18.3 per 1000 patients., Conclusion: There was a small increase in HIV testing rates over the study period, but this could not be attributed to the educational intervention. More effective and sustainable programmes tailored to each practice context are needed to change testing culture and HCP behaviour. Repeated training, supported by additional measures, such as testing prompts, may be needed to influence primary care HIV testing.

Introduction: Genital chlamydia is the most commonly reported bacterial sexually transmitted infection in developed countries. The majority of infections affect young adults under the age of 25 years., Methods and Outcomes: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of antibiotic treatment for men and non-pregnant women with uncomplicated genital chlamydial infection? What are the effects of antibiotic treatment for pregnant women with uncomplicated genital chlamydial infection? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)., Results: We found 26 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions., Conclusions: In this systematic review we present information relating to the effectiveness and safety of the following interventions - for men and non-pregnant women: antibiotics (single-dose) and antibiotics (multiple-dose regimens); for pregnant women: antibiotics (single-dose), erythromycin or amoxicillin (multiple-dose regimens), and clindamycin (multiple-dose regimens).

Cyclosporine is a member of a new family of drugs which interfere and modify the biological regulation of the immune system without being cytotoxic and has now been tested extensively in man. Observation of its toxicity in a homogeneous group of 72 patients with acute myeloblastic leukaemia receiving bone marrow transplants serves to illustrate some of the new and unexpected problems that may be seen when BIRM agents start to be tested in the clinic.

Twelve previously untreated patients with Ph1-positive chronic myeloid leukaemia received combination chemotherapy soon after diagnosis. There was karyotypic conversion in five: in four, the percentage of Ph1-positive cells fell to 10 or less. In two other patients, who had mosaic karyotypes at presentation, the percentage fell to 5% and zero.

A small pre-treatment 'priming' dose of cyclophosphamide will reduce gut damage due to high dose i.v. melphalan in mice and sheep but efforts to demonstrate this effect in man have been hampered by difficulty in the measurement of gut damage. We have evaluated the 51CR EDTA absorption test, a new method for measuring intestinal permeability, as a means of assessing damage due to high dose melphalan. The test was reliable, with a narrow normal range, easy to use and well tolerated. It detected an increase in intestinal permeability after high dose melphalan with a maximum occurring between 9 and 15 days after treatment and subsequently returning to normal. It was shown in 19 patients that a pre-treatment dose of cyclophosphamide was capable of significantly reducing the abnormalities in intestinal permeability which resulted from high dose melphalan.

Some patients present borderline features between acute myeloid leukemia (AML) and typical myelodysplastic syndromes (MDS): an excess of blasts insufficient to conclusively diagnose AML, yet above the figures usually compatible with MDS or the presence of Auer rods associated with a moderate excess of blasts. This presents considerable difficulties in diagnosis and management. The authors studied 28 such cases using the French-American-British Co-operative Group (FAB) classification, which groups them into a separate category termed "refractory anemia with excess of blasts in transformation" (RAEB-T). This was found to be a heterogenous group. Certain patients (4/28) had a previously established myelodysplasia, but most presented directly as RAEB-T. Two very different pictures emerged: a few patients (4/28) were young, with presentation and evolution similar to classic AML, for whom combination chemotherapy was effective; the majority (20/28) were older, with more varied clinical and cytologic presentation, for whom chemotherapy was of little effect and who presented a picture resembling classic RAEB with a median survival of 10 months.