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Key Points: Question: When trying to prevent atrial fibrillation after cardiac surgery (AFACS), is supplementing potassium only when its serum concentration falls below 3.6 mEq/L noninferior to supplementation when serum potassium concentration falls below 4.5 mEq/L? Findings: In the first 5 days after coronary artery bypass graft (CABG) surgery, patients who only received supplementation when serum potassium concentration dropped below 3.6 mEq/L (n = 830) did not have an increased incidence of new-onset AFACS compared with those who only received supplementation when serum potassium concentration dropped below 4.5 mEq/L (n = 837). There was no difference between the groups for other dysrhythmias or clinical outcomes. Meaning: The widespread practice of seeking to maintain high-normal serum potassium concentration after CABG surgery can be abandoned. This will reduce health care costs and decrease patient risk from an unnecessary intervention. IMPORTANCE: Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly. OBJECTIVE: To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger. DESIGN, SETTING, AND PARTICIPANTS: This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023. INTERVENTIONS: Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment. MAIN OUTCOMES AND MEASURES: The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm–related events, clinical outcomes, and cost related to the intervention. RESULTS: A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, −2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001). CONCLUSIONS AND RELEVANCE: For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or adverse clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04053816 This randomized clinical trial examines whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger for the prevention of atrial fibrillation after cardiac surgery. [ABSTRACT FROM AUTHOR]

Background: Atrial Fibrillation After Cardiac Surgery (AFACS) occurs in about one in three patients following Coronary Artery Bypass Grafting (CABG). It is associated with increased short- and long-term morbidity, mortality and costs. To reduce AFACS incidence, efforts are often made to maintain serum potassium in the high-normal range (≥ 4.5mEq/L). However, there is no evidence that this strategy is efficacious. Furthermore, the approach is costly, often unpleasant for patients, and risks causing harm. We describe the protocol of a planned randomized non-inferiority trial to investigate the impact of intervening to maintain serum potassium ≥ 3.6 mEq/L vs ≥ 4.5 mEq/L on incidence of new-onset AFACS after isolated elective CABG. Methods: Patients undergoing isolated CABG at sites in the UK and Germany will be recruited, randomized 1:1 and stratified by site to protocols maintaining serum potassium at either ≥ 3.6 mEq/L or ≥ 4.5 mEq/L. Participants will not be blind to treatment allocation. The primary endpoint is AFACS, defined as an episode of atrial fibrillation, flutter or tachycardia lasting ≥ 30 seconds until hour 120 after surgery, which is both clinically detected and electrocardiographically confirmed. Assuming a 35% incidence of AFACS in the 'tight control group', and allowing for a 10% loss to follow-up, 1684 participants are required to provide 90% certainty that the upper limit of a one-sided 97.5% confidence interval (CI) will exclude a > 10% difference in favour of tight potassium control. Secondary endpoints include mortality, use of hospital resources and incidence of dysrhythmias not meeting the primary endpoint (detected using continuous heart rhythm monitoring). Discussion: The Tight K Trial will assess whether a protocol to maintain serum potassium ≥ 3.6 mEq/L is non inferior to maintaining serum potassium ≥ 4.5 mEq/L in preventing new-onset AFACS after isolated CABG. Trial registration: ClinicalTrials.gov Identifier: NCT04053816. Registered on 13 August 2019. Last update 7 January 2021. [ABSTRACT FROM AUTHOR]

Background: The prevalence of genital chlamydia and gonorrhoea is higher in the 16-24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design: A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting: Recruitment was from 92 UK sexual health clinics. Participants: Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16-24 years. Allocation: Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention: The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42-79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator: A monthly message regarding trial participation. Main outcomes: The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results: Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial was 56.9% in the intervention group and 54.8% in the control group (odds ratio 1.11, 95% confidence interval 1.00 to 1.24) and having sex with someone new since joining the trial was 69.7% in the intervention group and 67.4% in the control group (odds ratio 1.13, 95% confidence interval 1.00 to 1.28). There were no differences in safety outcomes. Additional sensitivity and per-protocol analyses showed similar results. Limitations: Our understanding of the mechanism of action for the unanticipated effects is limited. Conclusions: The safetxt intervention did not reduce chlamydia and gonorrhoea infections, with slightly more infections in the intervention group. The intervention increased condom use but also increased the number of partners and new partners. Randomised controlled trials are essential for evaluating health communication interventions, which can have unanticipated effects. Future work: Randomised controlled trials evaluating novel interventions in this complex area are needed. Trial registration: This trial is registered as ISRCTN64390461. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 1. See the NIHR Journals Library website for further project information. [ABSTRACT FROM AUTHOR]

This correction notice addresses two instances in an article where the term "elective isolated CABG" was used incorrectly instead of "isolated CABG." The first instance is in the abstract's background section, and the second is in the Trial Population section under Methods. The study also included non-elective patients, so the term "elective" should be disregarded in both cases. The authors of the correction notice are Niall G. Campbell, Elizabeth Allen, Richard Evans, Zahra Jamal, Charles Opondo, Julie Sanders, Joanna Sturgess, Hugh E. Montgomery, Diana Elbourne, and Benjamin O'Brien. [Extracted from the article]

Plain English summary: Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage. [ABSTRACT FROM AUTHOR]

Background Black and minority ethnic (BME) men who have sex with men (MSM) face a major burden in relation to HIV infection. Using a cross-sectional correlational survey design, the present study explored the relationships between HIV knowledge and reported sexual health and sexual behaviour in this population.Methods: A convenience sample of 538 BME MSM was recruited in London, Leicester and Leeds: 346 (64%) self-identified as South Asian, 88 (16%) self-identified as Latin American, 76 (14%) self-identified as Black, 13 (2%) self-identified as mixed, and 15 (3%) self-identified as other.Results: HIV knowledge was low across the board, and South Asian MSM manifested the lowest scores. Respondents who perceived their HIV risk to be low possessed the least HIV knowledge. There were interethnic differences in the frequency of gay sauna visits, sex-seeking on mobile applications, drug use and attendance at sex parties. Respondents reported a high frequency of racism and discrimination, with Black MSM reporting highest frequency.Conclusions: There is an urgent need to raise awareness of HIV in BME MSM, and a culturally competent approach to HIV awareness-raising in BME MSM is required. These findings shed light on the contexts in which HIV prevention efforts should be targeted to reach specific ethnic groups, as well as some of the potential syndemics that can increase HIV risk or undermine HIV outcomes in BME MSM patients. [ABSTRACT FROM AUTHOR]

Black and minority ethnic (BME) men who have sex with men (MSM) face a major burden in relation to HIV infection. It was hypothesised that sexual abuse would predict sexual risk-taking, and that this relationship would be mediated by victimisation and maladaptive coping variables. Four hundred and thirty-two BME MSM completed the survey; 54% reported no sexual abuse and 27% reported sexual abuse. Mann–Whitney tests showed that MSM with a history of sexual abuse reported higher frequency of drug use, and of homophobia and racism than those reporting no prior sexual abuse. A structural equation model showed that the experience of sexual abuse was positively associated with sexual risk-taking and that this relationship was mediated by victimisation variables: frequency of racism and frequency of homophobia and by the maladaptive coping variable: frequency of drug use. The findings can inform the design of psycho-sexual and behavioural interventions for BME MSM. [ABSTRACT FROM PUBLISHER]

Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.