To describe: (1) the most visible information (from individuals or organisations) on UK social media regarding hormone replacement therapy (HRT)/menopause hormone treatment for menopause; (2) claims made by these sources for HRT and testosterone outwith the indications specified by the British National Formulary (BNF) and the National Institute of Health and Care Excellence (NICE) (ie, vasomotor instability, vaginal dryness, low mood associated with the menopause and, for testosterone, low libido after treatment with HRT) and for use for the prevention of future ill health and (3) conflicts of interest of commentators.

Cross-sectional study.

Online references to HRT, for use in menopause, in UK online media, comprising Facebook, Google, Instagram, TikTok and YouTube, 30 top ranked hits between 1 January 2022 and 1 June 2023 and Twitter (X) up to 1 May 2024.

Identification of the most visible information was performed via online searching with the term ‘HRT’ using incognito searches within each modality. Statements making claims were identified and analysed as to whether they were congruent with BNF and NICE advice on indications for use. Declarations of interest were extracted from the source or searched for if not apparent using a standardised search strategy. Data were entered into an Excel spreadsheet. Summary and descriptive statistics were used to summarise the results, including description of origin and types of claims, percentage of claims in agreement with NICE/BNF indications, relationship to financial interests and readership data, where available.

180 recommendations and/or claims for HRT were examined (30 from each of six platforms), made by professional individuals (53.4%), laypeople (41.7%) and patient, media and professional organisations (4.9%) completing the total. Overall, 67.2% of claims were outside of BNF/NICE recommendations. 139 (77.2%) were associated with a conflict of interest. In 117 cases, this was a conflict either directly or indirectly related to menopause, through provision of private practice, pharmaceutical industry funding or retail products marketed at the menopause.

Social media commonly contains claims for HRT outside BNF/NICE guidance. Conflicts of interest by commentators are also common, directly or indirectly related to menopause. Less than a quarter of media contained no commercial conflict. Policymakers should consider means to ensure that non-conflicted, evidence-based information is visible to professionals, patients and the public.

Open Science Framework (https://osf.io/r7e5c/).

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

NCT04569942

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.

Various psychological, cognitive, behavioural, medication and neurostimulation treatments can improve the outcomes of people with depressive and anxiety disorders. However, in usual practice, there is large variability in treatment delivery and treatments are poorly characterised. The effectiveness and quality of mental health services in the community are not accurately monitored and are poorly understood. At present, healthcare organisations, payers and policy makers know little about the quality of care they support. Similarly, patients and families have limited information on quality to guide choice of provider or organisation. It will be necessary to implement monitoring of treatment quality so that treatment and outcomes can be improved. This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure. This measure is based on routine, regular patient reports of their symptoms. It is designed to be aggregated at the provider, clinic, organisation or plan level; inform choice of provider; and be used to improve routine delivery of services and quality of care among patients with common psychiatric disorders.

The project analyses existing data with responses to a wide variety of items that are known to assess depression or anxiety and empirically selects symptom items for a transdiagnostic outcome-focused quality measure. The project informs risk adjustment and benchmarking of the quality measure by studying how patient, provider and practice factors, including health-related social needs, baseline symptom severity and diagnoses, affect outcomes. Drawing on these, the project specifies an outcome-focused quality measure that includes risk adjustment and benchmarks for improvement; and studies, at practices nationally, its feasibility and psychometric properties, the effect of treatment characteristics on the quality of care, and the effect of quality on health-related quality of life.

Results will be published. The quality measure is designed to be broadly relevant across community settings and populations and to be submitted for endorsement by regulatory and governing bodies.

It is unclear how mis- and disinformation regarding healthcare policy changes propagate throughout Latino communities via social media. This may lead to chilling effects that dissuade eligible individuals from enrolling in critical safety net programmes such as Medicaid. This study will examine pathways and mechanisms by which sentiment in response to mis- and disinformation regarding healthcare policies on social media differentially impact health disparity populations, thus supporting the design of tailored social media interventions to mitigate this.

We will search social media from X/Twitter, Facebook/Instagram and Reddit for keywords relating to health benefit programmes. Demographic, geographical location and other characteristics of users will be used to stratify social media data. Posts will be classified as fake-news-related or fact-related based on curated lists of fake-news-related websites. The number, temporal dissemination and positive or negative sentiment in reacting to posts and threads will be examined using the Python-based Valence Aware Dictionary and sEntiment Reasoner (VADER). Using a crowd-sourcing methodology, a novel Spanish-language VADER (S-VADER) will be created to rate sentiment to social media among Spanish-speaking Latinos. With the proposed approach, we will explore reactions to the dissemination of fake-news- or fact-related social media tweets and posts and their sources. Analyses of social media posts in response to healthcare-related policies will provide insights into fears faced by Latinos and Spanish speakers, as well as positive or negative perceptions relating to the policy over time among social media users.

Our study protocol was approved by the University of California, Los Angeles IRB (IRB#23–0 01 123). Results from this study will be disseminated in peer-reviewed journals and conference presentations, and S-VADER will be disseminated to public repositories such as GitHub.

Gaps in research evidence lead to research waste. In burns treatment, there is a paucity of reliable evidence or data. This contributes to inconsistent patient care, especially on a global scale, where low-resource countries often lack access to the latest research advancements. This umbrella review was undertaken as part of the James Lind Alliance Priorities in Global Burns Research Prioritisation Setting Partnership (PSP) and aimed to identify and assess the quality of evidence in thermal burns care. The objective was to map which interventions in thermal burns care are supported by a reliable evidence base and for which the evidence is lacking.

Systematic reviews of randomised controlled trials in thermal burns were identified and assessed using reliability criteria determined a priori. Multiple systematic review databases were searched in June 2023, including the Cochrane Library, KSR Evidence database and NIHR Journals Library. Summary of findings and, where available, Grading of Recommendations Assessment, Development and Evaluation was used to assess certainty of evidence. Reliable reviews were mapped onto clinical categories identified by patients, carers and healthcare professionals as part of the PSP.

232 systematic reviews were identified, of which 83 met reliability criteria and were included. The main reason for not meeting reliability criteria was poorly defined eligibility criteria (n=128). Of the 83 reliable reviews, most were conducted in pain (n=28) or wound management (n=14) and acute care (n=13). Certainty of evidence was mixed. Reviews mapped onto nine of the 17 clinical categories identified by the PSP.

This review summarises the available high-quality evidence in burns care and identifies evidence gaps, indicating that many important clinical questions remain unanswered. There is a discrepancy between the treatments investigated in high-quality research and the clinical areas considered as most important to stakeholders. These findings provide direction for future research to improve global burns care.

Clinical trials are needed to advance interventions such as chemoprevention that have potential to reduce the risk of malignant transformation in individuals with oral potentially malignant disorders. We explored the perspectives of those screened or invited to join an early phase clinical trial (the SAVER trial: Sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia). Our objectives were to inform the SAVER trial while it was ongoing and to provide insights for future trials and chemoprevention therapy development more broadly.

Qualitative study involving audio-recorded, semistructured interviews. Analysis of transcribed interviews drew on thematic approaches.

Five UK-based sites involved in SAVER.

Purposive sample of individuals (n=20) with suspected or diagnosed oral epithelial dysplasia (OED) who were approached about SAVER.

Most interviewees readily accepted that OED warranted preventive treatment and were positive about the potential of chemoprevention. However, they were often concerned about the side effects of the trial medication, and together with a dislike of biopsies and a perception that the trial might disadvantage treatment, these concerns made some hesitant to participate in SAVER. Interviewees indicated that the communication of staff influenced their understanding and experience of the trial and identified several opportunities for enhancing these aspects.

In indicating that individuals at risk of malignant transformation are accepting of chemoprevention in principle, our findings are supportive of future research on chemoprevention for this group. The findings also draw attention to the crucial role of communication in recruitment to chemoprevention trials. We provide recommendations to support staff during recruitment and enhance individuals’ experience of the trial.

ISRCTN12448611; Pre-results.

Amyotrophic lateral sclerosis (ALS) is a devastating illness that leads to muscle weakness and death usually within around 3 years of diagnosis. People with ALS (pwALS) often lose weight due to raised energy requirements and symptoms of the disease presenting significant challenges to taking adequate oral diet, with those who lose more weight being at a greater chance of earlier death. There is also some evidence to suggest that a higher calorie diet may benefit the disease course in pwALS, but further research is needed.

Two armed, parallel group, superiority, open labelled, randomised controlled trial, with internal pilot, to assess the effectiveness of an early high calorie diet on functional outcomes in ALS, comprising two treatment arms: (1) standard care, (2) standard care with additional active management using the OptiCALS complex intervention to achieve a high calorie diet (initially randomised 1:1, then 1:2 following a protocol amendment). Using a food first approach, pwALS will be encouraged and supported to follow a diet that meets an individualised calorie target from food before prescribing oral nutritional supplements. 259 pwALS will be recruited from up to 20 ALS centres across the United Kingdom and Ireland and followed up for a period of 12 months. Primary outcome is functional change measured over 12 months, using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. Secondary end points include measures of functional health, quality of life, calorie intake and weight, as well as time to gastrostomy and survival. A health economic analysis and process evaluation will also be undertaken. Participant recruitment is expected to complete in September 2025, and participant follow-up is expected to complete in September 2026. The results of this study are expected in March 2027.

The trial was approved by Greater Manchester—North West Research Ethics Committee, reference 20/NW/0334 on 8 September 2020. We will publish the study findings in peer-reviewed academic journals and present at local, national and international conferences where possible.

ISRCTN30588041.

While individuals living in rural areas often have poorer health outcomes and reduced access to healthcare services compared with those in urban areas, there is a disproportionate gap in research examining rural health issues and identifying solutions to healthcare challenges. This is likely due to the numerous barriers to conducting rural health research, including the centralisation of research in urban areas and limited trained personnel and resources to conduct research in rural communities. This realist review aims to identify articles focused on building rural health research capacity and develop an evidence-based framework to be used by researchers, clinicians and policymakers to improve rural health services and well-being for rural populations.

We will conduct a realist review using the following steps: (1) develop a search strategy, (2) conduct article screening and study selection, (3) perform data extraction, quality appraisal and synthesis, (4) engage stakeholders for feedback on our findings and (5) report our findings and engage in knowledge translation. Search terms include variations of the terms ‘research’, ‘capacity building’ and ‘rural’. Databases include (since inception) Ovid MEDLINE, Embase, CINAHL Plus, APA PsycINFO, ERIC and Scopus. A separate search of the same databases was also designed to identify relevant theories or frameworks related to research capacity building, using variations of the terms ‘research’, "‘capacity building’, ‘theory’ and ‘framework’. Studies will be screened by title and abstract and full text by two research team members and included based on their relevance to rural health research capacity building. We will exclude articles not published in English. We will also search the grey literature to identify rural health research centres, networks or training programmes that have not been described in the academic literature. Two research team members will extract relevant data from included studies and perform a qualitative analysis based on guidelines for realist reviews.

This review does not require ethical approval as it draws on secondary data that is publicly available. The findings will be disseminated at academic conferences, published in peer-reviewed journals and summarised in a lay report for individuals interested in developing strategies, programmes or policies to improve rural health research. The results will inform individuals developing rural health research training programmes, establishing rural research centres, or others interested in building rural health research capacity.

CRD42023444072.