Acute pain is an expected symptom for adolescents after outpatient surgery. In the USA, postoperative analgesic regimens frequently include prescription opioids. Increasing attention from clinicians, patients and other healthcare leaders has been directed toward non-opioid strategies, such as combining non-steroidal anti-inflammatory drugs (NSAIDs) plus acetaminophen, as potential first-line options for managing postoperative pain. However, the effectiveness and safety of home regimens that include versus exclude opioids for adolescents are unclear. The Comparing Analgesic Regimen Effectiveness and Safety after surgery for Kids study evaluates the effectiveness and safety of NSAIDs plus acetaminophen alone (NSAID regimen) versus NSAIDs and acetaminophen plus a low-dose opioid regimen (opioid regimen).

This study is a pragmatic, multicentre randomised controlled clinical trial recruiting 900 patients aged 12–20 years undergoing three common outpatient surgeries (tonsillectomy, laparoscopic cholecystectomy, knee arthroscopy) across four health systems. We will recruit patients prior to surgery and individuals will be randomised 1:1 with stratification to receive prescriptions for either the NSAID regimen or the opioid regimen. The primary effectiveness outcome is patient-reported pain intensity, while the primary safety outcome is adverse medication-related symptoms both assessed over the first 2 weeks after surgery. Secondary outcomes include quality of recovery, healthcare-related quality of life and rates of problematic substance use and chronic prescription opioid use, assessed up to 1 year after surgery.

The study incorporates stakeholder collaboration, including patient partners, surgeons, professional organisations., and health insurance payors, to ensure ethical conduct and relevance. This study is overseen by a single institutional review board with certificate of confidentiality. Findings will be disseminated through academic publications, conferences and community outreach to inform patients, parents, surgical teams and policymakers about optimal pain management strategies for adolescents after surgery.

NCT06671002.

A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.

From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.

This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.

This RCT was registered on www.clinicaltrials.gov (NCT04899024) prior to launching enrolment.

To identify and synthesise evidence pertaining to ‘health check’ programmes for the assessment of cardiovascular risk factors and disease delivered to adult populations in countries with universal healthcare.

A systematic umbrella review was undertaken. The protocol for this systematic umbrella review was registered on the PROSPERO registry and was undertaken based on Cochrane guidance and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline.

Medline, Embase, Cumulative Index of Nursing and Allied Health Literature (CINAHL), the Cochrane Database of Systematic Reviews, Scopus, Google Scholar and Health Management Information Consortium (HMIC) were searched. These searches identified records published between January 2009 and February 2025.

The inclusion criteria for the review were as follows: population—adults aged ≥18years; intervention—health checks including the assessment of cardiovascular risk factors and disease; comparators—non-recipients, variations of health checks and within-person pre/post assessments; outcomes—uptake and diagnosis rates, cardiovascular disease (CVD) and related clinical and behavioural risk factors, referral changes, and barriers and facilitators to uptake. Studies published prior to 2009 (when NHS Health Checks were introduced) and those from countries without universal healthcare provision were excluded. Screening was performed independently by two reviewers and conflicts were resolved via discussion or adjudication by a third reviewer.

Data extraction and quality appraisal were performed independently by a single reviewer and checked by a second reviewer. The quality of included reviews was assessed using the Risk of Bias in Systematic Reviews (ROBIS) (for quantitative evidence) and the Swedish Agency for Medical and Social Evaluation tool (for qualitative evidence). The results of this systematic umbrella review were synthesised narratively.

Results from meta-analyses reported by the included systematic reviews showed that the effects of health checks on cardiovascular and total mortality, stroke and coronary heart disease were mixed and generally non-significant. Conversely, health checks generally showed significant, positive effects (reductions) in CVD risk factors including blood pressure, body mass index and cholesterol levels. Non-significant reductions in smoking were found in two meta-analyses. Health checks were generally cost-effective; however, it was found that the cost-effectiveness of health checks could be improved through targeting towards ‘high risk’ populations defined based on socioeconomic factors, obesity and family history of CVD. Health check attendance versus non-attendance was related to demographic, attitudinal, socioeconomic and practical factors. The effectiveness of health checks was influenced by factors including social support to make changes to health behaviours and the availability and accessibility of referral options.

Overall, health checks had a positive impact on the detection of and improvement in the levels of cardiovascular risk factors. There was limited evidence of impact on the occurrence of longer term CVD events, which could reflect the limitations of onward treatment for CVD. Cardiovascular health checks could be more effective and cost-effective if targeted towards high-risk groups. The ability to access appointments at convenient times and venues and increased opportunities for social support may increase health check uptake, and increased availability and accessibility of referral options may improve their effectiveness.

CRD42024487529.

To evaluate the association between exposure to occupational biomechanical factors and the incidence of surgically treated osteoarthritis (OA) treated with arthroplasty in the hip and knee among male construction workers.

Longitudinal register-based cohort study.

Male construction workers (n=291 062) who participated in a national Swedish occupational health examination programme between 1971 and 1993, delivered through multiple primary-level nationwide occupational health centres.

Hip and knee arthroplasties performed due to OA from 1987 to 2019 were identified through linkage with the Swedish National Patient Register. Data on age, smoking habits, body mass index, job title and self-reported biomechanical exposures were collected during the health examinations. Occupational biomechanical workload was assessed using eight factors from a job-exposure matrix. Poisson regression was applied to estimate adjusted incidence rate ratios (IRRs) associated with each type of occupational biomechanical exposure.

The study included 10 336 cases of hip arthroplasties and 8926 cases of knee arthroplasties. All studied biomechanical risk factors were associated with an increased risk of knee OA requiring arthroplasty, especially for individuals exposed to static work in non-neutral lumbar postures (IRR 1.38, 95% CI 1.16 to 1.65) and those with a high frequency of kneeling (IRR 1.27, 95% CI 1.12 to 1.45). In contrast, only a few biomechanical factors were associated with an increased risk of hip OA requiring arthroplasty. Similar results were observed when alternative exposure measures, such as occupational group and self-reported exposure assessments, were employed.

Occupational workload was associated with an increased risk of knee arthroplasty due to OA, whereas the association for hip arthroplasty remains unclear.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.

A cross-sectional online survey.

Europe-wide.

Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.

Online survey from April to September 2024.

Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.

265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.

Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.

Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).

ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.

A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.

ISRCTN63917405.

Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.

This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.

The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.

NCT05952583.

This study aims to evaluate relationships between self-reported fine motor ability and quality of life (assessed by life satisfaction and life problems) from people with spinal cord injury (SCI) at T1 and above.

Observational cohort study (current analysis from a cross section)

279 individuals with SCI at T1 or above

Community members sampled from records from two Midwestern hospitals and a speciality hospital in the Southeast United States

Fine motor ability was assessed via the Spinal Cord Injury Functional Index-Short Form 9A, while two facets of quality of life, life satisfaction and life problems, were assessed by the Life Situation Questionnaire-Revised version (LSQ-R). Pearson correlations and multivariate analysis were utilised to identify cross-sectional relationships between fine motor ability, life satisfaction and life problems.

Fine motor ability was positively correlated with total life satisfaction score (r=0.16; p=0.02) and was negatively correlated with the total life problems score (r=–0.18; p=0.01), health problems factor (r=–0.24; pβ=0.25; p=0.02), fewer life problems (β=–0.40; pβ=–0.11; pβ=–0.10; p

The results identified significant, modest associations between self-reported outcomes, as better fine motor ability was related to less social isolation, fewer health problems and higher life satisfaction. Further investigation into the relationship between fine motor ability, life satisfaction and life problems is warranted.

Outward medical tourism is when people seek medical treatment in a different country to the one they live in. We aimed to identify all studies that describe the impact on the UK National Health Service (NHS) of patients who require treatment due to outward medical tourism for elective surgery and report on complications, costs and benefits.

A rapid literature review. Medical and grey literature databases were searched, limited to literature published between 2012 and 2024.

Studies published in the English language, conducted in any NHS setting, describing complications, costs or benefits due to outward medical tourism for elective surgery were included. We excluded emergency and semi-urgent surgery, dental and transplant surgery, cancer treatment and fertility treatment.

Primary outcomes were costs and savings to the NHS. Secondary outcomes were type and frequency, demographics, procedures, complications, treatment, follow-up care and use of NHS resources. Results were summarised narratively. Study quality was assessed using JBI critical appraisal tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for certainty of evidence for costs.

Some 35 case series and case reports and two surveys of NHS plastic surgeons were identified. Case studies described 655 patients treated in specific NHS hospitals between 2006 and 2024 for postoperative complications due to metabolic/bariatric surgery (n=385), cosmetic (n=265) and ophthalmic (n=5) surgery tourism. No cases relating to other surgical specialities were identified in the literature. Most patients were women (90%), with an average age of 38 (range 14–69) years. The most common destination for surgery was Turkey (61%). Complications were not well described for metabolic/bariatric surgery tourism; but for cosmetic surgery tourism, infection and wound dehiscence were most commonly reported. There was evidence that some patients needed complex treatment involving long hospital stays and multiple surgical interventions. Very low certainty evidence indicated that costs to the NHS from outward medical tourism for elective surgery ranged from £1058 to £19 549 per patient in 2024 prices. We found no studies that reported on the benefits of outward medical tourism.

A systematic approach is needed to collecting information on the number of people who travel abroad for elective surgery and the frequency and impact on the UK NHS of treating complications. Without these data, we cannot fully understand the risk of seeking surgery abroad.

Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.

A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.

Primary care.

The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.

19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.

This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.

NCT04543097.

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

To develop and validate a bilingual experience survey for use in any NHS healthcare setting, to support service improvement.

A prospective mixed-methods study.

Any healthcare setting in NHS Wales including primary, secondary, urgent and planned care.

An opportunistic sample of people with experience of using local healthcare services. Qualitative interviews and focus groups were held to develop a draft survey. These were followed by online data collection from a wide participant sample for statistical validation. The tool was translated and linguistically validated following recognised methods. Patient engagement leads were involved to ensure the tool met their needs.

We conducted and analysed five focus groups and four interviews, consisting of 33 people in total. 12 draft questions were developed related to key aspects of patient experience. A series of online surveys were conducted to test the draft questions, with 769 responses received. Data were analysed to assess completion rates, intra-rater reliability, internal consistency and convergent validity. One question had both sub-par intrarater reliability and poor convergent validity, and despite attempts to improve the wording, it failed to meet minimum requirements of validity and was subsequently removed. The final validated People’s Experience Survey (PES) was subsequently translated into Welsh and validated with service users.

The PES is a reliable and valid tool, suitable for use in any healthcare setting. The robust processes that have been undertaken ensure that the questions included are available bilingually to collect reliable, meaningful data to support service improvement work.