To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.

A prospective, randomised, double-blind, placebo-controlled study.

16 ED sites across the USA.

Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.

Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.

The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.

The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).

No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.

NCT04443608.

The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.

An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.

Two tertiary stroke care centres in South India participated in the study.

Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.

High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.

The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).

The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.

The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.

Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).

To assess anaesthesia capacity and practice in Sierra Leone by enumerating the anaesthesia workforce by volume, training level and distribution across urban and rural areas and facility ownership; estimating the prevalence of anaesthesia methods used for common surgical procedures by provider category; and evaluating hospital infrastructure and the availability of essential anaesthesia-related medications and equipment.

A nationwide, cross-sectional, facility-based study combining structured questionnaires administered through face-to-face interviews with facility leads and retrospective review of surgical and anaesthesia logbooks.

Public and private hospitals and clinics in Sierra Leone providing surgical care with general, regional or local anaesthesia within an operating theatre.

69 of 78 eligible surgical facilities nationwide were included. Facilities providing surgical services between September 2022 and August 2023 were eligible; facilities without registries or declining participation were excluded.

Across participating facilities, the anaesthesia workforce comprised 198 full-time positions, predominantly non-physician providers, with only 40.4% (80/198) trained to administer anaesthesia independently. Ketamine-based and spinal anaesthesia were most common, while general anaesthesia with a protected airway accounted for just 5.0% (415/8339) of procedures. Anaesthesia practices varied by provider training level. Essential infrastructure, equipment and medications fell below international minimum standards, with shortages most pronounced in rural facilities.

Severe shortages of certified anaesthesia providers, limited anaesthesia techniques and inadequate material resources remain major barriers to safe anaesthesia and surgical care in Sierra Leone. Targeted investments in workforce development, infrastructure and resource allocation—particularly in rural areas—are required to improve the safety, quality and equity of anaesthesia care nationwide.

Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

ISRCTN63724445.

To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Pilot cluster randomised controlled trial (c-RCT).

Community-based healthcare services across six UK sites representing primary and secondary care settings.

31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

To examine inpatient benzodiazepine receptor agonists prescribing patterns and assess how hospitalisation affects use at discharge.

Subanalysis of the WEsleep trial, a cluster-randomised controlled single-centre study conducted at Amsterdam University Medical Center (Amsterdam UMC) (two locations) between July 2023 and March 2024. Twelve departments (six medical, six surgical) were matched and randomised to intervention or standard care. On intervention wards, multiple measures to improve sleep were implemented, including minimising nighttime disruptions.

Amsterdam UMC, across medical and surgical hospital departments.

Adult patients admitted for ≥2 nights (medical) or undergoing elective non-cardiac surgery in a surgical department.

Benzodiazepine use was classified as no use, pre-admission use or new in-hospital initiation. Prescribing patterns were summarised descriptively according to type, timing, indication and discharge status.

Of 746 patients, 187 (25%) used benzodiazepines: 80 (43%) had pre-admission use, and 107 (57%) were newly initiated during their hospital stay. Among pre-admission users, two discontinued and five had adjustments at discharge. Among newly initiated users, 94 (88%) had their benzodiazepine discontinued at discharge. Approximately half of pre-admission prescriptions and one-third of in-hospital prescriptions lacked a documented indication.

Although most newly initiated benzodiazepine treatments were discontinued during hospitalisation, pre-existing use was rarely reassessed and nearly 10% of new users were discharged with a prescription. Structured deprescribing protocols, better documentation of indications and improved discharge planning are needed to promote safer and more rational benzodiazepine use.

NCT05683483.

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

NCT05953155.

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.

Cross-sectional analytical study.

Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.

A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.

The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.

The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R²=0.272).

This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.

To examine the association between workplace sexual harassment and post-traumatic stress disorder (PTSD) symptoms among nurses in southeast Iran.

Cross-sectional study.

Four teaching hospitals affiliated with Kerman University of Medical Sciences, Iran.

A total of 283 female nurses with at least 1 year of clinical experience participated in the study.

Data were collected using convenience sampling and assessed using a demographic questionnaire, the Nurses’ Sexual Harassment Questionnaire, and the Impact of Event Scale-Revised (IES-R). Non-parametric tests, Spearman’s rho correlation and multivariate logistic regression were used for analysis.

Overall, 39.1% of nurses reported experiencing sexual harassment sometimes to always. A total of 13.4% screened positive for PTSD. Sexual harassment was significantly associated with PTSD symptoms (OR: 1.26; 95% CI 1.164 to 1.364). Younger, single and less experienced nurses reported higher harassment levels, though sociodemographic variables were not associated with PTSD.

Workplace sexual harassment was significantly associated with increased PTSD symptoms among nurses. While demographic factors were related to harassment exposure, they were not linked to PTSD. Findings highlight the importance of preventive organisational strategies to mitigate harassment and protect nurses’ mental well-being.

This qualitative study explores the experiences of healthcare staff in creating safer cancer care environments for ethnic minority patients. People from ethnic minority groups, who face an increased risk of safety events, often encounter barriers such as language and cultural differences.1 The research highlights the diverse backgrounds of ethnic communities involved, emphasising the critical need for culturally competent care within global healthcare systems....

To explore cardiac rehabilitation (CR) professionals’ perspectives on kinesiophobia in patients with cardiovascular diseases. This study aims to understand the perspectives of healthcare professionals (HCPs) regarding their perceptions, assessments and management of kinesiophobia.

A qualitative descriptive study using in-depth interviews and thematic analysis.

The study was carried out through online interviews at a university teaching hospital in South India.

HCPs involved in CR, from around the world, were invited to participate through advertisements on social media and through professional forums. 12 HCPs, including CR nurses (n=1), CR physicians (n=1), cardiac surgeons (n=1), cardiac electrophysiologists (n=1), rehabilitation physicians (n=1), cardiologists (n=2), exercise physiologists (n=2) and physiotherapists (n=3), agreed to participate.

Not applicable (qualitative study without interventions).

Qualitative data collected through in-depth interviews focused on HCP perceptions regarding kinesiophobia and its assessment, management and awareness within CR.

Thematic analysis generated 337 codes, which formed seven subthemes: the perceived burden of kinesiophobia, reasons for kinesiophobia, HCP experiences with kinesiophobia, methods of assessing kinesiophobia, management strategies, reasons why kinesiophobia is overlooked and the importance of promoting awareness of kinesiophobia.

CR professionals recognise kinesiophobia as a significant issue among patients with heart disease but do not recognise the term or perceive it as a separate condition; instead, they view it as part of the overall clinical presentation. There is a strong need to advocate for early recognition and assessment of kinesiophobia and for the development of structured management strategies and its inclusion into CR programmes to improve patient outcomes during recovery.

The study was prospectively registered in the Clinical Trial Registry of India (CTRI/2022/05/042502). This study received approval from the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) with reference number IEC2:13/2022.

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

ClinicalTrials.gov PRS (ID NCT06451432).

Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).

This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.

The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.

NCT05777317.

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

ACTRN12624001061527.

Alcohol is consumed by an estimated 137.4 million people in the USA 12 years of age and older and, as a result, is estimated to have caused about 140 thousand deaths among people 20 to 64 years of age each year from 2015 up to and including 2019.

The proposed review of the evidence on alcohol’s impact on health aims to produce conclusions to inform the Dietary Guidelines for Americans, 2026–2030. A multi-method approach will be utilised to formulate conclusions on (i) weekly (ie, average) thresholds to minimise long-term and short-term risks of morbidity and mortality, (ii) daily thresholds to minimise the short-term risk of injury or acute illness due to per occasion drinking, (iii) alcohol use among vulnerable populations (eg, pregnant women) and (iv) situations and circumstances that are hazardous for alcohol use. To inform expert decisions, this project will also include a systematic review of existing low-risk drinking guidelines, a systematic review of meta-analyses which examine alcohol’s impact on key attributable disease and mortality outcomes, and of estimates of the lifetime absolute risk of alcohol-attributable mortality and morbidity based on a person’s sex and average level of alcohol use. The systematic reviews were designed in accordance with the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P). The preliminary conclusions produced as a result of this project will undergo public consultation, and data from these consultations will be qualitatively analysed. The results of the public consultations will be used to further revise and refine the project’s conclusions.

The study was granted an ethics exemption as only secondary data sources and unidentifiable public consultation will be utilised. Systematic reviews are pre-registered with PROSPERO (registration numbers CRD42024584924 and CRD42024584948).

This project will establish a scientific consensus concerning alcohol’s impact on health. This consensus is imperative for informing the upcoming Dietary Guidelines for Americans, 2026–2030, and for better informing individuals about the health risks associated with alcohol use.

The MD Anderson Oropharynx Cancer (MDA-OPC) cohort is a unique single-institution, prospective longitudinal cancer cohort. The cohort aims to enhance the therapeutic index of OPC management by supporting data needs for independent investigators to conduct rigorous observational studies examining exposures and factors associated with acute and late toxicities, cancer progression, recurrence, new malignancies and quality of life in OPC survivors.

A total of 1811 patients with OPC with a minimum follow-up of 6 months have been consented to our prospective registry between 18 March 2015 and 29 December 2023. Clinical and treatment (Tx) data are available on all patients, including previously untreated patients (1443, 80%). Most previously untreated patients (97%) consented to longitudinal patient-reported outcomes and functional assessments for critical time points including pre-Tx, during-Tx and post-Tx at 3–6 months, 12 months, 18–24 months and annually up to 5 years.

The median age for the MDA-OPC cohort is 66 years (range, 25–96) with the majority being male (89%), white (92%) and with human papillomavirus (HPV)/p16-associated OPC (88%) primarily located in the tongue base or tonsil (90%). For previously untreated patients, 79% were diagnosed with stage I/II disease, and nearly half underwent curative intent chemoradiation. Overall survival was significantly higher for HPV/p16-associated OPC at 1 year (98% vs 93%) and 5 years (83% vs 54%; p

Future work includes expansion of the MDA-OPC cohort and survivorship surveillance to 10 years under the recently funded OPC-SURVIVOR research programme (P01CA285249), which aims to identify non-invasive, clinic-ready biomarkers and examine novel phenotypes and mechanistically matched mitigation strategies for latent OPC sequelae. Additionally, we aim to expand our advanced data infrastructure by integrating large data streams from parallel clinical trials and imaging registries.

NCT01893307, NCT03145077.

Worldwide, there are 15 established trauma databases collecting data to better understand the patterns of injury and effectiveness of interventions, but interpreting the information is hampered by the varied approaches. The aim of this study was to determine the impact, practices, evolution in design and methods of analysis that are standardised and comparable within registries.

A thematic analysis using a narrative synthesis was used to develop threads for future study and identify the limitations in current practice.

PubMed, Ovid, Scopus and EMBASE were searched on the 2 October 2025. At the same time, ChatGPT (Open artificial intelligence) identified the most cited articles in orthopaedic trauma registries, cross-referencing lists as a form of triangulation to aid in snowballing references.

The review included 174 papers from trials and observational studies that analyse data from established trauma orthopaedic registries published in English.

Two independent reviewers used standardised methods to search, screen and code included studies assessing the papers using the Strengthening the Reporting of Observational Studies in Epidemiology checklist to assess the observational and cohort studies and the Downs and Black Quality Criteria for the remaining papers.

Outcome measures other than mortality are poorly collected, undermining the value of registries. Trauma patients reported considerable impairment 6 and 12 months after injury. Association between level of trauma care and mortality is evident for major trauma populations, but does not hold for general trauma populations. Level I trauma centres produce improved survival in severely injured, but this association could not be proven for non-fatal outcomes in general populations. There is a disparity between resources allocated to save and salvage cases within major trauma units, and hence, routine cases often have lower priority and delayed care.

There is a need to develop a standardised and reproducible method to evaluate data quality in trauma registries. National performance guidelines and trauma centre audits are integral steps towards optimum results. Routine collection of postinjury outcome measures beyond mortality will enable the development of quality improvement metrics that better reflect patient outcomes.