To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.

Meta-epidemiological study.

Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018.

Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis.

Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up.

Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p

Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout.

CRD42019117364.

To analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result

A retrospective and prospective cohort study.

GSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT

Patients with an FIT result

A total of 1299 patients with an FIT

This study demonstrates the effectiveness of RDCs as an alternate pathway for FIT

Peripheral artery disease (PAD) is a major risk factor for cardiovascular morbidity and mortality, despite surgical and endovascular treatments. Emerging evidence supports the use of immediate antithrombotic medications after endovascular intervention for PAD, however, there is a lack of consensus regarding choice and duration of antithrombotic therapy. Prescriber decision-making is a complex process, with prior studies demonstrating patient factors can influence variability in antithrombotic therapy for PAD. However, it remains unclear the relative contribution of these factors. This paper describes a planned study that aims to (1) determine the influence of patient factors on clinician preference for antithrombotic therapy following endovascular intervention and (2) compare differences in prescribing preferences between consultant vascular surgeons and trainees.

This cross-sectional survey will evaluate antithrombotic prescribing choices using a discrete choice experiment (DCE) that has been developed and piloted for this study. A list of attributes and levels was generated using a mixed-methods approach. This included an extensive literature review and semistructured interviews with prescribing clinicians. Following final selection of included attributes, specialised software was used to construct a D-efficient design for the DCE questionnaire. The electronic questionnaire will be administered to vascular trainees and consultant surgeons across Australia. These data will be analysed using multinomial logistic regression, treating the decision to prescribe antithrombotic therapy as a function of both the attributes of the two alternatives, as well as characteristics of the respondent. Latent class analysis will be used to explore heterogeneity of responses.

Ethics approval was obtained from the University of Sydney Human Ethics committee (2023/474). The results of this study will be published in peer-reviewed journals and presented at national vascular surgical conferences. These results will be used to improve understanding how clinicians make prescribing decisions and to inform future strategy to enhance guideline-directed prescribing.

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

ACTRN12623000990628.

To understand the extent to which various demographic and social determinants predict mental health status and their relative hierarchy of predictive power in order to prioritise and develop population-based preventative approaches.

Cross-sectional analysis of survey data.

Internet-based survey from 32 countries across North America, Europe, Latin America, Middle East and North Africa, Sub-Saharan Africa, South Asia and Australia, collected between April 2020 and December 2021.

270 000 adults aged 18–85+ years who participated in the Global Mind Project.

We used 120+ demographic and social determinants to predict aggregate mental health status and scores of individuals (mental health quotient (MHQ)) and determine their relative predictive influence using various machine learning models including gradient boosting and random forest classification for various demographic stratifications by age, gender, geographical region and language. Outcomes reported include model performance metrics of accuracy, precision, recall, F1 scores and importance of individual factors determined by reduction in the squared error attributable to that factor.

Across all demographic classification models, 80% of those with negative MHQs were correctly identified, while regression models predicted specific MHQ scores within ±15% of the position on the scale. Predictions were higher for older ages (0.9+ accuracy, 0.9+ F1 Score; 65+ years) and poorer for younger ages (0.68 accuracy, 0.68 F1 Score; 18–24 years). Across all age groups, genders, regions and language groups, lack of social interaction and sufficient sleep were several times more important than all other factors. For younger ages (18–24 years), other highly predictive factors included cyberbullying and sexual abuse while not being able to work was high for ages 45–54 years.

Social determinants of traumas, adversities and lifestyle can account for 60%–90% of mental health challenges. However, additional factors are at play, particularly for younger ages, that are not included in these data and need further investigation.

Obstetric fistula is a devastating childbirth injury primarily caused by prolonged, obstructed labour. It leaves women incontinent, severely stigmatised and isolated. Fistula repair surgery can restore a woman’s health and well-being. Fistula Foundation, a non-profit organisation, works in partnership with local hospitals and community organisations in Africa and Asia to address key barriers to treatment and to increase the number of women receiving surgical care. This paper presents data on fistula and fistula repair surgery across a large global network of hospitals supported by Fistula Foundation. The data were collected between 2019 and 2021.

Multicentre, retrospective, observational, descriptive study.

The study analysed deidentified data from 24 568 surgical repairs supported by Fistula Foundation to treat women with obstetric fistula at 110 hospitals in 27 countries.

The data highlight patient characteristics and key trends and outcomes from obstetric fistula repair surgeries and related procedures. Of those surgeries, 87% resulted in a successful outcome (fistula dry and closed) at the time of discharge, highlighting the effectiveness of fistula repair in restoring continence and improving quality of life. Over the period studied, the number of supported surgeries increased by 14%, but there remains an urgent need to strengthen local surgical capacity and improve access to treatment. Women suffered an average of 5.7 years before they received surgery and only 4% of women sought care independently. This underscores the importance of enhancing community awareness and strengthening referral networks.

This research provides essential insight from a vast, global network of hospitals providing highly effective fistula repair surgery. Further investment is needed to strengthen surgical capacity, increase awareness of fistula and remove financial barriers to treatment if stakeholders are to make significant progress towards the United Nations’ ambitious vision of ending fistula by 2030.

People in underserved groups have higher rates of tuberculosis (TB) and poorer treatment outcomes compared with people with no social risk factors.

This scoping review aimed to identify interventions that improve TB treatment adherence or completion rates.

Studies of any design focusing on interventions to improve adherence or completion of TB treatment in underserved populations in low incidence countries.

MEDLINE, Embase and Cochrane CENTRAL were searched (January 2015 to December 2023).

Piloted data extraction forms were used. Findings were tabulated and reported narratively. Formal risk of bias assessment or synthesis was not undertaken.

47 studies were identified. There was substantial heterogeneity in study design, population, intervention components, usual care and definition of completion rates. Most studies were in migrants or refugees, with fewer in populations with other risk factors (eg, homelessness, imprisonment or substance abuse). Based on controlled studies, there was limited evidence to suggest that shorter treatment regimens, video-observed therapy (compared with directly observed therapy), directly observed therapy (compared with self-administered treatment) and approaches that include tailored health or social support beyond TB treatment may lead to improved outcomes. This evidence is mostly observational and subject to confounding. There were no studies in Gypsy, Roma and Traveller populations, or individuals with mental health disorders and only one in sex workers. Barriers to treatment adherence included a lack of knowledge around TB, lack of general health or social support and side effects. Facilitators included health education, trusted relationships between patients and healthcare staff, social support and reduced treatment duration.

The evidence base is limited, and few controlled studies exist. Further high-quality research in well-defined underserved populations is needed to confirm the limited findings and inform policy and practice in TB management. Further qualitative research should include more people from underserved groups.

Despite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be achieved in many patients, even with two iron chelators at their maximum therapeutic doses. Here, we evaluate the efficacy and safety of triple combination treatment with deferoxamine, deferasirox and deferiprone over dual combination of deferoxamine and deferasirox on iron chelation in patients with transfusion-dependent β-thalassaemia with very high iron overload.

This is a single-centre, open-label, randomised, controlled clinical trial conducted at the Adult and Adolescent Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into intervention or control groups. The intervention arm will receive a combination of oral deferasirox, oral deferiprone and subcutaneous deferoxamine for 6 months. The control arm will receive the combination of oral deferasirox and subcutaneous deferoxamine for 6 months. Reduction in iron overload, as measured by a reduction in the serum ferritin after completion of the treatment, will be the primary outcome measure. Reduction in liver and cardiac iron content as measured by T2* MRI and the side effect profile of trial medications are the secondary outcome measures.

Ethical approval for the study has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (Ref. P/06/02/2023). The trial results will be disseminated in scientific publications in reputed journals.

The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2023/010).

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a