Exploring evidence gaps in clinical trials in thermal burns care: an umbrella review

Background
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.

Methods
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.

Results
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.

Conclusion
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.

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Challenges and facilitators in pathways to cancer diagnosis in Southern Africa: a qualitative study

Objectives
To explore healthcare workers’ (HCWs) experiences, barriers and facilitators in managing patients with symptoms of possible breast, cervical or colorectal cancer.

Design
A qualitative in-depth interview study with HCWs managing patients with breast, cervical and colorectal cancer symptoms. We also conducted workshops with a group of HCWs to check the credibility of the interview findings.

Setting
The study was conducted with staff working in primary, secondary and tertiary public health facilities in the Eastern and Western Cape in South Africa (SA), and Harare and Bulawayo and their referral provinces in Zimbabwe.

Participants
HCWs with experience in managing patients with symptoms of possible breast, cervical or colorectal cancer were recruited for the study. Participants were purposively sampled based on region, healthcare level and job role. A total of 56 participants (26 in SA and 30 in Zimbabwe) participated in the in-depth interviews. 26 (12 in SA and 14 in Zimbabwe) participated in four clinical advisory group workshops across both countries.

Results
Drawing on the Model of Pathways to Treatment, HCWs’ perceptions of patient-level factors influencing the diagnostic interval included financial limitations, patients’ absence and delays in attendance. Healthcare provider and system factors included: challenges with referral and feedback systems; training needs; low awareness of protocols and guidelines; inappropriate and suboptimal clinical assessments; and broader socioeconomic factors and resource limitations.

Conclusion
Improving the timely diagnosis of breast, cervical and colorectal cancer in Southern Africa necessitates targeted strategies that address both patient-related, provider and health-system delays.

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Association between preoperative high-density lipoprotein cholesterol levels and overall survival in gastric cancer patients: a retrospective cohort study

Objectives
This study aimed to evaluate the prognostic significance of preoperative serum lipid profiles, particularly high-density lipoprotein cholesterol (HDL-C), in gastric cancer (GC) patients undergoing gastrectomy.

Design
A hospital-based retrospective cohort study.

Setting
A tertiary hospital in Eastern China.

Participants
771 consecutive GC patients who underwent gastrectomy between 2014 and 2018, had complete pathological data, and received standardised adjuvant chemotherapy (fluoropyrimidine or taxane-based regimens).

Exposures
Preoperative serum lipid profiles, including total cholesterol (TC), triglycerides (TG), HDL-C and low-density lipoprotein cholesterol (LDL-C), along with clinicopathological data, were collected. Patients were stratified by sex-specific lipid tertiles (T1–T3).

Outcome measures
The primary outcome was overall survival (OS), defined as the time from surgery to death from any cause or to the last follow-up. Secondary outcomes included stage-specific survival rate (stage III+IV versus stage I/II; M0 versus M1 status). Mortality HRs were estimated using Cox proportional hazards models: Model 1 adjusted for age and sex, and Model 2 fully adjusted for Tumor-Node-Metastasis (TNM) stage and tumour characteristics. OS was analysed using Kaplan-Meier curves and log-rank tests. Subgroup analyses were performed for variables with significant interactions.

Results
The cohort had a median follow-up of 41.0 months (range: 0.03–89.8 months), and an OS rate of 58.2%. In multivariable analysis, HDL-C was an independent prognostic factor (highest versus lowest tertile: HR 0.728 (95% CI 0.558 to 0.949), P-trend=0.019). The strongest associations were observed in the stage III+IV subgroup (HR 0.699 (95% CI 0.515 to 0.949), p-trend=0.021) and the M0 subgroup (HR 0.734 (95% CI 0.560 to 0.963), p-trend=0.025). After full adjustment, no significant associations were found for TG, TC or LDL-C.

Conclusions
Preoperative HDL-C predicted OS in GC patients, especially in those with locally advanced or non-metastatic patients. These findings suggest that lipid metabolism may affect tumour biology and prognosis in operable GC.

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What drives clinic follow-up after traumatic spinal injury? An observational cohort study from Tanzania

Objectives
To evaluate factors associated with clinic follow-up after traumatic spinal injury (TSI) in Tanzania, focusing on demographic, injury-related and hospital variables. We hypothesised that socioeconomic and injury-specific factors would predict follow-up adherence.

Design
Retrospective observational cohort study.

Setting
Tertiary government referral centre for neurosurgery and orthopaedics in Dar es Salaam, Tanzania.

Participants
443 adults with TSI admitted between September 2016 and October 2021. Inclusion criteria included survival to discharge and availability of the discharge date. Patients with missing data were excluded.

Primary and secondary outcome measures
Primary outcomes were any clinic follow-up and 1-year follow-up post-discharge. Secondary outcome was time to loss of follow-up. Logistic regression was used to identify factors associated with follow-up, and Kaplan-Meier survival analysis assessed follow-up duration.

Results
Of 443 patients (85.8% male, median age 34 years), 52.4% returned for follow-up. Independent factors associated with return included private insurance (adjusted OR (aOR) 2.69, 95% CI 1.38 to 5.45, p=0.005), involvement in a road traffic accident (aOR 2.15, 95% CI 1.22 to 3.83, p=0.009), lumbar injuries (aOR 2.26, 95% CI 1.30 to 4.00, p=0.004), neurological improvement at discharge (aOR 3.52, 95% CI 1.72 to 7.64, p=0.001) and hospital stays shorter than 24 days (aOR 1.63, 95% CI 1.07 to 2.47, p=0.022). Among those who returned, only 25.4% completed 1 year of follow-up. Predictors of 1-year follow-up included being female (aOR 4.87, 95% CI 2.31 to 10.56, p

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Are client and provider preferences for HIV care coordination programme features concordant? Discrete choice experiments in Ryan White part A-funded New York City care coordination programmes

Objectives
The New York City (NYC) HIV Care Coordination Programme (CCP) is designed to help people with HIV (PWH) overcome barriers to care and treatment engagement. We assessed preferences for CCP components among programme enrollees (’clients’) and providers. Our objective is to compare client and provider preferences, which were previously analysed separately.

Design
We used a discrete choice experiment to assess preferences for four CCP features (‘attributes’): Help with Adherence to Antiretroviral Therapy (ART), Help with Primary Care Appointments, Help with Issues other than Primary Care and Where Programme Visits Happen. Each of these attributes had 3–4 variants (‘levels’). In the original surveys, levels within Where Programme Visits Happen varied by participant type (client vs provider). We recoded the levels by visit location (VL) or by travel time (TT) to make them comparable and report results from both approaches.

Setting
25 Ryan White Part A-funded NYC CCPs participated.

Participants
152 providers and 181 clients completed the survey.

Primary and secondary outcome measures
Preferences were quantified using the relative importance of the attributes and utility of the levels.

Results
From January 2020 to March 2021, 152 providers and 181 clients completed the survey. Most of the providers (52%) were

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Prevalence of autism among adults in Canada: results from a simulation modelling study

Objective
To estimate the prevalence of autism among adults living in Canada.

Design
A Monte Carlo simulation modelling approach was employed. Input parameters included adult population estimates and mortality rates; autism population all-cause mortality risk ratios; and autism prevalence estimates derived from child and youth data due to the lack of adult data. This approach was executed through 10 000 simulations, with each iteration generating a distinct data scenario. Prevalence estimates were reported as the mean with the 2.5th and 97.5th percentiles, corresponding to a 95% simulation interval (SI).

Setting
Where possible, Canadian data sources were used, including the 2019 Canadian Health Survey on Children and Youth and Statistics Canada mortality rates and population estimates.

Primary outcome measure
National prevalence estimates of autistic adults living in private dwellings in Canada, with variations in prevalence by sex at birth and province/territory considered.

Results
The findings suggest the prevalence of autism among adults in Canada to be 1.8% (95% SI 1.6%, 2.0%). National prevalence estimates by sex at birth were 0.7% (95% SI 0.6%, 0.9%) for females and 2.9% (95% SI 2.6%, 3.2%) for males. Provincial/territorial estimates ranged from 0.7% in Saskatchewan (95% SI 0.3%, 1.3%) to 3.6% in New Brunswick (95% SI 2.4%, 5.1%).

Conclusions
The limited availability of data on autistic adults constrains our ability to fully understand and address their unique needs. In this study, autism prevalence was estimated based on diagnosed cases, which excludes individuals without a formal diagnosis. Additionally, other factors such as data availability and methodological assumptions may influence the modelling of prevalence estimates. As a result, our findings should be interpreted within the context of these limitations. Nevertheless, this study provides a valuable reference point for understanding autism prevalence among adults in Canada.

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Treatment outcomes, medication adherence and predictors among patients with epilepsy in Mekelle City Hospitals, Ethiopia: a multicentre observational cross-sectional study

Objective
This study aimed to assess treatment outcome, medication adherence and predictors among epilepsy patients at three low-resource setting hospitals in Mekelle City, Northern Ethiopia.

Design
A multicentre hospital-based observational cross-sectional study was conducted.

Setting
The study was conducted in three resource-limited tertiary care hospitals in Mekelle City, Northern Ethiopia: Ayder Comprehensive Specialized Hospital, Mekelle General Hospital and Quiha General Hospital.

Participants
A total of 351 patients with epilepsy receiving regular follow-up care at adult neurology outpatient clinics in three low-resource setting hospitals were included in the study.

Main outcome measures
The study assessed adherence to antiepileptic drugs (AEDs), treatment outcomes and identified independent predictors of these outcomes.

Results
A total of 351 study participants were included in the final analysis, with a mean (±SD) age of 37.98±14.27 years. More than one-third (39%) had poorly controlled seizures. Living in urban areas (adjusted odds ratio (AOR)= 3.36, 95% CI 1.1 to 10.4, p=0.037), being government-employed (AOR = 4.0, 95% CI 1.1 to 14.5, p=0.035) and being a student (AOR = 4.0, 95% CI 1.1 to 14.5, p=0.035) were associated with good seizure control. Half of the participants (177, 50.6 %) were non-adherent to their medications. Being a farmer (AOR = 4.2, 95% CI 1.5 to 11.3, p=0.005), a housewife (AOR = 4.9, 95% CI 1.4 to 17.2, p=0.012), absence of seizure-triggering factors (AOR = 3.7, 95% CI 2.34 to 6.06, p

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Prognostic nutritional index in the prediction of adverse cardiac and cerebrovascular events in ST-segment elevation myocardial infarction patients with type 2 diabetes mellitus in Urumqi, China: a retrospective cohort study

Objective
Prognostic nutritional index (PNI) is an index for assessing nutritional and immune status. The aim of this study is to investigate the predictive value of PNI for long-term major adverse cardiac and cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) patients with type 2 diabetes mellitus (T2DM).

Design, setting and participants
This retrospective cohort study analysed 1582 STEMI patients with T2DM who underwent percutaneous coronary intervention from January 2015 to June 2023 in Urumqi, China. Patients were followed up for MACCE.

Primary and secondary outcome measures
The primary endpoint was new-onset MACCE including all-cause death, non-fatal MI and non-fatal stroke.

Results
This study ultimately included 1582 patients for analysis with a median follow-up period of 48 months (IQR: 24–84 months) and 282 patients (17.8%) developed MACCE. Of them, 138 (8.7%), 84 (5.3%) and 60 (3.8%) patients developed all-cause death, a non-fatal MI and a non-fatal stroke, respectively. Incidences of MACCE and all-cause death conversely correlated with PNI. Kaplan-Meier curves showed a significant difference in all components of MACCE between PNI quartiles (p

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Using qualitative research and the person-based approach to coproduce an inclusive intervention for postpartum blood pressure self-management

Objective
To coproduce an inclusive intervention for blood pressure (BP) self-management post partum.

Design
Using the person-based approach, an intervention was coproduced in three phases. Phase 1 entailed intervention coproduction with a diverse patient and public involvement panel and stakeholders (clinical, academic, government and third sector-based). Phase 2 involved intervention optimisation through think-aloud interviews with former patients and clinicians. Phase 3 was user-testing followed by semistructured interviews with current patients and their clinicians.

Setting
Patients and clinicians from primary and secondary care drawn from Southern and Northern England.

Participants
Seven former patients and 11 clinicians participated in think-aloud interviews to provide their views of intervention prototypes (phase 2). Additionally, 23 patients and 9 of their clinicians participated in semistructured interviews after using the intervention for 2 weeks (phase 3).

Intervention
An interactive patient app—My BP Care—and accompanying leaflet to support BP self-monitoring. These were linked to a clinician dashboard with alerts and an emailing system to facilitate appropriate titration of patient medication.

Results
The intervention was codeveloped following these guiding principles to ensure it was accessible and inclusive: easily comprehensible, motivating, simple and quick to use. Interview findings indicated that patient adherence to the intervention was promoted by the initial patient training conducted by the midwives, the enhanced clinical oversight they felt they received as a result of the intervention, the free BP monitor they received, reassurance they received of the medication safety for them and their baby, the intervention’s simplicity and the motivating reminders they received.

Conclusions
Through coproduction with a diverse group of patients and stakeholders, and optimisation through testing among further diverse patients and clinicians, we developed a multicomponent intervention that is accessible and engaging for diverse patients, compatible with prevailing clinical practice and adaptable to different clinical contexts.

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Randomised trial of home sleep apnoea testing compared to in-lab polysomnography for the evaluation of obstructive sleep apnoea in children: rationale and study protocol

Introduction
Obstructive sleep apnoea (OSA) affects 1–5% of the paediatric population, including 55–90% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.

Methods and analysis
This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 5–12 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.

Ethics and dissemination
This study has been approved by the Institutional Review Board at Children’s Hospital of Philadelphia (#21–0 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.

Trial registration number
NCT05382754.

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Beyond the puff: qualitative insights into smoking behaviours and societal perceptions among university students in India

Objectives
The objective of the study was to understand the smoking behaviour of adults and how societal perceptions influence the smoking behaviour of university students.

Design
Qualitative study.

Setting
National Institute of Medical Sciences university, India.

Participants
20 face-to-face interviews were carried out among university students who were in the age group of 19–30 years using a combination of purposive sampling, followed by snowball sampling methods.

Results
Qualitative responses revealed that stress, cravings for cigarettes and mealtimes were key triggers for smoking behaviour. Many participants felt guilty about their smoking and often became irritated by advice from non-smoking friends. All participants had experienced negative health effects, including physical and sensory issues, as well as other adverse experiences. Students expressed a dislike for judgemental attitudes from society. They respected elders and found it difficult to smoke in front of them. Rather than being blamed for their smoking, they preferred supportive assistance to help them quit.

Conclusions
The study highlights the importance of understanding college students’ smoking behaviour, as it greatly influences their smoking habits. Cessation efforts should target this group and emphasise the negative experiences associated with smoking. Additionally, students recommend creating a non-judgemental and supportive environment to aid in quitting, rather than a judgemental and blaming society.

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What are the expectations of patients regarding the communication of nuclear imaging results? Insights from a French national survey of 723 patients

Objectives
There are still some controversies regarding the role of nuclear medicine practitioners in delivering imaging findings to the patients as well as content and magnitude of information to be delivered. The aim of the study was to identify the expectations of patients regarding the communication of results from a nuclear imaging examination.

Design
A national survey was conducted among patients who underwent a nuclear imaging examination. In each participating centre, a questionnaire was administered to the patients.

Setting
Primary care in France.

Participants
The study involved 723 patients from 12 French Nuclear Medicine departments (university hospitals, general hospitals, comprehensive cancer centres and private centres).

Outcome measure
The primary endpoint was to determine the proportion of patients expressing a wish to consult a nuclear medicine physician at the end of the imaging session and to assess the rationale underlying this preference.

Results
Our results indicate that a significant majority (73.2%) of patients prefer to meet primarily with the nuclear medicine physician to receive an explanation of the imaging findings. Concerning the disclosure of these results, 66.1% of the patients prefer to receive an explanation from the nuclear medicine physician, either alongside or instead of the requesting physician alone. Furthermore, nearly all patients (96.1%) who wish to meet with the nuclear medicine physician also indicate their willingness to receive the examination results, even if they are unfavourable.

Conclusions
This study underscores the clear preference of patients to interact with nuclear medicine specialists and benefit from their expertise, irrespective of whether the results are positive or negative. This emphasises the critical need for implementing standardised recommendations across countries and ensuring adequate training for nuclear physicians to actually meet this demand. This aspect is likely to distinguish a nuclear medicine physician from a scan interpreter.

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Cost-effectiveness analysis of the Assessment of Burden of Chronic Conditions (ABCC) tool in primary care in the Netherlands

Objectives
The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.

Design and setting
This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.

Participants
The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.

Interventions
The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.

Outcome measures
Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.

Results
The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.

Conclusion
While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.

Trial registration number
NCT04127383.

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Evaluation of the outpatient parenteral antimicrobial therapy (OPAT) service in Malaysian public hospitals: a mixed-methods study protocol

Introduction
Outpatient parenteral antimicrobial therapy (OPAT) is an innovative approach to manage infections that require extended courses of intravenous antibiotics by enabling patients to receive treatment in an outpatient setting. In Malaysia, there has yet to be a systematic evaluation of the OPAT service. This study aims to describe the safety, clinical indications and treatment outcomes of the OPAT service in Malaysia, assess patients’ satisfaction and experiences and determine the facilitators and barriers associated with the provision of the OPAT service in Malaysia.

Methods and analysis
A mixed-methods approach combining qualitative and quantitative methods will be employed for a comprehensive understanding of the provision of the OPAT service in Malaysian public hospitals. The study consists of four distinct parts: systematic review, retrospective cohort analysis of clinical outcomes, patients’ satisfaction survey and focus group discussions on providers’ experiences. A longitudinal analysis of the clinical outcomes (treatment success/failure, infection cure, adverse events, readmission and mortality) of the OPAT patients’ cohort will be conducted using descriptive and conclusive statistics, in addition to rates of patients’ satisfaction and evaluation of providers’ experiences.

Ethics and dissemination
This study is registered in the National Medical Research Register (NMRR ID-24-00941-2C8) and approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia (Ref: 24-00941-2C8). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

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