FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerBMJ Open

Physical activity and psychosocial characteristics of individuals with and without chronic low back pain in daily life: protocol for the PRIA intensive longitudinal study

Por: Kolodziejczak-Krupp · K. · Zipper · V. · Wilhelm · L. O. · Thiel · L. · Stein · C. · Schäfer · T. · Pumberger · M. · Schmidt · H. · Fleig · L.
Introduction

Despite the high prevalence of chronic low back pain (cLBP), its underlying mechanisms remain poorly understood. Addressing modifiable psychosocial resources and health behaviours such as physical activity offers a promising avenue for reducing the impact of cLBP. Furthermore, although the relationship between physical activity and pain is theorised as a within-person process, previous research has primarily focused on between-person differences. In this article, we present the protocol for the prospective observational study PRIA (Psychologie und Rückengesundheit im Alltag), which is part of a larger interdisciplinary research consortium investigating preventive, diagnostic and therapeutic aspects of cLBP. Drawing on theories from health and pain psychology, the outlined study examines the interplay between different dimensions of cLBP and back health, physical activity and their psychosocial determinants within individuals in their everyday lives.

Methods and analysis

This prospective longitudinal study combines online questionnaires with ecological momentary assessment of health behaviours, cognitions, affect, social support and pain using a smartphone-based app (movisensXS) and continuous measurement of physical activity by accelerometry (movisens Move 4). Parameters will be recorded at baseline (T0), daily for the following 14 days (five times per day at 09:00, 12:00, 15:00, 18:00 and 21:00, resulting in up to 70 measurement occasions), 3 and 6 months later (T1 and T2). A total of 230 participants (115 individuals with cLBP and 115 without cLBP) aged 18–64 years will be enrolled. The associations between cLBP and the measured parameters will be examined using multilevel models.

Ethics and dissemination

The university’s ethics committee at the MSB Medical School Berlin approved the study on 8 March 2021 (approval number MSB-2021/59, amendment approved on 10 November 2023, amendment number MSB-2023/145). Ethical approval for the FOR 5177 initial screening was granted by Charité – Universitätsmedizin Berlin (EA1/058/21). All participants provided written informed consent. The results of this research will be published in peer-reviewed international journals, presented at national and international conferences, and reported to the German Research Foundation.

Trial registration number

DRKS00032978.

K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea

Por: Ryoo · S.-B. · Ahn · H.-M. · Nam · B.-H. · Song · Y. M. · Sohn · D. K.
Introduction

Low anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.

Setting

This is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea.

Methods and analysis

A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle.

Ethics and dissemination

The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT07041515.

Pain management and its challenges in Iranian cancer patients: a mixed-method study

Por: Esmaeili · M. · Rassouli · M. · Karami · M. · Beiranvand · S. · Hajibabaee · F. · Ashrafizadeh · H.
Objectives

To identify and explain the challenges of effective pain management in patients with cancer in Iran.

Design

A convergent mixed-methods study.

Setting

Oncology departments and palliative care units across multiple healthcare institutions in Iran.

Participants

Quantitative phase: 320 healthcare providers, including anaesthesiologists, general practitioners, oncologists, nurses and pharmacists, selected via convenience sampling. Qualitative phase: 10 stakeholders, including patients, caregivers, policy makers and clinicians.

Methods

Quantitative data were collected using a psychometrically validated 23-item questionnaire assessing knowledge, attitudes and perceived barriers to cancer pain management. Qualitative data were obtained through semistructured interviews and analysed using Graneheim and Lundman’s content analysis method with MaxQDA software. Integration was performed using a side-by-side approach.

Results

Quantitative data showed that over 65% of providers did not routinely assess pain, and only 29.1% believed pharmacological treatments were effective. Qualitative analysis identified 13 barriers across three domains—professional, patient and organisational—spanning physical, psychological, social and spiritual dimensions. Integrated findings revealed consistent patterns of underassessment, legal and cultural resistance and lack of interdisciplinary collaboration. These converging challenges highlight the need for holistic, system-level reform.

Conclusions

The convergence of quantitative and qualitative data reveals a multilayered system of barriers, professional, patient-related and organisational—rooted in physical, psychological, social and spiritual dimensions. These interlinked challenges contribute to fragmented pain management and limited interdisciplinary coordination. Addressing them requires a holistic reform strategy that integrates structural, cultural and clinical solutions.

Treatment outcome of acute coronary syndrome and associated factors among patients admitted to public hospitals in Harari Regional State, Eastern Ethiopia: a retrospective cross-sectional study

Por: Tessema · T. B. · Ahmed · A. · Adem · H. A. · Firdisa · D. · Abebe · T. · Mossie · Y. · Wondimneh · F.
Background

Acute coronary syndrome (ACS) is the leading cause of morbidity and mortality among individuals with cardiovascular disease, accounting for half of all global cardiovascular-related deaths. No prior research has examined ACS treatment outcomes and associated factors in the study area. This study aimed to evaluate the risk factors and treatment outcome of ACS patients admitted to public hospitals in Harari Regional State, Eastern Ethiopia.

Methods

A retrospective hospital-based cross-sectional study was conducted among 308 ACS patients. Patient records from admissions between 1 November 2018 and 31 October 2023 were reviewed, with data collected between 10 January and 10 February 2024 using a structured checklist adapted from previous research. Statistical analysis was performed using SPSS V.25.0, with bivariable and multivariable logistic regression identifying significant associations at a p value

Results

The mean patient age was 56.4±16 years, with males comprising 77.3% of participants. Half (51.6%) resided in rural areas, and only 16.2% presented within 12 hours of symptom onset. Overall, 81 patients (26.3%) experienced a poor treatment outcome for ACS, including 39 (12.7%) in-hospital deaths, 24 (7.8%) referrals to higher-level facilities and 18 (5.8%) who left against medical advice. Factors significantly associated with poor outcome included hospital presentation more than 72 hours after symptom onset (AOR 2.734 (95% CI 1.006 to 7.435)), left ventricular ejection fraction (LVEF)

Conclusion

Poor treatment outcome was independently predicted by the presence of ischaemia features on the echocardiography, LVEF (

Inequalities in care-seeking behaviour for childhood acute respiratory tract infection in Mauritania: evidence from the WHO health equity assessment toolkit of two national health surveys

Por: Tebeje · T. M. · Eshun · G.
Background

Acute respiratory infection (ARI) is one of the leading causes of childhood morbidity and mortality. In Mauritania, very few children who experience ARI receive medical treatment. Additionally, inequalities in the care-seeking behaviour for ARI have not been assessed in the country.

Objective

To examine inequalities in care-seeking behaviour for childhood ARI in Mauritania and assess the extent to which they have changed between 2000–2001 and 2019–2021.

Design

A population-based cross-sectional study using the WHO health equity assessment toolkit.

Setting

Mauritania.

Participants

Under-five children.

Primary and secondary outcome measures

We utilised inequality measures, including Difference (D), Ratio (R), Population Attributable Fraction (PAF) and Population Attributable Risk (PAR). The results were disaggregated based on five dimensions of inequality. We calculated these measures separately for each of the two surveys and then compared their estimates.

Results

The proportion of care-seeking behaviour for ARI rose slightly from 45.2% in 2000–2001 to 46.4% in 2019–2021, reflecting an increase of only 1.2%. Rural-urban inequalities showed the largest decline between 2000–2001 (D=30.0; R=2.0; PAF=33.5, PAR=15.2) and 2019–2021 (D=12.0; R=1.3; PAF=17.4, PAR=8.1). Disparities based on wealth (2000–2001: D=40.3; R=3.0; PAF=34.6, PAR=15.6; 2019–2021: D=30.5; R=2.1; PAF=25.1, PAR=11.6) and maternal education (2000–2001: D=25.1; R=1.6; PAF=49.8, PAR=22.5; 2019–2021: D=19.1; R=1.4; PAF=34.1, PAR=15.8) were also reduced. Inequalities related to the sex of the child were minimal. However, discrepancies across subnational regions were evident in both survey rounds.

Conclusion

Care-seeking behaviour for ARI in Mauritania has shown slow progress over the past 20 years. Large inequalities persist, particularly by place of residence, wealth and maternal education. Efforts to strengthen equitable health service access should prioritise reducing geographic and socioeconomic disparities by targeting children from poor households, with less educated mothers, and living in rural areas to ensure all children benefit equally from healthcare services.

How can we improve migrant health checks in UK primary care: 'Health Catch-UP! a protocol for a participatory intervention development study

Por: Carter · J. · Knights · F. · Mackey · K. · Deal · A. · Hassan · E. · Trueba · J. · Jayawardhena · N. · Alfred · J. · Al-Sharabi · I. · Ciftci · Y. · Aspray · N. · Harris · P. · Jayakumar · S. · Seedat · F. · Sanchez-Clemente · N. · Hall · R. · Majeed · A. · Harris · T. · Requena Mendez · A.
Introduction

Global migration has steadily risen, with 16% of the UK population born abroad. Migrants (defined here as foreign-born individuals) face unique health risks, including potential higher rates and delays in diagnosis of infectious and non-communicable diseases, compounded by significant barriers to healthcare. UK Public Health guidelines recommend screening at-risk migrants, but primary care often faces significant challenges in achieving this, exacerbating health disparities. The Health Catch-UP! tool was developed as a novel digital, multidisease screening and catch-up vaccination solution to support primary care to identify at-risk adult migrants and offer individualised care. The tool has been shown to be acceptable and feasible and to increase migrant health screening in previous studies, but to facilitate use in routine care requires the development of an implementation package. This protocol describes the development and optimisation of an implementation package for Health Catch-UP! following the person-based approach (PBA), a participatory intervention development methodology, and evaluates our use of this methodological approach for migrant participants.

Methods and analysis

Through engagement with both migrants and primary healthcare professionals (approximately 80–100 participants) via participatory workshops, focus groups and think-aloud interviews, the study aims to cocreate a comprehensive Health Catch-UP! implementation package. This package will encompass healthcare professional support materials, patient resources and potential Health Catch-UP! care pathways (delivery models), developed through iterative refinement based on user feedback and behavioural theory. The study will involve three linked phases (1) planning: formation of an academic–community coalition and cocreation of guiding principles, logic model and intervention planning table, (2) intervention development: focus groups and participatory workshops to coproduce prototype implementation materials and (3) intervention optimisation: think-aloud interviews to iteratively refine the final implementation package. An embedded mixed-methods evaluation of how we used the PBA will allow shared learning from the use of this methodology within the migrant health context.

Ethics and dissemination

Ethics approval granted by the St George’s University Research Ethics Committee (REC reference: 2024.0191). A community celebration event will be held to recognise contributions and to demonstrate impact.

Diet and diet-related challenges with specific focus on carbohydrates and carbohydrate counting in adults with type 1 diabetes: a cross-sectional study

Por: Sterner Isaksson · S. · Hellman · J. · Wijkman · M. · Imberg · H. · Olafsdottir · A. F. · Axelsen · M. · Lind · M.
Objectives

To explore dietary intake, diet-related challenges in glucose management and perceived needs for dietary support among Swedish adults with type 1 diabetes (T1D).

Design

Cross-sectional observational study based on an electronic survey that included the validated Meal-Q food frequency questionnaire and additional questions on dietary habits and management. Participant characteristics were retrieved from the Swedish National Diabetes Register. Descriptive and correlation analyses were conducted.

Setting

Three diabetes specialist clinics in Sweden.

Participants

375 adults with T1D.

Main outcome measures

Dietary intake and diet-related challenges in glucose management.

Results

A total of 191 persons (mean age 48 years; 48% female) consented to participate. The mean (SD) glycated haemoglobin A1c was 56 (13) mmol/mol, mean glucose 8.8 (2.2) mmol/L, time in range (TIR) 64% (18%) and BMI 27 (4.3) kg/m²; 41% used insulin pumps. Mean carbohydrate intake was 183 g/day (41% of energy, E%). Fibre intake was 23 g/day (3.1 g/MJ), and saturated fat intake was 29 g/day (15 E%), both inconsistent with dietary recommendations. About half (51%) found carbohydrate counting challenging, with 53% estimating carbohydrate intake visually and only 18% using advanced methods. Additionally, 48% reported reducing carbohydrate intake, and 61% avoided certain carbohydrate-rich foods due to glucose management difficulties. Approximately 40% of participants reported insufficient dietary guidance from their healthcare providers since diagnosis, 33% expressed interest in further dietitian support and 39% believed dietary changes could improve glucose control.

Conclusions

Participants reported lower fibre intake and higher saturated fat intake compared with dietary guidelines. Many found carbohydrate counting and carbohydrate-rich meals challenging. One-third expressed a wish for additional dietary support. These findings highlight the importance of improving access to tailored dietary counselling in routine T1D care.

Returning aggregate research results to participants: a scoping review of current practices, preferences and challenges

Por: Idnay · B. · Zhang · Y. · Sandra Therese · K. · Nestor · J. G. · Chung · W. K. · Weng · C.
Objectives

To synthesise the current evidence about practices, preferences and challenges related to returning aggregate research results to participants, with implications for public health, health equity and policy development.

Design

Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews framework.

Data sources

Four electronic databases—PubMed (National Library of Medicine), Excerpta Medica Database (Elsevier), Cumulative Index to Nursing and Allied Health Literature (Elton B. Stephens CO(mpany)) and Cochrane Library (Wiley)—were from inception to February 2025.

Eligibility criteria

English-language, peer-reviewed articles reporting practices or preferences for returning aggregate clinical research results to participants. Studies reporting only individual/incidental findings, opinion pieces and non-original research were excluded.

Data extraction and synthesis

Two reviewers independently screened studies and extracted data. Study quality was assessed using a modified Oxford Centre for Evidence-Based Medicine scale. Thematic synthesis identified patterns in dissemination methods, participant preferences and implementation barriers.

Results

Of 272 articles screened, 12 published between 2002 and 2019 were included. They employed cross-sectional, qualitative and mixed-methods design across North America, Europe, Africa and Australia. Half focused on cancer; others addressed malaria, autism, hypothyroidism, HIV prevention and preterm labour. Most (8/12) included patients; others also included researchers, caregivers or mixed stakeholders. Participants were predominantly middle-aged or older, female and well-educated. Only two studies assessed literacy, both using unvalidated self-reports. Eight studies explored preferences without returning results; four implemented disseminations via mailed reports, printed summaries, in-person discussions or digital platforms. Participants favoured mailed letters and face-to-face meetings over online methods. Six themes emerged: receiving results as respect; preference for personalised, timely formats; importance of cultural tailoring; emotional and ethical considerations; institutional barriers; and community engagement as a facilitator.

Conclusions

Returning aggregate research results to participants is ethically supported and strongly desired yet rarely practised. Bridging this gap requires clearer policy guidance, institutional support and equity-focused dissemination strategies. Health systems and researchers should adopt scalable, participant-centred approaches to fulfil ethical obligations and strengthen public trust in science.

Shaping well-being and healthy habits at work through tailored physical activity among remote and hybrid employees: study protocol for RCT

Por: Paluszak · A. · Molek-Winiarska · D. · Chomatowska · B. · Winiarski · S.
Introduction

This study aims to create a comprehensive model for shaping well-being and healthy habits at work through tailored training in physical activity among remote or hybrid workers.

Methods and analysis

This is a three-arm randomised controlled trial designed to assess the effects of tailored and general physical activity interventions compared with a no-intervention control group. It is assumed that both types of physical activity (general and tailored) might reduce musculoskeletal problems and presenteeism and improve well-being in a short time. However, a tailored type of training, prepared to reduce pain in specific muscles associated with long-term sedentary work, along with a detailed explanation of how exercises influence the muscles, will allow the development of healthy work habits and decrease negative symptoms in a long-term period. Therefore, short-term effects on well-being, presenteeism and musculoskeletal problems will be tested immediately after training and long-term ones—3 months after the end of the training. Well-being at work, presenteeism, work habits and workstations will be measured using research questionnaires. The level of musculoskeletal complaints will also be assessed using a standardised questionnaire specifying the location and the level of pain caused by the ailments. In addition, objective assessment tools will be used—electromyography (measuring the level of fatigue of specific muscles) and myotonometry (determining the level of muscle stiffness).

Ethics and dissemination

The study was approved by the Institutional Review Board (the Rector’s Commission on Research Ethics at the Wroclaw University of Economics and Business; Ethical Committee Decision number: 10/2025) and will be conducted in accordance with the Declaration of Helsinki. The findings of this research will be disseminated in the original article.

Trial registration number

ACTRN12624001311549.

Pregnant womens knowledge, attitudes and practices regarding hypothyroidism during pregnancy: a cross-sectional study at the Affiliated Hospital of Southwest Medical University

Por: Gan · Y. · Wan · Q. · Lin · H. · Zhang · Y. · Bai · X.
Objectives

This study examined the knowledge, attitudes and practices of pregnant women regarding hypothyroidism during pregnancy.

Design

A cross-sectional study.

Setting

Conducted at the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, China, between 10 March 2024 and 15 May 2024.

Participants

Data were obtained from 411 valid questionnaires (valid response rate: 74.46%). The average age of participants was 31.43±5.42 years.

Interventions

Data were collected using a specifically designed knowledge, attitudes and practices questionnaire.

Primary and secondary outcome measures

The median (IQR) scores for knowledge, attitude and practice were 14 (10, 17), 30 (23, 35) and 41 (33, 47), respectively. Awareness of thyroid hormone replacement safety during pregnancy, postpartum hypothyroidism risks and potential intellectual development issues in newborns was less than 50%.

Results

Multivariable logistic regression indicated that knowledge score (OR=1.068, p=0.008), attitude score (OR=1.075, p

Conclusion

The study finds that pregnant women generally possess good knowledge, positive attitudes and proactive practices regarding hypothyroidism. It emphasises the need for healthcare providers to implement educational interventions to improve understanding and health outcomes for pregnant women with hypothyroidism.

Development of explainable machine learning models to predict side effects in patients with rheumatoid arthritis taking methotrexate treatment: a nationwide multicentre cohort study

Por: Jang · J. · Kim · W. J. · Park · S. W. · Moon · K. W. W.
Objectives

Methotrexate (MTX) effectively controls rheumatoid arthritis (RA) but often leads to side effects (SE) such as gastrointestinal (GI) issues, liver toxicity and bone marrow suppression. To develop clinically interpretable machine learning (ML) models that accurately predict MTX-related SE in patients with RA taking MTX. The aim was to enhance predictive accuracy and to identify patient-specific risk factors using explainable artificial intelligence (XAI), thereby enabling transparent clinical interpretation. We specifically sought to address the unmet need for individualised risk stratification using real-world, multicentre observational data.

Design

Retrospective case-control study.

Setting

Across 23 rheumatology clinics in South Korea, based on data from a nationwide multicentre cohort.

Participants

A total of 5077 patients with RA were initially enrolled from the Korean Observational Study Network for Arthritis. After excluding those with missing clinical, demographic or prescription data and those not receiving MTX, 2375 patients remained eligible. Among these, 1654 and 1218 patients were included in the overall SE and GI SE analysis groups, respectively, after 1:1 propensity score matching. All patients were aged ≥18 years and met the 1987 American College of Rheumatology classification criteria.

Primary and secondary outcome measures

The primary outcome was the presence of SE in patients with RA taking MTX, categorised into overall SE and GI SE, based on standardised patient questionnaires and clinical assessments. The secondary outcome was the identification of key predictors using SHapley Additive exPlanations (SHAP) to enhance the interpretability of ML predictions.

Results

Among six ML classifiers, extreme gradient boosting demonstrated the highest performance in predicting overall SE (area under the curve (AUC) 0.781, F1 score 0.672, area under the precision-recall curve (AUPRC) 0.757) and GI SE (AUC 0.701, F1 score 0.690, AUPRC 0.670). SHAP analysis identified key predictive features including age, physician visual analogue scale score, alanine aminotransferase, Health Assessment Questionnaire score, celecoxib use and drug adherence. Logistic regression confirmed statistical significance for multiple variables (eg, OR 4.63; 95% CI 1.41 to 20.90 for non-adherence >30 days; OR 1.45; 95% CI 1.14 to 1.85 for celecoxib use). DeLong’s test indicated that boosting models significantly outperformed support vector machine (p

Conclusions

Interpretable ML models using real-world clinical data can accurately predict SE in patients with RA taking MTX. These models may facilitate early identification of high-risk individuals and inform personalised treatment strategies. Integration into clinical decision support systems could improve MTX safety monitoring. Further prospective validation in external cohorts is warranted.

Correlation between spiritual well-being and quality of life among patients with advanced cancer receiving palliative care in a tertiary cancer centre in Northern Kerala, India: a cross-sectional study

Por: M S · B. · Nair · S. · Shenoy · P. K. · Spruyt · O. · Venkateswaran · C. · K C · R. · K · R. · B · S. · D K · V.
Objectives

Spiritual well-being (SpWB) is a critical yet often underexplored component of holistic care for patients with advanced cancer. This study aimed to assess the SpWB and quality of life (QOL) levels and examine their correlation among patients receiving palliative care at a tertiary cancer centre in Kerala, India.

Design

Institution-based cross-sectional observational study among patients with advanced cancer conducted between August 2023 and December 2024.

Setting

The outpatient department of a major tertiary-level, autonomous cancer centre under the Government of Kerala, India.

Participants

398 patients with advanced cancer aged 18 and above.

Measures

SpWB and QOL were measured using validated Malayalam versions of the Functional Assessment of Chronic Illness Therapy–Spiritual well-being Expanded Version and European Organisation for Research and Treatment of Cancer, Quality of Life Core 30 questionnaires, respectively. Data collection included patient self-reports or assistance by a medical social worker.

Results

The median (IQR) age of participants was 59 (51–65) years; most were married (94.5%) and from an upper-lower socioeconomic background (55%). Hinduism was the predominant religion (67.1%). Almost all patients (99%) were aware of their diagnosis, but only 62.3% knew their prognosis. The median (IQR) SpWB score was 67.5 (57–76), significantly higher in females (p=0.02). The median (IQR) QOL score was 50 (41.7–66.7). SpWB was positively correlated with QOL (r=0.766, p

Conclusions

SpWB showed a strong positive correlation with QOL among patients with advanced cancer. Enhancing SpWB may play a pivotal role in improving overall QOL in palliative care settings.

INDEX study: intravenous dexamethasone palmitate for prophylaxis of postoperative nausea and vomiting: a study protocol for a randomised controlled study

Por: Ren · H. · Zhao · C. · Yuan · L. · Meng · L. · Shen · Y. · Luo · F.
Introduction

Dexamethasone is commonly used to prevent postoperative nausea and vomiting (PONV). However, PONV is an unresolved complex problem; even with preoperative dexamethasone administration, 14.0%–26.3% of patients undergoing minimally invasive endoscopic procedures still experience PONV within 24 hours postoperatively. Compared with dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, two to five times that of traditional water-soluble dexamethasone, with fewer adverse events. This trial aims to assess the efficacy and safety of preoperative dexamethasone palmitate administration on postoperative PONV.

Methods and analysis

The INDEX trial is a multicentre, open-label, randomised, positive-controlled trial. A total of 588 patients will be recruited from three centres in China. Eligible patients are adults (aged 18–65 years) who undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia. Eligible patients will be randomly assigned (1:1) to the dexamethasone palmitate or dexamethasone group. Patients in the dexamethasone palmitate group will receive intravenous injection of 8 mg of dexamethasone palmitate (containing 5 mg of dexamethasone), and those in the dexamethasone group will receive 5 mg of dexamethasone after anaesthesia induction and before surgical incision. The primary endpoint will be the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes will include the incidence of PONV, postoperative nausea, postoperative vomiting, number of vomiting or retching episodes, severity of PONV, participant satisfaction, use of rescue antiemetic drugs and quality of postoperative recovery. The safety of participants will be monitored. A primary analysis will be conducted to evaluate between-group differences in the incidence of PONV in the intention-to-treat population and within the first 24 hours postoperatively. We will also perform a sensitivity analysis to evaluate the effect of missing values in the outcome parameters on the results. There is no plan to conduct an interim analysis.

Ethics and dissemination

Ethical approval was obtained from the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY 2025-041-02-01). The results will be disseminated in open-access publications and plain-language summaries.

Trial registration number

NCT06981754

Psychometric Evaluations of the Hospital Survey on Patient Safety Culture Version 2.0 in Ethiopia (E-HSoPSC 2.0): A Cross-Sectional Study

Por: Fekadu · G. · Marshall · A. P. · Muir · R. · Tobiano · G. · Ireland · M. J.
Objectives

To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.

Design

A cross-sectional study.

Settings

Five public hospitals in Eastern Ethiopia.

Participants

Healthcare professionals (N=582).

Main outcome measure

An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.

Results

CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.

Conclusions

The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.

Clinical impact of multimodal cardiac imaging in Kawasaki disease: a prospective Kawasaki disease cardiac imaging (KDCI) cohort study with follow-up data in a Chinese population

Por: Zhu · Y. · Zhou · Z. · Hu · L. · Azhe · S. · Deng · X. · Peng · S. · Guo · Y.-k. · Wang · C. · Ma · Y. · Wen · L.-y.
Purpose

Coronary artery involvement remains the primary focus in the long-term management of Kawasaki disease (KD). However, previous studies suggest that myocardial abnormalities frequently persist beyond coronary artery involvement in KD patients. Yet, their temporal evolution and clinical implications remain poorly characterised. To address this gap, we established the Kawasaki disease cardiac imaging (KDCI) cohort, integrating cardiac magnetic resonance (CMR) with echocardiography, coronary CT angiography (CCTA) and invasive angiography. These multimodal imaging approaches enable comprehensive assessment of cardiac abnormalities and elucidate the role of cardiac imaging in optimising long-term KD management.

Participants

The KDCI cohort is a prospective study aiming to enrol 400–500 KD patients diagnosed at West China Second University Hospital from September 2018 to September 2035. To date, 207 participants have been recruited. Participants will perform the multimodal cardiac imaging including echocardiography, CMR, CCTA, invasive angiography and comprehensive laboratory testing under a scheduled protocol in the follow-up.

Findings to date

The KDCI cohort has established baseline characteristics for 207 KD patients. Of those included to date, 72.0% (149/207) received intravenous immunoglobulin (IVIG) treatment, with 26.1% (54/207) demonstrating IVIG resistance, and 37.7% (78/207) exhibiting coronary artery dilatation. Longitudinal follow-up data are available for 80.7% (167/207) of participants, with a median follow-up duration of 2.7 years and a follow-up patient-years of 594 patient-years. Of the 207 patients, 16.9% (35/207) patients experienced endpoint events, encompassing coronary artery thrombosis (8.2%, 17/207), coronary stenosis/obstruction (5.3% 11/207) and clinical myocardial infarction (1.9%, 4/207). Based on the data collected, we have demonstrated the cardiac abnormalities beyond coronary artery involvement in KD by CMR and CCTA.

Future plan

The KDCI cohort will maintain ongoing recruitment and longitudinal follow-up, with a projected enrolment exceeding 400 participants by 2035. This expansion will yield a median follow-up duration of 10 years, providing robust long-term outcome data. We have implemented standardised protocols for scheduled follow-up assessments and data collection in newly enrolled patients. Furthermore, planned genomic analyses will be incorporated to investigate the molecular pathogenesis and prognostic determinants of KD.

Telerehabilitation for people with Parkinsons disease: protocol of a randomised clinical trial of mixed methods

Por: Taveira · R. S. · Vasconcellos · L. S. d. · Bezerra · C. F. · Aires · D. N. · Dias de Oliveira · A. K. · da Silva · K. d. O. C. · Melo · L. P. d. · Ribeiro · T. S.
Introduction

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

Methods and analysis

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

Trial registration number

RBR-6h5knrj.

Identifying triggers for optimal timing of advance care planning in electronic primary health care records: a nested case-control study

Por: Tros · W. · van der Steen · J. · Numans · M. E. · Fiocco · M. · van Peet · P. G.
Objectives

To explore whether routine electronic healthcare records can be used to identify triggers for initiating advance care planning (ACP) and the optimal time window to initiate ACP. We aimed to assess the prevalence of triggers for initiating ACP as defined for use in routine data, whether their presence is associated with death, and what their position is relative to a previously identified ‘optimal time window for ACP’.

Design

Nested case-control study within a large dynamic population cohort dataset.

Setting

Primary care population-based, anonymised data extracted from GP centres in the South Holland province, The Netherlands.

Participants

We selected records of individuals aged ≥65 registered with their general practice from 1 Jan 2014 to 1 Jan 2017. Cases were individuals who died between 1 Jan 2017 and 1 Jan 2020. Controls were individuals who remained alive. Cases were matched by age to controls in a 1:4 ratio.

Main outcome measures

Outcomes include prevalence of triggers for ACP in the records of deceased and living individuals; association of the triggers’ presence with death; timing of the identified triggers in deceased individuals relative to the ‘optimal time window for ACP’.

Results

We included 17098 records, 4139 from deceased individuals (mean age 81) and 12959 from living individuals (mean age 79). Triggers most strongly associated with death were consultations concerning malignancy (OR 8.35, 95% CI 7.42 to 9.41), hospital admissions (OR 7.32, 95% CI 6.75 to 7.94), emergency department referrals (OR 7.11, 95% CI 6.52 to 7.75), registered home visits (OR 5.97, 95% CI 5.51 to 6.47), consultations concerning heart failure (OR 5.25, 95% CI 4.59 to 5.99), dementia (OR 4.75, 95% CI 3.99 to 6.56), opioid prescriptions (OR 4.58 (4.25–4.93), consultations concerning general decline/feeling old (OR 4.15, 95% CI 3.72 to 4.64) and skin ulcers/pressure sores (OR 4.04, 95% CI 3.55 to 4.61). Those closest to the median of the optimal time window for ACP were consultations regarding dyspnoea, general decline/feeling old, heart failure, skin ulcers/pressure sores and fever, opioid prescriptions, emergency department referrals, registered home visits and hospital admissions.

Conclusions

Clinical triggers for initiating ACP in general practice can be recognised within the routine electronic health records and they align well with the ‘window of opportunity’ to initiate ACP.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Prevalence of epilepsy and the epilepsy treatment gap in Bauchi, Northeast Nigeria: a cross-sectional study of two communities

Por: Nuhu · U. A. · Alkali · N. H. · Hassan · H. F. · Garba · M. · Abdulrauf · T. · Ibrahim · A. · Owolabi · L. · Ogunniyi · A. O.
Objective

Epilepsy prevalence varies widely across Nigeria, with rates ranging from 3.1 to 37.0/1000 population. There have been no studies on epilepsy prevalence and treatment gap in the Northeast Region of Nigeria. This study aimed to study epilepsy prevalence and the epilepsy treatment gap (ETG) in an urban and a rural community in Northeast Nigeria.

Design

Cross-sectional, community-based survey.

Setting

Epilepsy screening of residents in two communities in Northeast Nigeria using a WHO screening tool and a validated study questionnaire from 1 March to 10 June 2022.

Participants

8599 community residents aged ≥2 years.

Outcome measures

Prevalence of epilepsy, active epilepsy, ETG and associated factors.

Results

We screened 8599 residents, of whom 88 had epilepsy. Crude epilepsy prevalence was 10.2 per 1000 and was three times higher in the rural than in the urban community (18.5 vs 6.4; 2=26.79, p2=0.087, p=0.768). Logistic regression analysis showed that the ETG was associated with a lack of counselling (OR 15.8, 95% CI 3.5 to 70.7, p

Conclusion

The prevalence of epilepsy in Bauchi State was within the range reported in Nigeria but three times higher in the rural than in the urban community. A high ETG was associated with poor counselling of people with epilepsy. Epilepsy counselling, health education and wider access to neurology services could reduce the burden of epilepsy in Northeast Nigeria.

Measurement properties of assessment tools for affiliate stigma in parents of children with autism: a systematic review protocol

Por: Zhu · M. · Liu · J. · Xiao · H. · Shi · F. · Li · K. · Tao · L.
Introduction

Autism spectrum disorder (ASD) is a prevalent neurodevelopmental disorder. Parents of children with ASD often have a higher level of affiliate stigma, which impacts their physical and mental health, family relationships and social functions. Nowadays, a variety of assessment tools are available for measuring this stigma, but they have many limitations. This systematic review aims to critically appraise the measurement properties of instruments used to assess affiliate stigma in parents of children with autism and help researchers and healthcare professionals make more appropriate choices when using these tools.

Methods and analysis

This protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search five English databases (ie, PubMed, Web of Science, ScienceDirect Online, Embase and Cochrane Library) and four Chinese databases (ie, SinoMed, China National Knowledge Infrastructure, Wanfang Database and VIP information) from the databases’ inception to 30 September 2025. Eligible studies will evaluate instruments measuring affiliate stigma in parents of children with autism, including self-report and observer ratings. The psychometric properties assessed will include reliability, validity, responsiveness, interpretability and clinical utility. Only primary quantitative studies published in peer-reviewed journals will be included. The search will have no limitations on language or time. Two researchers will independently carry out data extraction and quality assessment, with disagreements resolved through consensus or a third researcher. The consensus-based standards for the selection of health measurement instruments risk of bias checklist and the Grading of Recommendations Assessment, Development and Evaluation approach will be used to evaluate each measure’s methodological quality and overall strength of evidence.

Ethics and dissemination

As this research constitutes a systematic review of pre-existing published data, formal ethics committee approval is deemed unnecessary in accordance with international research ethics guidelines. The synthesised findings will be submitted for publication in a rigorously peer-reviewed academic journal and presented at pertinent scientific conferences to ensure transparent knowledge dissemination within the academic community.

PROSPERO registration number

CRD420251043478.

❌