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Effectiveness of Virtual Baithak, an mHealth intervention to improve eye health literacy for the older adults in India: a protocol for a randomised controlled trial

Por: Rastogi · H. · Sarkar · D. · Rohilla · L. · Kumar · S. · Goyal · A. · Rana · G. S. · Singh · R. · Goyal · A. · Saini · S. K. · Gupta · V. · Pandav · S. · Duggal · M.
Introduction

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

Methods and analysis

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

Ethics and dissemination

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

Trial registration number

CTRI/2023/02/049383, dated 1 February 2023.

Comparing response rates between mobile web and telephone surveys for patient experience: a randomised experimental study in South Korea

Por: Koo · B. M. · Song · Y. · Choi · Y.-G. · Jo · M.-W. · Lee · Y. · Han · S. Y. · Kim · S. K. · Do · Y. K.
Objective

Healthcare quality improvement increasingly relies on patient experience data, yet traditional survey modes face declining response rates and rising costs. Mobile web surveys have emerged as a promising alternative for improving response rates. The primary aim of this study was to investigate the effectiveness of mobile web surveys in improving response rates in South Korea’s Patient Experience Assessment. We also aimed to assess the impact of a mixed-mode approach integrating mobile web and follow-up telephone surveys across different demographic groups.

Design

A randomised experimental design was employed to compare response rates as well as contact and cooperation rates among survey modes. A total of 4800 patients from four general hospitals were randomly allocated to telephone, mobile web or mixed-mode survey, with 1600 patients per mode. Each mode allowed five contact attempts through calls or mobile survey links. The mixed-mode survey included follow-up calls for mobile non-respondents.

Setting

The survey was conducted between October and November 2022 among patients discharged from four general hospitals in South Korea.

Participants

A total of 4800 patients aged 19 years or older who were hospitalised for more than 1 day and discharged within 2–56 days from four general hospitals were included in this study. Exclusion criteria included patients in day clinics, palliative care, paediatrics and neuropsychiatry, as well as those without personal information consent forms during hospital admission.

Primary and secondary outcome measures

The primary outcome measure was the response rate for each survey mode. Secondary outcome measures included the contact rate and the cooperation rate.

Results

The mobile web survey yielded an overall higher response rate (32.5%) than the telephone survey (22.4%), with the mixed-mode survey achieving the highest response rate (39.3%). Decomposing response rates revealed that while contact rates were comparable for both telephone and mobile web surveys, the cooperation rate was considerably higher for the mobile web survey (73.2%) compared with the telephone survey (52.2%). Substantial gender-age subgroup differences were found.

Conclusions

Adopting mobile web surveys for patient experience assessments, which aligns with the public’s preference for information and communication technologies, could significantly improve response rates in patient experience surveys.

Trial registration number

KCT0011374 (post-results).

Evaluation of non-ophthalmologist-led and offline AI-assisted models for diabetic retinopathy screening in India: a pragmatic diagnostic accuracy study

Por: Chauhan · A. · Vale · L. · Kankaria · A. · Tigari · B. · Kumar · S. · Yadav · M. · Kumar · L. · Kaur · G. · Bhadada · S. K. · Gupta · V. · Duggal · M.
Objectives

To assess and compare the diagnostic accuracy of non-ophthalmologist-led diabetic retinopathy screening (DRS) at health and wellness centres (HWCs) and offline artificial intelligence (AI)-assisted community-based screening, using specialist grading as the reference standard in India.

Design, settings and participants

Pragmatic diagnostic accuracy study in primary healthcare settings. The settings included HWCs and community-based screening sites in rural Block Boothgarh, Mohali District, Punjab, India. A total of 600 people with diabetes aged ≥30 years were enrolled across three screening models: (1) non-ophthalmologist-led DRS at the HWC, (2) AI-assisted smartphone-based DRS in the community and (3) standard referral-based care. Retinal images were captured using non-mydriatic fundus cameras and independently graded by two masked human graders; a senior retina specialist resolved any disagreements. The AI was assessed for its ability to detect diabetic retinopathy (DR) and referable diabetic retinopathy (RDR). Diagnostic performance metrics were reported.

Results

The non-ophthalmologist-led model demonstrated 86.4% sensitivity (95% CI 65.1% to 97.1%) and 94.3% specificity (95% CI 88.5% to 97.7%) for DR detection, with an ungradability rate of 8%. For RDR, sensitivity reached 95.8% (95% CI 78.9% to 99.9%) and specificity was 93.1% (95% CI 88.0% to 96.5%). The offline AI-assisted model achieved 93.3% sensitivity (95% CI 68.1% to 99.8%) and 85.1% specificity (95% CI 76.9% to 91.2%) for RDR, but with a higher ungradability rate (38%), mainly due to cataracts and poor image quality. Both approaches effectively identified referable cases; however, the non-ophthalmologist-led model demonstrated greater accuracy and operational feasibility.

Conclusions

This study demonstrates that non-ophthalmologist-led DRS at HWCs can enhance access to primary care. Offline AI-enabled screening demonstrates potential for community use but is currently limited by image quality and binary classification outputs. Integrating both approaches may strengthen DRS coverage in resource-limited settings.

Clinical trials registry of India

CTRI/2022/10/046283.

Digital Intervention for Psychedelic Preparation (DIPP): protocol for a randomised controlled feasibility trial comparing meditation- and music-based programmes in healthy volunteers

Por: McAlpine · R. · Jaglinska · M. · Jedlovszky · K. · Kuc · J. · Castro · A. · Piot · A. · Timmermann · C. · Skipper · J. I. · Sacchet · M. D. · Kamboj · S. K.
Introduction

Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the feasibility and preliminary efficacy of the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day mobile-accessible programme designed to prepare individuals for psychedelic experiences.

Methods and analysis

The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to one of two conditions: (1) DIPP-MEDITATE, which combines daily guided meditation with background music or (2) DIPP-MUSIC, which provides the same background music without guided meditation. Both groups will complete the 21-day digital intervention remotely. Following the intervention, participants will attend an in-person supervised psilocybin session, receiving a standardised 25 mg dose. Primary outcomes focus on feasibility metrics including recruitment efficiency, participant retention and adherence to the intervention protocol. Secondary outcomes assess subjective feasibility, acceptability and preliminary efficacy, specifically evaluating psychedelic preparedness, the quality of the psychedelic experience and changes in wellbeing, with follow-up assessments at 2 weeks, and at 3, 6 and 9 months post-session. Exploratory measures include neuroimaging, physiological, cognitive and psychological assessments, as well as voice note experience sampling through a chatbot (referred to as ‘DIPP-bot’) to monitor inner speech, thought and emotional states during the intervention and follow-up periods.

Ethics and dissemination

Approved by UCL Research Ethics Committee (ID: 19113/003), this study follows the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences. Confidentiality will be maintained throughout.

Trial registration number

NCT06815653.

Changes in the prevalence of adolescent tobacco use and its associated factors in Indonesia: analysis of repeated cross-sectional survey 2009-2019

Por: Suryadarma · A. Y. · Saputro · S. A. · Isnuwardana · R. · Destiwi · M. · Bassey · P. E. · Martini · S. · Sebayang · S. K.
Background

Adolescent tobacco use (ATU) is a global public health concern, causing significant morbidity and premature death. This study aimed to assess trends in the prevalence of ATU in Indonesia between 2009 and 2019 and to identify factors contributing to the observed changes.

Methods

This study performed secondary data analysis of three consecutive waves (2009, 2014, and 2019) of the Indonesian Global Youth Tobacco Survey (IGYTS). Weighted prevalence estimates and complex survey data analysed using multivariate logistic regression were established across the three-wave surveys. A pooled IGYTS data set was explored to determine the risk factors of the ATU. A multivariate decomposition analysis (MDA) was used to determine factors contributing to the prevalence change in male adolescents over the last two surveys.

Results

The prevalence of ATUs was 21.1% (38.2% in males; 6.4% in females), 18.6% (32.7% in males; 3.9% in females) and 19.8% (36.8% in males; 3.5% in females) for the three consecutive surveys, respectively. Being older adolescents, male, exposed to SHS (secondhand smoke) at home, tobacco industry promotion, not knowledgeable of the dangers of tobacco smoke and SHS, and against banning smoking in public places were associated with ATU consistently across the surveys. In addition, inadequate anti-cigarette media and not being knowledgeable of the difficulty of quitting smoking were also identified as risk factors in the pooled data. MDA showed that 88.94% of the explained change was due to differences in the composition of explanatory variables between the last two surveys.

Conclusions

This study suggests that social influence and tobacco industry promotion significantly impact ATU in Indonesia. Governments should emphasise these factors in their tobacco control interventions.

Enhancing palliative care in intensive care units: protocol of EPIC, a controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase

Por: Mentzelopoulos · S. D. · Hartog · C. S. · Tenge · T. · Schwenkglenks · M. · Piper · S. K. · Barbier · M. · Rusinova · K. · Neukirchen · M. · Schüürhuis · S. · Jensen · H. I. · van Heerden · V. · Dutzmann · J. · Drescher · D. · Zvara · M. · Metaxa · V. · Nachshon · A. · De Robertis
Introduction

Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.

Methods and analysis

This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.

The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.

Ethics and dissemination

EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.

Trial registration number

NCT06605079.

Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark - a stud

Por: Wolsing · S. K. · Hilberg · O. · Lokke · A. · Farver-Vestergaard · I. · Andersen · C. U. · Hansen · K. K.
Introduction

Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of 9-tetrahydrocannabinol (9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.

Methods

This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.

Discussion

This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.

Ethics and dissemination

Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.

Trial registration number

The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).

Development of prison-based parent-child joint intervention for incarcerated fathers: protocol for mixed-methods study

Por: Yiu · W. Y. · Fung · Y. L. · Tsang · S. K. M. · Chan · C. H. Y. · Wong · P. W. C.
Introduction

Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.

Methods and analysis

A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.

Ethics and dissemination

This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.

Understanding the impact of temporary childbirth migration on maternal and child health: study protocol of a community-based prospective cohort study in India

Por: Patil · R. · El Ayadi · A. M. · Tonde · K. · Choudhari · B. · Bhujbal · S. · Murro · R. · Agarwal · D. · Charlebois · E. · Bansal · P. · Nitnaware · N. · Kalantri · A. · Mundra · A. · Goyal · N. · Raut · A. · Rongsen-Chandola · T. · Juvekar · S. K. · Diamond-Smith · N.
Introduction

Temporary childbirth migration (TCM), where women return to their natal homes for pregnancy, delivery or postpartum for a limited duration, is a long-standing sociocultural practice in India. While often motivated by familial support and traditional norms, its implications for maternal and child health and health system engagement remain poorly understood. This study aims to quantify the impact of TCM on maternal and newborn outcomes and to explore how continuity of perinatal care and social support mediate these relationships.

Methods and analysis

We are conducting a three-site, community-based, prospective cohort study across the Health and Demographic Surveillance System sites of Vadu (Maharashtra), Sevagram (Maharashtra) and DEESHA (Delhi). A total of 3000 pregnant women will be enrolled in pregnancy (

Ethics and dissemination

This study has been approved by the Ethics committees at the KEM Hospital Research Centre Pune (KEMHRC/RVM/EC/1931), Society for Applied Studies (SAS/ERC/TCM Study/2024), Mahatma Gandhi Institute of Medical Sciences (MGIMS/lEC/COMMED/8412023) and University of California San Francisco (22-36484). All research activities are conducted in accordance with Indian Council of Medical Research Guidelines for biomedical research and the Declaration of Helsinki. On study completion, findings will be disseminated to diverse local, national and global stakeholders and published in academic journals.

Trial registration number

CTRI/2024/02/062881.

Variations in bronchopulmonary dysplasia prevalence and outcomes by definition: a multicentre cohort study from the Chinese Neonatal Network

Por: Yang · G. · Wang · L. · Gao · C. · Li · W. · Zhao · F. · Cao · Y. · Zhou · W. · Du · L. · Chen · C. · Lee · S. K. · Yang · J. · Zhang · H.
Objectives

To examine bronchopulmonary dysplasia (BPD) epidemiological data in Chinese very preterm infants and compare agreement between four diagnostic definitions and their predictive accuracy for discharge outcomes.

Design

Observational epidemiologic study of a multicentre cohort of the Chinese Neonatal Network (CHNN).

Setting

Tertiary neonatal intensive care units participating in the CHNN.

Participants

42 664 preterm infants born at

Measures

BPD was diagnosed using four definitions: Shennan 1988, the National Institute of Child Health and Human Development (NICHD) 2001 and 2018, and the Neonatal Research Network (NRN) 2019 definitions. BPD prevalence and severity were examined. Agreement was assessed using kappa statistics. Predictive accuracy for discharge outcomes was evaluated using c-statistics from multivariable generalised estimating equation models.

Results

Among 42 664 infants (mean gestational age, 29.0 weeks; 43.1% females), BPD prevalence varied significantly: Shennan 1988: 37.0%, NICHD 2001: 51.1%, NICHD 2018: 37.0%, NRN 2019: 37.0%. NICHD 2001 and 2018 definitions classified more infants as severe BPD (16.4% and 10.1%, respectively), while NRN 2019 classified more as grade 2 (moderate; 15.0%). Shennan 1988 showed good agreement with NICHD 2018 (=1.0) and Jensen 2019 (=1.0). Shennan 1988 (c-statistic range: 0.921–0.974), NICHD 2018 (0.948-0.978) and NRN 2019 (0.949-0.982) demonstrated higher discriminative accuracy for discharge outcomes than NICHD 2001 (0.854–0.925).

Conclusions

This study found a high prevalence of BPD among very preterm infants in China, varying by definitions. The Shennan 1988, NICHD 2018 and NRN 2019 definitions showed good agreement and better predictive accuracy for outcomes at discharge compared with NICHD 2001. These definitions could be prioritised for clinical use in our population.

Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)

Por: Al Alawi · A. M. · Al Busaidi · S. · Al Rasbi · S. K. · Al Farsi · R. S. · Al Zeedy · K. · Al Huraizi · A. R. · Al-Maqbali · J. S.
Objectives

To evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.

Design

Single-centre, double-blinded, randomised, placebo-controlled trial.

Setting

General medical wards of a tertiary hospital in Oman.

Participants

Patients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.

Interventions

Participants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.

Primary and secondary outcome measures

The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.

Results

The study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.

Conclusions

In this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.

Trial registration number

NCT06509191.

The journey to healing: exploring travel challenges and associated costs for cancer care at a tertiary care centre in Puducherry, Southern India - a mixed methods study

Por: Devaraj · L. · Ayiraveetil · R. · Arikrishnan · K. · Sahu · S. K. · Ganesan · P. · Karunanithi · G. · Auroprem · S. P. · Srinivasan · T. S. · Thulasingam · M.
Objectives

This study aims to assess travel time, associated costs, challenges and factors influencing healthcare facility choices among persons with cancer in Southern India.

Design

An explanatory sequential mixed methods study.

Setting

The study was conducted in the cancer care outpatient department at a tertiary care centre in Puducherry, Southern India.

Participants

A total of 192 persons with cancer aged 18 to 65 years, diagnosed with breast, lip and oral cavity, cervical, lung or upper gastrointestinal cancers, and attending the cancer care centre between 2023 and 2024, were enrolled in the study through systematic random sampling. Additionally, 10 in-depth interviews were conducted using purposive sampling.

Results

Of the 192 participants, 89 (46.4%) belonged to a lower socioeconomic group, and 178 (92.7%) reported experiencing financial hardship while undergoing cancer treatment. The median travel time to a tertiary care centre was 4.3 hours (IQR: 2.07–7.3), with a median direct non-medical cost of Indian Rupees (INR) 453 (IQR: 200–987). Median expenditures for travel, food and accommodation were INR 200 (IQR: 123–400), INR 360 (IQR: 150–613) and INR 30 (IQR: 20–60), respectively, per single visit. A significant proportion of participants (n=146, 76%) were unaware of nearby cancer treatment centres and relied on peer recommendations when choosing their place of treatment. Key challenges identified included long-distance travel, financial burden due to high food and transportation costs and limited affordability for accommodation.

Conclusion

The study highlights that prolonged travel time and associated costs pose substantial financial strain on cancer-affected families. Enhancing awareness of available healthcare facilities, implementing patient-friendly travel and accommodation support systems and decentralising cancer care services can improve accessibility and mitigate both travel and financial burdens.

Defining chronic ambulatory care sensitive conditions in Malaysia: a collaborative consensus study

Por: Md.Sharif · S. · Fun · W. H. · Chidambaram · S. K. · Saw · P. S. · Mohd Nasarruddin · A. · Mohd Fauzi · N. · Azali · A. · Jailani · A.-S. · Sararaks · S.
Objective

This paper aims to describe the development of an inventory of chronic ambulatory care sensitive conditions (ACSCs) relevant to the Malaysian context and identify potentially preventable hospitalisations in the Malaysian Ministry of Health (MOH) facilities based on the developed list.

Design

Consultative panel discussion, multi-panel modified Delphi and secondary health data analysis.

Setting: Malaysian MOH healthcare facilities.

Participants

42 experts from the family medicine and internal medicine specialties (modified Delphi), and 2022 inpatient data from MOH hospitals (secondary health data analysis).

Outcome measures

A list of chronic ACSCs tailored to the Malaysian context and the proportion of potentially preventable hospitalisation in MOH hospitals.

Results

10 conditions were identified as chronic ACSCs for Malaysia, namely angina, asthma, chronic kidney disease, convulsions and epilepsy, chronic obstructive pulmonary disease, diabetes mellitus, heart failure, hypertension, iron deficiency anaemia and ischaemic heart disease. In 2022, these conditions accounted for 8.6% of potentially preventable hospitalisations among the total hospitalisations in MOH hospitals.

Conclusion

This study provides a base list of chronic ACSCs tailored to the Malaysian context, which enables monitoring of potentially preventable hospitalisations due to chronic conditions. The findings underscore a proportion of hospital admissions that could potentially be avoided through interventions that enhance outpatient care. The conditions identified as ambulatory care sensitive provide specific targets for policy action and resource allocation to optimise outpatient health services and thus reduce the burden of hospitalisations in the country.

Trial registration number

Malaysian National Medical Research Register, NMRR ID-23–02149-TBZ (https://nmrr.gov.my/research-directory/45c901d6-f121-4e79-9f38-dd7d283ec9a6).

Implementation of the community health system innovation project in three low- and middle-income countries: COHESION-I study protocol

Por: Lazo-Porras · M. · Bernabe-Ortiz · A. · Damasceno · A. · Sharma · S. K. · Praveen · D. · Mayo-Puchoc · N. · Aya Pastrana · N. · Bazan Maccera · M. · Chauque · A. · Cahuana-Hurtado · L. · Cardenas · M. K. · Gautam · U. · Khanal · V. K. · Jessen · N. · Mugabe · N. · Pereyra · R. · Pesant
Background

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

Methods and analysis

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Ethics and dissemination

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number

NCT06989502.

Measuring and monitoring safety of older adults living in retirement homes: a scoping review protocol

Por: Backman · C. · Engel · F. D. · Tonjock Kolle · A. · Papp · R. · Lam · A. · Freeman · L. · Li · W. · Sterling · E. · Fung · S. G. · Sinha · S. K. · Manis · D. R. · Wang · T.-F. · Kehoe MacLeod · K. · Hecimovich · C. · Webber · C. · Maskerine · C. · Syrowatka · A. · Fancott · C. · Kobewka · D
Background

The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.

Methods

This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).

Ethics and dissemination

No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.

Maximizing Ageing Using Volunteer Engagement (MAUVE): one health systems journey to spread a volunteer-based intervention for acutely ill older adults - a prospective observational study

Por: Kokorelias · K. M. · Foster · N. · Gali · A. · Ellis · B. · Melady · D. · Sinha · S. K.
Objectives

Older inpatients face a higher risk of delirium, falls and functional decline during hospital stays. Volunteer programmes have been shown to improve patient outcomes in single settings, but little is known about their implementation and spread across multiple care environments. This study describes the implementation and system-wide spread of Maximizing Ageing Using Volunteer Engagement (MAUVE)—a volunteer-based programme supporting older patients’ cognitive, physical and social well-being—and evaluates its impact on healthcare staff satisfaction.

Design

A prospective observational service evaluation.

Setting

Emergency department, seven acute in-patient care units and two transitional care units within a Canadian hospital system from January to December 2019.

Participants

Older patients receiving care, volunteers delivering interventions and front-line nursing staff.

Interventions

Trained volunteers delivered up to six types of interventions targeting patients’ cognitive stimulation, physical activity, social engagement, functional support, orientation and companionship.

Outcome measures

Staff satisfaction with the MAUVE programme was measured using a structured survey administered 6 months after programme implementation. Data on patients and volunteers—including the number and type of interventions delivered, volunteer hours and patient reach—were also collected to assess feasibility and programme uptake.

Results

Over 12 months, 94 volunteers delivered 31 593 interventions to 3568 unique patients across three care settings. Front-line staff reported high satisfaction with the MAUVE programme, noting that volunteers enhanced patient care and enabled more direct patient interaction by staff.

Conclusions

The MAUVE programme is the first known volunteer-led patient engagement programme to be successfully implemented across acute, emergency and transitional care settings. This service evaluation demonstrates that structured volunteer engagement can support older patients’ well-being while enhancing staff satisfaction and enabling front-line care providers to deliver more direct care.

Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial)

Por: Yuen · S. K. K. · Liu · S. · Gauhar · V. · Mai · H. · He · W. · Hu · H. · Ke · C. · Dai · Y. · Shan · L. · Jiang · Y. · Yuan · J. · Cao · Z. · Zuo · L. · Yang · C. · Bai · B. · Bi · X. · Zhao · H. · Xi · M. · Ding · N. · Deng · S. · Tang · S. · Zeng · J. · Du · J. · Wu · W. · Ma · J. · Zhong · W. · Zhao
Introduction

Flexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS—which enables active controlled deflection—can improve the success rate of lower pole access during flexible ureteroscopy.

Methods and analysis

This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18–75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien–Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins.

Ethics and dissemination

The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences.

Trial registration number

NCT06898216.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A.
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

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