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Factors influencing data quality in electronic health records among health professionals in hospital settings: a scoping review protocol

Por: Brinkmann · E. M.-B. · Haahr · A. · Bossen · C. · Aadal · L.
Introduction

Data quality in electronic health records (EHRs) is central to data-informed healthcare. Health professionals play a key role in ensuring data quality yet the complexities of clinical data practices remain poorly understood. Previous reviews have focused on specific documentation domains or professions, leaving a gap in understanding the broader individual, organisational, technological and contextual factors influencing data quality in hospital settings. This scoping review aims to identify and map factors that promote or hinder data quality in EHRs among health professionals in hospital settings.

Methods and analysis

The review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR) checklist. Peer-reviewed studies will be identified through comprehensive searches in PubMed, Scopus, Web of Science, CINAHL and Google Scholar. Two independent reviewers will screen titles, abstracts and full texts and extract data using the JBI Extraction Form. Data will be charted and mapped according to the six dimensions of the Digital Health Data Quality Dimension and Outcome (DQ-DO) framework—accuracy, completeness, consistency, contextual validity, currency and accessibility—and analysed across professional groups and hospital contexts.

Ethics and dissemination

Ethical approval is not required for this scoping review as it is based on publicly available data. The findings will be disseminated through peer-reviewed publication and presentations at relevant academic and clinical conferences.

Registration

The protocol has been registered in the Open Science Framework: https://doi.org/10.17605/OSF.IO/YQ2DX

Effect of yoga on musculoskeletal complaints in women during endocrine treatment for breast cancer: protocol of the randomised controlled COBRA trial

Por: Veenhuizen · S. G. A. · Gal · R. · Cramer · H. · Bijlsma · R. M. · Blickle · P. · van der Palen · J. · Wagenaar · Q. R. C. M. · van Leer · E. · Konings · I. · van den Bongard · D. H. J. G. · May · A. M. · Monninkhof · E. M.
Introduction

Approximately 40% of women stop endocrine therapy for hormone-receptor-positive breast cancer within the first 5 years of prescribed treatment because of side effects. Musculoskeletal complaints are among the most frequently reported side effects. The Cancer Of the BReast Asanas (COBRA) study examines the effect of an 18-week yoga programme on endocrine therapy-associated musculoskeletal complaints in women with breast cancer.

Methods and analysis

In total, 140 women will be randomised in a 1:1 ratio to the intervention or waitlist control group. The intervention programme consists of two times a week 1-hour supervised Hatha or (easy) Vinyasa yoga classes at a yoga or sports centre for 18 weeks and once per week a half-hour at home using videos. The waitlist control group is asked to maintain their habitual lifestyle during the first 18 weeks and will participate in a similar yoga programme to the intervention group for the following 18 weeks. The control group yoga programme is offered live-remote. The primary outcome (musculoskeletal complaints) is assessed with the Brief Pain Inventory questionnaire at baseline and 18 weeks (primary comparison) and additionally at 36 weeks. Secondary outcomes include lower and upper extremity joint complaints, menopausal symptoms, fatigue, sleep, quality of life, anxiety and depression, cognitive complaints and habitual physical activity (all patient-reported), vital signs and anthropometrics, physical fitness, blood biomarkers, medication use, safety data and patient and teacher experiences. At baseline and 18 weeks, cognitive complaints are also assessed with an online neuropsychological test battery.

Ethics and dissemination

The COBRA study was approved by the Medical Ethical Committee of the University Medical Center Utrecht. The study started on 8 October 2024, and 65 participants have been included (20 January 2026). Results will be submitted to an international peer-reviewed journal.

Trial registration number

NCT06480513.

Spatial variation in HIV test non-uptake among antenatal care-attending pregnant women in sub-Saharan Africa: a cross-sectional study using demographic and health survey data

Por: Alemu · E. A. · Endalamew · S. G. · Alemaw · H. B. · Kebede · H. A. · Assefa · S. K. · Andarge · E. M. · Taye · E. A. · Asgedom · D. K. · Kebede · S. A. · Zegeye · A. T. · Abate · B. J.
Objectives

This study assessed the spatial distribution of HIV test non-uptake among pregnant women who attended antenatal care (ANC) in sub-Saharan Africa.

Design

Cross-sectional study design.

Setting

Sub-Saharan Africa (SSA) region. 24 SSA countries were included in this study.

Data source

Demographic and Health Survey (DHS), 2016–2024.

Participants

82 397 women who were pregnant in the last 2 years preceding the survey.

Outcome measure

HIV test non-uptake, which is a legacy indicator of HIV test among pregnant women.

Result

The HIV test non-uptake among ANC attending pregnant women was 39.6% (95% CI 39.27% to 39.93%). The spatial autocorrelation test revealed that HIV testing non-uptake among pregnant women was clustered. The global Moran’s I value was 0.48 with a p value

Conclusion

There was a significant geographical variation in HIV test non-uptake among pregnant women attending antenatal care (ANC) in sub-Saharan Africa. Prioritising hotspot areas with high rates of HIV test non-uptake for spatially targeted interventions is essential. Policymakers, health professionals, and other stakeholders should focus on improving women’s formal education, expanding health insurance coverage, and increasing ANC contacts to ensure that each visit includes HIV screening. Moreover, special attention should be given to younger women to enhance HIV testing uptake among those attending ANC in sub-Saharan Africa.

Implementation of a hospital deprescribing behaviour change intervention, the CompreHensive geriAtRician-led MEdication Review (CHARMER) trial: a process evaluation protocol

Por: Martin-Kerry · J. M. · Bhattacharya · D. · Taylor · J. · Kellar · I. · Atkins · B. · Jones · C. E. L. · Bywater-Florance · E. M. · Keevil · V. L. · Clark · A. B. · Wright · D. J. · Alldred · D. P. · Scott · S.
Introduction

Proactive deprescribing is the process of stopping a medicine and comprises four steps: (1) identify a patient for potential stop of a medicine, (2) evaluate a patient for potential stop of a medicine, (3) stop a medicine and (4) monitor after stopping.

The CHARMER (CompreHensive geriAtRician-led MEdication Review) trial is a stepped-wedge design to evaluate the effectiveness and cost-effectiveness of a behaviour change intervention to increase proactive deprescribing in hospitals. The CHARMER intervention comprises a deprescribing action plan, deprescribing briefings, videos of successful deprescribing consultations, deprescribing case studies workshop and a deprescribing performance dashboard. The process evaluation will explore trial processes, CHARMER intervention implementation, CHARMER behavioural mechanisms of action and contextual factors influencing these aspects.

Methods and analysis

The convergent parallel design process evaluation will follow the UK Medical Research Council guidance. We will interview: staff involved in CHARMER implementation, geriatricians and pharmacists who receive the intervention and research delivery staff involved in patient/carer recruitment and data collection. We will also interview patients/carers and primary care practitioners. Interviews will be supplemented with recordings of implementation activities and completed implementation manuals. Questionnaires will capture the extent to which the four proactive deprescribing steps are enacted by intervention recipients, measure the behavioural mechanisms by which the CHARMER intervention operates and capture the patient experience of proactive deprescribing. Qualitative data will be analysed thematically and then mapped to Normalisation Process Theory to explore implementation and the Theoretical Domains Framework to explore behaviour change. Most quantitative data will be analysed descriptively; however, changes in staff questionnaire responses preintervention and postintervention will be analysed using a Mann-Whitney test. We will triangulate qualitative and quantitative findings to explain intervention effects.

Ethics and dissemination

Ethical and governance approvals have been obtained by the Wales 2 Research Ethics Committee and the Health Research Authority, respectively. The dissemination strategy will be underpinned by the evidence-based Guide to Disseminating Research (GuiDiR) targeting healthcare practitioners, policy makers and patient-facing organisations.

Trial registration number

ISRCTN13248281.

Effect of iron dose in maternal multiple micronutrient supplement on perceived side effects, adherence, acceptability and preferences: protocol for a randomised crossover trial

Por: Sudfeld · C. R. · Muhihi · A. · Sylvetsky · A. C. · Metta · E. · Brownlee · V. S. · Oakley · E. M. · Bakari · M. · Fawzi · W. W. · Kinyogoli · S. · Kuiper · J. R. · Mugusi · S. · Pan · Q. · Sando · M. M. · Wylie · B. J. · Masanja · H. · Smith · E. R. · Pembe · A. B.
Introduction

Iron-folic acid (IFA) supplementation in pregnancy is recommended by the WHO, with a dose of 60 mg of iron in contexts where anaemia remains a severe public health problem. Iron-containing supplements may cause side effects that affect acceptability and adherence in a dose-response manner. Maternal multiple micronutrient supplements (MMS), which include iron and folic acid plus additional micronutrients, are also recommended in the context of rigorous research, and programmes are considering transitioning from IFA to MMS containing 30 mg of iron. We will evaluate the effect of iron dose in MMS on maternal acceptability, side effects, adherence and preferences.

Methods and analysis

The Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial is an individually randomised, quadruple-blind, non-inferiority crossover trial of daily antenatal MMS supplementation formulations that contain 60 mg, 45 mg and 30 mg elemental iron among pregnant women in Dar es Salaam, Tanzania. A total of 156 pregnant participants will be randomised to a sequence in which they receive each of the three MMS formulations for 1 month. Participants, investigators, outcome assessors and data analysts will be blinded to the treatment sequence. The primary trial outcome is participant-reported acceptability of each MMS formulation, measured on a Likert scale. Secondary and tertiary outcomes include preferred and least preferred formulation, identification of MMS formulation, reported side effects and adherence assessed by pill count. Regression analyses will be used to assess differences between formulations and will account for sequence and period effects of the crossover trial design. Qualitative in-depth interviews from a subsample of participants will be conducted to understand women’s perceptions and experiences taking the different MMS formulations.

Ethics and dissemination

The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board (IRB), the Ifakara Health Institute IRB, the Muhimbili University of Health and Allied Sciences IRB, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Results will be shared through publications and presentations at the local, regional and international levels.

Trial registration number

ClinicalTrials.gov Identifier: NCT06069869.

Incidence and risk factors of C. trachomatis, N. gonorrhoeae and syphilis among a cohort of urban Canadian gay, bisexual and other men who have sex with men, 2017-2023: informing the potential impact of doxycycline prophylaxis

Por: Lambert · G. · Fourmigue · A. · Dvorakova · M. · Moodie · E. E. M. · Moore · D. · Lachowsky · N. J. · Grace · D. · Hart · T. A. · Tan · D. H. S. · Jollimore · J. · Labbe · A.-C. · Fortin · C. · Maheu-Giroux · M. · Hull · M. · Grennan · T. · Brunelle-Newman · S. · Zhang · T. · Lal · A. · Go
Objectives

Doxycycline as post-exposure prophylaxis (doxy-PEP) has emerged as an efficacious strategy to reduce Chlamydia trachomatis (C. trachomatis), Neisseria gonorrhoeae (N. gonorrhoeae) and syphilis (sexually transmitted infections (STIs)) among gay, bisexual and other men who have sex with men (GBM). There is a need to identify prescribing criteria that maximise the number of STIs averted while minimising excessive use.

Design

In this prospective longitudinal cohort study with repeated measures and biobehavioural data collection, participants completed a questionnaire and tested for STIs at each visit.

Setting

Community-based, population-level study conducted in three large Canadian cities between February 2017 and July 2023.

Participants

2449 GBM were recruited through respondent-driven sampling (RDS); 1998 had ≥1 follow-up visit, contributing 7551 person-years of observation. Eligible participants were aged ≥16 years, cis- or transgender men, reported sex with another man in the past 6 months and resided in Montreal, Toronto or Vancouver.

Primary and secondary outcome measures

Adjusted rate ratios (aRR) of STIs, accounting for RDS recruitment, loss to follow-up and confounding were estimated using generalised estimating equations (GEE) Poisson regression. For identified STI risk factors, the proportions of STIs averted through doxy-PEP prescription (based on the efficacy of doxy-PEP for each bacterial STI) and the number needed to treat (NNT) for 1 year to avert one STI, assuming 100% adherence, were calculated.

Results

Among 1998 participants, the combined incidence rate of any C. trachomatis, N. gonorrhoeae and syphilis infection was 29.5 (95%CI 27.3 to 31.9) per 100 person-years. STI risk factors that had the most impact as doxy-PEP criteria were history of any of the three STIs in the past 12 months (P12M) (aRR=2.0, 95% CI 1.8 to 2.2, 36% STI averted, NNT=2.1); ≥10 male sexual partners in the past 6 months (P6M) (aRR=3.8, 95% CI 3.0 to 4.9, 41% STI averted, NNT=2.4); HIV-pre-exposure prophylaxis (PrEP) use P6M (aRR=1.7, 95% CI 1.5 to 2.0, 29% STI averted, NNT=2.5); use of any chemsex-related substance P6M (aRR=1.2, 95% CI 1.1 to 1.4, 28% STI averted, NNT=2.6); and group sex event attendance P6M (aRR=1.2, 95% CI 1.1 to 1.3, 27% STI averted, NNT=2.3). Reporting≥10 male sex partners P6M represented the most useful criterion for syphilis prevention (52% syphilis infections averted, NNT=20). Prescribing doxy-PEP to GBM having any of the following STI risk factors, namely, ≥1 bacterial STI P12M, ≥10 male sex partners P6M, or HIV-PrEP use P6M, would substantially increase the proportion of all STI diagnoses potentially averted (60%) with minimal increase of the NNT (2.7).

Conclusion

This work informs on the impact of various doxy-PEP clinical prescribing criteria and demonstrates the benefit of focusing on any of the following three criteria: ≥1 bacterial STI P12M, ≥10 male sex partners P6M or HIV-PrEP use P6M.

Effect and neurophysiological mechanisms of transcutaneous auricular vagus nerve stimulation (taVNS) for misophonia (taVNS-MISO): a study protocol for a single-centre double-blind randomised sham-controlled trial

Por: Rinaldi · L. J. · Karapanagiotidis · T. · Koch · E. M. W. · Sanderson · A. · Strawson · W. H. · Simner · J. · Eccles · J. · Critchley · H. · Aazh · H. · Poerio · G. L.
Introduction

Misophonia is a newly recognised sound sensitivity disorder with clinically significant symptoms affecting up to 18% of the population. It is characterised by extreme negative reactions to specific sounds which are often repetitive and generated by the human oral-nasal tract (eg, sniffing and eating sounds). Although misophonia currently has no standard treatment, research suggests that transcutaneous auricular vagus nerve stimulation (taVNS) holds promise therapeutically. This study aims to investigate both the effects of 4 weeks taVNS (compared with sham) on misophonia and related symptoms as well as its underlying neurophysiological mechanisms. To our knowledge, this is the first trial on taVNS in misophonia.

Methods and analysis

This is a single-centre double-blind sham-controlled trial in which 60 participants with clinically significant misophonia are randomly allocated in a 1:1 ratio to receive taVNS or sham stimulation. The intervention will be self-administered over 4 weeks (two times per day for 30 mins each). The primary efficacy outcome is self-reported misophonia severity with secondary outcomes, including mental health and audiological symptoms. In addition, all participants will undergo preintervention and postintervention testing, including MRI and physiology to investigate neurophysiological mechanisms underlying taVNS effects.

Ethics and dissemination

The study has been approved by the Brighton and Sussex Medical School ethics board (ER/GLP28/4). Results will be submitted for publication in peer-reviewed journals. Data will be anonymised and made available for sharing after completion of the study.

Trial registration number

This trial is registered in ISRCTN; ISRCTN79500062.

Seroprevalence of COVID-19 among healthcare workers in Hong Kong during the first 2 years of the COVID-19 pandemic (2020-2021): a longitudinal cohort study

Por: Lim · W. W. · Mak · L. · Ho · F. · Ng · T. W. Y. · Yau · E. M. · Ko · R. L. W. · Chen · D. · Xiao · J. · Seto · W. H. · Cheng · S. M. S. · Perera · R. A. P. M. · Ip · D. K. M. · Peiris · M. · Cowling · B. J.
Background

In the first 2 years of the COVID-19 pandemic, Hong Kong adopted strict public health and social measures to stop community transmission of SARS-CoV-2. These include border screening and control, isolation of cases and quarantine of their contacts and universal masking. During this period, attack rates in Hong Kong were among the lowest globally.

Objectives

To estimate the seroprevalence of COVID-19 among healthcare workers (HCWs) in Hong Kong in 2020 and 2021.

Methods

We reviewed contact tracing data from the Hong Kong Department of Health to identify COVID-19 cases reported among HCWs. Between June 2020 and December 2021, we conducted a longitudinal cohort study to estimate the seroprevalence of COVID-19 among HCWs working in hospitals and clinics in Hong Kong during the first 2 years of the COVID-19 pandemic.

Results

Overall seropositivity of COVID-19 by plaque reduction neutralisation test during the first (May–October 2020) and second round (November 2020–April 2021) of the study was 0% (95% CI 0.00% to 0.49%) and 0.52% (95% CI 0.14% to 1.33%). After COVID-19 vaccines were offered to HCWs in February 2021, seroprevalence by surrogate virus neutralisation assay among cohort participants who provided biannual blood samples rose to 68.7% (95% CI 65.9%, 71.3%) and 80.2% (95% CI 76.8%, 83.2%) in round 3 (May–October 2021) and the first 2 months of round 4 (November–December 2021).

Conclusions

Seroprevalence in Hong Kong HCWs in our study was low despite considerable exposure to confirmed COVID-19 cases in some study participants. However, the low rate of community transmission may have also contributed to the observed low seroprevalence among HCWs in our cohort.

Medication errors in practice: A mixed-methods study from Diwan Polyclinic-Muscat

Por: Al-Mukhaini · Z. A. M. · Passarin · I. · Palomares · E. M. M.
Objective

To explore healthcare professionals’ experiences with medication errors (MEs) in terms of types and factors that contribute to them.

Design

A mixed-methods study was conducted to explore the MEs experiences of healthcare professionals. Quantitative data were collected through a cross-sectional, self-administered questionnaire, whereas qualitative data were collected via face-to-face semi-structured interviews.

Setting

The study was conducted at Diwan Polyclinic in Muscat, a primary and secondary healthcare institute.

Participants

The study population included healthcare workers who were practising (not retired) and actively involved in patient care and the medication-use cycle, either by prescribing, dispensing or administering medication. The total number of participants was 83 (55 females and 28 males) healthcare professionals, comprising doctors (38), nurses (32), pharmacists and assistant pharmacists (13). Omani participants accounted for 72%, whereas non-Omani participants accounted for 28%. Six of 83 healthcare professionals were purposefully selected to provide additional qualitative insights into their experiences with MEs and the measures they use to reduce them.

Interventions

None.

Primary and secondary outcome measures

The primary outcomes focused on identifying types, causes and effects of MEs, and the secondary outcomes aimed to explore the emotional and professional implications on healthcare workers as well as suggested strategies to minimise MEs.

Results

A total of 83 participants (55 females and 28 males) were included, with 72% Omani and 28% non-Omani. Of these, 44 participants (53%) encountered MEs during their practice at Diwan Polyclinic. The most common type of MEs was prescribing errors (51%), followed by dispensing errors (39%) and administering errors (10%). Incorrect dosing was the most typical cause of prescribing errors.

In the qualitative part of the study, the interviewed participants implemented these measures to reduce MEs: 1) double-checking the prescribed medicines, patients ‘names and identity before dispensing and administering drugs, 2) patient education on polypharmacy and 3) alerting prescribing doctors to errors in their prescriptions or orders. Several measures have been suggested to mitigate MEs, including better communication among health professionals and between them and patients, focusing on staff well-being and development and innovative built-in modules and programmes in electronic medical records for drug verification.

Conclusion

The most common type of MEs was prescribing errors. Focusing on better communication and staff well-being, as well as the innovative development of electronic medical records, will help minimise MEs.

Advancing sustainable medication use in healthcare: a Delphi study on (de)prescribing interventions

Por: Smale · E. M. · van der Giessen · J. L. · Appels · C. W. Y. · Leegwater · E. · Dietz · M. · van den Bemt · P. M. L. A. · Coenradie · S. · Kool · R. B. · Kwint · H.-F. · Ista · E. · Hunfeld · N.
Objective

To identify and prioritise the most appropriate (de)prescribing interventions in inpatient and outpatient hospital care to advance environmentally sustainable healthcare.

Design

A modified RAND Delphi study.

Setting

Inpatient and outpatient hospital care in the Netherlands.

Participants

The Delphi panel consisted of 63 participants, comprising 36 physicians and 27 pharmacists working in Dutch hospitals.

Primary and secondary outcome measures

Consensus on the appropriateness of (de)prescribing interventions for frequently used medications in inpatient and outpatient hospital care to advance environmentally sustainable healthcare and the prioritisation of interventions per care setting (inpatient/outpatient) and intervention type (deprescribing/sustainable dosage form), culminating in a top 20.

Results

51 (de)prescribing interventions were identified for 18 medication classes, for which consensus on appropriateness was reached for 42 (82%). The top 20 highest ranked interventions were identified, starting with switching from intravenous to oral administration of paracetamol, stopping chronically used proton pump inhibitors without indication and initiating antibiotics orally in case of good bioavailability.

Conclusions

Most (de)prescribing interventions were considered appropriate for advancing sustainable medication use, highlighting support for their potential implementation to reduce the environmental burden of healthcare.

Compliance with current VTE prophylaxis guidelines and associated factors among admitted medical inpatients in Mehal Meda General Hospital, North Shewa Zone, Ethiopia: a cross-sectional study

Por: Yitbarek · T. · Tadesse · N. · Andarge · E. M. · Adem · Y. F.
Objectives

Venous thromboembolism (VTE) remains highly prevalent among medically ill patients and often leads to increased mortality. Therefore, this study aimed to assess compliance with VTE prophylaxis guidelines and associated factors among admitted medical inpatients at Mehal Meda General Hospital, North Shewa Zone, Ethiopia, in 2024.

Design

An institution-based cross-sectional study was conducted. Data were collected via medical chart review and interview-administered questionnaires, entered into EPI Data V.4.6, and exported to SPSS V.26 for analysis. Data were presented using frequency tables and graphs. Binary logistic regression was used to identify factors associated with compliance with VTE prophylaxis. Variables from the bivariable logistic regression analysis with a value of p

Setting

The study was conducted at Mehal Meda General Hospital.

Participants

The study was conducted among 365 admitted medical inpatients. The study participants were selected using a systematic random sampling technique.

Results

The overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was 24.2% (95% CI 19.9% to 28.8%). In this study, being a patient with heart failure (AOR = 6.8, 95% CI 3.7 to 12.54) and being a patient with diabetes (AOR = 3.98, 95% CI 2.2 to 7.2) were positively associated with compliance with VTE prophylaxis.

Conclusion

The overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was low compared with previous studies. Heart failure and diabetes were positively associated with compliance with VTE prophylaxis guidelines. Therefore, greater attention should be given to both, patients with diabetes and patients with heart failure.

Effectiveness of interventions involving parents on childrens eating behaviours: protocol for a systematic review and meta-analysis

Por: Khorramrouz · F. · Rae · S. · Kucab · M. · Uleryk · E. M. · Maguire · J. L. · Pechlivanoglou · P. · Thorpe · K. E. · Comelli · E. M. · Birken · C. S.
Background

Parents play a pivotal role in shaping their children’s food environment and eating behaviours. Involving parents in interventions designed to promote nutritional outcomes such as dietary intake in children has been shown to improve parental feeding practices. However, it remains unclear how such interventions influence children’s eating behaviour outcomes. This protocol describes the methods of a systematic review evaluating the effectiveness of interventions involving parents in improving the eating behaviours of healthy children aged 0–12 years.

Methods and analysis

Electronic databases including MEDLINE, EMBASE, CENTRAL, APA PsycINFO, CINAHL, Scopus and Web of Science will be searched from inception to September 2025. A search strategy is developed to identify randomised controlled trials directly involving parents and reporting eating behaviours in children as either primary or secondary outcomes. Two independent reviewers will screen identified records and extract data on study, participant and intervention characteristics. Study results relevant to our primary and secondary outcomes will also be extracted using a prepiloted standardised data extraction form. We will use the Revised Cochrane Risk of Bias tool (RoB2) and Grading of Recommendations Assessment, Development and Evaluation approach to assess risk of bias and certainty of evidence, respectively. Where possible, meta-analysis using random-effects models will be performed; otherwise a qualitative summary will be provided.

Ethics and dissemination

Ethics approval is not required for this study as no primary data will be collected. The findings will provide valuable insights for stakeholders to inform and optimise public health policies and practices aimed at empowering families to promote healthy eating behaviours early in childhood. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD420251076540.

Incidence and associated factors of inadequate emergence in elderly patients undergoing elective major abdominal surgery: a prospective cohort study in Northwest Ethiopia

Por: Bayable · S. D. · Debas · S. A. · Aligaz · E. M. · Endeshaw · A. S. · Ale · Y. F. · Amberbir · W. D. · Fetene · M. B. · Yetneberk · T. · Zegeye · S. T.
Background

Inadequate emergence is a common postoperative complication in elderly patients following major abdominal surgery. This study was designed to determine its incidence, identify associated risk factors and characterise its clinical subtypes within this high-risk cohort.

Design and setting

This prospective single-centre cohort study was conducted at a comprehensive specialised tertiary care hospital in Northwest Ethiopia. Consecutive patients aged 65 years and older scheduled for elective major abdominal surgery under general anaesthesia were enrolled.

Primary outcome measure

The primary outcome was the proportion of patients experiencing inadequate emergence.

Results

A total of 388 patients were analysed. Inadequate emergence occurred in 21.9% of participants (95% CI 14.3% to 31.6%), with hypoactive emergence observed in 10.7% and emergence delirium in 11.2%. Multivariable logistic regression identified several independent predictors, including advanced age (adjusted OR (AOR)=1.9; 95% CI 1.5 to 8.2), preoperative anxiety (AOR=2.7; 95% CI 1.2 to 7.2), prolonged preoperative fasting (AOR=2.1; 95% CI 1.8 to 9.1), non-ketofol-based induction (AOR=3.4; 95% CI 1.6 to 6.3), absence of abdominal field block (AOR=4.2; 95% CI 4.0 to 9.6), substantial intraoperative blood loss (>1000 mL; AOR=1.9; 95% CI 1.2 to 7.6), postoperative nausea and vomiting requiring antiemetics (AOR=2.2; 95% CI 2.1 to 7.1) and presence of an indwelling urinary catheter (AOR=2.4; 95% CI 1.8 to 7.9).

Conclusions

Inadequate emergence occurred in approximately one in five elderly patients undergoing elective major abdominal surgery. Independent predictors included advanced age, major intraoperative blood loss, postoperative nausea/vomiting requiring antiemetics, non-ketofol-based induction, preoperative anxiety, absence of abdominal field block, presence of an indwelling urinary catheter and prolonged preoperative fasting.

Individualised stimulation parameters in deep brain stimulation for Parkinsons disease based on disease phenotype and brain connectivity: protocol for a randomised feasibility study in a tertiary care centre (iDBS trial)

Por: de Ronde · E. M. · Birnie · E. · Rijpma · A. · Arnts · H. · Bartels · R. H. M. A. · Esselink · R. · Vinke · R. S.
Background

Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for advanced Parkinson’s disease (PD). Currently, programming of the DBS is done in a trial-and-error manner and it can take up to 12 months to reach optimal stimulation parameters. Technological advances in electrode design and implantable pulse generator capabilities lead to an almost infinite number of stimulation options. To explore the potential benefit of all these technological advances, a conventional trial-and-error approach is no longer sufficient. Consequently, there is a clear need for a more computational approach to programming DBS systems. This pilot study is a prospective trial to prove the feasibility of programming bilateral STN-DBS for PD in a computational fashion based on patient anatomy, electrode position and brain connectivity. In this study, we aim to assess the safety, practical feasibility and technical feasibility of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on a patient-specific DBS setting regarding sweet spots and structural connectivity of the STN. The results of this pilot study will be used to develop a computational approach for DBS programming to use in a future randomised clinical trial.

Methods and analysis

The iDBS trial will be a prospective randomised feasibility study carried out at the Radboud university medical center. A total of 24 patients with PD eligible for bilateral STN-DBS surgery implanted with Boston Scientific Cartesia leads will be included. Patients will be randomised to receive either (1) computational DBS programming (n=12) or (2) conventional DBS programming based on monopolar review (n=12). The primary endpoints are safety (occurrence of stimulation-induced side effects, duration of induced side effects (temporary or permanent), severity of the stimulation-induced side effects) and technical feasibility (time from surgery to DBS initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow.

Ethics and dissemination

Ethical approval for this study has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands (2024–17453). This study will be conducted in accordance with the Declaration of Helsinki and all applicable European and Dutch law. All participants will have to provide written informed consent. Results of the study will be submitted for publication in peer-reviewed journals and conferences.

Trial registration number

The study is registered in the OMON-registry (NL87334.091.24, NL-OMON57446).

Experiences of healthcare providers, survivors and caregivers with hospital-to-home stroke transitional care in Tanzania: a qualitative study

Por: Michael · N. A. · Mselle · L. T. · Bureta · C. A. · Tarimo · E. M. · Cao · Y.
Objective

To explore experiences of healthcare providers, stroke survivors and caregivers on stroke transitional care delivery at a tertiary hospital in Tanzania.

Design

A qualitative descriptive design with a phenomenological approach was used. Colaizzi’s thematic analysis was conducted using Dedoose software to identify significant information that describes the transitional care experiences of the study participants.

Setting

This study was conducted in the internal medicine and outpatient departments of a tertiary hospital in Tanzania.

Participants

15 triads of healthcare providers, stroke survivors and caregivers were purposively recruited to participate in semi-structured in-depth interviews between June and September 2024.

Results

The analysis identified four themes: communication and exchange of information, involvement of patients and caregivers in transitional care, coordination of transitional care and experiences with changing care setting. Effective communication and information exchange among healthcare providers, survivors and caregivers ensured that survivors and their caregivers were well informed about the care process, clinical condition, prognosis and transitional care needs. A collaborative care approach enabled survivors and caregivers to actively participate in care, decision-making and discharge planning during hospital-to-home transition. Coordination of care was equally important during hospital-to-home transition as it provided survivors with home-care instructions and opportunities for follow-up care. However, miscommunication among the healthcare team, insufficient information exchange, inadequate discharge planning, poor social support and lack of care coordination prevented smooth hospital-to-home transition leading to a crisis at home.

Conclusions

The experiences of healthcare providers, patients and caregivers during stroke transitional care in Tanzania highlight achievements and key areas for improvement. Hospital-to-home transition is often characterised by uncertainty and emotional strain, emphasising the need for effective communication, involving patients and caregivers in care, as well as coordinating transitional care to address medical and psychosocial needs of survivors and their caregivers during and after discharge.

Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial

Por: Faurholt-Jepsen · M. · Dyreholt · M. S. · Kyster · N. B. · Iversen · N. · Kortsen · E. M. · Amann · B. L. · Hogg · B. · Gatto · D. · Cordoba · C. d. · Petrovic · M. · Allenhof · C. · Schnitzspahn · K. · Reich · H. · Budtz-Jorgensen · E. · Kessing · L. V. · Hegerl · U.
Introduction

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

Methods and analysis

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

Ethics and dissemination

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

Trial registration number

NCT06919133.

Protocol version

Version 6, January 2026.

Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT05953155.

Impact of vitamin D non-reimbursement policy on therapy discontinuation in the general and rheumatic population in the Netherlands: a cross-sectional study

Por: Singh · A. · Huiskes · V. J. B. · van den Bemt · B. J. F. · van Ameijden · H. · Nurmohamed · M. T. · Spijkers · K. M. · Vervloet · M. · Brabers · A. E. M.
Objective

To assess the impact of the non-reimbursement policy on vitamin D therapy discontinuation in patients from the general and rheumatic populations.

Design

A cross-sectional study.

Setting

Research institute specialised in health research and two outpatient pharmacies in the Netherlands.

Participants

Patients from the general and rheumatic population with an active prescription for vitamin D supplementation therapy were included.

Data collection and analysis

Data were collected between April and May 2023 through self-reported questionnaires. Descriptive statistics and logistic regression were performed using STATA V. 17. P value

Primary and secondary outcome measures

The primary outcome was the proportion of patients who discontinued vitamin D supplementation therapy following the implementation of the non-reimbursement policy. Secondary outcomes included patient-reported reasons for therapy discontinuation and the association between patient-related characteristics and the risk of therapy discontinuation. In addition, the proportion of patients who switched to an alternative supplement and whether this switch had been made in consultation with a healthcare provider was examined.

Results

Of the 4800 patients, 302 (6.4%) patients discontinued their vitamin D therapy. The three most frequently reported reasons for therapy discontinuation were the inability to afford supplements without reimbursement, not willing to pay for supplements without reimbursement and being unaware of the alternative vitamin D supplements to switch to. Younger age, financial constraints and limited health literacy were significantly associated with vitamin D therapy discontinuation (p

Conclusion

The implementation of the non-reimbursement policy resulted in a small proportion of patients discontinuing their vitamin D therapy. Elevated discontinuation rates were associated with specific patient-related characteristics including patients aged

Study protocols for the GEPard project: systematic analysis of sex- and gender-specific differences in the efficacy of perioperative pain management - a two-pronged approach

Por: Floren · S. · Segelcke · D. · Machacek · P. A. · Vollert · J. · Norda · H. · Rohde · I. · Gilron · I. · Pogatzki-Zahn · E. M.
Introduction

Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.

Methods and analysis

The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.

Ethics and dissemination

No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.

PROSPERO registration number

The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).

Mixed-methods integration during data analysis in clinical trials of complex healthcare interventions: how is it done, and what can it do? Protocol for a systematic methodological review

Por: Sugg · H. V. R. · Shaw · N. · Vesterlund · E. M. · Woodford · J.
Introduction

The importance of conducting qualitative research alongside clinical trials of complex healthcare interventions is well established. There are various ways in which these two methodologies can be combined in mixed-methods research, including integrating data and/or results from the qualitative and quantitative strands during analysis, using techniques such as joint displays. The potential benefits of integration during data analysis include understanding intervention mechanisms, reasons for variation in outcomes, ways of tailoring interventions to individuals and barriers and facilitators to implementation. However, integration during data analysis may rarely be undertaken in practice, and the extent to which integration can provide valuable insights appears to be underappreciated in the field.

In this review, we aim to summarise current methods of integrating qualitative and quantitative raw data and/or results during analysis in clinical trials of complex healthcare interventions, and the yield of these different methods. Our specific research questions focus on (1) which integration techniques are used; (2) whether the results meet the study authors’ aims and/or answer their research questions; (3) the insights obtained and/or meta-inferences generated from these techniques (classified as either global or specific, and as relational, predictive, causal, comparative or elaborative); (4) any relationship between these insights and/or meta-inferences and the integration technique used and (5) the quality of these studies.

Methods and analysis

We will systematically search MEDLINE, Embase, PsycINFO, CENTRAL, CINAHL, Scopus and Web of Science, and manually search reference lists. We will include studies if they integrate, during data analysis, raw data and/or results from a clinical (randomised, non-randomised or single-arm) trial and an embedded or subsequent associated qualitative study of a complex, non-pharmaceutical healthcare intervention (where the effects on a health outcome were measured). Two independent reviewers will screen titles, abstracts and full texts and perform data extraction. We will develop a descriptive account of the data, including mapping the key characteristics of included studies and narratively reporting our findings in relation to each of our research questions. We will explore how integration was undertaken, what insights were obtained and/or meta-inferences generated, and whether and how these relate to the type of integration technique used.

Ethics and dissemination

This study does not require ethical approval. We intend to publish our findings in a peer-reviewed open-access journal and to present our findings at national and/or international conferences.

Registration

This protocol was registered with Open Science Framework on 22 October 2025 (ref osf.io/yxtb9).

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