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☐ ☆ ✇ BMJ Open

Finnish Retirement and Aging Study: a prospective cohort study

Por: Stenholm · S. · Suorsa · K. · Leskinen · T. · Myllyntausta · S. · Pulakka · A. · Pentti · J. · Vahtera · J. — Diciembre 10th 2023 at 15:59
Purpose

The Finnish Retirement and Aging (FIREA) Study was set up to study changes in health behavioural and cardiometabolic risk factors across retirement transition, and to examine the long-term consequences of work and retirement on health and functioning with advancing age.

Participants

Public sector workers whose estimated statutory retirement date was in 2014–2019 were invited to participate by sending them a questionnaire 18 months prior to their estimated retirement date. In the first phase of the FIREA Study, participants were followed up with annual surveys, accelerometer and clinical measurements during retirement transition into post-retirement years. The FIREA survey cohort includes 6783 participants, of which 908 belong also to the activity substudy and 290 to the clinical substudy.

Findings to date

Collected data include survey measures about health, lifestyle factors, psychosocial distress, work-related factors as well as retirement intentions. Accelerometer and GPS devices are used to measure 24-hour movement behaviours. Clinical examination includes blood and hair sample, measurements of anthropometry, cardiovascular function, physical fitness, physical and cognitive function. Our results suggest that in general retirement transition seems to have beneficial influence on health behaviours as well as on physical and mental health, but there are large individual differences, and certain behaviours such as sedentariness tend to increase especially among those retiring from manual occupations.

Future plans

The second phase of the FIREA Study will be conducted during 2023–2025, when participants are 70 years old. The FIREA Study welcomes research collaboration proposals that fall within the general aims of the project.

☐ ☆ ✇ BMJ Open

Specialist healthcare services for concussion/mild traumatic brain injury in England: a consensus statement using modified Delphi methodology

Por: Karvandi · E. · Helmy · A. · Kolias · A. G. · Belli · A. · Ganau · M. · Gomes · C. · Grey · M. · Griffiths · M. · Griffiths · T. · Griffiths · P. · Holliman · D. · Jenkins · P. · Jones · B. · Lawrence · T. · McLoughlin · T. · McMahon · C. · Messahel · S. · Newton · J. · Noad · R. · Raymont — Diciembre 9th 2023 at 17:51
Objective

To establish a consensus on the structure and process of healthcare services for patients with concussion in England to facilitate better healthcare quality and patient outcome.

Design

This consensus study followed the modified Delphi methodology with five phases: participant identification, item development, two rounds of voting and a meeting to finalise the consensus statements. The predefined threshold for agreement was set at ≥70%.

Setting

Specialist outpatient services.

Participants

Members of the UK Head Injury Network were invited to participate. The network consists of clinical specialists in head injury practising in emergency medicine, neurology, neuropsychology, neurosurgery, paediatric medicine, rehabilitation medicine and sports and exercise medicine in England.

Primary outcome measure

A consensus statement on the structure and process of specialist outpatient care for patients with concussion in England.

Results

55 items were voted on in the first round. 29 items were removed following the first voting round and 3 items were removed following the second voting round. Items were modified where appropriate. A final 18 statements reached consensus covering 3 main topics in specialist healthcare services for concussion; care pathway to structured follow-up, prognosis and measures of recovery, and provision of outpatient clinics.

Conclusions

This work presents statements on how the healthcare services for patients with concussion in England could be redesigned to meet their health needs. Future work will seek to implement these into the clinical pathway.

☐ ☆ ✇ BMJ Open

Psychosocial interventions promoting personal recovery in people with schizophrenia: a scoping review protocol

Por: Quistgaard · M. · Myklebust · O. L. P. · Aure · T. · Austin · S. F. · Berring · L. L. · Vernal · D. L. · Storebo · O. J. — Diciembre 9th 2023 at 17:51
Introduction

Personal recovery is an important aspect for many individuals diagnosed with schizophrenia, as people can live rich, fulfilling lives despite ongoing symptoms. Prior reviews have found several factors to be associated with personal recovery, but a comprehensive overview of the psychosocial interventions aimed at improving personal recovery in schizophrenia is needed.

Methods and analysis

Key terms relating to personal recovery and psychosocial interventions to promote personal recovery will be searched for in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, MEDLINE, Google Scholar, Web of Science Core Collection and Cochrane. Additionally, a simple search for grey literature will be conducted in The Networked Digital Library of Theses and Dissertations. Two reviewers will individually screen and extract the data, and the selection of sources will be documented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow chart. A content analysis will be conducted on the data, and the findings will be presented in tables, and narratively synthesised. Lastly, research gaps will be identified, and recommendations for future research will be proposed.

Ethics and dissemination

Ethics approval was not required for the development or publishing of this protocol. Findings will be disseminated through conferences, meeting with patient organisations and consumers, and published in a peer-reviewed scientific journal.

☐ ☆ ✇ BMJ Open

Mhealth tools for community-based infectious disease surveillance in Africa: a scoping review protocol

Por: Aku · F. Y. · Amuasi · J. H. · Debrah · L. B. · Opoku · D. · Gmanyami · J. M. · Hoerauf · A. · Debrah · A. Y. · Quentin · W. — Diciembre 9th 2023 at 17:51
Introduction

Countries in the WHO’s African region have found community-based surveillance useful in ensuring the effectiveness of the Integrated Disease Surveillance and Response strategy. This approach encourages community participation in the surveillance system, in addition to early detection of outbreaks and other health threats. Thus, advancements in mobile health have the potential to improve community-based surveillance in Africa. The purpose of this review is to map evidence on available mhealth tools for community-based infectious disease surveillance in Africa.

Methods and analysis

The scoping review will follow a mixed-methods approach in line with the framework of Arksey and O’Malley amended by Levac and colleagues and the Joanna Briggs Institute. To retrieve published literature, PubMed, Scopus, Web of Science, Google Scholar and Google databases will be explored. Websites of organisations involved in surveillance activities across the African region will also be explored. Authors will be interested in published literature between 2000 and 2022 in any language. The primary investigator and a second author will independently review the retrieved titles according to the inclusion criteria, while a third reviewer will resolve conflicts that may arise. The review will map evidence according to the key concepts (mhealth, community-based surveillance and Africa) to inform stakeholders and mhealth designers on best practices to adopt involving mhealth approaches at the community level and mhealth tool designs, respectively. Results following the review will be presented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review Guidelines.

Ethics and dissemination

Ethical approval is not required for scoping reviews as it does not involve the use of human subjects. This review is the first phase in an overall project on digital health. The findings of the review will be published in a peer-reviewed journal and disseminated at suitable forums and conferences.

☐ ☆ ✇ BMJ Open

'It was a joint plan we worked out together. How the I-WOTCH programme enabled people with chronic non-malignant pain to taper their opioids: a process evaluation

Por: Nichols · V. P. · Abraham · C. · Eldabe · S. · Sandhu · H. K. · Underwood · M. · Seers · K. · On behalf of the I-WOTCH team · Sharisse · Shyam · Lauren · Katie · Dawn · Furlan Andrea · Kirstie · C Paola · Ranjit · Andrea · Dipesh · Jennifer · Anisur · Jane · Tang Nicole · Stephanie — Diciembre 6th 2023 at 17:27
Background

The Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial found that a group-based educational intervention to support people using strong opioids for chronic non-malignant pain helped a significant proportion of people to stop or decrease opioid use with no increase in pain-related disability. We report a linked process evaluation of the group-based intervention evaluated in comparison to a usual-care control group that received a self-help booklet and relaxation CD.

Methods

We interviewed 18 intervention facilitators, and 20 intervention and 20 control participants who had chronic non-malignant pain and were recruited from general (family) practices in the UK. Quantitative data included change mechanism questions on the trial questionnaires which explored motivation, expectations and self-efficacy. Fidelity was assessed by listening to a sample of audio-recorded group sessions and nurse consultations. Quantitative and qualitative data were integrated using ‘follow a thread’ and a mixed-methods matrix.

Findings

Four overarching themes emerged: (1) the right time to taper, (2) the backdrop of a life with chronic pain, (3) needing support and (4) the benefits of being in a group. Delivery fidelity was good, adherence (83%) and competence (79%) across a range of intervention groups. Staff delivering the intervention found three typical responses to the intervention: resistance, open to trying and feeling it was not the right time. The group experience was important to those in the intervention arm. It provided people with a forum in which to learn about the current thinking about opioid usage and its effects. It also gave them examples of how feasible or personally relevant coming off opioids might be.

Conclusion

The process evaluation data showed that the I-WOTCH intervention was well delivered, well received and useful for most interviewees. Being ‘the right time’ to taper and having support throughout tapering, emerged as important factors within the context of living with chronic pain.

Trial registration number

ISRCTN49470934.

☐ ☆ ✇ BMJ Open

Impact of the COVID-19 pandemic on Canadian transplant journeys: a mixed methods study

Por: Fox · D. · Hall · M. · Thibodeau · C. · Coldwell · K. · Lauder · L. · Dewell · S. · Davidson · S. — Diciembre 1st 2023 at 16:59
Background

Navigating the organ donation and transplantation system in Canada can be challenging for individuals on transplant journeys. Although it is likely that the COVID-19 pandemic has further contributed to these challenges, the experiences of individuals during the pandemic in Canada have not been well elicited.

Objective

To illuminate how the COVID-19 pandemic has impacted individuals on transplant journeys in Canada.

Design

Convergent parallel mixed-methods study.

Setting

Canada.

Participants

Adult patients, caregivers, and donors on transplant journeys across Canada.

Data collection

Eight focus groups and an online survey between May and November 2021. Focus group transcripts were analysed using an inductive conventional content analysis approach. Survey data were analysed using descriptive statistics. The study was guided by individuals with lived experience of organ donation and transplantation.

Results

A total of 830 participants completed three COVID-19 related survey questions, with 21 participating in the focus groups. Survey results: over 50% of patients and caregivers reported that the pandemic impacted their access to their healthcare team, their mental health (60% and 65%, respectively) and their comfort going out in public (80% and 75%, respectively). Although many donors reported several factors that impacted their transplant journey, the impact appeared to be greater for patients and caregivers. Qualitative results: three themes emerged from the qualitative data that contextualise participant’s experiences: compounding isolation, disruption amid uncertainty and unforeseen benefits.

Conclusion

The COVID-19 pandemic has exacerbated many of the challenges that individuals on transplant journeys experience. It will be critical for transplant programmes to consider these factors in future care provision.

☐ ☆ ✇ BMJ Open

Understanding medication-related burden from patient perspectives: a qualitative study testing the applicability of the conceptual model among chronically ill outpatients in Finland

Por: Mikkola · H. · Dimitrow · M. · Hämeen-Anttila · K. · Laukkanen · E. · Airaksinen · M. — Diciembre 1st 2023 at 16:59
Objectives

Disease self-management and medication therapy can cause burden to patients that can influence adherence. The conceptual model ‘patients’ lived experience with medicine’ (PLEM) brings new insights into medication-related burden (MRB) from patient perspective. This study aimed to test the applicability of the PLEM model by interviewing chronically ill patients in Finland and to investigate the MRB experienced by the Finnish patients.

Design

Focus group discussion study conducted online via Zoom. Directed qualitative content analysis guided by the PLEM model.

Setting

Outpatient primary care in Finland.

Participants

Chronically ill outpatients (n=14) divided into five focus groups according to their chronic condition: asthma (n=3), heart disease (n=3), diabetes (n=6), intestinal disease (n=2).

Results

Our findings were mainly in line with the PLEM model although some new contributing factors to MRB emerged. In general, the participants were satisfied with their medication, and that it enabled them to live normal lives. The most common causes of MRB were medication routines and the healthcare system. The participants introduced two new aspects contributing to MRB: medication-related environmental anxiety associated with the waste resulting from medicine use, and the effect of medication use on their working life. Our findings are consistent with previous findings that a higher level of MRB may lead to independently modifying the medication regimen or not taking the medicine.

Conclusions

Our findings provide further evidence that the PLEM model is an applicable tool also in the Finnish context for gaining better understanding of MRB in chronically ill patients self-managing their long-term medications. The model provides a promising tool to understand the connection between MRB and the rationale for not always taking medicines as prescribed. Further research is needed to explore the potential of the model in extending patient perspectives in chronic disease management.

☐ ☆ ✇ BMJ Open

Population-based birth cohort study on diabetes in pregnancy and infant hospitalisations in Cree, other First Nations and non-Indigenous communities in Quebec

Por: Huang · R. · Xiao · L. · Zhu · J. · Cheng · J. · Torrie · J. · McHugh · N. G.-L. · Auger · N. · Luo · Z.-C. — Diciembre 1st 2023 at 16:59
Objectives

Diabetes in pregnancy, whether pre-gestational (chronic) or gestational (de novo hyperglycaemia), increases the risk of adverse birth outcomes. It is unclear whether gestational diabetes increases the risk of postnatal morbidity in infants. Cree First Nations in Quebec are at high risk for diabetes in pregnancy. We assessed whether pre-gestational or gestational diabetes may increase infant hospitalisation (an infant morbidity indicator) incidence, and whether this may be related to more frequent infant hospitalisations in Cree and other First Nations in Quebec.

Design

Population-based birth cohort study through administrative health data linkage.

Setting and participants

Singleton infants (≤1 year) born to mothers in Cree (n=5070), other First Nations (9910) and non-Indigenous (48 200) communities in rural Quebec.

Results

Both diabetes in pregnancy and infant hospitalisation rates were much higher comparing Cree (23.7% and 29.0%) and other First Nations (12.4% and 34.1%) to non-Indigenous (5.9% and 15.5%) communities. Compared with non-diabetes, pre-gestational diabetes was associated with an increased risk of any infant hospitalisation to a greater extent in Cree and other First Nations (relative risk (RR) 1.56 (95% CI 1.28 to 1.91)) than non-Indigenous (RR 1.26 (1.15 to 1.39)) communities. Pre-gestational diabetes was associated with increased risks of infant hospitalisation due to diseases of multiple systems in all communities. There were no significant associations between gestational diabetes and risks of infant hospitalisation in all communities. The population attributable risk fraction of infant hospitalisations (overall) for pre-gestational diabetes was 6.2% in Cree, 1.6% in other First Nations and 0.3% in non-Indigenous communities.

Conclusions

The study is the first to demonstrate that pre-gestational diabetes increases the risk of infant hospitalisation overall and due to diseases of multiple systems, but gestational diabetes does not. High prevalence of pre-gestational diabetes may partly account for the excess infant hospitalisations in Cree and other First Nations communities in Quebec.

☐ ☆ ✇ BMJ Open

Patient perspectives and barriers in the treatment of neovascular age-related macular degeneration in Denmark: a qualitative study

Por: Thinggaard · B. S. · Pedersen · M. · Sorensen · T. L. · Grauslund · J. · Stokholm · L. — Noviembre 28th 2023 at 15:15
Objectives

This qualitative study aims to identify patient-reported barriers to treatment for neovascular age-related macular degeneration (nAMD) and investigate their impact on quality of life.

Design

Using a qualitative explorative design.

Setting

Semi-structured individual or dyadic interviews were conducted with patients and their relatives.

Participants

Twenty-one patients completed the interview, with four of them having a relative present.

Interventions

Gadamer’s hermeneutics guided the epistemological approach, and maximum variation sampling was employed to capture diverse patient experiences. An advisory board consisting of patients, relatives and ophthalmologists ensured the relevance of the study. Thematic analysis was conducted using NVivo software.

Primary and secondary outcome measures

To investigate patient-reported barriers to the recommended treatment for nAMD and impact on quality of life.

Results

The study included 21 patients with nAMD, with a median age of 79 years. Five themes emerged: (1) good compliance with intravitreal treatment, (2) the dual role of relatives, (3) treatment commute, (4) hospital barriers, (5) preventive health literacy.

Conclusion

This study highlights the resilience and adherence of patients with nAMD in Denmark to their treatment despite various barriers. While the therapy may have negative effects on their well-being, patients do not opt out of treatment. These findings underscore the importance of personalised treatment plans that provide, for example, convenient access to care and clear future agreements at the hospital. By adopting more patient-centred approaches, healthcare providers can enhance patient satisfaction and improve treatment adherence, ultimately leading to better patient outcomes and quality of life.

☐ ☆ ✇ BMJ Open

Hidden sodium in effervescent-tablet dietary supplements and over-the-counter drugs: a comparative cross-sectional study

Por: Kunz · M. · Götzinger · F. · Jacobs · C. M. · Lauder · L. · Ukena · C. · Meyer · M. R. · Laufs · U. · Schulz · M. · Böhm · M. · Mahfoud · F. — Noviembre 27th 2023 at 17:08
Objective

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Design

Comparative cross-sectional study.

Setting and methods

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

Results

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Conclusion

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

☐ ☆ ✇ BMJ Open

Palliative care interventions for patients with head and neck cancer: protocol for a scoping review

Por: Ratnasekera · N. · Fazelzad · R. · Bagnarol · R. · Cunha · V. · Zimmermann · C. · Lau · J. — Noviembre 27th 2023 at 17:08
Introduction

A head and neck cancer (HNC) diagnosis significantly impacts a patient’s quality of life (QOL). Palliative care potentially improves their QOL. We will conduct a scoping review to identify existing knowledge about palliative care interventions for patients with HNC.

Methods and analysis

This scoping review was designed in accordance with the JBI Manual for Evidence Synthesis: Scoping Reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our eligibility criteria follow the Population, Intervention, Comparison or Control, Outcomes and Study characteristics framework. The population is adult patients with locally advanced, metastatic, unresectable and/or recurrent HNC. We include peer-reviewed journal articles and articles in the press, in English, reporting on palliative care interventions with at least two of the eight National Consensus Project on Clinical Practice Guidelines for Quality Palliative Care domains; studies with and without comparators will be included. The outcomes are patient QOL (primary) and symptom severity, patients’ satisfaction with care, patients’ mood, advance care planning and place of death (secondary). We developed a search strategy across ten databases, to be searched from the inception to 11 September 2023: Medline ALL (Medline and EPub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic+Embase, Emcare and PsycINFO all from the OvidSP platform; CINAHL from EBSCOhost, Scopus from Elsevier, Web of Science from Clarivate and Global Index Medicus from WHO. We will extract data using a piloted data form and analyse the data through descriptive statistics and thematic analysis.

Ethics and dissemination

Ethics approval is not needed for a scoping review. We will disseminate the findings to healthcare providers and policy-makers by publishing the results in a scientific journal.

☐ ☆ ✇ BMJ Open

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E. — Noviembre 27th 2023 at 17:08
Introduction

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

Methods and analysis

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

Ethics and dissemination

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

☐ ☆ ✇ BMJ Open

Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

Por: Weber · A. M. · Barbazza · S. · Fauzi · M. D. · Rachmadewi · A. · Zuhrina · R. · Putri · F. K. · Campos Ponce · M. · Hoeven · M. v. d. · Rimbawan · R. · Nasution · Z. · Giriwono · P. E. · Wieringa · F. T. · Soekarjo · D. D. · Ryan · E. P. — Noviembre 24th 2023 at 17:10
Introduction

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

Methods and analysis

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

Ethics and dissemination

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

Trial registration number

NCT05319717.

☐ ☆ ✇ BMJ Open

Experiences of adolescents using sexual health services on Reunion Island: protocol for a qualitative phenomenological study

Por: Reynaud · D. · Laboureur · E. · Marimoutou · C. · Cartron · E. — Noviembre 24th 2023 at 17:10
Introduction

Adolescence and early adulthood are often critical periods of sexual development. The discovery of sexual intercourse can lead to sexual risk-taking which may impact the incidence of sexually transmitted infections (STIs) and unwanted pregnancies. Despite available sexual health services on Reunion Island, sexual health indicators for adolescents are very poor showing a high number of teenage pregnancies and abortions, low use of contraception and an upsurge of STIs. In contrast, this French region is equipped with many services and resources that enable young adults to make informed sexual health choices. This study protocol describes the methodology to describe adolescent experiences of using sexual health services on Reunion Island.

Methods and analysis

A monocentric descriptive qualitative study using a phenomenological approach will be conducted from December 2022 to August 2023 and will be based on face-to-face semistructured interviews with participants aged 15–19 years and residing on Reunion Island. Recruitment will be distributed at various educational institutions and sexual health centres and will be facilitated by the ‘snowball’ and ‘word-of-mouth’ effect. Data analysis will be independently carried out by three investigators to increase reliability. An interpretative phenomenological analysis will be performed.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Hospital Center University De Bordeaux (CER-BDX-2022-55). Data generated do not fall within the field of biological or medical knowledge nor into the category of Research Involving the Human Person as defined in Articles L. 1121-1 and R. 1121-1 of the Public Health Code in France. All participants will receive information about the study in verbal and written forms and will give their oral consent before enrolment. Results will be published in a peer-reviewed journal as well as presented and disseminated at the Regional Health Agency of Reunion Island, conferences and in meetings with school directors.

☐ ☆ ✇ BMJ Open

Staff perceptions towards virtual reality-motivated treadmill exercise for care home residents: a qualitative feedback study with key stakeholders and follow-up interview with technology developer

Por: Bradwell · H. L. · Cooper · L. · Edwards · K. J. · Baxter · R. · Tomaz · S. A. · Ritchie · J. · Gaudl · S. · Veliz-Reyes · A. · Ryde · G. C. · Krizaj · T. · Warren · A. · Chatterjee · A. · Willis · K. · Haynes · R. · Hennessy · C. H. · Whittaker · A. C. · Asthana · S. · Jones · R. B. · On — Noviembre 23rd 2023 at 17:23
Objectives

Health and care resources are under increasing pressure, partly due to the ageing population. Physical activity supports healthy ageing, but motivating exercise is challenging. We aimed to explore staff perceptions towards a virtual reality (VR) omnidirectional treadmill (MOTUS), aimed at increasing physical activity for older adult care home residents.

Design

Interactive workshops and qualitative evaluation.

Settings

Eight interactive workshops were held at six care homes and two university sites across Cornwall, England, from September to November 2021.

Participants

Forty-four staff participated, including care home, supported living, clinical care and compliance managers, carers, activity coordinators, occupational therapists and physiotherapists.

Interventions

Participants tried the VR treadmill system, followed by focus groups exploring device design, potential usefulness or barriers for care home residents. Focus groups were audio-recorded, transcribed verbatim and thematically analysed. We subsequently conducted a follow-up interview with the technology developer (September 2022) to explore the feedback impact.

Results

The analysis produced seven key themes: anticipated benefits, acceptability, concerns of use, concerns of negative effects, suitability/unsuitability, improvements and current design. Participants were generally positive towards VR to motivate care home residents’ physical activity and noted several potential benefits (increased exercise, stimulation, social interaction and rehabilitation). Despite the reported potential, staff had safety concerns for frail older residents due to their standing position. Participants suggested design improvements to enhance safety, usability and accessibility. Feedback to the designers resulted in the development of a new seated VR treadmill to address concerns about falls while maintaining motivation to exercise. The follow-up developer interview identified significant value in academia–industry collaboration.

Conclusion

The use of VR-motivated exercise holds the potential to increase exercise, encourage reminiscence and promote meaningful activity for care home residents. Staff concerns resulted in a redesigned seated treadmill for those too frail to use the standing version. This novel study demonstrates the importance of stakeholder feedback in product design.

☐ ☆ ✇ BMJ Open

Dietitian-led cluster randomised controlled trial on the effectiveness of mHealth education on health outcomes among pregnant women: a protocol paper

Por: Er · Y. T. · Chan · Y. M. · Mohd Shariff · Z. · Abdul Hamid · H. · Mat Daud · Z. A. · Yong · H. Y. — Noviembre 21st 2023 at 04:50
Introduction

Nutrition education is the cornerstone to maintain optimal pregnancy outcomes including gestational weight gain (GWG). Nevertheless, default for appointments is common and often lead to suboptimal achievement of GWG, accompanied with unfavourable maternal and child health outcomes. While mobile health (mHealth) usage is increasing and helps minimising barriers to clinic appointments among pregnant mothers, its effectiveness on health outcomes has been inconclusive. Therefore, this study aimed to address the gap between current knowledge and clinical care, by exploring the effectiveness of mHealth on GWG as the primary outcome, hoping to serve as a fundamental work to achieve optimal health outcomes with the improvement of secondary outcomes such as physical activity, psychosocial well-being, dietary intake, quality of life and sleep quality among pregnant mothers.

Methods and analysis

A total of 294 eligible participants will be recruited and allocated into 3 groups comprising of mHealth intervention alone, mHealth intervention integrated with personal medical nutrition therapy and a control group. Pretested structured questionnaires are used to obtain the respondents’ personal information, anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary intake, quality of life, sleep quality and GWG. There will be at least three time points of data collection, with all participants recruited during their first or second trimester will be followed up prospectively (after 3 months or/and after 6 months) until delivery. Generalised linear mixed models will be used to compare the mean changes of outcome measures over the entire study period between the three groups.

Ethics and dissemination

Ethical approvals were obtained from the ethics committee of human subjects research of Universiti Putra Malaysia (JKEUPM-2022-072) and medical research & ethics committee, Ministry of Health Malaysia: NMRR ID-22-00622-EPU(IIR). The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

Trial registration number

Clinicaltrial.gov ID: NCT05377151.

☐ ☆ ✇ BMJ Open

Enhancing care quality and accessibility through digital technology-supported decentralisation of hypertension and diabetes management: a proof-of-concept study in rural Bangladesh

Por: Xie · W. · Paul · R. R. · Goon · I. Y. · Anan · A. · Rahim · A. · Hossain · M. M. · Hersch · F. · Oldenburg · B. · Chambers · J. · Mridha · M. K. — Noviembre 20th 2023 at 06:50
Objective

The critical shortage of healthcare workers, particularly in rural areas, is a major barrier to quality care for non-communicable diseases (NCD) in low-income and middle-income countries. In this proof-of-concept study, we aimed to test a decentralised model for integrated diabetes and hypertension management in rural Bangladesh to improve accessibility and quality of care.

Design and setting

The study is a single-cohort proof-of-concept study. The key interventions comprised shifting screening, routine monitoring and dispensing of medication refills from a doctor-managed subdistrict NCD clinic to non-physician health worker-managed village-level community clinics; a digital care coordination platform was developed for electronic health records, point-of-care support, referral and routine patient follow-up. The study was conducted in the Parbatipur subdistrict, Rangpur Division, Bangladesh.

Participants

A total of 624 participants were enrolled in the study (mean (SD) age, 59.5 (12.0); 65.1% female).

Outcomes

Changes in blood pressure and blood glucose control, patient retention and patient-visit volume at the NCD clinic and community clinics.

Results

The proportion of patients with uncontrolled blood pressure reduced from 60% at baseline to 26% at the third month of follow-up, a 56% (incidence rate ratio 0.44; 95% CI 0.33 to 0.57) reduction after adjustment for covariates. The proportion of patients with uncontrolled blood glucose decreased from 74% to 43% at the third month of follow-up. Attrition rates immediately after baseline and during the entire study period were 29.1% and 36.2%, respectively.

Conclusion

The proof-of-concept study highlights the potential for involving lower-level primary care facilities and non-physician health workers to rapidly expand much-needed services to patients with hypertension and diabetes in Bangladesh and in similar global settings. Further investigations are needed to evaluate the effectiveness of decentralised hypertension and diabetes care.

☐ ☆ ✇ BMJ Open

Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol

Por: Stynes · S. · Snell · K. I. · Riley · R. D. · Konstantinou · K. · Cherrington · A. · Daud · N. · Ostelo · R. · O'Dowd · J. · Foster · N. E. — Noviembre 20th 2023 at 06:50
Introduction

Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI.

Methods

POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model.

Ethics and dissemination

The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.

☐ ☆ ✇ BMJ Open

Impact of deintensifying hypoglycaemic drugs in older adults with type 2 diabetes: protocol for an emulation of a target trial

Por: Christiaens · A. · Simon-Tillaux · N. · Thompson · W. · Sinclair · A. J. · Henrard · S. · Boland · B. B. · Slaouti-Jegou · Y. · Lekens · B. · Bonnet-Zamponi · D. · Tubach · F. · Zerah · L. — Noviembre 20th 2023 at 06:50
Introduction

In older adults with type 2 diabetes (T2D), overtreatment with hypoglycaemic drugs (HDs: sulfonylureas, glinides and/or insulins) is frequent and associated with increased 1-year mortality. Deintensification of HD is thus a key issue, for which evidence is though limited. The primary objective of this study will be to estimate the effect of deintensifying HD on clinical outcomes (hospital admission or death) within 3 months in older adults (≥75 years) with T2D.

Methods

We will emulate with real-world data a target trial, within The Health Improvement Network cohort, a large-scale database of data collected from electronic medical records of 2000 general practitioners in France. From 1 January 2010 to 28 February 2019, we will include eligible patients ≥75 years who will have T2D, a stable dose of HDs, glycated haemoglobin A1c (HbA1c) value 75 mmol/mol within 1 year. Participants will be followed from baseline to 12 months after randomisation, administrative censoring, or death, whichever occurs first. A pooled logistic regression will be used to estimate the treatment effect on the incidence of the outcomes.

Dissemination and ethics

No ethical approval is needed for using retrospectively this fully anonymised database. The results will be disseminated during conferences and through publications in scientific journals.

☐ ☆ ✇ BMJ Open

Hospital variations in failure to rescue after abdominal surgery: a nationwide, retrospective observational study

Por: Augestad · K. M. · Skyrud · K. D. · Lindahl · A. K. · Helgeland · J. — Noviembre 18th 2023 at 02:44
Objectives

This study aims to determine hospital variation and intensive care unit characteristics associated with failure to rescue after abdominal surgery in Norway.

Design

A nationwide retrospective observational study.

Setting

All 52 hospitals in Norway performing elective and acute abdominal surgery.

Participants

All 598 736 patients undergoing emergency and elective abdominal surgery from 2011 to 2021.

Primary outcome measure

Primary outcome was failure to rescue within 30 days (FTR30), defined as in-hospital or out-of-hospital death within 30 days of a surgical patient who developed at least one complication within 30 days of the surgery (FTR30). Other outcome variables were surgical complications and hospital FTR30 variation. Statistical analysis was conducted separately for general surgery and abdominal surgery.

Results

The 30-day postoperative complication rate was 30.7 (183 560 of 598 736 surgeries). Of general surgical complications (n=25 775), circulatory collapse (n=6127, 23%), cardiac arrhythmia (n=5646, 21%) and surgical infections (n=4334, 16 %) were most common and 1507 (5.8 %) patients were reoperated within 30 days. One thousand seven hundred and forty patients had FTR30 (6.7 %). The severity of complications was strongly associated with FTR30. In multivariate analysis of general surgery, adjusted for patient characteristics, only the year of surgery was associated with FTR30, with an estimated linear trend of –0.31 percentage units per year (95% CI (–0.48 to –0.15)). The driving distance from local hospitals to the nearest referral intensive care unit was not associated with FTR30. Over the last decade, FTR30 rates have varied significantly among similar hospitals.

Conclusions

Hospital factors cannot explain Norwegian hospitals’ significant FTR variance when adjusting for patient characteristics. The national FTR30 measure has dropped around 30% without a corresponding fall in surgical complications. No association was seen between rural hospital location and FTR30. Policy-makers must address microsystem issues causing high FTR30 in hospitals.

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