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AnteayerBMJ Open

Work environment and hypertension in industrial settings in Benin in 2019: a cross-sectional study

Por: Adjobimey · M. · Houehanou · C. Y. · Cisse · I. M. · Mikponhoue · R. · Hountohotegbe · E. · Tchibozo · C. · Adjogou · A. · Dossougbete · V. · Gounongbe · F. · Ayelo · P. A. · Hinson · V. · Houinato · D. S.
Objective

To determine the association between occupational factors, particularly psychosocial factors, and hypertension.

Design

Descriptive and analytical cross-sectional study using logistic multivariate regression.

Setting

Fifteen cotton ginning plants in Benin.

Participants

Permanent and occasional workers in the cotton ginning industry.

Data collection

Data on sociodemographic, occupational, behavioural and clinical history characteristics were collected using a number of standardised, interviewer-administered questionnaires. These questionnaires were based on the WHO’s non-communicable disease questionnaire, Karasek questionnaire and Siegrist questionnaire. Weight, height and blood pressure were measured. Any worker with systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg according to the WHO criteria was considered hypertensive, as was any subject on antihypertensive treatment even if blood pressure was normal.

Results

A total of 1883 workers were included, with a male to female ratio of 9.08. Of these, 510 suffered from hypertension (27.1%, 95% CI 25.1 to 29.2). In the multivariate analysis, the risk factors identified were occupational stress (adjusted OR (aOR)=3.96, 95% CI 1.28 to 12.2), age ≥25 years (aOR=2.77, 95% CI 1.55 to 4.96), body mass index of 25–30 kg/m2 (aOR=1.71, 95% CI 1.32 to 2.2), body mass index >30 kg/m2 (aOR=2.74, 95% CI 1.84 to 4.09), permanent worker status (aOR=1.66, 95% CI 1.44 to 2.41) and seniority in the textile sector >5 years (aOR=2.18, 95% CI 1.7 to 2.8). Recognition at work emerged as an effect-modifying factor subject to stratification.

Conclusions

Occupational factors, particularly job strain and recognition at work, are modifiable factors associated with hypertension in the ginning plants sector and deserve to be corrected through occupational health promotion and prevention.

Development and applications of the Anaesthetists Non-Technical Skills behavioural marker system: a systematic review

Por: Kang · J. · Hu · J. · Yan · C. · Xing · X. · Tu · S. · Zhou · F.
Objectives

To comprehensively synthesise evidence regarding the validity and reliability of the Anaesthetists’ Non-Technical Skills (ANTS) behavioural marker system and its application as a tool for the training and assessment of non-technical skills to improve patient safety.

Design

Systematic review.

Data sources

We employed a citation search strategy. The Scopus and Web of Science databases were searched for articles published from 2002 to May 2022.

Eligibility criteria

English-language publications that applied the ANTS system in a meaningful way, including its use to guide data collection, analysis and reporting.

Data extraction and synthesis

Study screening, data extraction and quality assessment were performed by two independent reviewers. We appraised the quality of included studies using the Joanna Briggs Institute Critical Appraisal Checklists. A framework analysis approach was used to summarise and synthesise the included articles.

Results

54 studies were identified. The ANTS system was applied across a wide variety of study objectives, settings and units of analysis. The methods used in these studies varied and included quantitative (n=42), mixed (n=8) and qualitative (n=4) approaches. Most studies (n=47) used the ANTS system to guide data collection. The most commonly reported reliability statistic was inter-rater reliability (n=35). Validity evidence was reported in 51 (94%) studies. The qualitative application outcomes of the ANTS system provided a reference for the analysis and generation of new theories across disciplines.

Conclusion

Our results suggest that the ANTS system has been used in a wide range of studies. It is an effective tool for assessing non-technical skills. Investigating the methods by which the ANTS system can be evaluated and implemented for training within clinical environments is anticipated to significantly enhance ongoing enhancements in staff performance and patient safety.

PROSPERO registration number

CRD42022297773.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease

Por: Wright · G. · Senthil · K. · Zadeh-Kochek · A. · Au · J. H.-s. · Zhang · J. · Huang · J. · Saripalli · R. · Khan · M. · Ghauri · O. · Kim · S. · Mohammed · Z. · Alves · C. · Koduri · G.

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.

Objective

To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.

Method

Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (

Results

Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p

Conclusion

There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M.
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

Predictive machine learning models for ascending aortic dilatation in patients with bicuspid and tricuspid aortic valves undergoing cardiothoracic surgery: a prospective, single-centre and observational study

Por: Gaye · B. · Vignac · M. · Gadin · J. R. · Ladouceur · M. · Caidahl · K. · Olsson · C. · Franco-Cereceda · A. · Eriksson · P. · Björck · H. M.
Objectives

The objective of this study was to develop clinical classifiers aiming to identify prevalent ascending aortic dilatation in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).

Design and setting

A prospective, single-centre and observational cohort.

Participants

The study involved 543 BAV and 491 TAV patients with aortic valve disease and/or ascending aortic dilatation, excluding those with coronary artery disease, undergoing cardiothoracic surgery at the Karolinska University Hospital (Sweden).

Main outcome measures

Predictors of high risk of ascending aortic dilatation (defined as ascending aorta with a diameter above 40 mm) were identified through the application of machine learning algorithms and classic logistic regression models.

Exposures

Comprehensive multidimensional data, including valve morphology, clinical information, family history of cardiovascular diseases, prevalent diseases, demographic details, lifestyle factors, and medication.

Results

BAV patients, with an average age of 60.4±12.4 years, showed a higher frequency of aortic dilatation (45.3%) compared with TAV patients, who had an average age of 70.4±9.1 years (28.9% dilatation, p

Conclusion and recommendation

Cardiovascular risk profiles appear to be more predictive of aortopathy in TAV patients than in patients with BAV. This adds evidence to the fact that BAV-associated and TAV-associated aortopathy involves different pathways to aneurysm formation and highlights the need for specific aneurysm preventions in these patients. Further, our results highlight that machine learning approaches do not outperform classical prediction methods in addressing complex interactions and non-linear relations between variables.

Development of a tool for assessing the clinical competency of Chinese masters nursing students based on the mini-CEX: a Delphi method study

Por: Peng · Q. · Gao · Y. · Liu · N. · Gan · X.
Objective

To construct a scientific and systematic competency evaluation tool for master of nursing specialists (MNS) and to provide a reference for the training, assessment and competency evaluation of MNS.

Methods

A first draft of the indicators for assessing MNS core competencies was developed on the basis of published research and group discussions. Between June and December 2020, the indicators were revised using two rounds of the Delphi expert consultation method, with questionnaires completed by 16 experts from five provinces in China.

Results

The valid retrieval rate of the two questionnaires was 100.00%, and the coefficient of expert authority was 0.931. The Kendall’s concordance coefficients of the two rounds of questionnaires were 0.136 (p

Conclusions

The MNS competency assessment tool constructed in this study is focused and highly credible. The findings can be used as a guide for the training, assessment and competence evaluation of MNS in the future.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

Self-help friendliness and cooperation with self-help groups among rehabilitation clinics in Germany (KoReS): a mixed-methods study protocol

Por: Ziegler · E. · Bartzsch · T. · Trojan · A. · Usko · N. · Krahn · I. · Bütow · S. · Kofahl · C.
Introduction

Self-help is an important complement to medical rehabilitation for people with chronic diseases and disabilities. It contributes to stabilising rehabilitation success and further coping with disease and disability. Rehabilitation facilities are central in informing and referring patients to self-help groups. However, sustainable cooperation between rehabilitation and self-help, as can be achieved using the concept of self-help friendliness in healthcare, is rare, as is data on the cooperation situation.

Methods and analysis

The KoReS study will examine self-help friendliness and cooperation between rehabilitation clinics and self-help associations in Germany, applying a sequential exploratory mixed-methods design. In the first qualitative phase, problem-centred interviews and focus groups are conducted with representatives of self-help-friendly rehabilitation clinics, members of their cooperating self-help groups and staff of self-help clearinghouses involved based on a purposeful sampling. Qualitative data collected will be analysed through content analysis using MAXQDA. The findings will serve to develop a questionnaire for a quantitative second phase. Cross-sectional online studies will survey staff responsible for self-help in rehabilitation clinics nationwide, representatives of self-help groups and staff of self-help clearinghouses. Quantitative data analysis with SPSS will include descriptive statistics, correlation, subgroup and multiple regression analyses. Additionally, a content analysis of rehabilitation clinics’ websites will evaluate the visibility of self-help in their public relations.

Ethics and dissemination

The University Medical Center Hamburg-Eppendorf Local Psychological Ethics Committee at the Center for Psychosocial Medicine granted ethical approval (reference number LPEK-0648; 10.07.2023). Informed consent will be obtained from all participants. Results dissemination will comprise various formats such as workshops, presentations, homepages and publications for the international scientific community, rehabilitation centres, self-help organisations and the general public in Germany. For relevant stakeholders, practical guides and recommendations to implement self-help friendliness will derive from the results to strengthen patient orientation and cooperation between rehabilitation and self-help to promote the sustainability of rehabilitation processes.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K.
Objectives

To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

Design

Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

Setting

Two National Health Service (NHS) secondary care hospitals in England and Wales.

Participants

Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

Intervention

The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

Outcome measures

The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

Results

Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

Conclusions

This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

Trial registration number

ISRCTN14233189.

Implementation of an antibiotic resistance surveillance tool in Madagascar, the TSARA project: a prospective, observational, multicentre, hospital-based study protocol

Por: Elias · C. · Raad · M. · Rasoanandrasana · S. · Raherinandrasana · A. H. · Andriananja · V. · Raberahona · M. · Moore · C. E. · Randria · M. · Raskine · L. · Vanhems · P. · Babin · F.-X.
Introduction

Antimicrobial resistance (AMR) has become a significant public health threat. Without any interventions, it has been modelled that AMR will account for an estimated 10 million deaths annually by 2050, this mainly affects low/middle-income countries. AMR has a systemic negative perspective affecting the overall healthcare system down to the patient’s personal outcome. In response to this issue, the WHO urged countries to provide antimicrobial stewardship programmes (ASPs). ASPs in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, in particular in low-income countries such as Madagascar.

As part of an ASP, AMR surveillance provides essential information needed to guide medical practice. We developed an AMR surveillance tool—Technique de Surveillance Actualisée de la Résistance aux Antimicrobiens (TSARA)—with the support of the Mérieux Foundation. TSARA combines bacteriological and clinical information to provide a better understanding of the scope and the effects of AMR in Madagascar, where no such surveillance tool exists.

Methods and analysis

A prospective, observational, hospital-based study was carried out for data collection using a standardised data collection tool, called TSARA deployed in 2023 in 10 hospitals in Madagascar participating in the national Malagasy laboratory network (Réseau des Laboratoires à Madagascar (RESAMAD)). Any hospitalised patient where the clinician decided to take a bacterial sample is included. As a prospective study, individual isolate-level data and antimicrobial susceptibility information on pathogens were collected routinely from the bacteriology laboratory and compiled with clinical information retrieved from face-to-face interviews with the patient and completed using medical records where necessary. Analysis of the local ecology, resistance rates and antibiotic prescription patterns were collected.

Ethics and dissemination

This protocol obtained ethical approval from the Malagasy Ethical Committee n°07-MSANP/SG/AGMED/CNPV/CERBM on 24 January 2023. Findings generated were shared with national health stakeholders, microbiologists, members of the RESAMAD network and the Malagasy academic society of infectious diseases.

Enablers and barriers to a quaternary prevention approach: a qualitative study of field experts

Por: Otte · J. A. · Llargues Pou · M.
Objective

There is a growing concern about the sustainability of healthcare and the impacts of ‘overuse’ on patients and systems. Quaternary prevention (P4), a concept promoting the protection of patients from medical interventions in which harms outweigh benefits, is well positioned to stimulate reflection and inspire solutions, yet has not been widely adopted. We sought to identify enablers and barriers to a P4 approach, according to field experts and advocates in one health system.

Design

Qualitative methodology, using semistructured interviews and a grounded theory approach facilitated thematic analysis and development of a conceptual model.

Setting

Virtual interviews, conducted in British Columbia, Canada.

Participants

12 field experts, recruited based on their interest and work related to P4 and related concepts.

Results

Four factors were seen as promoting or hindering P4 efforts depending on context: relationship between patient and clinician, education of clinicians and the public, health system design and influencers. We extracted four broad enablers of P4: evidence-based medicine, personal experiences and questioning attitude, public P4 campaigns and experience in resource-poor contexts. There were six barriers: peer pressure between clinicians, awareness and screening campaigns, cognitive biases, cultural factors, complexity of the problem and industry influence.

Conclusions

Elicited facilitators and impediments to the application of P4 were similar to those seen in existing literature but framed uniquely; our findings place increased emphasis on the clinician–patient relationship as central to decision-making and position other drivers as influencing this relationship. A transition to a model of care that explicitly integrates conscious protection of patients by reducing overtesting, overdiagnosis and overtreatment will require changes across health systems and society.

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

Co-creating a new Charter for equitable and inclusive co-creation: insights from an international forum of academic and lived experience experts

Por: Mulvale · G. · Moll · S. · Phoenix · M. · Buettgen · A. · Freeman · B. · Murray-Leung · L. · Micsinszki · S. K. · Mulalu · L. · Vrzovski · A. · Foisy · C.
Background

Co-creation approaches, such as co-design and co-production, aspire to power-sharing and collaboration between service providers and service users, recognising the specific insights each group can provide to improve health and other public services. However, an intentional focus on equity-based approaches grounded in lived experience and epistemic justice is required considering entrenched structural inequities between service-users and service-providers in public and institutional spaces where co-creation happens.

Objectives

This paper presents a Charter of tenets and principles to foster a new era of ‘Equity-based Co-Creation’ (EqCC).

Methods

The Charter is based on themes heard during an International Forum held in August 2022 in Ontario, Canada, where 48 lived experience experts and researchers were purposively invited to deliberate challenges and opportunities in advancing equity in the co-creation field.

Results

The Charter’s seven tenets—honouring worldviews, acknowledging ongoing and historical harms, operationalising inclusivity, establishing safer and brave spaces, valuing lived experiences, ‘being with’ and fostering trust, and cultivating an EqCC heartset/mindset—aim to promote intentional inclusion of participants with intersecting social positions and differing historic oppressions. This means honouring and foregrounding lived experiences of service users and communities experiencing ongoing structural oppression and socio-political alienation—Black, Indigenous and people of colour; disabled, Mad and Deaf communities, women, 2S/LGBTQIA+ communities, people perceived to be mentally ill and other minoritised groups—to address epistemic injustice in co-creation methodologies and practice, thereby providing opportunities to begin to dismantle intersecting systems of oppression and structural violence.

Conclusions

Each Charter tenet speaks to a multilayered, multidimensional process that is foundational to shifting paradigms about redesigning our health and social systems and changing our relational practices. Readers are encouraged to share their reactions to the Charter, their experiences implementing it in their own work, and to participate in a growing international EqCC community of practice.

Barriers and enablers of quality high-acuity neonatal care in sub-Saharan Africa: protocol for a synthesis of qualitative evidence

Por: Mersha · A. · Demissie · A. · Nemera · G.
Introduction

Neonatal intensive care unit (NICU) in sub-Saharan Africa face limited resources and systemic challenges, resulting in poorer quality care, higher infant mortality, and dissatisfaction among both patients and healthcare workers. This review aims to bridge the knowledge gap by identifying and analysing the key barriers and enablers affecting quality care, informing interventions to improve patient outcomes and overall NICU effectiveness in this critical region.

Methods and analysis

This systematic review will search and gather data from a variety of databases, including JBI Database, Cochrane Database, MEDLINE/PubMed, CINAHL/EBSCO, EMBASE, PEDro, POPLINE, Proquest, OpenGrey (SIGLE), Google Scholar, Google, APA PsycINFO, Web of Science, Scopus and HINARI. The review will also include unpublished studies and grey literature from a variety of sources. This review will only include qualitative and mixed-methods studies that explore the barriers and enablers of quality care for high-acuity neonates using qualitative data collection and analysis methods. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research will be used by two independent reviewers to critically appraise the eligible studies. Any disagreements that arise will be resolved through discussion. Qualitative research findings will be pooled using the meta-aggregation approach in QARI software, where possible. Only unequivocal and credible findings will be included in the synthesis. If textual pooling is not possible, the findings will be presented in narrative form.

Ethics and dissemination

This systematic review does not require ethical clearance, and the findings will be disseminated to relevant stakeholders to ensure the widest possible outreach and impact.

PROSPERO registration number

CRD42023473134.

Relationship between social isolation and glycaemic control of people previously diagnosed with diabetes: secondary analysis from the CHARLS

Por: Lu · Q. · Qu · L. · Xie · C. · Shu · Y. · Gao · F. · Zou · M. · Fan · X. · Luo · X. · Meng · J. · Xue · Y. · Cao · Y.
Objectives

Social isolation may affect diabetes self-management. This study aimed to explore the relations between social isolation and glycaemic control in patients with diabetes and to explore lifestyle differences among individuals with different levels of social isolation.

Methods

The relevant data of 665 people previously diagnosed with diabetes included in the China Health and Retirement Longitudinal Study from 2011 to 2015 were extracted and analysed. The study included patient general information, blood glucose, lipids, glycosylated haemoglobin, social isolation index, health-related lifestyle factors and diabetes-related factors. Differences in metabolic abnormalities and modifiable lifestyles were compared among patients with varying levels of social isolation.

Results

Multiple linear regression analysis demonstrated that among men aged 45–64 years, the high social isolation group had significantly higher glycosylated haemoglobin levels compared with the low isolation group (7.29±1.81 vs 6.59±1.63, p=0.026). A positive correlation was observed between social isolation and blood glucose (β=14.16; 95% CI 2.75 to 25.57; p=0.015) and glycosylated haemoglobin (β=0.35; 95% CI 0.10 to 0.60; p=0.006), indicating that higher social isolation was associated with higher fasting blood glucose and glycosylated haemoglobin levels. However, no significant associations were observed in other age groups. Notably, men aged 45–65 years with high social isolation had higher depression rates (44.10% vs 24.60%, p=0.024), lower engagement in moderate exercise (5.70% vs 23.50%, p=0.019) and shorter 10-minute walks (17.10% vs 36.80%, p=0.027). Differences in other health-related and diabetes-related factors were not statistically significant.

Conclusion

Middle-aged men with diabetes with higher social isolation tend to have higher blood glucose and glycosylated haemoglobin levels. This subset of patients requires targeted attention to provide social support from family and friends for improved glycaemic control. If necessary, education on diabetes should be made available to family members and friends.

Operational priorities for engaging with Indias private healthcare sector for the control of tuberculosis: a modelling study

Por: Ricks · S. · Singh · A. · Sodhi · R. · Pal · A. · Arinaminpathy · N.
Objectives

To estimate the potential impact of expanding services offered by the Joint Effort for Elimination of Tuberculosis (JEET), the largest private sector engagement initiative for tuberculosis (TB) in India.

Design

We developed a mathematical model of TB transmission dynamics, coupled with a cost model.

Setting

Ahmedabad and New Delhi, two cities with contrasting levels of JEET coverage.

Participants

Estimated patients with TB in Ahmedabad and New Delhi.

Interventions

We investigated the epidemiological impact of expanding three different public–private support agency (PPSA) services: provider recruitment, uptake of cartridge-based nucleic acid amplification tests and uptake of adherence support mechanisms (specifically government supplied fixed-dose combination drugs), all compared with a continuation of current TB services.

Results

Our results suggest that in Delhi, increasing the use of adherence support mechanisms among private providers should be prioritised, having the lowest incremental cost-per-case-averted between 2020 and 2035 of US$170 000 (US$110 000–US$310 000). Likewise in Ahmedabad, increasing provider recruitment should be prioritised, having the lowest incremental cost-per-case averted of US$18 000 (US$12 000–US$29 000).

Conclusion

Results illustrate how intervention priorities may vary in different settings across India, depending on local conditions, and the existing degree of uptake of PPSA services. Modelling can be a useful tool for identifying these priorities for any given setting.

Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study

Por: Karihtala · T. · Puttonen · S. · Valtonen · A. M. · Kautiainen · H. · Hopsu · L. · Heinonen · A.
Objectives

This study aimed to investigate the association between recovery from work and insomnia and the role of objectively measured leisure-time physical activity and occupational physical activity in this association.

Design

Cross-sectional.

Setting and participants

Study with female early childhood education and care professionals (N=224) in Finland was conducted between April 2017 and September 2018.

Methods

Recovery from work was measured with the Need for Recovery scale and insomnia with the Jenkins Sleep Scale. Physical activity was measured with an accelerometer for 7 days and analysed to represent leisure-time physical activity and occupational physical activity (min/day).

Results

Both Jenkins Sleep Scale and occupational physical activity significantly predicted Need for Recovery (β=0.29; 95% CI 0.17 to 0.42 and β=0.14; 95% CI 0.01 to 0.27, respectively). A low relationship was observed between the Need for Recovery and Jenkins Sleep Scale (r=0.32, 95% Cl 0.19 to 0.44). After categorising participants into four groups based on median splits of occupational and leisure-time physical activity, relationships between the Need for Recovery and Jenkins Sleep Scale were low to moderate in the high occupational physical activity and leisure time physical activity group (r=0.38, 95% Cl 0.14 to 0.61), and in the high occupational physical activity and low leisure-time physical activity group (r=0.40, 95% Cl 0.18 to 0.63).

Conclusion

Both insomnia and physical activity at work seem to be relevant in recovery from work. To enhance recovery, especially those involved in high physical activity at work, should seek methods to improve recovery, by incorporating activities that promote recuperation both during their workday and in their leisure time. Further research on the relevance of physical activity in recovery with longitudinal setting is warranted.

Trial registration number

NCT03854877.

Experiences of the clinical academic pathway: a qualitative study in Greater Manchester to improve the opportunities of minoritised clinical academics

Por: Lin · C.-Y. · Greco · C. · Radhakrishnan · H. · Finn · G. M. · Cowen · R. L. · Gardiner · N. J.
Objectives

The aim of this study was to explore the barriers and facilitators faced by clinical academics (CAs) in the Greater Manchester region, with particular attention to the experiences of minoritised groups.

Design

A qualitative study using semistructured interviews and focus groups was conducted. A reflexive thematic analysis was applied to identify key themes.

Setting

University of Manchester and National Health Service Trusts in the Greater Manchester region.

Participants

The sample of this study was composed of 43 participants, including CAs, senior stakeholders, clinicians and medical and dental students.

Results

Six themes were identified. CAs face several barriers and facilitators, some of which—(1) funding insecurity and (2) high workload between the clinic and academia—are common to all the CAs. Other barriers, including (3) discrimination that translates into struggles with self-worth and feeling of not belonging, (4) being or being perceived as foreign and (5) unequal distribution of care duties, particularly affect people from minoritised groups. In contrast, (6) mentorship was commonly identified as one of the most important facilitators.

Conclusions

Cultural and structural interventions are needed, such as introducing financial support for early career CAs and intercalating healthcare students to promote wider social and cultural change and increase the feelings of belonging and representation across the entire CA pipeline.

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