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Sources and consequences of self-doubt in patients with Ehlers-Danlos syndrome: a qualitative study in Europe and North America

Por: Halverson · C. M. E. · Vershaw · S. L. · Francomano · C. A. · Doyle · T.
Objectives

To examine how clinicians’ scepticism regarding patients’ self-reports of subjective symptoms can be internalised, leading to psychosocial and medical harms.

Design

In-depth, semi-structured qualitative interviews with the resulting data analysed using reflexive thematic analysis.

Participants

43 individuals with Ehlers-Danlos syndrome (EDS) from Europe and North America completed a pre-survey, and 39 of those participants completed interviews for this study. Purposive sampling was used to obtain approximately equal numbers of participants with hypermobile EDS and the molecularly defined types of EDS.

Results

Patients with both hypermobile and molecularly defined types of EDS reported high levels of self-doubt, with 73% of survey respondents questioning the extent—and even reality—of their private experiences of pain. Participants attributed much of their self-doubt to repeated dismissal and minimisation of their symptoms in healthcare settings, especially during childhood. Ultimately, self-doubt transformed not merely how they communicated their symptoms but also how they recognised, evaluated and even experienced them at a phenomenological level. While some participants developed coping strategies, others withdrew from the conventional medical system altogether.

Conclusion

These findings have important implications for clinicians, who may inadvertently reinforce self-doubt through discussion of diagnostic uncertainty. Doubt need not be delegitamising. Recognising and mitigating these potential harms requires epistemic humility and attention to the psychosocial dynamics of patient-provider interaction.

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

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

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

Design

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

Setting

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

Participants

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

Main outcome measures

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

Results

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

Conclusions

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

Perception of primary-secondary care collaboration among general practitioners and specialists and the perceived potential for innovation: an exploratory qualitative study

Objectives

Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.

Design

A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.

Setting

Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.

Participants

37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).

Results

Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.

Conclusions

This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.

Use and reporting of intervention mapping for adaptation: a systematic review protocol

Por: Kang · E. · Sanchez-Blas · H. R. · Obekpa · E. O. · Fernandez · M. E.
Introduction

Intervention adaptation is likely to occur to some extent when implementing interventions in new implementation contexts. Using systematic frameworks can guide intentional and effective adaptation processes. Intervention Mapping for Adaptation (IM-ADAPT) is a framework that offers step-by-step guidance for systematic, theory-based intervention adaptation. Despite the increasing use of IM-ADAPT, there is limited understanding of the contexts in which it has been applied and how effectively it is used and reported. Addressing this knowledge gap can improve current adaptation practices and inform future enhancements of the IM-ADAPT framework and the broader science of intervention adaptation. This review aims to (1) determine the context in which IM-ADAPT is used, (2) assess how studies apply IM-ADAPT tasks and (3) evaluate how these studies report their IM-ADAPT findings.

Methods and analysis

This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The eligibility criteria include original peer-reviewed English articles that used Intervention Mapping or IM-ADAPT to adapt interventions. We searched PubMed/Medline, Web of Science, Embase and the Intervention Mapping literature library, and conducted forward citation searches using two landmark articles from inception to 19 July 2024. At least two independent coders will screen the records to determine eligibility and extract data from the included articles. Any discrepancies will be resolved through regular co-author meetings or in consultation with a senior author. The study protocol was registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/D5TCP).

Ethics and dissemination

As this systematic review only used published data, no ethics approval was required. We will disseminate the findings of this review through open-access channels and journals.

Assessing the efficacy, safety and utility of hybrid closed-loop glucose control compared with standard insulin therapy combined with continuous glucose monitoring in young people (>=16 years) and adults with cystic fibrosis-related diabetes (CL4P-CF s

Por: Kadiyala · N. · Coleman · R. · Lakshman · R. · Wilinska · M. E. · Brennan · A. · Lumb · A. · Holt · R. I. G. · Lau · D. · Yajnik · P. · Cheah · Y. S. · Safavi · S. · Felton · I. · MacGregor · G. · Clayton · A. · Lawton · J. · Rankin · D. · Churchill · S. · Adler · A. · Hovorka · R. · Boughto
Introduction

Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.

Methods and analysis

This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.

Ethics and dissemination

Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.

Trial registration number

NCT05562492.

NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

Methods and analysis

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethics and dissemination

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care

Por: Leong · Y. H. · Tay · V. Y. J. · Yang · X. · Tan · C. J. · Au-Yong · P.-S. · Sim · J. L. X. · Ng · R. R. G. · Ong · M. E. H. · Tan · B. P. Y. · Abdullah · H. R. · Ke · Y.
Introduction

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

Methods and analysis

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Ethics and dissemination

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

Trial registration number

ClinicalTrials.gov Identifier: NCT06633614

Predicting 30-day mortality in emergency department patients with suspected infection: external validation of the RISE UP score in a single tertiary centre

Por: van Baar de Knegt · S. M. E. · Uffen · J. W. · de Hond · T. A. P. · Stassen · P. M. · Zelis · N. · Kaasjager · K. A. H.
Objective

Rapid identification of high-risk and low-risk patients presenting to the emergency department (ED) influences clinical management and can help optimise patient outcomes as well as resource allocation. This study aims to externally validate the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) score in adult patients in the ED with suspected infection. Furthermore, generalisability was assessed by comparing the discriminatory ability of the RISE UP with the quick Sequential Organ Failure Assessment (qSOFA) as well as the Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS).

Design

Retrospective cohort study.

Setting

Single-centre study in the ED of a tertiary, university-affiliated hospital.

Participants

Adult patients with suspected infection presenting at the ED for internal medicine from 2016 to 2022.

Outcomes

The primary outcome was all-cause 30-day mortality. Secondary outcomes were all-cause 14-day mortality, 7-day mortality and intensive care unit (ICU) admission.

Methods

Prognostic performance was evaluated using discrimination (area under the receiver operating characteristic curve (AUC)) and a calibration plot.

Results

Of the included 5038 ED visits, there was a 30-day mortality of 7.1%. Discrimination of RISE UP for 30-day mortality was good (AUC 0.809; 95% CI 0.786 to 0.832) and significantly higher than that for the other risk scores: qSOFA (AUC 0.675; 95% CI 0.644 to 0.707), MEWS (AUC 0.688; 95% CI 0.658 to 0.718) and NEWS (AUC 0.725; 95% CI 0.696 to 0.754) (p

Conclusions

The RISE UP score outperformed the qSOFA, MEWS and NEWS in predicting 30-day mortality. It is generalisable to an adult infection-specific cohort and may facilitate distinction between high-risk and low-risk patients in the ED, particularly to rule out poor outcomes.

Global prioritised indicators for measuring WHOs quality-of-care standards for small and/or sick newborns in health facilities: development, global consultation and expert consensus

Por: Day · L. T. · Vaz · L. M. E. · Semrau · K. E. A. · Moxon · S. · Niermeyer · S. · Khadka · N. · Chitashvili · T. · Valentine · G. C. · Drake · M. · Ehret · D. E. Y. · Sheffel · A. · Sacks · E. · Greenspan · L. · Shaver · T. R. · Kak · L. · Hailegebriel · T. D. · Gupta · G. · Hill · K. · Jac
Objectives

The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.

Design

Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.

Setting

The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.

Participants

The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.

Results

The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).

Conclusions

The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.

Randomised controlled trial to assess the efficiency and effectiveness of remote care compared with in-clinic care for adult cochlear implant recipients in the first 12 months after activation: a protocol of the INSPIRE study

Por: Quaranta · N. · Murri · A. · Denys · S. · Verhaert · N. · Huinck · W. · Townsend · J. · Swinnen · F. · Dhooge · I. · de Klerk · A. · Mehta · D. · Brotto · D. · Craddock · L. · Hoskam · G. · Schou · I. M. · McBride · M. E. · Campbell-Bell · C.
Introduction

Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients.

Methods and analysis

This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation.

Ethics and dissemination

Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations.

Trial registration number

NCT05552118.

Comparative effectiveness of take-home dosing schedules for opioid agonist treatment in British Columbia, Canada: a target trial emulation protocol using a population-based observational study

Por: Kurz · M. · Guerra-Alejos · B. C. · Hossain · M. B. · Min · J. E. · Yan · R. · Bruneau · J. · Catherine · N. L. A. · Greenland · S. · Gustafson · P. · Hedden · L. · Karim · E. · McCandless · L. · Nolan · S. · Platt · R. W. · Bach · P. · Seaman · S. · Siebert · U. · Socias · M. E. · Nosyk
Introduction

The introduction of fentanyl and its analogues in the illicit drug supply has prompted greater emphasis on refining clinical treatment protocols to ensure sustained retention in opioid agonist treatment (OAT). Take-home dosing may lessen the treatment burden on clients and thus reduce the risk of treatment discontinuation. The evidence base supporting the use of take-home dosing, including the optimal duration of dispensations, is, however, limited. The objective of this study is to determine the comparative effectiveness of alternative take-home dosing schedules, as observed in clinical practice in British Columbia, Canada from 2010 to 2022.

Methods and analysis

We propose to emulate a target trial with a population-level retrospective study of individuals initiating methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022 who are 18 years of age or older and not currently incarcerated or pregnant with no history of cancer or palliative care. Our study will draw on nine linked health administrative databases from British Columbia and will evaluate take-home doses of 2–5 days, 6 days or >6 days compared with continuous daily dosing. The primary outcomes include OAT discontinuation and all-cause mortality on treatment. A causal per-protocol analysis is proposed with longitudinal matching and inverse probability of censoring weighting approaches to adjust for time-fixed and time-varying confounding. A range of sensitivity analyses will be executed to determine the robustness of results.

Ethics and dissemination

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

A prospective protocol for remotely investigating brain-behaviour-genetics associations in adolescent patients in a paediatric health system with pre-existing clinical brain MRIs

Por: Mercedes · L. · Buczek · M. J. · Kafadar · E. · DiDomenico · G. · Jung · B. · Zimmerman · D. · Schabdach · J. M. · Himes · M. M. · Sotardi · S. · Vossough · A. · Driesbaugh · K. H. · Moore · T. · Barzilay · R. · Calkins · M. E. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Whit
Introduction

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

Methods and analysis

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Ethics and dissemination

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

Reference standard for the prevention and management of hospital falls: a multidisciplinary Delphi consensus study

Por: Morris · M. E. · Said · C. M. · Haines · T. · Heng · H. W. F. · Batchelor · F. · Hutchinson · A. M. · McKercher · J. P. · Semciw · A. I. · Hill · A.-M. · Peterson · S. · Kane · R. · Fowler-Davis · S. · Campbell · S. · Sherrington · C. · Gilmartin-Thomas · J. · Phan · U. · Thwaites · C.
Background

Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.

Methods

A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.

Results

In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.

Conclusion

This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.

Trial registration number

ANZCTR 386960

Barriers, facilitators and solutions to equitable career progression for disabled doctors: an integrative review

Por: Brown · M. E. L. · Burford · B. · Vance · G.
Objectives

Disabled resident doctors face persistent structural, cultural and institutional barriers to career progression. This integrative review synthesises empirical and grey literature to identify the challenges disabled doctors encounter, the practices that support their careers and the potential solutions applicable to healthcare, in particular National Health Service (NHS), settings.

Design

Integrative literature review using a content analysis approach to data analysis. Included sources were published in English and examined disabled doctors’ career progression or included disabled doctors as a separate subgroup. Opinion pieces without empirical grounding and articles not available in full text were excluded.

Setting

International postgraduate medical education, with consideration for transferability and applicability to the UK NHS.

Participants

Focused on the experiences and careers of disabled resident doctors, at any stage of their career, prior to completion of training.

Results

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Equity guidelines, 53 sources were included and analysed. Structural ableism, inaccessible systems and stigma around disclosure were consistently identified as barriers to career progression. Facilitators included mentorship, affirming supervisory relationships and identity-affirming networks. Promising practices included universal design approaches, anticipatory rather than reactive approaches to making adjustments and integration of disability equity into organisational governance. However, most initiatives remain unevaluated, and UK-specific evidence is limited.

Conclusions

While awareness of barriers is growing, evidence-based solutions remain underdeveloped and unevenly implemented. To build a sustainable and representative medical workforce, workforce policy and planning must not only remove barriers to progression for disabled doctors, but also embed disability inclusion into the structures and cultures that shape medical career paths.

Patient navigation programmes in cancer care in Africa: protocol for a scoping review

Por: Igibah · C. O. · Asogun · D. O. · Okoduwa · B. · Uzoma · V. I. · Agbabi · O. M. · Osinaike · T. · Shittabey · M.-S. K. · Oigiangbe · M. E. · Lawal · Q. O.
Introduction

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

Methods and analysis

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

Ethics and dissemination

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

Leading practices in the development and delivery of case-based learning programmes for health and social care provider education: a scoping review protocol

Por: Saari · M. E. · Hudani · A. · Cardozo · V. · Giosa · J. L.
Introduction

As care needs increase in complexity, a shift to people-centred, integrated care is required to meet the full range of health and social care needs of clients. However, limited opportunities exist for care providers to develop interprofessional competencies as part of pre-licensing and/or continuing education. New learning models, such as case-based learning (CBL), that facilitate the development of interprofessional competencies and are aligned with practice realities of providers are needed. This scoping review will collate and codify leading practices and knowledge gaps in the development and delivery of CBL programmes in pre-licensing and continuing education for health and social care providers.

Methods and analysis

A scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. MEDLINE, CINAHL Plus, Scopus, ERIC Institute of Education Sciences, PsycINFO and Education Source will be searched for peer-reviewed literature; Google Scholar, ProQuest Dissertations and Web of Science will be searched for grey literature. Reference lists of full-text scholarly sources, key journals and authors will be searched manually. Study selection and extraction will be conducted by two independent reviewers. English sources published between 2014 and 2024 that discuss CBL epistemologies, characteristics, delivery mechanisms, programme limitations and/or programme evaluation in health and social care pre-licensing and/or professional training will be included. Data will be analysed using directed content analysis and synthesised as a narrative summary.

Ethics and dissemination

This scoping review protocol was reviewed by the Southlake Health Research Ethics Board and received ethics exemption. Findings will be disseminated through peer-reviewed publication, conferences, professional networks and social media, and used to inform the development of an evidence-based training programme for health and social care providers.

Registration details

Open Science Framework https://doi.org/10.17605/OSF.IO/6YXHN

Access to multidisciplinary outpatient heart failure clinics in Qatar: a qualitative study from the perspectives of patients and cardiologists

Por: Hajaj · A. · Grace · S. L. · Hamed Badr · A. M. · Hadi · M. A. · Abdel-Rahman · M. E. · Babu · G. R. · Turk-Adawi · K.
Objective

Heart failure clinics (HFCs) are associated with increased survival rates, lower hospitalisation and improved quality of life. This study investigated factors influencing patient access to multidisciplinary outpatient HFCs from the perspective of patients and cardiologists.

Design

This was a qualitative study. A trained researcher conducted semistructured face-to-face interviews with patients and online interviews with cardiologists. Interviews, conducted between March and October 2023, were audio-recorded. Transcripts were cleaned (deidentification, translation verification) and analysed by two trained researchers independently using systematic text condensation in NVivo v12. Codes were derived from the transcripts and grouped and organised into themes. Two authors independently coded data, reconciling disagreements with the senior author, followed by respondent validation. Member checking ensued.

Setting

Outpatient multidisciplinary HFCs in Qatar.

Participants

A purposive sample of patients diagnosed with heart failure who had attended at least one HFC appointment at Qatar’s Heart Hospital were approached in person or via phone, and cardiologists with the authority to make referrals to these clinics via the electronic medical record system were emailed; interviews ensued until theme saturation was achieved.

Results

26 individuals (14 patients and 12 cardiologists) participated in the interviews. Four major themes were identified: health system organisation (subthemes: benefits, HFC triage criteria, need/capacity), HFC referral processes (subthemes: electronic record system, patient communication and education), care continuity and communication (subthemes: patient navigators, clinician preferences) and access challenges (subthemes: transportation, costs).

Conclusions

Resources are needed to expand HFC capacity and coverage, leverage electronic medical record tools as well as telehealth, educate physicians and patients on referral guidelines and processes and engage primary care to ultimately improve patient outcomes.

Feasibility and acceptability of implementing the three-stage model of HIV and tuberculosis care in prisons in sub-Saharan Africa: a pilot implementation research study from Central Malawi

Por: Samwiri Nkambule · E. · Herce · M. E. · Mbakaya · B. C.
Objective

Malawi’s prisons are overcrowded, contributing to tuberculosis (TB) and Human Immunodeficiency Virus (HIV) transmission and service delivery gaps for both conditions. We applied an empirically supported three-stage model of HIV/TB care to guide the improvement of TB/HIV service delivery in select Malawian prisons.

Design

We conducted a pilot implementation research study using multimethods from May 2022 to April 2023.

Setting

Two semi-urban prisons in Malawi.

Participants

We purposively sampled participants detained at the study sites during the study period.

Methods and intervention

We collected data on sociodemographics, medical history and screening results for sexually transmitted infections (STIs), HIV and TB results. We conducted in-depth interviews with prison professional staff and used content analysis to explore the feasibility of implementing the three-stage model of HIV and TB care in Malawian prisons.

Results

Mean participant age was 35 years (SD 12.2 years). We screened 100 out of 647 (15%) incarcerated people for TB/HIV according to the three-stage model and identified the following: five cases of TB disease; two cases of HIV-associated TB; seven persons living with HIV; eight persons diagnosed and treated for STIs, including genital ulcer disease and syphilis. For those tested for HIV at entry, midpoint and exit screening, there was no documented case of seroconversion during the incarceration period. There was evidence of potential STI transmission during incarceration, as suggested by a 4% rate of new urethral discharge among participants. Qualitative data suggest that it is feasible to implement the three-stage model of HIV/TB in the Malawi prison setting.

Conclusions

We found evidence of HIV, TB and STIs among incarcerated people in two semi-urban prisons in Malawi, with low HIV status awareness on prison entry. It is feasible to implement the three-stage model of HIV/TB in prison settings, although with material support to overcome implementation challenges. Coordination with Ministry of Health officials could facilitate model feasibility and sustainability in Malawi’s prisons.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey

Por: Gregory · M. E. · Sieck · C. J. · Walker · D. M. · Di Tosto · G. · Edwards · M. C. · McAlearney · A. S. · Gebretsadik · S. · DeVos · T. V. · Hefner · J. L.
Objective

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Design

Measure development and psychometric evaluation.

Setting and participants

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

Methods

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Primary and secondary outcome measures

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

Results

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

Conclusions

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

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