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Assessing the impact of automated devices for enhancing health and reducing medication errors in older adults with long-term health conditions (ADHERE): a study protocol for a randomised controlled trial in Bedfordshire, Luton and Milton Keynes, UK

Por: Wainwright · J. E. · Bennett · A. · Randhawa · G. · Pappas · Y. · Singh · H. · Cook · E. J.
Introduction

Medication non-adherence in older adults with long-term conditions contributes to significant morbidity, mortality and healthcare costs. While adherence support tools exist, many interventions fail to reach those most at risk. Automated medication dispensers (AMDs) show promise in improving adherence and health outcomes, but their integration into routine community pharmacy practice remains underexplored. This study aims to assess the effectiveness of an AMD intervention with SMS reminders in enhancing medication adherence among older adults and to evaluate how this technology can be integrated into community pharmacy workflows.

Methods and analysis

This randomised controlled trial involves 144 participants recruited from eight community pharmacies who will be randomised to receive either the AMD intervention or usual care. Primary outcomes include medication adherence, measured through pharmacy records and self-report at baseline, 3 and 6 months. Secondary outcomes include Morisky Medication Adherence Scale, health-related quality of life (SF-12), and healthcare resource use. A nested mixed methods process evaluation will explore uptake, acceptability and implementation.

Ethics and dissemination

The study protocol has been approved by the University of Bedfordshire Institute for Health Research Ethics Committee (IHREC1039), the NHS and the local authority Research Governance and Research Ethics Committee (NHS REC reference: 25/EE/0026). The findings will be disseminated via a final report, peer-reviewed journal publications and presentations at relevant conferences.

Trial registration number

ISRCTN18849739.

International perspective on healthcare provider gender bias in musculoskeletal pain management: a scoping review

Por: Wilford · K. F. · Mena-Iturriaga · M. J. · Vugrin · M. · Wainer · M. · Seeber · G. H.
Objective

Musculoskeletal pain is a global issue affecting millions of individuals. Healthcare provider gender bias (HCP-GB) in pain management or treatment may have implications. This study aimed to systematically (1) identify and map the scientific and grey literature as it relates to HCP-GB in the assessment, diagnosis and management of musculoskeletal pain, and (2) identify current gaps that necessitate further research.

Design

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

Data sources

The following databases were searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (EBSCOhost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022 and updated in May 2025. Relevant grey literature was identified.

Eligibility criteria for selecting articles

All screening was performed by two reviewers during title/abstract screening and full-text screening stages. Articles published in English, Spanish and German were included if they involved participants with musculoskeletal pain and examined HCP-GB as the dependent variable.

Data extraction and synthesis

Two reviewers independently extracted data from the bibliometric, study characteristics and pain science variables. Results were descriptively mapped, and the frequency of concepts, population and characteristics was narratively reported.

Results

21 full-text articles were included. All articles were published in North America and Europe. A total of 3694 healthcare providers from various specialty areas were examined. A majority of studies (57.1%; n=12) measured HCP-GB using written case vignettes, 33.3% (n=7) used case vignettes plus virtual human pictures/videos, and 9.5% (n=2) used real patients. The influence of patients’ sex in HCP pain assessment was reported in 28.5% (n=6) of the articles, while 42.9% (n=9) reported gender bias regarding HCP non-pharmacological treatment recommendations. Male patients were more likely to receive exercise recommendations for back pain and laboratory testing, whereas female patients received more psychological treatment recommendations and counselling from their HCP.

Conclusions

While there appears to be inconsistent use of the terms sex and gender, the literature informing this review suggests an existence of gender bias in the management of patients with musculoskeletal pain. Future research should be more purposeful in the use of sex/gender-related terms and consider exploring the impact of implicit bias training to rectify potential gender biases present in HCP.

Evaluating the clinical care, quality of life and overall experiences of patients with primary biliary cholangitis (PBC) during the pandemic: A Canadian mixed-methods study

by Elizabeth Baguley, Madelyn Knaub, Jessica VanDyke, Gideon Hirschfield, Mark G. Swain, Gail Wright, Deirdre McCaughey, Abdel Aziz Shaheen

Pandemic restrictions impacted healthcare, particularly during the first year. We evaluated the impact of the pandemic on quality of life and clinical care among patients with primary biliary cholangitis (PBC). This mixed-methods study administered quality of life surveys (Fear of COVID-19 Scale [FCV-19S], EuroQol 5-dimension 3-level [EQ-5D-3L], 29-item Patient-Reported Outcomes Measurement Instrument Survey [PROMIS-29]) and a PBC Care Delivery questionnaire to 348 Canadian PBC patients, followed by two focus groups with patients (n = 14) and stakeholders (n = 3). Quality of life scores were compared among sub-groups (i.e., care delays and pandemic appointment type) and with various reference populations. Most participants were female (94.0%) and Caucasian (88.2%), with a median age of 63.0 years (IQR: 55.9–71.2). During the pandemic, 75.8% had the majority (≥ 50%) of their hepatologist appointments virtually, but only 22.4% preferred to continue with virtual care post-pandemic. Participants with care delays had worse scores on the FCV-19S (p = 0.014), EQ-5D-3L (p = 0.009), and PROMIS-29 (i.e., fatigue, anxiety, sleep disturbance, ability to participate in social roles and activities, p p 

The DEXACELL trial--a protocol for a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial to assess the effectiveness and cost-effectiveness of DEXAmethasone as an adjunctive therapy for the manag

Por: Joyce · K. · Lear · R. · Hamilton · F. W. · Arnold · D. · Chaudhuri · E. · Connors · J. · Cook · H. · Creanor · S. · Dawe · P. · Goodwin · E. · Hawton · A. · Hayward · C. · Lasserson · D. S. · Ridd · M. J. · Rowe · D. · Shipley · D. · Taylor · H. · Wainman · H. E. · Williams · O. M. · Carlto
Introduction

Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.

Methods and analysis

This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.

Ethics and dissemination

The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.

Trial registration number

ISRCTN76873478.

Association between hyperglycaemia, diabetes complications and development of fibrotic conditions among people living with type 1 and type 2 diabetes in England: a retrospective cohort study using UK Clinical Resource Datalink Aurum and Hospital Episode S

Por: Massen · G. M. · Cook · S. · Moss · S. T. · Chambers · R. · Jenkins · G. · Allen · R. J. · Wain · L. V. · Stewart · I. · Oliver · N. · Morganstein · D. L. · Quint · J. K. · on behalf of the DEMISTIFI Consortium
Objective

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Design and setting

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

Participants

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

Outcome measures

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

Results

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Conclusions

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

Vitamin B12 deficiency in long-term metformin use and clinician awareness: a scoping review protocol

Por: Parsonage · I. · Wainwright · D. · Barratt · J.
Introduction

A relationship between long-term metformin use and vitamin B12 deficiency has been long discussed in the literature. Nonetheless, prior to 2022, there was no official guidance. In June 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) published advice, stating that low vitamin B12 is now considered to be a common side effect. It advises checking levels in patients with symptoms of B12 deficiency, as well as monitoring those at risk of B12 deficiency.

Despite efforts to promote evidence-based practice, there is still a gap in the translation of research findings into policies and clinical practice. The above research has been shared widely in the academic and specialist diabetes literature over a prolonged period. The purpose of the scoping review is to explore what evidence is available regarding clinicians’ awareness of the association between metformin use and vitamin B12 deficiency in patients with type 2 diabetes mellitus, how this evidence is implemented into frontline clinical practice and what screening processes are recommended or exist.

Methods and analysis

This is a protocol for a scoping review to be guided by the Joanna Briggs Institute (JBI) methodology for scoping reviews 20. The databases to be searched will include MEDLINE (accessed via PubMed), British Nursing Index, Google Scholar, Cochrane, Embase, Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL) (accessed via EBSCO), alongside searching for grey literature such as Electronic Theses Online Service (EThOS), DART European and Kings College London Research Portal. Titles and abstracts of articles will be reviewed by the authors. If articles are representative of the inclusion criteria, the articles will go through a full-text review by the authors. The results of the search and study inclusion/exclusion process will be reported and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses flow diagram. Data will be extracted from papers, using the recommended JBI data extraction tool. The search will commence in August 2025, and the review is expected to be completed by November 2025.

The search will commence in August 2025, and the review is expected to be completed by November 2025.

Ethics and dissemination

As this is a scoping review protocol that did not involve any human participants, human data or human tissue, no ethical approval was required. Our dissemination strategy includes peer review publication, presentation at conferences and with relevant stakeholders.

Nurse Practitioner Regulatory Assessment: Transitioning From an Onsite to a Virtual Format

imageThe Nurse Practitioner Onsite Peer Review is an integral part of the British Columbia College of Nurses and Midwives Quality Assurance program. Traditionally an in-person assessment, Nurse Practitioner Onsite Peer Review involves a critical review of documentation by an experienced nurse practitioner assessor against regulatory standards and entry-level competencies. The onset of the COVID-19 pandemic and resulting environmental limitations required the college to rethink its approach to onsite reviews, resulting in the quality assurance program embarking on a pilot project to explore the feasibility of conducting reviews virtually. As there are many factors that can affect the transition of an onsite assessment to one that is virtual, it was important to consider the technical, workflow, and usability aspects in developing this new method of performance assessment. Therefore, including usability testing and a human factors approach to exploring this emerging method was vital to ensuring its success. In this article, we discuss our experience, including benefits, technical and administrative considerations, barriers, challenges, and lessons learned.
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