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Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
Introduction

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

Methods and analysis

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics and dissemination

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

Use of electronic point-of-care resources by early-career general practitioners and associations with their use during consultations: A cross-sectional analysis of consultation data.

Por: Mitchell · B. · Magin · P. · van Driel · M. L. · Tapley · A. · Ralston · A. · Davey · A. · Holliday · E. · Dizon · J. · Moad · D. · Fielding · A. · Fisher · K. · Clarke · L. · Spurling · G.
Objectives

To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.

Design

Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.

Setting

Australian training general practices.

Participants

3024 GP trainees in community-based vocational training.

Primary and secondary outcome measures

The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.

Results

A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.

Conclusions

Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.

Identification of novel molecular drivers, prognostic and diagnostic biomarkers for Inflammatory Bowel Disease (IBD): protocol for the Nottingham/AstraZeneca prospective IBD observational cohort study

Por: Serna-Valverde · A. L. · Rodriguez-Suarez · E. · Marks · D. J. B. · Gehrmann · U. · Neisen · J. · Clarke · S. · Chew · T. S. · Cummings · F. · De Silva · S. · Gordon · J. N. · Knight · P. · Limdi · J. · Patel · K. · Crooks · B. · Sebastian · S. · Polytarchou · C. · Hannan · N. R. F. · Mo
Introduction

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

Methods and analysis

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethics and dissemination

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy

Por: Campbell · K. A. · Clark · M. M. · Montgomery · A. A. · Partlett · C. · Dickinson · A. · Bradshaw · L. · Jones · M. · Huang · Y. · Aveyard · P. · Jiang · Y. · Holmes · C. M. · Coleman · T.
Introduction

Nicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.

Methods and analysis

A two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care,

Ethics and dissemination

Ethics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.

Trial registration number

ISRCTN84798566.

Healthcare professionals views of physiotherapy after cardiac surgery in children with congenital heart disease: a UK and Ireland survey

Por: Clarke · S. L. · Shkurka · E. · Menzies · J. C. · Drury · N. E.
Objectives

To understand healthcare professionals’ views on current physiotherapy service provision in children with congenital heart disease (CHD), how physiotherapy could be better used post-cardiac surgery and perceived barriers to service expansion.

Design

Cross-sectional survey using a one-off self-completed online questionnaire, with open and closed questions, in June–August 2024.

Setting

Each of the 12 level 1 paediatric cardiac surgical centres in the UK National Health Service and Children’s Health Ireland.

Participants

Healthcare professionals providing clinical care to children undergoing cardiac surgery.

Results

80 responses were obtained, with at least one response from each centre. Healthcare professionals conduct motor, developmental and functional evaluations across all age groups, with referrals to physiotherapy primarily based on physical examination (39, 87%). They expressed dissatisfaction with community physiotherapy services (64, 81%) compared with inpatient services (29, 36%), although they indicated that expanding services would positively impact patients and families. There is a lack of consensus regarding intervention frequency, duration and which patient groups should be prioritised. Respondents identified a lack of funding as the primary barrier to service expansion (76, 95%). Reported barriers for families included volume of medical appointments (69, 86%), transportation (66, 83%) and finances (62, 78%).

Conclusions

Healthcare professionals appreciate the positive impact physiotherapy can have on post-surgical management of children with CHD. The importance of expanding services was emphasised. However, to effectively support clinical practice, it is crucial to understand which patient groups should be prioritised and at what stage, as well as determining the optimal amount of physiotherapy that positively impacts patient outcomes.

Living with a loved one’s mental health issue: Recognizing the Lived Experiences of Military Spouses

by Emma Senior, Amanda Clarke, Gemma Wilson-Menzfeld

Limited evidence surrounds the lived experiences of military spouses whose partner has mental health issues. This lack of evidence may be due to factors such as global austerity, underfunding of armed forces, and inadequate healthcare systems. As a result, family members—especially spouses—often end up being the primary caregivers for their military partners with mental health issues. The study used a qualitative, biographical methodology, collecting data through life stories. Two face-to-face semi-structured interviews took place with nine military spouse recruited through military spouse networks and snowballing. Lieblich et al.’s (1998) framework provided analytical pluralism, which allowed for both narrative and thematic analysis. Stories are presented in the stages ‘in the beginning’, changing times’ and ‘this is me’. Thematic analysis identified six overarching categories; Living with disruption, living in the midst of it all, It isn’t enough, seeking support, Diagnosis and treatment, Living alongside. Whilst the first of its kind in the UK, this biographical study advances both national and global understanding of military spouse experiences in the context of mental health. Both the stories and the categories indicate that living with a serving partner who has mental health issues is a complex journey marked by both struggle and growth. A uniqueness arising from this study highlights the period leading up to a mental health diagnosis, emphasising the prolonged emotional and psychological strain experienced by military spouses before any formal recognition of mental illness in their serving partner. The study adds a new dimension to understanding the emotional toll on military spouses and underscores the importance of early recognition and support. While participants faced emotional detachment and feelings of invisibility, they also identified gains in resilience and strengthened relationships. Through the convergence of the narrative and thematic analysis the participants experience throughout their partners mental health issue is conceptualised in a Relationship Trajectory model. It illustrates the positive, early relational strength, superseded by relationship decline followed with relationship reinvention.

Validity of the International Classification of Diseases, 10th Revision codes for lithium toxicity in adult patients at hospital admission: a cohort study in Canada

Por: Ahmadi · F. · Muanda · F. T. · Ehiwario · J. · McArthur · E. · Jandoc · R. · Slater · J. · Vasudev · A. · Weir · M. A. · Clark · E. G. · Rej · S. · Herrmann · N. · Garg · A. X.
Objective

To assess the validity of the International Classification of Diseases, 10th Revision (ICD-10) healthcare database diagnosis codes for lithium toxicity at hospital admission in Ontario, Canada.

Design

Population-based retrospective validation study.

Setting

A total of 152 hospitals linked to a provincial laboratory database in Ontario, Canada, from 2007 to 2023.

Participants

Patients 50 years of age or older taking lithium with hospital-based serum lithium laboratory measurements during admission to the hospital (n=2804).

Outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparing an ICD-10 diagnostic coding algorithm for lithium toxicity to a serum lithium concentration of 1.5 mmol/L or more. The codes used in the algorithm were T568, T435, Y495, X41 and X49. Serum lithium values and changes in the concentration of serum lithium from baseline levels in patients with and without a diagnosis code for lithium toxicity (code-positive and code-negative, respectively).

Results

The sensitivity of the ICD-10 coding algorithm for identifying a serum lithium level≥1.5 mmol/L was 84% (95% CI 81% to 87%). The specificity and the NPV were over 88%, and the PPV was 63% (95% CI 60% to 66%). The median (IQR) serum lithium measurement in code-positive patients was 1.7 (1.2 to 2.2) mmol/L, and it was 0.6 (0.4 to 0.9) mmol/L in code-negative patients. The median (IQR) increase in serum lithium concentration compared with the most recent prehospital baseline values was 0.7 (0.2 to 1.3) mmol/L in code-positive patients and 0.0 (–0.2 to 0.2) mmol/L in code-negative patients.

Conclusion

In Ontario, the sensitivity of the ICD-10 coding algorithms was moderate for identifying a serum lithium level≥1.5 mmol/L at hospital admission. The presence or absence of the ICD-10 codes for lithium toxicity at hospital admission successfully differentiated two groups of patients with distinct serum lithium measurements.

Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

Abstract

Aim

Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.

Background

Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.

Design

This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.

Conclusion

The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.

Relevance to workforce development

This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study

Por: Jiwa · A. · Cameron · M. M. · Ademuyiwa · A. O. · Adisa · A. · Aguilera Arevalo · M. L. · Bahrami Hessari · M. · Bhangu · A. · Brennan · P. M. · Clark · N. · Cresswell · K. · Czerwinska · I. · DAdderio · L. · Gunn · E. · Haque · P. D. · Ikegwuonu · T. · Lawani · I. · Morton · D. · Nganwa
Introduction

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

Methods and analysis

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Ethics and dissemination

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

Trial registration number

NCT06565559.

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Utilisation of ambulatory ECG monitoring for prediction of heart failure and stroke events and healthcare expenditure in treated and untreated patients: a retrospective cohort study

Por: Schwennesen · H. · Li · Z. · Hammill · B. G. · Clark · A. G. · Pokorney · S. D. · Hytopoulos · E. · Turakhia · M. P. · Cambra · J. · Piccini · J. P.
Objective

We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients.

Design and setting

A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020.

Participants and outcomes

14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89 923 patients in the HF hospitalisation group, 75 870 in the new-onset HF group and 90 159 in the stroke hospitalisation group. Predictive models for new-onset HF, HF hospitalisation and stroke hospitalisation were generated using LASSO Cox regression with ambulatory ECG variables and components of the CHA2DS2-VASc. For each outcome, we scored patients using standardised linear predictors from three composite risk models, and we evaluated the association between risk score and total Medicare cost.

Results

The following hazard ratios per one SD increase in the new risk score were observed for the model that included all CHA2DS2-VASc components and ECG variables: HF hospitalisation in treated 2.94, 95% CI 2.75 to 3.15; new-onset HF in treated 1.84, 95% CI 1.75 to 1.93; HF hospitalisation in untreated 3.51, 95% CI 3.23 to 3.82; and new-onset HF in untreated 1.92, 95% CI 1.85 to 2.00. Risk scores generated by the model were also predictive of Medicare cost in both treated and untreated patients, with patients in the high-risk category for all outcomes having the greatest Medicare costs during 1 year of follow-up.

Conclusions

Integrating arrhythmia data from ambulatory ECG monitoring into clinical risk models allows for better prediction of healthcare utilisation and cost in both treated and untreated patients at high risk for HF and stroke events.

Finding the optimal regimen for Mycobacteroides abscessus treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial

Por: Jong · T. · Baird · T. · Barr · H. L. · Bell · S. · Bigirumurame · T. · Brady · K. · Burke · A. · Byrnes · J. · Caudri · D. · Clark · J. E. · Coin · L. J. M. · Goh · F. · Grimwood · K. · Hicks · D. · Jayawardana · K. · Joshi · S. · Lee · K. · Qvist · T. · Reid · D. · Rice · M. · Roberts · J. A.
Introduction

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

Methods and analysis

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

Ethics and dissemination

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

Trial registration numbers

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study)

Por: Morley · K. · Arunogiri · S. · Connor · J. P. · Clark · P. J. · Chatterton · M. L. · Baillie · A. · Slade · T. · Berk · M. · Lubman · D. · Haber · P. S.
Introduction

Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.

Methods and analysis

This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.

Ethics and dissemination

Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.

Trial registration number

NCT05408247.

Pragmatic trial evaluating a randomly allocated Supplemental Nutrition Assistance Program outreach and enrolment assistance programme in Michigan: study protocol

Por: Samuel · L. · Stuart · E. A. · Liu · Y. · Szanton · S. L. · Clark · A. L. · Miguel · M. · Schneider · M. · Mashrah · A. · Laretz · M. · Swenor · B.
Introduction

Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.

Methods and analysis

The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.

Ethics and dissemination

The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.

Barriers and Facilitators in Implementing Clinical Practice Guidelines Among Nurses in Emergency Departments and Critical Care Units: A Systematic Review

ABSTRACT

Aim

This systematic review explored the barriers and facilitators to the implementation of clinical practice guidelines (CPGs) among nurses in emergency departments (EDs) and critical care units (CCUs).

Design

Systematic review.

Method

A systematic review was performed using both qualitative and quantitative studies from five databases (CINAHL, Web of Science, Embase, Scopus and PubMed). The literature search was conducted in May 2024. The PRISMA framework was used to guide the review process. Findings were subject to a narrative, thematic analysis and critical appraisal.

Results

Eighteen studies were identified that met the inclusion criteria, yielding three themes related to barriers and facilitators of guideline implementation: individual-level, guideline-level and organisational-level. Key barriers included lack of awareness of guidelines, lack of knowledge and skills, attitudes towards guidelines, resource limitations, lack of perceived support, complexity of guidelines and lack of training. Facilitators to guideline use included colleague support, adequate training, effective leadership and refinement of guidelines to ensure relevance, local adaptation and user-friendly content.

Discussion

Numerous barriers to nurse implementation of CPGs exist in ED and CCU settings, reflecting a complex interplay of individual, CPG-related and organisational factors. To facilitate CPG implementation, it is important for staff to be educated and trained in their use, supported to implement (including resource allocation) and that CPGs are designed to be easily implemented in practice.

Conclusion

This systematic review highlights risk factors for poor CPG implementation and highlights the importance of addressing awareness, knowledge, resources and support for CPG use through targeted training, leadership and CPG design.

Relevance to Clinical Practice

An analysis of barriers and facilitators to CPG implementation among nurses in ED and CCU settings provides an important opportunity to address a gap in the literature, facilitating the development of strategies to promote CPG use and enhance care quality among nurses in these specific contexts.

Assessing the global variation in patient characteristics, management and short-term outcomes of spontaneous intracranial haemorrhage worldwide: a protocol for a global observational prospective multicentre study (the PLOT-ICH study)

Por: Venturini · S. · Clark · D. · Smith · B. G. · Hobbs · L. · Bath · M. F. · Mee · H. · Still · M. · Mediratta · S. · Soliman · M. A. · Kohler · K. · Whiffin · C. J. · Katambo · E. · Korhonen · T. K. · Tetri · S. · Bankole · N. D. A. · Rutabasibwa · N. · Bhebhe · A. · Munusamy · T. · Tirsit
Introduction

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

Methods and analysis

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

Ethics and dissemination

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

Trials registration number

NCT06731751.

Putting the patient at the centre: a call for research involvement of nurses, midwives and allied health professionals working in genomics

Por: Cowley · L. · Henriques · S. · Roberts · J. · Monje-Garcia · L. · Nolan · J. · Lubasch · K. · Theobald · R. · Greer · R. · Fennell · N. · Clarkson · A. · Clapham · M. · Chilton · S. · Allon · R. · Stopford · C. · Pierce · H. H. · Holliday · D.
Introduction

We report the collaborative views of a group of nurses, midwives and allied health professionals (NMAHPs) in the UK who have a genomics research remit or interest. Our group includes genetic counsellors under this diverse category of healthcare workers.

This group came together as part of the National Institute for Health and Social Care Research (NIHR) Genomics Research National Specialty Group. After responding to a survey to elicit the views of NMAHPs working in genomics, some of the original 45 respondents, along with others who learnt of the project by word of mouth, have worked together to produce this article.

Objective

The paper aims to set out in clear terms the value of NMAHPs to research that supports the patient-centred implementation of genomics in the National Health Service (NHS).

Key argument

We discuss four potential areas where NMAHPs, in particular, can contribute to the research. These are patient perspectives and epistemic justice, psychosocial impacts, the familial nature of genomics and equity. We argue that this group (NMAHPs) represents a potentially underused resource for the NHS as it seeks to ensure that advances in genomics are translated into patient benefit.

Conclusions

We propose that NMAHPs, with our research expertise, are well placed to shape and deliver a research agenda that explores models of patient-centred care in the genomics era. We call for increased funding for NMAHP research roles and funding opportunities to deliver this fundamental work.

Interpractice variability in antibiotic prescribing for acute respiratory tract infections: a cross-sectional study of Australian early-career general practitioners

Por: Turner · A. · van Driel · M. L. · Mitchell · B. · Holliday · E. · Davis · J. · Tapley · A. · Davey · A. · Ralston · A. · Dizon · J. · Baillie · E. · Fielding · A. · Mulquiney · K. · Clarke · L. · Spike · N. · Magin · P.
Objectives

Frequency of general practitioners’ (GPs’) antibiotic prescribing for acute, self-limiting respiratory tract infections (aRTIs) is high. The practice environment and culture influence the clinical behaviour, including prescribing behaviour, of GP specialist vocational trainees (registrars). We aimed to assess inter-practice variability in registrars’ antibiotic prescribing.

Design

This was a cross-sectional analysis from the Registrar Clinical Encounters in Training (ReCEnT) cohort study, from 2010 to 2020.

Setting

ReCEnT documents registrars’ clinical experiences and behaviours. Before 2016, 5 of 17 Australian training regions participated in ReCEnT. From 2016, three of nine regions (~40% of Australian registrars) participated.

Participants

3210 registrars (response rate 91.8%) from 1286 training practices contributed to the analysis.

Outcome measures

The outcomes were prescription of an antibiotic for new diagnoses of (1) all aRTIs and (2) acute bronchitis diagnoses specifically. Prescribing percentages were calculated at the training practice level. Intraclass correlation coefficients (ICCs) were used to measure the ratio of interpractice variation to total variance. Median ORs (MORs) were also estimated to quantify interpractice variability.

Results

Practice-level antibiotic prescribing percentages ranged from 0% to 100% for both aRTIs and acute bronchitis diagnoses in the primary analysis. ICCs for aRTI prescribing were 0.08 (unadjusted) and 0.02 (adjusted). For acute bronchitis, ICCs were 0.10 (unadjusted) and 0.05 (adjusted). MORs were 1.66 (unadjusted) and 1.32 (adjusted) for aRTIs. MORs for acute bronchitis were 1.80 (unadjusted) and 1.53 (adjusted). This indicates a marked variation in the odds of a patient receiving antibiotics for an aRTI if randomly attending different practices.

Conclusions

There was considerable interpractice variation in registrars’ antibiotic prescribing frequencies. Further research is required to examine the factors accounting for this variation and to develop practice-level interventions to reduce antibiotic prescribing in high-prescribing practices.

Neighbourhood deprivation and quality of comprehensive diabetes care: findings from a national retrospective cohort study of US Medicare Advantage enrollees

Por: Blass · B. · Mahoney · H. · Lusk · J. B. · Clark · A. G. · Corsino · L. · Hammill · B. G.
Objective

This study aims to assess the association between neighbourhood socioeconomic deprivation and outcomes reflecting comprehensive diabetes care (CDC).

Design

Retrospective cohort study

Setting

US Medicare Advantage (MA) data, 2015–2020.

Participants

National sample of MA enrollees with diabetes.

Outcome measures

Primary outcomes included six indicators of CDC from the Healthcare Effectiveness Data and Information Set: haemoglobin (Hb) A1c (HbA1c) testing, HbA1c control (9%), blood pressure control (

Results

There were 827 227 enrolments included in the final analysis. After adjusting for demographic (age, sex, race/ethnicity and dual eligibility) and regional characteristics (rurality and primary care providers per capita), high neighbourhood deprivation was associated only with worse glycaemic control (for HbA1c>9%, risk ratio (RR) 1.04, 95% CI 1.02 to 1.07). This relationship was significant for white and Asian patients (RR 1.08, 95% CI 1.05 to 1.11 and RR 1.18, 95% CI 1.05 to 1.32, respectively); outcomes for black and Hispanic patients were worse overall but independent of neighbourhood deprivation (RR 1.00, 95% CI 0.96 to 1.05 and RR 0.98, 95% CI 0.94 to 1.03, respectively). In the fully adjusted model, neighbourhood deprivation was not associated with measures that directly reflect access to care, including the occurrence of HbA1c testing and receipt of eye exams (RR 0.99, 95% CI 0.94 to 1.04 and RR 1.03, 95% CI 1.00 to 1.05).

Conclusions

An increased risk of poor glycaemic control was observed for patients from areas of high neighbourhood deprivation, independent of individual socioeconomic status. Neighbourhood factors and their intersection with racial and ethnic disparities are important considerations for achieving equity in diabetes care.

Effectiveness of predictive scoring systems in predicting mortality in relation to baseline kidney function in adult intensive care unit patients: a systematic review protocol

Por: El Wadia · H. · Buh · A. · Kabli · A. O. · Karim · M. · Biyani · N. · Shorr · R. · Lee · I. · Clark · E. G. · Akbari · A. · Knoll · G. · Hundemer · G. L.
Introduction

Predictive scoring systems support clinicians in decision-making by estimating the prognosis of patients in intensive care units (ICUs). However, there is limited evidence on the accuracy of these systems in predicting mortality and organ dysfunction in special populations. The aim of this review is to assess the performance of predictive scoring systems in forecasting mortality in adult ICU patients in relation to baseline kidney function. It is anticipated that the assessment of predictive scoring systems’ performance and patient outcomes in this review may reveal information that will contribute to improve the quality of care and outcomes for special or under-represented ICU patient populations. It might also inform future research and contribute to the development of novel risk prediction models to address identified gaps or unanswered questions.

Methods and analysis

This review will include only observational studies, as these allow us to assess the real-world performance of predictive scoring systems in ICU settings by examining the original validation studies. By excluding randomised trials, paediatric studies, case reports and machine learning-derived models, this review focuses on the direct practical use of the scoring systems in adult ICU patients. A comprehensive search of MEDLINE, Embase and Scopus was conducted from database inception to 10 October 2024. The data will be extracted on study characteristics, patient outcomes and performance metrics.

Ethics and dissemination

This review will analyse data from previously published studies; no ethical approval is required. All data that will be included in the analysis will be publicly available and will be included in the final manuscript. Results will be disseminated through publication in a peer-reviewed journal and will also be presented at seminars and conferences.

PROSPERO registration number

CRD42024611547.

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