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The cost-effectiveness of penicillin allergy assessment pathway (PAAP): a decision analysis

Por: Yang · M. · Bestwick · R. · Howdon · D. · Ahmed · S. · Powell · N. · Armitage · K. F. · Fielding · J. · Porter · C. E. · Savic · S. · West · R. M. · Howard · P. · Galal · U. · Pavitt · S. · Sandoe · J. A. · Mujica-Mota · R. E.
Objective

To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.

Design

A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.

Data sources

Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.

Interventions

Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).

Primary and secondary outcome measures

Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.

Results

PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.

Conclusion

The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.

Trial registration number

ISRCTN20579216.

Public health assistance for people with haemophilia in Brazil (PATCH study): a cross-sectional study protocol

Por: Roberti · M. d. R. F. · Gea · Y. R. e. A. · Marinho · I. A. · Inacio · P. P. · Camelo · R. M. · de Castro · T. F. · Batista · S. R. R.
Introduction

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

Methods and analysis

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethics and dissemination

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Protocol registration

Not applicable

Memory for Music (M4M) protocol for an international randomised controlled trial: effects of individual intensive musical training based on singing in non-musicians with Alzheimers disease

Por: Lichtensztejn · M. · Cui · A.-X. · Geretsegger · M. · Lundervold · A. J. · Koelsch · S. · Pfabigan · D. M. · Assmus · J. · Langeland · E. · Ruiz · M. · Tabernig · C. · Skogseth · R. E. · Gold · C.
Introduction

The number of people living with dementia is increasing worldwide. Alzheimer’s disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs.

Methods and analysis

Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale – Cognitive by an assessor blinded to the randomisation. Participants’ memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability.

Ethics and dissemination

Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412).

Trial registration number

Clinicaltrials.gov, NCT06611878.

Systematic protocol to identify 'clinical controls for paediatric neuroimaging research from clinically acquired brain MRIs

Por: Zimmerman · D. · Mandal · A. S. · Jung · B. · Buczek · M. J. · Schabdach · J. M. · Karandikar · S. · Kafadar · E. · Gardner · M. · Daniali · M. · Mercedes · L. · Kohler · S. · Abdel-Qader · L. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Williams · R. · Padmanabhan · V. · Seid
Introduction

Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.

Methods and analysis

The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.

Ethics and dissemination

Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.

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.

Scoping review of interventions aimed at promoting healthy screen use among adolescents

Por: Tock · W. L. · Gauvin · L. · Hudon · F. · Tremblay · F. · Belanger · R. E. · Turcotte-Tremblay · A.-M.
Objectives

The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.

Design

We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

Data sources

We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.

Eligibility criteria

We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.

Data extraction and synthesis

One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.

Results

From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.

Conclusion

This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures

Por: Kotcher · R. E. · Rosengart · M. R. · La Colla · L. · Lin · H.-H. S. · Vogt · K. M. · Xu · Y. · Neal · M. D.
Introduction

Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.

Methods and analysis

This is a randomised controlled trial in which adult trauma inpatients (18 years) with painful rib fractures will be allocated 1:1:1 to three arms: bright blue light intervention (peak 442 nm, ~1400 lux), bright full-spectrum light comparison (~1400 lux) and usual ambient light control. Bright light exposures will be administered for 4 consecutive hours daily for up to 3 days. The primary outcome will be any measurable changes in chest wall pain intensity during deep breathing, quantified using an 11-point Numerical Rating Scale. Secondary outcomes will assess chest wall pain intensity at rest, opioid requirements, delirium incidence, pulmonary complication incidence, hospital-free and intensive care unit-free days, and physiological markers of autonomic nervous system, circadian, and immune activation. Sample size analysis yields a total of 75 participants needed to detect a 2-point difference in pain scores with >80% power and assuming a 20% non-completion rate.

Ethics and dissemination

Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.

Trial registration number

NCT06626334.

Impact of abnormal ambulatory ECG findings when screening for atrial fibrillation in primary care: a qualitative study among participants of the PATCH-AF trial

Por: Brik · T. · Niekel · M. S. · Bak · M. A. R. · Himmelreich · J. C. L. · Harskamp · R. E. · Moll van Charante · E. P.
Background and aim

European cardiovascular guidelines recommend systematic atrial fibrillation (AF) screening in community-dwelling high-risk patients. However, little is known about the impact of abnormal screening findings, including AF and non-AF incidental findings on the target population. This gap highlights the need to assess both the benefits and potential harms from patients’ perspectives to fully understand the impact of AF screening. Therefore, the aim of this study is to explore patients’ experiences with AF screening among those who received abnormal findings from ambulatory ECG monitoring.

Design

We conducted a qualitative study using semistructured interviews, analysed thematically. Participants in the PATCH-AF trial, based in Amsterdam primary care, were purposively sampled based on their screening results (AF or non-AF incidental findings), sex and socioeconomic status.

Results

We achieved data saturation after conducting 16 interviews (6 with interviewees diagnosed with AF and 10 with non-AF incidental findings). Participants had a median age of 76 (73–79) years, and 56% were male. Their experiences, whether positive or negative, fluctuated throughout the screening process and depended on their initial motivations for participation in AF screening (seeking extra health checks, finding explanations for pre-existing symptoms or contributing to medical research), expectations and perceived benefits from clarification, diagnostic workup or treatment. Influencing factors included the type of finding (AF or non-AF incidental finding), healthcare provider communication and individual characteristics such as age, socioeconomic status and medical history.

Conclusion

This qualitative study highlights both positive and negative AF screening experiences from the patients’ perspective. It underscores how patients’ motivations and expectations for participation, the type of ambulatory ECG finding and communication and follow-up by healthcare providers shape their overall experiences. Healthcare providers should be aware of these factors to optimise screening consultations. Clear guidelines on communicating abnormal ambulatory ECG findings, especially incidental findings, are warranted.

Trial registeration number

The Netherlands Trial Register (NTR) number NL9656.

Appropriateness of NHS 111 Wales outcomes--using the Call Prioritisation Streaming System: a RAND/UCLA modified Delphi method

Por: Roynon · R. E. · Brady · M. · Noblett · P. · Malin · R. · Brown · C. · Fivaz · C.
Introduction

NHS 111 Wales offers 24-hour telephone assessment, care and referrals for urgent healthcare needs. Call handlers use the newly created and implemented Call Prioritisation Streaming System (CPSS) to assess patients. CPSS is a sophisticated Computer Decision Support Software designed to enhance decision-making processes. It achieves this by integrating individual patient data with a comprehensive computerised knowledge base, employing advanced software algorithms to produce recommendations and dispositions.

Objectives

While CPSS offers many advantages, its introduction marked a major shift in clinical digital processes. Because of this significant change, it was essential to ensure that the system was functioning correctly and safely after it was implemented. This process of verification and validation is known as postimplementation clinical assurance.

Methods

An adapted Delphi–Rand/UCLA appropriateness method assessed patient outcomes. In round 1, 189 random anonymised cases were reviewed by international expert clinicians from diverse clinical backgrounds, with consensus measured at >75%. Round 2 involved reviewing non-consensus cases and providing up to 250 characters of context for content analysis.

Results

In round 1, 49 participants reviewed all 189 cases (total 9913 reviews). In round 2, 41 participants continued to review (total 1746 reviews). Consensus on outcome appropriateness was achieved in 83% (7726 reviews of 144 cases), with a range of 100–76%. Non-consensus occurred in 16.6% (1535 reviews of 45 cases), with a range of 73–18%. For cases with consensus, participants agreed with the outcome 90.5% of the time; for non-consensus cases, outcome agreement was still 60.9%.

Discussion

Content analysis highlighted the complex interplay of clinician-added value and the aims of prioritisation and streaming. Three themes to enhance CPSS were identified: clinical considerations, referral pathways and system-driven safeguarding identification. No significant clinical safety concerns were found.

Conclusion

The evaluation of CPSS in NHS 111 Wales shows high levels of outcome appropriateness, assuring patients, service providers and stakeholders. CPSS effectively prioritises and streams patients to appropriate outcomes based on expert clinician consensus.

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