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

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.

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.

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

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.

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.

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.

ISRCTN20579216.

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

UMIN000052161.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

To identify the factors influencing professionals’ implementation of the National Institute for Health and Care Excellence (NICE) guidelines on self-harm.

A rapid review evidence synthesis

Five electronic databases (ASSIA, CINAHL, EMBASE, MEDLINE, PsycINFO) and five indexing databases (Science Citation Index Expanded (SCIE), Social Sciences Citation Index (SSCI), Arts and Humanities Citation Index (AHCI), Emerging Sources Citation Index (ESCI) and Conference Proceedings Citation Index (CPCI)), using the Web of Science platform, were searched in December 2023 and repeated in July 2024.

We included quantitative and qualitative studies that investigated professionals’ knowledge and implementation of NICE guidelines on self-harm, that were in English language and published between 2004 and July 2024.

One reviewer used standardised methods to search, screen, select, quality assess and synthesise the included studies, to accelerate the review. Quality assessment was conducted using the Mixed Methods Appraisal Tool. Data were extracted and synthesised thematically using NICE guidance implementation priorities.

The review included 10 studies. Six were conducted in accident and emergency (A&E) settings, two in general practice, one in a burns and plastic surgery hospital department and one involved cross-sectoral health professionals. Key findings indicate that awareness and implementation of self-harm guidelines is low among health professionals. Systemic barriers include lack of staff training, negative staff attitudes towards people who self-harm and lack of resources.

There is a need to develop and implement regular training on self-harm, incorporating NICE guidance and measures, to integrate knowledge and mobilise practice changes. Further research into the implementation of NICE guidelines in children who self-harm is needed, and in a wider variety of health and social care settings. The absence of studies from the social care sector into professionals’ awareness and implementation of NICE guidelines on self-harm is a key limitation.

Despite advancements in biomedical and healthcare research, the translation of evidence into routine practice within healthcare systems often lags, perpetuating inefficiencies and disparities in care delivery. Learning health systems (LHS), which integrate internal data and external evidence for continuous improvement, hold promise for addressing these gaps. Implementation science (IS), focused on promoting the systematic uptake of evidence-based practices, offers a robust framework to drive sustainable improvements within LHS. However, the practical application of IS principles in LHS remains underexplored. This scoping review aims to systematically map the literature on the application of IS in LHS, highlighting themes, gaps and opportunities for advancing future practices.

This review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews, supported by the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. The review employs a population-concept-context framework, focusing on studies engaged in LHS activities and the application of IS principles in various healthcare settings. Relevant literature will be searched across multiple databases, including OVID/Medline, Embase, Web of Science Core Collection and Health Policy Reference Center. Eligible studies will be screened, and data will be extracted and synthesised using both quantitative and qualitative methods. Key outcomes include characterising IS applications in LHS, evaluating barriers and facilitators, exploring equity integration, and identifying knowledge gaps.

As this study does not involve primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications and conference presentations to inform future research and practice.

This protocol has been registered on the Open Science Framework (DOI: 10.17605/OSF.IO/BMQ6J).