Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

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.

The Alberta’s Tomorrow Project (ATP) prospective cohort study was established in 2000 to investigate the causes of cancer and chronic disease. The cohort consists of almost 55 000 participants aged 35–69 years at the time of recruitment. From 2020 to 2022, ATP conducted a longitudinal substudy, the COVID-19 Antibody Testing (CAT) study, nested in this existing cohort, to understand the spread and impact of the SARS-CoV-2. In this cohort profile, we describe the CAT study design, recruitment and initial findings.

In this prospective cohort substudy, ~4000 participants completed online surveys and provided blood samples at a study centre every 4 months for 1 year, across four cities in Alberta, Canada. The study was launched on a rolling basis beginning in September 2020 and data collection was completed in May 2022. The surveys collected information on health and lifestyle factors, COVID-19 (testing, symptoms, vaccination, public health recommendations) and impacts of the pandemic (including economic, health services, mental health). Blood samples were tested for antinucleocapsid and antispike protein SARS-CoV-2 antibodies.

A total of 4102 participants consented and attended a study centre at baseline, and almost 90% of these completed the study. Overall, participants were aged 61±10 years, 60% female, 12% came from rural areas, 45% had at least a bachelor’s degree, 24% reported a household income 4 weeks). By the end of the study, 96% of participants had received at least one COVID-19 vaccine dose. Through investigating other outcomes, it was observed that participants under 50 years of age were more likely to be assessed to have mild or moderate-to-severe anxiety and depressive symptoms compared with older participants. In addition, approximately 15% of participants reported a moderate to major impact on their ability to meet financial obligations.

Serology results, together with health, lifestyle and sociodemographic data, and the continued follow-up of these participants as part of the broader ATP cohort study (planned through 2065), will provide opportunities to investigate the long-term sequelae of COVID-19 infection as well as the broader impacts of the pandemic on physical, mental and emotional health. Data are available to researchers on request through the ATP access process.

The UK Health Security Agency and the National Health Service England (NHSE) led a hepatitis C virus (HCV) patient re-engagement exercise beginning in 2018, which entailed sharing public health surveillance data with NHSE Operational Delivery Networks (ODNs) in England. The ODNs used the data to contact and offer testing and treatment to people historically diagnosed with HCV, but who did not have evidence of successfully clearing the virus. A quantitative evaluation found that of 55 329 individuals whose details were shared with ODNs, around 13% had treatment after the exercise commenced. This qualitative evaluation aims to identify the barriers and facilitators to the re-engagement exercise as reported by ODN staff.

Semistructured interviews. The topic guide and analysis were guided by the Theoretical Domains Framework, using a combined deductive framework and inductive thematic analysis approach.

21 staff from 13 ODNs. The sampling frame was designed to capture participants from all regions of England and with varied outcomes from the re-engagement exercise.

Interviewees reported the most barriers in environmental context and resources (including staffing limitations, interruptions during COVID-19, restricted laboratory access), and social influences (with limited responses from general practitioners and patients). Interviewees discussed whether it was appropriate for ODNs and individual staff to be assigned the data validation work and reported some stress and memory/attention barriers due to the volume of the exercise. They had varied beliefs about the consequences of the exercise, with most believing it was worthwhile due to treatment yield, lessons learnt and confirmation that some people had cleared the virus. Further facilitators included the ODN goals fitting with the exercise, and regional resources such as patient databases. Interviewees also reported adaptations to the exercise that facilitated patient contact, and their ongoing work to re-engage patients emphasised outreach partnerships and peer support.

The evaluation revealed insights into methods for re-engaging patients and of sharing and using public health data to support clinical practice. Government support and funding provision for regionally tailored holistic re-engagement approaches, alongside enhancements to health surveillance data, could enable barriers to re-engagement to be overcome.

We compared associations between self-reported and HearCheck screening device measures of hearing difficulty with subsequent general and domain-specific cognitive function in a population-based sample of older English adults.

Observational cohort study.

Population-based sample of older adults in wave 7 of the English Longitudinal Study of Ageing (ELSA) in 2014/15 and its Healthy Cognitive Ageing Project (HCAP) in 2018.

N=1119 adults aged ≥62 years.

Factor scores for general cognitive function and domains of memory, language, orientation and executive function were derived from the HCAP neuropsychological test battery (mean of 0 and SD of 1 for each). Hearing difficulty was assessed using a self-reported 5-point Likert-type scale and the HearCheck screening device, which administered a series of six tones in each ear.

According to the HearCheck device, 48% of participants had a mild or moderate-to-severe hearing difficulty, while 25% self-reported fair or poor hearing. In multivariable-adjusted, population-weighted linear regression models, hearing difficulty identified via HearCheck was associated with worse general cognitive function (β=–0.34 SD units; 95% CI –0.60 to –0.07 for moderate-to-severe hearing difficulty vs good hearing) as well as worse function in domains of memory, language and executive function, each with a dose-response relationship. Self-reported hearing difficulty was not associated with general or domain-specific cognitive function.

Peripheral hearing ability, as captured by the HearCheck screening device, may have stronger relevance for later-life cognitive outcomes than the broader construct of perceived hearing difficulty in one’s daily environment that is captured by a self-reported measure.

To assess the relationship of infant growth, feeding practices and tummy time to their motor development at 12 months, with a special focus on how maternal physical activity during late pregnancy relates to infants’ motor skills.

Longitudinal study.

Rural city in the Mid-Southern USA.

16 singleton pregnant women in the third trimester and their term infants were recruited, excluding mother–infant pairs with health issues that impact infants’ motor development and restrict mothers’ physical activity.

Maternal physical activity and sedentary time during the third trimester were measured using Actigraph activity monitors. Labour nurses measured neonatal birth weight and length using standard procedures. Infants’ motor percentiles at 4 and 12 months were measured respectively using the Alberta Infant Motor Scale and Peabody Developmental Motor Scales II test by a licensed paediatric physical therapist. Feeding practices, infants’ time spent in different positions and family composition were evaluated separately at 4 and 12 months using a study-specific survey.

Infant motor percentiles at 4 months were positively associated with their 12-month motor percentiles (r=0.649, p=0.009). For each additional percentile at 4 months, the mean 12-month percentile increased by 0.4. Motor percentiles at 12 months were also positively associated with infants’ birth weight (r=0.553, p=0.026) and length (r=0.637, p=0.008), but not significantly associated with tummy time (r=–0.069, p=0.840). Infant motor percentiles at 12 months were not associated with time spent sedentary (r=–0.134, p=0.634), light activity (r=0.213, p=0.447) or moderate activity (r=–0.050, p=0.858) during the third trimester. At 12 months, breastfeeding status (p=0.576) and having siblings (p=0.230) were not related to motor scores.

Motor percentiles at 4 months, birth weight and length correlated with motor skills at 12 months, whereas tummy time, siblings, and breastfeeding were not significant predictors. Physical activity during pregnancy did not significantly correlate to motor skills at 12 months.

Cystic fibrosis (CF) is an inherited condition, affecting approximately 150 000 people worldwide. Physical activity (PA) is an integral component in the management of CF. However, it is estimated that only a third of young people (with and without CF) achieve UK Chief Medical Officer guideline recommended levels of activity. The aim of this research was to use the person-based approach to develop an intervention supporting families with young people (aged 6–12 years) with CF to incorporate PA as a sustainable habit in their lives to increase the likelihood of sustained PA levels going into adolescence and adulthood.

Using the person-based approach, intervention content was created and iteratively adapted. This was initially guided by relevant literature; the guiding principles, logic model and preliminary content were developed via co-production with patient and public involvement (PPI) representatives (n=8) with lived experience of CF. The intervention was further refined/optimised using qualitative think-aloud and retrospective interviews, the results of the preliminary evaluation are reported. Think-aloud interviews were rapidly analysed using a table of changes analysis and used to inform adaptations to content. Retrospective interviews were analysed thematically.

Community settings in the UK.

Participants included six families with a child with CF aged between 6 years and 12 years old.

Intervention content consisted of nine sections and was delivered as a printable PDF file. Informed by the Capability, Opportunity, Motivation and Behaviour framework and self-determination theory, content focused on promotion of PA as a family activity that is fun, enjoyable, quick and achievable. It promoted ‘movement to make you feel good"’ and in short bursts of activity. Promotion of PA as medicine was avoided. The final intervention was considered to be engaging and acceptable.

Qualitative methods and PPI facilitated the development of a family-focused intervention supporting the integration of PA into daily life. This was viewed as acceptable and engaging among families of people with CF. Future research now needs to explore the effectiveness of the intervention for increasing PA behaviour.

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

NCT06176638.

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

ISRCTN17922845.

This study aims to assess the feasibility of respondent-driven sampling (RDS) to recruit participants with recent abortion experiences in humanitarian contexts, and describe the composition of the study sample generated with this sampling method.

This was a three-phase mixed-methods community-engaged research study employing an exploratory and explanatory sequential approach. We conducted in-depth interviews, focus group discussions, an interviewer-administered questionnaire on abortion experiences and a health facility assessment.

Bidibidi Refugee Settlement, Uganda and Kakuma Refugee Camp, Kenya from November 2021 to December 2022.

Using RDS, we recruited 600 participants in Kakuma and 601 participants in Bidibidi with recent abortion experiences. In Kakuma, participants were primarily from Burundi, the Democratic Republic of the Congo and South Sudan; participants in Bidibidi were primarily from South Sudan. Most participants in both sites had completed at least some primary school and were not employed.

RDS recruitment dynamics: convergence and bottlenecks on key sociodemographic variables, recruitment and population homophily, reciprocity of social ties, success and experiences recruiting.

There were minor violations of RDS assumptions, particularly regarding assumptions of reciprocity of ties and seed composition independent of sample. In addition, there was a strong tendency of participants to recruit those from the same home country and living within the same camp zone. However, sample proportions for age, home country, marital status, zone of residence and student status reached equilibrium (stabilised) by around 500 participants at each site, and we were able to quickly attain the study sample size.

While the true representativeness of our sample remains unknown, RDS is a practical and effective recruitment method in humanitarian contexts for sensitive topics, particularly for research questions in which no data or sampling frames exist. However, attention to representativeness and community engagement is essential to optimising its application and ensuring success.

Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

ISRCTN61751241.

To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.

Triangulation to integrate quantitative and qualitative data.

Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.

A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.

To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.

Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.

There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.

ISRCTN66682918.

To develop a behavioural intervention package to support non-allergist healthcare workers (HCWs) to remove incorrect penA records from medical and surgical adult inpatients. This paper describes the development of the penicillin allergy de-labelling (PADL) intervention and the implementation intervention that will support non-allergist-delivered PADL.

We combined evidence-based, theory-based and person-based approaches. Qualitative research with healthcare professionals and patients explored barriers and enablers to implementation of the proposed PADL pathway. Key intervention design objectives and the key features of the implementation intervention required to achieve each objective were then developed and captured as guiding principles. We produced a logic model, integrating the theoretical domains framework to identify the behavioural influences on PADL and the behaviour change wheel to show how the implementation intervention is hypothesised to address the target behaviours. The implementation intervention package was then reviewed by stakeholders and topic experts for further refinement and optimisation. Finally, we outline how the implementation intervention will be evaluated.

Single-centre District General Hospital in the SW England servicing a rural community of 575 000 people without local allergy services.

HCWs reported PADL needed to be structured, standardised, evidence based and supported by hospital approved guidelines with easy to access patient information leaflets, supported by a sustained programme of education and training with named PADL leaders and visible PADL champions. Patients wanted a good explanation of the benefits and risks of testing and the benefits of having their ‘penA’ record removed. The identified HCW target behaviours were: taking a penA allergy focused history and to risk assess the patient’s penA history; to then either de-label the patient on history alone (direct de-label; DDL) or prescribe a direct oral challenge (DOC) dose; to perform baseline and post-test observations and counsel the patient on the risks of penA records and on the risks and the benefits of PADL. We identified barriers to target behaviours that we considered both important and modifiable, which included: lack of confidence in taking a penA focused history, PADL not viewed as a priority, low confidence with differentiating low-risk and high-risk penA histories, concerns about the safety of DOC, a requirement for senior support for nurses to deliver the observations and senior support for the other HCWs to deliver PADL, access to an expert for advice when required, a lack of PADL champions to promote PADL, and PADL not being supported by the organisation. The identified patient target behaviours were acceptance of the opportunity to be de-labelled via either DDL or DOC and willingness to take penicillin when prescribed. We developed intervention components to target the HCW and patient target behaviours which included: Education, expert advice made available from Infection specialists, a named PADL champion, hospital endorsed PADL guideline with necessary tools to enable PADL and patient information leaflets. The implementation intervention was further optimised through workshops with PADL researchers and stakeholders. The Consolidated Framework for Implementation Research outcome addendum was used to define both implementation intervention and PADL intervention outcomes.

We have developed a theory-based and stakeholder-developed implementation intervention to support inpatient PADL delivered by a multiprofession workforce. The intervention will be tested in a single hospital and scalability explored.