Involving lived experience in regional efforts to address gambling-related harms: going beyond 'window dressing' and 'tick box exercises'.

BACKGROUND: Lived Experience (LE) involvement has been shown to improve interventions across diverse sectors. Yet LE contributions to public health approaches to address gambling-related harms remain underexplored, despite notable detrimental health and social outcomes linked to gambling. This paper analyses the potential of LE involvement in public health strategy to address gambling-related harms. It focuses on the example of a UK city-region gambling harms reduction intervention that presented multiple opportunities for LE input. METHODS: Three focus groups and 33 semi-structured interviews were conducted to hear from people with and without LE who were involved in the gambling harms reduction intervention, or who had previous experience of LE-informed efforts for addressing gambling-related harms. People without LE provided reflections on the value and contributions of others' LE to their work. Data analysis combined the Framework Method with themes developed inductively (from people's accounts) and deductively (from the literature, including grey literature). RESULTS: Four themes were identified: (1) personal journeys to LE involvement; (2) the value added by LE to interventions for addressing gambling-related harms; (3) emotional impacts on people with LE; and (4) collective LE and diverse lived experiences. Two figures outlining LE involvement specific to gambling harms reduction in the UK, where public health efforts aimed at addressing gambling-related harms coexist with industry-funded programmes, are proposed. CONCLUSIONS: Integrating a range of LE perspectives in a public health approach to gambling harms reduction requires local access to involvement for people with LE via diverse routes that are free from stigma and present people with LE with options in how they can engage and be heard in decision-making, and how they operate in relation to industry influence. Involving LE in gambling harms reduction requires enabling people to develop the affective and critical skills necessary to navigate complex emotional journeys and a challenging commercial and policy environment.

Tick bites, IgE to galactose-alpha-1,3-galactose and urticarial or anaphylactic reactions to mammalian meat: The alpha-gal syndrome.

The recent recognition of a syndrome of tick-acquired mammalian meat allergy has transformed the previously held view that mammalian meat is an uncommon allergen. The syndrome, mediated by IgE antibodies against the oligosaccharide galactose-alpha-1,3-galactose (alpha-gal), can also involve reactions to visceral organs, dairy, gelatin and other products, including medications sourced from non-primate mammals. Thus, fittingly, this allergic disorder is now called the alpha-gal syndrome (AGS). The syndrome is strikingly regional, reflecting the important role of tick bites in sensitization, and is more common in demographic groups at risk of tick exposure. Reactions in AGS are delayed, often by 2-6 h after ingestion of mammalian meat. In addition to classic allergic symptomatology such as urticaria and anaphylaxis, AGS is increasingly recognized as a cause of isolated gastrointestinal morbidity and alpha-gal sensitization has also been linked with cardiovascular disease. The unusual link with tick bites may be explained by the fact that allergic cells and mediators are mobilized to the site of tick bites and play a role in resistance against ticks and tick-borne infections. IgE directed to alpha-gal is likely an incidental consequence of what is otherwise an adaptive immune strategy for host defense against endo- and ectoparasites, including ticks.

IgE to common food allergens is associated with cardiovascular mortality in the National Health and Examination Survey and the Multi-Ethnic Study of Atherosclerosis.

BACKGROUND: In individuals without symptomatic food allergy, food-specific IgE is considered clinically irrelevant. However, recent studies have suggested that galactose-α-1,3-galactose (alpha-gal) IgE is associated with cardiovascular (CV) disease. OBJECTIVE: We sought to determine whether sensitization to common food allergens is associated with CV mortality. METHODS: The association between IgE sensitization to foods and CV mortality ascertained to 2019 was examined in the National Health and Examination Survey (NHANES) 2005-2006 and the Wake Forest site of the Multi-Ethnic Study of Atherosclerosis (MESA) cohort; MESA enrolled adults without baseline clinical CV diseases between 2000 and 2002. Total and specific IgE was measured to cow's milk, egg, peanut, shrimp, and a panel of aeroallergens (NHANES), and to cow's milk, alpha-gal, peanut, dust mite, and timothy grass (MESA). Cox proportional hazard models were constructed, adjusting for sex, age, race/ethnicity, smoking, education, and asthma. RESULTS: A total of 4414 adults from NHANES (229 CV deaths) and 960 from MESA (56 CV deaths) were included. In NHANES, sensitization to at least 1 food was associated with higher CV mortality (hazard ratio [HR], 1.7 [95% confidence interval (CI), 1.2-2.4], P = .005). Milk sensitization was particularly associated (HR, 2.0 [95% CI, 1.1-3.8], P = .026), a finding replicated in MESA (HR, 3.8 [95% CI, 1.6-9.1], P = .003). Restricting analyses in NHANES to consumers of the relevant allergen strengthened food sensitization relationships, unmasking shrimp and peanut sensitization as additional risk factors for CV mortality. CONCLUSIONS: The finding that food sensitization is associated with increased risk of CV mortality challenges the current paradigm that sensitization without overt allergy is benign. Further research is needed to clarify mechanisms of this association.

Alpha-Gal IgE Prevalence Patterns in the United States: An Investigation of 3,000 Military Recruits.

BACKGROUND: IgE to the oligosaccharide galactose-alpha-1,3-galactose (alpha-gal) is an important cause of allergic reactions to mammalian meat. The "alpha-gal syndrome" is strongly associated with a preceding history of tick bites and in the United States is most commonly reported in parts of the southeast, but there has been limited investigation into national alpha-gal sensitization patterns and the relevance of other risk factors. OBJECTIVE: To systematically investigate alpha-gal IgE prevalence, regional patterns, and risk factors. METHODS: Alpha-gal IgE was measured by ImmunoCAP in biobanked serum samples collected from 3000 service members who presented for intake to 1 of 10 military bases in the central/eastern United States. Alpha-gal IgE sensitization (cutoff 0.1 international units/mL) was related to home of record at enlistment. RESULTS: Of the cohort, 2456 (81.9%) subjects were male, median age was 19 years (interquartile range: 18-22 years), and alpha-gal IgE was detected in 179 (6.0%). Home of record spanned all 50 states, with a median of 36 recruits per state (range: 3-261). The highest prevalence rates were in Arkansas (39%), Oklahoma (35%), and Missouri (29%), with several other southeastern states >10%. Granular mapping revealed sensitization patterns that closely mimicked county-level Amblyomma americanum reports and Ehrlichia chaffeensis infections. Sensitization was associated with male sex, rural residence, and White race in univariate and multivariable models. CONCLUSIONS: In this systematic survey, the prevalence of alpha-gal IgE among incoming military personnel was 6.0%. There were significant regional differences, with an overall pattern consistent with the known range of the lone star tick (A. americanum) and highest frequency in an area including Arkansas, Oklahoma, and Missouri.

Gastrointestinal-isolated Distress is Common in Alpha-gal Allergic Patients on Mammalian Meat Challenge.

BACKGROUND AND AIMS: Alpha-gal allergy causes a delayed reaction to mammalian meats and has been reported worldwide. Patients with the allergy may present with isolated gastrointestinal (GI) symptoms, but this phenotype is poorly understood. METHODS: We pooled and analyzed symptoms and demographics of patients from two prospective cohorts of patients with a diagnosis of alpha-gal allergy who reacted after eating mammalian meat under observation. We compared the characteristics of patients who demonstrated GI-isolated symptoms on a challenge with those who exhibited symptoms outside the GI tract (skin, respiratory, and circulatory). RESULTS: Among the 91 children and adult alpha-gal allergic patients who exhibited symptoms after oral challenge with mammalian meat, 72.5% experienced GI distress with one or more GI symptoms, which was the most frequent class of symptoms, compared with skin changes in 57.1% and respiratory distress in 5.5%. The most common GI symptoms were abdominal pain (71%) and vomiting (22.0%). GI-isolated symptoms occurred in 37 patients (40.7%) who reacted, and those patients reacted more quickly than patients who exhibited systemic symptoms (median onset of symptoms in GI-isolated group 90 min vs 120 min) and were more likely to be children than adults (relative risk=1.94, 95% CI: 1.04-3.63). CONCLUSIONS: Isolated-GI distress occurred in 4 in every 10 alpha-gal allergic individuals who developed symptoms on oral food challenge with mammalian meat. Alpha-gal allergic patients, particularly children, may exhibit GI distress alone, and adult and pediatric gastroenterologists should be aware of the diagnosis and management of the allergy.

Prevalence and risk factors for allergic sensitization: 3 cross-sectional studies among schoolchildren from 1996 to 2017.

Background: The prevalence of allergic sensitization and allergic diseases has increased for decades in Northern Europe, but recent studies are lacking. Objective: We sought to study the prevalence trends of allergic sensitization, associated risk factors, and the association with asthma and allergic rhinitis (AR) among children in Northern Sweden. Methods: Three cohorts of children aged 7 to 8 years participated in a skin prick test (SPT) with 10 airborne allergens in 1996, 2006, and 2017, with 2148, 1693, and 1762 participants tested, respectively, representing 87% to 90% of schoolchildren in the catchment communities. Adjusted Poisson regression was used to identify risk factors for allergic sensitization and the association with asthma and AR. Results: The prevalence of any positive SPT response increased from 21% in 1996 to 30% in 2006 and remained at 30% in 2017 (P < .001). Sensitization to cat was the most common for all the years. The risk factor pattern for a positive SPT response was similar in all examinations, with positive and significant associations with a family history of allergy (risk ratio, 1.4-1.5) and negative and significant associations with having a cat at home (risk ratio, 0.7-0.8). The prevalence of physician-diagnosed asthma increased, but the association with allergic sensitization weakened. The opposite trends were found for AR-decreasing prevalence and strengthened association with allergic sensitization. Conclusions: The prevalence of allergic sensitization increased from 1996 to 2006 but plateaued in the next decade, whereas the risk factor pattern remained stable. The diverging trends of associations between allergic sensitization and asthma and AR suggest secular trends in the clinical management of allergic diseases.

A conversation on allergy: recognizing the past and looking to the future.

Allergy is an ever-evolving group of disorders, which includes asthma, atopic dermatitis, rhinitis and food allergies and that currently affects over 1 billion people worldwide. This group of disorders has exploded in incidence since around the start of the 20th century, implying that genetics is not solely responsible for its development but that environmental factors have an important role. Here, Fabio Luciani and Jonathan Coquet, in their role as editors at Immunology & Cell Biology, asked nine prominent researchers in the field of allergy to define the term 'allergy', discuss the role of genetics and the environment, nominate the most important discoveries of the past decade and describe the best strategies to combat allergy at the population level going forward.

Immunoglobulin G4 in eosinophilic esophagitis: Immune complex formation and correlation with disease activity.

BACKGROUND: Recent studies have shown deposition of immunoglobulin G4 (IgG4) and food proteins in the esophageal mucosa of eosinophilic esophagitis (EoE) patients. Our aims were to assess whether co-localization of IgG4 and major cow's milk proteins (CMPs) was associated with EoE disease activity and to investigate the proteins enriched in proximity to IgG4 deposits. METHODS: This study included adult subjects with EoE (n = 13) and non-EoE controls (n = 5). Esophageal biopsies were immunofluorescence stained for IgG4 and CMPs. Co-localization in paired samples from active disease and remission was assessed and compared to controls. The proteome surrounding IgG4 deposits was evaluated by the novel technique, AutoSTOMP. IgG4-food protein interactions were confirmed with co-immunoprecipitation and mass spectrometry. RESULTS: IgG4-CMP co-localization was higher in the active EoE group compared to paired remission samples (Bos d 4, p = .02; Bos d 5, p = .002; Bos d 8, p = .002). Co-localization was also significantly higher in the active EoE group compared to non-EoE controls (Bos d 4, p = .0013; Bos d 5, p = .0007; Bos d 8, p = .0013). AutoSTOMP identified eosinophil-derived proteins (PRG 2 and 3, EPX, RNASE3) and calpain-14 in IgG4-enriched areas. Co-immunoprecipitation and mass spectrometry confirmed IgG4 binding to multiple food allergens. CONCLUSION: These findings further contribute to the understanding of the interaction of IgG4 with food antigens as it relates to EoE disease activity. These data strongly suggest the immune complex formation of IgG4 and major cow's milk proteins. These immune complexes may have a potential role in the pathophysiology of EoE by contributing to eosinophil activation and disease progression.

Alpha-gal syndrome: A review for the dermatologist.

Alpha-gal syndrome (AGS) is an allergy to "red meat" and other mammalian products due to immunoglobulin E (IgE) antibodies against the sugar moiety galactose-alpha-1,3-galactose (alpha-gal), which is acquired following tick bites. Clinically, AGS presents with urticaria, abdominal pain, nausea, and occasionally anaphylaxis, and has wide inter- and intra-personal variability. Because symptom onset is generally delayed by 2 to 6 hours after meat consumption, AGS can be easily confused with other causes of urticaria and anaphylaxis, such as chronic spontaneous urticaria (CSU) and mast cell activation syndrome (MCAS). Diagnosis relies on a combination of clinical history, positive alpha-gal IgE blood testing and improvement on a mammalian-restricted diet. Management of the syndrome centers primarily on avoidance of mammalian meats (and occasionally dairy and other products) as well as acute management of allergic symptoms. Counseling about tick avoidance measures is also important as AGS will wane over time in many patients.

Consultation skills development in general practice: findings from a qualitative study of newly recruited and more experienced clinical pharmacists during the COVID-19 pandemic.

OBJECTIVE: The new structured medication review (SMR) service was introduced into the National Health Service in England during the COVID-19 pandemic, following a major expansion of clinical pharmacists within new formations known as primary care networks (PCNs). The aim of the SMR is to tackle problematic polypharmacy through comprehensive, personalised medication reviews involving shared decision-making. Investigation of clinical pharmacists' perceptions of training needs and skills acquisition issues for person-centred consultation practice will help better understand their readiness for these new roles. DESIGN: A longitudinal interview and observational study in general practice. SETTING AND PARTICIPANTS: A longitudinal study of 10 newly recruited clinical pharmacists interviewed three times, plus a single interview with 10 pharmacists recruited earlier and already established in general practice, across 20 newly forming PCNs in England. Observation of a compulsory 2-day history taking and consultation skills workshop. ANALYSIS: A modified framework method supported a constructionist thematic analysis. RESULTS: Remote working during the pandemic limited opportunities for patient-facing contact. Pharmacists new to their role in general practice were predominantly concerned with improving clinical knowledge and competence. Most said they already practiced person-centred care, using this terminology to describe transactional medicines-focused practice. Pharmacists rarely received direct feedback on consultation practice to calibrate perceptions of their own competence in person-centred communication, including shared decision-making skills. Training thus provided knowledge delivery with limited opportunities for actual skills acquisition. Pharmacists had difficulty translating abstract consultation principles into specific consultation practices. CONCLUSION: SMRs were introduced when the dedicated workforce was largely new and being trained. Addressing problematic polypharmacy requires structural and organisational interventions to enhance the communication skills of clinical pharmacists (and other health professionals), and their use in practice. The development of person-centred consultation skills requires much more substantial support than has so far been provided for clinical pharmacists.

STN7 is not essential for developmental acclimation of Arabidopsis to light intensity.

Plants respond to changing light intensity in the short term through regulation of light harvesting, electron transfer, and metabolism to mitigate redox stress. A sustained shift in light intensity leads to a long-term acclimation response (LTR). This involves adjustment in the stoichiometry of photosynthetic complexes through de novo synthesis and degradation of specific proteins associated with the thylakoid membrane. The light-harvesting complex II (LHCII) serine/threonine kinase STN7 plays a key role in short-term light harvesting regulation and was also suggested to be crucial to the LTR. Arabidopsis plants lacking STN7 (stn7) shifted to low light experience higher photosystem II (PSII) redox pressure than the wild type or those lacking the cognate phosphatase TAP38 (tap38), while the reverse is true at high light, where tap38 suffers more. In principle, the LTR should allow optimisation of the stoichiometry of photosynthetic complexes to mitigate these effects. We used quantitative label-free proteomics to assess how the relative abundance of photosynthetic proteins varied with growth light intensity in wild-type, stn7, and tap38 plants. All plants were able to adjust photosystem I, LHCII, cytochrome b6 f, and ATP synthase abundance with changing white light intensity, demonstrating neither STN7 nor TAP38 is crucial to the LTR per se. However, stn7 plants grown for several weeks at low light (LL) or moderate light (ML) still showed high PSII redox pressure and correspondingly lower PSII efficiency, CO2 assimilation, and leaf area compared to wild-type and tap38 plants, hence the LTR is unable to fully ameliorate these symptoms. In contrast, under high light growth conditions the mutants and wild type behaved similarly. These data are consistent with the paramount role of STN7-dependent LHCII phosphorylation in tuning PSII redox state for optimal growth in LL and ML conditions.

Alcohol, the overlooked drug: clinical pharmacist perspectives on addressing alcohol in primary care.

BACKGROUND: Attempts to routinely embed brief interventions in health systems have long been challenging, with healthcare professionals concerned about role adequacy, legitimacy, and support. This is the first study to explore clinical pharmacists' experiences of discussing alcohol with patients in their new role in UK primary care, in developing a novel approach to brief intervention. It investigates their confidence with the subject of alcohol in routine practice and explores views on a new approach, integrating alcohol into the medication review as another drug directly linked to the patient's health conditions and medicines, rather than a separated 'healthy living' issue. The study forms part of wider efforts to repurpose and reimagine the potential application of brief interventions and to rework their contents. METHODS: Longitudinal qualitative study of 10 recruits to the new clinical pharmacist role in English primary care, involving three semi-structured interviews over approximately 16 months, supplemented by 10 one-off interviews with pharmacists already established in general practice. RESULTS: When raised at all, enquiring about alcohol in medication reviews was described in terms of calculating dose and level of consumption, leading to crude advice to reduce drinking. The idea was that those who appeared dependent should be referred to specialist services, though few such referrals were recalled. Pharmacists acknowledged that they were not currently considering alcohol as a drug in their practice and were interested in learning more about this concept and the approach it entailed, particularly in relation to polypharmacy. Some recognised a linked need to enhance consultation skills. CONCLUSIONS: Alcohol complicates routine clinical care and adversely impacts patient outcomes, even for those drinking at seemingly unremarkable levels. Changing clinical practice on alcohol requires engaging with, and supportively challenging, routine practices and entrenched ideas of different kinds. Framing alcohol as a drug may help shift the focus from patients with alcohol problems to problems caused for patients by alcohol. This is less stigmatising and provides role legitimacy for pharmacists to address alcohol clinically in medication reviews, thus providing one element in the formation of a new prevention paradigm. This approach invites further innovations tailored to other healthcare professional roles.

AGA Clinical Practice Update on Alpha-Gal Syndrome for the GI Clinician: Commentary.

DESCRIPTION: Alpha-gal syndrome is an emerging allergy first described in the early 2000s. The allergy can cause anaphylaxis, gastrointestinal (GI) symptoms, and skin changes one to several hours after ingestion of mammalian products. A GI phenotype that is increasingly recognized manifests with nonspecific symptoms like abdominal pain, diarrhea, nausea or vomiting without predominant skin, respiratory or circulatory symptoms. Though the syndrome has been reported on all continents except Antarctica, in the United States most reports are within the range of the Lone Star tick, extending from New York and Iowa to Texas and Florida. The purpose of this AGA Clinical Practice Update (CPU) Commentary is to increase awareness among gastroenterologists about the presentation and management of alpha-gal syndrome. METHODS: This CPU commentary was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors. Formal ratings regarding the quality of evidence or strength of the presented considerations were not included since systematic reviews were not performed.

Enhanced SARS-CoV-2 IgG durability following COVID-19 mRNA booster vaccination and comparison of BNT162b2 with mRNA-1273.

BACKGROUND: BNT162b2 (Pfizer/BioNTech, Comirnaty) and mRNA-1273 (Moderna, Spikevax) are messenger RNA (mRNA) vaccines that elicit antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike receptor-binding domain (S-RBD) and have been approved by the US Food and Drug Administration to combat the coronavirus disease 2019 (COVID-19) pandemic. Because vaccine efficacy and antibody levels waned over time after the 2-shot primary series, the US Food and Drug Administration authorized a booster (third) dose for both mRNA vaccines to adults in the fall of 2021. OBJECTIVE: To evaluate the magnitude and durability of S-RBD immunoglobulin (Ig)G after the booster mRNA vaccine dose in comparison to the primary series. We also compared S-RBD IgG levels after BNT162b2 and mRNA-1273 boosters and explored effects of age and prior infection. METHODS: Surrounding receipt of the second and third homologous mRNA vaccine doses, adults in an employee-based cohort provided serum and completed questionnaires, including information about previous COVID-19 infection. The IgG to S-RBD was measured using an ImmunoCAP-based system. A subset of samples were assayed for IgG to SARS-CoV-2 nucleocapsid by commercial assay. RESULTS: There were 228 subjects who had samples collected between 7 and 150 days after their primary series vaccine and 117 subjects who had samples collected in the same time frame after their boost. Antibody levels from 7 to 31 days after the primary series and booster were similar, but S-RBD IgG was more durable over time after the boost, regardless of prior infection status. In addition, mRNA-1273 post-boost antibody levels exceeded BNT162b2 out to 5 months. CONCLUSION: The COVID-19 mRNA vaccine boosters increase antibody durability, suggesting enhanced long-term clinical protection from SARS-CoV-2 infection compared with the 2-shot regimen.

Food antigen consumption and disease activity affect food-specific IgG4 levels in patients with eosinophilic esophagitis (EoE).

INTRODUCTION: High levels of serum food-specific IgG4 (sIgG4) have been reported in patients with EoE. The objective of this study was to examine whether serum sIgG4 levels to foods and aeroallergens are higher in EoE patients than allergic controls and to investigate the association between sIgG4 and EoE clinical characteristics. METHODS: This was a case-control study nested in a prospective EoE Cohort. EoE cases were defined per consensus guidelines, and controls were individuals with symptoms who were confirmed to be EoE-negative on upper endoscopy. Demographic and clinical information was prospectively collected. Serum IgE and sIgG4 were measured to foods and aeroallergens by ImmunoCAP. Mean levels of sIgG4 were compared between cases and controls, and logistic regression models were used to examine predictors of elevated milk sIgG4 levels. RESULTS: The analysis included 123 individuals (EoE n = 93, control n = 30) with a similar distribution of allergic disease between EoE patients and controls (86% vs. 93%; p = .30). EoE patients had significantly higher sIgG4 levels to all allergens evaluated, with the exception of birch (p = .24). Milk sIgG4 levels were independently associated with milk consumption (OR 4.95; p = .01) and the presence of sIgE to milk (OR 4.23; p = .008). CONCLUSION: Serum sIgG4 levels to food and aeroallergen proteins were higher in patients with EoE than non-EoE controls, and higher levels of milk sIgG4 were independently associated with milk consumption and the presence of sIgE to milk proteins. Whether sIgG4 plays a pathogenic role in EoE or could be used as an EoE biomarker remains unknown and warrants further study.

Integration of a clinical pharmacist workforce into newly forming primary care networks: a qualitatively driven, complex systems analysis.

OBJECTIVE: The introduction of a new clinical pharmacist workforce via Primary Care Networks (PCNs) is a recent national policy development in the National Health Service in England. This study elicits the perspectives of people with responsibility for local implementation of this national policy package. Attention to local delivery is necessary to understand the contextual factors shaping the integration of the new clinical pharmacy workforce, and thus can be expected to influence future role development. DESIGN: A qualitative, interview study SETTING AND PARTICIPANTS: PCN Clinical Directors and senior pharmacists across 17 PCNs in England (n=28) ANALYSIS: Interviews were transcribed, coded and organised using the framework method. Thematic analysis and complex systems modelling were then undertaken iteratively to develop the themes. RESULTS: Findings were organised into two overarching themes: (1) local organisational innovations of a national policy under conditions of uncertainty; and (2) local multiprofessional decision-making on clinical pharmacy workforce integration and initial task assignment. Although a phased implementation of the PCN package was planned, the findings suggest that processes of PCN formation and clinical pharmacist workforce integration were closely intertwined, with underpinning decisions taking place under conditions of considerable uncertainty and workforce pressures. CONCLUSIONS: National policy decisions that required General Practitioners to form PCNs at the same time as they integrated a new workforce risked undermining the potential of both PCNs and the new workforce. PCNs require time and support to fully form and integrate clinical pharmacists if successful role development is to occur. Efforts to incentivise delivery of PCN pharmacy services in future must be responsive to local capacity.

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care.

BACKGROUND: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. METHODS: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. RESULTS: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. CONCLUSIONS: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. TRIAL REGISTRATION: ISRCTN: 51154948.

A qualitative formative evaluation of a patient facing intervention to improve care transitions for older people moving from hospital to home.

BACKGROUND: The Partners at Care Transitions (PACTs) intervention was developed to support older people's involvement in hospital to improve outcomes at home. A booklet, question card, record sheet, induction leaflet, and patient-friendly discharge letter support patients to be more involved in their health and wellbeing, medications, activities of daily living and post-discharge care. We aimed to assess intervention acceptability, identify implementation tools, and further develop the intervention. METHODS: This was a qualitative formative evaluation involving three wards from one hospital. We recruited 25 patients aged 75 years and older. Ward staff supported intervention delivery. Data were collected in wards and patients' homes, through semi-structured interviews, observation, and documentary analysis. Data were analysed inductively and iteratively with findings sorted according to the research aims. RESULTS: Patients and staff felt there was a need for, and understood the purpose of, the PACT intervention. Most patients read the booklet but other components were variably used. Implementation challenges included time, awareness, and balancing intervention benefits against risks. Changes to the intervention and implementation included clarifying the booklet's messages, simplifying the discharge letter to reduce staff burden, and using prompts and handouts to promote awareness. CONCLUSION: The PACT intervention offers a promising new way to improve care transitions for older people by supporting patient involvement in their care. After further development of the intervention and implementation package, it will undergo further testing. PATIENT OR PUBLIC CONTRIBUTION: This study regularly consulted a panel representing the local patient community, who supported the development of this intervention and its implementation.