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Abstract Background Digital therapeutic Sleepio has proven effective in improving sleep quality and decreasing symptoms of anxiety. The National Institute for Health and Care Excellence (NICE) guidance recommends Sleepio as an alternative treatment to usual sleep hygiene education and hypnotic medications. General practitioners (GPs) play a critical role in the adoption of digital therapeutics in patient care. Previous interventions did not adopt theoretical frameworks to systematically understand GPs behaviour toward referring patients to digital therapeutics. Objectives This study aimed to report the systematic and comprehensive development of an intervention to encourage GPs to refer insomnia patients to Sleepio, using the Behaviour Change Wheel (BCW). Methods The eight steps outlined in the BCW were followed to develop an intervention. The Capability Opportunity Motivation-Behaviour Self-Evaluation Questionnaire (COM-B-Qv1) was adopted to understand GPs perceived facilitators and barriers to refer insomnia patients to Sleepio. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate changes in GPs’ behaviour in relation to Sleepio. Results The BCW design process resulted in the identification of five intervention functions, three policy categories and five behaviour change techniques (BCTs) as potential active components for an intervention. The intervention includes providing GPs with an orientation about using Sleepio to improve their knowledge and confidence, sending visual reminders to GPs to recommend Sleepio to their patients, providing ongoing technical support. Conclusion The BCW can be successfully applied through a systematic process to understand the drivers of GPs’ behaviour and to develop an intervention that can encourage them to refer insomnia patients to Sleepio.

Polymerase β (POLB), with dual functionality as a lyase and polymerase, plays a critical role in the base excision repair (BER) pathway to maintain genomic stability. POLB knockout and rescue studies in BRCA1/2-mutant cancer cell lines revealed that inhibition of lyase and polymerase activity is required for the synthetic lethal interaction observed with PARP inhibitors, highlighting POLB as a valuable therapeutic target. Traditional biochemical assays to screen for enzyme inhibitors focus on a single substrate to product relationship and limit the comprehensive analysis of enzymes such as POLB that utilize multiple substrates or catalyze a multi-step reaction. This report describes the first high-throughput mass spectrometry-based screen to measure the two distinct biochemical activities of POLB in a single assay using a duplexed self-assembled monolayer desorption ionization (SAMDI) mass spectrometry methodology. A multiplexed assay for POLB dual enzymatic activities was developed optimizing for kinetically balanced conditions and a collection of 200,000 diverse small molecules was screened in the duplexed format. Small molecule modulators identified in the screen were confirmed in a traditional fluorescence-based polymerase strand-displacement assay and an orthogonal label-free binding assay using SAMDI affinity selection mass spectrometry (ASMS). This work demonstrates the flexibility of high-throughput mass spectrometry approaches in drug discovery and highlights a novel application of SAMDI technology that opens new avenues for multiplexed high-throughput screening.

Background Worldwide, patients are increasingly being offered access to their full online clinical records including the narrative reports written by clinicians (so-called “open notes”). Against these developments, there is growing interest in the use of generative artificial intelligence (AI) such as OpenAI's ChatGPT to co-assist clinicians with patient-facing documentation. Objective This study aimed to explore the effectiveness of OpenAI's ChatGPT 3.5 and GPT 4.0 in generating three patient-facing clinical notes from fictional general practice narrative reports. Methods On 1 October 2023 and 1 November 2023, we used ChatGPT 3.5 and 4.0 to generate notes for three validated fictional general practice notes, using a prompt in the style of a British primary care note for three commonly presented conditions: (1) type 2 diabetes, (2) major depressive disorder, and (3) a differential diagnosis for suspected bowel cancer. Outputs were analyzed for reading ease, sentiment analysis, empathy, and medical fidelity. Results ChatGPT 3.5 and 4.0 wrote longer notes than the original, and embedded more second person pronouns, with ChatGPT 3.5 scoring higher on both. ChatGPT expanded abbreviations, but readability metrics showed that the notes required a higher reading proficiency, with ChatGPT 3.5 demanding the most advanced level. Across all notes, ChatGPT offered higher signatures of empathy across cognitive, compassion/sympathy, and prosocial cues. Medical fidelity ratings varied across all three cases with ChatGPT 4.0 rated superior. Conclusions While ChatGPT improved sentiment and empathy metrics in the transformed notes, compared to the original they also required higher reading proficiency and omitted details impacting medical fidelity.

Abstract Background Dementia affects ability to remember, think, or make decisions that interfere with doing everyday activities. There is no cure, therefore any prevention or delay of the onset is of importance. This study aims to investigate the association between zoster and influenza vaccinations and the risk of developing dementia. Methods We conducted a retrospective population-based cohort study using electronic health records from 1469 general practices contributing to the Clinical Practice Research Datalink (CPRD) Aurum database with linked hospital episode statistics (HES) and Office for National Statistics (ONS) mortality records. We built two 'matched cohorts': zoster vaccine (854,745 exposed individuals) matched with 8.8 million comparators without a history of zoster vaccination, and influenza vaccine (742,487 exposed individuals) matched with 7.12 million comparators without a history of vaccination as another comparator group. The cohorts were then followed to assess the association of exposure (vaccine) with outcome (dementia diagnosis). Results Zoster vaccination was associated with a lower risk of dementia diagnosis (adjusted hazard ratio (HR) 0.78 with 95% CI: 0.77–0.79), Alzheimer’s diagnosis (adjusted HR 0.91 with 95% CI: 0.89–0.92 and other types of dementia (adjusted HR 0.71 with 95% CI: 0.69–0.72). Influenza vaccination also was associated with a slightly reduced hazard of dementia risk (adjusted HR 0.96 with 95% CI: 0.94–0.97). Conclusion Both zoster vaccine for prevention of shingles / herpes zoster and influenza vaccine to prevent influenza were associated with diminished risk of dementia, with the zoster association appearing more pronounced.

Abstract Introduction Remote (digital and/or telephone) access and consultation models are being driven by national policy with the goal being that the National Health Service operate on a remote‐first (digital‐first) basis by 2029. Previous research has suggested that remote methods of access to care and consulting may act to widen health inequalities for certain patients and/or groups such as those from ethnic minorities. South Asian (SA) patients comprise the largest ethnic minority group in England. Understanding the experiences and needs of this group is critical to ensuring that general practice can deliver equitable, quality health care. Methods Qualitative study. 37 participants (from Indian, Pakistani and/or Bangladeshi background) were recruited to take part in either in‐person preferred language focus groups or remote semistructured interviews in the English language. Thematic analysis was conducted to identify themes in the qualitative data. Findings Three major interlinked themes were identified: (1) reduced access, (2) reduced patient choice and (3) quality and safety concerns. The findings highlight access issues split by (i) general issues with appointment access via any remote means and (ii) specific issues related to language barriers creating additional barriers to access and care. Some patients valued the convenience of remote access but also raised concerns regarding appointment availability and reduced patient choice. Face‐to‐face consultations were preferable but less available. The findings underscore how participants perceived remote care to be of lesser quality and less safe. Concerns were greatest for those with limited English proficiency (LEP), with the removal of non‐verbal aspects of communication and ‘hands‐on’ care leading to perceptions of reduced psycho‐social safety. Conclusion SA patients' experiences of remote‐led primary care access and care delivery were negative with only a minority viewing it positively and for certain limited scenarios. Face‐to‐face models of care remain the preferred mode of consultation, particularly for those with LEP. Hybrid models of access offer patients the greatest choice, and are likely to meet the varying needs of the South‐Asian patient population going forwards. The remote first approach to primary care may be achievable as a service ideal, but its limitations need to be recognised and accounted for to ensure that primary care can be an equitable service, both now and in the future. Public Contribution Members of the public were involved in all phases of research in the study. This included co‐working in partnership throughout the study including, reviewing patient‐facing documents, recruiting participants, data facilitation, translation work, interpretation of the data and co‐authors on this manuscript. The key to the success of our study was collaborative teamwork, which involved experienced members of the public with SA cultural knowledge working together with and integral to the research team for all components.

Introduction The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care.Method and analysis We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.Ethics and dissemination Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists.Trial registration number NCT05344066.

Patients’ online record access (ORA) is growing worldwide. In some countries, including the United States and Sweden, access is advanced with patients obtaining rapid access to their full records on the web including laboratory and test results, lists of prescribed medications, vaccinations, and even the very narrative reports written by clinicians (the latter, commonly referred to as “open notes”). In the United States, patient’s ORA is also available in a downloadable form for use with other apps. While survey studies have shown that some patients report many benefits from ORA, there remain challenges with implementation around writing clinical documentation that patients may now read. With ORA, the functionality of the record is evolving; it is no longer only an aide memoire for doctors but also a communication tool for patients. Studies suggest that clinicians are changing how they write documentation, inviting worries about accuracy and completeness. Other concerns include work burdens; while few objective studies have examined the impact of ORA on workload, some research suggests that clinicians are spending more time writing notes and answering queries related to patients’ records. Aimed at addressing some of these concerns, clinician and patient education strategies have been proposed. In this viewpoint paper, we explore these approaches and suggest another longer-term strategy: the use of generative artificial intelligence (AI) to support clinicians in documenting narrative summaries that patients will find easier to understand. Applied to narrative clinical documentation, we suggest that such approaches may significantly help preserve the accuracy of notes, strengthen writing clarity and signals of empathy and patient-centered care, and serve as a buffer against documentation work burdens. However, we also consider the current risks associated with existing generative AI. We emphasize that for this innovation to play a key role in ORA, the cocreation of clinical notes will be imperative. We also caution that clinicians will need to be supported in how to work alongside generative AI to optimize its considerable potential.

Objective To describe the experiences and opinions of general practitioners (GPs) in England regarding patients having access to their full online GP health records.Design Convenience sample, online survey.Participants 400 registered GPs in England.Main outcome measures Investigators measured GPs’ experiences and opinions about online record access (ORA), including patient care and their practice.Results A total of 400 GPs from all regions of England responded. A minority (130, 33%) believed ORA was a good idea. Most GPs believed a majority of patients would worry more (364, 91%) or find their GP records more confusing than helpful (338, 85%). Most GPs believed a majority of patients would find significant errors in their records (240, 60%), would better remember their care plan (280, 70%) and feel more in control of their care (243, 60%). The majority believed they will/already spend more time addressing patients’ questions outside of consultations (357, 89%), that consultations will/already take significantly longer (322, 81%) and that they will be/already are less candid in their documentation (289, 72%) after ORA. Nearly two-thirds of GPs believed ORA would increase their litigation (246, 62%).Conclusions Similar to clinicians in other countries, GPs in our sample were sceptical of ORA, believing patients would worry more and find their records more confusing than helpful. Most GPs also believed the practice would exacerbate work burdens. However, the majority of GPs in this survey also agreed there were multiple benefits to patients having online access to their primary care health records. The findings of this survey also contribute to a growing body of contrastive research from countries where ORA is advanced, demonstrating clinicians are sceptical while studies indicate patients appear to derive multiple benefits.

BackgroundInternationally, patient-accessible electronic health records (PAEHRs) are increasingly being implemented. Despite reported benefits to patients, the innovation has prompted concerns among health care professionals (HCPs), including the possibility that access incurs a “dumbing down” of clinical records. Currently, no review has investigated empirical evidence of whether and how documentation changes after introducing PAEHRs. ObjectiveThis paper presents the protocol for a scoping review examining potential subjective and objective changes in HCPs documentation after using PAEHRs. MethodsThis scoping review will be carried out based on the framework of Arksey and O’Malley. Several databases will be used to conduct a literature search (APA PsycInfo, CINAHL, PubMed, and Web of Science Core Collection). Authors will participate in screening identified papers to explore the research questions: How do PAEHRs affect HCPs’ documentation practices? and What subjective and objective changes to the clinical notes arise after patient access? Only studies that relate to actual use experiences, and not merely prior expectations about PAEHRs, will be selected in the review. Data abstraction will include but will not be limited to publication type, publication year, country, sample characteristics, setting, study aim, research question, and conclusions. The Mixed Methods Appraisal Tool will be used to assess the quality of the studies included. ResultsThe results from this scoping review will be presented as a narrative synthesis structured along the key themes of the corpus of evidence. Additional data will be prepared in charts or tabular format. We anticipate the results to be presented in a scoping review at a later date. They will be disseminated at scientific conferences and through publication in a peer-reviewed journal. ConclusionsThis is the first scoping review that considers potential change in documentation after implementation of PAEHRs. The results can potentially help affirm or refute prior opinions and expectations among various stakeholders about the use of PAEHRs and thereby help to address uncertainties. Results may help to provide guidance to clinicians in writing notes and thus have immediate practical relevance to care. In addition, the review will help to identify any substantive research gaps in this field of research. In the longer term, our findings may contribute to the development of shared documentation guidelines, which in turn are central to improving patient communication and safety. International Registered Report Identifier (IRRID)PRR1-10.2196/46722

Abstract The purpose of this study was to evaluate the performance of machine learning algorithms to predict trabeculectomy surgical outcomes. Preoperative systemic, demographic and ocular data from consecutive trabeculectomy surgeries from a single academic institution between January 2014 and December 2018 were incorporated into models using random forest, support vector machine, artificial neural networks and multivariable logistic regression. Mean area under the receiver operating characteristic curve (AUC) and accuracy were used to evaluate the discrimination of each model to predict complete success of trabeculectomy surgery at 1 year. The top performing model was optimized using recursive feature selection and hyperparameter tuning. Calibration and net benefit of the final models were assessed. Among the 230 trabeculectomy surgeries performed on 184 patients, 104 (45.2%) were classified as complete success. Random forest was found to be the top performing model with an accuracy of 0.68 and AUC of 0.74 using 5-fold cross-validation to evaluate the final optimized model. These results provide evidence that machine learning models offer value in predicting trabeculectomy outcomes in patients with refractory glaucoma.

BackgroundIn 2022, NHS England announced plans to ensure that all adult primary care patients in England would have full online access to new data added to their general practitioner (GP) record. However, this plan has not yet been fully implemented. Since April 2020, the GP contract in England has already committed to offering patients full online record access on a prospective basis and on request. However, there has been limited research into UK GPs’ experiences and opinions about this practice innovation. ObjectiveThis study aimed to explore the experiences and opinions of GPs in England about patients’ access to their full web-based health record, including clinicians’ free-text summaries of the consultation (so-called “open notes”). MethodsIn March 2022, using a convenience sample, we administered a web-based mixed methods survey of 400 GPs in the United Kingdom to explore their experiences and opinions about the impact on patients and GPs’ practices to offer patients full online access to their health records. Participants were recruited using the clinician marketing service Doctors.net.uk from registered GPs currently working in England. We conducted a qualitative descriptive analysis of written responses (“comments”) to 4 open-ended questions embedded in a web-based questionnaire. ResultsOf 400 GPs, 224 (56%) left comments that were classified into 4 major themes: increased strain on GP practices, the potential to harm patients, changes to documentation, and legal concerns. GPs believed that patient access would lead to extra work for them, reduced efficiency, and increased burnout. The participants also believed that access would increase patient anxiety and incur risks to patient safety. Experienced and perceived documentation changes included reduced candor and changes to record functionality. Anticipated legal concerns encompassed fears about increased litigation risks and lack of legal guidance to GPs about how to manage documentation that would be read by patients and potential third parties. ConclusionsThis study provides timely information on the views of GPs in England regarding patient access to their web-based health records. Overwhelmingly, GPs were skeptical about the benefits of access both for patients and to their practices. These views are similar to those expressed by clinicians in other countries, including Nordic countries and the United States before patient access. The survey was limited by the convenience sample, and it is not possible to infer that our sample was representative of the opinions of GPs in England. More extensive, qualitative research is required to understand the perspectives of patients in England after experiencing access to their web-based records. Finally, further research is needed to explore objective measures of the impact of patient access to their records on health outcomes, clinician workload, and changes to documentation.

BackgroundMobile health (mHealth) apps have great potential to support the management of chronic conditions. Despite widespread acceptance of mHealth apps by the public, health care providers (HCPs) are reluctant to prescribe or recommend such apps to their patients. ObjectiveThis study aimed to classify and evaluate interventions aimed at encouraging HCPs to prescribe mHealth apps. MethodsA systematic literature search was conducted to identify studies published from January 1, 2008, to August 5, 2022, using 4 electronic databases: MEDLINE, Scopus, CINAHL, and PsycINFO. We included studies that evaluated interventions encouraging HCPs to prescribe mHealth apps. Two review authors independently assessed the eligibility of the studies. The “National Institute of Health’s quality assessment tool for before-and-after (pretest-posttest design) studies with no control group” and “the mixed methods appraisal tool (MMAT)” were used to assess the methodological quality. Owing to high levels of heterogeneity between interventions, measures of practice change, specialties of HCPs, and modes of delivery, we conducted a qualitative analysis. We adopted the behavior change wheel as a framework for classifying the included interventions according to intervention functions. ResultsIn total, 11 studies were included in this review. Most of the studies reported positive findings, with improvements in a number of outcomes, including increased knowledge of mHealth apps among clinicians, improved self-efficacy or confidence in prescribing, and an increased number of mHealth app prescriptions. On the basis of the behavior change wheel, 9 studies reported elements of environmental restructuring such as providing HCPs with lists of apps, technological systems, time, and resources. Furthermore, 9 studies included elements of education, particularly workshops, class lectures, individual sessions with HCPs, videos, or toolkits. Furthermore, training was incorporated in 8 studies using case studies or scenarios or app appraisal tools. Coercion and restriction were not reported in any of the interventions included. The quality of the studies was high in relation to the clarity of aims, interventions, and outcomes but weaker in terms of sample size, power calculations, and duration of follow-up. ConclusionsThis study identified interventions to encourage app prescriptions by HCPs. Recommendations for future research should consider previously unexplored intervention functions such as restrictions and coercion. The findings of this review can help inform mHealth providers and policy makers regarding the key intervention strategies impacting mHealth prescriptions and assist them in making informed decisions to encourage this adoption.

Objectives: Appearance-related interventions to promote healthy behaviour have been found effective to communicate health risks. The current study aimed to explore women smokers' experiences of age-progression software showing the effects of smoking on the face. Methods: A qualitative design was implemented, utilizing both individual interviews and focus groups within a critical realist framework. Fifteen, 19–52 year-old women smokers were administered an age-progression intervention. All participants responded to the intervention, engaged in semi-structured interviews, and were invited back to attend one of three focus groups. Data were analysed using inductive thematic analysis. Results: Four main themes were identified: Health versus Appearance, Shock Reaction, Perceived Susceptibility, and Intention to Quit. Participants found the intervention useful, voicing need for a comprehensive approach that includes both appearance and health. Despite increases in appearance-based apps which could diminish impact, women's accounts of shock induced by the aged smoking-morphed images were similar to previous work conducted more than ten years previously. Conclusions: The study provides novel insights in how women smokers currently perceive, and react to, an age-progression intervention for smoking cessation. Innovation: Findings emphasise the implementation of this intervention type accompanied by health information in a range of patient settings.

Abstract Background Patients presenting with chest pain represent a large proportion of attendances to emergency departments. In these patients clinicians often consider the diagnosis of acute myocardial infarction (AMI), the timely recognition and treatment of which is clinically important. Clinical prediction models (CPMs) have been used to enhance early diagnosis of AMI. The Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision aid is currently in clinical use across Greater Manchester. CPMs have been shown to deteriorate over time through calibration drift. We aim to assess potential calibration drift with T-MACS and compare methods for updating the model. Methods We will use routinely collected electronic data from patients who were treated using TMACS at two large NHS hospitals. This is estimated to include approximately 14,000 patient episodes spanning June 2016 to October 2020. The primary outcome of acute myocardial infarction will be sourced from NHS Digital’s admitted patient care dataset. We will assess the calibration drift of the existing model and the benefit of updating the CPM by model recalibration, model extension and dynamic updating. These models will be validated by bootstrapping and one step ahead prequential testing. We will evaluate predictive performance using calibrations plots and c-statistics. We will also examine the reclassification of predicted probability with the updated TMACS model. Discussion CPMs are widely used in modern medicine, but are vulnerable to deteriorating calibration over time. Ongoing refinement using routinely collected electronic data will inevitably be more efficient than deriving and validating new models. In this analysis we will seek to exemplify methods for updating CPMs to protect the initial investment of time and effort. If successful, the updating methods could be used to continually refine the algorithm used within TMACS, maintaining or even improving predictive performance over time. Trial registration ISRCTN number: ISRCTN41008456

BackgroundCurrent evidence supports the use of wearable trackers by people with cardiometabolic conditions. However, as the health benefits are small and confounded by heterogeneity, there remains uncertainty as to which patient groups are most helped by wearable trackers. ObjectiveThis study examined the effects of wearable trackers in patients with cardiometabolic conditions to identify subgroups of patients who most benefited and to understand interventional differences. MethodsWe obtained individual participant data from randomized controlled trials of wearable trackers that were conducted before December 2020 and measured steps per day as the primary outcome in participants with cardiometabolic conditions including diabetes, overweight or obesity, and cardiovascular disease. We used statistical models to account for clustering of participants within trials and heterogeneity across trials to estimate mean differences with the 95% CI. ResultsIndividual participant data were obtained from 9 of 25 eligible randomized controlled trials, which included 1481 of 3178 (47%) total participants. The wearable trackers revealed that over the median duration of 12 weeks, steps per day increased by 1656 (95% CI 918-2395), a significant change. Greater increases in steps per day from interventions using wearable trackers were observed in men (interaction coefficient –668, 95% CI –1157 to –180), patients in age categories over 50 years (50-59 years: interaction coefficient 1175, 95% CI 377-1973; 60-69 years: interaction coefficient 981, 95% CI 222-1740; 70-90 years: interaction coefficient 1060, 95% CI 200-1920), White patients (interaction coefficient 995, 95% CI 360-1631), and patients with fewer comorbidities (interaction coefficient –517, 95% CI –1188 to –11) compared to women, those aged below 50, non-White patients, and patients with multimorbidity. In terms of interventional differences, only face-to-face delivery of the tracker impacted the effectiveness of the interventions by increasing steps per day. ConclusionsIn patients with cardiometabolic conditions, interventions using wearable trackers to improve steps per day mostly benefited older White men without multimorbidity. Trial RegistrationPROSPERO CRD42019143012; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=143012

Objective To assess the diagnostic Read code usage for 18 conditions by examining their frequency and diversity in UK primary care between 2000 and 2013.Design Population-based cohort studySetting 684 UK general practices contributing data to the Clinical Practice Research Datalink (CPRD) GOLD.Participants Patients with clinical codes for at least one of asthma, chronic obstructive pulmonary disease, diabetes, hypertension (HT), coronary heart disease, atrial fibrillation (AF), heart failure, stroke, hypothyroidism, chronic kidney disease, learning disability (LD), depression, dementia, epilepsy, severe mental illness (SMI), osteoarthritis, osteoporosis and cancer.Primary and secondary outcome measures For the frequency ranking of clinical codes, canonical correlation analysis was applied to correlations of clinical code usage of 1, 3 and 5 years. Three measures of diversity (Shannon entropy index of diversity, richness and evenness) were used to quantify changes in incident and total clinical codes.Results Overall, all examined conditions, except LD, showed positive monotonic correlation. HT, hypothyroidism, osteoarthritis and SMI codes’ usage had high 5-year correlation. The codes’ usage diversity remained stable overall throughout the study period. Cancer, diabetes and SMI had the highest richness (code lists need time to define) unlike AF, hypothyroidism and LD. SMI (high richness) and hypothyroidism (low richness) can last for 5 years, whereas cancer and diabetes (high richness) and LD (low richness) only last for 2 years.Conclusions This is an under-reported research area and the findings suggest the codes’ usage diversity for most conditions remained overall stable throughout the study period. Generated mental health code lists can last for a long time unlike cardiometabolic conditions and cancer. Adopting more consistent and less diverse coding would help improve data quality in primary care. Future research is needed following the transfer to the Systematised Nomenclature of Medicine Clinical Terms (SNOMED CT) coding.

COVID-19 emergency use authorizations and approvals for vaccines were achieved in record time. However, there remains a need to develop additional safe, effective, easy-to-produce, and inexpensive prevention to reduce the risk of acquiring SARS-CoV-2 infection. This need is due to difficulties in vaccine manufacturing and distribution, vaccine hesitancy, and, critically, the increased prevalence of SARS-CoV-2 variants with greater contagiousness or reduced sensitivity to immunity. Antibodies from eggs of hens (immunoglobulin Y; IgY) that were administered the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein were developed for use as nasal drops to capture the virus on the nasal mucosa. Although initially raised against the 2019 novel coronavirus index strain (2019-nCoV), these anti-SARS-CoV-2 RBD IgY surprisingly had indistinguishable enzyme-linked immunosorbent assay binding against variants of concern that have emerged, including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), and Omicron (B.1.1.529). This is different from sera of immunized or convalescent patients. Culture neutralization titers against available Alpha, Beta, and Delta were also indistinguishable from the index SARS-CoV-2 strain. Efforts to develop these IgY for clinical use demonstrated that the intranasal anti-SARS-CoV-2 RBD IgY preparation showed no binding (cross-reactivity) to a variety of human tissues and had an excellent safety profile in rats following 28-day intranasal delivery of the formulated IgY. A double-blind, randomized, placebo-controlled phase 1 study evaluating single-ascending and multiple doses of anti-SARS-CoV-2 RBD IgY administered intranasally for 14 days in 48 healthy adults also demonstrated an excellent safety and tolerability profile, and no evidence of systemic absorption. As these antiviral IgY have broad selectivity against many variants of concern, are fast to produce, and are a low-cost product, their use as prophylaxis to reduce SARS-CoV-2 viral transmission warrants further evaluation.Clinical Trial Registrationhttps://www.clinicaltrials.gov/ct2/show/NCT04567810, identifier NCT04567810.

Introduction Cardiovascular disease (CVD) remains one of the leading causes of preventable death in Europe, therefore any opportunity to intervene and improve care should be maximised. Known CVD risk factors are routinely collected in the emergency department (ED), yet they are often not acted on. If the risk factors have prognostic value and a pathway can be created, then this would provide more holistic care for patients and reduce health system inefficiency.Methods and analysis In this mixed-methods study, we will use quantitative methods to investigate the prognostic characteristics of routinely collected data for long-term CVD outcomes, and qualitative methods to investigate how to use and implement this knowledge. The quantitative arm will use a database of approximately 21 000 chest pain patient episodes with a mean follow-up of 7.3 years. We will use Cox regression to evaluate the prognostic characteristics of routinely collected ED data for long-term CVD outcomes. We will also use a series of semi-structured interviews to co-design a prototype care pathway with stakeholders via thematic analysis. To enable the development of prototypes, themes will be structured into a logic model consisting of situation, inputs, outputs and mechanism.Ethics and dissemination This work has been approved by Research Ethics Committee (Wales REC7) and the Human Research Authority under reference 19/WA/0312 and 19/WA/0311. It has also been approved by the Confidentiality Advisory Group reference 19/CAG/0209. Dissent recorded in the NHS’ opt-out scheme will be applied to the dataset by NHS Digital. This work will be disseminated through peer-review publication, conference presentation and a public dissemination strategy.Trial registration number ISRCTN41008456.Protocol version V.1.0—7 June 2021.

Introduction People living with multiple long-term conditions (multimorbidity) (MLTC-M) experience an accumulating combination of different symptoms. It has been suggested that these symptoms can be tracked longitudinally using consumer technology, such as smartphones and wearable devices. Aim The aim of this study was to investigate longitudinal user engagement with a smartwatch application, collecting survey questions and active tasks over 90 days, in people living with MLTC-M. Methods ‘Watch Your Steps ’ was a prospective observational study, administering multiple questions and active tasks over 90 days. Adults with more than one clinician-diagnosed long-term conditions were loaned Fossil® Sport smartwatches, pre-loaded with the study app. Around 20 questions were prompted per day. Daily completion rates were calculated to describe engagement patterns over time, and to explore how these varied by patient characteristics and question type. Results Fifty three people with MLTC-M took part in the study. Around half were male ( = 26; 49%) and the majority had a white ethnic background ( n = 45; 85%). About a third of participants engaged with the smartwatch app nearly every day. The overall completion rate of symptom questions was 45% inter-quartile range (IQR 23–67%) across all study participants. Older patients and those with greater MLTC-M were more engaged, although engagement was not significantly different between genders. Conclusion It was feasible for people living with MLTC-M to report multiple symptoms per day over 3 months. User engagement appeared as good as other mobile health studies that recruited people with single health conditions, despite the higher daily data entry burden.

Objectives Primary care records have traditionally served the needs and demands of clinicians rather than those of the patient. In England, general practices must promote and offer registered patients online access to their primary care record, and research has shown benefits to both patients and clinicians of doing so. Despite this, we know little about patients’ needs and expectations regarding online access to their record. This study explored what patients and carers want from online access to their electronic primary care health record, their experiences of using it, how they would like to interact with their record and what support they may need.Design Focus groups and semistructured interviews using purposive sampling to achieve a good sociodemographic spread. Interviews were digitally audiorecorded, transcribed and coded using an established thematic approach.Setting Focus groups and interviews were conducted in community settings in the UK.Participants Fifty-four individuals who were either eligible for the National Health Service Health Check, living with more than one long-term condition or caring for someone else.Results Participants views regarding online access were categorised into four main themes: awareness, capabilities, consequences and inevitability. Participants felt online access should be better promoted, and suggested a number of additional functions, such as better integration with other parts of the healthcare system. It was felt that online access could improve quality of care (eg, through increased transparency) but also have potential negative consequences (eg, by replacing face to face contact). A move towards more online records access was considered inevitable, but participants noted a need for additional support and training in using the online record, especially to ensure that health inequalities are not exacerbated.Conclusions Discussions with patients and carers about their views of accessing online records have provided useful insights into future directions and potential improvements for this service.

Objectives Previous qualitative research investigating the experiences of women diagnosed with gestational diabetes (GD) has provided important insights into the development of behaviour change interventions. However, these studies often lack a theoretical underpinning. This study explored the use of the capability, opportunity, motivation and behaviour (COM-B) framework (which proposes that individuals need the capability, opportunity and motivation to perform a particular behaviour) to code and the socioecological model to contextualise participant responses to better inform intervention development.Design Qualitative semistructured interviews are using purposive sampling. Interviews were audio-recorded, transcribed and coded using the COM-B framework. A socioecological approach was adopted to understand the context of intervention facets.Setting Interviews were conducted in a secondary care setting in South Yorkshire.Participants Twenty-seven postnatal women with a previous diagnosis of GD were interviewed.Results Applying the COM-B framework to code participant, responses identified 16 key subthemes which reflected either: capability, opportunity or motivation components of the model. Four domains adapted from the socioecological model: individual, family life, community and healthcare provision; contextualised factors are important for these women in terms of behaviour change. Emotional response at the individual level was highly motivating or demotivating. Factors related to family life and community were particularly dominant and had the potential to either facilitate or impede change. We found many participants relied on healthcare provision during the prenatal and postnatal periods with timing and positive relationships being key to good care.Conclusions Our study provides further insight into the factors crucial for behaviour change in women diagnosed with GD. By innovatively applying the COM-B framework in a socioecological context, it is clear intervention facets need to target microlevel through the macrolevel to engage this population in behaviour change. Future work should consider family-level intervention as this could allow for sustained behaviour change and consequently prevent the development of type 2 diabetes mellitus.

Abstract Background Following an initial NHS Health Check appointment, the National Institute for Health and Care Excellence (NICE) suggest patients with QRISK2 scores of ≥10% should be offered advice on lifestyle and the risks and benefits of starting a statin. NICE recommend GPs should ascertain patients’ pre-existing knowledge of cardiovascular disease risk, explore health beliefs, assess readiness to change, offer support, and engage family members. Condensing this complex discussion into a short consultation may result in inadequate patient understanding of the benefits of preventive measures. An alternative approach is needed. We propose a digital adjunct giving patients the opportunity to interact with their health check results from home before returning to see their GP. Before embarking on funding applications we sought the views of patients and members of the public. Methods We consulted the Primary Care Research in Manchester Engagement Resource (PRIMER), an established departmental Patient and Public Involvement (PPI) group (N = 9) and then ran a workshop with 19 members of the public, co-facilitated by 4 members of PRIMER. Following a brief presentation on the background to the project, attendees were split into four groups and introduced to Ketso, a toolkit for creative engagement. Ketso was used to encourage group discussions regarding the project idea. Results This PPI work improved the study design and proposed intervention. Discussions focussed on three themes: 1) positive feedback, 2) challenges and solutions, and 3) improvements/alternatives. Positive feedback included benefits to the NHS and patients. Challenges identified related to: 1) access, 2) data security, 3) engagement, and 4) negative consequences. Workshop members generated various solutions to these challenges and made additional suggestions for improvement relating to: 1) population (e.g. also including those with QRISK2 scores ≤10%), 2) duration (e.g. ongoing access to provide continued feedback), and 3) platform content (e.g. signposting to relevant services). Conclusions This PPI work helped identify potential challenges and solutions not previously considered by the research team. Findings have informed the subsequent intervention design and strengthened the bid for funding. We aim to ensure ongoing patient and public involvement in all future stages.

In this article the authors introduce the Librarians’ Research Partnership (LRP), founded in 2013, at McGill and Concordia University Libraries. The Partnership was inspired by the Canadian Association of Research Libraries’ Librarians’ Research Institute (CARL LRI) which was attended by three of the authors in 2012 and is described here from the point of view of the participants. The authors touch upon the research culture at McGill and Concordia Libraries and discuss barriers and supports for research as prominent themes in the literature on the research role of Canadian academic librarians. The formation of the LRP and the eight subsequent meetings are explained in detail, as well as the factors that made the LRP a successful initiative between the two universities: physical proximity, similarity of working environments, and common organizational culture. The article also includes a discussion of how the LRP’s philosophy might diverge from that of the LRI.