Neuropsychiatric symptoms in Systemic Lupus Erythematosus: mixed methods analysis of patient-derived attributional evidence in the international INSPIRE project.

OBJECTIVE: Attribution of neuropsychiatric symptoms in systemic lupus erythematosus (SLE) relies heavily on clinician assessment. Limited clinic time, variable knowledge, and symptom under-reporting contributes to discordance between clinician assessments and patient symptoms. We obtained attributional data directly from patients and clinicians in order to estimate and compare potential levels of direct attribution to SLE of multiple neuropsychiatric symptoms using different patient-derived measures. METHODS: Quantitative and qualitative data analysed included: prevalence and frequency of neuropsychiatric symptoms, response to corticosteroids, and concurrence of neuropsychiatric symptoms with non-neuropsychiatric SLE disease activity. SLE patients were also compared with controls and inflammatory arthritis (IA) patients to explore attributability of neuropsychiatric symptoms to the direct disease effects on the brain/nervous system. RESULTS: We recruited 2,817 participants, including 400 clinicians. SLE patients (n = 609) reported significantly higher prevalences of neuropsychiatric symptoms than controls (n = 463) and IA patients (n = 489). SLE and IA patients' quantitative data demonstrated multiple neuropsychiatric symptoms relapsing/remitting with other disease symptoms such as joint pain. Over 45% of SLE patients reported resolution/improvement of fatigue, positive sensory symptoms, severe headache, and cognitive dysfunction with corticosteroids. Evidence of direct attributability in SLE was highest for hallucinations and severe headache. SLE patients had greater reported improvement from corticosteroids (p= 0.008), and greater relapsing-remitting with disease activity (p< 0.001) in the comparisons with IA patients for severe headache. Clinician and patients reported insufficient time to discuss patient-reported attributional evidence. Symptoms viewed as indirectly related/non-attributable were often less prioritised for discussion and treatment. CONCLUSION: We found evidence indicating varying levels of direct attributability of both common and previously unexplored neuropsychiatric symptoms in SLE patients, with hallucinations and severe headache assessed as the most directly attributable. There may also be-currently under-estimated-direct effects on the nervous system in IA and other systemic rheumatological diseases.

The feasibility of population screening for paroxysmal atrial fibrillation using hand-held electrocardiogram devices.

AIMS: There are few data on the feasibility of population screening for paroxysmal atrial fibrillation (AF) using hand-held electrocardiogram (ECG) devices outside a specialist setting or in people over the age of 75. We investigated the feasibility of screening when conducted without face-to-face contact ('remote') or via in-person appointments in primary care and explored impact of age on screening outcomes. METHODS AND RESULTS: People aged ≥65 years from 13 general practices in England participated in screening during 2019-20. This involved attending a practice nurse appointment (10 practices) or receiving an ECG device by post (three practices). Participants were asked to use a hand-held ECG for 1-4 weeks. Screening outcomes included uptake, quality of ECGs, AF detection rates, and uptake of anticoagulation if AF was detected. Screening was carried out by 2141 (87.5%) of people invited to practice nurse-led screening and by 288 (90.0%) invited to remote screening. At least 56 interpretable ECGs were provided by 98.0% of participants who participated for 3 weeks, with no significant differences by setting or age, except people aged 85 or over (91.1%). Overall, 2.6% (64/2429) screened participants had AF, with detection rising with age (9.2% in people aged 85 or over). A total of 53/64 (82.8%) people with AF commenced anticoagulation. Uptake of anticoagulation did not vary by age. CONCLUSION: Population screening for paroxysmal AF is feasible in general practice and without face-to-face contact for all ages over 64 years, including people aged 85 and over.

Reliability of single-lead electrocardiogram interpretation to detect atrial fibrillation: insights from the SAFER Feasibility Study.

BACKGROUND AND AIMS: Single-lead electrocardiograms (ECGs) can be recorded using widely available devices such as smartwatches and handheld ECG recorders. Such devices have been approved for atrial fibrillation (AF) detection. However, little evidence exists on the reliability of single-lead ECG interpretation. We aimed to assess the level of agreement on detection of AF by independent cardiologists interpreting single lead ECGs, and to identify factors influencing agreement. METHODS: In a population-based AF screening study, adults aged ≥65 years old recorded four single-lead ECGs per day for 1-4 weeks using a handheld ECG recorder. ECGs showing signs of possible AF were identified by a nurse, aided by an automated algorithm. These were reviewed by two independent cardiologists who assigned participant- and ECG-level diagnoses. Inter-rater reliability of AF diagnosis was calculated using linear weighted Cohen's kappa (kw). RESULTS: Out of 2,141 participants and 162,515 ECGs, only 1,843 ECGs from 185 participants were reviewed by both cardiologists. Agreement was moderate: kw = 0.48 (95% CI, 0.37-0.58) at participant-level; and kw = 0.58 (0.53-0.62) at ECG-level. At participant-level, agreement was associated with the number of adequate-quality ECGs recorded, with higher agreement in participants who recorded at least 67 adequate-quality ECGs. At ECG-level, agreement was associated with ECG quality and whether ECGs exhibited algorithm-identified possible AF. CONCLUSION: Inter-rater reliability of AF diagnosis from single-lead ECGs was found to be moderate in older adults. Strategies to improve reliability might include participant and cardiologist training and designing AF detection programmes to obtain sufficient ECGs for reliable diagnoses.

Prevalence and identification of neuropsychiatric symptoms in systemic autoimmune rheumatic diseases: an international mixed methods study.

OBJECTIVE: A limited range of neuropsychiatric symptoms have been reported in systemic autoimmune rheumatic diseases (SARDs), with varied symptom prevalence. This study aimed to investigate a wider range of potential symptoms than previous studies, compare patient self-reports with clinician estimates, and explore barriers to symptom identification. METHODS: Mixed methods were used. Data from SARDs patients (n = 1853) were compared with controls (n = 463) and clinicians (n = 289). In-depth interviews (n = 113) were analysed thematically. Statistical tests compared means of survey items between: patients and controls, 8 different SARD groups, and clinician specialities. RESULTS: Self-reported lifetime prevalences of all 30 neuropsychiatric symptoms investigated (including cognitive, sensorimotor and psychiatric) were significantly higher in SARDs than controls. Validated instruments assessed 55% of SARDs patients as currently having depression and 57% anxiety. Barriers to identifying neuropsychiatric symptoms included: 1) limits to knowledge, guidelines, objective tests, and inter-specialty cooperation; 2) subjectivity, invisibility and believability of symptoms; and 3) under-eliciting, under-reporting and under-documenting. A lower proportion of clinicians (4%) reported never/rarely asking patients about mental health symptoms than the 74% of patients who reported never/rarely being asked in clinic (p< 0.001). Over 50% of SARDs patients had never/rarely reported their mental health symptoms to clinicians; a proportion under-estimated at < 10% by clinicians (p< 0.001). CONCLUSION: Neuropsychiatric symptom self-reported prevalences are significantly higher in SARDs than controls, and greatly underestimated by most clinicians. Research relying on medical records and current guidelines is unlikely to accurately reflect patients' experiences of neuropsychiatric symptoms. Improved inter-specialty communication and greater patient involvement is needed in SARD care and research.

Attribution of neuropsychiatric symptoms and prioritisation of evidence in the diagnosis of neuropsychiatric lupus: mixed methods analysis of patient and clinician perspectives from the international INSPIRE study.

OBJECTIVE: Neuropsychiatric lupus (NPSLE) is challenging to diagnose. Many neuropsychiatric symptoms, such as headache and hallucinations, cannot be verified by tests or clinician assessment. We investigated prioritisations of methods for diagnosing NPSLE and attributional views. METHODS: Thematic and comparative analyses were used to investigate how clinicians prioritise sources of evidence from a 13-item list, and explore discordances in clinician and patient perspectives on attribution. RESULTS: We identified high levels of variability and uncertainty in clinicians' assessments of neuropsychiatric symptoms in SLE patients. In attributional decisions, clinicians (surveys n = 400, interviews n = 50) ranked clinicians' assessments above diagnostic tests (many of which they reported were often unenlightening in NPSLE). Clinicians ranked patient opinion of disease activity last, and 46% of patients reported never/rarely having been asked if their SLE was flaring, despite experienced patients often having "attributional insight". SLE Patients (surveys n = 676, interviews n = 27) estimated higher attributability of neuropsychiatric symptoms to the direct effects of SLE on the nervous system than clinicians (p < 0.001 for all symptoms excluding mania), and 24% reported that their self-assessment of disease activity was never/rarely concordant with their clinicians. Reports of misattributions were common, particularly of non-verifiable diffuse symptoms. Terminology differed between clinicians and influenced attribution estimates. CONCLUSION: NPSLE diagnostic tests and clinician assessments have numerous limitations, particularly in detecting diffuse neuropsychiatric symptoms that can be directly attributable and benefit from immunosuppression. Our findings suggest that incorporating patient attributional insights-although also subject to limitations-may improve attribution decision-making. Consensus regarding terminology and interpretations of "direct attributability" is required.

Medical students remote consulting from home and from the health centre: A survey of prevalence and supervisor perspectives.

PURPOSE: A shift to remote consulting characterised the early stages of the COVID-19 pandemic in general practice which resulted in significant changes in the delivery of medical education. It is unclear whether these changes have been sustained and how they are perceived by faculty. METHODS: We surveyed a defined population of GP practices during April 2022 with questions to elicit estimates of medical student involvement in different types of remote consultation and supervisor ratings of their confidence in supervising different modalities of remote consultation. We performed thematic analysis on free text responses from a 'resistance to change' perspective. RESULTS: A response rate of 96% (n = 115) was achieved. Analysis of quantitative data identified that a significant proportion of student consultations were remote, however there was a large variation between practices. Supervisor confidence was lowest for students consulting from home. Thematic analysis identified ways in which clinical supervisors may perceive the innovation to be at odds with their overriding commitments to safety, simplicity and quality. CONCLUSIONS: Remote consultations form a significant proportion of medical student activity in many practices. Some supervisors are reluctant to supervise medical students consulting from home and our findings suggest ways of addressing this so that the benefits of the innovation can be harnessed.

Telemedicine in rheumatology: a mixed methods study exploring acceptability, preferences and experiences among patients and clinicians.

OBJECTIVES: The Covid-19 pandemic necessitated a rapid global transition towards telemedicine; yet much remains unknown about telemedicine's acceptability and safety in rheumatology. To help address this gap and inform practice, this study investigated rheumatology patient and clinician experiences and views of telemedicine. METHODS: Sequential mixed methodology combined analysis of surveys and in-depth interviews. Between and within-group differences in views of telemedicine were examined for patients and clinicians using t-tests. RESULTS: Surveys (patients n = 1340, clinicians n = 111) and interviews (patients n = 31, clinicians n = 29) were completed between April 2021 and July 2021. The majority of patients were from the UK (96%) and had inflammatory arthritis (32%) or lupus (32%). Patients and clinicians rated telemedicine as worse than face-to-face consultations in almost all categories, although >60% found it more convenient. Building trusting medical relationships and assessment accuracy were great concerns (93% of clinicians and 86% of patients rated telemedicine as worse than face-to-face for assessment accuracy). Telemedicine was perceived to have increased misdiagnoses, inequalities and barriers to accessing care. Participants reported highly disparate telemedicine delivery and responsiveness from primary and secondary care. Although rheumatology clinicians highlighted the importance of a quick response to flaring patients, only 55% of patients were confident that their rheumatology department would respond within 48 hours. CONCLUSION: Findings indicate a preference for face-to-face consultations. Some negative experiences may be due to the pandemic rather than telemedicine specifically, although the risk of greater diagnostic inaccuracies using telemedicine is unlikely to be fully resolved. Training, choice, careful patient selection, and further consultation with clinicians and patients is required to increase telemedicine's acceptability and safety. TRIAL REGISTRATION: This telemedicine study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later Covid-related additions registered in March 2021, including a pre-registered statistical analysis plan.

Will 'the feeling of abandonment' remain? Persisting impacts of the COVID-19 pandemic on rheumatology patients and clinicians.

OBJECTIVE: To better understand rheumatology patient and clinician pandemic-related experiences, medical relationships and behaviours in order to help identify the persisting impacts of the COVID-19 pandemic and inform efforts to ameliorate the negative impacts and build upon the positive ones. METHODS: Rheumatology patients and clinicians completed surveys (patients n = 1543, clinicians n = 111) and interviews (patients n = 41, clinicians n = 32) between April 2021 and August 2021. A cohort (n = 139) of systemic autoimmune rheumatic disease patients was also followed up from March 2020 to April 2021. Analyses used sequential mixed methods. Pre-specified outcome measures included the Warwick-Edinburgh Mental wellbeing score (WEMWBS), satisfaction with care and healthcare behaviours. RESULTS: We identified multiple ongoing pandemic-induced/increased barriers to receiving care. The percentage of patients agreeing they were medically supported reduced from 74.4% pre-pandemic to 39.7% during-pandemic. Ratings for medical support, medical security and trust were significantly (P <0.001) positively correlated with patient WEMWBS and healthcare behaviours, and decreased during the pandemic. Healthcare-seeking was reduced, potentially long-term, including from patients feeling 'abandoned' by clinicians, and a 'burden' from government messaging to protect the NHS. Blame and distrust were frequent, particularly between primary and secondary care, and towards the UK government, who <10% of clinicians felt had supported clinicians during the pandemic. Clinicians' efforts were reported to be impeded by inefficient administration systems and chronic understaffing, suggestive of the pandemic having exposed and exacerbated existing healthcare system weaknesses. CONCLUSION: Without concerted action-such as rebuilding trust, improved administrative systems and more support for clinicians-barriers to care and negative impacts of the pandemic on trust, medical relationships, medical security and patient help-seeking may persist in the longer term. TRIAL REGISTRATION: This study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later COVID-related additions registered in March 2021, including a pre-registered statistical analysis plan.

A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness.

BACKGROUND: The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. OBJECTIVE: This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. METHODS: This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. RESULTS: A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI -7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI -13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. CONCLUSIONS: Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

When investigating depression and anxiety in undergraduate medical students timing of assessment is an important factor - a multicentre cross-sectional study.

BACKGROUND: Symptoms of depression and anxiety experienced by undergraduate medical students have become a prominent concern. Evidence about students' depression and anxiety including prevalence, trajectory during medical education, gender differences and comparisons with age-matched peers is conflicting. However few studies of medical students' mental health specify the precise time of assessment. Proximity to examinations may be relevant. Precise identification of the time of data collection might help explain contradictory findings and facilitate provision of more timely support. METHODS: This study addressed whether: 1)Proximity of final examinations affected students' depression and anxiety symptoms2)Males and females differed in this respect. We analysed data provided by 446 final year students from 6 UK medical schools. These students were a subset of data provided by 14 UK medical schools which participated in an online survey comparing first and final year students and in which final year response rates exceeded 30%. We used the Hospital Anxiety and Depression Scale to assess symptoms of depression and anxiety and the norms to indicate potentially clinically relevant cases. We grouped students into those for whom final exams were imminent i.e. within 2 months of completing the survey (n = 164) and those for whom exams were more distant or had been taken (n = 282). We used parametric and non-parametric tests to compare both groups and gender differences in respect of depression and anxiety sum scores and cases rates. RESULTS: For both depression and anxiety male and female students facing imminent final exams recorded greater prevalence and significantly higher mean scores. The effect size of differences for anxiety were large. No substantial gender differences were found for depression. Regardless of the timing of final exams female students recorded both significantly higher mean scores and clinically relevant rates for anxiety. CONCLUSIONS: Proximity to final exams negatively affected the mental health of both male and female final year students. The study suggests that there may be times in the undergraduate medical curriculum when additional or targeted support is needed. It also highlights the need for research to provide a greater specificity of context when investigating medical students' mental health.

Empathy among undergraduate medical students: A multi-centre cross-sectional comparison of students beginning and approaching the end of their course.

BACKGROUND: Although a core element in patient care the trajectory of empathy during undergraduate medical education remains unclear. Empathy is generally regarded as comprising an affective capacity: the ability to be sensitive to and concerned for, another and a cognitive capacity: the ability to understand and appreciate the other person's perspective. The authors investigated whether final year undergraduate students recorded lower levels of empathy than their first year counterparts, and whether male and female students differed in this respect. METHODS: Between September 2013 and June 2014 an online questionnaire survey was administered to 15 UK, and 2 international medical schools. Participating schools provided both 5-6 year standard courses and 4 year accelerated graduate entry courses. The survey incorporated the Jefferson Scale of Empathy-Student Version (JSE-S) and Davis's Interpersonal Reactivity Index (IRI), both widely used to measure medical student empathy. Participation was voluntary. Chi squared tests were used to test for differences in biographical characteristics of student groups. Multiple linear regression analyses, in which predictor variables were year of course (first/final); sex; type of course and broad socio-economic group were used to compare empathy scores. RESULTS: Five medical schools (4 in the UK, 1 in New Zealand) achieved average response rates of 55 % (n = 652) among students starting their course and 48 % (n = 487) among final year students. These schools formed the High Response Rate Group. The remaining 12 medical schools recorded lower response rates of 24.0 % and 15.2 % among first and final year students respectively. These schools formed the Lower Response Rate Group. For both male and female students in both groups of schools no significant differences in any empathy scores were found between students starting and approaching the end of their course. Gender was found to significantly predict empathy scores, with females scoring higher than males. CONCLUSIONS: Participant male and female medical students approaching the end of their undergraduate education, did not record lower levels of empathy, compared to those at the beginning of their course. Questions remain concerning the trajectory of empathy after qualification and how best to support it through the pressures of starting out in medical practice.

Administering injectable medications prescribed in the anticipation of the end of life in the community: A mixed-methods observational study.

BACKGROUND: The prescription of injectable anticipatory medications ahead of possible need for last-days-of-life symptom relief is established community practice internationally. Healthcare teams and policy makers view anticipatory medication as having a key role in optimising effective and timely symptom control. However, how these medications are subsequently administered (used) is unclear and warrants detailed investigation to inform interdisciplinary practice and guidance. OBJECTIVE: To identify the frequency, timing and recorded circumstances of the administration of injectable end-of-life anticipatory medications prescribed for patients living at home and in residential care. DESIGN: A retrospective mixed-methods observational study using general practitioner (family doctor) and community nursing held clinical records. SETTING(S): Community-based care in two English counties. PARTICIPANTS: 167 deceased adult patients (aged 18+) registered with eleven general practitioner practices and two associated community nursing services. These were patients prescribed anticipatory medications, identified from the 30 most recent deaths per practice. Patients died between 1 March 2017 and 25 September 2019, from any cause except trauma, sudden death or suicide. METHODS: Patient characteristics, anticipatory medication discussions, recorded administration contexts and decision-making, medication details, recorded symptom control and comfort at death were collected from clinical records. Data analysis combined quantitative and qualitative analyses in a mixed methods approach. RESULTS: Anticipatory medications were administered to 59.9 % (100/167) patients, commenced between 0 and 586 days before death (median 3 days). Their usage was similar for patients who died from cancer and non-cancer conditions. Anticipatory medications were almost universally started and titrated by visiting nurses. Eleven patients had medications started between 59 days and 586 days before death for recorded reversible non-end-of-life care conditions. Only 5 % (5/100) of patient records contained detailed accounts of patient participation in decisions to start medications: four were recorded as being reluctant to commence medications but agreed to trial injections to relieve symptoms. Crucially, there was recurrent under-recording of the effectiveness of injectable medications and patient comfort. CONCLUSIONS: Prescribed medications were commonly administered by visiting community nurses to help manage last-days-of-life symptoms. However, patient records infrequently referred to the effectiveness of administered medication and perceived patient comfort. Most recorded references to patient and family preferences for involvement in anticipatory medication decision-making and their experiences of care were brief and perfunctory. More detailed information should be routinely recorded in clinical records to enable assessment of the appropriate and effective use of anticipatory medicines and how inter-professional collaboration and services could be developed to provide adequate twenty-four-hour cover. TWEETABLE ABSTRACT: Effectiveness of injectable end-of-life symptom control medications and patient comfort often under-recorded @Ben_Bowers__ @PELi_Cam @TheQNI.

Wellbeing Impact Study of High-Speed 2 (WISH2): Protocol for a mixed-methods examination of the impact of major transport infrastructure development on mental health and wellbeing.

Although research has demonstrated that transport infrastructure development can have positive and negative health-related impacts, most of this research has not considered mental health and wellbeing separately from physical health. There is also limited understanding of whether and how any effects might be experienced differently across population groups, whether this differs according to the stage of development (e.g. planning, construction), and how changes to planned infrastructure may affect mental health and wellbeing. This paper presents a protocol for the Wellbeing Impact Study of HS2 (WISH2), which seeks to address these questions using a high-speed rail development in the UK as an applied example. WISH2 is a 10-year, integrated, longitudinal, mixed-methods project using general practices (primary medical care providers in the UK) as an avenue for participant recruitment and for providing a geographically defined population for which aggregated data on mental health indicators are available. The research comprises: (i) a combined longitudinal and repeated cross-sectional cohort study involving multiple waves of survey data collection and data from medical records; (ii) longitudinal, semi-structured interviews and focus groups with residents and community stakeholders from exposed areas; (iii) analysis of administrative data aggregated at the general practice population level; and (iv) health economic analysis of mental health and wellbeing impacts. The study findings will support the development of strategies to reduce negative impacts and/or enhance positive mental health and wellbeing impacts of high-speed rail developments and other large-scale infrastructure projects.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

BACKGROUND: Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. METHODS/DESIGN: The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. DISCUSSION: This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. TRIAL REGISTRATION: ISRCTN56702353.

Improving the diagnostic process for patients with possible bladder and kidney cancer: a mixed-methods study to identify potential missed diagnostic opportunities.

BACKGROUND: Patients with bladder and kidney cancer may experience diagnostic delays. AIM: To identify patterns of suboptimal care and contributors of potential missed diagnostic opportunities (MDOs). DESIGN AND SETTING: Prospective, mixed-methods study recruiting participants from nine general practices in Eastern England between June 2018 and October 2019. METHOD: Patients with possible bladder and kidney cancer were identified using eligibility criteria based on National Institute for Health and Care Excellence (NICE) guidelines for suspected cancer. Primary care records were reviewed at recruitment and at 1 year for data on symptoms, tests, referrals, and diagnosis. Referral predictors were examined using logistic regression. Semi-structured interviews were undertaken with 15 patients to explore their experiences of the diagnostic process, and these were analysed thematically. RESULTS: Participants (n = 940) were mostly female (n = 657, 69.9%), with a median age of 71 years (interquartile range 64-77 years). In total, 268 (28.5%) received a referral and 465 (48.5%) had a final diagnosis of urinary tract infection (UTI). There were 33 (3.5%) patients who were diagnosed with cancer, including prostate (n = 17), bladder (n = 7), and upper urothelial tract (n = 1) cancers. Among referred patients, those who had a final diagnosis of UTI had the longest time to referral (median 81.5 days). Only one-third of patients with recurrent UTIs were referred despite meeting NICE referral guidelines. Qualitative findings revealed barriers during the diagnostic process, including inadequate clinical examination, female patients given repeated antibiotics without clinical reviews, and suboptimal communication of test results to patients. CONCLUSION: Older females with UTIs might be at increased risk of MDOs for cancer. Targeting barriers during the initial diagnostic assessment and follow-up might improve quality of diagnosis.

The Cambridge Bachelor of Medicine (MB)/Doctor of Philosophy (PhD): graduate outcomes of the first MB/PhD programme in the UK.

We reviewed outcomes of the Cambridge Bachelor of Medicine (MB)/Doctor of Philosophy (PhD) programme for the period 1989-2010. Of the 90 alumni contacted, 80 (89%; 24 women) completed an anonymous questionnaire. Thirty were academic staff and 35 were in general professional (core) or higher medical training. Of the latter, 11 were specialty registrars, six were academic clinical fellows and three held academic foundation year posts. Eight alumni were overseas, including five in North America. Most (95%) respondents considered that their academic career goals were facilitated by the programme. Sixty-eight of the 80 alumni had conducted further research, 63 (79%) were active in research, and 90% had explicit plans for further full-time research. Twelve graduates had further substantive research support (six clinician scientist awards and three senior fellowships) and two were Wellcome Trust postdoctoral MB/PhD fellows. Alumni included two full university professors, one reader, six senior lecturers, two assistant professors and nine university clinical lecturers. MB/PhD programmes offer an alternative training pathway for clinician-scientists in UK medical schools: the Cambridge programme promotes scientific discovery and sustained academic development within the context of contemporary medicine and clinical practice.

The nature and prevalence of threats to medical student placement capacity in primary care: a survey of East of England GP practices.

BACKGROUND: GP practices deliver vital medical student teaching in the face of increasingly challenging circumstances. AIM: To understand the nature and scale of threats to medical student teaching capacity in primary care. DESIGN & SETTING: An electronic survey of a predefined population of 120 East of England GP practices that host medical student placements. METHOD: The survey was completed on behalf of the practice by the GP lead for medical student teaching. They were asked to pick (from a list of 16) the four main challenges they faced delivering medical student teaching placements, then explain their selection and suggest solutions. Thematic analysis of free-text responses was undertaken from an activity theory perspective. RESULTS: Responses were received from 114 of the 120 practices in the study population (95% response rate). The most commonly selected challenges to delivering placements were clinical/practice workload (picked by 92 practices), and lack of space in the practice (picked by 63 practices). Thematic analysis produced a model whereby a practice's decision to continue hosting students was influenced by level of motivation and burden of teaching, but only if a certain level of resource enablement is present. Analysis of free-text responses suggested that space pressures were perceived as being exacerbated by the need to accommodate more clinicians, especially advanced practitioners employed by primary care networks (PCNs) under the additional roles reimbursement scheme (ARRS). CONCLUSION: This study provides much-needed quantitative evidence to support the view that lack of space in GP premises is a major threat to the future of undergraduate general practice.

Prioritising electrocardiograms for manual review to improve the efficiency of atrial fibrillation screening.

Screening for atrial fibrillation (AF) could reduce the incidence of stroke by identifying undiagnosed AF and prompting anticoagulation. However, screening may involve recording many electrocardiograms (ECGs) from each participant, several of which require manual review which is costly and time-consuming. The aim of this study was to investigate whether the number of ECG reviews could be reduced by using a model to prioritise ECGs for review, whilst still accurately diagnosing AF. A multiple logistic regression model was created to estimate the likelihood of an ECG exhibiting AF based on the mean RR-interval and variability in RR-intervals. It was trained on 1,428 manually labelled ECGs from 144 AF screening programme participants, and evaluated using 11,443 ECGs from 1,521 participants. When using the model to order ECGs for review, the number of reviews for AF participants was reduced by 74% since no further reviews are required after an AF ECG is identified; however, it did not impact the number of reviews in non-AF participants (the vast majority of participants), so the overall number of reviews was reduced by 3% with no missed AF diagnoses. When using the model to also exclude ECGs from review, the overall number of reviews was reduced by 28% with no missed AF diagnoses, and by 53% with only 4% of AF diagnoses missed. In conclusion, the workload can be reduced by using a model to prioritise ECGs for review. Ordering ECGs alone only provides only a moderate reduction in workload. The additional use of a threshold to exclude ECGs from review provides a much greater reduction in workload at the expense of some missed AF diagnoses. Clinical Relevance-This shows the potential benefit of using a model to prioritise electrocardiograms for review in order to reduce the manual workload of AF screening.

Acceptability of the Medication Adherence for Patients Support intervention to improve adherence to patients prescribed medications for hypertension or comorbidities, as an adjunct to primary care: A qualitative study.

Tailored interventions delivered via text and voice messages can improve adherence to multiple medications. However, no such intervention has been developed in the UK primary-care setting. We conducted focus groups with 12 patients with hypertension, type 2 diabetes, or both conditions, presumed to be non-adherent and recruited from deprived neighborhoods, to assess the acceptability and inform the development of an intervention to provide ongoing support for adherence, as an adjunct to primary-care consultations. Patients recommended ways to improve the tailored content and delivery of the intervention; like highly interactive messages to report both medication taking and determinants of medication adherence.