Engagement With Stop Smoking Services After Referral or Signposting: A Mixed Methods Study.

INTRODUCTION: Screening for smoking when people interact with healthcare services and referral of those who smoke to stop smoking services (SSSs) is a key component of efforts to tackle tobacco use. However, little is known about what happens after someone is referred or signposted to SSSs. METHODS: As part of the Cessation of Smoking Trial in the Emergency Department (NCT04854616), those randomised to intervention (n= 505) were referred to local SSSs (along with receiving brief advice and an e-cigarette starter kit) and those randomised to control (n= 502) were given contact details for the same services (signposted). SSS engagement data was collected: 1) directly from participants and 2) from SSS, additional qualitative data came from 33 participant interviews. RESULTS: Engagement with SSSs was very low. 3.2% (n=16) of those in the intervention group and 2.4% (n=12) in the control group reported attending a one-to-one support session. From SSS data, engagement was also low with 8.9% (n=43) of those referred engaging and 3.1% (n=15) going on to quit with SSS support. The majority of the 24 intervention participants interviewed did not recall being contacted by an SSS. CONCLUSION: Referral or signposting to stop smoking services within an Emergency Department based trial resulted in very low levels of engagement. Barriers to engagement identified included participants not being contacted by SSSs and the support offered not meeting their needs. IMPLICATIONS: Referral or signposting of those who smoke to Stop smoking services from the Emergency Department resulted in low rates of engagement in this large multi-centre randomised controlled trial. In order to better support those who smoke it may be more effective for smoking cessation advice to be offered 'in the moment' within clinical settings, and follow-up to be proactively offered rather than relying on people being motivated to contact the services themselves or engaging when contacted.

Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1.

BACKGROUND: Diabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually 'reactive' after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm. METHOD: We will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data. DISCUSSION: The aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally. TRIAL REGISTRATION: UK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.

Ambulance clinician use of capillary blood ketone meters to improve emergency hyperglycaemia care: A stepped-wedged controlled, mixed-methods feasibility study.

AIM: To determine whether it was feasible, safe and acceptable for ambulance clinicians to use capillary blood ketone meters for 'high-risk' diabetic ketoacidosis (DKA) recognition and fluid initiation, to inform the need for a full-powered, multi-centre trial. METHODS: Adopting a stepped-wedge controlled design, participants with hyperglycaemia (capillary blood glucose >11.0 mmol/L) or diabetes and unwell were recruited. 'High-risk' DKA intervention participants (capillary blood ketones ≥3.0 mmol/L) received paramedic-led fluid therapy. Participant demographic and clinical data were collated from ambulance and hospital care records. Twenty ambulance and Emergency Department clinicians were interviewed to understand their hyperglycaemia and DKA care experiences. RESULTS: In this study, 388 participants were recruited (Control: n = 203; Intervention: n = 185). Most presented with hyperglycaemia, and incidence of type 1 and type 2 diabetes was 18.5% and 74.3%, respectively. Ketone meter use facilitated 'high-risk' DKA identification (control: 2.5%, n = 5; intervention: 6.5%, n = 12) and was associated with improved hospital pre-alerting. Ambulance clinicians appeared to have a high index of suspicion for hospital-diagnosed DKA participants. One third (33.3%; n = 3) of Control and almost half (45.5%; n = 5) of Intervention DKA participants received pre-hospital fluid therapy. Key interview themes included clinical assessment, ambulance DKA fluid therapy, clinical handovers; decision support tool; hospital DKA management; barriers to hospital DKA care. CONCLUSIONS: Ambulance capillary blood ketone meter use was deemed feasible, safe and acceptable. Opportunities for improved clinical decision making, support and safety-netting, as well as in-hospital DKA care, were recognised. As participant recruitment was below progression threshold, it is recommended that future-related research considers alternative trial designs. CLINICALTRIALS: gov: NCT04940897.

Prevalence of asymptomatic valvular heart disease in the elderly population: a community-based echocardiographic study.

AIMS: With an ageing population, the presence of asymptomatic valvular heart disease (VHD) in the community remains unknown. The aim of this study is to determine the prevalence and associated factors of asymptomatic VHD in individuals ≥60 years old and to evaluate the feasibility of echocardiographic screening for VHD in this population. METHODS AND RESULTS: This was a prospective cohort study conducted between 2007 and 2016 in the UK. Asymptomatic patients with no prior indication for echocardiography were invited to participate and evaluated with a health questionnaire, clinical examination, and transthoracic echocardiography. A total of 10,000 individuals were invited through their general practices. A total of 5429 volunteered to participate, of whom 4237 were eligible for inclusion. VHD was diagnosed in more than a quarter of patients (28.2%). The most common types of VHD were regurgitation of the tricuspid (13.8%), mitral (12.8%), and aortic (8.3%) valves (trivial regurgitation was not included). The rate of prevalence of clinically significant VHD was 2.4% (2.2% moderate and 0.2% severe), with mitral and aortic regurgitation being the most common. The only parameter associated with significant VHD was age (odds ratio 1.07 per 1 year increment, 95% confidence interval 1.05-1.09, P < 0.001). The number needed to scan to diagnose one clinically significant case of VHD is 42 for individuals ≥60 and 15 for those ≥75 years old. CONCLUSION: Asymptomatic VHD is present in a significant proportion of otherwise healthy individuals without known VHD over 60 years old. Age is strongly associated with an increased incidence of significant VHD.

Developing a core outcome set for evaluating medication adherence interventions for adults prescribed long-term medication in primary care.

BACKGROUND: Approximately half of people prescribed medications do not take them as prescribed. There is a significant unmet need regarding the barriers to medication adherence not being addressed in primary care. There is no agreement on which outcomes should be measured and reported in trials of medication adherence interventions. OBJECTIVE: To develop a core outcome set (COS) for trials of medication adherence interventions in primary care for adults prescribed medications for long-term health conditions. METHODS: A list of potentially relevant outcomes from the literature was developed. Using a two-round Delphi survey of stakeholder groups representing patients and their carers; primary care staff; and academic researchers with an interest in medication adherence; each outcome was scored in terms of importance for determining the effectiveness of medication adherence interventions in primary care. This was followed by two consensus workshops, where importance, as well as feasibility and acceptability of measurement, were considered in order to finalise the COS. RESULTS: One hundred and fifty people took part in Delphi Round 1 and 101 took part in Round 2. Eight people attended the workshops (four attendees per workshop). Seven outcomes were identified as most important, feasible and acceptable to collect in medication adherence trials: Health-related quality of life, number of doses taken, persistence with medicines, starting (initiating) a medicine, relevance of the medication adherence intervention for an individual, mortality, and adverse medicine events. CONCLUSIONS: This COS represents the minimum outcomes that should be collected and reported in all medication adherence trials undertaken in primary care. When developing and finalizing the COS, feasibility and acceptability of collection of outcomes has been considered. In addition to the COS, medication adherence trials can choose to include outcomes to suit their specific context such as the health condition associated with their medication adherence intervention.

Assessment of the impact of social deprivation, distance to hospital and time to diagnosis on survival in idiopathic pulmonary fibrosis.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive condition associated with a variable prognosis. The relationship between socioeconomic status or distance travelled to respiratory clinics and prognosis is unclear. RESEARCH QUESTION: To determine whether socioeconomic status, distance to hospital and time to referral affects survival in patients with IPF. STUDY DESIGN AND METHODS: In this retrospective cohort study, we used data collected from the British Thoracic Society Interstitial Lung Diseases Registry, between 2013 and 2021 (n = 2359) and calculated the quintile of Index of Multiple Deprivation 2019 score, time from initial symptoms to hospital attendance and distance as the linear distance between hospital and home post codes. Survival was assessed using Cox proportional hazards models. RESULTS: There was a significant association between increasing quintile of deprivation and duration of symptoms prior to hospital presentation, Gender Age Physiology (GAP) index and receipt of supplemental oxygen and antifibrotic therapies at presentation. The most deprived patients had worse overall survival compared to least deprived after adjusting for smoking status, GAP index, distance to hospital and time to referral (HR = 1.39 [1.11, 1.73]; p = 0.003). Patients living furthest from a respiratory clinic also had worse survival compared to those living closest (HR = 1.29 [1.01, 1.64]; p = 0.041). INTERPRETATION: The most deprived patients with IPF have more severe disease at presentation and worse outcomes. Living far from hospital was also associated with poor outcomes. This suggests inequalities in access to healthcare and requires consideration in delivering effective and equitable care to patients with IPF.

The test-retest reliability of non-navigated transcranial magnetic stimulation (TMS) measures of corticospinal pathway excitability early after stroke.

PURPOSE: Motor evoked potential (MEP) characteristics are potential biomarkers of whether rehabilitation interventions drive motor recovery after stroke. The test-retest reliability of Transcranial Magnetic Stimulation (TMS) measurements in sub-acute stroke remains unclear. This study aims to determine the test-retest reliability of upper limb MEP measures elicited by non-neuronavigated transcranial magnetic stimulation in sub-acute-stroke. METHODS: In two identical data collection sessions, 1-3 days apart, TMS measures assessed: motor threshold (MT), amplitude, latency (MEP-L), silent period (SP), recruitment curve slope in the biceps brachii (BB), extensor carpi radialis (ECR), and abductor pollicis brevis (APB) muscles of paretic and non-paretic upper limbs. Test-retest reliability was calculated using the intra-class correlation coefficient (ICC) and 95% confidence intervals (CI). Acceptable reliability was set at a lower 95% CI of 0.70 or above. The limits of agreement (LOA) and smallest detectable change (SDC) were calculated. RESULTS: 30 participants with sub-acute stroke were included (av 36 days post stroke) reliability was variable between poor to good for the different MEP characteristics. The SDC values differed across muscles and MEP characteristics in both paretic and less paretic limbs. CONCLUSIONS: The present findings indicate there is limited evidence for acceptable test-retest reliability of non-navigated TMS outcomes when using the appropriate 95% CI for ICC, SDC and LOA values. CLINICAL TRIAL REGISTRATION: Current Controlled Trials: ISCRT 19090862, http://www.controlled-trials.com.

This study identified that Non-navigated Transcranial Magnetic Stimulation (TMS) demonstrates low reliability of TMS measures in upper limb with variation between muscles and measures in sub-acute strokeWhen using non-navigated TMS to explore corticospinal pathway excitability the individual target muscle and TMS measure should be taken into considerationNon-navigated TMS may be more useful in exploring group differences rather than individual differences in corticospinal pathway excitabilityNon-navigated TMS could provide a means of measuring recovery in clinical practice and could inform the development of more effective interventions but this needs further development before it can be used as a clinical recovery biomarker.

Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial.

BACKGROUND: Supporting people to quit smoking is one of the most powerful interventions to improve health. The Emergency Department (ED) represents a potentially valuable opportunity to deliver a smoking cessation intervention if it is sufficiently resourced. The objective of this trial was to determine whether an opportunistic ED-based smoking cessation intervention can help people to quit smoking. METHODS: In this multicentre, parallel-group, randomised controlled superiority trial conducted between January and August 2022, adults who smoked daily and attended one of six UK EDs were randomised to intervention (brief advice, e-cigarette starter kit and referral to stop smoking services) or control (written information on stop smoking services). The primary outcome was biochemically validated abstinence at 6 months. RESULTS: An intention-to-treat analysis included 972 of 1443 people screened for inclusion (484 in the intervention group, 488 in the control group). Of 975 participants randomised, 3 were subsequently excluded, 17 withdrew and 287 were lost to follow-up. The 6-month biochemically-verified abstinence rate was 7.2% in the intervention group and 4.1% in the control group (relative risk 1.76; 95% CI 1.03 to 3.01; p=0.038). Self-reported 7-day abstinence at 6 months was 23.3% in the intervention group and 12.9% in the control group (relative risk 1.80; 95% CI 1.36 to 2.38; p<0.001). No serious adverse events related to taking part in the trial were reported. CONCLUSIONS: An opportunistic smoking cessation intervention comprising brief advice, an e-cigarette starter kit and referral to stop smoking services is effective for sustained smoking abstinence with few reported adverse events. TRIAL REGISTRATION NUMBER: NCT04854616.

Is there a lower visual field advantage for object affordances? A registered report.

It's been repeatedly shown that pictures of graspable objects can facilitate visual processing, even in the absence of reach-to-grasp actions, an effect often attributed to the concept of affordances. A classic demonstration of this is the handle compatibility effect, characterised by faster reaction times when the orientation of a graspable object's handle is compatible with the hand used to respond, even when the handle orientation is task-irrelevant. Nevertheless, it is debated whether the speeded reaction times are a result of affordances or spatial compatibility. First, we investigated whether we could replicate the handle compatibility effect while controlling for spatial compatibility. Participants (N = 68) responded with left or right-handed keypresses to whether the object was upright or inverted and, in separate blocks, whether the object was red or green. We failed to replicate the handle compatibility effect, with no significant difference between compatible and incompatible conditions, in both tasks. Second, we investigated whether there is a lower visual field (VF) advantage for the handle compatibility effect in line with what has been found for hand actions. A further 68 participants responded to object orientation presented either in the upper or lower VF. A significant handle compatibility effect was observed in the lower VF, but not the upper VF. This suggests that there is a lower VF advantage for affordances, possibly as the lower VF is where our actions most frequently occur. However, future studies should explore the impact of eye movements on the handle compatibility effect and tool affordances.

Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England.

OBJECTIVES: To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. DESIGN: Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study. SETTING: National Health Service (NHS) providers in five English hospitals. PARTICIPANTS: Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers. INTERVENTION: Usual care: usual NHS care. EXPERIMENTAL: usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions. RANDOMISATION AND BLINDING: Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding. MAIN OUTCOME MEASURES: Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals. RESULTS: 102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable. CONCLUSIONS: The HIP HELPER programme was acceptable to patient-caregiver dyads and health professionals. The COVID-19 pandemic impacting on site's ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT. TRIAL REGISTRATION NUMBER: ISRCTN13270387.

Perspectives of informal caregivers who support people following hip fracture surgery: a qualitative study embedded within the HIP HELPER feasibility trial.

OBJECTIVES: This study aims to illuminate the perspectives of informal caregivers who support people following hip fracture surgery. DESIGN: A qualitative study embedded within a now completed multicentre, feasibility randomised controlled trial (HIP HELPER). SETTING: Five English National Health Service hospitals. PARTICIPANTS: We interviewed 20 participants (10 informal caregivers and 10 people with hip fracture), following hip fracture surgery. This included one male and nine females who experienced a hip fracture; and seven male and three female informal caregivers. The median age was 72.5 years (range: 65-96 years), 71.0 years (range: 43-81 years) for people with hip fracture and informal caregivers, respectively. METHODS: Semistructured, virtual interviews were undertaken between November 2021 and March 2022, with caregiver dyads (person with hip fracture and their informal caregiver). Data were analysed thematically. FINDINGS: We identified two main themes: expectations of the informal caregiver role and reality of being an informal caregiver; and subthemes: expectations of care and services; responsibility and advocacy; profile of people with hip fracture; decision to be a caregiver; transition from hospital to home. CONCLUSION: Findings suggest informal caregivers do not feel empowered to advocate for a person's recovery or navigate the care system, leading to increased and unnecessary stress, anxiety and frustration when supporting the person with hip fracture. We suggest that a tailored information giving on the recovery pathway, which is responsive to the caregiving population (ie, considering the needs of male, younger and more active informal caregivers and people with hip fracture) would smooth the transition from hospital to home. TRIAL REGISTRATION NUMBER: ISRCTN13270387.Cite Now.

Validation of the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q); a Behavioural Science-Underpinned Tool for Identifying Non-Adherence and Diagnosing an Individual's Barriers to Adherence.

Purpose: To validate the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) as a tool to guide practitioners to identify patients who require support to take their medicines as prescribed, their key barriers to adherence and select relevant behaviour change techniques. Patients and Methods: Adults prescribed medication for cardiovascular disease prevention were recruited from nine community pharmacies in England. Participants completed the IMAB-Q comprising 30 items representing potential barriers to adherence developed from our previous mixed methods study (scoping review and focus groups) underpinned by the Theoretical Domains Framework. Participants also self-reported their adherence on a visual analogue scale (VAS) ranging from perfect adherence (100) to non-adherence (1). A subgroup of 30 participants completed the IMAB-Q twice to investigate test-retest reliability using weighted Kappa. Mokken scaling was used to investigate IMAB-Q structure. Spearman correlation was used to investigate IMAB-Q criterion validity compared to the VAS score. Results: From 1407 invitations, 608 valid responses were received. Respondents had a mean (SD) age of 70.12 (9.9) years and were prescribed a median (IQ) 4 (3, 6) medicines. Worry about unwanted effects (n = 212, 34.5%) and negative emotions evoked by medicine taking (n = 99, 16.1%) were most frequently reported. Mokken scaling did not organise related IMAB-Q items according to the TDF domains (scalability coefficient H = 0.3 to 0.6). Lower VAS self-reported adherence correlated with greater IMAB-Q reported barriers (rho = -0.14, p = 0.001). Test-retest reliability of IMAB-Q items ranged from kappa co-efficient 0.9 to 0.3 (p < 0.05). Conclusion: The IMAB-Q is valid and reliable for identifying people not adhering and their barriers to adherence. Each IMAB-Q item is linked to a TDF domain which in turn is linked to relevant behaviour change techniques. The IMAB-Q can therefore guide patients and practitioners to select strategies tailored to a patient's identified barriers.

Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT).

Background: Malignant pleural effusion (MPE) is the build-up of pleural fluid in the space between the lung and chest wall due to advanced cancer. It is treated initially by large volume drainage (therapeutic aspiration). If the fluid reaccumulates, a definitive procedure is performed. There is wide variation in rate of reaccumulation. Patients with rapid reaccumulation often attend hospital as an emergency. Conversely, patients with slow reaccumulation do not need a definitive procedure and may experience cancelled or unnecessary procedures. This study aims to create and validate a multivariable prediction model to predict how quickly pleural fluid will reaccumulate in patients with MPE following therapeutic aspiration. Research question: Can we predict how quickly pleural fluid will reaccumulate in patients with MPEs? Methods: A total of 200 patients with known or suspected MPE attending for therapeutic aspiration will be recruited from 5-10 UK hospitals over 20 months. Patients will be enrolled prior to undergoing aspiration. Following this, they will undergo chest X-ray, which will be repeated one week later (treatment as usual). Rate of reaccumulation will be calculated based on change of size of the effusion seen on X-ray. Data will be collected on common clinical biomarkers e.g., size of effusion on pre-aspiration chest X-ray, volume of fluid drained. This data will be analysed to create a clinical score.A further validation cohort of 40 patients will be enrolled in parallel with creation of the score. Anticipated impact: The ability to predict rate of reaccumulation of MPE will enable patients and clinicians to make better informed treatment decisions. For patients with predicted rapid reaccumulation, a definitive procedure could be offered as first-line treatment, rather than a therapeutic aspiration. This will prevent emergency hospital admissions and decrease number of procedures. By contrast, patients whose effusions will recur slowly may avoid an unnecessary procedure.

People with incurable cancer commonly feel breathless due to buildup of fluid around the lung. We treat this by draining fluid off, but it often comes back. When this happens, we offer the patient a permanent implanted drain, so they can drain the fluid off at home. However, sometimes the fluid builds up very quickly. The patient becomes very breathless and needs an emergency hospital admission. In other people, the fluid builds up slowly and they may never need another drain. The aim of this study is to improve treatment by finding a way to predict how quickly fluid will come back. It will be run in five hospitals across England and involve 240 patients over three years. When patients first come to have fluid drained, we will record information about them and their disease. We will measure how quickly the fluid comes back and record hospital admissions and need for fluid drainage over the following three months. We will use this information to create a clinical score. We will then test this score in a second group of patients to make sure it works. The idea for this study came from one of our patients who had just had fluid drained and asked, 'when will it come back?' We couldn't answer his question and therefore developed this study. Our patients and the public have been involved in the design of this study and will continue to be involved. This score will be used to inform patients so they can choose the best treatment for them. If we know the fluid will build up quickly, we can offer patients a permanent drain straight away. If patients know their fluid will build up slowly, they may choose to have the fluid drained when needed without a permanent drain.

Impact of the increase in tuition fees and demographic factors on medical student intercalation rates between 2006 and 2020.

Introduction: No quantitative research has assessed the trends in English medical student intercalation. In addition, the impacts of the increase in tuition fees, introduced in 2012, and demographic factors on intercalation rates are unknown. Methods: Freedom of information requests were sent to all UK universities. Regression analysis compared intercalation rates before (2006-2012) and after (2012-2020) the tuition fee increase. Student's t-tests compared demographics of medical students who intercalated. Questionnaires were sent to all UK universities to explore reasons for intercalating. Results: In total, 101,085 students from seven universities responded. The intercalation rate increased from 4.70% to 10.53% (mean percentage difference (MPD) 5.84; 95% confidence interval (CI) 2.94-8.73). Intercalating students were more likely to be <25 years of age (MPD 33.36%; 95%CI 28.34-38.39), without a previous degree (MPD 8.56%; 95% CI 7.00-10.11) and without a disability (MPD 3.15%; 95% CI 0.88-5.42). In total, 389 completed questionnaires were received from 10 universities. Medical students believed an intercalated degree made them a better doctor. Discussion: The proportion of students who intercalated was greater following the increase in tuition fees. This might be explained by the value medical that students placed on the skills and opportunities that accompany an intercalated degree.

A double-blinded randomised controlled trial of vitamin A drops to treat post-viral olfactory loss: study protocol for a proof-of-concept study for vitamin A nasal drops in post-viral olfactory loss (APOLLO).

BACKGROUND: Smell loss is a common problem with an estimated 5% of the population having no functioning sense of smell. Viral causes of smell loss are the second most common cause and the coronavirus (COVID-19) pandemic is estimated to have caused 20,000 more people this year to have a lasting loss of smell. Isolation, depression, anxiety, and risk of danger from hazards such as toxic gas and spoiled food are all negative impacts. It also affects appetite with weight loss/gain in two-thirds of those affected. Phantosmia or smell distortion can also occur making most foods seem unpalatable. Smell training has been tried with good results in the immediate post-viral phase. Evidence behind treatment with steroids has not shown to have proven effectiveness. With this, a key problem for patients and their clinicians is the lack of proven effective therapeutic treatment options. Based on previous studies, there is some evidence supporting the regenerative potential of retinoic acid, the metabolically active form of vitamin A in the regeneration of olfactory receptor neurons. It is based on this concept that we have chosen vitamin A as our study comparator. AIM: To undertake a two-arm randomised trial of intranasally delivered vitamin A vs no intervention to determine proof of concept. METHODS/DESIGN: The study will compare 10,000 IU once daily Vitamin A self-administered intranasal drops versus peanut oil drops (placebo) delivered over 12 weeks in patients with post-viral olfactory loss. Potentially eligible patients will be recruited from the Smell & Taste Clinic and via the charity Fifth Sense. They will be invited to attend the Brain Imaging Centre at the University of East Anglia on two occasions, 3 months apart. If they meet the eligibility criteria, they will be consented to enter the study and randomised to receive vitamin A drops or no treatment in a 2:1 ratio. MRI scanning will enable volumetric measurement of the OB and ROS; fMRI will then be conducted using an olfactometer to deliver pulsed odours-phenethylalcohol (rose-like) and hydrogen sulphide (rotten eggs). Participants will also perform a standard smell test at both visits as well as complete a quality-of-life questionnaire. Change in OB volume will be the primary outcome measure. DISCUSSION: We expect the outputs of this study to enable a subsequent randomised controlled trial of Vitamin A versus placebo. With PPI input we will make the outputs publicly available using journals, conferences, and social media via Fifth Sense. We have already prepared a draft RCT proposal in partnership with the Norwich Clinical Trials Unit and plan to develop this further in light of the findings. TRIAL REGISTRATION: ISRCTN registry 39523. Date of registration in the primary registry: 23rd February 2021.

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking.

INTRODUCTION: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective. METHODS AND ANALYSIS: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life. ETHICS AND DISSEMINATION: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners. TRIAL REGISTRATION NUMBER: ISRCTN70307341.

Test-retest repeatability for Fatigue Assessment Scale, Short-Form 6-Dimension and King's Sarcoidosis Questionnaire in people with sarcoidosis associated fatigue.

BACKGROUND AND AIM: Patient related outcomes are important in sarcoidosis but the medium-term repeatability of the key patient reported outcome measure is not known. We aimed to test the repeatability of the Fatigue Assessment Scale (FAS), Short Form 6-Dimension (SF-6D), and King's Sarcoidosis Questionnaire (KSQ) in free living people with sarcoidosis associated fatigue. METHODS: Twelve people with sarcoidosis associated fatigue completed the FAS, short form 36 questionnaire (SF-36) and the KSQ at baseline and 12 weeks. The SF-6D utility was calculated from the SF-36. The difference between baseline and 12 week assessments was measured. RESULTS: The interclass correlation (95% confidence interval) showed good agreement between the baseline and 3 months measurements: FAS 0.91 (0.74, 0.71), SF-36 0.98 (0.94, 1), KSQ 0.98 (0.93, 0.99), SF-6D utility 0.98 (0.93, 0.99). The baseline (standard deviation) FAS was 27.83 (5.86) and at 12 weeks was 27.25 (7.55) representing 0.58 difference (95% CI for difference (-1.89, 3.06)), SF-6D utility was 0.69 (0.16) at baseline and 0.68 (0.17) after 3 months representing at 0.00 (-0.03, 0.03) difference and corresponding values for KSQ were 59.12 (18.68) and 56.91 (27.26) with a difference of -1.87 (5.49,1.76). CONCLUSIONS: There was good repeatability of FAS, SF-36, SF-6D and KSQ in free living people with sarcoidosis associated fatigue. Fatigue, general and disease specific health related quality of life showed no significant change over a 12 week period. Studies identifying changes in these outcomes can confidently report a true change and not measurement error or regression to the mean.

Opioid burden in patients with inoperable pancreatic adenocarcinoma and the development of a multivariable risk prediction model for opioid use: A retrospective cohort study.

INTRODUCTION: Risk prediction models to guide patient selection for early pre-emptive endoscopic ultrasound guided coeliac plexus neurolysis are lacking. This study aimed to determine in patients with inoperable pancreatic cancer: (1) opioid burden, (2) the relationship between opioid use and all-cause mortality, (3) risk factors for opioid use, and (4) develop and internally validate a risk prediction model for opioid use at three months. METHODS: This was a single-centre retrospective cohort study of patients with confirmed pancreatic cancer. Cox proportional hazard regression estimated the association between opioid use at baseline and all-cause mortality. Logistic regression estimated the associations between clinical and radiological variables with opioid use by three months. Two risk prediction models were developed for opioid use (clinical and clinical-radiological). Model discrimination and calibration was assessed. RESULTS: In total, 383 patients with inoperable pancreatic cancer were included. Prevalence of pain ranged between 37% and 47% at three monthly intervals in the first year of diagnosis. Opioid use at baseline was associated with poorer survival. Age, pain at presentation, performance status, tumour distance from the right ganglion, the anterior-posterior and the latero-lateral tumour dimensions were independent risk factors for the opioid use at three months. The Area Under Curve (AUC) for the clinical and clinical-radiological models was 0.81 and 0.84, respectively. Models were well calibrated. CONCLUSIONS: Opioid use is prevalent in patients with pancreatic cancer, associated with poor prognosis, and can be predicted based on clinical and radiological variables. External validation of this predictive model is required.

Prevalence and Associated Factors of Medication Non-Adherence in CRS Patients following Endoscopic Sinus Surgery.

This study aimed to evaluate factors that may predispose patients to not adhere to prescribed medication after endoscopic sinus surgery (ESS) and to compare SNOT-22 scores at 0-12 months post-operatively between adherent and non-adherent patients. CRS patients who underwent ESS between 2012 and 2016 were recruited to this retrospective cohort study. Adherence was assessed through a questionnaire and review of medical notes. Ninety-four participants were included (61% male, mean age 60). Of those, 66% did not adhere to their prescribed post-operative CRS medication timing or dosage. The most common reason for non-adherence was improvement of symptoms (17%), followed by deterioration of symptoms (11%) and side effects (10%). Post-operative SNOT-22 scores were lowest for non-intentionally non-adherent (NINA) participants with a mean of 10.5 [95% CI: 7.47-13.5], compared to 25.0 for intentionally non-adherent (INA) [95% CI: 17.6-32.4] and 17.7 for adherent patients [95% CI: 13.7-21.7], p = 0.01. This study identifies that almost two-thirds of patients are not compliant with CRS medications after ESS. NINA participants reported lower post-operative SNOT-22 scores compared to INA and adherent participants. Future studies should focus on educating patients to continue with medications post-operatively despite an initial improvement in symptoms.