Further development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ).

OBJECTIVES: To undertake further psychometric testing of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and examine whether reversing the scale reduced floor effects. DESIGN: Survey. SETTING: UK primary care. PARTICIPANTS: Adults (≥18 years) with three or more long-term conditions randomly selected from four general practices and invited by post. MEASURES: Baseline survey: sociodemographics, MTBQ (original or version with scale reversed), Treatment Burden Questionnaire (TBQ), four questions (from QQ-10) on ease of completing the questionnaires. Follow-up survey (1-4 weeks after baseline): MTBQ, TBQ and QQ-10. Anonymous data collected from electronic GP records: consultations (preceding 12 months) and long-term conditions. The proportion of missing data and distribution of responses were examined for the original and reversed versions of the MTBQ and the TBQ. Intraclass correlation coefficient (ICC) and Spearman's rank correlation (Rs) assessed test-retest reliability and construct validity, respectively. Ease of completing the MTBQ and TBQ was compared. Interpretability was assessed by grouping global MTBQ scores into 0 and tertiles (>0). RESULTS: 244 adults completed the baseline survey (consent rate 31%, mean age 70 years) and 225 completed the follow-up survey. Reversing the scale did not reduce floor effects or data skewness. The global MTBQ scores had good test-retest reliability (ICC for agreement at baseline and follow-up 0.765, 95% CI 0.702 to 0.816). Global MTBQ score was correlated with global TBQ score (Rs 0.77, p<0.001), weakly correlated with number of consultations (Rs 0.17, p=0.010), and number of different general practitioners consulted (Rs 0.23, p<0.001), but not correlated with number of long-term conditions (Rs -0.063, p=0.330). Most participants agreed that both the MTBQ and TBQ were easy to complete and included aspects they were concerned about. CONCLUSION: This study demonstrates test-retest reliability and ease of completion of the MTBQ and builds on a previous study demonstrating good content validity, construct validity and internal consistency reliability of the questionnaire.

Does a local Alcohol Health Champion programme have a measurable impact on health and crime outcomes? A natural experiment evaluation of Communities in Charge of Alcohol (CICA) based on triangulation of methods.

BACKGROUND AND AIM: Drinking alcohol may cause harm to an individual's health and social relationships, while a drinking culture may harm societies as it may increase crime rates and make an area feel less safe. Local councils in Greater Manchester, UK, developed the Communities in Charge of Alcohol (CICA) intervention, in which volunteers were trained to give alcohol-related advice to the public and taught how to influence policies to restrict when, where and how alcohol is sold. As part of a larger study, the aim of the current project is to measure the impact of CICA on health and crime outcomes at the lower super output (LSOA) geographical aggregation. DESIGN: Quantitative evaluation using four time series analytic methods (stepped-wedge design, and comparisons to local controls, national controls and synthetic controls) with findings triangulated across these methods. A cost-benefit analysis was carried out alongside the effectiveness analysis. SETTING AND PARTICIPANTS: The general public in Greater Manchester, UK, between 2010 and 2020. MEASUREMENTS: The primary outcome of interest was alcohol-related hospital admissions. Secondary outcomes were accident and emergency (A&E) attendances, ambulance callouts, recorded crimes and anti-social behaviour incidents. FINDINGS: Triangulation of the results did not indicate any consistent effect on area-level alcohol-related hospital admissions, A&E attendances, ambulance callouts, reported crimes or anti-social behaviour associated with the implementation of CICA. The primary stepped-wedge analysis indicated an increase in alcohol-related hospital admissions following the implementation of CICA of 13.4% (95% confidence interval -3.3%, +30.1%), which was consistent with analyses based on other methods with point estimates ranging from +3.4% to 16.4%. CONCLUSION: There is no evidence of a measurable impact of the Communities in Charge of Alcohol (CICA) programme on area-level health and crime outcomes in Greater Manchester, UK, within 3 years of the programme start. The increase in alcohol-related hospital admissions was likely the result of other temporal trends rather than the CICA programme. Possible explanations include insufficient follow-up time, too few volunteers trained, volunteers being unwilling to get involved in licensing decisions or that the intervention has no direct impact on the selected outcomes.

Advertisement of unhealthy commodities in Bristol and South Gloucestershire and rationale for a new advertisement policy.

BACKGROUND: Bristol City Council introduced a new advertisement policy in 2021/2022 which included prohibiting the advertising of unhealthy food and drink (HFSS), alcohol, gambling and payday loans across council-owned advertising spaces. This mixed methods study is part of the BEAR study, and aimed to explore the rationale and the barriers and facilitators to implementing the policy, and describe the perceived advertising environment prior to implementation. METHODS: Semi-structured interviews were carried out with seven stakeholders involved in the design and implementation of the advertising policy. A stakeholder topic guide was developed before interviews took place to help standardise the lines of inquiry between interviewees. A resident survey was developed to collect socio-demographic data and, for the purpose of this study, information regarding observations of advertising for HFSS products, alcohol and gambling. RESULTS: Fifty-eight percent of respondents residing in Bristol and South Gloucestershire reported seeing advertisements for unhealthy commodities in the week prior to completing the survey. This was highest for HFSS products (40%). 16% of residents reported seeing HFSS product advertisements specifically appealing to children. For HFSS products in particular, younger people were more likely to report seeing adverts than older people, as were those who were from more deprived areas. An advertisement policy that restricts the advertisement of such unhealthy commodities, and in particular for HFSS products, has the potential to reduce health inequalities. This rationale directly influenced the development of the advertisement policy in Bristol. Implementation of the policy benefitted from an existing supportive environment following the 'health in all policies' initiative and a focus on reducing health inequalities across the city. CONCLUSIONS: Unhealthy product advertisements, particularly for unhealthy food and drinks, were observed more by younger people and those living in more deprived areas. Policies that specifically restrict such advertisements, therefore, have the potential to reduce health inequalities, as was the hope when this policy was developed. Future evaluation of the policy will provide evidence of any public health impact.

Assessing exposure to outdoor advertisement for products high in fat, salt and sugar (HFSS); is self-reported exposure a useful exposure metric?

BACKGROUND: Exposure to advertising of unhealthy commodities such as fast-food and gambling is recognised as a risk factor for developing non-communicable diseases. Assessment of the impact of such advertisement and the evaluation of the impact of any policies to restrict such advertisements on public health are reliant on the quality of the exposure assessment. A straightforward method for assessing exposure is to ask people whether they noticed any such advertisements in their neighbourhoods. However, the validity of this method is unclear. We assessed the associations between measured exposure to outdoor advertising, self-reported exposure, and self-reported consumption. METHODS: We collected exposure information in January-March 2022 using two methods: (i) through a resident survey investigating advertising and consumption of unhealthy products, distributed across Bristol and neighbouring South Gloucestershire, and (ii) through in-person auditing. Self-reported exposure was obtained from the resident survey (N = 2,560) and measured exposure from photos obtained for all Council owned advertisement sites (N = 973 bus stops). Both data sources were geographically linked at lower-super-output-area level. Reporting ratios (RRs), 95% confidence intervals (CIs), and Cohen's kappas, are presented. RESULTS: 24% of advertisements displayed food and/or drink advertising. Bristol respondents in neighbourhoods displaying food/drink adverts were more likely to also report seeing these adverts compared to those in neighbourhoods without food/drink adverts (59% vs. 51%, RR = 1.15, 95%CI 1.01-1.31). There was no such association in South Gloucestershire (26% vs. 32%, RR = 0.82, 95%CI 0.58-1.14). Respondents in both Bristol and South Gloucestershire who recalled seeing advertising for unhealthy food and drink products were more likely to consume them (e.g. for fast-food: 22% vs. 11%, RR = 2.01, 95%CI 1.68-2.42). There was no such association between measured food and drink adverts in respondents' local areas and self-reported consumption of HFSS product (90.1% vs. 90.7%, RR = 0.99, 95%CI 0.96-1.03). CONCLUSIONS: Self-reported outdoor advertisement exposure is correlated with measured exposure, making this a useful methodology for population studies. It has the added advantage that it correlates with consumption. However, given that measurement error can be significant and self-reported exposure is known to be susceptible to various biases, inferences from studies using this exposure metric should be made with caution.

Educational interventions to prevent paediatric abusive head trauma in babies younger than one year old: A systematic review and meta-analyses.

BACKGROUND: Paediatric abusive head trauma (AHT) occurs in young children due to violent shaking or blunt impact. Educational and behavioural programmes modifying parent/infant interactions may aid primary prevention. This systematic review aims to assess the effectiveness of such interventions to prevent AHT in infants. METHODS: We searched Embase, MEDLINE, PsycINFO, The Cochrane library, CINAHL databases and trial registries to September 2021, for studies assessing the effectiveness of educational and behavioural interventions in preventing AHT. Eligible interventions had to include messaging about avoiding or dangers of infant shaking. Randomised controlled trials (RCTs) reporting results for primary (AHT, infant shaking) or secondary outcomes (including parental responses to infant crying, mental wellbeing), and non-randomised studies (NRSs) reporting primary outcomes were included. Evidence from combinable studies was synthesised using random-effects meta-analyses. Certainty of evidence was assessed using GRADE framework. PROSPERO registration CRD42020195644. FINDINGS: Of 25 identified studies, 16 were included in meta-analyses. Five NRSs reported results for AHT, of which four were meta-analysed (summary odds ratio [OR] 0.95, 95 % confidence intervals [CI] 0.80-1.13). Two studies assessed self-reported shaking (one cluster-RCT, OR 0.11, 95 % CI 0.02-0.53; one cohort study, OR 0.36, 95 % CI 0.20-0.64, not pooled). Meta-analyses of secondary outcomes demonstrated marginal improvements in parental response to inconsolable crying (summary mean difference 1.58, 95 % CI 0.11-3.06, on a 100-point scale) and weak evidence that interventions increased walking away from crying infants (summary incidence rate ratio 1.52, 95 % CI 0.94-2.45). No intervention effects were found in meta-analyses of parental mental wellbeing or other responses to crying. INTERPRETATION: Low certainty evidence suggests that educational programmes for AHT prevention are not effective in preventing AHT. There is low to moderate certainty evidence that educational interventions have no effect or only marginally improve some parental responses to infant crying.

Evaluating a pre-surgical health optimisation programme: a feasibility study.

BACKGROUND: Health optimisation programmes are increasingly popular and aim to support patients to lose weight or stop smoking ahead of surgery, yet there is little published evidence about their impact. This study aimed to assess the feasibility of evaluating a programme introduced by a National Health Service (NHS) clinical commissioning group offering support to smokers/obese patients in an extra 3 months prior to the elective hip/knee surgery pathway. METHODS: Feasibility study mapping routinely collected data sources, availability and completeness for 502 patients referred to the hip/knee pathway in February-July 2018. RESULTS: Data collation across seven sources was complex. Data completeness for smoking and ethnicity was poor. While 37% (184) of patients were eligible for health optimisation, only 28% of this comparatively deprived patient group accepted referral to the support offered. Patients who accepted referral to support and completed the programme had a larger median reduction in BMI than those who did not accept referral (- 1.8 BMI points vs. - 0.5). Forty-nine per cent of patients who accepted support were subsequently referred to surgery, compared to 61% who did not accept referral to support. CONCLUSIONS: Use of routinely collected data to evaluate health optimisation programmes is feasible though demanding. Indications of the positive effects of health optimisation interventions from this study and existing literature suggest that the challenge of programme evaluation should be prioritised; longer-term evaluation of costs and outcomes is warranted to inform health optimisation policy development.

Supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital cardiac arrest: the AIRWAYS-2 cluster RCT.

BACKGROUND: When a cardiac arrest occurs, cardiopulmonary resuscitation should be started immediately. However, there is limited evidence about the best approach to airway management during cardiac arrest. OBJECTIVE: The objective was to determine whether or not the i-gel® (Intersurgical Ltd, Wokingham, UK) supraglottic airway is superior to tracheal intubation as the initial advanced airway management strategy in adults with non-traumatic out-of-hospital cardiac arrest. DESIGN: This was a pragmatic, open, parallel, two-group, multicentre, cluster randomised controlled trial. A cost-effectiveness analysis accompanied the trial. SETTING: The setting was four ambulance services in England. PARTICIPANTS: Patients aged ≥ 18 years who had a non-traumatic out-of-hospital cardiac arrest and were attended by a participating paramedic were enrolled automatically under a waiver of consent between June 2015 and August 2017. Follow-up ended in February 2018. INTERVENTION: Paramedics were randomised 1 : 1 to use tracheal intubation (764 paramedics) or i-gel (759 paramedics) for their initial advanced airway management and were unblinded. MAIN OUTCOME MEASURES: The primary outcome was modified Rankin Scale score at hospital discharge or 30 days after out-of-hospital cardiac arrest, whichever occurred earlier, collected by assessors blinded to allocation. The modified Rankin Scale, a measure of neurological disability, was dichotomised: a score of 0-3 (good outcome) or 4-6 (poor outcome/death). The primary outcome for the economic evaluation was quality-adjusted life-years, estimated using the EuroQol-5 Dimensions, five-level version. RESULTS: A total of 9296 patients (supraglottic airway group, 4886; tracheal intubation group, 4410) were enrolled [median age 73 years; 3373 (36.3%) women]; modified Rankin Scale score was known for 9289 patients. Characteristics were similar between groups. A total of 6.4% (311/4882) of patients in the supraglottic airway group and 6.8% (300/4407) of patients in the tracheal intubation group had a good outcome (adjusted difference in proportions of patients experiencing a good outcome: -0.6%, 95% confidence interval -1.6% to 0.4%). The supraglottic airway group had a higher initial ventilation success rate than the tracheal intubation group [87.4% (4255/4868) vs. 79.0% (3473/4397), respectively; adjusted difference in proportions of patients: 8.3%, 95% confidence interval 6.3% to 10.2%]; however, patients in the tracheal intubation group were less likely to receive advanced airway management than patients in the supraglottic airway group [77.6% (3419/4404) vs. 85.2% (4161/4883), respectively]. Regurgitation rate was similar between the groups [supraglottic airway group, 26.1% (1268/4865); tracheal intubation group, 24.5% (1072/4372); adjusted difference in proportions of patients: 1.4%, 95% confidence interval -0.6% to 3.4%], as was aspiration rate [supraglottic airway group, 15.1% (729/4824); tracheal intubation group, 14.9% (647/4337); adjusted difference in proportions of patients: 0.1%, 95% confidence interval -1.5% to 1.8%]. The longer-term outcomes were also similar between the groups (modified Rankin Scale: at 3 months, odds ratio 0.89, 95% confidence interval 0.69 to 1.14; at 6 months, odds ratio 0.91, 95% confidence interval 0.71 to 1.16). Sensitivity analyses did not alter the overall findings. There were no unexpected serious adverse events. Mean quality-adjusted life-years to 6 months were 0.03 in both groups (supraglottic airway group minus tracheal intubation group difference -0.0015, 95% confidence interval -0.0059 to 0.0028), and total costs were £157 (95% confidence interval -£270 to £583) lower in the tracheal intubation group. Although the point estimate of the incremental cost-effectiveness ratio suggested that tracheal intubation may be cost-effective, the huge uncertainty around this result indicates no evidence of a difference between groups. LIMITATIONS: Limitations included imbalance in the number of patients in each group, caused by unequal distribution of high-enrolling paramedics; crossover between groups; and the fact that participating paramedics, who were volunteers, might not be representative of all paramedics in the UK. Findings may not be applicable to other countries. CONCLUSION: Among patients with out-of-hospital cardiac arrest, randomisation to the supraglottic airway group compared with the tracheal intubation group did not result in a difference in outcome at 30 days. There were no notable differences in costs, outcomes and overall cost-effectiveness between the groups. FUTURE WORK: Future work could compare alternative supraglottic airway types with tracheal intubation; include a randomised trial of bag mask ventilation versus supraglottic airways; and involve other patient populations, including children, people with trauma and people in hospital. TRIAL REGISTRATION: This trial is registered as ISRCTN08256118. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and supported by the NIHR Comprehensive Research Networks and will be published in full in Health Technology Assessment; Vol. 26, No. 21. See the NIHR Journals Library website for further project information.

BACKGROUND: Cardiac arrest is a serious medical emergency in which the heartbeat and breathing stop suddenly. Every year in the UK, a large number of patients (around 123 per 100,000) suffer a cardiac arrest outside hospital. Only 7­9% of these patients survive to leave hospital. The best initial treatment in cardiac arrest is cardiopulmonary resuscitation (commonly known as CPR), during which it is vital to give chest compressions and maintain a clear airway. Two main techniques are used to keep the airway clear: tracheal intubation (inserting a breathing tube into the windpipe) and a supraglottic airway device (a newer device that is inserted less deeply and sits just above the voicebox). Both techniques are used routinely by paramedics in the UK when treating a cardiac arrest, but there is no evidence about which technique is best. The AIRWAYS-2 trial aimed to find out whether or not a supraglottic airway device is better than tracheal intubation. WHO PARTICIPATED AND WHAT WAS INVOLVED?: Paramedics from four UK ambulance services were put into one of two groups at random. One group was randomly chosen to use tracheal intubation and the other group was randomly chosen to use a supraglottic airway device at all adult cardiac arrests they attended for approximately 2 years. Paramedics were able to apply their clinical judgement and use a different device if they felt that this would be best for the patient. A total of 1523 paramedics took part and enrolled 9296 patients. Following cardiac arrest, a patient's recovery was assessed as good or poor (including patients who did not survive). WHAT DID THE TRIAL FIND?: A similar percentage of patients in both groups had a good recovery. There was no evidence to suggest that the supraglottic airway device was any better than tracheal intubation for treating a cardiac arrest.

Prognostic value of National Early Warning Scores (NEWS2) and component physiology in hospitalised patients with COVID-19: a multicentre study.

BACKGROUND: National Early Warning Scores (NEWS2) are used to detect all-cause deterioration. While studies have looked at NEWS2, the use of virtual consultation and remote monitoring of patients with COVID-19 mean there is a need to know which physiological observations are important. AIM: To investigate the relationship between outcome and NEWS2, change in NEWS2 and component physiology in COVID-19 inpatients. METHODS: A multi-centre retrospective study of electronically recorded, routinely collected physiological measurements between March and June 2020. First and maximum NEWS2, component scores and outcomes were recorded. Areas under the curve (AUCs) for 2-day, 7-day and 30-day mortality were calculated. RESULTS: Of 1263 patients, 26% died, 7% were admitted to intensive care units (ICUs) before discharge and 67% were discharged without ICU. Of 1071 patients with initial NEWS2, most values were low: 50% NEWS2=0-2, 27% NEWS2=3-4, 14% NEWS2=5-6 and 9% NEWS2=7+. Maximum scores were: 14% NEWS2=0-2, 22% NEWS2=3-4, 17% NEWS2=5-6 and 47% NEWS2=7+. Higher first and maximum scores were predictive of mortality, ICU admission and longer length of stay. AUCs based on 2-day, 7-day, 30-day and any hospital mortality were 0.77 (95% CI 0.70 to 0.84), 0.70 (0.65 to 0.74), 0.65 (0.61 to 0.68) and 0.65 (0.61 to 0.68), respectively. The AUCs for 2-day mortality were 0.71 (0.65 to 0.77) for supplemental oxygen, 0.65 (0.56 to 0.73) oxygen saturation and 0.64 (0.56 to 0.73) respiratory rate. CONCLUSION: While respiratory parameters were most predictive, no individual parameter was as good as a full NEWS2, which is an acceptable predictor of short-term mortality in patients with COVID-19. This supports recommendation to use NEWS2 alongside clinical judgement to assess patients with COVID-19.

Systematic review with meta-analysis: the accuracy of serological tests to support the diagnosis of coeliac disease.

BACKGROUND: There is growing support for a biopsy avoidant approach to diagnose coeliac disease in both children and adults, using a serological diagnosis instead. AIMS: To assess the diagnostic accuracy of serological tests for coeliac disease in adults and children. METHODS: Seven electronic databases were searched between January 1990 and August 2020. Eligible diagnostic studies evaluated the accuracy of serological tests for coeliac disease against duodenal biopsy. Risk of bias assessment was performed using QUADAS-2. Bivariate random-effects meta-analyses were used to estimate serology sensitivity and specificity at the most commonly reported thresholds. RESULTS: 113 studies (n = 28,338) were included, all in secondary care populations. A subset of studies were included in meta-analyses due to variations in diagnostic thresholds. Summary sensitivity and specificity of immunoglobulin A (IgA) anti-tissue transglutaminase were 90.7% (95% confidence interval: 87.3%, 93.2%) and 87.4% (84.4%, 90.0%) in adults (5 studies) and 97.7% (91.0%, 99.4%) and 70.2% (39.3%, 89.6%) in children (6 studies); and of IgA endomysial antibodies were 88.0% (75.2%, 94.7%) and 99.6% (92.3%, 100%) in adults (5 studies) and 94.5% (88.9%, 97.3%) and 93.8% (85.2%, 97.5%) in children (5 studies). CONCLUSIONS: Anti-tissue transglutaminase sensitivity appears to be sufficient to rule out coeliac disease in children. The high specificity of endomysial antibody in adults supports its use to rule in coeliac disease. This evidence underpins the current development of clinical guidelines for a serological diagnosis of coeliac disease. Studies in primary care are needed to evaluate serological testing strategies in this setting.

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial.

AIM: Optimal airway management during out-of-hospital cardiac arrest (OHCA) is uncertain. Complications from tracheal intubation (TI) may be avoided with supraglottic airway (SGA) devices. The AIRWAYS-2 cluster randomised controlled trial (ISRCTN08256118) compared the i-gel SGA with TI as the initial advanced airway management (AAM) strategy by paramedics treating adults with non-traumatic OHCA. This paper reports the trial cost-effectiveness analysis. METHODS: A within-trial cost-effectiveness analysis of the i-gel compared with TI was conducted, with a six-month time horizon, from the perspective of the UK National Health Service (NHS) and personal social services. The primary outcome measure was quality-adjusted life years (QALYs), estimated using the EQ-5D-5L questionnaire. Multilevel linear regression modelling was used to account for clustering by paramedic when combining costs and outcomes. RESULTS: 9296 eligible patients were attended by 1382 trial paramedics and enrolled in the AIRWAYS-2 trial (4410 TI, 4886 i-gel). Mean QALYs to six months were 0.03 in both groups (i-gel minus TI difference -0.0015, 95% CI -0.0059 to 0.0028). Total costs per participant up to six months post-OHCA were £3570 and £3413 in the i-gel and TI groups respectively (mean difference £157, 95% CI -£270 to £583). Based on mean difference point estimates, TI was more effective and less costly than i-gel; however differences were small and there was great uncertainty around these results. CONCLUSION: The small differences between groups in QALYs and costs shows no difference in the cost-effectiveness of the i-gel and TI when used as the initial AAM strategy in adults with non-traumatic OHCA.

Changes in presentations with features potentially indicating cancer in primary care during the COVID-19 pandemic: a retrospective cohort study.

OBJECTIVES: To investigate how the COVID-19 pandemic affected the number of people aged 50+ years presenting to primary care with features that could potentially indicate cancer, and to explore how reporting differed by patient characteristics and in face-to-face vs remote consultations. DESIGN, SETTING AND PARTICIPANTS: A retrospective cohort study of general practitioner (GP), nurse and paramedic primary care consultations in 21 practices in South-West England covering 123 947 patients. The models compared potential cancer indicators reported in April-July 2019 with April-July 2020. MAIN OUTCOME MEASURES: Potential indicators of cancer were identified using code lists for symptoms, signs, test results and diagnoses listed in the National Institute for Health and Care Excellence suspected cancer referral guidance (NG12). RESULTS: During April-July 2019, 17% of registered patients aged 50+ years reported a potential cancer indicator in a consultation with a GP or nurse. During April-July 2020, this reduced to 11% (incidence rate ratio (IRR) 0.64, 95% CI 0.62 to 0.67, p<0.001). Reductions in potential cancer indicators were stable across age group, sex, ethnicity, index of multiple deprivation quintile and shielding status, but less marked in patients with mental health conditions than without (IRR 0.75, 95% CI 0.72 to 0.79, interaction p<0.001). Proportions of GP consultations with potential indicators of cancer reduced between 2019 and 2020 for face-to-face consultations (IRR 0.84, 95% CI 0.76 to 0.92, p<0.001) and increased for remote consultations (IRR 1.17, 95% CI 1.07 to 1.29, p=0.001), although it remained lower in remote consulting than face-to-face in April-July 2020. This difference was greater for nurse/paramedic consultations (face-to-face: IRR 0.61, 95% CI 0.44 to 0.83, p=0.002; remote: IRR 1.60, 95% CI 1.10 to 2.333, p=0.014). CONCLUSION: The number of patients consulting with presentations that could potentially indicate cancer reduced during the first wave of the COVID-19 pandemic. Patients should be encouraged to continue contacting primary care for persistent signs and symptoms, and GPs and nurses should be encouraged to probe patients for further information during remote consulting, in the absence of non-verbal cues.

Commissioner, clinician, and patient experiences of a pre-surgical health optimisation programme - a qualitative study.

BACKGROUND: Health optimisation programmes are an increasingly popular policy intervention that aim to support patients to lose weight or stop smoking ahead of surgery. There is little evidence about their impact and the experience of their use. The aim of this study was to investigate the experiences and perspectives of commissioners, clinicians and patients involved in a locality's health optimisation programme in the United Kingdom. The programme alters access to elective orthopaedic surgery for patients who smoke or are obese (body mass index ≥ 30 kg/m2), diverting them to a 12-week programme of behavioural change interventions prior to assessment for surgical referral. METHODS: A thematic analysis of semi-structured interviews (n = 20) with National Health Service and Local Authority commissioners and planners, healthcare professionals, and patients using the pathway. RESULTS: Health optimisation was broadly acceptable to professionals and patients in our sample and offered a chance to trigger both short term pre-surgical weight loss/smoking cessation and longer-term sustained changes to lifestyle intentions post-surgery. Communicating the nature and purpose of the programme to patients was challenging and consequently the quality of the explanation received and understanding gained by patients was generally low. Insight into the successful implementation of health optimisation for the hip and knee pathway, but failure in roll-out to other surgical specialities, suggests placement of health optimisation interventions into the 'usual waiting time' for surgical referral may be of greatest acceptability to professionals and patients. CONCLUSIONS: Patients and professionals supported the continuation of health optimisation in this context and recognised likely health and wellbeing benefits for a majority of patients. However, the clinicians' communication to patients about health optimisation needs to improve to prepare patients and optimise their engagement.

Implementation of remote consulting in UK primary care following the COVID-19 pandemic: a mixed-methods longitudinal study.

BACKGROUND: To reduce contagion of COVID-19, in March 2020 UK general practices implemented predominantly remote consulting via telephone, video, or online consultation platforms. AIM: To investigate the rapid implementation of remote consulting and explore impact over the initial months of the COVID-19 pandemic. DESIGN AND SETTING: Mixed-methods study in 21 general practices in Bristol, North Somerset and South Gloucestershire. METHOD: Longitudinal observational quantitative analysis compared volume and type of consultation in April to July 2020 with April to July 2019. Negative binomial models were used to identify if changes differed among different groups of patients. Qualitative data from 87 longitudinal interviews with practice staff in four rounds investigated practices' experience of the move to remote consulting, challenges faced, and solutions. A thematic analysis utilised Normalisation Process Theory. RESULTS: There was universal consensus that remote consulting was necessary. This drove a rapid change to 90% remote GP consulting (46% for nurses) by April 2020. Consultation rates reduced in April to July 2020 compared to 2019; GPs and nurses maintained a focus on older patients, shielding patients, and patients with poor mental health. Telephone consulting was sufficient for many patient problems, video consulting was used more rarely, and was less essential as lockdown eased. SMS-messaging increased more than three-fold. GPs were concerned about increased clinical risk and some had difficulties setting thresholds for seeing patients face-to-face as lockdown eased. CONCLUSION: The shift to remote consulting was successful and a focus maintained on vulnerable patients. It was driven by the imperative to reduce contagion and may have risks; post-pandemic, the model will need adjustment.

A randomized controlled trial comparing controlled reoxygenation and standard cardiopulmonary bypass in paediatric cardiac surgery.

OBJECTIVES: Controlled reoxygenation on starting cardiopulmonary bypass (CPB) rather than hyperoxic CPB may confer clinical advantages during surgery for congenital cyanotic heart disease. METHODS: A single-centre, randomized controlled trial was carried out to compare the effectiveness of controlled reoxygenation (normoxia) versus hyperoxic CPB in children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2). The co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay. Analysis of the primary outcomes included data from a previous trial (Oxic-1) conducted to the same protocol. RESULTS: Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial. There were no significant differences between the groups for any of the co-primary outcomes: inotrope duration geometric mean ratio (normoxia/hyperoxic) 0.97, 95% confidence interval (CI) (0.69-1.37), P-value = 0.87; intubation time hazard ratio (HR) 1.03, 95% CI (0.74-1.42), P-value = 0.87; postoperative ICU stay HR 1.14 95% CI (0.77-1.67), P-value = 0.52, hospital stay HR 0.90, 95% CI (0.65-1.25), P-value = 0.53. Lower oxygen levels were successfully achieved during the operative period in the normoxic group. Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5. Childhood developmental outcomes were similar. In the year following surgery, 85 serious adverse events were reported (51 normoxic group and 34 hyperoxic group). CONCLUSIONS: Controlled reoxygenation (normoxic) CPB is safe but with no evidence of a clinical advantage over hyperoxic CPB. CLINICAL TRIAL REGISTRATION NUMBER: Current Controlled Trials-ISRCTN81773762.

Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months.

AIM: The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months. METHODS: Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods. RESULTS: 767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings. CONCLUSION: There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.

Exploring trends in admissions and treatment for ankle fractures: a longitudinal cohort study of routinely collected hospital data in England.

BACKGROUND: Evidence on the most effective and cost-effective management of ankle fractures is sparse but evolving. A recent large RCT in older patients with unstable fractures found that management with close-contact-casting was functionally equivalent and more cost-effective than internal fixation. We describe temporal and geographic variation in ankle fracture management and estimate the potential savings if close-contact-casting was used more often in older patients. METHODS: Patients admitted to hospital in England between 2007/08 and 2016/17 with an ankle fracture were identified using routine hospital episode statistics. We tested whether the use of internal fixation, and the proportion of internal fixations using intramedullary implants, changed over time. We estimated the potential annual cost savings if patients aged 60+ years were treated with close-contact-casting rather than internal fixation, in line with emerging evidence. RESULTS: Over the 10-year period, there were 223,465 hospital admissions with a primary ankle fracture diagnosis. The incidence (per 100,000) of internal fixation was fairly consistent over time in younger (33.2 in 2007/08, 30.9 in 2016/17) and older (36.5 in 2007/08, 37.4 in 2016/17) patients. The proportion of internal fixations which used intramedullary implants increased in both age groups (17.0-19.5% < 60 years; 15.2-17.4% 60+ years). In 2016/17, the cost of inpatient hospital care for ankle fractures in England was over £63.1million. If 50% of older patients who had an internal fixation instead had close-contact-casting, we estimate that approximately £1.56million could have been saved. CONCLUSIONS: Despite emerging evidence that non-surgical and surgical management achieve equivalent functional outcomes in older patients, the rate of surgical fixation has remained relatively stable over the decade. The health service could achieve substantial savings if a higher proportion of older patients were treated with close-contact-casting, in line with recent evidence.

What methods are being used to create an evidence base on the use of laboratory tests to monitor long-term conditions in primary care? A scoping review.

BACKGROUND: Studies have shown unwarranted variation in test ordering among GP practices and regions, which may lead to patient harm and increased health care costs. There is currently no robust evidence base to inform guidelines on monitoring long-term conditions. OBJECTIVES: To map the extent and nature of research that provides evidence on the use of laboratory tests to monitor long-term conditions in primary care, and to identify gaps in existing research. METHODS: We performed a scoping review-a relatively new approach for mapping research evidence across broad topics-using data abstraction forms and charting data according to a scoping framework. We searched CINAHL, EMBASE and MEDLINE to April 2019. We included studies that aimed to optimize the use of laboratory tests and determine costs, patient harm or variation related to testing in a primary care population with long-term conditions. RESULTS: Ninety-four studies were included. Forty percent aimed to describe variation in test ordering and 36% to investigate test performance. Renal function tests (35%), HbA1c (23%) and lipids (17%) were the most studied laboratory tests. Most studies applied a cohort design using routinely collected health care data (49%). We found gaps in research on strategies to optimize test use to improve patient outcomes, optimal testing intervals and patient harms caused by over-testing. CONCLUSIONS: Future research needs to address these gaps in evidence. High-level evidence is missing, i.e. randomized controlled trials comparing one monitoring strategy to another or quasi-experimental designs such as interrupted time series analysis if trials are not feasible.

Association between National Early Warning Scores in primary care and clinical outcomes: an observational study in UK primary and secondary care.

BACKGROUND: NHS England has mandated use of the National Early Warning Score (NEWS), more recently NEWS2, in acute settings, and suggested its use in primary care. However, there is reluctance from GPs to adopt NEWS/NEWS2. AIM: To assess whether NEWS calculated at the point of GP referral into hospital is associated with outcomes in secondary care. DESIGN AND SETTING: An observational study using routinely collected data from primary and secondary care. METHOD: NEWS values were prospectively collected for 13 047 GP referrals into acute care between July 2017 and December 2018. NEWS values were examined and multivariate linear and logistic regression used to assess associations with process measures and clinical outcomes. RESULTS: Higher NEWS values were associated with faster conveyance for patients travelling by ambulance, for example, median 94 minutes (interquartile range [IQR] 69-139) for NEWS ≥7; median 132 minutes, (IQR 84-236) for NEWS = 0 to 2); faster time from hospital arrival to medical review (54 minutes [IQR 25-114] for NEWS ≥7; 78 minutes [IQR 34-158] for NEWS = 0 to 2); as well as increased length of stay (5 days [IQR 2-11] versus 1 day [IQR 0-5]); intensive care unit admissions (2.0% versus 0.5%); sepsis diagnosis (11.7% versus 2.5%); and mortality, for example, 30-day mortality 12.0% versus 4.1% for NEWS ≥7 versus NEWS = 0 to 2, respectively. On average, for patients referred without a NEWS value (NEWS = NR), most clinical outcomes were comparable with patients with NEWS = 3 to 4, but ambulance conveyance time and time to medical review were comparable with patients with NEWS = 0 to 2. CONCLUSION: This study has demonstrated that higher NEWS values calculated at GP referral into hospital are associated with a faster medical review and poorer clinical outcomes.

Acceptability of a primary care-based opioid and pain review service: a mixed-methods evaluation in England.

BACKGROUND: Primary care opioid prescribing to treat chronic non-cancer pain (CNCP) has progressively increased despite a lack of evidence for long-term safety and effectiveness. Developing primary care interventions to reduce opioid dependence in patients with CNCP is a public health priority. AIM: To report the acceptability of the South Gloucestershire pain and opioid review service for patients with CNCP, which aimed to help patients understand their relationship with prescribed opioids and support non-drug-based pain management strategies. DESIGN AND SETTING: A mixed-methods evaluation was performed on the service, which was based in two GP practices in South Gloucestershire, England, and delivered by project workers. METHOD: Descriptive data were collected on delivered-within-service and community-based interventions. Twenty-five semi-structured interviews (n = 18 patients, n = 7 service providers) explored experiences of the service. RESULTS: The enrolment process, person-centred primary care-based delivery, and service content focused on psychological issues underlying CNCP were found to be acceptable to patients and service providers. Patients welcomed having time to discuss their pain, its management, and related psychological issues. Maintaining a long-term approach was desired as CNCP is a complex issue that takes time to address. GPs recommended that funding was needed to ensure they have dedicated time to support a similar service and to ensure that project workers received adequate clinical supervision. CONCLUSION: This service model was acceptable and may be a useful means to manage patients with CNCP who develop opioid dependence after long-term use of opioids. A randomised controlled trial is needed to formally test the effectiveness of the service.

Evaluation of a primary care-based opioid and pain review service: a mixed-methods evaluation in two GP practices in England.

BACKGROUND: Opioid prescribing to treat chronic non-cancer pain has rapidly increased, despite a lack of evidence for long-term safety and effectiveness. A pain review service was developed to work with patients taking opioids long-term to explore opioid use, encourage non-drug-based alternatives, and, where appropriate, support dose reduction. AIM: To evaluate the service and its potential impact on opioid use, health and wellbeing outcomes, and quality of life (QoL). DESIGN AND SETTING: Mixed-methods evaluation of a one-to-one service based in two GP practices in South Gloucestershire, England, which took place from September 2016 to December 2017. METHOD: Quantitative data were collected on baseline demographics; data on opioid use, misuse, and dose, health, wellbeing, QoL, and pain and interference with life measures were collected at baseline and follow-up. Twenty-five semi-structured interviews (n = 18 service users, n = 7 service providers) explored experiences of the service including perceived impacts and benefits. RESULTS: Of 59 patients who were invited, 34 (57.6%) enrolled in the service. The median prescribed opioid dose reduced from 90 mg (average daily morphine equivalent; interquartile range [IQR] 60 to 240) at baseline to 72 mg (IQR 30 to 160) at follow-up (P<0.001); three service users stopped using opioids altogether. On average, service users showed improvement on most health, wellbeing, and QoL outcomes. Perceived benefits were related to wellbeing, for example, improved confidence and self-esteem, use of pain management strategies, changes in medication use, and reductions in dose. CONCLUSION: The service was well received, and health and wellbeing outcomes suggest a potential benefit. Following further service development, a randomised controlled trial to test this type of care pathway is warranted.