Now showing items 1-20 of 29

    • Thinking ahead about medical treatments in advanced illness: a qualitative study of barriers and enablers in end-of-life care planning with patients and families from ethnically diverse backgrounds

      Islam, Zoebia; Pollock, Kristian; Patterson, Anne; Hanjari, Matilda; Wallace, Louise; Mururajani, Irfhan; Conroy, Simon; Faull, Christina (2023-06)
      Background: This study explored whether or not, and how, terminally ill patients from ethnically diverse backgrounds and their family caregivers think ahead about deterioration and dying, and explored their engagement with health-care professionals in end-of-life care planning. Objective: The aim was to address the question, what are the barriers to and enablers of ethnically diverse patients, family caregivers and health-care professionals engaging in end-of-life care planning? Design: This was a qualitative study comprising 18 longitudinal patient-centred case studies, interviews with 19 bereaved family caregivers and 50 public and professional stakeholder responses to the findings. Setting: The study was set in Nottinghamshire and Leicestershire in the UK. Results: Key barriers - the predominant stance of patients was to live with hope, considering the future only in terms of practical matters (wills and funerals), rather than the business of dying. For some, planning ahead was counter to their faith. Health-care professionals seemed to feature little in people's lives. Some participants indicated a lack of trust and experienced a disjointed system, devoid of due regard for them. However, religious and cultural mores were of great importance to many, and there were anxieties about how the system valued and enabled these. Family duty and community expectations were foregrounded in some accounts and concern about being in the (un)care of strangers was common. Key enablers - effective communication with trusted individuals, which enables patients to feel known and that their faith, family and community life are valued. Health-care professionals getting to 'know' the person is key. Stakeholder responses highlighted the need for development of Health-care professionals' confidence, skills and training, Using stories based on the study findings was seen as an effective way to support this. A number of behavioural change techniques were also identified. Limitations: It was attempted to include a broad ethnic diversity in the sample, but the authors acknowledge that not all groups could be included. Conclusions: What constitutes good end-of-life care is influenced by the intersectionality of diverse factors, including beliefs and culture. All people desire personalised, compassionate and holistic end-of-life care, and the current frameworks for good palliative care support this. However, health-care professionals need additional skills to navigate complex, sensitive communication and enquire about aspects of people's lives that may be unfamiliar. The challenge for health-care professionals and services is the delivery of holistic care and the range of skills that are required to do this.
    • Cohort Profile: Virus Watch-understanding community incidence, symptom profiles and transmission of COVID-19 in relation to population movement and behaviour

      Byrne, Thomas; Kovar, Jana; Beale, Sarah; Braithwaite, Isobel; Fragaszy, Ellen; Fong, Wing Lam Erica
      • Virus Watch is a national community cohort study of COVID-19 in households in England and Wales, established in June 2020. The study aims to provide evidence on which public health approaches are most effective in reducing transmission, and to investigate community incidence, symptoms and transmission of COVID-19 in relation to population movement and behaviours. • In all, 28 527 households and 58 628 participants of age (0–98 years, mean age 48), were recruited between June 2020 and March 2022. • Data collected include demographics and details of occupation, comorbidities, medications and infection-prevention behaviours. Households are followed up weekly with illness surveys capturing symptoms and their severity, activities in the week prior to symptom onset and any COVID-19 test results. Additional occasional surveys capture household finance, employment, mental health, access to health care, vaccination uptake, activities and contacts. Data have been linked to Hospital Episode Statistics (HES), inpatient and critical care episodes, outpatient visits, emergency care contacts, mortality, virology testing and vaccination data held by National Health Service (NHS) Digital. • Nested within Virus Watch are a serology and Polymerase Chain Reaction (PCR) cohort study (n ¼ 12 877) and a vaccine evaluation study (n ¼ 19 555). • Study data are deposited in the Office of National Statistics (ONS) Secure Research Service (SRS). Survey data are available under restricted access upon request to ONS SRS.
    • Randomised, placebo-controlled trial and meta-analysis show benefit of ondansetron for irritable bowel syndrome with diarrhoea: The TRITON trial

      Gunn, David; Corsetti, Maura; Spiller, Robin C (2023-06)
      Background: Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D). Aim: To conduct a 12-week parallel group, randomised, double-blind, placebo-controlled trial of ondansetron 4 mg o.d. (titrated up to 8 mg t.d.s.) in 400 IBS-D patients. Primary endpoint: % responders using the Food and Drug Administration (FDA) composite endpoint. Secondary and mechanistic endpoints included stool consistency (Bristol Stool Form Scale) and whole gut transit time (WGTT). After literature review, results were pooled with other placebo-controlled trials in a meta-analysis to estimate relative risks (RR), 95% confidence intervals (CIs) and number needed to treat (NNT). Results: Eighty patients were randomised. On intention-to-treat analysis, 15/37 (40.5%; 95% CI 24.7%-56.4%) met the primary endpoint on ondansetron versus 12/43 (27.9%; 95% CI 14.5%-41.3%) on placebo (p = 0.19). Ondansetron improved stool consistency compared with placebo (adjusted mean difference - 0.7; 95% CI -1.0 to-0.3, p < 0.001). Ondansetron increased WGTT between baseline and week 12 (mean (SD) difference 3.8 (9.1) hours, versus placebo -2.2 (10.3) hours, p = 0.01). Meta-analysis of 327 patients from this, and two similar trials, demonstrated ondansetron was superior to placebo for the FDA composite endpoint (RR of symptoms not responding = 0.86; 95% CI 0.75-0.98, NNT = 9) and stool response (RR = 0.65; 95% CI 0.52-0.82, NNT = 5), but not abdominal pain response (RR = 0.95; 95% CI 0.74-1.20). Conclusions: Although small numbers meant the primary endpoint was not met in this trial, when pooled with other similar trials meta-analysis suggests ondansetron improves stool consistency and reduces days with loose stool and urgency. Trial registration -
    • Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trial

      Blair, Peter S; Young, Grace; Clement, Clare; Dixon, P; Seume, Penny; Ingram, Jenny; Taylor, Jodi; Cabral, Christie; Lucas, Patricia J; Beech, Elizabeth; et al. (2023-04)
      Objective: To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. Design: Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. Setting: English primary care practices using the EMIS electronic medical record system. Participants: Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. Intervention: Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. Main outcome measures: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). Results: Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). Conclusions: This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way.
    • Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS)

      Taylor, Adrian H; Thompson, Tom P; Streeter, Adam; Chynoweth, Jade; Snowsill, Tristan; Ingram, Wendy; Ussher, Michael; Aveyard, Paul; Murray, Rachael L; Harris, Tess; et al. (2023-06)
      Aims: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. Design: A multi-centred pragmatic two-arm parallel randomised controlled trial. Setting: Primary care and the community across four United Kingdom sites. Participants: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. Interventions: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. Measurements: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. Findings: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. Conclusions: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.
    • Scaling-up a pharmacist-led information technology intervention (PINCER) to reduce hazardous prescribing in general practices: Multiple interrupted time series study

      Rodgers, Sarah; Taylor, Amelia C; Roberts, Stephen A; Allen, Thomas; Ashcroft, Darren; Barrett, James; Boyd, Matthew J; Elliott, Rachel A; Khunti, Kamlesh; Sheikh, Aziz; et al.
      Background: We previously reported on a randomised trial demonstrating the effectiveness and cost-effectiveness of a pharmacist-led information technology intervention (PINCER). We sought to investigate whether PINCER was effective in reducing hazardous prescribing when rolled out at scale in UK general practices. Methods and findings: We used a multiple interrupted time series design whereby successive groups of general practices received the PINCER intervention between September 2015 and April 2017. We used 11 prescribing safety indicators to identify potentially hazardous prescribing and collected data over a maximum of 16 quarterly time periods. The primary outcome was a composite of all the indicators; a composite for indicators associated with gastrointestinal (GI) bleeding was also reported, along with 11 individual indicators of hazardous prescribing. Data were analysed using logistic mixed models for the quarterly event numbers with the appropriate denominator, and calendar time included as a covariate. PINCER was implemented in 370 (94.1%) of 393 general practices covering a population of almost 3 million patients in the East Midlands region of England; data were successfully extracted from 343 (92.7%) of these practices. For the primary composite outcome, the PINCER intervention was associated with a decrease in the rate of hazardous prescribing of 16.7% (adjusted odds ratio (aOR) 0.83, 95% confidence interval (CI) 0.80 to 0.86) at 6 months and 15.3% (aOR 0.85, 95% CI 0.80 to 0.90) at 12 months postintervention. The unadjusted rate of hazardous prescribing reduced from 26.4% (22,503 patients in the numerator/853,631 patients in the denominator) to 20.1% (11,901 patients in the numerator/591,364 patients in the denominator) at 6 months and 19.1% (3,868 patients in the numerator/201,992 patients in the denominator). The greatest reduction in hazardous prescribing associated with the intervention was observed for the indicators associated with GI bleeding; for the GI composite indicator, there was a decrease of 23.9% at both 6 months (aOR 0.76, 95% CI 0.73 to 0.80) and 12 months (aOR 0.76, 95% CI 0.70 to 0.82) postintervention. The unadjusted rate of hazardous prescribing reduced from 31.4 (16,185 patients in the numerator/515,879 patients in the denominator) to 21.2% (7,607 patients in the numerator/358,349 patients in the denominator) at 6 months and 19.5% (2,369 patients in the numerator/121,534 patients in the denominator). We adjusted for calendar time and practice, but since this was an observational study, the findings may have been influenced by unknown confounding factors or behavioural changes unrelated to the PINCER intervention. Data were also not collected for all practices at 6 months and 12 months postintervention. Conclusions: The PINCER intervention, when rolled out at scale in routine clinical practice, was associated with a reduction in hazardous prescribing by 17% and 15% at 6 and 12 months postintervention. The greatest reductions in hazardous prescribing were for indicators associated with risk of GI bleeding. These findings support the wider national rollout of PINCER in England.
    • What Should Be Considered When Assessing Hyperacusis? A Qualitative Analysis of Problems Reported by Hyperacusis Patients

      Fackrell, Kathryn; Sereda, Magdalena; Smith, Sandra; Sheldrake, Jacqueline; Hoare, Derek James (2022-11)
      Hyperacusis (decreased sound tolerance) is a prevalent complaint. Yet, to date, no research has qualitatively evaluated the types of problems experienced by adults with hyperacusis. Our service evaluation aims to determine the hyperacusis-related problem domains reported by patients and the degree to which these domains were reported together. Retrospective analysis was conducted on an anonymised clinical dataset from 306 patients who attended a UK tinnitus and hyperacusis treatment centre between 1994 and 2017. Conventional content analysis was used to categorise responses to the question 'Why is hyperacusis a problem?' into domains which were then subjected to a cluster analysis. Twenty-five problem domains were identified, of which 12 were further classified into three overarching categories. 'Fear', 'Reduced quality of life' and 'Physical reaction to sound' were most frequently reported problems. Cluster analysis revealed that 'Sleep difficulties' and 'Despondency', were commonly reported together. Adults with hyperacusis face many challenges in their everyday lives. The nature of these problems indicates the need to develop complex interventions and assessments to aid management of hyperacusis. Current hyperacusis questionnaires may be useful in identifying some problem domains, but further assessment thorough patient interviews is required to fully explore all potential problems and make informed decisions about treatment.
    • Acceptability of integrating smoking cessation treatment into routine care for people with mental illness: A qualitative study

      Sawyer, Katherine; Fredman Stein, Kim; Freeman, Tom P; Blackwell, Anna K M; Metcalfe, Chris; Kessler, David; Munafo, Marcus R; Aveyard, Paul; Taylor, Gemma M J (2023-02)
      Introduction: Improving Access to Psychological Therapies (IAPTs) Services could offer smoking cessation treatment to improve physical and psychological outcomes for service users, but it currently does not. This study aimed to understand participants' views and experiences of receiving a novel smoking cessation intervention as part of the ESCAPE trial (intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety). We used the Capability, Opportunity and Motivation Model of Behaviour (COM-B) to understand the (i) acceptability of the integrated smoking cessation treatment, (ii) views of psychological well-being practitioners' (PWPs) ability to deliver the smoking cessation treatment and (iii) positive and negative impacts of smoking cessation treatment. Methods: This was a qualitative study embedded within a feasibility randomized-controlled trial (ESCAPE) in primary care services in the United Kingdom (IAPT). Thirty-six participants (53% female) from both usual care and intervention arms of the ESCAPE trial, including both quitters and nonquitters, were interviewed using semi-structured interviews. Data were analysed using a framework approach to thematic analysis, using the COM-B as a theoretical frame. Results: Psychological Capability: Integrated smoking cessation treatment was acceptable and encouraged participants to reflect on their mental health. Some participants found it difficult to understand nicotine withdrawal symptoms. Motivation: Participants were open to change during the event of presenting to IAPT. Some described being motivated to take part in the intervention by curiosity, to see whether quitting smoking would help their mental health. Physical Opportunity: IAPT has a natural infrastructure for supporting integrated treatment, but there were some barriers such as session duration and interventions feeling segmented. Social Opportunity: Participants viewed PWPs as having good interpersonal skills to deliver a smoking cessation intervention. Conclusion: People with common mental illness generally accepted integrated smoking cessation and mental health treatment. Smoking cessation treatment fits well within IAPT's structure; however, there are barriers to implementation.
    • Empagliflozin in Patients with Chronic Kidney Disease

      The EMPA-KIDNEY Collaborative Group (2023-01)
      Background: The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients. Methods: We enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m2 of body-surface area, or who had an eGFR of at least 45 but less than 90 ml per minute per 1.73 m2 with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 200. Patients were randomly assigned to receive empagliflozin (10 mg once daily) or matching placebo. The primary outcome was a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes. Results: A total of 6609 patients underwent randomization. During a median of 2.0 years of follow-up, progression of kidney disease or death from cardiovascular causes occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% confidence interval [CI], 0.64 to 0.82; P<0.001). Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.86; 95% CI, 0.78 to 0.95; P = 0.003), but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes (which occurred in 4.0% in the empagliflozin group and 4.6% in the placebo group) or death from any cause (in 4.5% and 5.1%, respectively). The rates of serious adverse events were similar in the two groups. Conclusions: Among a wide range of patients with chronic kidney disease who were at risk for disease progression, empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo. (Funded by Boehringer Ingelheim and others; EMPA-KIDNEY number, NCT03594110; EudraCT number, 2017-002971-24.).
    • Using cancer risk algorithms to improve risk estimates and referral decisions

      Kostopoulou, Olga; Arora, Kavleen; Palfi, Bence
      Background: Cancer risk algorithms were introduced to clinical practice in the last decade, but they remain underused. We investigated whether General Practitioners (GPs) change their referral decisions in response to an unnamed algorithm, if decisions improve, and if changing decisions depends on having information about the algorithm and on whether GPs overestimated or underestimated risk. Methods: 157 UK GPs were presented with 20 vignettes describing patients with possible colorectal cancer symptoms. GPs gave their risk estimates and inclination to refer. They then saw the risk score of an unnamed algorithm and could update their responses. Half of the sample was given information about the algorithm's derivation, validation, and accuracy. At the end, we measured their algorithm disposition. We analysed the data using multilevel regressions with random intercepts by GP and vignette. Results: We find that, after receiving the algorithm's estimate, GPs' inclination to refer changes 26% of the time and their decisions switch entirely 3% of the time. Decisions become more consistent with the NICE 3% referral threshold (OR 1.45 [1.27, 1.65], p < .001). The algorithm's impact is greatest when GPs have underestimated risk. Information about the algorithm does not have a discernible effect on decisions but it results in a more positive GP disposition towards the algorithm. GPs' risk estimates become better calibrated over time, i.e., move closer to the algorithm. Conclusions: Cancer risk algorithms have the potential to improve cancer referral decisions. Their use as learning tools to improve risk estimates is promising and should be further investigated.
    • Impact of meningococcal ACWY conjugate vaccines on pharyngeal carriage in adolescents: evidence for herd protection from the UK MenACWY programme

      Carr, Jeremy P; MacLennan, Jenny M; Plested, Emma; Bratcher, Holly B; Turner, David P J (2022-12)
      Objective: Serogroup W and Y invasive meningococcal disease increased globally from 2000 onwards. Responding to a rapid increase in serogroup W clonal complex 11 (W:cc11) invasive meningococcal disease, the UK replaced an adolescent booster dose of meningococcal C conjugate vaccine with quadrivalent MenACWY conjugate vaccine in 2015. By 2018, the vaccine coverage in the eligible school cohorts aged 14 to 19 years was 84%. We assessed the impact of the MenACWY vaccination programme on meningococcal carriage. Methods: An observational study of culture-defined oropharyngeal meningococcal carriage prevalence before and after the start of the MenACWY vaccination programme in UK school students, aged 15 to 19 years, using two cross-sectional studies: 2014 to 2015 "UKMenCar4" and 2018 "Be on the TEAM" (ISRCTN75858406). Results: A total of 10 625 participants preimplementation and 13 438 postimplementation were included. Carriage of genogroups C, W, and Y (combined) decreased from 2.03 to 0.71% (OR 0.34 [95% CI 0.27-0.44], p < 0.001). Carriage of genogroup B meningococci did not change (1.26% vs 1.23% [95% CI 0.77-1.22], p = 0.80) and genogroup C remained rare (n = 7/10 625 vs 17/13 438, p = 0.135). The proportion of serogroup positive isolates (i.e. those expressing capsule) decreased for genogroup W by 53.8% (95% CI -5.0 - 79.8, p = 0.016) and for genogroup Y by 30.1% (95% CI 8.946·3, p = 0.0025). Discussion: The UK MenACWY vaccination programme reduced carriage acquisition of genogroup and serogroup Y and W meningococci and sustained low levels of genogroup C carriage. These data support the use of quadrivalent MenACWY conjugate vaccine for indirect (herd) protection.
    • Peripheral artery disease (PAD) in primary care-educational experiences for PAD primary care in England - a mixed-method study

      Bridgwood, Bernadeta M; Sayers, Rob D
      Background: Peripheral artery disease (PAD), the pathophysiologic narrowing of arterial blood vessels of the lower leg due to atherosclerosis, is a highly prevalent disease, with sharp increases in prevalence with age. Primary care is ideally located to identify and manage PAD. Objectives: This study aims to identify the educational experiences, opinions, and confidence of primary care clinicians (PCCs) regarding PAD. Method: This mixed-method study was conducted within primary care in England. An online survey was completed with follow-on semistructured interviews, between January and September 2021, with PCCs, namely GPs, practice nurses, and allied professionals (survey n = 874, interviews n = 50). Results: PCCs report variation in PAD education received, where the content could not often be recalled. Patient-focussed experiential and self-directed learning, formed the largest method to gain PAD education. All PCCs recognized that they have an important role in recognizing PAD yet confidence in recognizing and diagnosing PAD was lacking. PCCs acknowledged that late or missed PAD diagnosis resulted in significant patient morbidity and mortality. Yet many did not recognize PAD as a common disease. Conclusion: As "specialist-generalists" with finite resources, education provided to primary care needs to be applicable for the multimorbid patient presentations often seen, utilizing resources available in primary care, with consideration to the time constraints endured.
    • The use of locum doctors in the NHS – results of a national survey of NHS Trusts in England

      Stringer, Gemma; Ferguson, Jane; Walshe, Kieran; Grigoroglou, Chris; Allen, Thomas; Kontopantelis, Evan; Ashcroft, Darren (2023-08)
      Background: Locum working in healthcare organisations has benefits for individual doctors and organisations but there are concerns about the impact of locum working on continuity of care, patient safety, team function and cost. We conducted a national survey of NHS Trusts in England to explore locum work, and better understand why and where locum doctors were needed; how locum doctors were engaged, supported, perceived and managed; and any changes being made in the way locums are used. Methods: An online survey was sent to 191 NHS Trusts and 98 were returned (51%) including 66 (67%) acute hospitals, 26 (27%) mental health and six (6%) community health providers. Data was analysed using frequency tables, t-tests and correlations. Free-text responses were analysed using thematic analysis. Results: Most NHS Trusts use locums frequently and for varying lengths of time. Trusts prefer to use locums from internal locum banks but frequently rely on locum agencies. The benefits of using locums included maintaining workforce capacity and flexibility. Importantly, care provided by locums was generally viewed as the same or somewhat worse when compared to care provided by permanent doctors. The main disadvantages of using locum agencies included cost, lack of familiarity and impact on organisational development. Some respondents felt that locums could be unreliable and less likely to be invested in quality improvement. NHS Trusts were broadly unfamiliar with the national guidance from NHS England for supporting locums and there was a focus on processes like compliance checks and induction, with less focus on providing feedback and support for appraisal. Conclusions: Locum doctors provide a necessary service within NHS Trusts to maintain workforce capacity and provide patient care. There are potential issues related to the way that locums are perceived, utilised, and supported which might impact the quality of the care that they provide. Future research should consider the arrangements for locum working and the performance of locums and permanent doctors, investigating the organisation of locums in order to achieve safe and high-quality care for patients.
    • Locum doctors in the NHS: Understanding and improving the quality and safety of healthcare

      Walshe, Kieran; Ferguson, Jane; Allen, Thomas; Grigoroglou, Chris; Stringer, Gemma; Kontopantelis, Evan; Ashcroft, Darren (2023)
      The NHS needs locum doctors. They are a key component of the In summary: medical workforce in the NHS and provide necessary flexibility and additional capacity for healthcare organisations and services. But they should be used appropriately, and where they are used, they should be supported effectively. The number of doctors working as locums, and the costs of this to the NHS have caused some concerns nationally in recent years. It has also been suggested that locum doctors may not provide as good a quality of care as permanent doctors. So, we set out to find out more, through two large surveys of NHS trusts and general practices in England; interviews and focus group discussions with staff in NHS organisations and with locums, locum agencies and patients; and by analysing data that had already been collected about the NHS workforce and about clinical care. This report presents our findings and their implications.
    • Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: a mixed methods study

      Polykarpos, Angelos Nomikos; Hall, Michelle; Fuller, Amy; Millar, Bonnie; Ogollah, Reuben; Valdes, Ana; Doherty, Michael; Walsh, David A; das Nair, Roshan; Abhishek, A (2021-07)
      Objectives: To evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain. Setting: Secondary care. Single-centre study. Study design: Mixed methods study. Participants: Eighteen adults with chronic knee pain. Inclusion criteria: Age >40 years, knee pain present for longer than 3 months, knee pain for most days of the previous month, at least moderate pain in two of the five domains of Western Ontario and McMaster Universities Osteoarthritis Index pain scale. Interventions: Nurse-led non-pharmacological intervention comprising assessment, education, exercise, use of hot/cold treatments, footwear modification, walking aids and weight-loss advice (if required). Outcomes: Primary: fidelity of delivery of intervention, secondary: nurses' experience of delivering intervention. Methods: Each intervention session with every participant was video recorded and formed part of fidelity assessment. Fidelity checklists were completed by the research nurse after each session and by an independent researcher, after viewing the video-recordings blinded to nurse ratings. Fidelity scores (%), percentage agreement and 95% Confidence Intervals (CI) were calculated. Two semi-structured interviews were conducted with the research nurse. Results: Fourteen participants completed all visits. 62 treatment sessions took place. Nurse self-report and assessor video rating scores for all 62 treatment sessions were included in fidelity assessment. Overall fidelity was higher on nurse self-report (97.7%) than on objective video-rating (84.2%). Percentage agreement between nurse self-report and video-rating was 73.3% (95% CI 71.3 to 75.3). Fidelity was lowest for advice on footwear and walking aids. The nurse reported difficulty advising on thermal treatments, footwear and walking aids, and did not feel confident negotiating achievable and realistic goals with participants. Conclusions: A trained research nurse can deliver most components of a non-pharmacological intervention for knee pain to a high degree of fidelity. Future research should assess intervention fidelity in a routine clinical setting, and examine its clinical and cost-effectiveness.
    • Effectiveness of systematically delivered evidence-based home safety promotion to improve child home safety practices: a controlled before-and-after study

      Taylor, Michael James; Orton, Elizabeth; Patel, Tina; Timblin, Clare; Clarke, Rachel; Watson, Michael Craig; Hayes, Mike; Jones, Matthew; Coupland, Carol; Kendrick, Denise
      Objective: Evaluate the effectiveness of systematically delivered evidence-based home safety promotion for improving child home safety practices. Design: Controlled before-and-after study. Setting: Nine electoral wards in Nottingham, UK. Participants: 361 families with children aged 2-7 months at recruitment living in four intervention wards with high health, education and social need; and 401 in five matched control wards. Intervention: Evidence-based home safety promotion delivered by health visiting teams, family mentors and children's centres including 24 monthly safety messages; home safety activity sessions; quarterly 'safety weeks'; home safety checklists. Outcomes: Primary: composite measure comprising having a working smoke alarm, storing poisons out of reach and having a stairgate. Secondary: other home safety practices; medically attended injuries. Parents completed questionnaires at 12 and 24 months after recruitment plus optional three monthly injury questionnaires. Results: At 24 months there was no significant difference between groups in the primary outcome (55.8% vs 48.8%; OR 1.58, 95% CI 0.98 to 2.55) or medically attended injury rates (incidence rate ratio 0.89, 95% CI 0.51 to 1.56), but intervention families were more likely to store poisons safely (OR 1.81, 95% CI 1.06 to 3.07), have a fire escape plan (OR 1.81, 95% CI 1.06 to 3.08), use a fireguard or have no fire (OR 3.17, 95% CI 1.63 to 6.16) and perform more safety practices (β 0.46, 95% CI 0.13 to 0.79). Conclusions: Systematic evidence-based home safety promotion in areas with substantial need increases adoption of some safety practices. Funders should consider commissioning evidence-based multicomponent child home safety interventions.
    • Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials

      Santer, Miriam; Muller, Ingrid; Becque, Taeko; Stuart, Beth; Hooper, Julie; Steele, Mary; Wilczynska, Sylvia; Sach, Tracey H; Ridd, Matthew J; Roberts, Amanda; et al. (2022-12)
      Objective To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management. Design Two independent, pragmatic, parallel group, unmasked, randomised controlled trials. Setting 98 general practices in England. Participants Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure). Interventions Participants were randomised (1:1) using online software to receive usual eczema care or an online ( behavioural intervention for eczema plus usual care. Main outcome measures Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles. Results 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score −1.5 (95% confidence interval −2.5 to −0.6; P=0.002) for parents or carers and −1.9 (−3.0 to −0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks −0.7 (95% confidence interval −1.0 to −0.4) for parents or carers and −0.9 (−1.3 to −0.6) for young people. No harms were identified in either group. Conclusions Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care.
    • Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial

      Kai, Joe; Dutton, Brittany; Vinogradova, Yana; Hilken, Nicholas; Gupta, Janesh; Daniels, Jane (2022-12)
      Background: Heavy menstrual bleeding (HMB) is a common problem that can significantly affect women's lives. There is a lack of evidence on long-term outcomes after seeking treatment. Aim: To assess continuation rates of medical treatments and rates of surgery in women 10 years after initial management for HMB in primary care. Design and setting: This was a prospective observational cohort study. Method: Women with HMB who participated in the ECLIPSE primary care trial (ISRCTN86566246) completed questionnaires 10 years after randomisation to the levonorgestrel-releasing intrauterine system (LNG-IUS) or other usual medical treatments (oral tranexamic acid, mefenamic acid, combined oestrogen-progestogen; or progesterone alone). Outcomes were rates of surgery, medical treatments, and quality of life using the 36-item Short-Form Health Survey (SF-36) and EuroQoL EQ-5D. Results: The responding cohort of 206 women was demographically and clinically representative of the original trial population. Mean age at baseline was 41.9 years (SD 4.9) and 53.7 years (SD 5.1) at follow-up. Over the 10-year follow-up, 60 of 206 (29.1%) women had surgery (hysterectomy n = 34, 16.5%; endometrial ablation n = 26, 12.6%). Between 5 and 10 years, 89 women (43.2%) ceased all medical treatments and 88 (42.7%) used LNG-IUS alone or in combination with other treatments. Fifty-six women (27.2%) were using LNG-IUS at 10 years. There were improvements over time in quality-of-life scores, with no evidence of differences in these or other outcomes between the two groups. Conclusion: Medical treatments for women with HMB can be successfully initiated in primary care, with low rates of surgery and improvement in quality of life observed a decade later.
    • Scale, scope and impact of skill mix change in primary care in England: a mixed-methods study

      McDermott, Imelda; Spooner, Sharon; Goff, Mhorag; Gibson, Jon; Dalgarno, Elizabeth; Francetic, Igor; Hann, Mark; Hodgson, Damian; McBride, Anne; Checkland, Katherine; et al. (2022-05)
      Background: General practices have had difficulty recruiting and retaining enough general practitioners to keep up with increasing demand for primary health care in recent years. Proposals to increase workforce capacity include a policy-driven strategy to employ additional numbers and a wider range of health professionals. Objectives: Our objective was to conduct a comprehensive study of the scale, scope and impact of changing patterns of practitioner employment in general practice in England. This included an analysis of employment trends, motivations behind employment decisions, staff and patient experiences, and how skill mix changes are associated with outcome measures and costs. Design: NHS Digital workforce data (2015–19) were used to analyse employment changes and to look at their association with outcomes data, such as the General Practitioner Patient Survey, General Practitioner Worklife Survey, prescribing data, Hospital Episode Statistics, Quality and Outcomes Framework and NHS payments to practices. A practice manager survey (August–December 2019) explored factors motivating general practices’ employment decisions. An in-depth case study of five general practices in England (August–December 2019) examined how a broader range of practitioners is experienced by practice staff and patients. Results: We found a 2.84% increase in reported full-time equivalent per 1000 patients across all practitioners during the study period. The full-time equivalent of general practitioner partners decreased, while the full-time equivalent of salaried general practitioners, advanced nurse practitioners, clinical pharmacists, physiotherapists, physician associates and paramedics increased. General practitioners and practice managers reported different motivating factors regarding skill mix employment. General practitioners saw skill mix employment as a strategy to cope with a general practitioner shortage, whereas managers prioritised potential cost-efficiencies. Case studies demonstrated the importance of matching patients’ problems with practitioners’ competencies and ensuring flexibility for practitioners to obtain advice when perfect matching was not achieved. Senior clinicians provided additional support and had supervisory and other responsibilities, and analysis of the General Practitioner Worklife Survey data suggested that general practitioners’ job satisfaction may not increase with skill mix changes. Patients lacked information about newer practitioners, but felt reassured by the accessibility of expert advice. However, General Practitioner Patient Survey data indicated that higher patient satisfaction was associated with a higher general practitioner full-time equivalent. Quality and Outcomes Framework achievement was higher when more practitioners were employed (i.e. full-time equivalent per 1000 patients). Higher clinical pharmacist full-time equivalents per 1000 patients were associated with higher quality and lower cost prescribing. Associations between skill mix and hospital activity were mixed. Our analysis of payments to practices and prescribing costs suggested that NHS expenditure may not decrease with increasing skill mix employment.
    • Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial

      Hawkey, Chris; Avery, Anthony; Coupland, Carol A C; Crooks, Colin; Dumbleton, Jennifer; Kendrick, Denise; Morris, Clive; Stevenson, Diane (2022-11)
      Background: Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. Methods: We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96. Findings: Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients). Interpretation: H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term.