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Recent Submissions

  • Evaluation of a Web-Based ADHD Awareness Training in Primary Care: Pilot Randomized Controlled Trial With Nested Interviews

    French, Blandine; Hall, Charlotte; Perez Vallejos, Elvira; Sayal, Kapil; Daley, David (2020-12)
    Background: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder affecting up to 5% of children and adults. Undiagnosed and untreated ADHD can result in adverse long-term health, educational, and social impacts for affected individuals. Therefore, it is important to identify this disorder as early as possible. General practitioners (GPs) frequently play a gatekeeper role in access to specialist services in charge of diagnosis and treatment. Studies have shown that their lack of knowledge and understanding about ADHD can create barriers to care. Objective: This pilot randomized controlled trial assesses the efficacy of a web-based psychoeducation program on ADHD tailored for GPs. Methods: A total of 221 participants were randomized to either a sham intervention control or an awareness training intervention and they completed questionnaires on ADHD knowledge, confidence, and attitude at 3 time points (preintervention, postintervention, and 2-week follow-up). Participants in the intervention arm were invited to participate in a survey and follow-up interview between 3 and 6 months after the intervention. Results: The responses of 109 GPs were included in the analysis. The knowledge (P<.001) and confidence (P<.001) of the GPs increased after the intervention, whereas misconceptions decreased (P=.04); this was maintained at the 2-week follow-up (knowledge, P<.001; confidence, P<.001; misconceptions, P=.03). Interviews and surveys also confirmed a change in practice over time. Conclusions: These findings demonstrate that a short web-based intervention can increase GPs' understanding, attitude, and practice toward ADHD, potentially improving patients' access to care.
  • Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial

    Ridd, Matthew J; Santer, Miriam; MacNeill, Stephanie J; Sanderson, Emily; Wells, Sian; Webb, Douglas; Banks, Jonathan; Sutton, Eileen; Roberts, Amanda; Liddiard, Lyn; et al.
    Background To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments. Methods We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529. Findings Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2–8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI –0·48 to 1·32), gel versus lotion 0·17 (–0·75 to 1·09), ointment versus lotion –0·01 (–0·93 to 0·91), gel versus cream –0·25 (–1·15 to 0·65), ointment versus cream –0·43 (–1·34 to 0·48), and ointment versus gel –0·18 (–1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135). Interpretation We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively.
  • Navigating possible endometriosis in primary care: a qualitative study of GP perspectives

    Dixon, Sharon; McNiven, Abigail; Talbot, Amelia; Hinton, Lisa (2021-09)
    Background: Endometriosis affects approximately 6-10% of women, with well documented delays between initial presentation with symptoms and diagnosis. In England, women typically seek help first in primary care, making this setting pivotal in women's pathways to diagnosis and treatment. English GP perspectives on managing possible endometriosis have not been previously reported. Aim: To explore what GPs identify as important considerations when caring for women with symptoms that raise the possibility of endometriosis. Design and setting: Qualitative study in English primary care. Method: Semi-structured scenario-based telephone interviews with 42 GPs from April 2019 to January 2020, based around a fictional scenario of a woman presenting to primary care with symptoms suggesting possible endometriosis. Interviews were thematically coded and analysed. Results: Managing possible endometriosis in primary care brings challenges. While knowledge and awareness were prerequisites for considering endometriosis, other important considerations were raised. Symptoms suggestive of endometriosis are non-specific, making endometriosis one possible consideration of many. GPs move through a diagnostic hierarchy to exclude sinister causes and utilise trials of treatment as both therapeutic interventions and diagnostic tools; processes which take time. An endometriosis label or diagnosis has advantages and risks. GPs reported sharing decisions about investigation and referral while holding women's priorities as pivotal. These conversations were underpinned by their knowledge of uncertainties and unknowns, including the wide spectrum and unpredictability of endometriosis. Conclusion: GPs considerations are more complex than simply lacking awareness. The unknowns surrounding endometriosis matter to GPs. Further research and tailored resources for primary care, where women present with undifferentiated symptoms, are needed.
  • Sustaining interventions in care homes initiated by quality improvement projects: a qualitative study

    Devi, Reena; Martin, Graham P; Banerjee, Jaydip; Gladman, John RF; Dening, Tom; Barat, Atena; Gordon, Adam Lee
    Introduction: Inadequate and varied quality of care in care homes has led to a proliferation of quality improvement (QI) projects. This study examined the sustainability of interventions initiated by such projects. Method: This qualitative study explored the sustainability of seven interventions initiated by three QI projects between 2016 and 2018 in UK care homes and explored the perceived influences to the sustainability of interventions. QI projects were followed up in 2019. Staff leading QI projects (n=9) and care home (n=21, from 13 care homes) and healthcare (n=2) staff took part in semi-structured interviews. Interventions were classified as sustained if the intervention was continued at the point of the study. Thematic analysis of interview data was performed, drawing on the Consolidated Framework for Sustainability (CFS), a 40-construct model of sustainability of interventions. Results: Three interventions were sustained and four interventions were not. Seven themes described perceptions around what influenced sustainability: monitoring outcomes and regular check-in; access to replacement intervention materials; staff willingness to dedicate time and effort towards interventions; continuity of staff and thorough handover/inductions in place for new staff; ongoing communication and awareness raising; perceived effectiveness; and addressing care home priorities. All study themes fell within 18 of the 40 CFS constructs. Discussion: Our findings resonate with the CFS and are also consistent with implementation theories, suggesting sustainability is best addressed during implementation rather than treated as a separate process which follows implementation. Commissioning and funding QI projects should address these considerations early on, during implementation.
  • Remote COVID-19 Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies

    Espinosa-Gonzalez, Ana; Prociuk, Denys; Fiorentino, Francesca; Ramtale, Christian; Mi, Ella; Glampson, Ben; Neves, Ana Luisa; Okusi, Cecilia; Husain, Laiba; Macartney, Jack; et al.
    Background: Accurate assessment of COVID-19 severity in the community is essential for patient care and requires COVID-19-specific risk prediction scores adequately validated in a community setting. Following a qualitative phase to identify signs, symptoms, and risk factors, we aimed to develop and validate two COVID-19-specific risk prediction scores. Remote COVID-19 Assessment in Primary Care-General Practice score (RECAP-GP; without peripheral oxygen saturation [SpO2]) and RECAP-oxygen saturation score (RECAP-O2; with SpO2). Methods: RECAP was a prospective cohort study that used multivariable logistic regression. Data on signs and symptoms (predictors) of disease were collected from community-based patients with suspected COVID-19 via primary care electronic health records and linked with secondary data on hospital admission (outcome) within 28 days of symptom onset. Data sources for RECAP-GP were Oxford-Royal College of General Practitioners Research and Surveillance Centre (RCGP-RSC) primary care practices (development set), northwest London primary care practices (validation set), and the NHS COVID-19 Clinical Assessment Service (CCAS; validation set). The data source for RECAP-O2 was the Doctaly Assist platform (development set and validation set in subsequent sample). The two probabilistic risk prediction models were built by backwards elimination using the development sets and validated by application to the validation datasets. Estimated sample size per model, including the development and validation sets was 2880 people. Findings: Data were available from 8311 individuals. Observations, such as SpO2, were mostly missing in the northwest London, RCGP-RSC, and CCAS data; however, SpO2 was available for 1364 (70·0%) of 1948 patients who used Doctaly. In the final predictive models, RECAP-GP (n=1863) included sex (male and female), age (years), degree of breathlessness (three point scale), temperature symptoms (two point scale), and presence of hypertension (yes or no); the area under the curve was 0·80 (95% CI 0·76-0·85) and on validation the negative predictive value of a low risk designation was 99% (95% CI 98·1-99·2; 1435 of 1453). RECAP-O2 included age (years), degree of breathlessness (two point scale), fatigue (two point scale), and SpO2 at rest (as a percentage); the area under the curve was 0·84 (0·78-0·90) and on validation the negative predictive value of low risk designation was 99% (95% CI 98·9-99·7; 1176 of 1183). Interpretation: Both RECAP models are valid tools to assess COVID-19 patients in the community. RECAP-GP can be used initially, without need for observations, to identify patients who require monitoring. If the patient is monitored and SpO2 is available, RECAP-O2 is useful to assess the need for treatment escalation.
  • Allied Health Professionals’ Perceptions of Research in the United Kingdom National Health Service: a survey of research capacity and culture

    Comer, Christine; Collings, Richard; McCracken, Alison; Payne, Carol; Moore, Ann
    Background With growing recognition of the importance of research in allied healthcare, the new Health Education England (HEE) research strategy articulates a need to transform Allied Health Professional (AHP) identities, culture and roles. An understanding of current AHP research capacity and culture is first required. Methods A cross-sectional survey targeted AHPs working in NHS health and social care settings across the United Kingdom. The validated Research Capacity and Culture tool was modified and distributed through research and professional networks. Aggregate median scores for perceived research success were categorised as adequate, more than, or less than adequate. Results Of 3344 participants, 3145 identified as HEE-defined AHP. Individual- and organisation-level research success was perceived as adequate (median scores 4 (IQR 2 to 6); 4 (IQR 2 to 7) respectively). Team-level research success was rated less than adequate (median score 2 (IQR 1–5)). Conclusions In the UK, AHPs working in NHS health and social care perceive individual and organisational level research skill/success to be adequate. In contrast, inadequacies in research skill/support at team level were exposed, which may hinder successful integration of allied health research into everyday health and social care practice. Recommendations are made with reference to the HEE AHP strategy.
  • Eleventh National GP Worklife Survey 2021

    Odebiyi, Bolanle; Walker, Ben; Gibson, Jon; Sutton, Matt; Spooner, Sharon; Checkland, Kath (2022-04)
    The University of Manchester has undertaken a national survey of General Practitioners’ working lives approximately every two years since 1998. This report describes the eleventh survey conducted during 2021.
  • Antibiotics for lower respiratory tract infection in children presenting in primary care (ARTIC-PC): the predictive value of molecular testing

    Little, Paul; Read, Robert C; Becque, Taeko; Francis, Nick A; Hay, Alastair D; Stuart, Beth; O'Reilly, Gilly; Thompson, Natalie; Hood, Kerenza; Faust, Saul; et al.
    Objectives: This study aimed to assess whether the presence of bacteria or viruses in the upper airway of children presenting with uncomplicated lower respiratory tract infection (LRTI) predicts the benefit of antibiotics. Methods: Children between 6 months and 12 years presenting to UK general practices with an acute LRTI were randomized to receive amoxicillin 50 mg/kg/d for 7 days or placebo. Children not randomized (ineligible or clinician/parental choice) could participate in a parallel observational study. The primary outcome was the duration of symptoms rated moderately bad or worse. Throat swabs were taken and analyzed for the presence of bacteria and viruses by multiplex PCR. Results: Swab results were available for most participants in the trial (306 of 432; 71%) and in the observational (182 of 326; 59%) studies. Bacterial pathogens potentially sensitive to amoxicillin (Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae) were detected among 51% of the trial placebo group and 49% of the trial antibiotic group. The median difference in the duration of symptoms rated moderately bad or worse between antibiotic and placebo was similar when potentially antibiotic-susceptible bacteria were present (median: -1 day; 99% CI, -12.3 to 10.3) or not present (median: -1 day; 99% CI, -4.5 to 2.5). Furthermore, bacterial genome copy number did not predict benefit. There were similar findings for all secondary outcomes and when including the data from the observational study. Discussion: There was no clear evidence that antibiotics improved clinical outcomes conditional on the presence or concentration of bacteria or viruses in the upper airway. Before deploying microbiologic point-of-care tests for children with uncomplicated LRTI in primary care, rigorous validating trials are needed.
  • Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT

    Armstrong-Buisseret, Lindsay; Brittain, Clare; Kai, Joe; David, Miruna; Anstey Watkins, Jocelyn; Ozolins, Mara; Jackson, Louise; Abdali, Zainab; Hepburn, Trish; Griffiths, Frances; et al. (2022-01)
    Background: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. Objectives: The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi). Design: This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial. Setting: This took place in one general practice and 19 sexual health centres in the UK. Participants: Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part. Interventions: The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control). Main outcome measures: The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness. Results: Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204; 70%) than with lactic acid gel (97/205; 47%) (adjusted risk difference -23.2%, 95% confidence interval -32.3% to -14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71%; lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole. Limitations: Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment. Conclusions: A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal samples would be useful to identify additional factors affecting response to treatment.