Recent Submissions

  • 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 (www.EczemaCareOnline.org.uk) 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.
  • 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.