BJGP Open最新文献

{"title":"Acute cystitis in men- a nationwide study from primary care: antibiotic prescriptions, risk factors, and complications.","authors":"Håkon Sætre, Marius Skow, Ingvild Vik, Sigurd Høye, Louise Emilsson","doi":"10.3399/BJGPO.2023.0207","DOIUrl":"10.3399/BJGPO.2023.0207","url":null,"abstract":"<p><strong>Background: </strong>Research on acute cystitis in men is scarce and treatment guidelines differ between countries. Improved antibiotic stewardship is needed.</p><p><strong>Aim: </strong>To analyse antibiotic prescriptions and outcomes of Norwegian men diagnosed with cystitis in primary care.</p><p><strong>Design & setting: </strong>A nationwide retrospective study was undertaken in primary care in Norway.</p><p><strong>Method: </strong>We identified all episodes of acute cystitis in men diagnosed in Norwegian primary care during 2012-2019. Choice of antibiotic (from the Norwegian Prescription Database), treatment failure, re-prescription, and complications were stratified by age, calendar year, and risk factors. We used logistic regression to explore predefined risk factors (diabetes, prostate cancer, benign prostate hyperplasia [BPH], urinary retention, and any cancer) with complications (pyelonephritis, prostatitis, and hospitalisation) and re-prescriptions. Linear regression was used to explore time trends.</p><p><strong>Results: </strong>In total, 108 994 individuals contributed 148 635 episodes. Narrow-spectrum antibiotics were first-choice treatment in 71.0% of the episodes (52.5% of all prescriptions were pivmecillinam). More than 75% of the episodes with narrow-spectrum versus 82.2% of broad-spectrum treatment did not lead to any re-prescription or complication. Complications occurred in 1.8% of all episodes (0.5% prostatitis, 0.7% pyelonephritis, and 0.7% hospitalisation). BPH was associated with increased risk of complications and re-prescription. Diabetes was associated with a lower risk of re-prescriptions. Prostate cancer and urinary retention were associated with a lower risk of both complications and re-prescriptions.</p><p><strong>Conclusion: </strong>Our results support narrow-spectrum antibiotics as first-line treatment. Risk factor analyses warrants further investigation.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gender inequalities across ethnicities in primary care cancer referrals: a scoping review protocol.","authors":"Deepthi Lavu, Adnan Khan, Judit Konya, Tanimola Martins, Sarah Price, Richard Neal","doi":"10.3399/BJGPO.2023.0211","DOIUrl":"10.3399/BJGPO.2023.0211","url":null,"abstract":"<p><strong>Background: </strong>Early cancer diagnosis is associated with improved mortality and morbidity; however, studies indicate that women and individuals from ethnic minorities experience longer times to diagnosis and worse prognosis compared with their counterparts for various cancers. In countries with a gatekeeper healthcare system, such as the UK, most suspected cancer referrals are initiated in primary care.</p><p><strong>Aim: </strong>To understand the extent of evidence available on the relationship between primary care cancer referral pathways and cancer outcomes in relation to gender across different ethnic groups. This will identify research gaps and enable development of strategies to ease potential inequalities in cancer diagnosis.</p><p><strong>Design & setting: </strong>A scoping review of articles written in English, based on the Joanna Briggs Institute methodology. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) will be used.</p><p><strong>Method: </strong>Electronic databases and private collections of the team members will be searched for studies. Two independent reviewers will carry out the study selection and data extraction. Based on Population (or participants), Concept, and Context (PCC) framework, this review will consider studies after year 2000, which explored the relationship between gender, across various ethnic groups, and cancer outcomes, following primary care cancer referral in countries with gatekeeper healthcare systems (UK, New Zealand, Sweden, Australia, Canada, Denmark, Republic of Ireland, and Norway). Results will be presented as a narrative analysis.</p><p><strong>Conclusion: </strong>The results are expected to provide an overview of the discrepancies in primary care cancer referrals based on gender across ethnic groups, which will be crucial to define an appropriate range of strategies to ease any inequalities in primary healthcare cancer diagnosis.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An evaluation of the social deprivation practice grant in Irish general practice.","authors":"Muireann O Shea, Bridget Kiely, Patrick O'Donnell, Susan M Smith","doi":"10.3399/BJGPO.2023.0195","DOIUrl":"10.3399/BJGPO.2023.0195","url":null,"abstract":"<p><strong>Background: </strong>The inverse care law states that availability of good medical care varies inversely with the need for it in the population served. In 2019, the main medical union and the Department of Health in the Republic of Ireland (RoI), agreed on funding a social deprivation practice grant for general practices in urban deprived areas.</p><p><strong>Aim: </strong>To examine the implementation and impact of the social deprivation practice grant in participating general practices.</p><p><strong>Design & setting: </strong>A mixed-methods study with sequential design based in Irish general practice.</p><p><strong>Method: </strong>Data were collected using a questionnaire and online semi-structured interviews with GPs and practice staff. Data were analysed separately, and the findings compared to examine the extent to which they converged or diverged.</p><p><strong>Results: </strong>There were 25 survey responses and nine interviews. All practices reported the grant was beneficial and most practices utilised the grant to fund additional doctor hours (17/25). Both surveys and interviews indicated that a small amount of additional funding allowed additional clinical need in areas of deprivation to be addressed, but there were some barriers identified in accessing the grant and implementing planned expenditure.</p><p><strong>Conclusion: </strong>Delivery of health care in areas of socioeconomic deprivation presents significant challenges. While there were some problems with implementation, the introduction of a small, targeted grant for general practices in areas of social deprivation allowed those practices to enhance their services, with tailored initiatives seeking to meet the needs of their patient populations.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139940962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peripheral artery disease recognition, diagnosis, and management in general practice in the Republic of Ireland and England: an online survey.","authors":"Judit Konya, Sinead Tj McDonagh, Peter Hayes, Sebastian Debus, Victor Aboyans, Christopher E Clark","doi":"10.3399/BJGPO.2023.0150","DOIUrl":"10.3399/BJGPO.2023.0150","url":null,"abstract":"<p><strong>Background: </strong>Peripheral artery disease (PAD) is common and associated with future cardiovascular events. PAD is underdiagnosed, which limits opportunities to address secondary prevention of cardiovascular disease. It is unknown how closely guidelines for detection of PAD are followed in primary care.</p><p><strong>Aim: </strong>To survey GPs' attitudes to diagnosis and follow-up of patients with PAD.</p><p><strong>Design & setting: </strong>Online survey of GPs in England and the Republic of Ireland (RoI).</p><p><strong>Method: </strong>GPs' approaches to management of PAD were assessed using likelihood ratings (scales of 0-10) and discrete questions. Findings were summarised as proportions, or median and interquartile ranges (IQR).</p><p><strong>Results: </strong>In total, 111 responses were analysed; 68 (61%) from England and 43 (39%) from the RoI. Considering a hypothetical patient at risk of PAD, likelihood of GPs enquiring about PAD symptoms (leg pains: 3/10 or erectile dysfunction: 2/10) was low. GPs in the RoI compared with GPs in England more often examined the heart (10/10 versus 7/10) or carotid vessels (5/10 versus 1/10). Lower limb pulses were palpated in response to symptoms or signs of PAD. In England 25% of practitioners, and in the RoI 55% of practitioners, reported that they do not measure ankle-brachial index (ABI).</p><p><strong>Conclusion: </strong>Currently, detection of PAD is generally triggered by 'classical' leg claudication symptoms, while known vascular risk factors appear to elicit little consideration. ABI measurement is not performed by many practitioners, suggesting that a proportion of vascular referrals must be based on history and examination findings alone. Opportunities to recognise PAD are missed.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140029194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The commercial determinants of health in Ireland: fueling an industrial epidemic at home and abroad.","authors":"Mélissa Mialon, James Larkin, Clare Patton, Mimi Tatlow-Golden, Kathryn Reilly, Paula Leonard, Malvina Walsh, Norah Campbell","doi":"10.3399/BJGPO.2024.0029","DOIUrl":"10.3399/BJGPO.2024.0029","url":null,"abstract":"","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140870109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Barriers, enablers, benefits, and drawbacks to point-of-care testing: a survey of the general practice out-of-hours service in Scotland.","authors":"Sarah Ee Mills, Sm Babar Akbar, Virginia Hernandez-Santiago","doi":"10.3399/BJGPO.2023.0094","DOIUrl":"10.3399/BJGPO.2023.0094","url":null,"abstract":"<p><strong>Background: </strong>The general practice out-of-hours (GPOOH) service is under pressure to treat more patients in less time, while reducing referrals and minimising diagnostic errors. Point-of-care (POC) testing involves rapid clinical tests that can be used to generate results during the consultation, and has the potential to facilitate managing these competing demands safely.</p><p><strong>Aim: </strong>To describe current availability of POC tests in GPOOH in Scotland, and identify barriers, enablers, benefits, and drawbacks to its use.</p><p><strong>Design & setting: </strong>Cross-sectional mixed-methods study, which surveyed opinions of clinicians working in the GPOOH service in NHS Scotland.</p><p><strong>Method: </strong>An electronic questionnaire was developed, designed, piloted, and distributed to clinicians, which had closed questions and areas for free text.</p><p><strong>Results: </strong>In total, 142 responses were received. Urine dipstick testing (99.2%), pregnancy tests (98.5%), oxygen saturation (97.7%), and blood glucose testing (93.9%), were the only POC tests commonly available in GPOOH in NHS Scotland. There was strongest support for the provision of POC tests, particularly C-reactive protein (CRP; 79.4%), strep A (76.0%), and D-dimer (75.2%). Responders felt that POC tests would improve confidence (92.3%) and safety (89.8%) surrounding clinical decision making, improve patient satisfaction (80.6%), and reduce hospital and secondary care referrals (77.5%). Barriers to POC test use were availability of the test kits and machines (94.5%), training requirements on how to use the machine (71.1%) and interpret results (56.3%), and time to do the test (62.0%).</p><p><strong>Conclusion: </strong>Few POC tests are in regular use in GPOOH in Scotland. GPOOH clinicians are supportive of using POC testing. They identified a number of benefits to its use, with very few drawbacks. Increased provision of POC testing in GPOOH in NHS Scotland should be considered urgently.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138810025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GPs' views on emergency care treatment plans: an online survey.","authors":"Martin Underwood, Angela Noufaily, Hazel Blanchard, Jeremy Dale, Jenny Harlock, Paramjit Gill, Frances Griffiths, Rachel Spencer, Anne-Marie Slowther","doi":"10.3399/BJGPO.2023.0192","DOIUrl":"10.3399/BJGPO.2023.0192","url":null,"abstract":"<p><strong>Background: </strong>A holistic approach to emergency care treatment planning is needed to ensure that patients' preferences are considered should their clinical condition deteriorate. To address this, emergency care and treatment plans (ECTPs) have been introduced. Little is known about their use in general practice.</p><p><strong>Aim: </strong>To find out GPs' experiences of, and views on, using ECTPs.</p><p><strong>Design & setting: </strong>Online survey of GPs practising in England.</p><p><strong>Method: </strong>A total of 841 GPs were surveyed using the monthly online survey provided by medeConnect, a market research company.</p><p><strong>Results: </strong>Forty-one per cent of responders' practices used Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) plans for ECTP, 8% used other ECTPs, and 51% used Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) forms. GPs were the predominant professional group completing ECTPs in the community. There was broad support for a wider range of community-based health and social care professionals being able to complete ECTPs. There was no system for reviewing ECTPs in 20% of responders' practices. When compared with using a DNACPR form, GPs using a ReSPECT form for ECTP were more comfortable having conversations about emergency care treatment with patients (odds ratio [OR] = 1.72, 95% confidence interval [CI] = 1.1 to 2.69) and family members (OR =1.85, 95% CI = 1.19 to 2.87).</p><p><strong>Conclusion: </strong>The potential benefits and challenges of widening the pool of health and social care professionals initiating and/or completing the ECTP process needs consideration. ReSPECT plans appear to make GPs more comfortable with ECTP discussions, supporting their implementation. Practice-based systems for reviewing ECTP decisions should be strengthened.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Overprescribing of potentially harmful medication: an observational study in England's general practice.","authors":"Tasneem Khan, Bethan Copsey, Paul Carder, Stella Johnson, Mohammed Imran, Kaiwen Wang, Sarah Alderson","doi":"10.3399/BJGPO.2023.0156","DOIUrl":"10.3399/BJGPO.2023.0156","url":null,"abstract":"<p><strong>Background: </strong>Overprescribing of potentially harmful medication in UK general practice has a complex association with socioeconomic deprivation.</p><p><strong>Aim: </strong>To assess trends in general practice prescribing of five high-risk medications and their relationship with deprivation.</p><p><strong>Design & setting: </strong>An observational study was conducted using general practice data from three English regions with varied sociodemographic factors: West Yorkshire and Harrogate (WY), Black Country and West Birmingham (BC), and Surrey and East Sussex (SE).</p><p><strong>Method: </strong>Practice-level prescribing data were obtained from 2016-2021 for five drug classes: opioids, hypnotics, gabapentinoids, non-steroidal anti-inflammatory drugs (NSAIDs), and antibacterials. Prescribing trends were demonstrated using a linear model.</p><p><strong>Results: </strong>Reduction in NSAID, opioid, hypnotic and antibacterial prescriptions, and the increase in gabapentinoid prescriptions, were significant at each financial year time period. Index of Multiple Deprivation (IMD) was positively associated with all drug classes except antibacterials, which showed a positive association when incorporating the interaction term between IMD and age.When adjusting for IMD and population, region was independently associated with prescribing rate. Compared with WY, IMD had a smaller association with prescribing in BC for NSAIDs (coefficient = -0.01578, <i>P</i> = 0.004) and antibacterials (coefficient = -0.02769, <i>P</i> = 0.007), whereas IMD had a greater association with prescribing in SE for NSAIDs (coefficient = 0.02443, <i>P</i><0.001), opioids (coefficient = 0.08919, <i>P</i><0.001), hypnotics (coefficient = 0.09038, <i>P</i><0.001), gabapentinoids (coefficient = 0.1095, <i>P</i><0.001), and antibacterials (coefficient = 0.01601, <i>P</i> = 0.19).</p><p><strong>Conclusion: </strong>The association of socioeconomic deprivation with overprescribing of high-risk medication in general practice varies by region and drug type. Geographical location is associated with overprescribing, independent of socioeconomic status.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139521976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How, when and who should ask about pregnancy intentions in primary care? A qualitative study of primary health care professionals' preferences.","authors":"Jennifer Hall, Helen Carr, Anne Connolly, Geraldine Barrett","doi":"10.3399/BJGPO.2024.0148","DOIUrl":"https://doi.org/10.3399/BJGPO.2024.0148","url":null,"abstract":"<p><strong>Background: </strong>Knowing people's pregnancy intentions would help health care professionals (HCPs) to take a holistic approach to reproductive health, and particularly to providing preconception care.</p><p><strong>Aim: </strong>To assess the feasibility of implementation of questions about pregnancy preferences in a range of primary care settings in Great Britain, including digital implementation.</p><p><strong>Design & setting: </strong>Qualitative study using online semi-structured interviews with primary care professionals across Great Britain in 2022.</p><p><strong>Method: </strong>Twelve online interviews were conducted with GPs (n=3), practice nurses (n=3), sexual and reproductive health professionals (n=4) and health visitors (n=2). Framework analysis was conducted in Nvivo, adapting a coding frame from complementary interviews with women.</p><p><strong>Results: </strong>HCPs perceived asking about pregnancy preferences as valuable in meeting patients' reproductive health needs and most suited to women's health consultations, medication and disease reviews, baby checks, or as an addition to lifestyle questions leading to health promotion advice. An introductory, non-discriminatory signposting sentence was well-liked, and the preferred question in a face-to-face clinical encounter was asking how the person would feel about a pregnancy in the next year, in line with women's preference. Guidance and training would give clinicians confidence in knowing how to ask about pregnancy preferences and advise their patients accordingly.</p><p><strong>Conclusion: </strong>Asking about pregnancy intentions is acceptable to women and HCPs and feasible in primary care, but implementation needs to be adapted to the patient and context. Digital options that enable patients to self-manage can reduce the need for HCP input and avoid medicalising a normal process.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice.","authors":"Dajana Tare, Samuel Coenen, An De Sutter, Stefan Heytens, Dirk Devroey, Laetitia Buret, Birgitte Schoenmakers, Nicolas Delvaux, Jan Y Verbakel, Kris Bogaerts, Ann van den Bruel","doi":"10.3399/BJGPO.2023.0109","DOIUrl":"10.3399/BJGPO.2023.0109","url":null,"abstract":"<p><strong>Background: </strong>The DAWN antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment.</p><p><strong>Aim: </strong>To explore which factors contributed to the premature termination.</p><p><strong>Design & setting: </strong>General practice in Belgium.</p><p><strong>Method: </strong>Patients were randomised to camostat or placebo (patients and physicians blinded) between June 2021 and July 2022; a third arm evaluating molnupiravir (open label) was opened in March 2022. The outcome assessor was blinded for all comparisons except for the patient reported outcomes in case of molnupiravir. The authors analysed available trial data and evaluated trial context, implementation, and mechanisms of impact based on semi-structured interviews with trial stakeholders.</p><p><strong>Results: </strong>The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years), and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; and staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun.</p><p><strong>Conclusion: </strong>The DAWN antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as a small and inexperienced sponsor and clinical teams, delays in regulatory processes, and research capacity in routine settings could be overcome by established research infrastructure and standardisation of processes.</p>","PeriodicalId":36541,"journal":{"name":"BJGP Open","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138177487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}