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Feasibility and Acceptability of Community COVID-19 Testing Strategies (FACTS) in a University Setting
Background: During the COVID-19 pandemic in 2020, the UK government began a mass SARS-CoV-2 testing programme. This study aimed to determine the feasibility and acceptability of organised regular self-testing for SARS-CoV-2.Methods: This was a mixed methods observational cohort study in asymptomatic students and staff at University of Oxford, who performed SARS-CoV-2 antigen lateral flow self-testing. Data on uptake and adherence, acceptability, and test interpretation were collected via a smartphone app, an online survey, and qualitative interviews.Findings: Across three main sites, 551 participants (25% of those invited) performed 2728 tests during a follow-up of 5.6 weeks. 447 participants (81%) completed at least two, and 340 (62%) completed at least four tests. The survey, completed by 214 participants (39%), found that 98% of people were confident to self-test and believed self-testing to be beneficial. Acceptability of self-testing was high, with 91% of ratings being acceptable or very acceptable. 2711 (99.4%) test results were negative, nine were positive and eight were inconclusive. Results from eighteen qualitative interviews with staff and students revealed that participants valued regular testing, but there were concerns about test accuracy that impacted uptake and adherence.Interpretation: This is the first study to assess feasibility and acceptability of regular SARS-CoV-2 self-testing. It provides evidence to inform recruitment, adherence to, and acceptability of regular SARS-CoV-2 self-testing programmes for asymptomatic individuals using lateral flow tests. We found that self-testing is acceptable and people were able to interpret results accurately.Funding: This work was funded by Oxford University Medical Science DivisionsDeclaration of Interests: LT works part-time for Sensyne Health as R&D Director and holds share options in the company. He also reports a research grant and personal fees from the company.Ethics Approval Statement: FACTS is a mixed methods cohort study conducted at the University of Oxford. It was approved by the University of Oxford Research Ethics Committee in October 2020 (CUREC ethics reference R72896/RE001).
Non-contact physiological monitoring of post-operative patients in the Intensive Care Unit
Abstract Prolonged non-contact camera-based monitoring in critically ill patients presents unique challenges, but may facilitate safe recovery. A study was designed to evaluate the feasibility of introducing a non-contact video camera monitoring system into an acute clinical setting. We assessed the accuracy and robustness of the video camera-derived estimates of the vital signs against the electronically-recorded reference values in both day and night environments. We demonstrated non-contact monitoring of heart rate and respiratory rate for extended periods of time in 15 post-operative patients. Across day and night, heart rate was estimated for up to 53.2% (103.0 hours) of the total valid camera data with a mean absolute error (MAE) of 2.5 beats/min in comparison to two reference sensors. We obtained respiratory rate estimates for 63.1% (119.8 hours) of the total valid camera data with a MAE of 2.4 breaths/min against the reference value computed from the chest impedance pneumogram. Non-contact estimates detected relevant changes in the vital-sign values between routine clinical observations. Pivotal respiratory events in a post-operative patient could be identified from the analysis of video-derived respiratory information. Continuous vital-sign monitoring supported by non-contact video camera estimates could be used to track early signs of physiological deterioration during post-operative care.
Identification of barriers and facilitators to information exchange about a deteriorating patient’s escalation of care: A Human Factors Analysis
Failure to identify and treat physiological deterioration in hospitalised patients is a recurring theme in acute care literature. This results in increased Intensive Care Unit (ICU) admissions, length of hospital stay and mortality. There is evidence of unacceptable time-delays between significant physiological deterioration and referral to the ICU medical team. Despite advances in standardising patient care there continues to be Failure to Rescue (FTR) events. Contributing factors have been cited such as poor understanding of illness severity, lack of situational awareness from clinical staff and information barriers. Little is known about the ‘work as done’, workarounds and facilitators within escalation of care (EOC). Qualitative research has identified many contextual factors which affect FTR, but there is little human factors research that frames information exchange during the deteriorating patient’s EOC. https://epostersonline.com/soa2017/node/1061
Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.
Comparative accuracies of automated and manual office blood pressure measurements in a Chinese population
We aimed to assess the difference in the accuracy of readings from automated office blood pressure machines with each other or with manual office blood pressure measurements in Chinese individuals. We collected awake 48-h ambulatory blood pressure monitoring, two automated office blood pressure device (BpTRU and WatchBP) readings, and manual office blood pressure measurements in Chinese patients (n = 135) with hypertension in a randomized sequence. Differences were compared using paired t-tests and Bland–Altman plots. The sensitivity and specificity of the techniques for detecting elevated blood pressure were calculated using awake ambulatory blood pressure monitoring as the reference standard. The WatchBP device’s and awake ambulatory blood pressure readings were similar. The BpTRU device provided significantly lower mean systolic (P < 0.001) and diastolic (P < 0.001) blood pressure readings, while manual office BP provided significantly higher mean systolic (P = 0.008) and diastolic (P < 0.001) blood pressure readings than the awake automated office blood pressure readings. Automated and manual office blood pressure measurements showed similar sensitivity, specificity, and 95% limits of agreement as based on Bland–Altman plots. The mean systolic (P < 0.001) and diastolic (P < 0.02) blood pressure readings of WatchBP and BpTRU differed, and their diagnostic performances were not superior than those of manual office blood pressure measurements in Chinese patients. Therefore, automated office blood pressure measurements cannot be routinely recommended for Chinese individuals in clinical practice. More studies are needed to confirm these results.
Frequencies and patterns of microbiology test requests from primary care in Oxfordshire, UK, 2008-2018: a retrospective cohort study of electronic health records to inform point-of-care testing.
OBJECTIVES: To inform point-of-care test (POCT) development, we quantified the primary care demand for laboratory microbiology tests by describing their frequencies overall, frequencies of positives, most common organisms identified, temporal trends in testing and patterns of cotesting on the same and subsequent dates. DESIGN: Retrospective cohort study. SETTING: Primary care practices in Oxfordshire. PARTICIPANTS: 393 905 patients (65% female; 49% aged 18-49). PRIMARY AND SECONDARY OUTCOME MEASURES: The frequencies of all microbiology tests requested between 2008 and 2018 were quantified. Patterns of cotesting were investigated with heat maps. All analyses were done overall, by sex and age categories. RESULTS: 1 596 752 microbiology tests were requested. Urine culture±microscopy was the most common of all tests (n=673 612, 42%), was mainly requested without other tests and was the most common test requested in follow-up within 7 and 14 days. Of all urine cultures, 180 047 (27%) were positive and 172 651 (26%) showed mixed growth, and Escherichia coli was the most prevalent organism (132 277, 73% of positive urine cultures). Antenatal urine cultures and blood tests in pregnancy (hepatitis B, HIV and syphilis) formed a common test combination, consistent with their use in antenatal screening. CONCLUSIONS: The greatest burden of microbiology testing in primary care is attributable to urine culture ± microscopy; genital and routine antenatal urine and blood testing are also significant contributors. Further research should focus on the feasibility and impact of POCTs for these specimen types.
A natural experiment comparing the effectiveness of the “healthy eagles” child weight management intervention in school versus community settings
Behavioural weight management interventions are recommended for the treatment of obesity in children. However, the evidence for these is limited and often generated under trial conditions with White, middle-class populations. Healthy Eagles is a behavioural weight management intervention designed to treat excess weight in children. It ran in the London Borough of Croydon from 2017 to 2020 and was delivered in both school and community settings, providing a natural experiment to compare outcomes. A total of 1560 participants started the Healthy Eagles programme; 347 were in the community setting and 703 in the school setting. Data were analysed for those who completed 70% of the programme. In the school setting, there was a small but significant reduction in BMI z-score (M = −0.04, 95% CI = −0.08, −0.01) for participants above a healthy weight, especially in those with severe obesity (M = −0.09, 95% CI = −0.15, −0.03); there was no significant change in any subgroup in the community setting. Linear regression analysis showed the school setting was associated with a 0.26 (95% CI = 0.13, 0.49) greater reduction in BMI z-score than the community setting after adjusting for ethnicity, deprivation, age and gender. Across both programmes, the effect was somewhat greater in participants from a Black (African/Caribbean/Other) ethnic background (M = −0.06, 95% CI = −0.09, −0.02) and from the two most deprived quintiles (M = −0.06, 95% CI = −0.11, −0.01). Data were limited, but minimal changes were measured in nutrition and physical activity behaviours regardless of setting. This evaluation provides indirect evidence of a small but significant benefit to running weight management interventions in a school versus community setting.
Effectiveness of interventions that support penicillin allergy assessment and de-labelling of patients by non-allergy specialists: a systematic review protocol.
OBJECTIVE: This review will systematically examine and synthesize the evidence evaluating the effectiveness and safety of interventions that enable non-allergy specialist health care workers to assess allergy risk in patients with reported penicillin allergies and subsequently remove erroneous allergy records. INTRODUCTION: The potential benefits of removing erroneous penicillin allergy labels (de-labeling) are wide-ranging. Penicillin allergy assessment and de-labeling is an antibiotic stewardship priority. Delivery of such assessment and de-labeling by non-allergy specialists has been reported in several studies, but the effectiveness and safety have not been formally synthesized. This is a necessary step in the upscaling of penicillin allergy assessment services. INCLUSION CRITERIA: This review will consider quantitative studies using appropriate designs. The studies will include adults and pediatric patients who have undergone penicillin allergy assessment and de-labeling by non-allergy specialists in any health care setting. METHODS: A range of databases will be searched to identify studies published in English, with no date limit. Unpublished studies and gray literature will also be searched. Title and abstract screening, and assessment of selected full texts against the inclusion criteria will be conducted by at least two independent reviewers. Identified studies will be assessed for methodological quality using standardized critical appraisal instruments. Data will be extracted and categorized using the EPOC taxonomy, and the effectiveness and safety of the intervention will be determined. Where possible, data will be pooled to facilitate meta-analysis. Data from heterogeneous studies will be reported narratively. The GRADE approach for grading the certainty of evidence will be followed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020219044.
When I use a word . . . . No jab, no job? A benefit:harm balance analysis.
The current debate about whether individuals should be entitled to work in the healthcare sector if they decline to be vaccinated against SARS-CoV2 has been largely informed by personal opinions and argument by analogy. A benefit:harm balance analysis suggests that while vaccination has a highly favourable benefit:harm balance, the balance in instituting a "no jab, no job" policy is highly uncertain and may be unfavourable. Furthermore, there are practical difficulties and legal uncertainties. The much misunderstood precautionary principle dictates that if the benefit:harm balance of an intervention is unclear and may be unfavourable, the intervention should not be undertaken. Furthermore, the onus is on those who believe that the benefit:harm balance will be favourable to prove that it is so; it is not for the sceptics to prove that it isn't. In the absence of good evidence in favour, this is an intervention that would be best avoided.
Value, challenges and practical considerations when designing, conducting and analysing a longitudinal qualitative study in family medicine.
Qualitative longitudinal design has a long tradition in a variety of social science disciplines and is increasingly used in applied healthcare research, including family medicine. While there are many definitions of longitudinal qualitative research (LQR), its most common characteristics are multiple data collection points and its focus on temporality, which prioritise the study of change and continuity. Thus, LQR can provide insights into the nature, causes and consequences of change (or its absence). In this paper, we discuss the key steps and considerations related to designing and conducting LQR in family medicine and community health. These include (1) deciding on the length of data collection and timing and number of interviews, (2) planning recruitment: attrition versus oversampling, (3) approaching data collection: asking the same or different questions, (4) planning and conducting the analysis and writing up findings, and (5) conducting ethical LQR. We also highlight what LQR can offer family medicine and community health, including (1) allowing exploration of views and experiences of a variety of participants over time; (2) following participants through important transitions; (3) studying implementation of new practices, processes or interventions; (4) exploring the importance of historical change and/or macro context on individuals' lives; and (5) developing a deeper understanding of phenomena under study. While a lot of attention has been paid to using LQR when studying patients' and/or carers' experiences, we highlight its value when studying a variety of actors relevant to family medicine, including healthcare professionals and policy makers.
Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial
BACKGROUND Inhaled budesonide has shown efficacy for treating COVID-19 in the community but has not yet been tested in effectiveness trials. METHODS We performed a multicenter, open-label, multi-arm, adaptive platform randomized controlled trial involving people aged ≥65 years, or ≥50 years with comorbidities, and unwell ≤14 days with suspected COVID-19 in the community (PRINCIPLE). Participants were randomized to usual care, usual care plus inhaled budesonide (800µg twice daily for 14 days), or usual care plus other interventions. The co-primary endpoints are time to first self-reported recovery, and hospitalization/death related to COVID-19, both measured over 28 days from randomisation and analysed using Bayesian models. RESULTS The trial opened on April 2, 2020. Randomization to inhaled budesonide began on November 27, 2020 and was stopped on March 31, 2021 based on an interim analysis using data from March 4, 2021. Here, we report updated interim analysis data from March 25, 2021, at which point the trial had randomized 4663 participants with suspected COVID-19. Of these, 2617 (56.1%) tested SARS-CoV-2 positive and contributed data to this interim budesonide primary analysis; 751 budesonide, 1028 usual care and 643 to other interventions. Time to first self-reported recovery was shorter in the budesonide group compared to usual care (hazard ratio 1.208 [95% BCI 1.076 – 1.356], probability of superiority 0.999, estimated benefit [95% BCI] of 3.011 [1.134 – 5.41] days). Among those in the interim budesonide primary analysis who had the opportunity to contribute data for 28 days follow up, there were 59/692 (8.5%) COVID-19 related hospitalizations/deaths in the budesonide group vs 100/968 (10.3%) in the usual care group (estimated percentage benefit, 2.1% [95% BCI −0.7% – 4.8%], probability of superiority 0.928). CONCLUSIONS In this updated interim analysis, inhaled budesonide reduced time to recovery by a median of 3 days in people with COVID-19 with risk factors for adverse outcomes. Once 28 day follow up is complete for all participants randomized to budesonide, final analyses of time to recovery and hospitalization/death will be published. (Funded by the National Institute of Health Research/ United Kingdom Research Innovation [MC_PC_19079]; PRINCIPLE ISRCTN number, ISRCTN86534580 .)
Point-of-care blood tests during home visits by out-of-hours primary care clinicians; A mixed methods evaluation of a service improvement
© © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Objectives We aimed to evaluate test usage and patient and clinician experience following the introduction of point-of-care (POC) blood tests into a primary care out-of-hours service. Design A mixed methods service evaluation comprising quantitative records of the clinical contexts of tests taken and qualitative interviews with clinicians. Research permissions and governance were obtained for patient interviews. Setting Out-of-hours primary care. Participants All patients requiring home visits from the service during the implementation period. Interventions The i-STAT POC blood test platform was introduced to two bases providing home visits for a period of 8 months. Venous blood samples were used and two cartridges were available. The CHEM8 cartridge measures sodium, potassium, chloride, total carbon dioxide (TCO2), anion gap, ionised calcium, glucose, urea, creatinine, haematocrit and haemoglobin. The CG4 cartridge measures lactate, pH, PaO2 and PCO2, TCO2, bicarbonate, base excess and oxygen saturation. Primary and secondary outcome measures The proportion of home visits where tests were taken, the clinical contexts of those tests, the extent to which clinicians felt the tests had influenced their decisions, time taken to perform the test and problems encountered. Clinician and patient experiences of using POC tests. Results i-STAT POC tests were infrequently used, with successful tests taken at just 47 contacts over 8 months of implementation. The patients interviewed felt that testing had been beneficial for their care. Clinician interviews suggested barriers to POC tests, including practical challenges, concerns about time, doubt over whether they would improve clinical decision making and concern about increased medicolegal risk. Suggestions for improving adoption included sharing learning, adopting a whole team approach and developing protocols for usage. Conclusions POC tests were not successfully adopted by an out-of-hours home visiting service in Oxfordshire. While some clinicians felt they could not add value, in other cases they resulted in improved patient experience. Adoption could be promoted by improving technical, team and education factors.