Effectiveness and safety of pulse oximetry in remote patient monitoring of patients with COVID-19: a systematic review.

The COVID-19 pandemic has led health systems to increase the use of tools for monitoring and triaging patients remotely. In this systematic review, we aim to assess the effectiveness and safety of pulse oximetry in remote patient monitoring (RPM) of patients at home with COVID-19. We searched five databases (MEDLINE, Embase, Global Health, medRxiv, and bioRxiv) from database inception to April 15, 2021, and included feasibility studies, clinical trials, and observational studies, including preprints. We found 561 studies, of which 13 were included in our narrative synthesis. These 13 studies were all observational cohorts and involved a total of 2908 participants. A meta-analysis was not feasible owing to the heterogeneity of the outcomes reported in the included studies. Our systematic review substantiates the safety and potential of pulse oximetry for monitoring patients at home with COVID-19, identifying the risk of deterioration and the need for advanced care. The use of pulse oximetry can potentially save hospital resources for patients who might benefit the most from care escalation; however, we could not identify explicit evidence for the effect of RPM with pulse oximetry on health outcomes compared with other monitoring models such as virtual wards, regular monitoring consultations, and online or paper diaries to monitor changes in symptoms and vital signs. Based on our findings, we make 11 recommendations across the three Donabedian model domains and highlight three specific measurements for setting up an RPM system with pulse oximetry.

Factors associated with enrolment into a national COVID-19 pulse oximetry remote monitoring programme in England: a retrospective observational study.

BACKGROUND: Hypoxaemia is an important predictor of severity in individuals with COVID-19 and can present without symptoms. The COVID Oximetry @home (CO@h) programme was implemented across England in November, 2020, providing pulse oximeters to higher-risk people with COVID-19 to enable early detection of deterioration and the need for escalation of care. We aimed to describe the clinical and demographic characteristics of individuals enrolled onto the programme and to assess whether there were any inequalities in enrolment. METHODS: This retrospective observational study was based on data from a cohort of people resident in England recorded as having a positive COVID-19 test between Oct 1, 2020, and May 3, 2021. The proportion of participants enrolled onto the CO@h programmes in the 7 days before and 28 days after a positive COVID-19 test was calculated for each clinical commissioning group (CCG) in England. Two-level hierarchical multivariable logistic regression with random intercepts for each CCG was run to identify factors predictive of being enrolled onto the CO@h programme. FINDINGS: CO@h programme sites were reported by NHS England as becoming operational between Nov 21 and Dec 31, 2020. 1 227 405 people resident in 72 CCGs had a positive COVID-19 test between the date of programme implementation and May 3, 2021, of whom 19 932 (1·6%) were enrolled onto the CO@h programme. Of those enrolled, 14 441 (72·5%) were aged 50 years or older or were identified as clinically extremely vulnerable (ie, having a high-risk medical condition). Higher odds of enrolment onto the CO@h programme were found in older individuals (adjusted odds ratio 2·21 [95% CI 2·19-2·23], p<0·001, for those aged 50-64 years; 3·48 [3·33-3·63], p<0·001, for those aged 65-79 years; and 2·50 [2·34-2·68], p<0·001, for those aged ≥80 years), in individuals of non-White ethnicity (1·35 [1·28-1·43], p<0·001, for Asian individuals; 1·13 [1·04-1·22], p=0·005, for Black individuals; and 1·17 [1·03-1·32], p=0·015, for those of mixed ethnicity), in those who were overweight (1·31 [1·26-1·37], p<0·001) or obese (1·69 [1·63-1·77], p<0·001), or in those identified as clinically extremely vulnerable (1·58 [1·51-1·65], p<0·001), and lower odds were reported in those from the least socioeconomically deprived areas compared with those from the most socioeconomically deprived areas (0·75 [0·69-0·81]; p<0·001). INTERPRETATION: Nationally, uptake of the CO@h programme was low, with clinical judgment used to determine eligibility. Preferential enrolment onto the pulse oximetry monitoring programme was observed in people known to be at the highest risk of developing severe COVID-19. FUNDING: NHS England, National Institute for Health Research, and The Wellcome Trust.

Evaluating the impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in patients with COVID-19 assessed in emergency departments in England: a retrospective matched cohort study.

BACKGROUND: To identify the impact of enrolment onto a national pulse oximetry remote monitoring programme for COVID-19 (COVID-19 Oximetry @home; CO@h) on health service use and mortality in patients attending Emergency Departments (EDs). METHODS: We conducted a retrospective matched cohort study of patients enrolled onto the CO@h pathway from EDs in England. We included all patients with a positive COVID-19 test from 1 October 2020 to 3 May 2021 who attended ED from 3 days before to 10 days after the date of the test. All patients who were admitted or died on the same or following day to the first ED attendance within the time window were excluded. In the primary analysis, participants enrolled onto CO@h were matched using demographic and clinical criteria to participants who were not enrolled. Five outcome measures were examined within 28 days of first ED attendance: (1) Death from any cause; (2) Any subsequent ED attendance; (3) Any emergency hospital admission; (4) Critical care admission; and (5) Length of stay. RESULTS: 15 621 participants were included in the primary analysis, of whom 639 were enrolled onto CO@h and 14 982 were controls. Odds of death were 52% lower in those enrolled (95% CI 7% to 75%) compared with those not enrolled onto CO@h. Odds of any ED attendance or admission were 37% (95% CI 16% to 63%) and 59% (95% CI 32% to 91%) higher, respectively, in those enrolled. Of those admitted, those enrolled had 53% (95% CI 7% to 76%) lower odds of critical care admission. There was no significant impact on length of stay. CONCLUSIONS: These findings indicate that for patients assessed in ED, pulse oximetry remote monitoring may be a clinically effective and safe model for early detection of hypoxia and escalation. However, possible selection biases might limit the generalisability to other populations.

Clinical pathway of COVID-19 patients in primary health care in 30 European countries: Eurodata study.

BACKGROUND: Most COVID-19 patients were treated in primary health care (PHC) in Europe. OBJECTIVES: To demonstrate the scope of PHC workflow during the COVID-19 pandemic emphasising similarities and differences of patient's clinical pathways in Europe. METHODS: Descriptive, cross-sectional study with data acquired through a semi-structured questionnaire in PHC in 30 European countries, created ad hoc and agreed upon among all researchers who participated in the study. GPs from each country answered the approved questionnaire. Main variable: PHC COVID-19 acute clinical pathway. All variables were collected from each country as of September 2020. RESULTS: COVID-19 clinics in PHC facilities were organised in 8/30. Case detection and testing were performed in PHC in 27/30 countries. RT-PCR and lateral flow tests were performed in PHC in 23/30, free of charge with a medical prescription. Contact tracing was performed mainly by public health authorities. Mandatory isolation ranged from 5 to 14 days. Sick leave certification was given exclusively by GPs in 21/30 countries. Patient hotels or other resources to isolate patients were available in 12/30. Follow-up to monitor the symptoms and/or new complementary tests was made mainly by phone call (27/30). Chest X-ray and phlebotomy were performed in PHC in 18/30 and 23/30 countries, respectively. Oxygen and low-molecular-weight heparin were available in PHC (21/30). CONCLUSION: In Europe PHC participated in many steps to diagnose, treat and monitor COVID-19 patients. Differences among countries might be addressed at European level for the management of future pandemics.

The use of mobile apps and fitness trackers to promote healthy behaviors during COVID-19: A cross-sectional survey.

OBJECTIVES: To examine i) the use of mobile apps and fitness trackers in adults during the COVID-19 pandemic to support health behaviors; ii) the use of COVID-19 apps; iii) associations between using mobile apps and fitness trackers, and health behaviors; iv) differences in usage amongst population subgroups. METHODS: An online cross-sectional survey was conducted during June-September 2020. The survey was developed and reviewed independently by co-authors to establish face validity. Associations between using mobile apps and fitness trackers and health behaviors were examined using multivariate logistic regression models. Subgroup analyses were conducted using Chi-square and Fisher's exact tests. Three open-ended questions were included to elicit participants' views; thematic analysis was conducted. RESULTS: Participants included 552 adults (76.7% women; mean age: 38±13.6 years); 59.9% used mobile apps for health, 38.2% used fitness trackers, and 46.3% used COVID-19 apps. Users of mobile apps or fitness trackers had almost two times the odds of meeting aerobic physical activity guidelines compared to non-users (odds ratio = 1.91, 95% confidence interval 1.07 to 3.46, P = .03). More women used health apps than men (64.0% vs 46.8%, P = .004). Compared to people aged 18-44 (46.1%), more people aged 60+ (74.5%) and more people aged 45-60 (57.6%) used a COVID-19 related app (P < .001). Qualitative data suggest people viewed technologies (especially social media) as a 'double-edged sword': helping with maintaining a sense of normalcy and staying active and socially connected, but also having a negative emotional effect stemming from seeing COVID-related news. People also found that mobile apps did not adapt quickly enough to the circumstances caused by COVID-19. CONCLUSIONS: Use of mobile apps and fitness trackers during the pandemic was associated with higher levels of physical activity, in a sample of educated and likely health-conscious individuals. Future research is needed to understand whether the association between using mobile devices and physical activity is maintained in the long-term.

Remote COVID-19 Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies.

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. FUNDING: Community Jameel and the Imperial College President's Excellence Fund, the Economic and Social Research Council, UK Research and Innovation, and Health Data Research UK.

General practitioners' perceptions of using virtual primary care during the COVID-19 pandemic: An international cross-sectional survey study.

With the onset of COVID-19, general practitioners (GPs) and patients worldwide swiftly transitioned from face-to-face to digital remote consultations. There is a need to evaluate how this global shift has impacted patient care, healthcare providers, patient and carer experience, and health systems. We explored GPs' perspectives on the main benefits and challenges of using digital virtual care. GPs across 20 countries completed an online questionnaire between June-September 2020. GPs' perceptions of main barriers and challenges were explored using free-text questions. Thematic analysis was used to analyse the data. A total of 1,605 respondents participated in our survey. The benefits identified included reducing COVID-19 transmission risks, guaranteeing access and continuity of care, improved efficiency, faster access to care, improved convenience and communication with patients, greater work flexibility for providers, and hastening the digital transformation of primary care and accompanying legal frameworks. Main challenges included patients' preference for face-to-face consultations, digital exclusion, lack of physical examinations, clinical uncertainty, delays in diagnosis and treatment, overuse and misuse of digital virtual care, and unsuitability for certain types of consultations. Other challenges include the lack of formal guidance, higher workloads, remuneration issues, organisational culture, technical difficulties, implementation and financial issues, and regulatory weaknesses. At the frontline of care delivery, GPs can provide important insights on what worked well, why, and how during the pandemic. Lessons learned can be used to inform the adoption of improved virtual care solutions and support the long-term development of platforms that are more technologically robust and secure.

Population-level impact of a pulse oximetry remote monitoring programme on mortality and healthcare utilisation in the people with COVID-19 in England: a national analysis using a stepped wedge design.

BACKGROUND: To identify the population-level impact of a national pulse oximetry remote monitoring programme for COVID-19 (COVID Oximetry @home (CO@h)) in England on mortality and health service use. METHODS: We conducted a retrospective cohort study using a stepped wedge pre-implementation and post-implementation design, including all 106 Clinical Commissioning Groups (CCGs) in England implementing a local CO@h programme. All symptomatic people with a positive COVID-19 PCR test result from 1 October 2020 to 3 May 2021, and who were aged ≥65 years or identified as clinically extremely vulnerable were included. Care home residents were excluded. A pre-intervention period before implementation of the CO@h programme in each CCG was compared with a post-intervention period after implementation. Five outcome measures within 28 days of a positive COVID-19 test: (i) death from any cause; (ii) any ED attendance; (iii) any emergency hospital admission; (iv) critical care admission and (v) total length of hospital stay. RESULTS: 217 650 people were eligible and included in the analysis. Total enrolment onto the programme was low, with enrolment data received for only 5527 (2.5%) of the eligible population. The period of implementation of the programme was not associated with mortality or length of hospital stay. The period of implementation was associated with increased health service utilisation with a 12% increase in the odds of ED attendance (95% CI: 6% to 18%) and emergency hospital admission (95% CI: 5% to 20%) and a 24% increase in the odds of critical care admission in those admitted (95% CI: 5% to 47%). In a secondary analysis of CO@h sites with at least 10% or 20% of eligible people enrolled, there was no significant association with any outcome measure. CONCLUSION: At a population level, there was no association with mortality before and after the implementation period of the CO@h programme, and small increases in health service utilisation were observed. However, lower than expected enrolment is likely to have diluted the effects of the programme at a population level.

Safety implications of remote assessments for suspected COVID-19: qualitative study in UK primary care.

BACKGROUND: The introduction of remote triage and assessment early in the pandemic raised questions about patient safety. We sought to capture patients and clinicians' experiences of the management of suspected acute COVID-19 and generate wider lessons to inform safer care. SETTING AND SAMPLE: UK primary healthcare. A subset of relevant data was drawn from five linked in-pandemic qualitative studies. The data set, on a total of 87 participants recruited via social media, patient groups and snowballing, comprised free text excerpts from narrative interviews (10 survivors of acute COVID-19), online focus groups (20 patients and 30 clinicians), contributions to a Delphi panel (12 clinicians) and fieldnotes from an online workshop (15 patients, clinicians and stakeholders). METHODS: Data were uploaded onto NVivo. Coding was initially deductive and informed by WHO and Institute of Medicine frameworks of quality and safety. Further inductive analysis refined our theorisation using a wider range of theories-including those of risk, resilience, crisis management and social justice. RESULTS: In the early weeks of the pandemic, patient safety was compromised by the driving logic of 'stay home' and 'protect the NHS', in which both patients and clinicians were encouraged to act in a way that helped reduce pressure on an overloaded system facing a novel pathogen with insufficient staff, tools, processes and systems. Furthermore, patients and clinicians observed a shift to a more transactional approach characterised by overuse of algorithms and decision support tools, limited empathy and lack of holistic assessment. CONCLUSION: Lessons from the pandemic suggest three key strategies are needed to prevent avoidable deaths and inequalities in the next crisis: (1) strengthen system resilience (including improved resourcing and staffing; support of new tools and processes; and recognising primary care's role as the 'risk sink' of the healthcare system); (2) develop evidence-based triage and scoring systems; and (3) address social vulnerability.

Use and impact of virtual primary care on quality and safety: The public's perspectives during the COVID-19 pandemic.

INTRODUCTION: With the onset of Coronavirus disease (COVID-19), primary care has swiftly transitioned from face-to-face to virtual care, yet it remains largely unknown how this has impacted the quality and safety of care. We aim to evaluate patient use of virtual primary care models during COVID-19, including change in uptake, perceived impact on the quality and safety of care and willingness of future use. METHODOLOGY: An online cross-sectional survey was administered to the public across the United Kingdom, Sweden, Italy and Germany. McNemar tests were conducted to test pre- and post-pandemic differences in uptake for each technology. One-way analysis of variance was conducted to examine patient experience ratings and perceived impacts on healthcare quality and safety across demographic characteristics. RESULTS: Respondents (n = 6326) reported an increased use of telephone consultations ( + 6.3%, p < .001), patient-initiated services ( + 1.5%, n = 98, p < 0.001), video consultations ( + 1.4%, p < .001), remote triage ( + 1.3, p < 0.001) and secure messaging systems ( + 0.9%, p = .019). Experience rates using virtual care technologies were higher for men (2.4 ± 1.0 vs. 2.3 ± 0.9, p < .001), those with higher literacy (2.8 ± 1.0 vs. 2.3 ± 0.9, p < .001), and participants from Germany (2.5 ± 0.9, p < .001). Healthcare timeliness and efficiency were the dimensions most often reported as being positively impacted by virtual technologies (60.2%, n = 2793 and 55.7%, n = 2,401, respectively), followed by effectiveness (46.5%, n = 1802), safety (45.5%, n = 1822), patient-centredness (45.2%, n = 45.2) and equity (42.9%, n = 1726). Interest in future use was highest for telephone consultations (55.9%), patient-initiated digital services (56.1%), secure messaging systems (43.4%), online triage (35.1%), video consultations (37.0%) and chat consultations (30.1%), although significant variation was observed between countries and patient characteristics. DISCUSSION: Future work must examine the drivers and determinants of positive experiences using remote care to co-create a supportive environment that ensures equitable adoption and use. Comparative analysis between countries and health systems offers the opportunity for policymakers to learn from best practices internationally.

COVID-19 surveillance data quality issues: a national consecutive case series.

OBJECTIVES: High-quality data are crucial for guiding decision-making and practising evidence-based healthcare, especially if previous knowledge is lacking. Nevertheless, data quality frailties have been exposed worldwide during the current COVID-19 pandemic. Focusing on a major Portuguese epidemiological surveillance dataset, our study aims to assess COVID-19 data quality issues and suggest possible solutions. SETTINGS: On 27 April 2020, the Portuguese Directorate-General of Health (DGS) made available a dataset (DGSApril) for researchers, upon request. On 4 August, an updated dataset (DGSAugust) was also obtained. PARTICIPANTS: All COVID-19-confirmed cases notified through the medical component of National System for Epidemiological Surveillance until end of June. PRIMARY AND SECONDARY OUTCOME MEASURES: Data completeness and consistency. RESULTS: DGSAugust has not followed the data format and variables as DGSApril and a significant number of missing data and inconsistencies were found (eg, 4075 cases from the DGSApril were apparently not included in DGSAugust). Several variables also showed a low degree of completeness and/or changed their values from one dataset to another (eg, the variable 'underlying conditions' had more than half of cases showing different information between datasets). There were also significant inconsistencies between the number of cases and deaths due to COVID-19 shown in DGSAugust and by the DGS reports publicly provided daily. CONCLUSIONS: Important quality issues of the Portuguese COVID-19 surveillance datasets were described. These issues can limit surveillance data usability to inform good decisions and perform useful research. Major improvements in surveillance datasets are therefore urgently needed-for example, simplification of data entry processes, constant monitoring of data, and increased training and awareness of healthcare providers-as low data quality may lead to a deficient pandemic control.

An Early Warning Risk Prediction Tool (RECAP-V1) for Patients Diagnosed With COVID-19: Protocol for a Statistical Analysis Plan.

BACKGROUND: Since the start of the COVID-19 pandemic, efforts have been made to develop early warning risk scores to help clinicians decide which patient is likely to deteriorate and require hospitalization. The RECAP (Remote COVID-19 Assessment in Primary Care) study investigates the predictive risk of hospitalization, deterioration, and death of patients with confirmed COVID-19, based on a set of parameters chosen through a Delphi process performed by clinicians. We aim to use rich data collected remotely through the use of electronic data templates integrated in the electronic health systems of several general practices across the United Kingdom to construct accurate predictive models. The models will be based on preexisting conditions and monitoring data of a patient's clinical parameters (eg, blood oxygen saturation) to make reliable predictions as to the patient's risk of hospital admission, deterioration, and death. OBJECTIVE: This statistical analysis plan outlines the statistical methods to build the prediction model to be used in the prioritization of patients in the primary care setting. The statistical analysis plan for the RECAP study includes the development and validation of the RECAP-V1 prediction model as a primary outcome. This prediction model will be adapted as a three-category risk score split into red (high risk), amber (medium risk), and green (low risk) for any patient with suspected COVID-19. The model will predict the risk of deterioration and hospitalization. METHODS: After the data have been collected, we will assess the degree of missingness and use a combination of traditional data imputation using multiple imputation by chained equations, as well as more novel machine-learning approaches to impute the missing data for the final analysis. For predictive model development, we will use multiple logistic regression analyses to construct the model. We aim to recruit a minimum of 1317 patients for model development and validation. We will then externally validate the model on an independent dataset of 1400 patients. The model will also be applied for multiple different datasets to assess both its performance in different patient groups and its applicability for different methods of data collection. RESULTS: As of May 10, 2021, we have recruited 3732 patients. A further 2088 patients have been recruited through the National Health Service Clinical Assessment Service, and approximately 5000 patients have been recruited through the DoctalyHealth platform. CONCLUSIONS: The methodology for the development of the RECAP-V1 prediction model as well as the risk score will provide clinicians with a statistically robust tool to help prioritize COVID-19 patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04435041; https://clinicaltrials.gov/ct2/show/NCT04435041. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30083.

Virtual primary care in high-income countries during the COVID-19 pandemic: Policy responses and lessons for the future.

BACKGROUND: Telemedicine, once defined merely as the treatment of certain conditions remotely, has now often been supplanted in use by broader terms such as 'virtual care', in recognition of its increasing capability to deliver a diverse range of healthcare services from afar. With the unexpected onset of COVID-19, virtual care (e.g. telephone, video, online) has become essential to facilitating the continuation of primary care globally. Over several short weeks, existing healthcare policies have adapted quickly and empowered clinicians to use digital means to fulfil a wide range of clinical responsibilities, which until then have required face-to-face consultations. OBJECTIVES: This paper aims to explore the virtual care policies and guidance material published during the initial months of the pandemic and examine their potential limitations and impact on transforming the delivery of primary care in high-income countries. METHODS: A rapid review of publicly available national policies guiding the use of virtual care in General Practice was conducted. Documents were included if issued in the first six months of the pandemic (March to August of 2020) and focussed primarily on high-income countries. Documents must have been issued by a national health authority, accreditation body, or professional organisation, and directly refer to the delivery of primary care. RESULTS: We extracted six areas of relevance: primary care transformation during COVID-19, the continued delivery of preventative care, the delivery of acute care, remote triaging, funding & reimbursement, and security standards. CONCLUSION: Virtual care use in primary care saw a transformative change during the pandemic. However, despite the advances in the various governmental guidance offered, much work remains in addressing the shortcomings exposed during COVID-19 and strengthening viable policies to better incorporate novel technologies into the modern primary care clinical environment.

Evaluating the Impact of COVID-19 on the Adoption of Virtual Care in General Practice in 20 Countries (inSIGHT): Protocol and Rationale Study.

BACKGROUND: In recent decades, virtual care has emerged as a promising option to support primary care delivery. However, despite the potential, adoption rates remained low. With the outbreak of COVID-19, it has suddenly been pushed to the forefront of care delivery. As we progress into the second year of the COVID-19 pandemic, there is a need and opportunity to review the impact remote care had in primary care settings and reassess its potential future role. OBJECTIVE: This study aims to explore the perspectives of general practitioners (GPs) and family doctors on the (1) use of virtual care during the COVID-19 pandemic, (2) perceived impact on quality and safety of care, and (3) essential factors for high-quality and sustainable use of virtual care in the future. METHODS: This study used an online cross-sectional questionnaire completed by GPs distributed across 20 countries. The survey was hosted in Qualtrics and distributed using email, social media, and the researchers' personal contact networks. GPs were eligible for the survey if they were working mainly in primary care during the period of the COVID-19 pandemic. Descriptive statistical analysis will be performed for quantitative variables, and relationships between the use of virtual care and perceptions on impact on quality and safety of care and participants' characteristics may be explored. Qualitative data (free-text responses) will be analyzed using framework analysis. RESULTS: Data collection took place from June 2020 to September 2020. As of this manuscript's submission, a total of 1605 GP respondents participated in the questionnaire. Further data analysis is currently ongoing. CONCLUSIONS: The study will provide a comprehensive overview of the availability of virtual care technologies, perceived impact on quality and safety of care, and essential factors for high-quality future use. In addition, a description of the underlying factors that influence this adoption and perceptions, in both individual GP and family doctor characteristics and the context in which they work, will be provided. While the COVID-19 pandemic may prove the first great stress test of the capabilities, capacity, and robustness of digital systems currently in use, remote care will likely remain an increasingly common approach in the future. There is an imperative to identify the main lessons from this unexpected transformation and use them to inform policy decisions and health service design. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30099.

Reorganisation of GP surgeries during the COVID-19 outbreak: analysis of guidelines from 15 countries.

BACKGROUND: General practitioners (GPs) play a key role in managing the COVID-19 outbreak. However, they may encounter difficulties adapting their practices to the pandemic. We provide here an analysis of guidelines for the reorganisation of GP surgeries during the beginning of the pandemic from 15 countries. METHODS: A network of GPs collaborated together in a three-step process: (i) identification of key recommendations of GP surgery reorganisation, according to WHO, CDC and health professional resources from health care facilities; (ii) collection of key recommendations included in the guidelines published in 15 countries; (iii) analysis, comparison and synthesis of the results. RESULTS: Recommendations for the reorganisation of GP surgeries of four types were identified: (i) reorganisation of GP consultations (cancelation of non-urgent consultations, follow-up via e-consultations), (ii) reorganisation of GP surgeries (area partitioning, visual alerts and signs, strict hygiene measures), (iii) reorganisation of medical examinations by GPs (equipment, hygiene, partial clinical examinations, patient education), (iv) reorganisation of GP staff (equipment, management, meetings, collaboration with the local community). CONCLUSIONS: We provide here an analysis of guidelines for the reorganisation of GP surgeries during the beginning of the COVID-19 outbreak from 15 countries. These guidelines focus principally on clinical care, with less attention paid to staff management, and the area of epidemiological surveillance and research is largely neglected. The differences of guidelines between countries and the difficulty to apply them in routine care, highlight the need of advanced research in primary care. Thereby, primary care would be able to provide recommendations adapted to the real-world settings and with stronger evidence, which is especially necessary during pandemics.

Predicting Risk of Hospital Admission in Patients With Suspected COVID-19 in a Community Setting: Protocol for Development and Validation of a Multivariate Risk Prediction Tool.

BACKGROUND: During the pandemic, remote consultations have become the norm for assessing patients with signs and symptoms of COVID-19 to decrease the risk of transmission. This has intensified the clinical uncertainty already experienced by primary care clinicians when assessing patients with suspected COVID-19 and has prompted the use of risk prediction scores, such as the National Early Warning Score (NEWS2), to assess severity and guide treatment. However, the risk prediction tools available have not been validated in a community setting and are not designed to capture the idiosyncrasies of COVID-19 infection. OBJECTIVE: The objective of this study is to produce a multivariate risk prediction tool, RECAP-V1 (Remote COVID-19 Assessment in Primary Care), to support primary care clinicians in the identification of those patients with COVID-19 that are at higher risk of deterioration and facilitate the early escalation of their treatment with the aim of improving patient outcomes. METHODS: The study follows a prospective cohort observational design, whereby patients presenting in primary care with signs and symptoms suggestive of COVID-19 will be followed and their data linked to hospital outcomes (hospital admission and death). Data collection will be carried out by primary care clinicians in four arms: North West London Clinical Commissioning Groups (NWL CCGs), Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), Covid Clinical Assessment Service (CCAS), and South East London CCGs (Doctaly platform). The study involves the use of an electronic template that incorporates a list of items (known as RECAP-V0) thought to be associated with disease outcome according to previous qualitative work. Data collected will be linked to patient outcomes in highly secure environments. We will then use multivariate logistic regression analyses for model development and validation. RESULTS: Recruitment of participants started in October 2020. Initially, only the NWL CCGs and RCGP RSC arms were active. As of March 24, 2021, we have recruited a combined sample of 3827 participants in these two arms. CCAS and Doctaly joined the study in February 2021, with CCAS starting the recruitment process on March 15, 2021. The first part of the analysis (RECAP-V1 model development) is planned to start in April 2021 using the first half of the NWL CCGs and RCGP RSC combined data set. Posteriorly, the model will be validated with the rest of the NWL CCGs and RCGP RSC data as well as the CCAS and Doctaly data sets. The study was approved by the Research Ethics Committee on May 27, 2020 (Integrated Research Application System number: 283024, Research Ethics Committee reference number: 20/NW/0266) and badged as National Institute of Health Research Urgent Public Health Study on October 14, 2020. CONCLUSIONS: We believe the validated RECAP-V1 early warning score will be a valuable tool for the assessment of severity in patients with suspected COVID-19 in the community, either in face-to-face or remote consultations, and will facilitate the timely escalation of treatment with the potential to improve patient outcomes. TRIAL REGISTRATION: ISRCTN registry ISRCTN13953727; https://www.isrctn.com/ISRCTN13953727. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29072.

What items should be included in an early warning score for remote assessment of suspected COVID-19? qualitative and Delphi study.

BACKGROUND: To develop items for an early warning score (RECAP: REmote COVID-19 Assessment in Primary Care) for patients with suspected COVID-19 who need escalation to next level of care. METHODS: The study was based in UK primary healthcare. The mixed-methods design included rapid review, Delphi panel, interviews, focus groups and software development. Participants were 112 primary care clinicians and 50 patients recovered from COVID-19, recruited through social media, patient groups and snowballing. Using rapid literature review, we identified signs and symptoms which are commoner in severe COVID-19. Building a preliminary set of items from these, we ran four rounds of an online Delphi panel with 72 clinicians, the last incorporating fictional vignettes, collating data on R software. We refined the items iteratively in response to quantitative and qualitative feedback. Items in the penultimate round were checked against narrative interviews with 50 COVID-19 patients. We required, for each item, at least 80% clinician agreement on relevance, wording and cut-off values, and that the item addressed issues and concerns raised by patients. In focus groups, 40 clinicians suggested further refinements and discussed workability of the instrument in relation to local resources and care pathways. This informed design of an electronic template for primary care systems. RESULTS: The prevalidation RECAP-V0 comprises a red flag alert box and 10 assessment items: pulse, shortness of breath or respiratory rate, trajectory of breathlessness, pulse oximeter reading (with brief exercise test if appropriate) or symptoms suggestive of hypoxia, temperature or fever symptoms, duration of symptoms, muscle aches, new confusion, shielded list and known risk factors for poor outcome. It is not yet known how sensitive or specific it is. CONCLUSIONS: Items on RECAP-V0 align strongly with published evidence, clinical judgement and patient experience. The validation phase of this study is ongoing. TRIAL REGISTRATION NUMBER: NCT04435041.