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in category primary care research

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1: Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial
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Posted 08 Feb 2021

Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial
27,186 downloads medRxiv primary care research

Sanjay Ramakrishnan, Dan V Nicolau, Beverly Langford, Mahdi Mahdi, Helen Jeffers, Christine Mwasuku, Karolina Krassowska, Robin Fox, Ian Binnian, Victoria Glover, Stephen Bright, Christopher Butler, Jennifer L Cane, Andreas Halner, Philippa C. Matthews, Louise E Donnelly, Jodie L Simpson, Jonathan R Baker, Nabil T Fadai, Stefan Peterson, Thomas Bengtsson, Peter J Barnes, Richard E K Russell, Mona Bafadhel

Background Multiple early hospital cohorts of coronavirus disease 2019 (COVID-19) showed that patients with chronic respiratory disease were significantly under-represented. We hypothesised that the widespread use of inhaled glucocorticoids was responsible for this finding and tested if inhaled glucorticoids would be an effective treatment for early COVID-19 illness. Methods We conducted a randomised, open label trial of inhaled budesonide, compared to usual care, in adults within 7 days of the onset of mild Covid-19 symptoms. The primary end point was COVID-19-related urgent care visit, emergency department assessment or hospitalisation. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. Results 146 patients underwent randomisation. For the per protocol population (n=139), the primary outcome occurred in 10 participants and 1 participant in the usual care and budesonide arms respectively (difference in proportion 0.131, p=0.004). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was 8. Clinical recovery was 1 day shorter in the budesonide arm compared to the usual care arm (median of 7 days versus 8 days respectively, logrank test p=0.007). Proportion of days with a fever and proportion of participants with at least 1 day of fever was lower in the budesonide arm. Fewer participants randomised to budesonide had persistent symptoms at day 14 and day 28 compared to participants receiving usual care. Conclusion Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.

2: Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial
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Posted 12 Apr 2021

Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial
11,595 downloads medRxiv primary care research

The PRINCIPLE Trial Collaborative Group, Ly-Mee Yu, Mona Bafadhel, Jienchi Dorward, Gail Hayward, Benjamin R Saville, Oghenekome Gbinigie, Oliver van Hecke, Emma Ogburn, Philip H Evans, Nicholas PB Thomas, Mahendra G Patel, Nicholas Berry, Michelle A Detry, Christina Saunders, Mark Fitzgerald, Victoria Harris, Simon de Lusignan, Monique Andersson, Peter J Barnes, Richard E K Russell, Dan V Nicolau, Sanjay Ramakrishnan, F.D Richard Hobbs, Christopher C Butler

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 (800g 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.)

3: Analysis of severe outcomes associated with the SARS-CoV-2 Variant of Concern 202012/01 in England using ICNARC Case Mix Programme and QResearch databases.
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Posted 12 Mar 2021

Analysis of severe outcomes associated with the SARS-CoV-2 Variant of Concern 202012/01 in England using ICNARC Case Mix Programme and QResearch databases.
3,525 downloads medRxiv primary care research

Martina Patone, Karen Thomas, Robert Hatch, Pui San Tan, Weiqi Liao, Carol A C Coupland, Paul Mouncey, David Harrison, Kathryn Rowan, Peter Horby, Peter Watkinson, Julia Hippisley-Cox

Background: A new, more transmissible variant of SARS-CoV-2, variant of concern (VOC) 202012/01 or lineage B.1.1.7, has emerged in the UK. We estimate the risk of critical care admission, mortality in critical ill patients, and overall mortality associated with VOC B.1.1.7 compared with the original variant. We also compare clinical outcomes between these variants' groups. Methods: We linked a large primary care (QResearch), the national critical care (ICNARC CMP) and the COVID-19 testing (PHE) database and extracted two cohorts. The first was used to explore the association between VOC B.1.1.7 and critical care admission and 28-day mortality. The second to determine the risk of mortality in critically ill patients with VOC B.1.1.7 compared to those without. We used Royston-Parmar models adjusted for age, sex, region, other socio-demographics and comorbidities (asthma, COPD, type I and II, hypertension). We reported information on types and duration of organ supports for the two variants' groups. Findings: The first cohort included 198,420 patients. Of these, 80,494 had VOC B.1.1.7, 712 were critically ill and 630 died by 28 days. The second cohort included 3432 critically ill patients. Of these, 2019 had VOC B.1.1.7 and 822 died at the end of critical care. Using the first cohort, we estimated adjusted hazard ratios for critical care admission and mortality to be 1.99 (95% CI: 1.59, 2.49) and 1.59 (95% CI: 1.25-2.03) for VOC B.1.1.7 compared with the original variant group, respectively. The adjusted hazard ratio for mortality in critical care, estimated using the second cohort, was 0.93 (95% CI 0.76-1.15) for patients with VOC B.1.1.7, compared to those without. Interpretation: VOC B.1.1.7 appears to be more severe. Patients with VOC B.1.1.7 are at increased risk of critical care admission and mortality compared with patients without. For patients receiving critical care, mortality appears independent of virus strain.

4: Exit strategies: optimising feasible surveillance for detection, elimination and ongoing prevention of COVID-19 community transmission
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Posted 23 Apr 2020

Exit strategies: optimising feasible surveillance for detection, elimination and ongoing prevention of COVID-19 community transmission
3,038 downloads medRxiv primary care research

Kamalini Lokuge, Emily Banks, Stephanie Davis, Leslee Roberts, Tatum Street, Declan O'Donovan, Grazia Caleo, Kathryn Glass

Background Following successful implementation of strong containment measures by the community, Australia is now close to the point of eliminating detectable community transmission of COVID-19. We aimed to develop an efficient, rapid and scalable surveillance strategy for detecting all remaining COVID-19 community transmission through exhaustive identification of every active transmission chain. We also identified measures to enable early detection and effective management of any reintroduction of transmission once containment measures are lifted to ensure strong containment measures do not need to be reinstated. Methods We compared efficiency and sensitivity to detect community transmission chains through testing of: hospital cases; primary care fever and cough patients; or asymptomatic community members, using surveillance evaluation methods and mathematical modelling, varying testing capacities and prevalence of COVID-19 and non-COVID-19 fever and cough, and the reproduction number. System requirements for increasing testing to allow exhaustive identification of all transmission chains, and then enable complete follow-up of all cases and contacts within each chain, were assessed per million population. Findings Assuming 20% of cases are asymptomatic and all symptomatic COVID-19 cases present to primary care, with high transmission (R=2.2) there are a median of 13 unrecognised community cases (5 infectious) when a transmission chain is identified through hospital surveillance versus 3 unrecognised cases (1 infectious) through primary care surveillance. 3 unrecognised community upstream community cases themselves are estimated to generate a further 22-33 contacts requiring follow-up. The unrecognised community cases rise to 5 if only 50% of symptomatic cases present to primary care. Screening for asymptomatic disease in the community cannot exhaustively identify all transmission under any of the scenarios assessed. The additional capacity required to screen all fever and cough primary care patients would be approximately 2,000 tests/million population per week using 1/16 pooling of samples. Interpretation Screening all syndromic fever and cough primary care presentations, in combination with exhaustive and meticulous case and contact identification and management, enables appropriate early detection and elimination of community transmission of COVID-19. If testing capacity is limited, interventions such as pooling allow increased case detection, even given reduced test sensitivity. Wider identification and testing of all upstream contacts, (i.e. potential sources of infection for identified cases, and their related transmission chains) is critical, and to be done exhaustively requires more resources than downstream contact tracing. The most important factor in determining the performance of such a surveillance system is community participation in screening and follow up, and as such, appropriate community engagement, messaging and support to encourage presentation and compliance is essential. We provide operational guidance on implementing such a system.

5: IVERMECTIN REPROPOSING FOR COVID-19 TREATMENT OUTPATIENTS IN MILD STAGE IN PRIMARY HEALTH CARE CENTERS
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Posted 30 Mar 2021

IVERMECTIN REPROPOSING FOR COVID-19 TREATMENT OUTPATIENTS IN MILD STAGE IN PRIMARY HEALTH CARE CENTERS
2,376 downloads medRxiv primary care research

Rossana Elena Chahla, Luis Medina Ruiz, Teresa Mena, Yolanda Brepe, Paola Terranova, Eugenia Silvana Ortega, Guillermo Gabriel Barrenechea,, Daniel Gustavo Goroso, Maria de los Angeles Peral de Bruno

Background: The emergence of COVID-19 requires alternative treatments based on the reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS-COV-2. The goal was to evaluate the use of ivermectin in mild stage outpatients to heal and / or reverse the progression of COVID-19 disease towards the development of moderate or severe stages. Methods: Cluster Assigned Clinical Trial (2:1) in outpatients, n = 234. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 62). The EG received ivermectin orally 4 drops of 6 mg = 24 mg every 7 days for 4 weeks. All participants were diagnosed by positive RT-PCR for COVID-19 and were evaluated by clinical examination, at the beginning and the end of protocol. Data analyzed were applied the proportion, bivariate, and logical regression tests with level significance p < 0.05. This study was registered at ClinicalTrials.gov Identifier NCT04784481. Findings: Both groups were similar in age, sex, and comorbidities (EG: 56F, median age= 40.0, range: 18.0 - 75.0; CG: 34F, median age = 37.5, range: 18.0 - 71.0). A significant reduction in the symptom numbers was observed in the EG when the medical examination was performed from 5th to 9th days, after starting treatment (p = 0.0026). Although, medical examination from 10th to 14th day, showed a progressive reduction of the percentage symptom numbers, these were not significative in both groups. A higher proportion of medical release was observed in EG (98.2%) vs CG (87.1%) (p = 0.003). EG showed 8 times more chance of receiving medical release than CG (OR 7.99, 95% CI: 1.64 -38.97, p = 0.003). The treatment effect with ivermectin to obtain medical release was analyzed by the logistic regression model based in the following control variables: sex, age, and comorbidities. Then, the chance to obtain medical release was maintained in EG (OR 10.37, 95% CI: 2.05 - 52.04, p = 0.005). Interpretation: Treatment with ivermectin in outpatients with mild stage COVID-19 disease managed to slightly reduce the symptom numbers. Also, this treatment improved the clinical state to obtain medical release, even in the presence of comorbidities. The treatment with ivermectin could significantly prevent the evolution to serious stages since the EG did not present any patient with referral to critical hospitalization.

6: Remote Covid Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies.
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Posted 25 Dec 2021

Remote Covid Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies.
2,257 downloads medRxiv primary care research

Ana B Espinosa-Gonzalez, Denys Prociuk, Francesca Fiorentino, Christian Ramtale, Ella Mi, Emma Mi, Ben Glampson, Cecilia Okusi, Jack Macartney, Laiba Husain, Martina Brown, Ben Browne, Caroline Warren, Rachna Chowla, Jonty Heaversedge, Trisha Greenhalgh, Simon de Lusignan, Brendan C Delaney

Background Accurate assessment of COVID-19 severity in the community is essential for best patient care and efficient use of services and requires a risk prediction score that is COVID-19 specific and adequately validated in a community setting. Following a qualitative phase to identify signs, symptoms and risk factors, we sought to develop and validate two COVID-19-specific risk prediction scores RECAP-GP (without peripheral oxygen saturation (SpO2)) and RECAP-O2 (with SpO2). Methods Prospective cohort study using multivariable logistic regression for model development. Data on signs and symptoms (model predictors) were collected on community-based patients with suspected COVID-19 via primary care electronic health records systems and linked with secondary data on hospital admission (primary outcome) within 28 days of symptom onset. Data sources: RECAP-GP: Oxford-Royal College of General Practitioners Research and Surveillance Centre (RSC) primary care practices (development), Northwest London (NWL) primary care practices, NHS COVID-19 Clinical Assessment Service (CCAS) (validation). RECAP-O2: Doctaly Assist platform (development, and validation in subsequent sample). Estimated sample size was 2,880 per model. Findings Data were available from 8,311 individuals. Observations, such SpO2, were mostly missing in NWL, RSC, and CCAS data; however, SpO2 was available for around 70% of Doctaly patients. In the final predictive models, RECAP-GP included sex, age, degree of breathlessness, temperature symptoms, and presence of hypertension (Area Under the Curve (AUC): 0.802, Validation Negative Predictive Value (NPV) of low risk 98.8%. RECAP-O2 included age, degree of breathlessness, fatigue, and SpO2 at rest (AUC: 0.843), Validation NPV of low risk 99.4%. Interpretation Both RECAP models are a valid tool in the assessment of 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 at home and SpO2 is available, RECAP-O2 is useful to assess the need for further treatment escalation.

7: Suspected COVID-19 in primary care: how GP records contribute to understanding differences in prevalence by ethnicity.
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Posted 26 May 2020

Suspected COVID-19 in primary care: how GP records contribute to understanding differences in prevalence by ethnicity.
2,097 downloads medRxiv primary care research

Sally A Hull, Crystal Williams, Mark Ashworth, Chris Carvalho, Kambiz Boomla

Abstract Background The first wave of the London COVID-19 epidemic peaked in April 2020. Attention initially focussed on severe presentations, intensive care capacity, and the timely supply of equipment. General practice has seen a rapid take up of technology to allow virtual consultations, enabling the management of mild and moderate community cases. Aim To quantify the prevalence and time-course of suspected COVID-19 presenting to general practices during the London epidemic. To report disease prevalence by ethnic group, and explore how far differences by ethnicity can be explained by data in the electronic health record (EHR). Design and Setting Cross-sectional study using anonymised data from the primary care records of 1.3 million people registered with 157 practices in four adjacent east London clinical commissioning groups (CCGs). The study area includes 48% of people from ethnic minorities and is in the top decile of social deprivation in England. Method Suspected COVID-19 cases were identified using SNOMED codes. Explanatory variables included age, gender, self-reported ethnicity and measures of social deprivation. Clinical factors included 16 long-term conditions, latest body mass index and smoking status. Results There were 8,985 suspected COVID-19 cases. Ethnicity recording was 78% complete. Univariate analysis showed a two-fold increase in odds of infection for South Asian and Black adults compared to White. In a fully adjusted analysis, including clinical factors, the odds were: South Asian OR 1.93 (95% CI = 1.83 to 2.04) Black OR 1.47 (95% CI 1.38 to 1.57) Conclusions Using data in GP records Black and south Asian ethnicity remain as predictors of community cases of COVID-19, with levels of risk similar to hospital admission cases. Further understanding of these differences requires social and occupational data.

8: Diagnostic accuracy of Faecal Immunochemical Testing for patients with symptoms of colorectal cancer: a retrospective cohort study of 14,487 consecutive test requests from English primary care.
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Posted 19 May 2020

Diagnostic accuracy of Faecal Immunochemical Testing for patients with symptoms of colorectal cancer: a retrospective cohort study of 14,487 consecutive test requests from English primary care.
2,057 downloads medRxiv primary care research

Brian D Nicholson, Tim J James, Maria Paddon, Steve Justice, Jason L Oke, James E. East, Brian Shine

Objective: To ascertain the diagnostic performance of faecal immunochemical test (FIT) in symptomatic primary care patients, to provide objective data on which to base referral guidelines. Design: Stool samples from routine primary care practice in Oxfordshire, UK were analysed using the HM-JACKarc FIT method between March 2017 to March 2020. Clinical details described on the test request were recorded. Patients were followed up for up-to 36 months in linked hospital records for evidence of benign and serious (colorectal cancer, high-risk adenomas and bowel inflammation) colorectal disease. The diagnostic accuracy of FIT is reported by gender, age, and FIT threshold. Results: In 9,896 adult patients with at least 6 months of follow-up, a FIT result [&ge;]10 ug/g had an overall sensitivity for colorectal cancer of 90.5% (95% CI 84.9%-96.1%), women 90.0 (80.7-99.3), men 90.8 (83.7-97.8); overall specificity 91.3 (90.8-91.9), women 92.4 (91.8-93.1), men 89.8 (88.8-90.7); overall Positive Predictive Value (PPV) 10.1 (8.15-12.0), women 7.64 (5.24-10.0), men 12.5 (9.52-15.5)); and an overall Negative Predictive Value (NPV) 99.9 (99.8-100.0), women 99.8 (99.7-100.), men 99.9 (99.9-100.0). The PPV and specificity of FIT were higher for serious colorectal disease combined and the sensitivity and NPV were lower than for colorectal cancer alone. The Area Under the Curve (AUC) for all patients did not change substantially by increasing the minimum age of testing. In this population, 10% would be further investigated to detect 91% of the cancers at 10ug/g and 3% further investigated to detect 54% of the cancers at 150ug/g. The number needed to scope to detect one cancer at was ten using FIT at 10ug/g. Conclusion: A FIT threshold of 10ug/g is appropriate to triage adult patients presenting to primary care with symptoms of serious colorectal disease. FIT may provide an appropriate approach to reprioritising patients colorectal cancer symptoms whose tests have been delayed by the COVID-19 pandemic.

9: An Exploration of Impact of COVID 19 on mental health -Analysis of tweets using Natural Language Processing techniques
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Posted 04 Aug 2020

An Exploration of Impact of COVID 19 on mental health -Analysis of tweets using Natural Language Processing techniques
1,823 downloads medRxiv primary care research

Sohini Sengupta, Sareeta Mugde, Garima Sharma

Twitter is one of the world's biggest social media platforms for hosting abundant number of user-generated posts. It is considered as a gold mine of data. Majority of the tweets are public and thereby pullable unlike other social media platforms. In this paper we are analyzing the topics related to mental health that are recently (June, 2020) been discussed on Twitter. Also amidst the on-going pandemic, we are going to find out if covid-19 emerges as one of the factors impacting mental health. Further we are going to do an overall sentiment analysis to better understand the emotions of users.

10: Evaluation of the Panbio rapid antigen test for SARS-CoV-2 in primary health care centers and test sites.
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Posted 16 Nov 2020

Evaluation of the Panbio rapid antigen test for SARS-CoV-2 in primary health care centers and test sites.
1,737 downloads medRxiv primary care research

Oana Bulilete, Patricia Lorente, Alfonso Leiva, Eugenia Carandell, Antonio Oliver, Estrella Rojo, Pau Pericas, Joan Llobera, on behalf of COVID-19 Primary Care Research Group

BackgroundRapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 and real-world evaluations are needed to establish their performance characteristics. Main objectiveTo evaluate the accuracy of the Panbio Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard. MethodsThis was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group. ResultsA total of 1369 participants were included; mean age 42.5 {+/-} 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms or close contact, and more than 70% had high viral loads. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load. ConclusionAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive.

11: RT-PCR testing to detect a COVID-19 outbreak in Austria: rapid, accurate and early diagnosis in primary care (The REAP study)
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Posted 15 Jul 2020

RT-PCR testing to detect a COVID-19 outbreak in Austria: rapid, accurate and early diagnosis in primary care (The REAP study)
1,570 downloads medRxiv primary care research

Werner Leber, Oliver Lammel, Monika Redlberger-Fritz, Maria Elisabeth Mustafa-Korninger, Karin Stiasny, Reingard Christina Glehr, Eva-Maria Hochstrasser, Christian Hoellinger, Andrea Siebenhofer, Chris Griffiths, Jasmina Panovska-Griffiths

Background Delay in COVID-19 detection has led to a major pandemic. We report rapid early detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction (RT-PCR), comparing it to the serostatus of convalescent infection, at an Austrian National Sentinel Surveillance Practice in an isolated ski-resort serving a population of 22,829 people. Methods Retrospective dataset of all 73 patients presenting with mild to moderate flu-like symptoms to a sentinel practice in the ski-resort of Schladming-Dachstein, Austria, between 24 February and 03 April, 2020. We split the outbreak in two halves, by dividing the period from the first to the last case by two, to characterise the following three cohorts of patients with confirmed infection: people with reactive RT-PCR presenting during the first half (early acute infection) vs. those presenting in the second half (late acute), and people with non-reactive RT-PCR (late convalescent). For each cohort we report the number of cases detected, the accuracy of RT-PCR and the duration of symptoms. We also report multivariate regression of 15 clinical symptoms as covariates, comparing all people with convalescent infection to those with acute infection. Findings All 73 patients had SARS-CoV-2 RT-PCR testing. 22 patients were diagnosed with COVID-19, comprising: 8 patients presenting early acute, and 7 presenting late acute and 7 late convalescent respectively; 44 patients tested SARS-COV-2 negative, and 7 were excluded. RT-PCR sensitivity was high (100%) among acute presenters, but dropped to 50% in the second half of the outbreak; specificity was 100%. The mean duration of symptoms was 2 days (range 1-4) among early acute presenters, and 4.4 days (1-7) among late acute and 8 days (2-12) among late convalescent presenters respectively. Convalescent infection was only associated with loss of taste (ORs=6.02;p=0.047). Acute infection was associated with loss of taste (OR=571.72;p=0.029), nausea and vomiting (OR=370.11;p=0.018), breathlessness (OR=134.46;p=0.049), and myalgia (OR=121.82;p=0.032); but not loss of smell, fever or cough. Interpretation RT-PCR rapidly and reliably detects early COVID-19 among people presenting with viral illness and multiple symptoms in primary care, particularly during the early phase of an outbreak. RT-PCR testing in primary care should be prioritised for effective COVID-19 prevention and control.

12: A primary care approach to the COVID-19 pandemic: clinical features and natural history of 2,073 suspected cases in the Corona Sao Caetano programme, Sao Paulo, Brazil
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Posted 23 Jun 2020

A primary care approach to the COVID-19 pandemic: clinical features and natural history of 2,073 suspected cases in the Corona Sao Caetano programme, Sao Paulo, Brazil
1,497 downloads medRxiv primary care research

Fabio E. Leal, Maria C Mendes-Correa, Lewis Buss, Silvia F. Costa, Joao CS Bizario, Sonia RP Souza, Osorio Thomaz, Tania R Tozetto-Mendoza, Lucy S. Villas-Boas, Lea CO Silva, Regina MZ Grespan, Ligia Capuani, Renata Buccheri, Helves Domingues, Neal Alexander, Philippe Mayaud, Ester C. Sabino

Background: Despite most cases not requiring hospital care, there are limited community-based clinical data on COVID-19. Methods and findings: The Corona Sao Caetano program is a primary care initiative offering COVID-19 care to all residents of Sao Caetano do Sul, Brazil. After triage of potentially severe cases, consecutive patients presenting between 13th April and 13th May 2020 were tested at home with SARS-CoV-2 reverse transcriptase (RT) PCR; positive patients were followed up for 14 days. RT-PCR-negative patients were offered SARS-CoV-2 serology. We describe the clinical features, virology and natural history of this prospective population-based cohort. Of 2,073 suspected COVID-19 cases, 1,583 (76.4%) were tested by RT-PCR, of whom 444 (28.0%, 95%CI: 25.9% - 30.3%) were positive; 604/1,136 (53%) RT-PCR-negative patients underwent serology, of whom 52 (8.6%) tested SARS-CoV-2 seropositive. The most common symptoms of COVID-19 were cough, fatigue, myalgia and headache; whereas self-reported fever, anosmia, and ageusia were most associated with a positive COVID-19 diagnosis. RT-PCR cycle thresholds were lower in men, older patients, those with fever and arthralgia, and around symptom onset. The rates of hospitalization and death among 444 RT-PCR-positive cases were 6.7% and 0.7%, respectively, with older age and obesity more frequent in the hospitalized group. Conclusions: COVID-19 presents similarly to other mild respiratory disease in primary care. Some symptoms assist the differential diagnosis. Most patients can be managed at home.

13: Symptoms and risk factors for hospitalization of COVID-19 presented in primary care
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Posted 29 Mar 2021

Symptoms and risk factors for hospitalization of COVID-19 presented in primary care
1,391 downloads medRxiv primary care research

Susanne Rabady, Kathryn Hoffmann, Markus Brose, Oliver Lammel, Stephanie Poggenburg, Monika Redlberger-Fritz, Karin Stiasny, Maria Wendler, Lukas Weseslindtner, Sonja Zehetmayer, Gustav Kamenski

BackgroundEarly detection is essential to control COVID-19. Symptoms are often unspecific. Data collected merely from patients tested according to testing criteria might lead to missing a bulk of spreaders. Knowledge of symptom development during the disease helps to detect complications early. Few data have been collected in primary care so far. AimTo extend knowledge of early symptoms as a precondition of timely diagnosis, isolation and contact tracing. To gain understanding of associations between symptoms and complicated disease to help avoid hospitalization. Design and SettingsThis study was designed as a retrospective observational study in Austrian GP practices in the year 2020. MethodsPatients above 18 years with a positive SARS-CoV-2 test were included. Data collection comprised basic demographic data, risk factors and the recording of symptoms at several points in time during the course of the infection. Further descriptive data analysis was carried out by using the statistical software program R. ResultsSymptoms clearly typical for COVID-19 are rare. Most symptoms are nonspecific, like malaise, fatigue or joint ache. We found symptoms indicating complicated disease, depending on the time of their occurrence. Anosmia we found to develop only after several days in many cases. At the end of the isolation period many patients still experience symptoms. ConclusionLow threshold contact in GP practices including testing can prevent overlooking early symptoms. Patients may benefit from early monitoring. We recommend a medical check-up at the end of the isolation period. How this fits inMost testing strategies for COVID-19 are based on symptoms assumed to be typical for the disease. We found strong hints that in the general practice-setting patients frequently do not present any of the "typical" symptoms and, thus, might be overlooked by "traditional" testing strategies. It is those patients though, who are mobile enough to widely spread the disease. Identifying them early in the course of their disease is a requirement for effective containment strategies, e.g. "Test-Trace-Isolate".

14: Distinguishing between COVID-19 and the common cold in a primary care setting - comparison of patients with positive and negative SARS-CoV-2 PCR results.
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Posted 05 May 2020

Distinguishing between COVID-19 and the common cold in a primary care setting - comparison of patients with positive and negative SARS-CoV-2 PCR results.
1,384 downloads medRxiv primary care research

Johannes Just, Marie-Therese Puth, Felix Regenold, Klaus Weckbecker, Markus Bleckwenn

Background: Combating the COVID-19 pandemic is a major challenge for health systems, citizens and policy makers worldwide. Early detection of affected patients within the large and heterogeneous group of patients with common cold symptoms is an important element of this effort, but often hindered by limited testing resources and the lack of pathognomonic symptoms in COVID-19. Therefore, we aimed to identify predictive risk factors for a positive SARS-CoV-2 PCR (CovPCR) result in a primary care setting. Method: We performed a multi-center cross-sectional cohort study on predictive clinical characteristics for a positive CovPCR over a period of 4 weeks in primary care patients in Germany. Findings: In total, 374 patients in 14 primary care centers received CovPCR and were included in this analysis. The median age was 44.0 (IQR: 31.0-59.0) and a fraction of 10.7% (n=40) tested positive for COVID-19. Patients who reported anosmia had a higher odds ratio (OR: 4.54; 95%-CI: 1.51-13.67) for a positive test result while patients with a sore throat had a lower OR (OR: 0.33; 95%-CI: 0.11-0.97). Patients who had a first grade contact with an infected persons and showed symptoms themselves also had an increased OR for positive testing (OR: 5.16; 95% CI: 1.72-15.51). This correlation was also present when they themselves were still asymptomatic (OR: 12.55; 95% CI: 3.97-39.67). Conclusions: Several anamnestic criteria may be helpful to assess pre-test probability of COVID-19 in patients with common cold symptoms

15: The implementation of a virtual ward using digital solutions informing community clinicians in early supported discharge of patients with SARS-Cov2 respiratory symptoms from an acute hospital setting
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Posted 31 Mar 2021

The implementation of a virtual ward using digital solutions informing community clinicians in early supported discharge of patients with SARS-Cov2 respiratory symptoms from an acute hospital setting
1,378 downloads medRxiv primary care research

Jim Swift, Alex woodward, Zoe Harris, Noel I O'Kelly, Chris Barker, Sudip Ghosh

ObjectivesTo assess the short run successes and challenges of the implementation of a digitally supported accelerated acute hospital discharge scheme for patients admitted with Covid-19. DesignAnalysis of the safety, resource use and health outcomes within the virtual service for the first 65 patients that have been discharged from a virtual respiratory ward. SettingCommunity based intervention using digital technology and a multi-disciplinary team of specialist clinicians to monitor patients at home. Participants65 patients discharged from hospital followed until discharge from the virtual ward. Results24.6% of 65 patients had symptoms that were coded red (urgent response required) in CliniTouch Vie in the first day after hospital discharge falling to 7.7% on their final day on the virtual ward; p=0.049. Reductions in red days decreased significantly over time, from 33.8% of patients in their first three days to 10.8% in their final three days; all patients p=0.002. Four patients were re-admitted to hospital, all for clotting disorders. There was one death within this group, which following senior clinical review was deemed to be unrelated to infection with Covid-19. The most important gain for Glenfield hospital was in expediting the rapid discharge of patients admitted with Covid-19 into a supported environment and the freeing up of beds. On 15th January, 48% of beds were taken up with patients admitted with Covid-19 symptoms. In November 2020, immediately prior to the launch of the virtual ward, the mean length of stay for patients who did not access high dependency care or oxygen was 5.5 (+/-1.3) days. The mean length of stay in patients discharged into the virtual ward thereafter was 3.3 (+/-0.4) days; relative reduction, 40.3% (p<0.001). The cost of care provision in the virtual ward was 8,165 UK Pounds in total and 124.31 UK pounds per patient. The estimated overall savings were 68,550 UK Pounds and the mean saving per patient was estimated at {pound}1,055 UK Pounds. ConclusionsThe virtual ward appeared to assist with earlier discharges, had a low rate of clinically necessary re-admissions, the safety of patients was not compromised and whilst cost savings were not the primary objective, it seemed to also reduce overall resource use and costs.

16: Primary Care Practitioners' Response to 2019 Novel Coronavirus Outbreak in China
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Posted 12 Feb 2020

Primary Care Practitioners' Response to 2019 Novel Coronavirus Outbreak in China
1,369 downloads medRxiv primary care research

Zhijie Xu, Yi Qian, Lizheng Fang, Mi Yao

The emerging outbreak of the 2019 novel coronavirus (2019-nCoV) originated from Wuhan poses a great challenge to healthcare system in China.1 Primary care practitioners (PCPs) have an important role in district communicable disease control.2 However, because primary health-care system in China still needs to be substantially strengthened,3,4 whether PCPs are proactive and capable in responding to the outbreak remains unclear. Using an electronic questionnaire, we surveyed a national sample of PCPs to assess their response to novel coronavirus outbreak.

17: Parents' and guardians' views and experiences of accessing routine childhood vaccinations during the coronavirus (COVID-19) pandemic: A mixed methods study in England
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Posted 07 Sep 2020

Parents' and guardians' views and experiences of accessing routine childhood vaccinations during the coronavirus (COVID-19) pandemic: A mixed methods study in England
1,319 downloads medRxiv primary care research

Sadie L Bell, Richard Clarke, Pauline Paterson, Sandra Mounier-Jack

Objective: To explore parents' and guardians' views and experiences of accessing National Health Service (NHS) general practices for routine childhood vaccinations during the coronavirus (COVID-19) pandemic in England. Design: Mixed methods approach involving an online cross-sectional survey (conducted between 19th April and 11th May 2020) and semi-structured telephone interviews (conducted between 27th April and 27th May 2020). Participants: 1252 parents and guardians (aged 16+ years) who reported living in England with a child aged 18 months or under completed the survey. Nineteen survey respondents took part in follow-up interviews. Results: The majority of survey respondents (85.7%) considered it important for their children to receive routine vaccinations on schedule during the COVID-19 pandemic; however, several barriers to vaccination were identified. These included a lack of clarity around whether vaccination services were operating as usual, particularly amongst respondents from lower income households and those self-reporting as Black, Asian, Chinese, Mixed or Other ethnicity; difficulties in organising vaccination appointments; and fears around contracting COVID-19 while attending general practice. Concerns about catching COVID-19 while accessing general practice were weighed against concerns about children acquiring a vaccine-preventable disease if they did not receive scheduled routine childhood vaccinations. Many parents and guardians felt their child's risk of acquiring a vaccine-preventable disease was low as the implementation of stringent physical distancing measures (from March 23rd 2020) meant they were not mixing with others. Conclusion: To promote routine childhood vaccination uptake during the current COVID-19 outbreak, further waves of COVID-19 infection, and future pandemics, prompt and sustained national and general practice level communication is needed to raise awareness of vaccination service continuation and the importance of timely vaccination, and invitation-reminder systems for vaccination need to be maintained. To allay concerns about the safety of accessing general practice, practices should communicate the measures being implemented to prevent COVID-19 transmission.

18: The COVID-19 Pandemic Impact on Primary Health Care services: An Experience from Qatar
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Posted 24 Jul 2020

The COVID-19 Pandemic Impact on Primary Health Care services: An Experience from Qatar
1,269 downloads medRxiv primary care research

Mohamed Ghaith Al-Kuwari, Mariam Abdulmalik, Samya Al Abdulla, Ahmad Haj Bakri, John Gibb, Mujeeb Kandy

Introduction: In March 2020, Qatar started reporting increased numbers of COVID-19 positive cases. The Ministry of Public Health in Qatar has developed an emergency action plan to respond to the outbreak with the Primary Health Care Corporation (PHCC) as a main component of that response. Aim: The aim of this review is to understand and document the Impact of COVID 19 on PHCC in Qatar in terms of response, modifications of services and introduction of new alternatives Methodology: A retrospective data analysis was conducted for all the COVID-19 swabbing activities and for all the utilization services volume across the PHCC health centers between January 2018 and May 2020. Results: PHCC allocated testing sites for COVID-19 resulted in conducting 54824 swabs with 11455 positive cases and positivity rate of 20.8% between 14th of March and 15th of June 2020. The overall PHCC services utilization declined with overall reduction of 50% in April 2020. Alternative virtual and remote services were provided, telemedicine was introduced, and it made up 50% of the consultation volumes for April 2020. Home refill delivery medications managed to provide a total of 20920 delivered prescriptions by end of May 2020. Conclusion and recommendations: To decrease the risk of infection to the patients and health care workers, PHCC in Qatar cancelled the appointments for some high-risk population. However, PHCC introduced virtual remote services that managed to make up for the in-person utilization volume and reflected acceptance in patients behaviours. PHCC continued in detecting positive COVID-19 cases among its targeted communities. keywords: COVID-19, Qatar, Primary care, Service Utilization, Teleconsultation

19: Decontamination of filtering facepiece respirators in primary care using medical autoclave
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Posted 01 May 2020

Decontamination of filtering facepiece respirators in primary care using medical autoclave
1,172 downloads medRxiv primary care research

Ralf E Harskamp, Bart van Straten, Jonathan Bouman, Bernadette van Maltha - van Santvoort, John J van den Dobbelsteen, Joost van der Sijp, Tim Horemand

Objective: There are widespread shortages of personal protective equipment as a result of the coronavirus disease 2019 (COVID-19) pandemic. Reprocessing filtering facepiece respirators may provide an alternative solution in keeping health care professionals safe. Design: prospective, bench-to-bedside Setting: A primary care-based study using filtering facepiece particles (FFP) type 2 respirators without exhalation valve (3M Aura 1862+, Maco Pharma ZZM002), FFP2 respirators with valve (3M Aura 9322+ and San Huei 2920V), and valved FFP type 3 respirators (Safe Worker 1016). Interventions: All masks were reprocessed using a medical autoclave (34-minute total cycle time of steam sterilization, with 17 minutes at 121 degrees Celsius) and subsequently tested up to 3 times whether these decontaminated respirators retained their integrity (seal check, pressure drop) and ability to filter small particles (0.3-5.0 microns) in the laboratory using a particle penetration test. Results: We tested 32 respirators, and 63 samples for filter capacity. All 27 FFP-2 respirators retained their shape, whereas half of the sterilized FFP-3 respirators (Safe Worker 1116) showed deformities and failed the seal check. The filtering capacity of the 3M Aura 1862 was best retained after 1, 2, and 3 sterilization cycles (0.3 microns: 99.3+/-0.3% (new) versus 97.0+/-1.3, 94.2+/-1.3% or 94.4+/-1.6, p<0.001). Of the other FFP-2 respirators, the San Huei 2920V had 95.5+/-0.7% at baseline versus 92.3+/-1.7% versus 90.0+/-0.7 after one- and two-time sterilization, respectively (p<0.001). The tested FFP-3 respirator (Safe Worker 1016) had a filter capacity of 96.5+/-0.7% at baseline and 60.3+/-5.7% after one-time sterilization (p<0.001). Breathing and pressure resistance tests indicated no relevant pressure changes between respirators that were used once, twice or thrice. Conclusion: This study shows that selected FFP2-type respirators may be reprocessed for use in primary care, as the tested masks retain their shape, ability to retain particles and breathing comfort after decontamination using a medical autoclave.

20: Seroprevalence against COVID-19 and follow-up of suspected cases in primary health care in Spain
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Posted 16 Jun 2020

Seroprevalence against COVID-19 and follow-up of suspected cases in primary health care in Spain
1,171 downloads medRxiv primary care research

Carlos Brotons, Jordi Serrano, Diana Fernandez, Carlos Garcia-Ramos, Begona Ichazo, Jeannine Lemaire, Patricia Montenegro, Irene Moral, Ricky Perez- Wienese, Marc Pitarch, Mireia Puig, Maria Teresa Vilella, Jaume Sellares

Background During the coronavirus disease 2019 (COVID-19) pandemic little information has been available about patients with mild or moderate symptoms attended and followed in the primary care setting, most of whom had an unknown status for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Objectives We aim to measure the seroprevalence of antibodies against SARS-CoV-2 infection in a community sample of asymptomatic individuals and among symptomatic patients (without confirmed diagnosis) followed in a primary care setting. As a secondary objective, we estimated the proportions of symptomatic patients seeing at an emergency department (ED), hospitalized or dying, and identified the most important clinical symptoms associated with a positive infection. Methods From April 21 to April 24 2020, we selected a random sample of 600 individuals stratified by age groups, from a total population of 19,899 individuals from a community area in Barcelona (study population 1). From April 29 to May 5 2020, we also invited all the patients that had been followed by general practitioners (GPs) (study population 2). We used for both populations COVID-19 Rapid lateral flow immunoassay which qualitatively assesses the presence of patient-generated IgG and IgM in approximately 10-15 minutes. The prevalence (95% confidence intervals [CI]) of infection (past and current) was defined as the proportion of individuals with antibody seropositivity. Odds ratios (ORs) for a positive test result were estimated using logistic regression analysis. Results Three hundred and eleven asymptomatic individuals from the randomly selected sample accepted to participate in the study. The overall mean age was 43.7 years (SD 21.79, range 1-94) and 55% were women. Seventeen individuals were seropositive for IgM and/or IgG, resulting an overall prevalence of 5,47% (95% CI, 3.44-8.58). Six-hundred and thirty-four symptomatic patients were followed by GPs. The overall mean age was 46.97 years (SD 20.05, range 0-92) and 57.73% were women. Of these, 244 patients (38.49%) were seropositive for IgM and/or IgG. During the follow-up period, 27.13% of symptomatic patients attended the ED, 11.83% were hospitalized and about 2% died. Results of the multivariate logistic regression analysis showed that the OR for a positive test was significantly increased in patients who had fever (>38{degrees}C), ageusia and contact with a patient diagnosed with COVID-19. Conclusions The seroprevalence of antibodies against SARS-CoV-2 among asymptomatic individuals in the general population was lower than expected. Approximately 40% of the symptomatic patients followed by GPs during the peak months of the pandemic in Barcelona, were positive. Fever (>38{degrees}C), anosmia, ageusia and contact with a patient diagnosed with COVID-19 were associated with a positive test result.

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