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1. Consistency, completeness and external validity of ethnicity recording in NHS primary care records: a cohort study in 25 million patients’ records at source using OpenSAFELY

Author: Andrews, Colm D., Mathur, Rohini, Massey, Jon, Park, Robin, Curtis, Helen J., Hopcroft, Lisa, Mehrkar, Amir, Bacon, Seb, Hickman, George, Smith, Rebecca, Evans, David, Ward, Tom, Davy, Simon, Inglesby, Peter, Dillingham, Iain, Maude, Steven, O’Dwyer, Thomas, Butler-Cole, Ben F. C., Bridges, Lucy, Bates, Chris, Parry, John, Hester, Frank, Harper, Sam, Cockburn, Jonathan, Goldacre, Ben, MacKenna, Brian, Tomlinson, Laurie A., Walker, Alex J., and Hulme, William J.
Published: 2024
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2. Trends in weight gain recorded in English primary care before and during the Coronavirus-19 pandemic: An observational cohort study using the OpenSAFELY platform

Author: Samuel, Miriam, Park, Robin Y., Eastwood, Sophie V., Eto, Fabiola, Morton, Caroline E., Stow, Daniel, Bacon, Sebastian, Mehrkar, Amir, Morley, Jessica, Dillingham, Iain, Inglesby, Peter, Hulme, William J., Khunti, Kamlesh, Mathur, Rohini, Valabhji, Jonathan, MacKenna, Brian, and Finer, Sarah
Subjects: Epidemics -- Complications and side effects -- Social aspects -- Control -- United Kingdom, Weight gain -- Forecasts and trends -- Health aspects -- Causes of, Market trend/market analysis, Biological sciences
Abstract: Background Obesity and rapid weight gain are established risk factors for noncommunicable diseases and have emerged as independent risk factors for severe disease following Coronavirus Disease 2019 (COVID-19) infection. Restrictions imposed to reduce COVID-19 transmission resulted in profound societal changes that impacted many health behaviours, including physical activity and nutrition, associated with rate of weight gain. We investigated which clinical and sociodemographic characteristics were associated with rapid weight gain and the greatest acceleration in rate of weight gain during the pandemic among adults registered with an English National Health Service (NHS) general practitioner (GP) during the COVID-19 pandemic. Methods and findings With the approval of NHS England, we used the OpenSAFELY platform inside TPP to conduct an observational cohort study of routinely collected electronic healthcare records. We investigated changes in body mass index (BMI) values recorded in English primary care between March 2015 and March 2022. We extracted data on 17,742,365 adults aged 18 to 90 years old (50.1% female, 76.1% white British) registered with an English primary care practice. We estimated individual rates of weight gain before ([delta]-prepandemic) and during ([delta]-pandemic) the pandemic and identified individuals with rapid weight gain (>0.5 kg/m.sup.2 /year) in each period. We also estimated the change in rate of weight gain between the prepandemic and pandemic period ([delta]-change = [delta]-pandemic-[delta]-prepandemic) and defined extreme accelerators as the 10% of individuals with the greatest increase in their rate of weight gain ([delta]-change [greater than or equal to]1.84 kg/m.sup.2 /year) between these periods. We estimated associations with these outcomes using multivariable logistic regression adjusted for age, sex, index of multiple deprivation (IMD), and ethnicity. P-values were generated in regression models. The median BMI of our study population was 27.8 kg/m.sup.2, interquartile range (IQR) [24.3, 32.1] in 2019 (March 2019 to February 2020) and 28.0 kg/m.sup.2, IQR [24.4, 32.6] in 2021. Rapid pandemic weight gain was associated with sex, age, and IMD. Male sex (male versus female: adjusted odds ratio (aOR) 0.76, 95% confidence interval (95% CI) [0.76, 0.76], p < 0.001), older age (e.g., 50 to 59 years versus 18 to 29 years: aOR 0.60, 95% CI [0.60, 0.61], p < 0.001]); and living in less deprived areas (least-deprived-IMD-quintile versus most-deprived: aOR 0.77, 95% CI [0.77, 0.78] p < 0.001) reduced the odds of rapid weight gain. Compared to white British individuals, all other ethnicities had lower odds of rapid pandemic weight gain (e.g., Indian versus white British: aOR 0.69, 95% CI [0.68, 0.70], p < 0.001). Long-term conditions (LTCs) increased the odds, with mental health conditions having the greatest effect (e.g., depression (aOR 1.18, 95% CI [1.17, 1.18], p < 0.001)). Similar characteristics increased odds of extreme acceleration in the rate of weight gain between the prepandemic and pandemic periods. However, changes in healthcare activity during the pandemic may have introduced new bias to the data. Conclusions We found female sex, younger age, deprivation, white British ethnicity, and mental health conditions were associated with rapid pandemic weight gain and extreme acceleration in rate of weight gain between the prepandemic and pandemic periods. Our findings highlight the need to incorporate sociodemographic, physical, and mental health characteristics when formulating research, policies, and interventions targeting BMI in the period of post pandemic service restoration and in future pandemic planning., Author(s): Miriam Samuel 1,*, Robin Y. Park 2, Sophie V. Eastwood 3, Fabiola Eto 1, Caroline E. Morton 1,2, Daniel Stow 1, Sebastian Bacon 2, Amir Mehrkar 2, Jessica Morley [...]
Published: 2024
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3. Changes in opioid prescribing during the COVID-19 pandemic in England: an interrupted time-series analysis in the OpenSAFELY-TPP cohort

Author: Bridges, Lucy, Butler-Cole, Benjamin FC, Davy, Simon, Dillingham, Iain, Evans, David, Fisher, Louis, Green, Amelia, Hart, Liam, Hickman, George, Maude, Steven, O'Dwyer, Thomas, Smith, Rebecca M, Stokes, Pete, Ward, Tom, Cockburn, Johnathan, Harper, Sam, Hester, Frank, Parry, John, Schaffer, Andrea L, Andrews, Colm D, Brown, Andrew D, Croker, Richard, Hulme, William J, Nab, Linda, Quinlan, Jane, Speed, Victoria, Wood, Christopher, Wiedemann, Milan, Massey, Jon, Inglesby, Peter, Bacon, Seb C J, Mehrkar, Amir, Bates, Chris, Goldacre, Ben, Walker, Alex J, and MacKenna, Brian
Published: 2024
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4. Clinical and health inequality risk factors for non-COVID-related sepsis during the global COVID-19 pandemic: a national case-control and cohort study

Author: Walker, Alex J., MacKenna, Brian, Inglesby, Peter, Goldacre, Ben, Curtis, Helen J., Morley, Jessica, Mehrkar, Amir, Bacon, Sebastian C.J., Hickman, George, Croker, Richard, Evans, David, Ward, Tom, DeVito, Nicholas J., Fisher, Louis, Green, Amelia C.A., Massey, Jon, Smith, Rebecca M., Hulme, William J., Davy, Simon, Andrews, Colm D., Hopcroft, Lisa E.M., Dillingham, Iain, Higgins, Rose, Cunningham, Christine, Wiedemann, Milan, Nab, Linda, Maude, Steven, Macdonald, Orla, Butler-Cole, Ben F.C., O'Dwyer, Thomas, Stables, Catherine L., Wood, Christopher, Brown, Andrew D., Speed, Victoria, Bridges, Lucy, Schaffer, Andrea L., Walters, Caroline E., Bates, Christopher, Cockburn, Jonathan, Parry, John, Hester, Frank, Harper, Sam, Zhong, Xiaomin, Ashiru-Oredope, Diane, Pate, Alexander, Martin, Glen P., Sharma, Anita, Dark, Paul, Felton, Tim, Lake, Claire, Hand, Kieran, Bladon, Sian, Cunningham, Neil, Gilham, Ellie, Brown, Colin S., Mirfenderesky, Mariyam, Palin, Victoria, and van Staa, Tjeerd Pieter
Published: 2023
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5. Comparative effectiveness of nirmatrelvir/ritonavir versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised high-risk patients during Omicron waves: observational cohort study using the OpenSAFELY platform

Author: Zheng, Bang, Tazare, John, Nab, Linda, Green, Amelia CA., Curtis, Helen J., Mahalingasivam, Viyaasan, Herrett, Emily L., Costello, Ruth E., Eggo, Rosalind M., Speed, Victoria, Bacon, Sebastian CJ., Bates, Christopher, Parry, John, Cockburn, Jonathan, Hester, Frank, Harper, Sam, Schaffer, Andrea L., Hulme, William J., Mehrkar, Amir, Evans, Stephen JW., MacKenna, Brian, Goldacre, Ben, Douglas, Ian J., and Tomlinson, Laurie A.
Published: 2023
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6. Ethnic differences in the indirect effects of the COVID-19 pandemic on clinical monitoring and hospitalisations for non-COVID conditions in England: a population-based, observational cohort study using the OpenSAFELY platform

Author: Chaturvedi, Nishi, Park, Chloe, Carnemolla, Alisia, Williams, Dylan, Knueppel, Anika, Boyd, Andy, Turner, Emma L., Evans, Katharine M., Thomas, Richard, Berman, Samantha, McLachlan, Stela, Crane, Matthew, Whitehorn, Rebecca, Oakley, Jacqui, Foster, Diane, Woodward, Hannah, Campbell, Kirsteen C., Timpson, Nicholas, Kwong, Alex, Soares, Ana Goncalves, Griffith, Gareth, Toms, Renin, Jones, Louise, Annie, Herbert, Mitchell, Ruth, Palmer, Tom, Sterne, Jonathan, Walker, Venexia, Huntley, Lizzie, Fox, Laura, Denholm, Rachel, Knight, Rochelle, Northstone, Kate, Kanagaratnam, Arun, Horne, Elsie, Forbes, Harriet, North, Teri, Taylor, Kurt, Arab, Marwa A.L., Walker, Scott, Coronado, Jose I.C., Karthikeyan, Arun S., Ploubidis, George, Moltrecht, Bettina, Booth, Charlotte, Parsons, Sam, Wielgoszewska, Bozena, Bridger-Staatz, Charis, Steves, Claire, Thompson, Ellen, Garcia, Paz, Cheetham, Nathan, Bowyer, Ruth, Freydin, Maxim, Roberts, Amy, Goldacre, Ben, Walker, Alex, Morley, Jess, Hulme, William, Nab, Linda, Fisher, Louis, MacKenna, Brian, Andrews, Colm, Curtis, Helen, Hopcroft, Lisa, Green, Amelia, Patalay, Praveetha, Maddock, Jane, Patel, Kishan, Stafford, Jean, Jacques, Wels, Tilling, Kate, Macleod, John, McElroy, Eoin, Shah, Anoop, Silverwood, Richard, Denaxas, Spiros, Flaig, Robin, McCartney, Daniel, Campbell, Archie, Tomlinson, Laurie, Tazare, John, Zheng, Bang, Smeeth, Liam, Herrett, Emily, Cowling, Thomas, Mansfield, Kate, Costello, Ruth E., Wang, Kevin, Mansfield, Kathryn, Mahalingasivam, Viyaasan, Douglas, Ian, Langan, Sinead, Brophy, Sinead, Parker, Michael, Kennedy, Jonathan, McEachan, Rosie, Wright, John, Willan, Kathryn, Badrick, Ellena, Santorelli, Gillian, Yang, Tiffany, Hou, Bo, Steptoe, Andrew, Giorgio, Di Gessa, Zhu, Jingmin, Zaninotto, Paola, Wood, Angela, Cezard, Genevieve, Ip, Samantha, Bolton, Tom, Sampri, Alexia, Rafeti, Elena, Almaghrabi, Fatima, Sheikh, Aziz, Shah, Syed A., Katikireddi, Vittal, Shaw, Richard, Hamilton, Olivia, Green, Michael, Kromydas, Theocharis, Kopasker, Daniel, Greaves, Felix, Willans, Robert, Glen, Fiona, Sharp, Steve, Hughes, Alun, Wong, Andrew, Howes, Lee Hamill, Rapala, Alicja, Nigrelli, Lidia, McArdle, Fintan, Beckford, Chelsea, Raman, Betty, Dobson, Richard, Folarin, Amos, Stewart, Callum, Ranjan, Yatharth, Carpentieri, Jd, Sheard, Laura, Fang, Chao, Baz, Sarah, Gibson, Andy, Kellas, John, Neubauer, Stefan, Piechnik, Stefan, Lukaschuk, Elena, Saunders, Laura C., Wild, James M., Smith, Stephen, Jezzard, Peter, Tunnicliffe, Elizabeth, Sanders, Zeena-Britt, Finnigan, Lucy, Ferreira, Vanessa, Green, Mark, Rhead, Rebecca, Kibble, Milla, Wei, Yinghui, Lemanska, Agnieszka, Perez-Reche, Francisco, Piehlmaier, Dominik, Teece, Lucy, Parker, Edward, Walker, Alex J., Inglesby, Peter, Curtis, Helen J., Morton, Caroline E., Morley, Jessica, Mehrkar, Amir, Bacon, Sebastian C.J., Hickman, George, Croker, Richard, Evans, David, Ward, Tom, DeVito, Nicholas J., Green, Amelia C.A., Massey, Jon, Smith, Rebecca M., Hulme, William J., Davy, Simon, Andrews, Colm D., Hopcroft, Lisa E.M., Drysdale, Henry, Dillingham, Iain, Park, Robin Y., Higgins, Rose, Cunningham, Christine, Wiedemann, Milan, Maude, Steven, Macdonald, Orla, Butler-Cole, Ben F.C., O'Dwyer, Thomas, Stables, Catherine L., Wood, Christopher, Brown, Andrew D., Speed, Victoria, Bridges, Lucy, Schaffer, Andrea L., Walters, Caroline E., Rentsch, Christopher T., Bhaskaran, Krishnan, Schultze, Anna, Williamson, Elizabeth J., McDonald, Helen I., Tomlinson, Laurie A., Mathur, Rohini, Eggo, Rosalind M., Wing, Kevin, Wong, Angel Y.S., Grieve, Richard, Grint, Daniel J., Mansfield, Kathryn E., Douglas, Ian J., Evans, Stephen J.W., Walker, Jemma L., Cowling, Thomas E., Herrett, Emily L., Parker, Edward P.K., Bates, Christopher, Cockburn, Jonathan, Parry, John, Hester, Frank, Harper, Sam, O'Hanlon, Shaun, Eavis, Alex, Jarvis, Richard, Avramov, Dima, Griffiths, Paul, Fowles, Aaron, Parkes, Nasreen, Nicholson, Brian, Perera, Rafael, Harrison, David, Khunti, Kamlesh, Sterne, Jonathan AC., Quint, Jennifer, Henderson, Alasdair D., Carreira, Helena, Bidulka, Patrick, Warren-Gash, Charlotte, Hayes, Joseph F., Quint, Jennifer K., Katikireddi, Srinivasa Vittal, and Langan, Sinéad M.
Published: 2023
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7. Changes in COVID-19-related mortality across key demographic and clinical subgroups in England from 2020 to 2022: a retrospective cohort study using the OpenSAFELY platform

Author: Nab, Linda, Parker, Edward P K, Andrews, Colm D, Hulme, William J, Fisher, Louis, Morley, Jessica, Mehrkar, Amir, MacKenna, Brian, Inglesby, Peter, Morton, Caroline E, Bacon, Sebastian C J, Hickman, George, Evans, David, Ward, Tom, Smith, Rebecca M, Davy, Simon, Dillingham, Iain, Maude, Steven, Butler-Cole, Ben F C, O’Dwyer, Thomas, Stables, Catherine L, Bridges, Lucy, Bates, Christopher, Cockburn, Jonathan, Parry, John, Hester, Frank, Harper, Sam, Zheng, Bang, Williamson, Elizabeth J, Eggo, Rosalind M, Evans, Stephen J W, Goldacre, Ben, Tomlinson, Laurie A, and Walker, Alex J
Published: 2023
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8. Comparison of methods for predicting COVID-19-related death in the general population using the OpenSAFELY platform

Author: Williamson, Elizabeth J., Tazare, John, Bhaskaran, Krishnan, McDonald, Helen I., Walker, Alex J., Tomlinson, Laurie, Wing, Kevin, Bacon, Sebastian, Bates, Chris, Curtis, Helen J., Forbes, Harriet J., Minassian, Caroline, Morton, Caroline E., Nightingale, Emily, Mehrkar, Amir, Evans, David, Nicholson, Brian D., Leon, David A., Inglesby, Peter, MacKenna, Brian, Davies, Nicholas G., DeVito, Nicholas J., Drysdale, Henry, Cockburn, Jonathan, Hulme, William J., Morley, Jessica, Douglas, Ian, Rentsch, Christopher T., Mathur, Rohini, Wong, Angel, Schultze, Anna, Croker, Richard, Parry, John, Hester, Frank, Harper, Sam, Grieve, Richard, Harrison, David A., Steyerberg, Ewout W., Eggo, Rosalind M., Diaz-Ordaz, Karla, Keogh, Ruth, Evans, Stephen J. W., Smeeth, Liam, and Goldacre, Ben
Published: 2022
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9. Weight trends among adults with diabetes or hypertension during the COVID-19 pandemic: an observational study using OpenSAFELY.

Author: Samuel, Miriam, Park, Robin Y, Eastwood, Sophie V, Eto, Fabiola, Morton, Caroline E, Stow, Daniel, Bacon, Sebastian, Goldacre, Ben, Mehrkar, Amir, Morley, Jessica, Dillingham, Iain, Inglesby, Peter, Hulme, William J, Khunti, Kamlesh, Mathur, Rohini, Valabhji, Jonathan, MacKenna, Brian, and Finer, Sarah
Subjects: COVID-19 pandemic, TYPE 2 diabetes, WEIGHT gain, BODY mass index, PRIMARY health care
Abstract: Background: COVID-19 pandemic restrictions may have influenced behaviours related to weight. Aim: To describe patterns of weight change among adults living in England with type 2 diabetes (T2D) and/or hypertension during the pandemic. Design and setting: An observational cohort study using the routinely collected health data of approximately 40% of adults living in England, accessed through the OpenSAFELY service inside TPP. Method: Clinical and sociodemographic characteristics associated with rapid weight gain (>0.5 kg/m2/year) were investigated using multivariable logistic regression. Results: Data were extracted on adults with T2D (n = 1 231 455, 43.9% female, and 76.0% White British) or hypertension (n = 3 558 405, 49.7% female, and 84.3% White British). Adults with T2D lost weight overall (median δ = −0.1 kg/m2/year [interquartile range {IQR} −0.7–0.4]). However, rapid weight gain was common (20.7%) and associated with the following: sex (male versus female: adjusted odds ratio [aOR] 0.78 [95% confidence interval {CI} = 0.77 to 0.79]); age (older age reduced odds, for example, aged 60–69 years versus 18–29 years: aOR 0.66 [95% CI = 0.61 to 0.71]); deprivation (least deprived Index of Multiple Deprivation [IMD] quintile versus most deprived IMD quintile: aOR 0.87 [95% CI = 0.85 to 0.89]); White ethnicity (Black versus White: aOR 0.95 [95% CI = 0.92 to 0.98]); mental health conditions (for example, depression: aOR 1.13 [95% CI = 1.12 to 1.15]); and diabetes treatment (non-insulin treatment versus no pharmacological treatment: aOR 0.68 [95% CI = 0.67 to 0.69]). Adults with hypertension maintained stable weight overall (median δ = 0.0 kg/m2/year [IQR −0.6–0.5]); however, rapid weight gain was common (24.7%) and associated with similar characteristics as in T2D. Conclusion: Among adults living in England with T2D and/or hypertension, rapid pandemic weight gain was more common among females, younger adults, those living in more deprived areas, and those with mental health conditions. [ABSTRACT FROM AUTHOR]
Published: 2024
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10. Quantifying and Adjusting for Confounding From Health-Seeking Behavior and Health Care Access in Observational Research.

Author: Graham, Sophie, Walker, Jemma L, Andrews, Nick, Hulme, William J, Nitsch, Dorothea, Parker, Edward P K, and McDonald, Helen I
Subjects: FLU vaccine efficacy, HEALTH services accessibility, HEALTH behavior, VACCINATION, VACCINE effectiveness
Abstract: Background Health-seeking behavior and health care access (HSB/HCA) are recognized confounders in many observational studies but are not directly measurable in electronic health records. We used proxy markers of HSB/HCA to quantify and adjust for confounding in observational studies of influenza and COVID-19 vaccine effectiveness (VE). Methods This cohort study used primary care data prelinked to secondary care and death data in England. We included individuals aged ≥66 years on 1 September 2019 and assessed influenza VE in the 2019–2020 season and early COVID-19 VE (December 2020–March 2021). VE was estimated with sequential adjustment for demographics, comorbidities, and 14 markers of HSB/HCA. Influenza vaccination in the 2019–2020 season was also considered a negative control exposure against COVID-19 before COVID-19 vaccine rollout. Results We included 1 991 284, 1 796 667, and 1 946 943 individuals in the influenza, COVID-19, and negative control exposure populations, respectively. Markers of HSB/HCA were positively correlated with influenza and COVID-19 vaccine uptake. For influenza, adjusting for HSB/HCA markers in addition to demographics and comorbidities increased VE against influenza-like illness from −1.5% (95% CI, −3.2% to.1%) to 7.1% (95% CI, 5.4%–8.7%) with a less apparent trend for more severe outcomes. For COVID-19, adjusting for HSB/HCA markers did not change VE estimates against infection or severe disease (eg, 2 doses of BNT162b2 against infection: 82.8% [95% CI, 78.4%–86.3%] to 83.1% [95% CI, 78.7%–86.5%]). Adjusting for HSB/HCA markers removed bias in the negative control exposure analysis (−7.5% [95% CI, −10.6% to −4.5%] vs −2.1% [95% CI, −6.0% to 1.7%] before vs after adjusting for HSB/HCA markers). Conclusions Markers of HSB/HCA can be used to quantify and account for confounding in observational vaccine studies. [ABSTRACT FROM AUTHOR]
Published: 2024
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11. The impact of the COVID-19 pandemic on Antidepressant Prescribing with a focus on people with learning disability and autism: An interrupted time-series analysis in England using OpenSAFELY-TPP

Author: Cunningham, Christine, primary, Macdonald, Orla, additional, Schaffer, Andrea L, additional, Brown, Andrew D, additional, Wiedemann, Milan, additional, Fisher, Louis, additional, Curtis, Helen J, additional, Mehrkar, Amir, additional, Higgins, Rose, additional, Hulme, William J, additional, Speed, Victoria, additional, Ward, Thomas, additional, Croker, Richard, additional, Walker, Alex J, additional, Butler-Cole, Benjamin, additional, Andrews, Colm D, additional, Parry, John, additional, Bates, Chris, additional, Evans, David, additional, Inglesby, Peter, additional, Dillingham, Iain, additional, Davy, Simon, additional, Bridges, Lucy, additional, O'Dwyer, Thomas, additional, Maude, Steven, additional, Smith, Rebecca, additional, Hart, Liam, additional, Goldacre, Ben, additional, Bacon, Sebastian, additional, and MacKenna, Brian, additional
Published: 2024
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12. Effect of pre-exposure use of hydroxychloroquine on COVID-19 mortality: a population-based cohort study in patients with rheumatoid arthritis or systemic lupus erythematosus using the OpenSAFELY platform

Author: Rentsch, Christopher T, DeVito, Nicholas J, MacKenna, Brian, Morton, Caroline E, Bhaskaran, Krishnan, Brown, Jeremy P, Schultze, Anna, Hulme, William J, Croker, Richard, Walker, Alex J, Williamson, Elizabeth J, Bates, Chris, Bacon, Seb, Mehrkar, Amir, Curtis, Helen J, Evans, David, Wing, Kevin, Inglesby, Peter, Mathur, Rohini, Drysdale, Henry, Wong, Angel Y S, McDonald, Helen I, Cockburn, Jonathan, Forbes, Harriet, Parry, John, Hester, Frank, Harper, Sam, Smeeth, Liam, Douglas, Ian J, Dixon, William G, Evans, Stephen J W, Tomlinson, Laurie, and Goldacre, Ben
Published: 2021
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13. HIV infection and COVID-19 death: a population-based cohort analysis of UK primary care data and linked national death registrations within the OpenSAFELY platform

Author: Bhaskaran, Krishnan, Rentsch, Christopher T, MacKenna, Brian, Schultze, Anna, Mehrkar, Amir, Bates, Chris J, Eggo, Rosalind M, Morton, Caroline E, Bacon, Sebastian C J, Inglesby, Peter, Douglas, Ian J, Walker, Alex J, McDonald, Helen I, Cockburn, Jonathan, Williamson, Elizabeth J, Evans, David, Forbes, Harriet J, Curtis, Helen J, Hulme, William J, Parry, John, Hester, Frank, Harper, Sam, Evans, Stephen J W, Smeeth, Liam, and Goldacre, Ben
Published: 2021
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14. Effectiveness of mRNA COVID-19 Vaccines as First Booster Doses in England: An Observational Study in OpenSAFELY-TPP.

Author: Horne, Elsie M. F., Hulme, William J., Parker, Edward P. K., Keogh, Ruth H., Williamson, Elizabeth J., Walker, Venexia M., Palmer, Tom M., Denholm, Rachel, Knight, Rochelle, Curtis, Helen J., Walker, Alex J., Andrews, Colm D., Mehrkar, Amir, Morley, Jessica, MacKenna, Brian, Bacon, Sebastian C. J., Goldacre, Ben, Hernán, Miguel A., and Sterne, Jonathan A. C.
Abstract: Background: The UK delivered its first “booster” COVID-19 vaccine doses in September 2021, initially to individuals at high risk of severe disease, then to all adults. The BNT162b2 Pfizer-BioNTech vaccine was used initially, then also Moderna mRNA-1273. Methods: With the approval of the National Health Service England, we used routine clinical data to estimate the effectiveness of boosting with BNT162b2 or mRNA-1273 compared with no boosting in eligible adults who had received two primary course vaccine doses. We matched each booster recipient with an unboosted control on factors relating to booster priority status and prior COVID-19 immunization. We adjusted for additional factors in Cox models, estimating hazard ratios up to 182 days (6 months) following booster dose. We estimated hazard ratios overall and within the following periods: 1–14, 15–42, 43–69, 70–97, 98–126, 127–152, and 155–182 days. Outcomes included a positive SARS-CoV-2 test, COVID-19 hospitalization, COVID-19 death, non-COVID-19 death, and fracture. Results: We matched 8,198,643 booster recipients with unboosted controls. Adjusted hazard ratios over 6-month follow-up were: positive SARS-CoV-2 test 0.75 (0.74, 0.75); COVID-19 hospitalization 0.30 (0.29, 0.31); COVID-19 death 0.11 (0.10, 0.14); non- COVID-19 death 0.22 (0.21, 0.23); and fracture 0.77 (0.75, 0.78). Estimated effectiveness of booster vaccines against severe COVID- 19-related outcomes peaked during the first 3 months following the booster dose. By 6 months, the cumulative incidence of positive SARS-CoV-2 test was higher in boosted than unboosted individuals. Conclusions: We estimate that COVID-19 booster vaccination, compared with no booster vaccination, provided substantial protection against COVID-19 hospitalization and COVID-19 death but only limited protection against positive SARS-CoV-2 test. Lower rates of fracture in boosted than unboosted individuals may suggest unmeasured confounding. Observational studies should report estimated vaccine effectiveness against nontarget and negative control outcomes. [ABSTRACT FROM AUTHOR]
Published: 2024
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15. The impact of COVID‐19 on medication reviews in English primary care. An OpenSAFELY‐TPP analysis of 20 million adult electronic health records.

Author: Wood, Christopher, Speed, Victoria, Fisher, Louis, Curtis, Helen J., Schaffer, Andrea L., Walker, Alex J., Croker, Richard, Brown, Andrew D., Cunningham, Christine, Hulme, William J., Andrews, Colm D., Butler‐Cole, Ben F. C., Evans, David, Inglesby, Peter, Dillingham, Iain, Bacon, Sebastian C. J., Davy, Simon, Ward, Tom, Hickman, George, and Bridges, Lucy
Subjects: MEDICATION reconciliation, ELECTRONIC health records, PRIMARY care, COVID-19 pandemic, COVID-19, CUCUMBER mosaic virus
Abstract: Aims: The COVID‐19 pandemic caused significant disruption to routine activity in primary care. Medication reviews are an important primary care activity ensuring safety and appropriateness of prescribing. A disruption could have significant negative implications for patient care. Using routinely collected data, our aim was first to describe codes used to record medication review activity and then to report the impact of COVID‐19 on the rates of medication reviews. Methods: With the approval of NHS England, we conducted a cohort study of 20 million adult patient records in general practice, in‐situ using the OpenSAFELY platform. For each month, between April 2019 and March 2022, we report the percentage of patients with a medication review coded monthly and in the previous 12 months with breakdowns by regional, clinical and demographic subgroups and those prescribed high‐risk medications. Results: In April 2019, 32.3% of patients had a medication review coded in the previous 12 months. During the first COVID‐19 lockdown, monthly activity decreased (−21.1% April 2020), but the 12‐month rate was not substantially impacted (−10.5% March 2021). The rate of structured medication review in the last 12 months reached 2.9% by March 2022, with higher percentages in high‐risk groups (care home residents 34.1%, age 90+ years 13.1%, high‐risk medications 10.2%). The most used medication review code was Medication review done 314530002 (59.5%). Conclusions: There was a substantial reduction in the monthly rate of medication reviews during the pandemic but rates recovered by the end of the study period. Structured medication reviews were prioritized for high‐risk patients. [ABSTRACT FROM AUTHOR]
Published: 2024
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16. OpenSAFELY: a platform for analysing electronic health records designed for reproducible research

Author: Nab, Linda, primary, Schaffer, Andrea, additional, Hulme, William J, additional, DeVito, Nicholas J, additional, Dillingham, Iain, additional, Wiedemann, Milan, additional, Andews, Colm, additional, Curtis, Helen, additional, Fisher, Louis, additional, Green, Amelia, additional, Massey, Jon, additional, Walters, Caroline, additional, Higgins, Rose, additional, Cunningham, Christine, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Hart, Liam, additional, Davy, Simon, additional, Evans, David, additional, Hickman, George, additional, Inglesby, Peter, additional, Morton, Caroline E, additional, Smith, Rebecca M, additional, Ward, Thomas, additional, O'Dwyer, Thomas, additional, Maude, Steven, additional, Bridges, Lucy, additional, Butler-Cole, Benjamin FC, additional, Stables, Catherine L, additional, Stokes, Pete, additional, Bates, Christopher, additional, Cockburn, Jonathan, additional, Hester, Frank, additional, Parry, John, additional, Bhaskaran, Krishnan, additional, Schultze, Anna, additional, Rentsch, Christopher T., additional, Mathur, Rohini, additional, Tomlinson, Laurie, additional, Williamson, Elizabeth, additional, Smeeth, Liam, additional, Walker, Alex, additional, Bacon, Sebastian, additional, MacKenna, Brian, additional, and Goldacre, Ben, additional
Published: 2024
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17. Weight trends amongst adults with diabetes or hypertension during the COVID-19 pandemic: an observational study using OpenSAFELY

Author: Samuel, Miriam, primary, Park, Robin Y, additional, Eastwood, Sophie V, additional, Eto, Fabiola, additional, Morton, Caroline, additional, Stow, Daniel, additional, Bacon, Sebastian, additional, Goldacre, Ben, additional, Mehrkar, Amir, additional, Morley, Jessica, additional, Dillingham, Iain, additional, Inglesby, Peter, additional, Hulme, William J, additional, Khunti, Kamlesh, additional, Mathur, Rohini, additional, Valabhji, Jonathan, additional, MacKenna, Brian, additional, and Finer, Sarah, additional
Published: 2023
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18. Clinical and health inequality risk factors for non-COVID-related sepsis during the global COVID-19 pandemic: a national case-control and cohort study

Author: Zhong, Xiaomin, primary, Ashiru-Oredope, Diane, additional, Pate, Alexander, additional, Martin, Glen P., additional, Sharma, Anita, additional, Dark, Paul, additional, Felton, Tim, additional, Lake, Claire, additional, MacKenna, Brian, additional, Mehrkar, Amir, additional, Bacon, Sebastian C.J., additional, Massey, Jon, additional, Inglesby, Peter, additional, Goldacre, Ben, additional, Hand, Kieran, additional, Bladon, Sian, additional, Cunningham, Neil, additional, Gilham, Ellie, additional, Brown, Colin S., additional, Mirfenderesky, Mariyam, additional, Palin, Victoria, additional, van Staa, Tjeerd Pieter, additional, Walker, Alex J., additional, Curtis, Helen J., additional, Morley, Jessica, additional, Hickman, George, additional, Croker, Richard, additional, Evans, David, additional, Ward, Tom, additional, DeVito, Nicholas J., additional, Fisher, Louis, additional, Green, Amelia C.A., additional, Smith, Rebecca M., additional, Hulme, William J., additional, Davy, Simon, additional, Andrews, Colm D., additional, Hopcroft, Lisa E.M., additional, Dillingham, Iain, additional, Higgins, Rose, additional, Cunningham, Christine, additional, Wiedemann, Milan, additional, Nab, Linda, additional, Maude, Steven, additional, Macdonald, Orla, additional, Butler-Cole, Ben F.C., additional, O'Dwyer, Thomas, additional, Stables, Catherine L., additional, Wood, Christopher, additional, Brown, Andrew D., additional, Speed, Victoria, additional, Bridges, Lucy, additional, Schaffer, Andrea L., additional, Walters, Caroline E., additional, Bates, Christopher, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, and Harper, Sam, additional
Published: 2023
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19. Challenges in Estimating Effectiveness of 2 Doses of COVID-19 Vaccines Beyond 6 Months in England

Author: Horne, Elsie M F, primary, Hulme, William J, additional, Keogh, Ruth H, additional, Palmer, Tom M, additional, Williamson, Elizabeth J, additional, Parker, Edward P K, additional, Walker, Venexia M, additional, Knight, Rochelle, additional, Wie, Yinghui, additional, Taylor, Kurt, additional, Fisher, Louis, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Dillingham, Iain, additional, Bacon, Sebastian, additional, Goldacre, Ben, additional, Sterne, Jonathan A C, additional, and Collaborative, The OpenSAFELY, additional
Published: 2023
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20. Overall and cause-specific hospitalisation and death after COVID-19 hospitalisation in England: A cohort study using linked primary care, secondary care, and death registration data in the OpenSAFELY platform

Author: Bhaskaran, Krishnan, Rentsch, Christopher T., Hickman, George, Hulme, William J., Schultze, Anna, Curtis, Helen J., Wing, Kevin, Warren-Gash, Charlotte, Tomlinson, Laurie, Bates, Chris J., Mathur, Rohini, MacKenna, Brian, Mahalingasivam, Viyaasan, Wong, Angel, Walker, Alex J., Morton, Caroline E., Grint, Daniel, Mehrkar, Amir, Eggo, Rosalind M., Inglesby, Peter, Douglas, Ian J., McDonald, Helen I., Cockburn, Jonathan, Williamson, Elizabeth J., Evans, David, Parry, John, Hester, Frank, Harper, Sam, Evans, Stephen JW, Bacon, Sebastian, Smeeth, Liam, and Goldacre, Ben
Subjects: Hospital care -- Patient outcomes -- Risk factors, Biological sciences
Abstract: Background There is concern about medium to long-term adverse outcomes following acute Coronavirus Disease 2019 (COVID-19), but little relevant evidence exists. We aimed to investigate whether risks of hospital admission and death, overall and by specific cause, are raised following discharge from a COVID-19 hospitalisation. Methods and findings With the approval of NHS-England, we conducted a cohort study, using linked primary care and hospital data in OpenSAFELY to compare risks of hospital admission and death, overall and by specific cause, between people discharged from COVID-19 hospitalisation (February to December 2020) and surviving at least 1 week, and (i) demographically matched controls from the 2019 general population; and (ii) people discharged from influenza hospitalisation in 2017 to 2019. We used Cox regression adjusted for age, sex, ethnicity, obesity, smoking status, deprivation, and comorbidities considered potential risk factors for severe COVID-19 outcomes. We included 24,673 postdischarge COVID-19 patients, 123,362 general population controls, and 16,058 influenza controls, followed for [less than or equal to]315 days. COVID-19 patients had median age of 66 years, 13,733 (56%) were male, and 19,061 (77%) were of white ethnicity. Overall risk of hospitalisation or death (30,968 events) was higher in the COVID-19 group than general population controls (fully adjusted hazard ratio [aHR] 2.22, 2.14 to 2.30, p < 0.001) but slightly lower than the influenza group (aHR 0.95, 0.91 to 0.98, p = 0.004). All-cause mortality (7,439 events) was highest in the COVID-19 group (aHR 4.82, 4.48 to 5.19 versus general population controls [p < 0.001] and 1.74, 1.61 to 1.88 versus influenza controls [p < 0.001]). Risks for cause-specific outcomes were higher in COVID-19 survivors than in general population controls and largely similar or lower in COVID-19 compared with influenza patients. However, COVID-19 patients were more likely than influenza patients to be readmitted or die due to their initial infection or other lower respiratory tract infection (aHR 1.37, 1.22 to 1.54, p < 0.001) and to experience mental health or cognitive-related admission or death (aHR 1.37, 1.02 to 1.84, p = 0.039); in particular, COVID-19 survivors with preexisting dementia had higher risk of dementia hospitalisation or death (age- and sex-adjusted HR 2.47, 1.37 to 4.44, p = 0.002). Limitations of our study were that reasons for hospitalisation or death may have been misclassified in some cases due to inconsistent use of codes, and we did not have data to distinguish COVID-19 variants. Conclusions In this study, we observed that people discharged from a COVID-19 hospital admission had markedly higher risks for rehospitalisation and death than the general population, suggesting a substantial extra burden on healthcare. Most risks were similar to those observed after influenza hospitalisations, but COVID-19 patients had higher risks of all-cause mortality, readmission or death due to the initial infection, and dementia death, highlighting the importance of postdischarge monitoring., Author(s): Krishnan Bhaskaran 1,*, Christopher T. Rentsch 1, George Hickman 2, William J. Hulme 2, Anna Schultze 1, Helen J. Curtis 2, Kevin Wing 1, Charlotte Warren-Gash 1, Laurie Tomlinson [...]
Published: 2022
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21. Ethnic differences in the indirect effects of the COVID-19 pandemic on clinical monitoring and hospitalisations for non-COVID conditions in England: a population-based, observational cohort study using the OpenSAFELY platform

Author: Costello, Ruth E., primary, Tazare, John, additional, Piehlmaier, Dominik, additional, Herrett, Emily, additional, Parker, Edward P.K., additional, Zheng, Bang, additional, Mansfield, Kathryn E., additional, Henderson, Alasdair D., additional, Carreira, Helena, additional, Bidulka, Patrick, additional, Wong, Angel Y.S., additional, Warren-Gash, Charlotte, additional, Hayes, Joseph F., additional, Quint, Jennifer K., additional, MacKenna, Brian, additional, Mehrkar, Amir, additional, Eggo, Rosalind M., additional, Katikireddi, Srinivasa Vittal, additional, Tomlinson, Laurie, additional, Langan, Sinéad M., additional, Mathur, Rohini, additional, Chaturvedi, Nishi, additional, Park, Chloe, additional, Carnemolla, Alisia, additional, Williams, Dylan, additional, Knueppel, Anika, additional, Boyd, Andy, additional, Turner, Emma L., additional, Evans, Katharine M., additional, Thomas, Richard, additional, Berman, Samantha, additional, McLachlan, Stela, additional, Crane, Matthew, additional, Whitehorn, Rebecca, additional, Oakley, Jacqui, additional, Foster, Diane, additional, Woodward, Hannah, additional, Campbell, Kirsteen C., additional, Timpson, Nicholas, additional, Kwong, Alex, additional, Soares, Ana Goncalves, additional, Griffith, Gareth, additional, Toms, Renin, additional, Jones, Louise, additional, Annie, Herbert, additional, Mitchell, Ruth, additional, Palmer, Tom, additional, Sterne, Jonathan, additional, Walker, Venexia, additional, Huntley, Lizzie, additional, Fox, Laura, additional, Denholm, Rachel, additional, Knight, Rochelle, additional, Northstone, Kate, additional, Kanagaratnam, Arun, additional, Horne, Elsie, additional, Forbes, Harriet, additional, North, Teri, additional, Taylor, Kurt, additional, Arab, Marwa A.L., additional, Walker, Scott, additional, Coronado, Jose I.C., additional, Karthikeyan, Arun S., additional, Ploubidis, George, additional, Moltrecht, Bettina, additional, Booth, Charlotte, additional, Parsons, Sam, additional, Wielgoszewska, Bozena, additional, Bridger-Staatz, Charis, additional, Steves, Claire, additional, Thompson, Ellen, additional, Garcia, Paz, additional, Cheetham, Nathan, additional, Bowyer, Ruth, additional, Freydin, Maxim, additional, Roberts, Amy, additional, Goldacre, Ben, additional, Walker, Alex, additional, Morley, Jess, additional, Hulme, William, additional, Nab, Linda, additional, Fisher, Louis, additional, Andrews, Colm, additional, Curtis, Helen, additional, Hopcroft, Lisa, additional, Green, Amelia, additional, Patalay, Praveetha, additional, Maddock, Jane, additional, Patel, Kishan, additional, Stafford, Jean, additional, Jacques, Wels, additional, Tilling, Kate, additional, Macleod, John, additional, McElroy, Eoin, additional, Shah, Anoop, additional, Silverwood, Richard, additional, Denaxas, Spiros, additional, Flaig, Robin, additional, McCartney, Daniel, additional, Campbell, Archie, additional, Smeeth, Liam, additional, Cowling, Thomas, additional, Mansfield, Kate, additional, Costello, Ruth E., additional, Wang, Kevin, additional, Mansfield, Kathryn, additional, Mahalingasivam, Viyaasan, additional, Douglas, Ian, additional, Langan, Sinead, additional, Brophy, Sinead, additional, Parker, Michael, additional, Kennedy, Jonathan, additional, McEachan, Rosie, additional, Wright, John, additional, Willan, Kathryn, additional, Badrick, Ellena, additional, Santorelli, Gillian, additional, Yang, Tiffany, additional, Hou, Bo, additional, Steptoe, Andrew, additional, Giorgio, Di Gessa, additional, Zhu, Jingmin, additional, Zaninotto, Paola, additional, Wood, Angela, additional, Cezard, Genevieve, additional, Ip, Samantha, additional, Bolton, Tom, additional, Sampri, Alexia, additional, Rafeti, Elena, additional, Almaghrabi, Fatima, additional, Sheikh, Aziz, additional, Shah, Syed A., additional, Katikireddi, Vittal, additional, Shaw, Richard, additional, Hamilton, Olivia, additional, Green, Michael, additional, Kromydas, Theocharis, additional, Kopasker, Daniel, additional, Greaves, Felix, additional, Willans, Robert, additional, Glen, Fiona, additional, Sharp, Steve, additional, Hughes, Alun, additional, Wong, Andrew, additional, Howes, Lee Hamill, additional, Rapala, Alicja, additional, Nigrelli, Lidia, additional, McArdle, Fintan, additional, Beckford, Chelsea, additional, Raman, Betty, additional, Dobson, Richard, additional, Folarin, Amos, additional, Stewart, Callum, additional, Ranjan, Yatharth, additional, Carpentieri, Jd, additional, Sheard, Laura, additional, Fang, Chao, additional, Baz, Sarah, additional, Gibson, Andy, additional, Kellas, John, additional, Neubauer, Stefan, additional, Piechnik, Stefan, additional, Lukaschuk, Elena, additional, Saunders, Laura C., additional, Wild, James M., additional, Smith, Stephen, additional, Jezzard, Peter, additional, Tunnicliffe, Elizabeth, additional, Sanders, Zeena-Britt, additional, Finnigan, Lucy, additional, Ferreira, Vanessa, additional, Green, Mark, additional, Rhead, Rebecca, additional, Kibble, Milla, additional, Wei, Yinghui, additional, Lemanska, Agnieszka, additional, Perez-Reche, Francisco, additional, Teece, Lucy, additional, Parker, Edward, additional, Walker, Alex J., additional, Inglesby, Peter, additional, Curtis, Helen J., additional, Morton, Caroline E., additional, Morley, Jessica, additional, Bacon, Sebastian C.J., additional, Hickman, George, additional, Croker, Richard, additional, Evans, David, additional, Ward, Tom, additional, DeVito, Nicholas J., additional, Green, Amelia C.A., additional, Massey, Jon, additional, Smith, Rebecca M., additional, Hulme, William J., additional, Davy, Simon, additional, Andrews, Colm D., additional, Hopcroft, Lisa E.M., additional, Drysdale, Henry, additional, Dillingham, Iain, additional, Park, Robin Y., additional, Higgins, Rose, additional, Cunningham, Christine, additional, Wiedemann, Milan, additional, Maude, Steven, additional, Macdonald, Orla, additional, Butler-Cole, Ben F.C., additional, O'Dwyer, Thomas, additional, Stables, Catherine L., additional, Wood, Christopher, additional, Brown, Andrew D., additional, Speed, Victoria, additional, Bridges, Lucy, additional, Schaffer, Andrea L., additional, Walters, Caroline E., additional, Rentsch, Christopher T., additional, Bhaskaran, Krishnan, additional, Schultze, Anna, additional, Williamson, Elizabeth J., additional, McDonald, Helen I., additional, Tomlinson, Laurie A., additional, Wing, Kevin, additional, Grieve, Richard, additional, Grint, Daniel J., additional, Douglas, Ian J., additional, Evans, Stephen J.W., additional, Walker, Jemma L., additional, Cowling, Thomas E., additional, Herrett, Emily L., additional, Bates, Christopher, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, O'Hanlon, Shaun, additional, Eavis, Alex, additional, Jarvis, Richard, additional, Avramov, Dima, additional, Griffiths, Paul, additional, Fowles, Aaron, additional, Parkes, Nasreen, additional, Nicholson, Brian, additional, Perera, Rafael, additional, Harrison, David, additional, Khunti, Kamlesh, additional, Sterne, Jonathan AC., additional, and Quint, Jennifer, additional
Published: 2023
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22. Comparative effectiveness of two- and three-dose COVID-19 vaccination schedules involving AZD1222 and BNT162b2 in people with kidney disease: a linked OpenSAFELY and UK Renal Registry cohort study

Author: Parker, Edward P.K., primary, Horne, Elsie M.F., additional, Hulme, William J., additional, Tazare, John, additional, Zheng, Bang, additional, Carr, Edward J., additional, Loud, Fiona, additional, Lyon, Susan, additional, Mahalingasivam, Viyaasan, additional, MacKenna, Brian, additional, Mehrkar, Amir, additional, Scanlon, Miranda, additional, Santhakumaran, Shalini, additional, Steenkamp, Retha, additional, Goldacre, Ben, additional, Sterne, Jonathan A.C., additional, Nitsch, Dorothea, additional, and Tomlinson, Laurie A., additional
Published: 2023
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23. CHALLENGES IN ESTIMATING THE EFFECTIVENESS OF 2 DOSES OF COVID-19 VACCINE BEYOND 6 MONTHS IN ENGLAND.

Author: Horne, Elsie M F, Hulme, William J, Keogh, Ruth H, Palmer, Tom M, Williamson, Elizabeth J, Parker, Edward P K, Walker, Venexia M, Knight, Rochelle, Wei, Yinghui, Taylor, Kurt, Fisher, Louis, Morley, Jessica, Mehrkar, Amir, Dillingham, Iain, Bacon, Sebastian, Goldacre, Ben, Sterne, Jonathan A C, and Collaborative, for the OpenSAFELY
Subjects: *COVID-19, *IMMUNIZATION, *CONFIDENCE intervals, *COVID-19 vaccines, *TIME, *VACCINATION coverage, *VACCINE effectiveness, *DESCRIPTIVE statistics, *HOSPITAL care, *DEATH, *EVALUATION
Abstract: The article discusses a study which examined the effectiveness of two doses of coronavirus disease 2019 (COVID-19) vaccine beyond six months in England. Topics include increase in the cumulative incidence of receiving a third dose of vaccine during the eight weeks following eligibility, basis of the effectiveness of two doses during later comparison periods, and important factors in interpreting estimated vaccine effectiveness (VE).
Published: 2024
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24. Challenges in Estimating the Effectiveness of COVID-19 Vaccination Using Observational Data

Author: Hulme, William J., primary, Williamson, Elizabeth, additional, Horne, Elsie M.F., additional, Green, Amelia, additional, McDonald, Helen I., additional, Walker, Alex J., additional, Curtis, Helen J., additional, Morton, Caroline E., additional, MacKenna, Brian, additional, Croker, Richard, additional, Mehrkar, Amir, additional, Bacon, Seb, additional, Evans, David, additional, Inglesby, Peter, additional, Davy, Simon, additional, Bhaskaran, Krishnan, additional, Schultze, Anna, additional, Rentsch, Christopher T., additional, Tomlinson, Laurie, additional, Douglas, Ian J., additional, Evans, Stephen J.W., additional, Smeeth, Liam, additional, Palmer, Tom, additional, Goldacre, Ben, additional, Hernán, Miguel A., additional, and Sterne, Jonathan A.C., additional
Published: 2023
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25. Comparative effectiveness of BNT162b2 versus mRNA-1273 covid-19 vaccine boosting in England: matched cohort study in OpenSAFELY-TPP

Author: Hulme, William J, primary, Horne, Elsie M F, additional, Parker, Edward P K, additional, Keogh, Ruth H, additional, Williamson, Elizabeth J, additional, Walker, Venexia, additional, Palmer, Tom M, additional, Curtis, Helen J, additional, Walker, Alex J, additional, Andrews, Colm D, additional, Mehrkar, Amir, additional, Morley, Jessica, additional, MacKenna, Brian, additional, Bacon, Sebastian C J, additional, Goldacre, Ben, additional, Hernán, Miguel A, additional, and Sterne, Jonathan A C, additional
Published: 2023
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26. Comparative effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in patients on kidney replacement therapy: observational study using the OpenSAFELY-UKRR and SRR databases.

Author: Zheng, Bang, Campbell, Jacqueline, Carr, Edward J, Tazare, John, Nab, Linda, Mahalingasivam, Viyaasan, Mehrkar, Amir, Santhakumaran, Shalini, Steenkamp, Retha, Loud, Fiona, Lyon, Susan, Scanlon, Miranda, Hulme, William J, Green, Amelia C A, Curtis, Helen J, Fisher, Louis, Parker, Edward, Goldacre, Ben, Douglas, Ian, and Evans, Stephen
Subjects: RENAL replacement therapy, MOLNUPIRAVIR, COVID-19, PROPORTIONAL hazards models, TREATMENT effectiveness
Abstract: Background Due to limited inclusion of patients on kidney replacement therapy (KRT) in clinical trials, the effectiveness of coronavirus disease 2019 (COVID-19) therapies in this population remains unclear. We sought to address this by comparing the effectiveness of sotrovimab against molnupiravir, two commonly used treatments for non-hospitalised KRT patients with COVID-19 in the UK. Methods With the approval of National Health Service England, we used routine clinical data from 24 million patients in England within the OpenSAFELY-TPP platform linked to the UK Renal Registry (UKRR) to identify patients on KRT. A Cox proportional hazards model was used to estimate hazard ratios (HRs) of sotrovimab versus molnupiravir with regards to COVID-19-related hospitalisations or deaths in the subsequent 28 days. We also conducted a complementary analysis using data from the Scottish Renal Registry (SRR). Results Among the 2367 kidney patients treated with sotrovimab (n = 1852) or molnupiravir (n = 515) between 16 December 2021 and 1 August 2022 in England, 38 cases (1.6%) of COVID-19-related hospitalisations/deaths were observed. Sotrovimab was associated with substantially lower outcome risk than molnupiravir {adjusted HR 0.35 [95% confidence interval (CI) 0.17–0.71]; P = .004}, with results remaining robust in multiple sensitivity analyses. In the SRR cohort, sotrovimab showed a trend toward lower outcome risk than molnupiravir [HR 0.39 (95% CI 0.13–1.21); P = .106]. In both datasets, sotrovimab had no evidence of an association with other hospitalisation/death compared with molnupiravir (HRs ranged from 0.73 to 1.29; P > .05). Conclusions In routine care of non-hospitalised patients with COVID-19 on KRT, sotrovimab was associated with a lower risk of severe COVID-19 outcomes compared with molnupiravir during Omicron waves. [ABSTRACT FROM AUTHOR]
Published: 2023
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27. First dose COVID-19 vaccine coverage amongst adolescents and children in England: an analysis of 3.21 million patients' primary care records in situ using OpenSAFELY

Author: Hopcroft, Lisa E., primary, Curtis, Helen J., additional, Brown, Andrew D., additional, Hulme, William J., additional, Andrews, Colm D., additional, Morton, Caroline E., additional, Inglesby, Peter, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Bacon, Sebastian C., additional, Eggo, Rosalind M., additional, Mahalingasivam, Viyaasan, additional, Parker, Edward P. K., additional, Tomlinson, Laurie A., additional, Bates, Christopher, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Goldacre, Ben, additional, Walker, Alex J., additional, and MacKenna, Brian, additional
Published: 2023
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28. OpenSAFELY NHS Service Restoration Observatory 2: changes in primary care activity across six clinical areas during the COVID-19 pandemic

Author: Curtis, Helen J, primary, MacKenna, Brian, additional, Wiedemann, Milan, additional, Fisher, Louis, additional, Croker, Richard, additional, Morton, Caroline E, additional, Inglesby, Peter, additional, Walker, Alex J, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Bacon, Sebastian CJ, additional, Hickman, George, additional, Evans, David, additional, Ward, Tom, additional, Davy, Simon, additional, Hulme, William J, additional, Macdonald, Orla, additional, Conibere, Robin, additional, Lewis, Tom, additional, Myers, Martin, additional, Wanninayake, Shamila, additional, Collison, Kiren, additional, Drury, Charles, additional, Samuel, Miriam, additional, Sood, Harpreet, additional, Cipriani, Andrea, additional, Fazel, Seena, additional, Sharma, Manuj, additional, Baqir, Wasim, additional, Bates, Chris, additional, Parry, John, additional, and Goldacre, Ben, additional
Published: 2023
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29. Trends, variation, and clinical characteristics of recipients of antiviral drugs and neutralising monoclonal antibodies for covid-19 in community settings: retrospective, descriptive cohort study of 23.4 million people in OpenSAFELY

Author: Green, Amelia C A, primary, Curtis, Helen J, additional, Higgins, Rose, additional, Nab, Linda, additional, Mahalingasivam, Viyaasan, additional, Smith, Rebecca M, additional, Mehrkar, Amir, additional, Inglesby, Peter, additional, Drysdale, Henry, additional, DeVito, Nicholas J, additional, Croker, Richard, additional, Rentsch, Christopher T, additional, Bhaskaran, Krishnan, additional, Tazare, John, additional, Zheng, Bang, additional, Andrews, Colm D, additional, Bacon, Sebastian C J, additional, Davy, Simon, additional, Dillingham, Iain, additional, Evans, David, additional, Fisher, Louis, additional, Hickman, George, additional, Hopcroft, Lisa E M, additional, Hulme, William J, additional, Massey, Jon, additional, MacDonald, Orla, additional, Morley, Jessica, additional, Morton, Caroline E, additional, Park, Robin Y, additional, Walker, Alex J, additional, Ward, Tom, additional, Wiedemann, Milan, additional, Bates, Christopher, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Douglas, Ian J, additional, Evans, Stephen J W, additional, Goldacre, Ben, additional, Tomlinson, Laurie A, additional, and MacKenna, Brian, additional
Published: 2023
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30. Factors associated with COVID-19 vaccine uptake in people with kidney disease: an OpenSAFELY cohort study

Author: Collaborative, The OpenSAFELY, Parker, Edward PK, Tazare, John, Hulme, William J, Bates, Christopher, Carr, Edward J, Cockburn, Jonathan, Curtis, Helen J, Fisher, Louis, Green, Amelia CA, Harper, Sam, Hester, Frank, Horne, Elsie MF, Loud, Fiona, Lyon, Susan, Mahalingasivam, Viyaasan, Mehrkar, Amir, Nab, Linda, Parry, John, Santhakumaran, Shalini, Steenkamp, Retha, Sterne, Jonathan AC, Walker, Alex J, Williamson, Elizabeth J, Willicombe, Michelle, Zheng, Bang, Goldacre, Ben, Nitsch, Dorothea, and Tomlinson, Laurie A
Subjects: FOS: Clinical medicine, Immunology, Infectious Disease, Cell Biology
Abstract: Objective To characterise factors associated with COVID-19 vaccine uptake among people with kidney disease in England. Design Retrospective cohort study using the OpenSAFELY-TPP platform, performed with the approval of NHS England. Setting Individual-level routine clinical data from 24 million people across GPs in England using TPP software. Primary care data were linked directly with COVID-19 vaccine records up to 31 August 2022 and with renal replacement therapy (RRT) status via the UK Renal Registry (UKRR). Participants A cohort of adults with stage 3–5 chronic kidney disease (CKD) or receiving RRT at the start of the COVID-19 vaccine roll-out was identified based on evidence of reduced estimated glomerular filtration rate (eGFR) or inclusion in the UKRR. Main outcome measures Dose-specific vaccine coverage over time was determined from 1 December 2020 to 31 August 2022. Individual-level factors associated with receipt of a 3-dose or 4-dose vaccine series were explored via Cox proportional hazards models. Results 992 205 people with stage 3–5 CKD or receiving RRT were included. Cumulative vaccine coverage as of 31 August 2022 was 97.5%, 97.0% and 93.9% for doses 1, 2 and 3, respectively, and 81.9% for dose 4 among individuals with one or more indications for eligibility. Delayed 3-dose vaccine uptake was associated with younger age, minority ethnicity, social deprivation and severe mental illness—associations that were consistent across CKD severity subgroups, dialysis patients and kidney transplant recipients. Similar associations were observed for 4-dose uptake. Conclusion Although high primary vaccine and booster dose coverage has been achieved among people with kidney disease in England, key disparities in vaccine uptake remain across clinical and demographic groups and 4-dose coverage is suboptimal. Targeted interventions are needed to identify barriers to vaccine uptake among under-vaccinated subgroups identified in the present study.
Published: 2023
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31. Comparative effectiveness of two- and three-dose COVID-19 vaccination schedules involving AZD1222 and BNT162b2 in people with kidney disease: a linked OpenSAFELY and UK Renal Registry cohort study

Author: Collaborative, The OpenSAFELY, Parker, Edward PK, Horne, Elsie MF, Hulme, William J, Tazare, John, Zheng, Bang, Carr, Edward J, Loud, Fiona, Lyon, Susan, Mahalingasivam, Viyaasan, MacKenna, Brian, Mehrkar, Amir, Scanlon, Miranda, Santhakumaran, Shalini, Steenkamp, Retha, Goldacre, Ben, Sterne, Jonathan AC, Nitsch, Dorothea, Tomlinson, Laurie A, and Collaborative, The LH&W NCS
Subjects: FOS: Clinical medicine, Immunology, Infectious Disease, Cell Biology
Abstract: Background: Kidney disease is a key risk factor for COVID-19-related mortality and suboptimal vaccine response. Optimising vaccination strategies is essential to reduce the disease burden in this vulnerable population. We therefore compared the effectiveness of two- and three-dose schedules involving AZD1222 (AZ; ChAdOx1-S) and BNT162b2 (BNT) among people with kidney disease in England. Methods: With the approval of NHS England, we performed a retrospective cohort study among people with moderate-to-severe kidney disease. Using linked primary care and UK Renal Registry records in the OpenSAFELY-TPP platform, we identified adults with stage 3–5 chronic kidney disease, dialysis recipients, and kidney transplant recipients. We used Cox proportional hazards models to compare COVID-19-related outcomes and non-COVID-19 death after two-dose (AZ–AZ vs BNT–BNT) and three-dose (AZ–AZ–BNT vs BNT–BNT–BNT) schedules. Findings: After two doses, incidence during the Delta wave was higher in AZ–AZ (n = 257,580) than BNT–BNT recipients (n = 169,205; adjusted hazard ratios [95% CIs] 1.43 [1.37–1.50], 1.59 [1.43–1.77], 1.44 [1.12–1.85], and 1.09 [1.02–1.17] for SARS-CoV-2 infection, COVID-19-related hospitalisation, COVID-19-related death, and non-COVID-19 death, respectively). Findings were consistent across disease subgroups, including dialysis and transplant recipients. After three doses, there was little evidence of differences between AZ–AZ–BNT (n = 220,330) and BNT–BNT–BNT recipients (n = 157,065) for any outcome during a period of Omicron dominance. Interpretation: Among individuals with moderate-to-severe kidney disease, two doses of BNT conferred stronger protection than AZ against SARS-CoV-2 infection and severe disease. A subsequent BNT dose levelled the playing field, emphasising the value of heterologous RNA doses in vulnerable populations. Funding: National Core Studies, Wellcome Trust, MRC, and Health Data Research UK.
Published: 2023
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32. Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform

Author: Zheng, Bang, primary, Green, Amelia C A, additional, Tazare, John, additional, Curtis, Helen J, additional, Fisher, Louis, additional, Nab, Linda, additional, Schultze, Anna, additional, Mahalingasivam, Viyaasan, additional, Parker, Edward P K, additional, Hulme, William J, additional, Bacon, Sebastian C J, additional, DeVito, Nicholas J, additional, Bates, Christopher, additional, Evans, David, additional, Inglesby, Peter, additional, Drysdale, Henry, additional, Davy, Simon, additional, Cockburn, Jonathan, additional, Morton, Caroline E, additional, Hickman, George, additional, Ward, Tom, additional, Smith, Rebecca M, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Walker, Alex J, additional, Evans, Stephen J W, additional, Douglas, Ian J, additional, MacKenna, Brian, additional, Goldacre, Ben, additional, and Tomlinson, Laurie A, additional
Published: 2022
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33. Recording of ’COVID-19 vaccine declined‘: a cohort study on 57.9 million National Health Service patients’ records in situ using OpenSAFELY, England, 8 December 2020 to 25 May 2021

Author: Curtis, Helen J, primary, Inglesby, Peter, additional, MacKenna, Brian, additional, Croker, Richard, additional, Hulme, William J, additional, Rentsch, Christopher T, additional, Bhaskaran, Krishnan, additional, Mathur, Rohini, additional, Morton, Caroline E, additional, Bacon, Sebastian CJ, additional, Smith, Rebecca M, additional, Evans, David, additional, Mehrkar, Amir, additional, Tomlinson, Laurie, additional, Walker, Alex J, additional, Bates, Christopher, additional, Hickman, George, additional, Ward, Tom, additional, Morley, Jessica, additional, Cockburn, Jonathan, additional, Davy, Simon, additional, Williamson, Elizabeth J, additional, Eggo, Rosalind M, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, O’Hanlon, Shaun, additional, Eavis, Alex, additional, Jarvis, Richard, additional, Avramov, Dima, additional, Griffiths, Paul, additional, Fowles, Aaron, additional, Parkes, Nasreen, additional, Evans, Stephen JW, additional, Douglas, Ian J, additional, Smeeth, Liam, additional, and Goldacre, Ben, additional
Published: 2022
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34. Waning effectiveness of BNT162b2 and ChAdOx1 covid-19 vaccines over six months since second dose: OpenSAFELY cohort study using linked electronic health records

Author: Horne, Elsie M F, primary, Hulme, William J, additional, Keogh, Ruth H, additional, Palmer, Tom M, additional, Williamson, Elizabeth J, additional, Parker, Edward P K, additional, Green, Amelia, additional, Walker, Venexia, additional, Walker, Alex J, additional, Curtis, Helen, additional, Fisher, Louis, additional, MacKenna, Brian, additional, Croker, Richard, additional, Hopcroft, Lisa, additional, Park, Robin Y, additional, Massey, Jon, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Bacon, Sebastian, additional, Evans, David, additional, Inglesby, Peter, additional, Morton, Caroline E, additional, Hickman, George, additional, Davy, Simon, additional, Ward, Tom, additional, Dillingham, Iain, additional, Goldacre, Ben, additional, Hernán, Miguel A, additional, and Sterne, Jonathan A C, additional
Published: 2022
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35. Comparative effectiveness of ChAdOx1 versus BNT162b2 covid-19 vaccines in health and social care workers in England: cohort study using OpenSAFELY

Author: Hulme, William J, primary, Williamson, Elizabeth J, additional, Green, Amelia C A, additional, Bhaskaran, Krishnan, additional, McDonald, Helen I, additional, Rentsch, Christopher T, additional, Schultze, Anna, additional, Tazare, John, additional, Curtis, Helen J, additional, Walker, Alex J, additional, Tomlinson, Laurie A, additional, Palmer, Tom, additional, Horne, Elsie M F, additional, MacKenna, Brian, additional, Morton, Caroline E, additional, Mehrkar, Amir, additional, Morley, Jessica, additional, Fisher, Louis, additional, Bacon, Sebastian C J, additional, Evans, David, additional, Inglesby, Peter, additional, Hickman, George, additional, Davy, Simon, additional, Ward, Tom, additional, Croker, Richard, additional, Eggo, Rosalind M, additional, Wong, Angel Y S, additional, Mathur, Rohini, additional, Wing, Kevin, additional, Forbes, Harriet, additional, Grint, Daniel J, additional, Douglas, Ian J, additional, Evans, Stephen J W, additional, Smeeth, Liam, additional, Bates, Chris, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Sterne, Jonathan A C, additional, Hernán, Miguel A, additional, and Goldacre, Ben, additional
Published: 2022
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36. Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform

Author: Walker, Jemma L, primary, Schultze, Anna, additional, Tazare, John, additional, Tamborska, Arina, additional, Singh, Bhagteshwar, additional, Donegan, Katherine, additional, Stowe, Julia, additional, Morton, Caroline E, additional, Hulme, William J, additional, Curtis, Helen J, additional, Williamson, Elizabeth J, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Rentsch, Christopher T, additional, Mathur, Rohini, additional, Bacon, Sebastian, additional, Walker, Alex J, additional, Davy, Simon, additional, Evans, David, additional, Inglesby, Peter, additional, Hickman, George, additional, MacKenna, Brian, additional, Tomlinson, Laurie, additional, CA Green, Amelia, additional, Fisher, Louis, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Bates, Christopher, additional, Evans, Stephen JW, additional, Solomon, Tom, additional, Andrews, Nick J, additional, Douglas, Ian J, additional, Goldacre, Ben, additional, Smeeth, Liam, additional, and McDonald, Helen I, additional
Published: 2022
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37. OpenSAFELY: Representativeness of Electronic Health Record platform OpenSAFELY-TPP data compared to the population of England

Author: Andrews, Colm D, primary, Schultze, Anna, additional, Curtis, Helen J, additional, Hulme, William J, additional, Tazare, John, additional, Evans, Stephen JW, additional, Mehrkhar, Amir, additional, Bacon, Seb, additional, Hickman, George, additional, Bates, Chris, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Cockburn, Jonathan, additional, Evans, David, additional, Ward, Tom, additional, Davey, Simon, additional, Inglesby, Peter, additional, Goldacre, Ben, additional, MacKenna, Brian, additional, Tomlinson, Laurie, additional, and Walker, Alex J, additional
Published: 2022
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38. Effectiveness of BNT162b2 booster doses in England: an observational study in OpenSAFELY-TPP

Author: Hulme, William J, primary, Williamson, Elizabeth J, additional, Horne, Elsie, additional, Green, Amelia, additional, Nab, Linda, additional, Keogh, Ruth, additional, Parker, Edward PK, additional, Walker, Venexia, additional, Palmer, Tom, additional, Curtis, Helen, additional, Wiedemann, Milan, additional, Cunningham, Christine, additional, Walker, Alex J, additional, Fisher, Louis, additional, MacKenna, Brian, additional, Rentsch, Christopher T, additional, Schultze, Anna, additional, Bhaskaran, Krishnan, additional, Tazare, John, additional, Tomlinson, Laurie, additional, McDonald, Helen I, additional, Morton, Caroline E, additional, Croker, Richard, additional, Andrews, Colm, additional, Parks, Robin, additional, Hopcroft, Lisa, additional, Massey, Jon, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Bacon, Seb, additional, Evans, Dave, additional, Inglesby, Peter, additional, Hickman, George, additional, Davy, Simon, additional, Dillingham, Iain, additional, Ward, Tom, additional, Mahalingasivam, Viyasaan, additional, Zheng, Bang, additional, Douglas, Ian J, additional, Evans, Stephen JW, additional, Bates, Chris, additional, Sterne, Jonathan AC, additional, Hernán, Miguel A, additional, and Goldacre, Ben, additional
Published: 2022
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39. OpenSAFELY NHS Service Restoration Observatory 2: changes in primary care activity across six clinical areas during the COVID-19 pandemic

Author: Curtis, Helen J, primary, MacKenna, Brian, additional, Wiedemann, Milan, additional, Fisher, Louis, additional, Croker, Richard, additional, Morton, Caroline E, additional, Inglesby, Peter, additional, Walker, Alex J, additional, Morley, Jessica, additional, Mehrkar, Amir, additional, Bacon, Sebastian CJ, additional, Hickman, George, additional, Evans, David, additional, Ward, Tom, additional, Davy, Simon, additional, Hulme, William J, additional, Macdonald, Orla, additional, Conibere, Robin, additional, Lewis, Tom, additional, Myers, Martin, additional, Wanninayake, Shamila, additional, Collison, Kiren, additional, Drury, Charles, additional, Samuel, Miriam, additional, Sood, Harpreet, additional, Cipriani, Andrea, additional, Fazel, Seena, additional, Sharma, Manuj, additional, Baqir, Wasim, additional, Bates, Chris, additional, Parry, John, additional, and Goldacre, Ben, additional
Published: 2022
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40. OpenSAFELY NHS Service Restoration Observatory 2: changes in primary care clinical activity in England during the COVID-19 pandemic.

Author: Curtis, Helen J, MacKenna, Brian, Wiedemann, Milan, Fisher, Louis, Croker, Richard, Morton, Caroline E, Inglesby, Peter, Walker, Alex J, Morley, Jessica, Mehrkar, Amir, Bacon, Sebastian CJ, Hickman, George, Evans, David, Ward, Tom, Davy, Simon, Hulme, William J, Macdonald, Orla, Conibere, Robin, Lewis, Tom, and Myers, Martin
Subjects: COVID-19 pandemic, PRIMARY care, CLINICAL medicine, OBSERVATORIES, KEYWORD searching
Abstract: Background: The COVID-19 pandemic has disrupted healthcare activity across a broad range of clinical services. The NHS stopped non-urgent work in March 2020, later recommending services be restored to near-normal levels before winter where possible. Aim: To describe changes in the volume and variation of coded clinical activity in general practice across six clinical areas: cardiovascular disease, diabetes, mental health, female and reproductive health, screening and related procedures, and processes related to medication. Design and setting: With the approval of NHS England, a cohort study was conducted of 23.8 million patient records in general practice, in situ using OpenSAFELY. Method: Common primary care activities were analysed using Clinical Terms Version 3 codes and keyword searches from January 2019 to December 2020, presenting median and deciles of code usage across practices per month. Results: Substantial and widespread changes in clinical activity in primary care were identified since the onset of the COVID-19 pandemic, with generally good recovery by December 2020. A few exceptions showed poor recovery and warrant further investigation, such as mental health (for example, for 'Depression interim review' the median occurrences across practices in December 2020 was down by 41.6% compared with December 2019). Conclusion: Granular NHS general practice data at population-scale can be used to monitor disruptions to healthcare services and guide the development of mitigation strategies. The authors are now developing real-time monitoring dashboards for the key measures identified in this study, as well as further studies using primary care data to monitor and mitigate the indirect health impacts of COVID-19 on the NHS. [ABSTRACT FROM AUTHOR]
Published: 2023
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41. Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe COVID-19 outcomes in non-hospitalised patients: an observational cohort study using the OpenSAFELY platform

Author: Zheng, Bang, primary, Green, Amelia CA, additional, Tazare, John, additional, Curtis, Helen J, additional, Fisher, Louis, additional, Nab, Linda, additional, Schultze, Anna, additional, Mahalingasivam, Viyaasan, additional, Parker, Edward PK, additional, Hulme, William J, additional, Bacon, Sebastian CJ, additional, DeVito, Nicholas J, additional, Bates, Christopher, additional, Evans, David, additional, Inglesby, Peter, additional, Drysdale, Henry, additional, Davy, Simon, additional, Cockburn, Jonathan, additional, Morton, Caroline E, additional, Hickman, George, additional, Ward, Tom, additional, Smith, Rebecca M, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Walker, Alex J, additional, Evans, Stephen JW, additional, Douglas, Ian J, additional, MacKenna, Brian, additional, Goldacre, Ben, additional, and Tomlinson, Laurie A, additional
Published: 2022
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42. Waning effectiveness of BNT162b2 and ChAdOx1 COVID-19 vaccines over six months since second dose: a cohort study using linked electronic health records

Author: Horne, Elsie MF, primary, Hulme, William J, additional, Keogh, Ruth H, additional, Palmer, Tom M, additional, Williamson, Elizabeth J, additional, Parker, Edward PK, additional, Green, Amelia, additional, Walker, Venexia, additional, Walker, Alex J, additional, Curtis, Helen, additional, Fisher, Louis, additional, MacKenna, Brian, additional, Croker, Richard, additional, Hopcroft, Lisa, additional, Park, Robin Y, additional, Massey, Jon, additional, Morely, Jessica, additional, Mehrkar, Amir, additional, Bacon, Sebastian, additional, Evans, David, additional, Inglesby, Peter, additional, Morton, Caroline E, additional, Hickman, George, additional, Davy, Simon, additional, Ward, Tom, additional, Dillingham, Iain, additional, Goldacre, Ben, additional, Hernan, Miguel A, additional, and Sterne, Jonathan AC, additional
Published: 2022
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43. Comparison of methods for predicting COVID-19-related death in the general population using the OpenSAFELY platform

Author: OpenSAFELY Collaborative, Williamson, Elizabeth J, Tazare, John, Bhaskaran, Krishnan, McDonald, Helen I, Walker, Alex J, Tomlinson, Laurie, Wing, Kevin, Bacon, Sebastian, Bates, Chris, Curtis, Helen J, Forbes, Harriet J, Minassian, Caroline, Morton, Caroline E, Nightingale, Emily, Mehrkar, Amir, Evans, David, Nicholson, Brian D, Leon, David A, Inglesby, Peter, MacKenna, Brian, Davies, Nicholas G, DeVito, Nicholas J, Drysdale, Henry, Cockburn, Jonathan, Hulme, William J, Morley, Jessica, Douglas, Ian, Rentsch, Christopher T, Mathur, Rohini, Wong, Angel, Schultze, Anna, Croker, Richard, Parry, John, Hester, Frank, Harper, Sam, Grieve, Richard, Harrison, David A, Steyerberg, Ewout W, Eggo, Rosalind M, Diaz-Ordaz, Karla, Keogh, Ruth, Evans, Stephen JW, Smeeth, Liam, and Goldacre, Ben
Abstract: BACKGROUND: Obtaining accurate estimates of the risk of COVID-19-related death in the general population is challenging in the context of changing levels of circulating infection. METHODS: We propose a modelling approach to predict 28-day COVID-19-related death which explicitly accounts for COVID-19 infection prevalence using a series of sub-studies from new landmark times incorporating time-updating proxy measures of COVID-19 infection prevalence. This was compared with an approach ignoring infection prevalence. The target population was adults registered at a general practice in England in March 2020. The outcome was 28-day COVID-19-related death. Predictors included demographic characteristics and comorbidities. Three proxies of local infection prevalence were used: model-based estimates, rate of COVID-19-related attendances in emergency care, and rate of suspected COVID-19 cases in primary care. We used data within the TPP SystmOne electronic health record system linked to Office for National Statistics mortality data, using the OpenSAFELY platform, working on behalf of NHS England. Prediction models were developed in case-cohort samples with a 100-day follow-up. Validation was undertaken in 28-day cohorts from the target population. We considered predictive performance (discrimination and calibration) in geographical and temporal subsets of data not used in developing the risk prediction models. Simple models were contrasted to models including a full range of predictors. RESULTS: Prediction models were developed on 11,972,947 individuals, of whom 7999 experienced COVID-19-related death. All models discriminated well between individuals who did and did not experience the outcome, including simple models adjusting only for basic demographics and number of comorbidities: C-statistics 0.92-0.94. However, absolute risk estimates were substantially miscalibrated when infection prevalence was not explicitly modelled. CONCLUSIONS: Our proposed models allow absolute risk estimation in the context of changing infection prevalence but predictive performance is sensitive to the proxy for infection prevalence. Simple models can provide excellent discrimination and may simplify implementation of risk prediction tools.
Published: 2022

44. Additional file 1 of Comparison of methods for predicting COVID-19-related death in the general population using the OpenSAFELY platform

Author: Williamson, Elizabeth J., Tazare, John, Bhaskaran, Krishnan, McDonald, Helen I., Walker, Alex J., Tomlinson, Laurie, Wing, Kevin, Bacon, Sebastian, Bates, Chris, Curtis, Helen J., Forbes, Harriet J., Minassian, Caroline, Morton, Caroline E., Nightingale, Emily, Mehrkar, Amir, Evans, David, Nicholson, Brian D., Leon, David A., Inglesby, Peter, MacKenna, Brian, Davies, Nicholas G., DeVito, Nicholas J., Drysdale, Henry, Cockburn, Jonathan, Hulme, William J., Morley, Jessica, Douglas, Ian, Rentsch, Christopher T., Mathur, Rohini, Wong, Angel, Schultze, Anna, Croker, Richard, Parry, John, Hester, Frank, Harper, Sam, Grieve, Richard, Harrison, David A., Steyerberg, Ewout W., Eggo, Rosalind M., Diaz-Ordaz, Karla, Keogh, Ruth, Evans, Stephen J. W., Smeeth, Liam, and Goldacre, Ben
Abstract: Additional file 1. Supplementary materials
Published: 2022
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45. Clinical coding of long COVID in English primary care: a federated analysis of 58 million patient records in situ using OpenSAFELY

Author: Walker, Alex J, MacKenna, Brian, Inglesby, Peter, Tomlinson, Laurie, Rentsch, Christopher T, Curtis, Helen J, Morton, Caroline E, Morley, Jessica, Mehrkar, Amir, Bacon, Seb, Hickman, George, Bates, Chris, Croker, Richard, Evans, David, Ward, Tom, Cockburn, Jonathan, Davy, Simon, Bhaskaran, Krishnan, Schultze, Anna, Williamson, Elizabeth J, Hulme, William J, McDonald, Helen I, Mathur, Rohini, Eggo, Rosalind M, Wing, Kevin, Wong, Angel Ys, Forbes, Harriet, Tazare, John, Parry, John, Hester, Frank, Harper, Sam, O'Hanlon, Shaun, Eavis, Alex, Jarvis, Richard, Avramov, Dima, Griffiths, Paul, Fowles, Aaron, Parkes, Nasreen, Douglas, Ian J, Evans, Stephen Jw, and (The OpenSAFELY Collaborative)
Abstract: BACKGROUND: Long COVID describes new or persistent symptoms at least 4 weeks after onset of acute COVID-19. Clinical codes to describe this phenomenon were recently created. AIM: To describe the use of long-COVID codes, and variation of use by general practice, demographic variables, and over time. DESIGN AND SETTING: Population-based cohort study in English primary care. METHOD: Working on behalf of NHS England, OpenSAFELY data were used encompassing 96% of the English population between 1 February 2020 and 25 May 2021. The proportion of people with a recorded code for long COVID was measured overall and by demographic factors, electronic health record software system (EMIS or TPP), and week. RESULTS: Long COVID was recorded for 23 273 people. Coding was unevenly distributed among practices, with 26.7% of practices having never used the codes. Regional variation ranged between 20.3 per 100 000 people for East of England (95% confidence interval [CI] = 19.3 to 21.4) and 55.6 per 100 000 people in London (95% CI = 54.1 to 57.1). Coding was higher among females (52.1, 95% CI = 51.3 to 52.9) than males (28.1, 95% CI = 27.5 to 28.7), and higher among practices using EMIS (53.7, 95% CI = 52.9 to 54.4) than those using TPP (20.9, 95% CI = 20.3 to 21.4). CONCLUSION: Current recording of long COVID in primary care is very low, and variable between practices. This may reflect patients not presenting; clinicians and patients holding different diagnostic thresholds; or challenges with the design and communication of diagnostic codes. Increased awareness of diagnostic codes is recommended to facilitate research and planning of services, and also surveys with qualitative work to better evaluate clinicians' understanding of the diagnosis.
Published: 2021

46. Comparative effectiveness of ChAdOx1 versus BNT162b2 COVID-19 vaccines in Health and Social Care workers in England: a cohort study using OpenSAFELY

Author: Hulme, William J, primary, Williamson, Elizabeth J, additional, Green, Amelia, additional, Bhaskaran, Krishnan, additional, McDonald, Helen I, additional, Rentsch, Christopher T, additional, Schultze, Anna, additional, Tazare, John, additional, Curtis, Helen J, additional, Walker, Alex J, additional, Tomlinson, Laurie, additional, Palmer, Tom, additional, Horne, Elsie, additional, MacKenna, Brian, additional, Morton, Caroline E, additional, Mehrkar, Amir, additional, Fisher, Louis, additional, Bacon, Seb, additional, Evans, Dave, additional, Inglesby, Peter, additional, Hickman, George, additional, Davy, Simon, additional, Ward, Tom, additional, Croker, Richard, additional, Eggo, Rosalind M, additional, Wong, Angel YS, additional, Mathur, Rohini, additional, Wing, Kevin, additional, Forbes, Harriet, additional, Grint, Daniel, additional, Douglas, Ian J, additional, Evans, Stephen JW, additional, Smeeth, Liam, additional, Bates, Chris, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Sterne, Jonathan AC, additional, Hernán, Miguel, additional, and Goldacre, Ben, additional
Published: 2021
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47. Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform.

Author: Bang Zheng, Green, Amelia C. A., Tazare, John, Curtis, Helen J., Fisher, Louis, Nab, Linda, Schultze, Anna, Mahalingasivam, Viyaasan, Parker, Edward P. K., Hulme, William J., Bacon, Sebastian C. J., DeVito, Nicholas J., Bates, Christopher, Evans, David, Inglesby, Peter, Drysdale, Henry, Davy, Simon, Cockburn, Jonathan, Morton, Caroline E., and Hickman, George
Subjects: THERAPEUTIC use of monoclonal antibodies, COVID-19, SCIENTIFIC observation, ANTIVIRAL agents, MANN Whitney U Test, SEVERITY of illness index, TREATMENT effectiveness, T-test (Statistics), DESCRIPTIVE statistics, CHI-squared test, DATA analysis software, SENSITIVITY & specificity (Statistics), LONGITUDINAL method, ADULTS
Published: 2022
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48. Overall and cause-specific hospitalisation and death after COVID-19 hospitalisation in England: cohort study in OpenSAFELY using linked primary care, secondary care and death registration data

Author: Bhaskaran, Krishnan, primary, Rentsch, Christopher T, additional, Hickman, George, additional, Hulme, William J, additional, Schultze, Anna, additional, Curtis, Helen J, additional, Wing, Kevin, additional, Warren-Gash, Charlotte, additional, Tomlinson, Laurie, additional, Bates, Chris J, additional, Mathur, Rohini, additional, MacKenna, Brian, additional, Mahalingasivam, Viyaasan, additional, Wong, Angel, additional, Walker, Alex J, additional, Morton, Caroline E, additional, Grint, Daniel, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Inglesby, Peter, additional, Douglas, Ian J, additional, McDonald, Helen I, additional, Cockburn, Jonathan, additional, Williamson, Elizabeth J, additional, Evans, David, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Evans, Stephen JW, additional, Bacon, Sebastian, additional, Smeeth, Liam, additional, and Goldacre, Ben, additional
Published: 2021
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49. Factors associated with deaths due to COVID-19 versus other causes: population-based cohort analysis of UK primary care data and linked national death registrations within the OpenSAFELY platform

Author: Bhaskaran, Krishnan, primary, Bacon, Sebastian, additional, Evans, Stephen JW, additional, Bates, Chris J, additional, Rentsch, Christopher T, additional, MacKenna, Brian, additional, Tomlinson, Laurie, additional, Walker, Alex J, additional, Schultze, Anna, additional, Morton, Caroline E, additional, Grint, Daniel, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Inglesby, Peter, additional, Douglas, Ian J, additional, McDonald, Helen I, additional, Cockburn, Jonathan, additional, Williamson, Elizabeth J, additional, Evans, David, additional, Curtis, Helen J, additional, Hulme, William J, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Spiegelhalter, David, additional, Smeeth, Liam, additional, and Goldacre, Ben, additional
Published: 2021
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50. Rates of serious clinical outcomes in survivors of hospitalisation with COVID-19: a descriptive cohort study within the OpenSAFELY platform

Author: Tazare, John, Walker, Alex J, Tomlinson, Laurie, Hickman, George, Rentsch, Christopher T, Williamson, Elizabeth J, Bhaskaran, Krishnan, Evans, David, Wing, Kevin, Mathur, Rohini, Wong, Angel YS, Schultze, Anna, Bacon, Seb, Bates, Chris, Morton, Caroline E, Curtis, Helen J, Nightingale, Emily, McDonald, Helen I, Mehrkar, Amir, Inglesby, Peter, Davy, Simon, MacKenna, Brian, Cockburn, Jonathan, Hulme, William J, Warren-Gash, Charlotte, Bhate, Ketaki, Nitsch, Dorothea, Powell, Emma, Mulick, Amy, Forbes, Harriet, Minassian, Caroline, Croker, Richard, Parry, John, Hester, Frank, Harper, Sam, Eggo, Rosalind M, Evans, Stephen JW, Smeeth, Liam, Douglas, Ian J, and Goldacre, Ben
Abstract: BackgroundPatients with COVID-19 are thought to be at higher risk of cardiometabolic and pulmonary complications, but quantification of that risk is limited. We aimed to describe the overall burden of these complications in survivors of severe COVID-19.MethodsWorking on behalf of NHS England, we used linked primary care records, death certificate and hospital data from the OpenSAFELY platform. We constructed three cohorts: patients discharged following hospitalisation with COVID-19, patients discharged following hospitalisation with pneumonia in 2019, and a frequency-matched cohort from the general population in 2019. We studied eight cardiometabolic and pulmonary outcomes. Absolute rates were measured in each cohort and Cox regression models were fitted to estimate age/sex adjusted hazard ratios comparing outcome rates between discharged COVID-19 patients and the two comparator cohorts.ResultsAmongst the population of 31,716 patients discharged following hospitalisation with COVID-19, rates for majority of outcomes peaked in the first month post-discharge, then declined over the following four months. Patients in the COVID-19 population had markedly increased risk of all outcomes compared to matched controls from the 2019 general population, especially for pulmonary embolism (HR 12.86; 95% CI: 11.23 - 14.74). Outcome rates were more similar when comparing patients discharged with COVID-19 to those discharged with pneumonia in 2019, although COVID-19 patients had increased risk of type 2 diabetes (HR 1.23; 95% CI: 1.05 - 1.44).InterpretationCardiometabolic and pulmonary adverse outcomes are markedly raised following hospitalisation for COVID-19 compared to the general population. However, the excess risks were more comparable to those seen following hospitalisation with pneumonia. Identifying patients at particularly high risk of outcomes would inform targeted preventive measures.FundingWellcome, Royal Society, National Institute for Health Research, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, UK Research and Innovation, Health and Safety Executive.
Published: 2021

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