Individual Participant Data Meta-Analysis (IPDMA) of long-term COVID-19 outcomes in a systematic review-informed, international, multidisciplinary database.
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Ali Myzoon, Brady Marian C, Campbell Pauline, Rooney Scott, Williams Linda, Paul Lorna, Mason Helen, Manoukian Sarkis, Chung Charlie, Barber Mark, McGoldrick Claire, Smith Andrew, Basu Neil, Patel Manish, VandenBerg Kathryn, Papadopoulou Aikaterini, Abdelaal Azza, Abraham Samuel Jk, Abu Sayf Alaa, Agergaard Jane, Alawna Motaz, Albu Sergiu, Alric Laurent, Andino Paulette, Antczak Jakub, Arutyunov Alexander, Ayyıldız Aylin, Badrick Ellena, Yalcin Bahat Pınar, Ballouz Tala, Balsano Clara, Bassetti Matteo, Bendersky Mariana, Berton Danilo, Biancari Fausto, Blomberg Bjorn, Boari Gianluca Em, Bonetti Silvia, Bosaeed Mohammad, Bouteleux Benoit, Brugaletta Salvatore, Bychinin Mikhail, Callebaut Ina, Carter Stephen J, Chudzik Michal, Coelho Julien, Cornejo-Giraldo Mario, Costi Stefania, Darcis Gilles, Darley David R, Di Baigio Antonio, Di Stadio Arianna, Dreher Michael, Enikeev Dmitry, Evans Rachael, Falcão Luiz Fábio Magno, Fehrmann Clara, Fugazzaro Stefania, Gamberini Lorenzo, Gencer Fatma Ketenci, Alberto Gonzalez Carlos, Hamilton Fergus, Harrison Chelsea, Hayden Markus C, Hedlin Haley, Heijenbrok-Kal Majanka, Hellemons Merel E, Ingadottir Brynja, Jagannathan Prasanna, Khokhlov Roman, Khokhlov Leonid, Knight Dacre, Kollum Marc, Kolstad Henrik, Kopittke Luciane, Ashman Kröönström Linda, Langeland Nina, Lawlor Christian, Levitt Mark L, Santos Lira Fabio, Loffler-Ragg Judith, Lui David Tw, Mahmud Reaz, Małek Łukasz, Margalit Ili, Marti-Beltran Sergi, Martineau Adrian, Masia Mar, Mathew Paul, Mautner Gisela, Mazeraud Aurélien, Menges Dominik, Meyhoff Christian S, Milne Alice, Sadat Mirfazeli Fatemeh, Moein Shima T, Mohamed-Hussein Aliae Ar, Monteleone Giovanni, Murai Igor H, Niklassen Andreas Steenholt, Nune Arvind, Nunez Maria Natividad Seisdedos, Ortega-Paz Luis, Ouellette Daniel, Paranhos Alna Carolina Mendes, Pehlivan Esra, Pelà Giovanna, Pereira Filipe Alexandre, Persson Hanna C, Piva Simone, Plasse Terry F, Platteel Tamara, Porcelli Simone, Prediletto Irene, Raday Gilead, Raghavan Kadalraja, Reetz Kathrin, Rizzoni Damiano, Salinas Mauricio, Santorelli Gillian, Sarker H N, P Sathyamurthy, Sayed Islam Galal, Sekine Leo, Shapiro Susan, Shinjo Samuel Katsuyuki, Simonovich Ventura, Sinatti Gaia, Sonnweber Thomas, Stavrou Vasileios T, Stessel Björn, Sunnerhagen Katharina Stibrant, Vallejos Julio, van den Berg-Emons Rita Jg, Visvabharathy Lavanya, Wan Yize I, Wilkinson John, Yasuda Clarissa Lin, Yuan Zuobiao, Zavascki Alexandre Prehn, Zeron Maria Del Pilar Brito, Zoëga Sigridur, Zoni Cesar
Аннотация
OBJECTIVES: To create an international, multidisciplinary COVID-19 database, and synthesise long-term outcomes, predictors and costs.
DESIGN: Systematic identification of COVID-19 data sets and meta-analysis of individual participant data on long-term outcomes after COVID-19.
SETTING: Contributed data were collected in clinical, community and research settings.
INTERVENTIONS: Interventions from original studies were included as covariates in models.
DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Web of Science, PsycInfo® (American Psychological Association, Washington, DC, USA), Cumulative Index to Nursing and Allied Health Literature, World Health Organization Global Index Medicus, Epistemonikos, LitCOVID; World Health Organization International Clinical Trials Registry Platform; ClinicalTrials.gov and supplementary searches for studies (November 2019-November 2021) were searched for studies on > 10 people from cohort, case-control, survey or randomised controlled trial studies, across any setting, describing validated assessment instruments, symptoms, hospitalisation, discharge destination or mortality beyond 28-days after COVID-19 onset. Data were extracted by two independent reviewers.
METHODS: Principal investigators contributed fully anonymised individual participant data. Demography, equity and symptoms were described. Assessment instruments were mapped to the International Classification of Functioning, Disability and Health. Factors associated with outcomes at 3-6 months, 9-12 months and beyond 12 months of index infection, for n > 500 individual participant data and > 1 data set were described using ratio of difference, point estimates, odds ratio and 95% confidence interval, as appropriate. The Mixed Methods Appraisal Tool described study quality; models were appraised using a Grading of Recommendations Assessment, Development and Evaluation-informed approach; heterogeneity was described using I2.
OUTCOME MEASURES: Included overall perception of health, multidomain cognitive function, anxiety, depression, stress, post-traumatic stress disorder, fatigue, strength, walking ability, mobility, coping with daily life, breathlessness, mortality, later hospitalisation and health-related quality of life.
RESULTS: PRECIOUS collated 116 data sets from 40 countries (individual participant data = 62,849), comprising 20 randomised controlled trials, 13 case-control, 60 cohort 2 longitudinal, 1 survey and 20 other study types. Participants' median age was 58 years interquartile range (45-68); 34,185 (54.4%) were female; 158 unique symptoms and 137 unique assessment instruments were captured, predominantly describing International Classification of Function, Disability and Health-body functions. Women had poorer outcomes across 30/37 models, compared with men. In 15/37 models, pre-existing lung disease and increasing age were associated with poorer outcomes; hospitalisation, diabetes and chronic kidney disease were each associated with poorer outcomes in 8/37 models. Initial hospitalisation resulted in lower health-related quality of life that did not recover for up to 2 years after initial infection. Heterogeneity was low in 34/37 models; 22/37 models were of moderate and 11/37 were of low quality.
LIMITATIONS: Use of secondary data limits available covariates, outcomes and time points to those included in primary data sets; evidence was primarily based on high-income countries. There was a lack of data on longer-term healthcare resource use to estimate the costs to the healthcare system.
CONCLUSIONS: PRECIOUS contributes to the overall picture of long-term COVID-19 outcomes beyond the long-COVID condition and highlights poorer long-term outcomes in women and people with pre-existing comorbidities.
FUTURE WORK: Evidence gaps included healthcare resource use, isolation, loneliness, societal participation and return to work outcomes. Data are needed on the role of health inequity on long-term outcomes.
STUDY REGISTRATION: This study is registered as PROSPERO (CRD42020224323, IRAS ID: 293578).
FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR132895) and is published in full in Health and Social Care Delivery Research; Vol. 14, No. 29. See the NIHR Funding and Awards website for further award information.