[ad_1]
Despite the low quality of this study due to poor handling of confounders and participants lost to follow-up who had poor outcomes, a surge of prescriptions for the therapeutic and prophylactic use of hydroxychloroquine created shortages for patients with systemic lupus erythematosus and other rheumatic diseases who rely on this medication to treat their disease. Subsequently, an increased incidence of cardiac arrhythmias was observed in patients with COVID-19 treated with hydroxychloroquine. Thus, there is a need to determine whether the benefits of hydroxychloroquine for COVID-19 outweigh the risk of harms.
,
,
,
,
An alternative research design, the retrospective observational study, can usually be carried out relatively quickly and at comparatively low cost, but is limited by numerous potential sources of bias. The appropriate scientific contribution of observational studies, it is argued, is to provide estimates of disease outcomes in real-world patient populations and to generate hypotheses to support further research. Improving the validity of the results of observational studies requires construction of comprehensive models that identify all potential confounding and modulating variables that could link the intervention to the outcome. So far, validated measures of important variables are not routinely available.
leveraged a large dataset derived from the electronic health record of the US Veterans Health Administration (VHA) to carry out a retrospective, observational, propensity-matched analysis comparing the rate of laboratory-confirmed COVID-19 in adults with rheumatic diseases prescribed hydroxychloroquine with patients treated with other rheumatic disease medications. From 70 270 patients with an International Classification of Diseases (10th revision; ICD-10) diagnosis of rheumatic disease, the authors compared 10 703 patients treated with hydroxychloroquine who demonstrated satisfactory hydroxychloroquine adherence to 21 406 patients not treated with hydroxychloroquine. Commendably, the two groups were propensity matched for several dozen variables, including zip code of residence, comorbidities, laboratory test results, emergency or urgent care encounters, influenza titres, SARS-CoV-2 titres, date of death, medications, and hospital admissions.
,
and in the general population within the setting of an RCT.
Once established, the phenomic library will greatly facilitate observational research using validated measures. To facilitate COVID-19-related research, the VA has implemented a standardised and validated definition for COVID-19 and is developing a COVID-19-specific Social Risks Screening questionnaire for inclusion in the electronic health record.
Over the next several years, the number of standardised and validated phenomic definitions will be expanded, patient reported outcome questionnaires will be routinely administered, and social determinants of disease data will be increasingly incorporated into the electronic health record. As a consequence, validity threats associated with the retrospective observational design might be reduced. These incremental improvements will permit investigators to carry out higher-quality observational studies that supplement (and in some cases replace) evidence from RCTs.
AHJK reports personal fees from Exagen Diagnostics, GlaxoSmithKline, Aurinia Pharmaceuticals, and Annexon Biosciences, and is supported by the US National Institute of Arthritis and Musculoskeletal and Skin Disease (National Institutes of Health) and Rheumatology Research Foundation. SAE is supported by an investigator-initiated research grant from Bristol Myers Squibb.
References
- 1.
Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.
Int J Antimicrob Agents. 2020; 56105949
- 2.
A randomized trial of hydroxychloroquine as postexposure prophylaxis for Covid-19.
N Engl J Med. 2020; 383: 517-525
- 3.
Observational study of hydroxychloroquine in hospitalized patients with Covid-19.
N Engl J Med. 2020; 382: 2411-2418
- 4.
Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries.
Lancet Rheumatol. 2020; 2: e250-e253
- 5.
Baseline use of hydroxychloroquine in systemic lupus erythematosus does not preclude SARS-CoV-2 infection and severe COVID-19.
Ann Rheum Dis. 2020; ()
- 6.
Association of treatment with hydroxychloroquine or azithromycin with in-hospital mortality in patients with COVID-19 in New York State.
JAMA. 2020; 323: 2493-2502
- 7.
Long-term hydroxychloroquine use in patients with rheumatic conditions and development of SARS-CoV-2 infection: a retrospective cohort study.
Lancet Rheumatol. 2020; ()
- 8.
Social determinants of health.
- 9.
Introduction to VA Phenomics Library.
- 10.
HSR&D Collaborates to Develop VA COVID-19 Social Risks Screening Questions.
Article Info
Publication History
Published: September 21, 2020
Identification
Copyright
© 2020 Elsevier Ltd. All rights reserved.
ScienceDirect
Linked Articles
[ad_2]
Source link