Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?
Objectives: We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19). Study design and setting: Scientific databases were...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-12-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S120197122032186X |
| _version_ | 1818446337161560064 |
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| author | Faizan Mazhar Muhammad Abdul Hadi Chia Siang Kow Albaraa Mohammed N. Marran Hamid A. Merchant Syed Shahzad Hasan |
| author_facet | Faizan Mazhar Muhammad Abdul Hadi Chia Siang Kow Albaraa Mohammed N. Marran Hamid A. Merchant Syed Shahzad Hasan |
| author_sort | Faizan Mazhar |
| collection | DOAJ |
| description | Objectives: We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19). Study design and setting: Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials. Results: Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall ‘low’ risk of bias, while four of the trials had a ‘high’, ‘critical’, or ‘serious’ risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions. Conclusion: In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources. |
| first_indexed | 2024-12-14T19:46:07Z |
| format | Article |
| id | doaj.art-27afd839dd454500b6659f57f63f91d3 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-14T19:46:07Z |
| publishDate | 2020-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-27afd839dd454500b6659f57f63f91d32022-12-21T22:49:34ZengElsevierInternational Journal of Infectious Diseases1201-97122020-12-01101107120Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials?Faizan Mazhar0Muhammad Abdul Hadi1Chia Siang Kow2Albaraa Mohammed N. Marran3Hamid A. Merchant4Syed Shahzad Hasan5Department of Biomedical and Clinical Sciences L. Sacco, ''Luigi Sacco'' University Hospital, Università di Milano, Milan, ItalySchool of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham, United KingdomSchool of Postgraduate Studies, International Medical University, Kuala Lumpur, MalaysiaDepartment of Pharmaceutical Care, Prince Mohammed Bin Nasser Hospital, Jizan, Saudi ArabiaSchool of Applied Sciences, University of Huddersfield, Huddersfield, United KingdomSchool of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom; Corresponding author at: University of Huddersfield, Huddersfield, United Kingdom.Objectives: We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19). Study design and setting: Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials. Results: Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall ‘low’ risk of bias, while four of the trials had a ‘high’, ‘critical’, or ‘serious’ risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions. Conclusion: In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources.http://www.sciencedirect.com/science/article/pii/S120197122032186XCoronavirus 2019Harm reportingAdverse eventsHydroxychloroquineChloroquine |
| spellingShingle | Faizan Mazhar Muhammad Abdul Hadi Chia Siang Kow Albaraa Mohammed N. Marran Hamid A. Merchant Syed Shahzad Hasan Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? International Journal of Infectious Diseases Coronavirus 2019 Harm reporting Adverse events Hydroxychloroquine Chloroquine |
| title | Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? |
| title_full | Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? |
| title_fullStr | Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? |
| title_full_unstemmed | Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? |
| title_short | Use of hydroxychloroquine and chloroquine in COVID-19: How good is the quality of randomized controlled trials? |
| title_sort | use of hydroxychloroquine and chloroquine in covid 19 how good is the quality of randomized controlled trials |
| topic | Coronavirus 2019 Harm reporting Adverse events Hydroxychloroquine Chloroquine |
| url | http://www.sciencedirect.com/science/article/pii/S120197122032186X |
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