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The Indian Journal of Medical Research logoLink to The Indian Journal of Medical Research
. 2020 Jul-Aug;152(1-2):120. doi: 10.4103/0971-5916.290073

Authors’ response

Pranab Chatterjee 1, Tanu Anand 7, Kh Jitenkumar Singh 2, Reeta Rasaily 3, Ravinder Singh 4, Santasabuj Das 8, Harpreet Singh 5, Ira Praharaj 6, Raman R Gangakhedkar 6, Balram Bhargava , Samiran Panda 9,*
PMCID: PMC7853274  PMID: 32773411

We thank the authors for their close reading of our article and comments on the same1. The preferred approach to select controls in a case-control study is to sample controls from a population which could have become cases in the study, had they developed the disease. In the investigation we conducted, controls had symptoms like that of the cases, but were not detected to have SARS-CoV-2 infection on real-time reverse transcription-polymerase chain reaction (RT-PCR) test, and thus qualified to be considered as controls. This similarity between cases and controls added strength to the process followed by us in the selection of controls and minimized biases, which could have otherwise been introduced if separate sampling considerations for cases and controls would have been used.

Contrary to the statement by the authors, we identified potential benefit of exposure to hydroxychloroquine (HCQ) in the univariate analysis and indicated the same in the results1. While doing so, we remained cognizant of the fact that the precision of a 95 per cent confidence interval is guided by the width of the interval (which was narrow in our study), rather than solely by the inclusion of null or any specific value within an interval2. Further, the adverse effects experienced by the study participants, during the course of HCQ intake as prophylaxis, were self-reported. As such, there were no provisions for undertaking specific adverse event monitoring within the mandate of the current design except for brief telephonic interviews.

While we reiterate that the evidence from randomized controlled trials (RCTs) are awaited to support further actions pertaining to pre-exposure prophylaxis, the RCT on post-exposure prophylaxis, cited by the authors, refers to a completely different clinical context3. The findings of the cited RCT had their own strengths and limitations, which were aptly elaborated upon in an accompanying editorial4.

References

  • 1.Chatterjee P, Anand T, Singh KJ, Rasaily R, Singh R, Das S, et al. Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19. Indian J Med Res. 2020;151:459–67. doi: 10.4103/ijmr.IJMR_2234_20. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Greenland S, Senn SJ, Rothman KJ, Carlin JB, Poole C, Goodman SN, et al. Statistical tests, P values, confidence intervals, and power: A guide to misinterpretations. Eur J Epidemiol. 2016;31:337–50. doi: 10.1007/s10654-016-0149-3. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3.Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, et al. A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19. N Engl J Med. 2020 doi: 10.1056/NEJMoa2016638. NEJMoa2016638. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.Cohen MS. Hydroxychloroquine for the prevention of COVID-19 - searching for evidence. N Engl J Med. 2020 doi: 10.1056/NEJMe2020388. NEJMe2020388. [DOI] [PMC free article] [PubMed] [Google Scholar]

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