Moni Merlin, Madathil Thushara, Palabatla Rahul, Balachandran Sabarish, Edathadathil Fabia, Gutjahr Georg, Madathil Sai B, Pai Rajesh, Kv Beena, Jayant Aveek, Sathyapalan Dipu T
Department of General Medicine and Division of Infectious Diseases, Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala.
Department of Anaesthesiology and Critical Care Medicine, Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala.
J Public Health Res. 2020 Dec 30;9(4):1888. doi: 10.4081/jphr.2020.1888. eCollection 2020 Oct 14.
India currently has the second largest burden of infections due to COVID-19. Health Care Worker (HCW) shortages are endemic to Indian healthcare. It should therefore be a huge priority to protect this precious resource as a critical component of the systemic response to this pandemic. Advisories from the Indian Council of Medical Research (ICMR) have focused on using hydroxychloroquine prophylaxis against COVID-19 in at risk HCW. This prophylaxis strategy has no evidence. In further jeopardy there appear to insubstantial attempts to build this evidence as well. In this connection, we commissioned a survey within our Institution to estimate the penetration of hydroxychloroquine (HCQ) use and use this to statistically model the impact of current ongoing studies in India. We also briefly review the literature on HCQ prophylaxis for COVID-19. A structured survey designed using RedCAP application was disseminated among healthcare professionals employed at an academic referral tertiary care centre via online social media platforms. The survey was kept open for the entire month of June 2020. The survey was additionally used to statistically model the size of studies required to comprehensively address the efficacy of HCQ in this setting. 522 responses were received, of which 4 were incomplete. The ICMR strategy of 4 or more doses of HCQ was complete only in 15% of HCW in our survey. The majority of respondents were doctors (238, 46%). Amongst all category of responders, only 12% (n=63) received the full course. A majority of those who initiated the chemoprophylaxis with HCQ turned out to be medical professionals (59/63) with neither nurse nor other categories of healthcare workers accessing the medication. The respondents of our institutional survey did not report any life-threatening side effects. Presuming efficacy as per ICMR modelling for new registry trial on the lines of the published case control study, equal allocation between cases and controls and assuming a RR of 1.3.6, the power of such a study would be very low for n=2000 for event rates from 2.5-12.5%. We report the low penetration of HCQ chemoprophylaxis among the healthcare workers of our institution. We highlight the inherent drawbacks in the study design of current national COVID related trial based on the statistical modelling of our survey results and published literature, and thereby emphasis the need of evidence-based strategies contributing to research policy at national level.
印度目前是因新冠病毒感染而负担第二重的国家。医护人员短缺是印度医疗体系的痼疾。因此,将这一宝贵资源作为应对这场大流行的系统性应对措施的关键组成部分加以保护,应成为重中之重。印度医学研究理事会(ICMR)的咨询意见聚焦于让有风险的医护人员使用羟氯喹预防新冠病毒。这一预防策略并无证据支持。此外,似乎也没有实质性的努力来获取这方面的证据。在此背景下,我们在本机构内开展了一项调查,以估计羟氯喹(HCQ)的使用普及率,并据此对印度正在进行的研究的影响进行统计建模。我们还简要回顾了关于使用HCQ预防新冠病毒的文献。一项使用RedCAP应用程序设计的结构化调查通过在线社交媒体平台在一家学术转诊三级护理中心工作的医护人员中进行传播。该调查在2020年6月整月开放。该调查还被用于对全面评估HCQ在此情况下疗效所需研究规模进行统计建模。共收到522份回复,其中4份不完整。在我们的调查中,ICMR提出的4剂或更多剂HCQ的策略在仅15%的医护人员中得到落实。大多数受访者是医生(238人,占46%)。在所有类别的受访者中,只有12%(n = 63)接受了完整疗程。大多数开始使用HCQ进行化学预防的人是医学专业人员(59/63),护士和其他类别的医护人员均未使用该药物。我们机构调查的受访者未报告任何危及生命的副作用。假设按照ICMR针对已发表病例对照研究进行新注册试验的模型计算疗效,病例与对照平均分配,并假设相对危险度为1.3.6,对于事件发生率在2.5 - 12.5%之间、样本量n = 2000的此类研究,检验效能将非常低。我们报告了HCQ化学预防在我们机构医护人员中的低普及率。基于我们的调查结果和已发表文献的统计建模,我们强调了当前国家新冠相关试验研究设计中固有的缺陷,从而强调了基于证据的策略对国家层面研究政策的重要性。