key: cord-0918130-nsisvkxh authors: BONILLA, CÉSAR RAÚL GONZALEZ title: Response to: Regarding the Article: A Multimodal Strategy to Reduce the Risk of Hospitalization/death in Ambulatory Patients with COVID-19 date: 2022-05-10 journal: Arch Med Res DOI: 10.1016/j.arcmed.2022.05.002 sha: b7ecc6d012d5b893f20dac39bbe5465fad132112 doc_id: 918130 cord_uid: nsisvkxh nan We would like to thank the interesting comments related to our study titled "A Multimodal Strategy to Reduce the Risk of Hospitalization/death in Ambulatory Patients with COVID-19" We first would like to point out that our study is an objective description and evaluation of an emergency strategy implemented by our institution to deal with the epidemiological emergency poised by the COVID-19 pandemic. In our country, like in other countries around the world, the COVID-19 pandemic has resulted in an unprecedented hospitalization and lethality rate. The information contained in our database was obtained directly from the daily consultation registry of patients diagnosed with COVID-19 as part of the epidemiological surveillance system (SINOLAVE) of the Mexican Institute of Social Security (IMSS) without any external repositories linkage. All personal information was removed to ensure confidentiality; patients were neither localized, nor From the initial 571,330 data entries identified, 453,663 were excluded due to incomplete information on the delivery of the treatment kit and 17,940 had incomplete data on the COVID-19 notification. We found 8,203 duplicated entries; 8,848 entries without laboratory test results; 46 entries with rejected samples; 50,458 entries with negative laboratory results; 1,171 entries of patients younger than 20 years of age; and 2,953 entries with symptoms onset before January 2021. Thus, we were able to analyze 28,048 records with complete information including treatment kit acceptance and telephone follow-up, as well as the clinical outcomes. Indeed, the information on adherence to treatment and the period of remote monitoring is limited, due variations in patient care. The family physician was responsible for the remote monitoring as well as for the delivery of the treatment. Both strategies were implemented in the Family Medicine Units to help reduce lethality and reduce operating pressure in IMSS hospitals, given the growing demand for hospitalization beds. The criteria for remote monitoring of patients and referral to hospitalization were established in the Guidelines for quality assurance of care for COVID-19 in the IMSS, in October 2020. The use of the treatment kits was based on evidence published in 2020, when there was still no accurate scientific evidence on treatments for COVID-19. It was not possible to carry out a clinical trial at the peak of the epidemic, due to the growing number of infections, and because a rapid and timely institutional response had to be implemented, to mitigate the number of infections, and reduce the high number of hospitalizations and deaths from COVID-19. The imbalances among groups were also another limitation of our report. We found that subject with telephonic follow-up showed lower rates of hospitalization, intubation, and death, compared to patients without follow-up; but the first group was also younger and had a lower proportion of Although the use of unproven interventions could be ethical during pandemics, they must not compromise efforts needed to conduct clinical trials (3). The high progress rate of pandemics has forced the development of new knowledge acquisition tools other than the standard clinical trial protocols. If the therapy is untested, the only reasonable conclusion is that its efficacy is unknown. However, the situation is rarely as simple as a complete absence of study data. Clinicians are often faced with the dilemma of poor evidence or data from one condition that they are attempting to COVID-19 pandemic: Ethical challenges of healthcare and research Emergency use of unproven interventions outside of research. Ethics guidance for the COVID-19 pandemic Considerations for regulatory oversight of clinical trials in the COVID-19 pandemic Ethical Dimensions of Public Health Actions and Policies With Special Focus on COVID-19 Antiviral Therapy during the Coronavirus Disease (COVID-19) Pandemic: Is It Appropriate to Treat Patients in the Absence of Significant Evidence? Safety of COVID-19 Patients and Use of Medicines Without Scientific Evidence of Their Benefit Pan American Health Organization Lineamiento estandarizado de vigilancia epidemiológica y por laboratorio de la enfermedad respiratoria viral Institutional Review Boards: Purpose and Challenges The research ethics review process (RECs/IRBs