key: cord-0740106-mrhjth8p
authors: Emami, Amir; Akbari, Ali; Javanmardi, Fatemeh; Lotfi, Mehrzad; Moghadami, Mohsen; Sharifi, Mehrdad; Bakhtiari, Hamid; Falahati, Farshad
title: Designing a Multicenter Registry of COVID-19 and Other Respiratory Infections in Fars, Iran
date: 2021-04-06
journal: Disaster medicine and public health preparedness
DOI: 10.1017/dmp.2021.100
sha: e26f62364d6a9264de3db2f1bb085b31a3aaac4a
doc_id: 740106
cord_uid: mrhjth8p

OBJECTIVE: A year after the emergence of a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as a new crisis in respiratory infections, there remain many uncertainties and unknowns about SARS-CoV-2 and the disease it causes, called coronavirus disease (COVID-19). Although COVID-19 is known as a respiratory disease, some atypical manifestations have been seen, different from those seen in other types of viral respiratory infections. This paper aims to describe designing, launching, and implementing a data collection system for all respiratory diseases, with a focus on SARS-CoV-2 from the onset of this pandemic. METHOD: The current registry is designed in compliance with the standard Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, along with the declaration of Helsinki principles. RESULTS: A respiratory disease registry, with an emphasis on COVID-19 and other co-infections, was developed. Data consisted of demographic, clinical, and supporting information about SARS-CoV-2 and other respiratory viral diseases. CONCLUSION: It is hoped that the current data registry will facilitate patient evaluation and improve the outcomes of cases of respiratory infection defined by a particular condition, disease, or exposure. Moreover, the registry can harmonize data about the treatment, outcomes, and well-being of patients who receive care over time, and identify best practices.

A year after the emergence of a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as a new crisis in respiratory infections, there remain many uncertainties and unknowns about SARS-CoV-2 and the disease it causes, called coronavirus disease . Even the mortality rate and rate of spread of infection across communities are debatable and unspecified. 1 Besides the plethora of management strategies and infection control policies from the World Health Organization (WHO) and Centers for Disease Control and Prevention, evidence-based studies are critical for better understanding the nature of the current outbreaks and how best to treat the patients. It is very important to diagnose the disease pattern, from asymptomatic to severe cases and, moreover, to identify high-risk individuals. 2 Common symptoms have changed from first recognition of the disease until now. Although COVID-19 is known as a respiratory disease, some atypical manifestations have been seen, different from other types of viral respiratory infections. 3, 4 Skin vesicular, cerebrovascular, neurological complications, dry eye, itching, and ocular involvement have been reported. [5] [6] [7] On the other hand, co-infections with COVID-19 and other respiratory viruses (eg, influenza viruses, adenoviruses) have been detected. 8 Exact information about positive cases with respiratory diseases, especially SARS-CoV-2, their symptoms, complications, and comorbidities are required to clarify the ambiguities of these viral infections. 9 Therefore, a comprehensive database registry would be helpful for specialists and health policy-makers to manage and control the disease and improve treatment. This paper is intended to explain design and implementation of a registry for data collection for all respiratory diseases, with a focus on SARS-CoV-2 from the onset of this pandemic.

Based on standards for disease registries, the development of the registry program was done in several steps: (1) definition of the target population, (2) diagnosis of infected cases, (3) data gathering and appropriate related checklists, (4) data storage program, (5) assessing the quality of data, and, finally, (6) data analysis and reporting outputs. The current registry is designed in compliance with the standard Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, along with the declaration of Helsinki principles. 10, 11 The current registry is approved by the ethical committee at Shiraz University of Medical Sciences, approval IR.SUMS.REC.1399.022.

The entire process is in consultation with scientific committees, including microbiologists, infectious disease specialists, radiologists, anesthesiologists, neurologists, cardiologists, emergency medicine, pharmacologists, and biostatisticians. This committee is responsible for providing protocols, supervising the data access, quality assessment of data, and managing the reports and outputs. Moreover, launching a biobank related to prevalent viral infections (such as COVID-19) and accompanying information has recently been added to the current registry. Detailed information about included variables is provided in Table 1 .

In order to manage the infected patients, the admission criteria were divided into 4 levels, based on the severity of disease and treatment requirements, and patient location (hospitalized in 3 levels of centers or isolated at home). Characteristics of included patients are provided in Table 2 . The definitions of the hospital ratings are as follows:

Referral and tertiary hospitals: Several medical teams and specialists, including expert health care workers in respiratory diseases, pulmonary department; more intensive care unit (ICU) beds are provided in these centers and allocated for severe patients.

General hospitals: These centers are one of the multifunctional hospitals in Fars Province. Based on the WHO guidelines, some departments and wards are allocated for COVID-19 patients and changed to infectious disease. Mildly ill patients were admitted to these centers.

Designated hospitals: These centers are prepared for the admission of patients in case of an increasing trend in the current outbreak. New trained medical staff care for moderately ill patients.

Isolation: These patients isolate at home, rest, and implement health care protocols. Their status is screened and followed by the Medical Care Monitoring Center; if in need of special care, they will be moved to one of the centers described previously.

Although the second presentation of the disease has been reported rarely, following the pandemic, some cases in our region are seen readmitted in our centers. In general, re-presentation of the respiratory symptoms in our study means individuals recovered after being infected and confirmed for COVID-19 once before and later admitted again with the recent crisis guideline criteria.

This paper described the rationale and fundamentals of launching a respiratory disease registry, with an emphasis on COVID-19 and other co-infections, with data consisting of demographic, clinical, and supporting information about SARS-CoV-2 and other respiratory viruses and diseases. Although this new virus is from a known family of viruses (Coronaviridae), due to ambiguous points about complications and symptoms of this virus with respect to the previous coronavirus infections (SARS-CoV, MERS-CoV), prior insights were insufficient. Therefore, a comprehensive database will be helpful to support researchers and clinicians for a better understanding of the disease and proper treatments. 12 As of March 1, 2021, COVID-19 has affected 217 countries and territories with more than 114 million confirmed cases around the world. In Iran, there have been more than 1.6 million total cases and over 60 000 deaths. Based on the current registry, data such as the following will be provided: total tests, confirmed cases, final status, readmissions, laboratory data, underlying diseases, risk factors, and complications.

Based on previous experiences on registry data analysis, it was found that having a registry is crucial for pandemic diseases since it may help in designing infection control protocols, managing the transmission mode, identifying epidemiological changes, and recognizing disease patterns to improve treatment in order to save human lives. 13, 14 Research studies are essential for this outbreak, especially since no one is assured of SARS-CoV-2 immunity. It is hoped that the current data registry will evaluate and improve the outcomes of this infectious respiratory disease and infected cases defined by a particular condition, complication, and presentation. Moreover, in a specific insight, we can harmonize data about the treatment, outcomes, and well-being of patients who receive care over time. Several research papers have been derived from this registry, which were very useful for managing the disease and codification of guidelines. 5, [15] [16] [17] Conclusion An electronic registry system for patients with respiratory infections focused on COVID-19 was developed in Fars Province, southwest of Iran. This registry should help researchers and policy-makers, as well as clinicians, collect reliable and up-to-date information on respiratory infections.

Conflict(s) of Interest. The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this paper. 

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