CARE for COVID-19: A Checklist for Documentation of Coronavirus Disease 2019 Case Reports and Case Series

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Paul G Werthmann, MD^1,2; David Riley, MD^3,4; Gunver Sophia Kienle, MD^1,2

Perm J 2020;24:20.127

https://doi.org/10.7812/TPP/20.127

E-pub: 08/12/2020

ABSTRACT

Coronavirus disease 2019 (COVID-19) is a new, rapidly spreading pandemic that can lead to a life-threatening disease. Accurate and transparent COVID-19 case reports provide systematic clinical observations supporting researchers designing clinical trials and clinicians delivering health care. The checklist described here is designed to systematically and accurately capture data from case reports and case series for documentation on COVID-19. It is aligned with the CARE guidelines, available from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network.

INTRODUCTION

Coronavirus disease 2019 (COVID-19) is a viral infection with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), first detected in December 2019 in Wuhan, China.¹ COVID-19 spread as a pandemic throughout the world, with more than 9 million confirmed cases and more than 470,000 deaths worldwide as of June 23, 2020.² The widespread and sometimes fatal outcome of this pandemic necessitates the acquisition of reliable knowledge about this disease. Much of the early evidence has come from case reports and case series.^3-10 Prospective clinical research trials and reviews on COVID-19 have begun; however, the clinical observations of patients captured in accurate and transparent COVID-19 case reports provide systematic clinical observations supporting researchers designing clinical trials and clinicians delivering health care. This information will gather important observations across different fields of medicine treating different patients with different treatment approaches as well as the frequency and types of adverse events and complications. In 2013 and 2017 the CARE Group published the health research reporting guideline for case reports,^11,12 which has been adopted and adapted by many medical fields.^13,14

DOCUMENTATION CHECKLIST CARE FOR COVID-19

We present here a documentation checklist for the elaboration of COVID-19 case reports (Table 1). This checklist is designed to systematically and accurately capture data from case reports and case series for documentation on COVID-19 and is aligned with the CARE ¹⁵ guidelines; this and other health research reporting guidelines are available from the EQUATOR ¹⁶ (Enhancing the QUAlity and Transparency Of health Research) Network. This checklist aims to support the collection of important clinical information as generally given in the items 5, 6, 8, 9, and 10 of the CARE Guideline Checklist.¹¹ The checklist has been elaborated by 3 members of the CARE Group and represents a tool for clinicians and researchers who want to present new information with importance for the medical community.

Guideline Development

For elaboration of this guideline, data from clinical and scientific literature (eg, ^1,3-10,17,18) and from current research projects (eg, NCT04331509, NCT04333407, NCT04291053, NCT04344171, NCT04323332, DRKS00021145¹⁹) were screened and included in the elaboration of the checklist. Items were especially included if they represent a special characteristic of the patient regarding risk, diagnostic certainty, and severity of the disease. This checklist is compatible with the Lean European Open Survey on SARS-CoV-2 (LEOSS; https://leoss.net), the publicly funded European COVID-19 registry. As the disease has different grades of severity and complications (Figure 1), additional items ask to give details about the patient’s course in the intensive care unit.

The item collection was done by 1 author (PGW) and checked by 2 others (GSK, DR). After completion, the checklist was sent out to several researchers and physicians in charge of patients with COVID-19. Feedback from these experts was included in the revision of the checklist. The checklist was then sent out in English and in translations (German, Portuguese, and Spanish) to physicians in charge of patients with COVID-19. Their feedback was included in another revision of the current checklist. The checklist is currently available in English, German, Portuguese, Russian, and Spanish (see supplemental material to this article available at www.thepermanentejournal.org/files/2020/20.127supp.pdf).

How to Use This Checklist

This checklist can be used to achieve a more complete documentation and description of patients with COVID-19, including therapeutic treatment with off-label conventional medicine or complementary and alternative therapies. In case reports and case series mentioning new therapeutic interventions, additional information may be necessary such as TIDieR (template for intervention description and replication),²⁰ a guideline designed to clarify therapeutic interventions that is available from the EQUATOR¹⁶ Network.

For the preparation of a COVID-19 case report or case series, follow the structure of the CARE guideline checklist.¹¹ For the details about the patient information, use this CARE for COVID-19 checklist to include all important items. Judge for yourself whether all the items of this list are applicable to your report and use those that are applicable.

Improvement of This Checklist and Future Outlook

Although more than 2000 articles about COVID-19 are already displayed in MEDLINE, the knowledge about this disease is still growing rapidly. Future progress in diagnosis and treatment of this disease will lead to a more precise description about the main symptoms, rarer symptoms, classification of disease stages, complications, pathophysiology, immune processes, interventions, long-term outcomes, and ethical issues related to it. We tried to implement the current knowledge from the literature and signs and symptoms from clinicians into this checklist while leaving it lean and clear for easy use. The checklist might therefore expand or change over time to account for the change in our knowledge of COVID-19 and potential therapeutic interventions.

We hope this checklist will help to build up a well-funded evidence base in this disease, and it might become an example for new emerging diseases in the future.

Disclosure Statement

The author(s) have no conflicts of interest to disclose.

Acknowledgments

We thank the researchers and physicians in charge of patients with COVID-19 for reviewing the item collection checklist. For help in translating the CARE for COVID-19 Checklist, we thank Iracema de Almeida Benevides, MD, public health consultant, Belo Horizonte, Brazil; Dr Denis Koshechkin, MD, Medical Centrum “Terapeuticum,” St Petersburg, Russia; and Dr Yván Villegas, MD, Centro Médico Antroposófico, Lima, Peru.

Kathleen Louden, ELS, of Louden Health Communications performed a primary copy edit.

Author Affiliations

¹ Faculty of Medicine, University of Freiburg, Institute for Infection Prevention and Hospital Epidemiology, Center for Complementary Medicine, Freiburg, Germany

² Institute for Applied Epistemology and Medical Methodology, University of Witten/Herdecke, Freiburg, Germany

³ Scientific Writing in Health and Medicine, Portland, OR

⁴ National University of Natural Medicine, Portland, OR

Corresponding Author

Paul G Werthmann, MD (paul.werthmann@ifaemm.de)

Author Contributions

Paul Georg Werthmann, MD, created the item collection checklist and wrote the first draft of the article. David Riley, MD, and Gunver Sophia Kienle, MD, checked the item collection checklist and revised and contributed to the article. All authors read and approved the final version of the article.