Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology

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Abstract

Background

COVID-19 triggered an unprecedented crisis affecting society at every level. Research in pediatric and congenital cardiology is currently in full development and may have been disrupted. The aim of the study was to determine the impact of COVID-19 on pediatric and congenital cardiology clinical research and to analyze decision-making and adaptation processes, from a panel of ongoing academic and industry-sponsored research at the time of the pandemic.

Methods

This observational study was carried out in April 2020, from a CHD clinical research network involving five tertiary care pediatric and congenital cardiology centers. Investigators and clinical research assistants from each participating research center completed an online survey questionnaire, and each principal investigator underwent a 1-h web-based videoconference interview.

Results

: A total of 34 study questionnaires were collected, reporting that 18 studies were totally suspended. Upon the investigator's decision, after discussion on ethical issues and with facilitating support from health authorities, 16 studies were resumed. The rate of study suspension in interventional research (53%) was similar to that in non-interventional research (56%). Logistical problems were predominantly reported in both continued and suspended trials. Research protocols were adapted, largely thanks to telemedicine, which in some cases even improved the course of the study.

Conclusion

The impact of the COVID-19 pandemic on clinical research in pediatric and congenital cardiology has been limited by a rapid adaptation of all research structures and an extensive use of telemedicine at all stages of the studies.

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Most cited references 27

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Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

Chaolin Huang, Yeming Wang, Xingwang Li … (2020)

Summary Background A recent cluster of pneumonia cases in Wuhan, China, was caused by a novel betacoronavirus, the 2019 novel coronavirus (2019-nCoV). We report the epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of these patients. Methods All patients with suspected 2019-nCoV were admitted to a designated hospital in Wuhan. We prospectively collected and analysed data on patients with laboratory-confirmed 2019-nCoV infection by real-time RT-PCR and next-generation sequencing. Data were obtained with standardised data collection forms shared by WHO and the International Severe Acute Respiratory and Emerging Infection Consortium from electronic medical records. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Outcomes were also compared between patients who had been admitted to the intensive care unit (ICU) and those who had not. Findings By Jan 2, 2020, 41 admitted hospital patients had been identified as having laboratory-confirmed 2019-nCoV infection. Most of the infected patients were men (30 [73%] of 41); less than half had underlying diseases (13 [32%]), including diabetes (eight [20%]), hypertension (six [15%]), and cardiovascular disease (six [15%]). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market. One family cluster was found. Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα. Interpretation The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of disease need fulfilment by future studies. Funding Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission.

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Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science

Emily A. Holmes, Rory C O'Connor, V. Perry … (2020)

Summary The coronavirus disease 2019 (COVID-19) pandemic is having a profound effect on all aspects of society, including mental health and physical health. We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research. These priorities were informed by surveys of the public and an expert panel convened by the UK Academy of Medical Sciences and the mental health research charity, MQ: Transforming Mental Health, in the first weeks of the pandemic in the UK in March, 2020. We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time. The need to maintain high-quality research standards is imperative. International collaboration and a global perspective will be beneficial. An immediate priority is collecting high-quality data on the mental health effects of the COVID-19 pandemic across the whole population and vulnerable groups, and on brain function, cognition, and mental health of patients with COVID-19. There is an urgent need for research to address how mental health consequences for vulnerable groups can be mitigated under pandemic conditions, and on the impact of repeated media consumption and health messaging around COVID-19. Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required. Rising to this challenge will require integration across disciplines and sectors, and should be done together with people with lived experience. New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure. This Position Paper provides a strategy that may be both adapted for, and integrated with, research efforts in other countries.

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Telemedicine and the COVID-19 Pandemic, Lessons for the Future

Rashid Bashshur, Charles Doarn, Julio M. Frenk … (2020)

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Author and article information

Journal

Journal ID (nlm-ta): Arch Pediatr

Journal ID (iso-abbrev): Arch Pediatr

Title: Archives De Pediatrie

Publisher: French Society of Pediatrics. Published by Elsevier Masson SAS.

ISSN (Print): 0929-693X

ISSN (Electronic): 1769-664X

Publication date PMC-release: 20 April 2022

Publication date (Electronic): 20 April 2022

Affiliations

[a ]Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Clinical Investigation Centre, University Hospital, Montpellier, France

[b ]PhyMedExp, CNRS, INSERM, University of Montpellier, Montpellier, France

[c ]Cardiac Neurodevelopmental Program, Department of Psychiatry, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA

[d ]Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France

[e ]Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, CIC 1436, Toulouse University Hospital, Toulouse, France

[f ]Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, APHM La Timone University Hospital, Marseille, France

[g ]Pediatric and Congenital Cardiology Department, M3C National Reference Centre, Centre Medico-Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France

[h ]Pediatric and Congenital Cardiology Department, M3C National Reference Centre, Bordeaux University Hospital, Bordeaux, France

[i ]IHU Liryc, Electrophysiology and Heart Modelling Institute, Bordeaux University Foundation, Pessac, France

Author notes

[* ]Corresponding author: Dr. Pascal AMEDRO: Department of Pediatric and Adult Congenital Cardiology, M3C National Reference Centre, Bordeaux University Hospital, Haut-Lévêque Hospital, Avenue de Magellan, 33604 Pessac Cedex, France, Tel: +33 (0) 5 24 54 92 19; Fax: +33 5 57 65 66 63

Article

Publisher Item ID: S0929-693X(22)00106-3

DOI: 10.1016/j.arcped.2022.03.004

PMC ID: 9020482

PubMed ID: 35523633

SO-VID: 31725c0d-46a6-49ac-b1ff-43c364e7dbb6

License:

Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

History

Date received : 13 September 2021

Date revision received : 21 February 2022

Date accepted : 26 March 2022

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Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology

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Novel Coronavirus Disease COVID-19

Most cited references 27

Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science

Telemedicine and the COVID-19 Pandemic, Lessons for the Future

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