Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes

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Abstract

PURPOSE:

The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals.

METHODS:

We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests.

RESULTS:

A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08).

CONCLUSION:

More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

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Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Paul A. Harris, Robert Taylor, Robert Thielke … (2009)

Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

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Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019

Jianbo Lai, Simeng Ma, Ying Wang … (2020)

Key Points Question What factors are associated with mental health outcomes among health care workers in China who are treating patients with coronavirus disease 2019 (COVID-19)? Findings In this cross-sectional study of 1257 health care workers in 34 hospitals equipped with fever clinics or wards for patients with COVID-19 in multiple regions of China, a considerable proportion of health care workers reported experiencing symptoms of depression, anxiety, insomnia, and distress, especially women, nurses, those in Wuhan, and front-line health care workers directly engaged in diagnosing, treating, or providing nursing care to patients with suspected or confirmed COVID-19. Meaning These findings suggest that, among Chinese health care workers exposed to COVID-19, women, nurses, those in Wuhan, and front-line health care workers have a high risk of developing unfavorable mental health outcomes and may need psychological support or interventions.