Outcome reporting from protocols of clinical trials of Coronavirus Disease 2019 (COVID-19): a review

  1. Ruijin Qiu
  2. Xuxu Wei
  3. Mengzhu Zhao
  4. Changming Zhong
  5. Chen Zhao
  6. Jiayuan Hu
  7. Min Li
  8. Ya Huang
  9. Songjie Han
  10. Tianmai He
  11. Jing Chen
  12. Hongcai Shang

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Abstract

To examine heterogeneity of outcomes in protocols of clinical trials of Coronavirus Disease 2019 (COVID-19) and to identify outcomes for prioritization in developing a core outcome set (COS) in this field.

Design

This study is a review.

Data sources

Databases of ICMJE-accepted clinical trial registry platform were searched on February 14, 2020.

Eligibility Criteria

Randomized controlled trials (RCTs) and non-RCTs of COVID-19 were considered. Conditions of patients include common type, severe type or critical type. Interventions include traditional Chinese medicine (TCM) and Western medicine. We excluded trials that for discharged patients, psychological intervention and complications of COVID-19.

Data extraction and synthesis

The general information and outcomes, outcome measurement instruments and measurement times were extracted. The results were analysed by descriptive analysis.

Results

19 registry platforms were searched. A total of 97 protocols were included from 160 protocols. For protocols of TCM clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of outcomes were reported only once; the most frequently reported outcome was time of SARS-CoV-2 RNA turns to negative. 27 (27/76, 35.53%) outcomes were provided one or more outcome measurement instruments. 10 outcomes were provided one or more measurement time frame. For protocols of western medicine clinical trials, 126 outcomes from 17 outcome domains were reported; almost half (62/126, 49.21%) of outcomes were reported only once; the most frequently reported outcome was proportion of patients with negative SARS-CoV-2. 27 outcomes were provided one or more outcome measurement instruments. 40 (40/126, 31.75%) outcomes were provided one or more measurement time frame.

Conclusion

Outcome reporting in protocols of clinical trials of COVID-19 is inconsistent. Thus, developing a core outcome set is necessary.

Strengths and limitations of this study

  • 1.

    This review is the first to describe variation in outcomes, outcome measurement instruments and outcome measurement time reporting in clinical trials for Coronavirus Disease 2019 (COVID-19).

  • 2.

    All the database of ICMJE-accepted clinical trial registry platform were searched, and randomized controlled trials and observational studies were considered.

  • 4.

    The aim of this review was to provide a list of outcomes for clinical trials of COVID-19, both interventions of Traditional Chinese Medicine and western medicine were considered.

  • 5.

    When the searching was conducted, no clinical trials were registered by countries out of China, so all of included protocols were from China.

    • Article activity feed

    1. ScreenIT

      SciScore for 10.1101/2020.03.04.20031401: (What is this?)

      Please note, not all rigor criteria are appropriate for all manuscripts.

      Table 1: Rigor

      Institutional Review Board Statementnot detected.
      Randomizationnot detected.
      Blindingnot detected.
      Power Analysisnot detected.
      Sex as a biological variablenot detected.

      Table 2: Resources

      Software and Algorithms
      SentencesResources
      The taxonomy of outcome domains were developed by the researchers from COMET initiative [7].
      COMET
      suggested: (CoMet, RRID:SCR_011925)

      Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

      Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

      Results from TrialIdentifier: No clinical trial numbers were referenced.

      Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

      Results from JetFighter: We did not find any issues relating to colormaps.

      Results from rtransparent:
      • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
      • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
      • No protocol registration statement was detected.

      About SciScore

      SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

    2. Version published to 10.1101/2020.03.04.20031401 on medRxiv