Post-acute sequelae of COVID-19 and adverse psychiatric outcomes: an etiology and risk systematic review protocol

  1. Andem Effiong

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Abstract

Introduction

The post-acute sequelae of COVID-19 (PASC) is a syndrome characterized by persistent COVID-19 symptoms or the onset of new symptoms following recovery from the initial or acute phase of the illness. Such symptoms often occur four or more weeks after being diagnosed with COVID-19. Although a lot of work has gone into understanding the long-term mental health effects of PASC, many questions related to the etiology and risk of this condition remain. Thus, this protocol is for a systematic review assessing the association between PASC and adverse psychiatric outcomes and whether people with PASC are at greater risk of developing an adverse psychiatric outcome than those without PASC.

Methods and analysis

Various medical databases (e.g., PubMed and EMBASE) will be searched for eligible articles using predefined search criteria. Gray literature will also be explored. Epidemiological observational studies and secondary analyses of randomized controlled trials that report a quantitative relationship between PASC and at least one adverse psychiatric outcome will be included. The Population, Exposure of interest, Comparator, and Outcome (PECO) framework will be used as a standardized framework for the inclusion criteria. The Joanna Briggs Institute (JBI) critical appraisal tools will be used to assess methodological quality and critically appraise the risk of bias in included studies. A random-effects meta-analysis will be conducted if possible. A formal narrative synthesis will be performed if a meta-analysis is impossible due to substantial heterogeneity across studies. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to rate the cumulative certainty of the evidence for all outcomes.

Ethics and Dissemination

Ethical approval is not required for this study. The study results will be published in a peer-reviewed journal.

Prospero registration number

CRD42022308737

Strengths and limitations of this study

  • ▪

    This study documents and addresses etiology, risk factors, and long-term symptoms of COVID-19 among people with post-acute sequelae of COVID-19 (PASC).

  • ▪

    It focuses on a key priority area for new evidence syntheses on the clinical management of COVID-19 and pandemic-related conditions.

  • ▪

    It will include evidence on non-hospitalized and hospitalized patients with a history of PASC.

  • ▪

    Substantial heterogeneity across studies may limit the ability to perform a meta-analysis.

  • ▪

    Findings will inform disease prevention, decision-making, healthcare policy, and clinical research.

    • Article activity feed

    1. PeerRef

      Peer review report

      Reviewer: Daniel Griffin, MD PhD,
      Institution: Columbia University ORCID: 0000-0001-5853-6906 email: danielgriffinmd@gmail.com, dgriffin@cumc.columbia.edu

      Please describe your research in a sentence or a few key words

      COIVD-19, general infectious disease, immunology, virology

      General comments

      The authors lay out a reasonable protocol for this type of investigation.

      Section 1 – Serious concerns

      • Do you have any serious concerns about the manuscript such as fraud, plagiarism, unethical or unsafe practices? No
      • Have authors’ provided the necessary ethics approval (from authors’ institution or an ethics committee)? Yes

      Section 2 – Language quality

      • How would you rate the English language quality? High quality

      Section 3 – validity and reproducibility

      • Is the reasons for conducting the study and its objectives clearly explained? Yes

      • Is the study design appropriate? Yes

      • Are sufficient details provided so that the method can be replicated? Yes

      • Are datasets available so that others could use them? not applicable

      Section 4 – Suggestions

      • Based on your answers in section 3 how could the author improve the protocol? Fine as is.

      • Do you have any other feedback or comments for the Author?

      The authors lay out a reasonable protocol for this type of investigation that is based on a fairly standard approach with the standard GRADE grading.

      Section 5 – Decision

      Verified manuscript: The content is scientifically sound, only minor amendments (if any) are suggested.

    2. PeerRef

      Discussion, revision and decision

      Decision

      Verified manuscript — The content is scientifically sound, only minor amendments (if any) are suggested.

      Revision

      Reviewer: Dacre Knight

      (1) Included the World Health Organization (WHO) and the National Institute for Health and CARE Excellence (NICE) definitions of PASC. See: Lines 51; 332-339

      (2) The PECO criteria is listed (and not just implied) in the body of the manuscript. See: Lines 207-237.

      Decision changed — Verified manuscript: The content is scientifically sound.

      Reviewer: Yin Qianlan

      (3) The purpose of the study was revised for clarity. See: Lines 114-171

      Reviewer did not respond. Therefore, a third reviewer (Daniel Griffin) was asked to review the manuscript. They gave the decision, verified manuscript.

    3. Version published to 10.1101/2022.02.07.22270646v2 on medRxiv
    4. PeerRef

      Peer review report

      Reviewer: Yin Qianlan Institution: Navy Medical University email: yinqianlan@smmu.edu.cn

      Section 1 – Serious concerns

      • Do you have any serious concerns about the manuscript such as fraud, plagiarism, unethical or unsafe practices? No
      • Have authors’ provided the necessary ethics approval (from authors’ institution or an ethics committee)? Yes

      Section 2 – Language quality

      • How would you rate the English language quality? High quality

      Section 3 – validity and reproducibility

      • Is the reasons for conducting the study and its objectives clearly explained? No

      • Is the study design appropriate? Yes

      • Are sufficient details provided so that the method can be replicated? Yes

      • Are datasets available so that others could use them? not applicable

      Section 4 – Suggestions

      • Based on your answers in section 3 how could the author improve the protocol?

      As an important part of a review is the declaration of the purpose, the introduction should be the core of the article. However, after reading the beginning of the paper, I could realize the seriousness of COVID-19, but I cannot see the key point of the research. There is a lot of data to emphasize the worse results, but I don’t know how this data contributed to the relationship between the major topic of Post-acute sequelae of COVID-19 and adverse psychiatric outcomes, for example, the introduction about the effect of therapies. Hence, more organized structure for the introduction of could be more concise and easier for readers.

      Section 5 – Decision

      Requires revisions: The manuscript contains objective errors or fundamental flaws that must be addressed and/or major revisions are suggested.

    5. PeerRef

      Peer review report

      Reviewer: Dacre Knight, MD Institution: Mayo Clinic email: Knight.dacre@mayo.edu

      Section 1 – Serious concerns

      • Do you have any serious concerns about the manuscript such as fraud, plagiarism, unethical or unsafe practices? No
      • Have authors’ provided the necessary ethics approval (from authors’ institution or an ethics committee)? not applicable

      Section 2 – Language quality

      • How would you rate the English language quality? High quality

      Section 3 – validity and reproducibility

      • Is the reasons for conducting the study and its objectives clearly explained? Yes

      • Is the study design appropriate? Yes

      • Are sufficient details provided so that the method can be replicated? Yes

      • Are datasets available so that others could use them? not applicable

      Section 4 – Suggestions

      • Based on your answers in section 3 how could the author improve the protocol?

      There is a more specific definition of PASC that should be included (with reference). Need to list specific medical databases to search, not just “various”. PECO criteria needs to be listed, not only implied that it will be used.

      • Do you have any other suggestions, feedback, or comments for the Author?

      GRADE approach will be useful, as is mentioned along with narrative synthesis if needed. Strengths and limits seem accurate, good to list.

      Section 5 – Decision

      Verified with reservations: The content is scientifically sound but has shortcomings that could be improved by further studies and/or minor revisions.

    6. ScreenIT

      SciScore for 10.1101/2022.02.07.22270646: (What is this?)

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

      Table 1: Rigor

      Ethicsnot detected.
      Sex as a biological variablenot detected.
      RandomizationSecondary analyses of randomized controlled trials will also be included.
      Blindingnot detected.
      Power Analysisnot detected.

      Table 2: Resources

      Software and Algorithms
      SentencesResources
      Risk factors predispose people with PASC to an adverse psychiatric outcome.
      PASC
      suggested: (PASC , RRID:SCR_016642)
      The following databases and evidence sources will be searched: PubMed, Ovid MEDLINE, EMBASE, JBI EBP Database, CINAHL Plus, UpToDate, APA PsycInfo, Google Scholar, ProQuest Dissertations & Theses Global, Scopus, Web of Science, the University of Toronto COVID-19 Data & Statistical Sources, Centre for Addiction and Mental Health (CAMH) COVID-19 National Survey Dashboard reports, and COVID-END.
      EMBASE
      suggested: (EMBASE, RRID:SCR_001650)
      PsycInfo
      suggested: (PsycINFO, RRID:SCR_014799)
      Google Scholar
      suggested: (Google Scholar, RRID:SCR_008878)
      See Appendix 1 for a sample of the PubMed search strategy.
      PubMed
      suggested: (PubMed, RRID:SCR_004846)

      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.

      Results from scite Reference Check: We found no unreliable references.

      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.

    7. Version published to 10.1101/2022.02.07.22270646v1 on medRxiv