<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.121821.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: peer review discontinued]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Rutjes-Weurding</surname>
                        <given-names>Laura</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Pouwels</surname>
                        <given-names>Sjaak</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-6390-7692</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>van Oers</surname>
                        <given-names>Jos</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>de Haas</surname>
                        <given-names>Mechteld</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>van Slobbe</surname>
                        <given-names>Christel</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ruitinga</surname>
                        <given-names>Renske</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Oomen</surname>
                        <given-names>Margo</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ramnarain</surname>
                        <given-names>Dharmanand</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-8005-2780</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Intensive Care Medicine, Elisabeth-Tweesteden Hospital, Hilvarenbeekseweg 60, Tilburg, 5022 GC, The Netherlands</aff>
                <aff id="a2">
                    <label>2</label>Emergency Medicine, Catharina Hospital, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands</aff>
                <aff id="a3">
                    <label>3</label>General and Abdominal Surgery, Helios Klinikum, Lutherplatz 40, Krefeld, 47805, Germany</aff>
                <aff id="a4">
                    <label>4</label>Intensive Care Medicine, Saxenburgh Medical Center, Jan Weitkamplaan 4a, Hardenberg, 7772 SE, The Netherlands</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:laura.weurding@catharinaziekenhuis.nl">laura.weurding@catharinaziekenhuis.nl</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>27</day>
                <month>6</month>
                <year>2022</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2022</year>
            </pub-date>
            <volume>11</volume>
            <elocation-id>707</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>13</day>
                    <month>6</month>
                    <year>2022</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2022 Rutjes-Weurding L et al.</copyright-statement>
                <copyright-year>2022</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/11-707/pdf"/>
            <abstract>
                <p>
                    <bold>Background:</bold> The SARS-CoV-2 pandemic puts patients and their relatives at risk of developing post-intensive care syndrome (PICS and PICS-family). The use of an intensive care unit (ICU) diary for these patients could help fill in memory gaps and complete their fragmented illness narrative.</p>
                <p>
                    <bold>Objectives:</bold> The aim of this study is to evaluate the effect of an ICU diary on the occurrence of impaired mental health in patients admitted with a SARS-CoV-2 infection and their relatives.</p>
                <p>
                    <bold>Methods:</bold> An observational cohort study of SARS-CoV-2 patients treated in the ICU of Elizabeth-Tweesteden Hospital (ETZ) in Tilburg, The Netherlands will be conducted. Adult patients admitted at the ICU because of respiratory insufficiency due to SARS-CoV-2, who are mechanically ventilated, are included. During treatment in the ICU a diary is kept of the patient. Anxiety, depression and post-traumatic stress disorder, cognitive dysfunction and quality of life will be screened in patients and their relatives by using the psychosocial screening instrument for adult trauma patients (PSIT), the Cognitive Failure Questionnaire (CFQ) and the short-form health survey 36 (SF-36). The recollection of patients&#x2019; memory of the ICU stay will be evaluated by the ICU memory tool. The appreciation of the ICU diary will be assessed using a questionnaire.</p>
                <p>
                    <bold>Results:</bold> Participants&#x2019; characteristics including how they valued the diary, and their memory of ICU treatment will be reported. Multiple logistic regression analysis will be performed for analyzing the relation between mental health outcome and the use of ICU diaries. Change in PICS symptoms over time will be analyzed using longitudinal data analysis. Missing values in questionnaires will be analyzed using missing value analysis and multiple imputations at item level will be performed if necessary.</p>
                <p>
                    <bold>Conclusions:</bold> This study will contribute to the knowledge of mental health outcome in SARS-CoV-2 patients and the use of ICU diaries in this group.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Sars-Cov-2</kwd>
                <kwd>Intensive Care</kwd>
                <kwd>ICU-diary</kwd>
                <kwd>Mental Health</kwd>
                <kwd>Quality of Life</kwd>
                <kwd>Memories</kwd>
                <kwd>Post-Intensive Care Syndrome (PICS)</kwd>
                <kwd>PICS-Family.</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>During intensive care unit (ICU) admission patients experience significant physical and psychological stressors. In recent years there has been more attention on the long-term effects of ICU admission on patients and their family (
                <xref ref-type="bibr" rid="ref19">Marra 
                    <italic toggle="yes">et al.</italic>, 2018</xref>). The adverse effects, such as muscle weakness, cognitive dysfunction or mental health problems, are known as post-intensive care syndrome (PICS) and post-intensive care syndrome family (PICS-F) (
                <xref ref-type="bibr" rid="ref4">Davidson 
                    <italic toggle="yes">et al.</italic>, 2012</xref>; 
                <xref ref-type="bibr" rid="ref21">Mikkelsen 
                    <italic toggle="yes">et al.</italic>, 2020</xref>). Patients and caregivers are at risk of developing anxiety, depression or post-traumatic stress disorder (PTSD) symptoms with prevalence ranging from 10 up to 57 percent (
                <xref ref-type="bibr" rid="ref18">Lewis 
                    <italic toggle="yes">et al.,</italic> 2018</xref>). A meta-analysis of (
                <xref ref-type="bibr" rid="ref27">Parker 
                    <italic toggle="yes">et al.,</italic> 2015</xref>) showed that one in five critical illness survivors has clinically important PTSD symptoms. Post-ICU patients are at risk of suffering from delusional memories and gaps in their memory (
                <xref ref-type="bibr" rid="ref8">Egerod 
                    <italic toggle="yes">et al.,</italic> 2011</xref>). These delusional memories can be one of the triggers to developing PTSD symptoms (
                <xref ref-type="bibr" rid="ref14">Jones &amp; Griffiths, 2007</xref>; 
                <xref ref-type="bibr" rid="ref27">Parker 
                    <italic toggle="yes">et al.,</italic> 2015</xref>). The absence of memories of the ICU period can be devastating for patients and puts strain on the relationship with family who are asked to fill in the gaps, but who have difficulty talking about it (
                <xref ref-type="bibr" rid="ref14">Jones &amp; Griffiths, 2007</xref>).</p>
            <p>SARS-CoV-2 has added even more stressors to the ICU admission. Patients were isolated from their loved ones and faced an uncertain course of the disease (
                <xref ref-type="bibr" rid="ref5">Dutheil 
                    <italic toggle="yes">et al.</italic>, 2021</xref>). Most patients with SARS-CoV-2 who required ICU care and mechanical ventilation, had a long ICU length of stay, needed prolonged sedation, analgesia and even muscular blocking agents (
                <xref ref-type="bibr" rid="ref22">Nanwani-Nanwani 
                    <italic toggle="yes">et al.</italic>, 2022</xref>). This increases the risk of impaired recall and therefore PTSD, as mentioned above. Relatives also experienced worrisome times, with extra limitations and concerns due to SARS-CoV-2 (
                <xref ref-type="bibr" rid="ref5">Dutheil 
                    <italic toggle="yes">et al.</italic>, 2021</xref>). Hospitals visitation policies became more strict (
                <xref ref-type="bibr" rid="ref36">Weiner 
                    <italic toggle="yes">et al.</italic>, 2021</xref>); for example at Elisabeth-Tweesteden Hospital relatives were allowed limited time to visit or were not able to visit as patients were transported to different hospitals across the country. Relatives could often not support the patients during admission or intubation other than 
                <italic toggle="yes">via</italic> phone and they themselves were also limited in receiving support due to lock-down regulations. This may enhance the mental health problems associated with PICS-F (
                <xref ref-type="bibr" rid="ref5">Dutheil 
                    <italic toggle="yes">et al.</italic>, 2021</xref>).</p>
            <p>ICU diaries have been investigated as a tool to prevent or reduce psychological problems after ICU admission, such as anxiety, depression or PTSD (
                <xref ref-type="bibr" rid="ref20">McIlroy 
                    <italic toggle="yes">et al.,</italic> 2019</xref>). It is important to make a difference between the prevention and the reduction of symptoms in, for example PTSD and anxiety. Studies showed no significant effect on prevention of PTSD (
                <xref ref-type="bibr" rid="ref34">Wang 
                    <italic toggle="yes">et al.,</italic> 2020</xref>), but did show a reduction of symptoms (
                <xref ref-type="bibr" rid="ref27">Parker 
                    <italic toggle="yes">et al.,</italic> 2015</xref>). It is also important to make a distinction of the effect on patients and the effect on relatives. The systematic review of (
                <xref ref-type="bibr" rid="ref20">McIlroy 
                    <italic toggle="yes">et al.,</italic> 2019</xref>) showed no reduction of PTSD symptoms in patients, but (
                <xref ref-type="bibr" rid="ref20">McIlroy 
                    <italic toggle="yes">et al.,</italic> 2019</xref>) and (
                <xref ref-type="bibr" rid="ref13">Jones 
                    <italic toggle="yes">et al.,</italic> 2012</xref>) did show a significant reduction of these symptoms in their relatives. Multiple studies have shown a significant reduction of anxiety and depression symptoms in patients due to ICU diaries (
                <xref ref-type="bibr" rid="ref16">Knowles &amp; Tarrier, 2009</xref>; 
                <xref ref-type="bibr" rid="ref17">Kredentser 
                    <italic toggle="yes">et al.,</italic> 2018</xref>; 
                <xref ref-type="bibr" rid="ref20">McIlroy 
                    <italic toggle="yes">et al.,</italic> 2019</xref>).</p>
            <p>Besides the impact of the ICU diaries on the symptoms, patients have stated they value the diaries and that the diaries can help fill in the gaps and complete their fragmented illness narrative (
                <xref ref-type="bibr" rid="ref6">Egerod &amp; Bagger, 2010</xref>; 
                <xref ref-type="bibr" rid="ref10">Glimelius Petersson 
                    <italic toggle="yes">et al.</italic>, 2018</xref>; 
                <xref ref-type="bibr" rid="ref26">O&#x2019;Gara &amp; Pattison, 2016</xref>; 
                <xref ref-type="bibr" rid="ref28">Pattison 
                    <italic toggle="yes">et al.,</italic> 2019</xref>; 
                <xref ref-type="bibr" rid="ref32">Tavares 
                    <italic toggle="yes">et al.,</italic> 2019</xref>). The ICU diaries may aid in the communication between patients and family members (
                <xref ref-type="bibr" rid="ref11">Huynh 
                    <italic toggle="yes">et al.,</italic> 2017</xref>; 
                <xref ref-type="bibr" rid="ref13">Jones 
                    <italic toggle="yes">et al.,</italic> 2012</xref>; 
                <xref ref-type="bibr" rid="ref28">Pattison 
                    <italic toggle="yes">et al.,</italic> 2019</xref>) or strengthen the bond by sharing the story (
                <xref ref-type="bibr" rid="ref25">Nielsen, 
                    <italic toggle="yes">et al.</italic>, 2019</xref>). Participating in writing the diary can help family members cope, maintain the relationship and support the patient (
                <xref ref-type="bibr" rid="ref23">Nielsen &amp; Angel, 2016</xref>; 
                <xref ref-type="bibr" rid="ref30">Roulin, Hurst, &amp; Spirig, 2007</xref>).</p>
            <p>The results of the studies are promising, but the overall quality is lacking (
                <xref ref-type="bibr" rid="ref18">Lewis 
                    <italic toggle="yes">et al.,</italic> 2018</xref>). More research is needed on the possibilities of ICU diaries to help patients and their relatives. This study will contribute to the research on PICS(-F) and ICU diaries. This study protocol describes the methods of research on this topic in SARS-CoV-2 patients. It pioneers on the psychological problems of PICS of SARS-CoV-2 patients and the use of ICU diaries in this group.</p>
        </sec>
        <sec id="sec2" sec-type="methods">
            <title>Methods</title>
            <sec id="sec3">
                <title>Objectives</title>
                <p>The goal of this study is to evaluate the effect of ICU diaries on the prevalence of PTSD, anxiety and depression symptoms in patients, admitted with SARS-CoV-2 and their relatives. The secondary objectives are to evaluate:
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>The effect of ICU diaries on symptoms of PTSD, anxiety and depression over time; three months after initial testing.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>The effect of ICU diaries on the recollection of memories.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>The way the patients and relatives value and use the diary.</p>
                        </list-item>
                    </list>
                </p>
                <p>We hypothesize that the ICU diary will aid in processing the negative experiences of the ICU admission and thereby lower the prevalence of PTSD, anxiety and depression symptoms over time. We also expect the diary to contribute to the recollection of memories and help patients and relatives with the completion of their illness narrative.</p>
            </sec>
            <sec id="sec4">
                <title>Study design</title>
                <p>This study is an observational single center cohort study that will be performed at the Elisabeth-Tweesteden Hospital in Tilburg, the Netherlands.</p>
            </sec>
            <sec id="sec5">
                <title>Patient inclusion</title>
                <p>Patients are admitted to the ICU either directly from the emergency department or from a SARS-CoV-2 ward. Patients with Sars-Cov-2 admitted to the ICU are included following the inclusion and exclusion criteria.</p>
                <p>Inclusion criteria are as follows:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Age 18 year or older.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Admission to the ICU because of respiratory insufficiency due to SARS-CoV-2 pneumonia.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Proven SARS-Cov-2 by PCR or computer aided tomography- (CAT) scan before or during admission to the ICU.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Mechanical ventilation for more than 48 hours.</p>
                        </list-item>
                    </list>
                </p>
                <p>Exclusion criteria are as follows:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Patients who are unable to fill in the questionnaires.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Patient deceased during IC treatment.</p>
                        </list-item>
                    </list>
                </p>
                <p>A relative, chosen by the patient will be included. This relative needs to be 18 years or older. Informed consent for the study will be obtained after discharge. Patients who do not desire to visit the post-ICU after care clinic will be asked to participate in the research from home.</p>
            </sec>
            <sec id="sec6">
                <title>SARS-CoV-2 detection</title>
                <p>From patients admitted to the hospital, suspected for SARS-CoV-2, a PCR test on SARS-CoV-2 is conducted in a pharyngeal swab. If the first PCR test is negative and there is a clinically high suspicion, PCR testing in sputum and faeces is continued. If a PCR test is positive or a chest CAT-scan showed abnormalities highly suspect for SARS-CoV-2, the patient is considered SARS-CoV-2 positive. Abnormalities on the chest CAT-scan are considered highly suspicious of a SARS-CoV-2 infection with a COVID-19 Reporting and Data System (CO-RADS) score of five. CO-RADS is a standardized assessment for pulmonary involvement of SARS-Cov-2 developed by the Dutch Radiological Society (
                    <xref ref-type="bibr" rid="ref29">Prokop 
                        <italic toggle="yes">et al.,</italic> 2020</xref>). SARS-CoV-2 infection may become definite during any time of the hospital stay (
                    <xref ref-type="bibr" rid="ref31">Sethuraman 
                        <italic toggle="yes">et al.</italic>, 2020</xref>).</p>
            </sec>
            <sec id="sec7">
                <title>Collection of diary input</title>
                <p>From the first day the patient is admitted to the ICU unit it is standard care to keep a diary daily onwards. During every shift the nurse writes a few sentences on the events of the day, a feeling or conclusion, in a paper diary. At the ICU, the patient&#x2019;s family is encouraged to contribute to the diary and take pictures of the patient. At discharge the patient receives the diary. If the patient passed away during their stay, the diary is given to the family. The family member will then be excluded from the study.</p>
            </sec>
            <sec id="sec8">
                <title>Data collection</title>
                <p>At three months after discharge all ICU patients are invited to the post-ICU aftercare clinic for follow-up. During this visit patients will be screened for mental or cognitive health problems using the psychosocial screening instrument for adult trauma patients (PSIT) and the cognitive failure questionnaire (CFQ). In addition to this standard care, patients will receive, during this study, the short-form health survey 36 (SF-36), the ICU memory tool and a questionnaire on how they used and valued the diary. The questionnaires will also be handed to a relative chosen by the patient. The questionnaires will be completed either digitally or written.</p>
                <p>The PSIT, a validated tool for adult trauma patients., consists of 15 items measuring three subscales on a 4-point Likert scale: mood disturbances, anxiety and/or PTSD and social or sexual problems/decreased self-confidence (
                    <xref ref-type="bibr" rid="ref15">Karabatzakis 
                        <italic toggle="yes">et al.</italic>, 2019</xref>). The PSIT is internally consistent, with an alpha coefficient of 0.92 (
                    <xref ref-type="bibr" rid="ref15">Karabatzakis 
                        <italic toggle="yes">et al.</italic>, 2019</xref>). Cognitive dysfunction will be screened using the Cognitive Failure Questionnaire (CFQ) (
                    <xref ref-type="bibr" rid="ref3">Broadbent 
                        <italic toggle="yes">et al.</italic>, 1982</xref>). The CFQ tests the frequency of mistakes using 25 items with a 5-point scale. A higher score corresponds with a higher frequency in cognitive mistakes. CFQ is internally consistent (alpha coefficient 0.92-0.93) (
                    <xref ref-type="bibr" rid="ref2">Bridger 
                        <italic toggle="yes">et al.</italic>, 2013</xref>). Quality of life will be assessed by the short-form health survey 36 (SF-36) (
                    <xref ref-type="bibr" rid="ref35">Ware &amp; Sherbourne, 1992</xref>). The SF-36 consists of 36 questions addressing physical performance, social functioning, mental health and perceived health. A higher score corresponds with a better health condition. The internal consistency is measured at a Cronbach&#x2019;s alpha score 0.71 to 0.93 (
                    <xref ref-type="bibr" rid="ref33">Vander Zee 
                        <italic toggle="yes">et al.</italic>, 1996</xref>). The recollection of patients&#x2019; of their ICU stay will be evaluated by the ICU memory tool; consisting of fourteen questions about factual and delusional memories, amnesic periods and quality of the memories. The ICU memory tool is internally consistent with Cronbach&#x2019;s alpha measured at 0.86 (
                    <xref ref-type="bibr" rid="ref12">Jones 
                        <italic toggle="yes">et al.,</italic> 2000</xref>). To assess the appreciation of the diary a questionnaire is developed on how participants used the diary and how they valued it. The questionnaire consists of one question on how many times the diary is used, three questions, using a 5-point Likert scale, addressing if the diary aided in processing the admission and if it helped to clarify memories and one open-ended question for comments on the diary.</p>
                <p>The five questionnaires (PSIT, CFQ, SF-36, ICU memory tool and the value questionnaire) will also be sent, digitally or on paper, to patients who do not wish to visit the ICU aftercare clinic but do want to participate in this research.</p>
                <p>Three months after the initial testing the patient and their relative will receive the questionnaires, by mail or e-mail, a second time. See 
                    <xref ref-type="fig" rid="f1">Figure 1</xref> for the study timeline.</p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>Figure 1. </label>
                    <caption>
                        <title>Study timeline.</title>
                        <p>PSIT: psychosocial screening instrument adult trauma patients, CFQ: Cognitive Failure Questionnaire, SF36: short-form health survey-36, ICU: intensive care unit.</p>
                    </caption>
                    <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/133724/82cadedc-4b3c-4a74-82ad-230ac20d798e_figure1.gif"/>
                </fig>
                <p>The following patient characteristics are recorded: gender, age, medical history, duration of SARS-CoV-2 symptoms, number of days between first day of illness and ICU admission, total duration of hospital stay, duration of ICU stay, use of muscular blocking agents and complications, deceased relatives.</p>
                <p>The following characteristics are recorded for each selected relative: gender, age, relationship with patient, history of SARS-CoV-2 infection, number of times family member visited the patient, whether or not the family member wrote in the diary.</p>
            </sec>
            <sec id="sec9">
                <title>Statistical analysis</title>
                <p>
                    <italic toggle="yes">Data processing, statistical analyses and power calculation</italic>
                </p>
                <p>Due to the nature of the study, no official power calculation was done. The study of 
                    <xref ref-type="bibr" rid="ref22">Nanwani-Nanwani 
                        <italic toggle="yes">et al.</italic> (2022)</xref> showed a higher prevalence of PICS in mechanically ventilated SARS-CoV-2 patients compared to the regular ICU population (
                    <xref ref-type="bibr" rid="ref21">Mikkelsen 
                        <italic toggle="yes">et al.</italic>, 2020</xref>); respectively 75% versus 64%. When considering the possible effect of ICU diaries on PICS in SARS-CoV-2 patients no data are published to date. In an earlier single center study of (
                    <xref ref-type="bibr" rid="ref17">Kredentser 
                        <italic toggle="yes">et al.</italic>, 2018</xref>), who included 58 regular ICU patients, patients with ICU diaries had significantly lower psychological PICS symptoms. Based on previous studies, the prevalence of PICS, which is higher in the SARS-CoV-2 population, and considering the follow-up time of six months we aim to include 50 patients (and their relatives). Considering 10% loss to follow-up 55 patients will be recruited for this study.</p>
                <p>Normally distributed variables will be presented as mean and standard deviation (SD). Categorical variables will be presented as frequency with percentages. The quantitative data of the PSIT, CFQ, SF-36 will be compared over time in patients and in their relatives. Participants&#x2019; characteristics including if they received a diary, how they valued it and the memory recollection of ICU treatment will be reported. Multiple logistic regression analysis will be performed for analyzing the relation between mental health outcome and the use of ICU diaries in patients as well as their relatives. Change in PICS symptoms over time will be analyzed using longitudinal data analysis. Missing value analysis will be performed on missing data. Missing items in questionnaires will be addressed using multiple item imputation when necessary.</p>
                <p>Demographic data will be extracted from the electronic patient file. Questionnaire data will be processed anonymously: outcomes of the questionnaire are coded, transcribed and analysed in data management software.</p>
                <p>Partial result of participants who are lost during follow-up, will only be used in analysis of the first period. The number of missing data and participants lost to follow-up will be reported.</p>
                <p>P-values of p&lt;0.05 are considered statistically significant. Statistical Package for Social Sciences (SPSS, Chicago, IL, USA Version 27.0) (RRID:SCR_002865) will be used for data management and statistical analysis.</p>
            </sec>
            <sec id="sec10">
                <title>Ethics and dissemination</title>
                <p>The medical ethics committee (MEC) of the Elisabeth-Tweesteden Hospital, part of the MEC of Brabant, the Netherlands approved the study (NW2021-68). The insights from this study will be used for the awareness of psychological PICS(-F) complaints and the development of prevention tools and aftercare for post-ICU Sars-CoV-2 patients. The results of the study will be published in a peer-reviewed journal.</p>
            </sec>
            <sec id="sec11">
                <title>Study status</title>
                <p>In May 2022 the first participants have received their follow-up questionnaires. More participants are being included.</p>
            </sec>
        </sec>
        <sec id="sec12" sec-type="discussion">
            <title>Discussion</title>
            <p>Post-intensive care syndrome has gained more attention in the recent years. Intensivists are aware of the importance of reducing the physical, psychological and cognitive consequences of an ICU admission. However, more research is needed on how to prevent these consequences. One promising tool, the ICU diary, has shown different results in the reduction or prevention of mental health problems in recent studies (
                <xref ref-type="bibr" rid="ref9">Garrouste-Orgeas 
                    <italic toggle="yes">et al.</italic>, 2019</xref>; 
                <xref ref-type="bibr" rid="ref20">McIlroy 
                    <italic toggle="yes">et al.,</italic> 2019</xref>). With the SARS-CoV-2 virus the world faces a new challenge, with known and unknown consequences. Due to the need of long sedation and mechanical ventilation the risk of developing PICS is expected to be higher in this group (
                <xref ref-type="bibr" rid="ref1">Bhatraju 
                    <italic toggle="yes">et al.,</italic> 2020</xref>). Due to impaired memory, possibly accompanied by hallucinations or delusions, in post-ICU patients and limited visits for family, both patients and their families could benefit from an ICU diary to help complete the fragmented illness narrative (
                <xref ref-type="bibr" rid="ref7">Egerod &amp; Christensen, 2010</xref>; 
                <xref ref-type="bibr" rid="ref6">Egerod &amp; Bagger, 2010</xref>; 
                <xref ref-type="bibr" rid="ref8">Egerod 
                    <italic toggle="yes">et al.,</italic> 2011</xref>; 
                <xref ref-type="bibr" rid="ref26">O&#x2019;Gara &amp; Pattison, 2016</xref>; 
                <xref ref-type="bibr" rid="ref28">Pattison 
                    <italic toggle="yes">et al.,</italic> 2019</xref>). This protocol outlines a study which will provide insight on the psychological problems of post-ICU SARS-CoV-2 patients and the possible effect of an ICU diary on PICS.</p>
            <p>However, some limitations are worth mentioning. This study screens for anxiety, depression, PTSD, cognitive dysfunction, quality of life and memories by using different validated tools. Anxiety, depression and PTSD is screened using the psychosocial screening instrument for adult trauma patient (PSIT). The PSIT is a validated tool for adult trauma patients. Because of the similarities with ICU-patients, it is expected this tool is also applicable to ICU-patients, however this has not yet been validated in these patients. The psychological problems of patients and their family are investigated; however, it is important to realise different variables affect the mental health. For example, if a relative or friend has passed away due to SARS-CoV-2 this has an additional impact on the patient, it is not possible to adjust for these circumstances in the analysis of the data. If a patient has passed away, the family member will be excluded from the study. Not every diary is the same, as it is written by different members of the ICU staff and some have additional comments from family members. A content analysis is needed to elucidate the most helpful or important parts of a diary. As patients can choose whether or not to participate in the research, this may cause a selection bias. An attempt to minimize this bias has been to include patients who do not wish to visit the ICU-aftercare clinic but do want to participate.</p>
        </sec>
        <sec id="sec13" sec-type="conclusions">
            <title>Conclusions</title>
            <p>In conclusion, this study protocol contributes to the limited research on ICU diaries and this study pioneers on the psychological problems of post-ICU SARS-CoV-2 patients. The results of this study are expected to show the importance of ICU diaries for the prevention of psychological problems in this group.</p>
        </sec>
        <sec id="sec14">
            <title>Data availability</title>
            <p>No data are associated with this article.</p>
        </sec>
    </body>
    <back>
        <ack>
            <title>Acknowledgements</title>
            <p>This study was presented as an E-Poster at the European Society of Intensive Care Medicine (ESICM) &#x2013; LIVES Digital conference 6-9 December 2020. The abstract was published in the conference proceedings:</p>
            <p>Rutjes-Weurding L, Pouwels S, Oomen M, Op &#x2018;t Hoog SAJJ, Prins-Smulders M, van Slobbe C, Marijnissen-de Jong R, Ramnarain D. The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study. ESICM &#x2013; LIVES Digital, 33rd Annual Congress, 6-9 December 2020.</p>
        </ack>
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