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      The Collaborative Outcomes study on Health and Functioning during Infection Times in Adults (COH-FIT-Adults): Design and methods of an international online survey targeting physical and mental health effects of the COVID-19 pandemic.

      research-article
      1 , 2 , 3 , * , 4 , 5 , 6
      Journal of Affective Disorders
      Elsevier B.V.
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          Abstract

          Background

          : High-quality comprehensive data on short-/long-term physical/mental health effects of the COVID-19 pandemic are needed.

          Methods

          : The Collaborative Outcomes study on Health and Functioning during Infection Times (COH-FIT) is an international, multi-language (n=30) project involving >220 investigators from 49 countries, endorsed by national/international professional associations. COH-FIT is a multi-wave, on-line anonymous, cross-sectional survey [wave 1: 04/2020 until the end of the pandemic, waves 2/3 starting 6/24 months threreafter] for adults, adolescents (14-17), and children (6-13), utilizing non-probability/snowball and representative sampling. COH-FIT aims to identify non-modifiable/modifiable risk factors/treatment targets to inform prevention/intervention programs to improve social/health outcomes in the general population/vulnerable subgrous during/after COVID-19. In adults, co-primary outcomes are change from pre-COVID-19 to intra-COVID-19 in well-being (WHO-5) and a composite psychopathology P-Factor. Key secondary outcomes are a P-extended factor, global mental and physical health. Secondary outcomes include health-service utilization/functioning, treatment adherence, functioning, symptoms/behaviors/emotions, substance ab-/use, violence.

          Results

          : Starting 04/26/2020, up to 01/27/2021 >120,000 people from 152 countries/six continents have participated. Representative samples of ≥1,000 adults have been collected in 15 countries. Overall, 48.7% had prior physical disorders, 18.0% had prior mental disorders, 17.0% were health care workers, 7.3% were aged ≥65 years, 11.5% were exposed to someone infected with COVID-19, 16.2% had been in quarantine, and 1.1% had been COVID 19-positive.

          Limitations

          : Cross-sectional survey, preponderance of non-representative participants.

          Conclusions

          : Results from COH-FIT will comprehensively quantify the impact of COVID-19, seeking to identify high-risk groups in need for acute and long-term intervention, and inform evidence-based health policies/strategies during this/future pandemics.

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          Most cited references55

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

          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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            A brief measure for assessing generalized anxiety disorder: the GAD-7.

            Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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              The PHQ-9: validity of a brief depression severity measure.

              While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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                Author and article information

                Journal
                J Affect Disord
                J Affect Disord
                Journal of Affective Disorders
                Elsevier B.V.
                0165-0327
                1573-2517
                19 July 2021
                19 July 2021
                Affiliations
                [1 ]Department of Neurosciences, University of Padua, Padua, Italy.
                [2 ]Padua Neurosciences Center, University of Padua, Padua, Italy.
                [3 ]Early Psychosis: Interventions and Clinical-detection (EPIC) Laboratory, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
                [4 ]Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA.
                [5 ]Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
                [6 ]Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany.
                Author notes
                [* ] Corresponding author: Marco Solmi, Neurosciences Department, University of Padua, Italy. Tel.: +39 049 8213831.
                Article
                S0165-0327(21)00727-8
                10.1016/j.jad.2021.07.048
                8288233
                34949568
                c2c1a041-1a33-49a2-84eb-0634109bdfde
                © 2021 Elsevier B.V. All rights reserved.

                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
                : 25 February 2021
                : 11 July 2021
                Categories
                Research Paper

                Clinical Psychology & Psychiatry
                Clinical Psychology & Psychiatry

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