key: cord-1008513-jowp0hb2 authors: De Maria, Maddalena; Ferro, Federico; Ausili, Davide; Alvaro, Rosaria; De Marinis, Maria Grazia; Di Mauro, Stefania; Matarese, Maria; Vellone, Ercole title: Development and Psychometric Testing of the Self-Care in COVID-19 (SCOVID) Scale, an Instrument for Measuring Self-Care in the COVID-19 Pandemic date: 2020-10-26 journal: Int J Environ Res Public Health DOI: 10.3390/ijerph17217834 sha: a4843c4de5148fd876c53cfc4ac131ee0bd6b422 doc_id: 1008513 cord_uid: jowp0hb2 Aim: To develop the Self-Care in COVID-19 (SCOVID) scale and to test its psychometric characteristics in the general population. Methods: We tested SCOVID scale content validity with 19 experts. For factorial and construct validity, reliability, and measurement error, we administered the 20-item SCOVID scale to a sample of 461 Italians in May/June 2020 (mean age: 48.8, SD ± 15.8). Results: SCOVID scale item content validity ranged between 0.85–1.00, and the total scale content validity was 0.94. Confirmatory factor analysis supported SCOVID scale factorial validity (comparative fit index = 0.91; root mean square error of approximation = 0.05). Construct validity was supported by significant correlations with other instrument scores measuring self-efficacy, positivity, quality of life, anxiety, and depression. Reliability estimates were good with factor score determinacy, composite reliability, global reliability index, Cronbach’s alpha, and test-retest reliability ranging between 0.71–0.91. The standard error of measurement was adequate. Conclusions: The SCOVID scale is a new instrument measuring self-care in the COVID-19 pandemic with adequate validity and reliability. The SCOVID scale can be used in practice and research for assessing self-care in the COVID-19 pandemic to preventing COVID-19 infection and maintaining wellbeing in the general population. The COVID-19 pandemic, caused by the Sars-Cov-2 virus, has profoundly affected the lives of the global population. As of 18 October 2020, over 40 million people were affected by COVID-19, and 1100 million deaths were recorded worldwide [1] . According to the current evidence, the Sars-Cov-2 is transmitted by direct contact with infected individuals through respiratory droplets and by indirect contact through the transfer of the virus from contaminated hands or surfaces to the mouth, nose, or eyes [2, 3] . Infected droplets can also be spread by asymptomatic subjects [3] , making epidemic containment more challenging [4] . We developed and tested the SCOVID scale in a three-phase process, described in the following workflow ( Figure 1 ). (a) First Phase: Development of the SCOVID Scale Items: In this phase, we reviewed the literature [13] and recommendations issued by national and international organizations (WHO, CDC, ECDC) addressed to the general population [5] [6] [7] , and we identified 20 potential items complying with our definition of self-care in the COVID-19 pandemic. These items were grouped in the pre-identified self-care dimensions, as follows: "individual protective measures", four items; "social distancing", four items; "environmental disinfection", three items; "psychological wellbeing", five items; and "healthy lifestyle", four items. To each item, we assigned a 5-point Likert scale for responses indicating the frequency of the behavior from 1 (never) to 5 (always). (b) Second Phase: Content Validity of the SCOVID Scale Items: For content validity, we followed the standards proposed by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) [14] . We selected a panel of 19 experts possessing expertise both in public health and in self-care. Through a Delphi survey, we asked experts to rate the relevance of each item in measuring the construct of self-care in the COVID-19 pandemic. Experts could rate each item on a 4-point Likert scale from 1 ("completely irrelevant") to 4 ("completely relevant"). To assess comprehensiveness, we asked the experts to propose other items as well that they thought could describe remaining aspects of the construct of COVID-19 self-care not included in the items listed. After, we conducted cognitive interviews with a purposive sample of 20 individuals (mean age 47.3, SD ± 19.5, 60% were female, 55% had ≤8 years education) representing the general population to establish the comprehensibility of the items, instructions, and score response and to check if the intended meaning of each item was understood; further, we asked for suggestions regarding other behaviors performed by the participants to prevent COVID-19 and guarantee their wellbeing. (c) Third Phase: Testing of the SCOVID Scale: To test the scale factorial and construct validity and reliability, we administered the SCOVID scale to a quota sample representative of the general Italian adult population stratified by age and gender according to the Italian Institute of Statistics (ISTAT) in 2019. We adopted the following inclusion criteria to select participants for testing: (1) aged 18-80 years old; (2) comprehension of the Italian language, and: (3) living in Italy during the epidemic period. We excluded healthcare workers and people already infected by the Sars-Cov-2 from the study because the first sub-population is presumed to have more knowledge of COVID-19, and the second is more interested in performing behaviors to manage the disease. We administered the SCOVID scale in May/June 2020 during the so-called "phase two" of the Italian COVID-19 pandemic, which included the reopening of many commercial and job activities along with strong recommendations related to COVID-19 prevention (e.g., frequent hand hygiene). We collected data through an electronic questionnaire created with Google Modules ® (Google, LLC; Mountain View, CA, USA); about 10 min were required for administration. In case participants were not able to complete the Google Modules ® , we administered the SCOVID scale by telephone in about a 15-minute call. For test-retest reliability, we administered the scale a second time after two weeks in a subsample of 100 participants [15] . In this phase, we reviewed the literature [13] and recommendations issued by national and international organizations (WHO, CDC, ECDC) addressed to the general population [5] [6] [7] , and we identified 20 potential items complying with our definition of self-care in the COVID-19 pandemic. These items were grouped in the pre-identified self-care dimensions, as follows: "individual protective measures", four items; "social distancing", four items; "environmental disinfection", three items; "psychological wellbeing", five items; and "healthy lifestyle", four items. To each item, we Factorial and construct validity were assessed through confirmatory factor analysis (CFA) and hypothesis testing, respectively. Since literature reports that people performing better self-care have better self-efficacy [16] , greater positivity [17] and quality of life [18] , and lower anxiety [19] and depression [20] , we administered the following instruments in association with the SCOVID scale for hypothesis testing. The General Self-Efficacy (GSE) scale [21] is an eight-item instrument that assesses self-efficacy in life in the general population. The total GSE scale score ranges from 1-5, with higher scores indicating higher self-efficacy. The Positivity scale [22] is an eight-item instrument that evaluates people's positivity in life. The Positivity scale's scores range between 1 and 5, with a higher score meaning higher positivity. The Short Form 36 Health Survey (SF-36) [23] is a 36-item generic instrument that evaluates quality of life in eight dimensions. Each dimension has a possible score of 0-100, with a higher score indicating a better quality of life. The General Anxiety Disorder-7 (GAD-7) [24] is a seven-item scale that assesses anxiety in the general population. Scores can range from 0-21, where higher scores designate greater anxiety. The Patient Health Questionnaire-9 (PHQ-9) [25] is a nine-item scale evaluating depressive disorders. The PHQ-9 total score ranges from 0-27, with a higher score indicating greater depression. The SCOVID scale was administered within a study aimed at testing the psychometric characteristics of this scale in the general population during the COVID-19 pandemic. Participants were only asked to respond to the above instruments. The study was approved by an ethical committee of the University of Rome Tor Vergata (letter number: 157.20.) which is composed of an interdisciplinary team, including physicians from several specialties, nurses, lawyers, patient representatives, pharmacologists, a priest, and a statistician. Participants were fully informed about the study's aims and gave their consent. Instruments were all anonymous, and patients were assured about data confidentiality. Also, participants were informed that they could withdraw from the study at any moment without giving a reason. The Content Validity Index (CVI) was used to assess the level of agreement among experts concerning each item's relevance [26] . Experts' responses of "1" (not relevant) and "2" (poor relevant) indicated poor validity and were coded as "0" while responses of "3" (relevant) and "4" (very relevant) were coded as "1" We calculated a mean score of all experts' responses to obtain the CVI per each item (I-CVI), and we calculated the CVI for the entire SCOVID scale (S-CVI). A cut-off of ≥0.78 for I-CVI was used for item retention [26] . In the third phase, we performed data analyses in the following steps. In the first step, we used descriptive statistics to describe the sample sociodemographic characteristics and the responses to the SCOVID scale items. In the second step, we tested the SCOVID scale factorial validity. As the SCOVID scale was based on a theoretical definition of self-care, including five dimensions, we specified these dimensions in the CFA. Additionally, we specified the second-order factor "preventing COVID-19" to include "individual protective measures", "social distancing", and "environmental disinfection". The second-order factor "maintaining wellbeing" included the "psychological wellbeing" and "healthy lifestyle" factors. Because the second-order factors are two dimensions of the entire SCOVID scale, we also specified a third-order factor to include the two second-order factors. As several items slightly violated the normality assumption, we used the robust maximum likelihood (MLR) method for parameter estimation. In the CFA, we used the following goodness-of-fit indices [27] : the Comparative Fit Index (CFI) and Tucker-Lewis Index (TLI), with values of 0.90-0.95 indicating acceptable fit, and values ≥ 0.95 indicating a good model fit; the Root Mean Square Error of Approximation (RMSEA), with values of ≤0.05 or 0.08 indicating a good fit as well as the rejection of the null hypothesis (for p < 0.05) associated with its 90% confidence interval; and the Standardized Root Mean Square Residual (SRMR), with values of 0.08 or less indicating a good fit. Moreover, we used traditional chi-square statistics, which were interpreted together with the above fit indices. In the third step, we tested the construct validity via hypothesis testing by correlating the SCOVID scale scores with those of the other instruments. These correlations were performed with two-tailed Pearson's r. A correlation coefficient ranging between 0.10-0.29 was considered weak, a coefficient ranging between 0.30-0.50 was considered moderate, and a coefficient >0.50 was considered strong [28] . In the third step, we evaluated the SCOVID scale's reliability. Specifically, we computed the factor score determinacy coefficient [29] and the composite reliability [30] for every single first-, second-, and third-order factor as well as the global reliability index for multidimensional scales [31] and Cronbach's alpha for the overall SCOVID scale. All of these reliability estimates should have a value >0.70. Finally, we tested the SCOVID scale test-retest reliability with the intraclass correlation coefficient (ICC) [15] . An ICC value of 0.75 is considered to represent good reliability, and a value greater than 0.90 demonstrates excellent reliability [15] . Finally, to evaluate responsiveness to changes, a measure of instrument precision, we tested the SCOVID scale measurement error using the standard error of measurement (SEM) and the smallest detectable change (SDC). The formula that we used for the SEM was standard deviation (SD) × √ (1 − reliability coefficient) [32] , where the SD was the SD of the SCOVID scale score, and the reliability coefficient was the factor score determinacy coefficient. The SEM identifies a more precise instrument if its value is