What is the impact of post-COVID-19 syndrome on health-related quality of life and associated factors: a cross-sectional analysis

Study design and study population

NEUROCOVID is an ongoing prospective and monocentric study conducted at the National Institute for Infectious Diseases “L. Spallanzani” IRCCS in Rome, Italy, enrolling patients during the acute phase of COVID-19 and/or during the post-COVID-19 period. The study protocol (NeuroCovid Study, version 2.0, January 08, 2021), approved by the Ethical Committee of the Institute (approval number 265/2021), included four main sub-studies, two of which aimed (1) to assess patients’ neuropsychological profile and (2) to evaluate HRQoL self-reported by the patients. Patients were asked to adhere to one or more specific sub-studies, driven by clinical decision. All the patients with 18 years or older and with documented SARS-CoV-2 infection, ongoing or previous, were considered eligible after having signed a specific informed. Patients with cerebral focal pathologies, major depression in progress, presence of psychosis and other serious psychiatric pathologies, current drug use, opioid treatment, abuse of psychiatric drugs, visual impairment, motor deficit of the dominant hand, mental delay, lack of command of the Italian language and cultural disadvantage were excluded from the study.

Here, we present a cross-sectional analysis including patients referred to our post-COVID-19 outpatient service, with and without prior hospitalization, by considering only their first access, from June 2020 to October 2021, evaluated 3 months after the acute infection and, according to clinical decision, at 6 and 12 months, approximately. Each participant agreed to be enrolled in the second sub-study (HRQoL evaluation), a subgroup in the first one (neuropsychological assessment). Demographic, pharmacological and clinical data, including information on comorbidities (cardiologic, respiratory and neurologic diseases, active malignancies and diabetes), were collected anonymously into an Electronic Case Report Forms (eCRF); subjects were identified by numeric codes only, password protected.

Questionnaires

The psychological instruments used in this study were chosen based on their psychometric properties and ability to measure self-perception of health status and HRQoL [11, 12]. This assessment was carried out through two specific tools SF-36 and EQ-5D, and patients were asked to fill them at each visit. The validated Italian version of both instruments, SF-36 [13] and EQ-5D (available at the EuroQol website http://www.euroqol.org), was administered and Italian normative values reported in earlier studies were used as comparison [13,14,15].

The SF-36 [13, 16] is a self-administered questionnaire containing 36 items which takes about five/ten minutes to be completed; it may be applied to people having many different types of treatment or conditions and in all the different states of health. It is one of the most widely employed generic measures of HRQoL, used to evaluate individual patients, to estimate the cost-effectiveness of a treatment and to monitor and compare the disease burden; in fact, it has been shown to discriminate between subjects with different chronic conditions and between subjects with different severity levels of the same disease [13, 17]. In addition, the Italian version of the SF-36 has demonstrated a high degree of reliability [13]. The SF-36 questionnaire measures mental and physical health by considering eight multi items dimensions, covering functional status, well-being, and overall evaluation of health: items are claimed to detect positive as well as negative states of health. In six of the eight dimensions, patients are asked to rate their responses on three- or six-point scales (box). For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health). The SF-36 comprises eight health scales: physical role functioning (PF, 10 items), role limitations–physical (RP, 4 items), bodily pain (BP, 2 items), general health perceptions (GH, 5 items), vitality (VT, 4 items), social role functioning (SF, 2 items), emotional role functioning (RE, 3 items), and mental health (MH, 5 items). Two core dimensions of health, physical (PH) and mental (MH), can be derived from these eight scales in order to obtain a mental components score (MCS) and a physical components score (PCS). The exact balance between the physical and the mental components and their contributions to the HRQoL is unknown, thus we did not calculate any global score of HRQoL such as the “SF-36 Total/Global/Overall Score”, a measure with poor validity, which is not supported by the SF-36 developers [18].

The EQ-5D [19, 20] was built with the aim of becoming a generic and extremely flexible tool for measuring the self-perception of quality of life, short and easy to use in self-administration. Although recently an expanded five-level version of the EQ-5D instrument (EQ-5D-5L) has become available and was translated for use across countries, the original three-level version of the EQ-5D (EQ-5D-3L), here referred to as EQ-5D, was used for our study. The EQ-5D is made up of two separate sections. The first section asks for a subjective evaluation of five dimensions of health (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression) on three severity level (1. no problems, 2. some problems, 3. extreme limitation). The aggregation of the answers represents the respondent's state of health and allows to highlight the presence/absence of any problems and their intensity. The second section of the EQ-5D includes a self-rating of “your health today” using a visual analogue scale (VAS) graphically represented by a graduated scale ranging from 0 (the worst possible state of health) to 100 (the best possible health state) on which the interview indicates their perceived level of health. For the present study, we considered only the VAS score of the EQ-5D (EQ-VAS) with showed a moderate level of reliability in our country [21].

Neuropsychiatric symptom assessment

In a subgroup of patients enrolled in the sub-study consisting of a complete neuropsychological assessment, the Beck Anxiety Inventory (BAI), the Beck Depression Inventory (BDI II) and the Pittsburgh Sleep Quality Index (PSQI) were administered in order to assess the presence of anxiety and depressive symptoms and sleep disorders, respectively.

The BAI is a self-report tool that allows to assess the severity of anxiety symptoms in adults, through a questionnaire of 21 items (descriptions of symptoms of somatic, subjective or phobia-related anxiety), to be evaluated on a four-point scale (from 0 to 3). Scores > 85% indicates the presence of pathological symptoms (85–90 condition of anxiety bordering on pathological aspects; 91–95 anxiety condition that causes discomfort and difficulty for the subject; > 95 particularly alarmed reaction index for the subject) [22, 23]. The BDI-II is a self-report tool that allows to assess the presence and intensity of symptoms correlated to depression. This test of 21 items returns a total score and two other scores relating to somatic-affective area (which concerns the somatic-affective manifestations of depression such as loss of interest, loss of energy, changes in sleep and appetite, shaking and crying) and to cognitive area (which concerns cognitive manifestations such as pessimism, guilt, self-criticism). Scores > 85% indicates the presence of pathological symptoms (85–90 condition of dysphoria bordering on pathological aspects; 91–95 condition of dysphoria that causes discomfort and difficulty for the subject; > 95 particularly alarmed reaction index for the subject) [24, 25]. The PSQI is a self-assessment scale consisting of 19 items, grouped into 7 composite items, evaluated on a scale from 0 to 3, which give the overall score of the PSQI, ranging from 0 to 21. These 7 composite items represent subjective quality of sleep, sleep latency, sleep duration, habitual sleep efficacy, sleep disturbances, hypnotic drug use, and disturbances during the day. If score > 5 indicates the presence of poor sleep quality [26].

The Italian version of the BAI, BDI-II and PSQI showed an overall good reliability, indicating a high degree of internal consistency [23, 25, 26].

Statistical analyses

Descriptive characteristics were provided using medians and interquartile ranges (IQR) for continuous variables, and frequencies and percentages for categorical variables. Student’s T-test was employed to compare SF-36 and EQ-VAS mean scores to the normative values, and a linear regression was used to assess for the presence of a trend over time by month of evaluation after the acute infection (continuous measure in month). Finally, two different linear regression models were fitted. The first one was built using as dependent variable, scores in SF-36 (splitted in PCS and MCS) and in EQ-VAS, and as covariates, demographic, clinical and therapeutic variables, including distance from the acute infection. This association was studied in both uni- and multivariable analyses. In the subgroup of patients with neuropsychiatric symptoms’ evaluation, linear regression, was used in order to explore the correlation between alterations in BAI, BDI II, and PSQI, with the perception of PH and MH status and HRQoL. A statistically significant difference in the variables tested was indicated as p-value < 0.05 (two-sided). Statistical analysis was performed using STATA 15.1 software.

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