Interrelationships Among Inflammation, Physical Symptoms, Mental Symptoms and Quality of Life in Subjects With Chronic Inflammatory Physical Diseases.

Assessment of atopic dermatitis

时间窗: At recruitment (T0)

Severity of atopic dermatitis will be assessed by means of the Eczema Area and Severity Index (EASI). It evaluates four body regions: head/neck, trunk, upper and lower extremities. Each of them is separately assessed for erythema (redness), induration/papulation/edema (thickness), excoriation (scratching), and lichenification. The average degree of severity of each sign in each regions is scored from 0 to 3. Symptoms (e.g. pruritus) and secondary signs (e.g. xerosis, scaling) are excluded from the area assessments. For each region, the clinician evaluates the intensity for each of the four signs and calculates the severity score. For each region, the severity score is multiplied by the area score and by a multiplier, that is different for each body site. The final EASI score is the sum of total scores of the four regions. The minimum EASI score is 0, the maximum is 72.

The Hospital Anxiety and Depression

时间窗: At recruitment (T0)

The Hospital Anxiety and Depression Scale (HADS), a tool designed to assess anxiety and depression in physically ill patients, will be used. It is a 14-item self-assessment scale including two subscales, respectively composed by seven items measuring anxiety and seven measuring depression. Responses are scored from 0 to 3, with subscale total scores ranging from 0 to 21 points (score ranges for severity: 0-7 = normal; 8-10 = mild; 11-14 = moderate; 15-21 = severe).

Global Physical Assessments: Patient Global Assessment

时间窗: At recruitment (T0)

The Patient Global Assessment Visual-Analogic Scale, a self-administered scale, will be used to evaluate how physical condition is considered subjectively from the patient. The scale consist of a simple, single item (with no subscale) that measures the overall impact of the disease on the global health of the patient at a specific point in time. It is scored using a visual analogue scale (VAS), anchored on an unnumbered 10-cm horizontal line. Higher scores represent a higher level of disease activity and a worse global health. The proposed definition of "low global assessment" is ≤2.0 (scale 0-10).

Global Physical Assessments: severity of physical diseases

时间窗: At recruitment (T0)

The assessment of the severity of physical diseases will be performed using the Modified Cumulative Illness Rating Scale (CIRS). It includes elements related to 13 clinical areas: heart; hypertension; circulation; respiratory system; head and neck; upper digestive tract; lower digestive tract; liver; kidney; genitourinary system; musculoskeletal and integumentary systems; nervous system and endocrine-metabolic system. For each system, in case two or more pathologies are present, only the one with the greatest clinical impact or associated with the greatest disability will be scored; each score ranges from 0 (the system is not affected by any pathology,) to 4 (very serious pathology and/or need for urgent treatment and/or organ failure and/or severe functional disability). The scale will generate four scores: total score, number of affected systems, severity index (total score/number of affected systems) and number of affected systems with scores of 4-5 (serious or extremely serious).

Assessment of quality of life

时间窗: At recruitment (T0)

The 12-Item Short Form Health Survey (SF-12), a brief, self-administered questionnaire, will assess health-related quality of life, including eight domains: physical functioning, role limitations due to physical health, pain, general health, vitality (energy/fatigue), social functioning, role limitations due to mental health. Items are rated on a dichotomous or a Likert scale. The score of each dimension is computed and transformed into a scale from zero (worst health) to 100 (best health). The 8 scales can be summarized into a mental component summary (MCS) score and a physical component summary (PCS) score, that are expressed as T-scores.

Stigma

时间窗: At recruitment (T0)

The Stigma Scale for Chronic Illness-8 (SSCI-8) will be used to assess internalized stigma (patient feelings and thoughts concerning his/her condition) and externalized stigma (instances of actual discrimination related to the disease) related to chronic diseases.

Plasma levels of TNF-α

时间窗: At recruitment (T0)

Plasma concentration of TNF-α will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

Socio-demographic Data

时间窗: At recruitment (T0)

A clinical form will be filled in to collect socio-demographic and clinical data such as age, education level, marital status, employment, age of onset and treatments.

Assessment of hidradenitis suppurativa

时间窗: At recruitment (T0)

Severity of hidradenitis suppurativa will be evaluated by using the Hurley staging system. It classifies patients into three stages: I, single or multiple abscesses without sinus tracts and cicatrization; II, single or multiple, recurrent, widely separated abscesses with tract formation and cicatrization; III, diffuse involvement, or multiple interconnected tracts.

Lifetime psychiatric comorbidity

时间窗: At recruitment (T0)

The Mini International Neuropsychiatric Interview-Plus (MINI-PLUS) will be administered to all subjects to assess lifetime comorbidity with Axis I psychiatric disorders.

Assessment of psoriasis

时间窗: At recruitment (T0)

The Psoriasis Area and Severity Index (PASI) will be used to assess the severity of psoriasis. According to this tool, psoriatic plaques are graded based on three criteria: redness, thickness, and scaliness. Severity is rated for each index on a 0-4 scale (0 for no involvement up to 4 for severe involvement). The body is divided into four regions comprising head, upper extremities, trunk, and lower extremities. In each of these areas, the fraction of total surface area affected is graded on a 0-6 scale (0 for no involvement, 6 for greater than 90% involvement). Various body regions are weighted to reflect their respective proportion of body surface area (BSA). The composite PASI score can then be calculated by multiplying the sum of the individual-severity scores for each region by the weighted area-of-involvement score for that respective region, and then summing the four resulting values. The highest potential PASI score is 72; the lowest is 0.

Assessment of Fibrogen levels

时间窗: At recruitment (T0)

Fibrinogen levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

Assessment of white blood cells levels

时间窗: At recruitment (T0)

White blood cells (WBC) levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

Assessment of PLT levels

时间窗: At recruitment (T0)

PLT levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

Markers of subclinical inflammatory damage: assessment of bone quality

时间窗: At recruitment (T0)

Markers of bone quality will be evaluated by means of Bone quantitative ultrasound (QUS), a technique based on high frequency sound waves generated by the device to determine bone health status. T-scores and Z-scores will be calculated.

Global Physical Assessments: Physician Assessment

时间窗: At recruitment (T0)

The global severity of the physical diseases listed in the inclusion criteria will be assessed using the Physician Global Assessment Visual-Analogic Scale, a scale administered by the clinician. This scale consist of a simple, single item (with no subscale) that measures the overall impact of the disease on the global health of the patient at a specific point in time as evaluated by the physician. It is scored using a visual analogue scale (VAS), anchored on an unnumbered 10-cm horizontal line. Higher scores represent a higher level of disease activity and a worse global health. The proposed definition of "low global assessment" is ≤2.0 (scale 0-10).

Plasma levels of ICAM-1

时间窗: At recruitment (T0)

Plasma concentration of ICAM-1 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

Neurocognitive domains

时间窗: At recruitment (T0)

Neurocognition will be evaluated by means of the Cambridge Neuropsychological Test Automated Battery (CANTAB), a computer-based cognitive assessment system. It consists of a battery of neuropsychological tests that can be administered via an iPad.

Plasma levels of IL-1α

时间窗: At recruitment (T0)

Plasma concentration of IL-1α will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

Markers of subclinical inflammatory damage: assessment of subclinical endothelial damage

时间窗: At recruitment (T0)

To assess markers of subclinical endothelial damage, an Ultrasonography of the epi-aortic vessels will be performed by using a power colour-Doppler instrument with 7.5 MHz probes. Characteristics of the intima will be evaluated. A minimum of three measurements will be collected on the common carotid artery (1 cm before the carotid bifurcation and at carotid bifurcation) and on the internal carotid (1 cm after the carotid bifurcation and 2 cm after the carotid bifurcation). An intima-media thickness (IMT) of \>1 mm will be considered to be pathological. Atherosclerotic plaques, if present, will be described. All images will be photographed and properly archived.

Assessment of hs-CRP levels

时间窗: At recruitment (T0)

Levels of a high-sensitivity C-reactive protein (hs-CRP) will be assessed through plasma analysis in the clinical and molecular laboratory services of the University Hospital.

Anxiety

时间窗: At recruitment (T0)

The Hamilton Anxiety Rating Scale (HAM-A), a clinician-administered rating scale of 14 items, will be used to measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score ranging from 0 to 56 (score ranges for severity of anxiety: \<17 = mild; 18-24 = mild to moderate; \>25 = moderate to severe).

Depression

时间窗: At recruitment (T0)

The Hamilton Depression Rating Scale (HAM-D-17) will be used to assess severity of depressive symptoms. It is a clinician-administered rating scale including 17 items pertaining to symptoms of depression experienced over the past week. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe, while the remaining nine items are scored from 0 to 2. Sum of item scores ranges from 0 to 50 (score ranges for severity of depression: 0-7 = absent; 8-13 = mild; 14-18 = moderate; 19-22 = severe; ≥ 23 = very severe).

Assessment of disability

时间窗: At recruitment (T0)

The World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS-II) will be used to assess disability. It is a 36-item self-administered questionnaire on health-related difficulties experienced in the previous month. The instrument evaluates six domains: communication, mobility, self-care, getting along with people, life activities (divided into household and work) and participation in society. Answers are rated on a 5-point scale, from "no difficulties" to "cannot do the activity". Total and subscale scores are calculated, with higher scores reflecting greater disability.

Coping skills

时间窗: At recruitment (T0)

Coping skills will be assessed using the Coping Orientation to Problems Experienced inventory - Brief (Brief-COPE) including 28 items and 14 subscales: positive reframing, self-distraction, expression, use of instrumental support, active coping, denial, religion, humor, behavioral disengagement, use of emotional support, substance use, acceptance, planning, self-blame. Sum of item scores ranges from 28 to 112.

Plasma levels of IL-6

时间窗: At recruitment (T0)

Plasma concentration of IL-6 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

Plasma levels of VCAM-1

时间窗: At recruitment (T0)

Plasma concentration of VCAM-1 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

Assessment of D-dimers levels

时间窗: At recruitment (T0)

D-dimers will be assessed in the clinical and molecular laboratory services of the University Hospital.

Assessment CD4 and CD8

时间窗: At recruitment (T0)

Levels of CD4 and CD8 will be assessed by calculating the CD4/CD8 ratio through plasma analysis in the clinical and molecular laboratory services of the University Hospital.