Consistency of safety monitoring using routine national databases: results using a quality of care interpretative model.

BACKGROUND: In the framework of targeted action for continuous safety monitoring, we aimed to evaluate the consistency of indicators derived from available databases for regular reporting. METHODS: We used a quality of care interpretative model to select characteristics from five national databases, aggregated and linked by homogeneous groups of providers. The target population included all subjects admitted to public hospitals for acute care in four regions of Italy between 2011 and 2013. The association between structures, processes and safety-related outcomes was investigated using odds ratios from generalized estimating equations logistic regression. Outcome measures included claims of malpractice and five patient safety indicators calculated from discharge abstracts using standardized algorithms. RESULTS: Over 3 years, claims of malpractice and sepsis increased, whereas deep vein thrombosis and pulmonary embolism decreased. Hospitals with high vs. low volume of discharges were associated with -16% lower rates of claims, but +12% increased risk of sepsis. Compared with research institutes, university clinics had -17% lower rates of claims and -41% cases of dehiscence, with a +32% increased risk of deep vein thrombosis. Local health care authorities recorded -49% deep vein thrombosis, -26% pulmonary embolism, -40% sepsis and +37% risk of claims. Hospitals submitting cases of safe practices and implementing safety recommendations showed significantly higher rates for most outcome measures. CONCLUSIONS: Indicators from regular databases can be conveniently used to develop a national safety monitoring system for hospital care. Although deeper analysis is needed, institutions with a higher propensity to implement safe practices and recommendations consistently showed higher rates of adverse events.

Relationship Between Psychosocial Burden of Skin Conditions and Symptoms: Measuring the Attributable Fraction.

Skin conditions often have a severe impact on the physical and psychosocial domains of patients' quality of life, but the relationship between these domains has been studied little. This study estimated the fraction of psychosocial burden that may be attributable to symptoms, using the Skindex-17 quality of life questionnaire (symptoms and psychosocial scales) in 2,487 outpatients. The excess proportion of psychosocial burden for each skin condition was computed. Overall, 79.8% of the psychosocial burden of patients with severe symptoms may be attributable to the symptoms. For patients with mild symptoms this figure is 49.7%. A great heterogeneity was observed, from -0.9% for patients with scars, up to more than 90% for conditions such as lichen planus and psoriasis. While these results will have to be confirmed in longitudinal studies, they seem to indicate that, by targeting specific symptoms, a substantial portion of the psychosocial burden of skin diseases could be spared.

Predictive validity of the Italian parental questionnaire for developmental evaluation at age 4 (QS4-G).

AIM: To examine whether the results at 4 years of age of the developmental questionnaire QS4-G can predict the outcome of cognitive, neuropsychological and academic abilities 4-6 years later. The QS4-G is a validated parental questionnaire designed for the screening and surveillance of the neuropsychological and behavioural developmental status of 4-year-olds (93 questions). METHODS: Longitudinal prospective study on a subsample of the QS4-G validation original sample was conducted. According to previous results, the sample was divided into two groups: 'at risk' and 'not at risk'. Sensitivity, specificity, accuracy and likelihood ratios were assessed and referred to outcomes. RESULTS: Thirty-five children were classified as 'not at risk' and 16 as 'at risk'. There were significant associations between past QS4-G score and cognitive, neuropsychological and academic abilities 4-6 years later. With the same cut-off identified at the first cross-sectional study, sensitivity and specificity for difficulties in cognitive development were 90% and 83% while in the neuropsychological abilities 62% and 90%, respectively. A lower predictive validity was found for difficulties in academic abilities (sensitivity 43%, specificity 86%). QS4-G specific area scores showed significant correlations with related academic tests at follow-up (rho range: 0.404-0.565, P < 0.005). CONCLUSIONS: QS4-G shows good predictive validity for cognitive development and neuropsychological abilities. The risk of false negatives for academic abilities can be reduced by analysing the specific area results of QS4-G, which show good correlations with related tests at follow-up.

Developmental evaluation at age 4: Validity of an Italian parental questionnaire.

AIM: To validate an Italian parental questionnaire designed to evaluate the neuropsychological and behavioural developmental status of 4-year-olds and identify children in need of further evaluation. METHODS: The questionnaire (Questionario per la valutazione dello Sviluppo di bambini a 4 anni - Genitori (QS4-G) ) consisted of 93 questions divided into 10 areas: language, visual-motor abilities, memory/attention, fine and gross motor and self-help abilities, lateralisation, social skills, stress, sleep, alimentation and evacuation. It was distributed to 263 parents of 4-year-olds: 94 healthy preterm (gestational age <33 weeks and/or <1500 g, without major neurosensory damage); 44 children with developmental disorders and 125 children with typical development. Cognitive and neuropsychological evaluations were performed using standardised tests. RESULTS: The internal consistency of the areas was adequate (Cronbach's alpha: 0.69-0.79). The correlation coefficients (r=|0.30|-|0.68|) with standardised tests (Griffiths, Vineland and neuropsychological tests) indicated a good concurrent validity. The receiver operating characteristic curve, for predicting a Griffiths Quotient less than 81, showed an area under the curve of 0.90 and a high diagnostic and discriminatory capacity (sensitivity of 0.88 and specificity of 0.84) for the optimal cut-off (value 48.4). CONCLUSION: The QS4-G seems to be a valid tool for identifying 4-year-old children at risk for low or borderline cognitive development and/or problematic behaviour who need a complete assessment. It can describe individual neuropsychological profiles. QS4-G is not a diagnostic tool. It is useful for outcome studies in preterm children and in other pathologies. It could also be useful for preschooler prevention programmes.

Measuring disability of women with systemic sclerosis: validation of the italian version of the systemic sclerosis questionnaire.

BACKGROUND: The aim of this study was to validate the Italian version of Systemic Sclerosis Questionnaire (SySQ) and to evaluate its psychometric characteristics on a sample of inpatient and outpatient women with systemic sclerosis (SSc). METHODS: Internal and external validity of the Italian version of SySQ were analyzed. Internal validity included: 1) construct validity by means of factor analysis; 2) internal consistency for each category of SySQ through Cronbach's alpha; and 3) reproducibility over time with test-retest using both Pearson's correlation and Intraclass Correlation Coefficient. External validity included: 1) concurrent validity, i.e. correlation with Skindex-17; and 2) discriminant validity, through comparison of scores for different groups of patients. RESULTS: We obtained data on 115 patients with SSc: 68 had the limited clinical form (lSSc) and 47 had the diffuse clinical form (dSSc). The structure of SySQ was confirmed by factor analysis. The questionnaire showed optimal internal consistency for all SySQ categories (Cronbach's alpha >0.84) and very good reproducibility over time (0.79-0.93, P<0.001). Regarding external validity, SySQ showed good correlation with Skindex-17 (P<0.01) and a satisfactory power of discrimination between groups affected by different clinical conditions. CONCLUSIONS: The study confirmed that the SySQ maintains good psychometric properties also in a language different from the original. It is a disease-specific tool that can be routinely used in clinical practice for the evaluation of the level of disability in patients with SSc.

Development and Initial Validation of a Questionnaire to Measure Health-Related Quality of Life of Adults with Common Variable Immune Deficiency: The CVID_QoL Questionnaire.

BACKGROUND: Generic health status quality of life (QoL) instruments have been used in patients with common variable immune deficiency (CVID). However, by their nature, these tools may over- or underestimate the impact of diseases on an individual's QoL. OBJECTIVE: The objective of this study was to develop and validate a questionnaire to measure specific-health-related QoL for adults with CVID (CVID_QoL). METHODS: The 32-item content of the CVID_QoL questionnaire was developed using focus groups and individual patient interviews. Validation studies included 118 adults with CVID who completed Short Form-36, Saint George Respiratory Questionnaire, General Health Questionnaire-12, and EuroQol-5D questionnaire in a single session. Principal component and factor analysis solutions identified 3 scores to be similar in number and content for each solution. Validation of 3 factor scores was performed by construct validity. Reproducibility, reliability, convergent validity, and discriminant validity were evaluated. Matrices consisting of correlations between the 32 items in the CVID_QOL were calculated. RESULTS: Factor analysis identified 3 dimensions: emotional functioning (EF), relational functioning (RF), and gastrointestinal and skin symptoms (GSS). The instrument had good internal consistency (Cronbach's alpha, min. 0.74 for GSS, max. 0.84 for RF, n = 118) and high reproducibility (intraclass correlation coefficient, min. 0.79 for RF, max 0.90 for EF, n = 27). EF and RF scores showed good convergent validity correlating with conceptually similar dimensions of other study scales. Acute and relapsing infections had a significant impact on EF and RF. CONCLUSIONS: This study provides evidence of the reliability and construct validity of the CVID_QoL to identify QoL issues in patients with CVID that may not be addressed by generic instruments.

Factors associated with the prescription of "traditional" or "biological" systemic treatment in psoriasis.

Abstract The choice of an adequate psoriasis treatment is critical to good disease management and to overall patient health. It is estimated that about 20-30% of patients requires systemic treatment: "traditional" (methotrexate, acitretina and cyclosporin) or "biological" (etanercept, adalimumab and infliximab). Clinical records of 784 outpatients with psoriasis were analyzed. 51.5% received traditional treatments and 48.5% a biological treatment. Males were 67.8% of patients. Psoriatic arthritis was observed in 37.3%. Females and younger patients were more likely to receive biological treatments. No differences were observed for Body Mass Index or for presence of comorbidities. Patients with psoriatic arthritis were also more frequently prescribed biological drug treatment. In a multivariate logistic regression model, only the older age-group (≥60 years) had a statistically significant OR (p=0.001) with a reduction of about 80% the likelihood of receiving biological treatment compared to the younger age-group (<40 years). Patients with a PASI score ≥20 and patients with arthritis have a probability to be prescribed biologics about five times higher than the other patients. In conclusion, younger age, psoriatic arthritis and the previous use of systemic drugs are factors associated with the use of biological treatment rather than the traditional systemic drugs.

Longitudinal study on health-related quality of life in a cohort of 96 patients with common variable immune deficiencies.

Health-related quality of life (HRQoL) in common variable immunodeficiency diseases (CVID) was evaluated by different tools, which were mainly used to compare different schedules of immunoglobulins administration in cross-sectional or short-term longitudinal studies. We assessed the HRQoL and psychological status of CVID patients in a longitudinal study over a 6-year period by a generic, non-disease-specific instrument (SF-36), and by a General Health Questionnaire (GHQ-12) for the risk of depression/anxiety. At baseline, 96 patients were enrolled. After 1 year, a second assessment was performed on 92 patients and, after 6 years, a third assessment was performed on 66 patients. Eighteen patients died during the study time. HRQoL was low, with mental health scales less affected than physical scales. A decline in the score on SF-36 scales was observed between the first and the third assessment for the Physical Functioning, Body Pain, General Health, Social Functioning, and Role-Emotional scales. The General Health scale showed a lower score in these patients, when compared to patients with other chronic diseases. Approximately one-third of the patients were at risk of anxiety/depression at all observation times, a percentage that reached two thirds of the patients, considering only the group of females. Over the 6 years of the study, the health condition of 11/66 patients worsened, passing from "GHQ-negative" to "GHQ-positive"; their score on SF-36 scales also decreased. A decrement of one point in each of the Physical Functioning, Vitality, Social Functioning, and Mental Health SF-36 scales increased the risk of developing anxiety/depression from three to five percent. A negative variation of the Physical Functioning score increased the risk of psychological distress. In a survival analysis with dichotomized variables, Physical Functioning scores <50 were associated with a relative risk (RR) of 4.4, whereas Social Functioning scores <37.5 were associated with a RR of 10.0. In our study, it was the clinical condition, as opposed to the different treatment strategies with immunoglobulins, which had a major role on the deterioration of HRQoL. Moreover, in a quality-of-life evaluation, disorders such as anxiety/depression should be assessed, as they yet often go unrecognized. Our results might be helpful in the interpretation of currently available data on quality of life in CVID patients.

Comparison of the performance of four different tools in diagnosing disease-associated anorexia and their relationship with nutritional, functional and clinical outcome measures in hospitalized patients.

BACKGROUND & AIMS: In hospitalized patients, lack of appetite, i.e., disease-associated anorexia, is the main factor determining insufficient food intake and weight loss, which in turn increase morbidity and mortality. Controversies exist on which tool should be preferred when diagnosing anorexia. Aim of the study was to evaluate in hospitalized medical patients, the performance of 4 different tools [i.e., self-assessment of appetite, FAACT-ESPEN score, visual analog scale (VAS), and the Anorexia Questionnaire (AQ)] in assessing disease-associated anorexia and predicting nutritional and clinical variables. MATERIALS AND METHODS: Hospitalized patients consecutively admitted to the Internal Medicine ward at our institution were considered. After informed consent was obtained, patients were asked to self-assess their appetite vs the previous month. The VAS, the FAACT-ESPEN score and the Anorexia Questionnaire were also submitted. Food intake immediately following the interview was recorded. Nutritional (i.e., body weight, height), functional (i.e., handgrip strength) and clinical variables (i.e., length of stay) were registered upon admission and before discharge. RESULTS: We studied 105 patients (74M:31F; 66.2 ± 16.3 yrs). The prevalence of anorexia as assessed by patients' self assessment, FAACT-ESPEN score, and the Anorexia Questionnaire was 23%, 10% and 48%, respectively. VAS did not show any correlation with food intake. Anorexic patients as identified by the self assessment of appetite showed reduced food intake and weaker handgrip strength than non-anorexic. The FAACT-ESPEN score correlated with body weight, food intake and handgrip strength, but was not related with length of stay. Anorexic patients as identified by the Anorexia Questionnaire showed reduced food intake, lower body weight, weaker handgrip strength and longer hospital stay than non-anorexic patients. DISCUSSION: The prevalence of anorexia significantly varies according to the diagnostic tool used. Except for VAS, all the tested tools identify patients with impaired nutritional and functional variables. However, only the Anorexia Questionnaire identifies patients with longer hospital stay. Our results suggest that in clinical practice, modification of appetite reflects different underlying mechanisms whose impacts on clinical outcome measures may differ. Therefore, an ideal anorexia assessment tool does not appear to exist, but it should be chosen according to the outcome measures to be assessed (i.e., Anorexia Questionnaire to predict length of stay).