Methodological issues on the use of administrative data in healthcare research: the case of heart failure hospitalizations in Lombardy region, 2000 to 2012.

BACKGROUND: Administrative data are increasingly used in healthcare research. However, in order to avoid biases, their use requires careful study planning. This paper describes the methodological principles and criteria used in a study on epidemiology, outcomes and process of care of patients hospitalized for heart failure (HF) in the largest Italian Region, from 2000 to 2012. METHODS: Data were extracted from the administrative data warehouse of the healthcare system of Lombardy, Italy. Hospital discharge forms with HF-related diagnosis codes were the basis for identifying HF hospitalizations as clinical events, or episodes. In patients experiencing at least one HF event, hospitalizations for any cause, outpatient services utilization, and drug prescriptions were also analyzed. RESULTS: Seven hundred one thousand, seven hundred one heart failure events involving 371,766 patients were recorded from 2000 to 2012. Once all the healthcare services provided to these patients after the first HF event had been joined together, the study database totalled about 91 million records. Principles, criteria and tips utilized in order to minimize errors and characterize some relevant subgroups are described. CONCLUSIONS: The methodology of this study could represent the basis for future research and could be applied in similar studies concerning epidemiology, trend analysis, and healthcare resources utilization.

Home-based telesurveillance program in chronic heart failure: effects on clinical status and implications for 1-year prognosis.

BACKGROUND: Studies focusing on the effects of telemanagement programs for chronic heart failure (CHF) on functional status are lacking, and the prognostic value of the clinical response to the programs is unknown. In the Lombardy region of Italy, a home-based telesurveillance program (HTP) including multidisciplinary management and remote telemonitoring for patients with CHF was introduced in 2000 and was formally adopted, as part of the services delivered by the regional healthcare system, in 2006. This article reports the effect of the HTP on the functional status and quality of life and describes the main outcomes observed within 1 year from the end of the program. MATERIALS AND METHODS: Six-month variations of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), 6-min walking distance (6MWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score were evaluated in 602 CHF patients. Patients showing at least two of the following conditions-NYHA class reduction, increase in LVEF ≥5%, 6MWD >30 m, and a reduction of >24 points of MLHFQ-were defined as "responders." One-year events included unplanned cardiovascular readmissions and mortality. RESULTS: A significant improvement in NYHA class, LVEF, 6MWD, and MLHFQ was observed. Clinical events occurred in 24.1% of non-responders and in 15.9% of responders (p=0.03). An unfavorable response to the program, the presence of an implantable cardioverter defibrillator, and multiple comorbidities were predictors of poor outcome. CONCLUSIONS: The HTP was effective in improving CHF patient functional status, and an unsuccessful response to the intervention seems to be an independent marker of poor prognosis.

Trends in heart failure hospitalizations, patient characteristics, in-hospital and 1-year mortality: A population study, from 2000 to 2012 in Lombardy.

BACKGROUND: This study was undertaken to evaluate trends in heat failure hospitalizations (HFHs) and 1-year mortality of HFH in Lombardy, the largest Italian region, from 2000 to 2012. METHODS: Hospital discharge forms with HF-related ICD-9 CM codes collected from 2000 to 2012 by the regional healthcare service (n=699797 in 370538 adult patients), were analyzed with respect to in-hospital and 1-year mortality; Group (G) 1 included most acute HF episodes with primary cardiac diagnosis (70%); G2 included cardiomyopathies without acute HF codes (17%); and G3 included non-cardiac conditions with HF as secondary diagnosis (13%). Patients experiencing their first HFH since 2005 were analyzed as incident cases (n=216782). RESULTS: Annual HFHs number (mean 53830) and in-hospital mortality (9.4%) did not change over the years, the latter being associated with increasing age (p<0.0001) and diagnosis Group (G1 9.1%, G2 5.6%, G3 15.9%, p<0.0001). Incidence of new cases decreased over the years (3.62 [CI 3.58-3.67] in 2005 to 3.13 [CI 3.09-3.17] in 2012, per 1000 adult inhabitants/year, p<0.0001), with an increasing proportion of patients aged ≥85y (22.3% to 31.4%, p<0.0001). Mortality lowered over time in <75y incident cases, both in-hospital (5.15% to 4.36%, p<0.0001) and at 1-year (14.8% to 12.9%, p=0.0006). CONCLUSIONS: The overall burden and mortality of HFH appear stable for more than a decade. However, from 2005 to 2012, there was a reduction of new, incident cases, with increasing age at first hospitalization. Meanwhile, both in-hospital and 1-year mortality decreased in patients aged <75y, possibly due to improved prevention and treatment.

Regional right ventricular dysfunction in acute pulmonary embolism and right ventricular infarction.

BACKGROUND: A normally contracting right ventricular apex associated to a severe hypokinesia of the mid-free wall ('McConnell sign') has been considered a distinct echocardiographic pattern of acute pulmonary embolism. OBJECTIVE: To evaluate the clinical utility of the 'McConnell sign' in the bedside diagnostic work-up of patients presenting to the Emergency Department with an acute right ventricular dysfunction due to pulmonary embolism or right ventricular infarction. DESIGN: Among 201 patients, consecutively selected from our clinical database and diagnosed as having massive or submassive pulmonary embolism or right ventricular infarction, 161 were suitable for an echocardiographic review of regional right ventricular contraction and were included in the study. There were 107 cases with pulmonary embolism (group 1) and 54 cases with right ventricular infarction (group 2). All echocardiographic studies were randomly examined by two experienced and independent echocardiographers, blinded to the patient diagnosis and without Doppler informations. RESULTS: The McConnell sign was detected in 75 of 107 patients in group 1 (70%) and in 36 of 54 patients in group 2 (67%); the finding was absent in 32 cases in group 1 and in 18 cases in group 2 (P=0.657). The sensitivity, specificity, positive and negative predictive values of the McConnell sign for the diagnosis of pulmonary embolism were respectively 70, 33, 67 and 36%. CONCLUSIONS: In a clinical setting of patients with acute right ventricular dysfunction the McConnell sign cannot be considered a specific marker of pulmonary embolism.