Healthcare utilization database and real world evidence are we able to grasp an extraordinary challenge?

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Building reliable evidence from real-world data: methods, cautiousness and recommendations

Routinely stored information on healthcare utilisation in everyday clinical practice has proliferated over the past several decades. There is, however, some reluctance on the part of many health professionals to use observational data to support healthcare decisions, especially when data are derived from large databases. Challenges in conducting observational studies based on electronic databases include concern about the adequacy of study design and methods to minimise the effect of both misclassifications (in the absence of direct assessments of exposure and outcome validity) and confounding (in the absence of randomisation). This paper points out issues that may compromise the validity of such studies, and approaches to managing analytic challenges. First, strategies of sampling within a large cohort, as an alternative to analysing the full cohort, will be presented. Second, methods for controlling outcome and exposure misclassifications will be described. Third, several techniques that take into account both measured and unmeasured confounders will also be presented. Fourth, some considerations regarding random uncertainty in the framework of observational studies using healthcare utilisation data will be discussed. Finally, some recommendations for good research practice are listed in this paper. The aim is to provide researchers with a methodological framework, while commenting on the value of new techniques for more advanced users

Towards the rational use of Healthcare Utilization Databases for generating real-world evidence new challenges and proposals

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Real-world data from the health decision maker perspective. What are we talking about?

Healthcare decision-makers are increasingly developing policies that seek information on “real-world” data providing “evidence” to support and monitor changes in clinical practice or policy decisions. Many strategies may be evaluated in experimental circumstances, but this does rarely reflect clinical practice. Due to the current focus on information and computer technology to provide safer and more efficient healthcare delivery, the amount of electronic medical records and other electronic healthcare data is increasing exponentially, and these real-world data can be used for evidence generation. This review describes why and how healthcare/policy decision making could benefit from real-world data, it introduces methods to investigate real-world clinical practice, lists potentialities of routinely collected real-world data, reviews their availability in the word, and outlines future challenges in this field

Effectiveness of clinical pathway in subjects with heart failure: A real-world study from Italian health claims

Background: Several process-of-care indicators have been developed and implemented to improve the quality of heart failure (HF) patients care. The aim of this study is to assess the relationship between a set of recommendations for HF care with measurable clinical outcomes, also in terms of outcomes that could be avoided. Methods: A retrospective cohort study was carried out on subjects with at least one hospitalization with a primary diagnosis of HF in 2007. Data were retrieved from healthcare utilization databases of Lombardy region (Italy). Exposure to selected recommendations (periodic control of echocardiogram and use of blockers of the renin-angiotensin system and beta-blockers) was recorded. All cause mortality and hospitalization with primary diagnosis of HF were considered as outcomes. Multivariable Cox models and Poisson model were fitted to estimate the exposure-outcome association. Results: Among 8207 cases of HF, those who adhered to none, one or all recommendations during the first year after diagnosis were 11%, 60% and 30%, respectively. Compared to patients who adhered to no recommendation, a significant mortality risk reduction of 24% (95% CI 17-31%) and 44% (36 52%) were observed for those who adhered to one and all recommendations, respectively. A significant reduction in the rate of re-hospitalizations in subjects adhered to at least one recommendation was also observed. A decreased trend in Population Attributable Fraction for death cases according to follow-up time was observed. Conclusion: A strict control of patients with HF through regular clinical examinations must be considered as fundamental for the reduction of mortality and re-hospitalizations

Confronto tra Inquiry-based Science Education ed insegnamento tradizionale delle Scienze in alcune scuole superiori italiane

This study aims to evaluate if inquiry-based science education (IBSE) at the high school level allows the achievement of better learning objectives with respect to conventional science education (CSE). The findings would help to understand if, how, and why IBSE can be used as a successful teaching approach. The study included four high schools with different specialties, eight experienced science teachers and approximately 350 students, attending sixteen classes. Two biochemistry topics were taught by the same teacher in two classes. A two stage quasi experimental, crossover design was adopted. The primary outcome compared the difference in the average pre-teaching and post-teaching test-scores, using a 3-multilevel analysis. On average, the outcome in terms of scores significantly improved by 4% with IBSE with respect to the CSE approach, demonstrating differences among the school specialties. In conclusion, our study indicates that IBSE is significantly more effective in enhancing skills.Questo studio mira a valutare se l’approccio “Inquiry-based science education” (IBSE) consenta il raggiungimento di obiettivi di apprendimento, a livello di scuola superiore, in modo più efficacerispetto all’educazione scientifica convenzionale (CSE). I risultati possono aiutare a capire se, come e perché IBSE può essere utilizzato come approccio didattico di successo. Lo studio ha inclusoquattro scuole superiori con diversi indirizzi, otto insegnanti di scienze con esperienza e circa 350 studenti, suddivisi in sedici classi. Due tematiche di biochimica sono state insegnate dallo stesso docente in due classi parallele. È stato adottato un disegno quasi sperimentale, crossover, a due fasi. Obiettivo primario è stato confrontare la differenza nei punteggi medi nei test prima e dopo le attività, utilizzando un’analisi gerarchica a 3 livelli. In media, il risultato in termini di punteggi è migliorato significativamente del 4% con IBSE rispetto all’approccio CSE, dimostrando differenze tra gli indirizzi scolastici. In conclusione, il nostro studio indica che IBSE è significativamente più efficace nel migliorare le competenze

Acute myocardial infarction and stroke registries. The Italian experience

Cardiovascular diseases (CVD) are the leading causes of death and hospitalisation in nearly all European countries and accounted for almost 40% of all deaths in 2013. With the exception of few rigorous but limited studies carried out in some geographical areas, data available on CVD incidence and prevalence is generally limited and of poor quality, despite the magnitude of the CVD phenomenon. The EUROCISS Project, supported by the Health Monitoring Programme of the DG SANCO from 2000 to 2007, provided general guidance and updated methods for the surveillance of Acute Myocardial Infarction and Stroke. The Italian population-based registry of major coronary and cerebrovascular events was set up following EUROCISS recommendations; it also took into account the experience acquired by Italy in the MONICA project since the mid-1980s and continued with the coordination of the EUROCISS The project: “A population-based AMI register: assessing the feasibility for a pilot study to implement a surveillance system of acute myocardial infarction (AMI) in Mediterranean countries according to EUROCISS recommendations” in the framework of the EuroMed Programme, followed major practical and operative issues for the implementation of a population-based registry for coronary and cerebrovascular events, which are here described. This paper includes the definition of target population, data sources, events, indicators, quality methods, and the description of a software used to implement the registry

Adherence With Antihypertensive Drug Therapy and the Risk of Heart Failure in Clinical Practice

Randomized clinical trials have shown that antihypertensive treatment reduces the risk of heart failure (HF). Limited evidence exists, however, on whether and to what extent this benefit is translated into real-life practice. A nested case–control study was carried out by including the cohort of 76 017 patients from Lombardy (Italy), aged 40 to 80 years, who were newly treated with antihypertensive drugs during 2005. Cases were the 622 patients who experienced hospitalization for HF from initial prescription until 2012. Up to 5 controls were randomly selected for each case. Logistic regression was used to model the HF risk associated with adherence to antihypertensive drugs, which was measured by the proportion of days covered by treatment (PDC). Data were adjusted for several covariates. Sensitivity analyses were performed to account for possible sources of systematic uncertainty. Compared with patients with very low adherence (PDC, ≤25%), low, intermediate, and high adherences were associated with progressively lower risk of HF, reduction in the high-adherence group (>75%) being 34% (95% confidence interval, 17%–48%). Similar effects were observed in younger (40–70 years) and older (71–80 years) patients and between patients treated with angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and diuretics. There was no evidence that adherence with calcium-channel blockers reduced the HF risk. Antihypertensive treatment lowers the HF risk in real-life practice, but adherence to treatment is necessary for a substantial benefit to take place. This is the case with a variety of antihypertensive drugs

Acute myocardial infarction and stroke registries. The italian experience

Cardiovascular diseases (CVD) are the leading causes of death and hospitalisation in nearly all European countries and accounted for almost 40% of all deaths in 2013. With the exception of few rigorous but limited studies carried out in some geographical areas, available data on CVD incidence and prevalence are generally limited and of poor quality, despite the magnitude of the CVD phenomenon. The EUROCISS Project, supported by the Health Monitoring Programme of the DG SANCO from 2000 to 2007, provided general guidance and updated methods for the surveillance of Acute Myocardial Infarction (AMI) and Stroke. The Italian population-based registry of major coronary and cerebrovascular events was set up following EUROCISS Project recommendations; it also took into account the experience acquired by Italy in the WHO-MONICA project since the mid-1980s and continued with the coordination of the EUROCISS Project. The project: “A population-based AMI register: assessing the feasibility for a pilot study to implement a surveillance system of AMI in Mediterranean countries according to EUROCISS recommendations”, in the framework of the EuroMed Programme, followed major practical and operative issues for the implementation of a population-based registry for coronary and cerebrovascular events, which are here described. This paper includes the definition of target population, data sources, events, indicators, quality methods, and the description of a software used to implement the registry

Comorbidity-adjusted relative survival in newly hospitalized heart failure patients: A population-based study

Background This study aims to identify comorbidities through various sources and assess their short-term impact on relative survival in a cohort of heart failure (HF) patients. Methods Newly hospitalized HF patients were identified from hospital discharge abstracts (HDA) of Lombardy Region, Italy, from 2008 to 2010. Charlson comorbidities were assessed using the HDA and supplemented with drug prescriptions and disease-specific exemptions. A Cox model was fit for the one-year relative survival from HF. Results The cohort consisted of 51,061 HF patients (53% women; median age 80\uc2\ua0years). After integrating information from all sources, the prevalence rates of diabetes, chronic pulmonary disease and renal disease were 27.6%, 26.2% and 14.2%, respectively. The prevalence of comorbidity increased to 78%. Survival in the HF cohort was worse with increasing number of comorbidities and was inferior to that in the reference population. Notably, the overall performance of the relative survival models was similar regardless of the strategy used to ascertain comorbidity. Conclusions Comorbidities cluster in hospitalized HF patients, and increasing comorbidity burden is associated with worse survival. Integration of a comprehensive search of electronic records to supplement HDA improves the prevalence estimates of comorbidities, although it does not improve discrimination of the risk prediction model