Quality Assessment of Healthcare Databases

The assessment of data quality and suitability plays an important role in improving the validity and generalisability of the results of studies based on secondary use of health databases. The availability of more and more updated and valid information on data quality and suitability provides data users and researchers an useful tool to optimize their activities. In this paper, we have summarized and synthesized the main aspects of Data Quality Assessment (DQA) applied in the field of secondary use of healthcare databases, with the aim of drawing attention to the critical aspects having to be considered and developed for improving the correct and effective use of secondary sources. Four developing features are identified: standardizing DQA methods, reporting DQA methods and results, synergy between data managers and data users, role of Institutions. Interdisciplinarity, multi-professionality and connection between government institutions, regulatory bodies, universities and the scientific community will provide the "toolbox" for i) developing standardized and shared DQA methods for health databases, ii) defining the best strategies for disseminating DQA information and results

Socio-economic disparities in the appropriateness of diabetes care in an Italian region: findings of AEQUITAS study

Background: To evaluate socio-economic disparities in diabetes prevalence and care in Marches (a region of central Italy) in 2003-2010 through a cross-sectional study. Methods: The databases of 52 general practitioners were mined for people with diabetes (age ≥20 years). These data were linked with records from other regional administrative databases. Healthcare disparities, specifically potentially preventable hospitalizations (PPH) related to diabetes and its complications, were analysed using participants’ gender, age, and education data and the Italian Deprivation Index. Crude, age-specific and gender-specific diabetes prevalence was estimated for each year of observation. A time-trend analysis was performed. Admissions that might have been prevented according to Agency for Healthcare Research and Quality criteria were used to calculate the PPH rate for each level of social condition indicators. Rate ratios and 95% confidence intervals were estimated with a multiple Poisson regression model. Results: The search found 6,494 participants with diabetes mellitus aged ≥20 years. Disease prevalence ranged from 5.4% (2003) to 7.8% (2010), with a significant 0.31% positive trend. Those aged ≤44 years were at significantly higher risk of PPH than older people. A significant PPH excess was found among people living in socio-economically disadvantaged areas. Education and gender did not significantly affect PPH. Conclusion. People with diabetes seem to use primary care services appropriately irrespective of socio-economic status. Outpatient services are not equally distributed on the regional territory; this may increase disease severity and/or the risk of diabetes complications and affect appropriateness of diabetes care

Utilizzo degli archivi elettronici sanitari nell’epidemiologia analitica: aspetti metodologici del disegno dello studio e dell’analisi statistica dei dati applicati alla stima del rischio di un evento clinico raro

La crescente disponibilità di banche dati informatizzate sanitarie ha reso gli studi osservazionali uno strumento potente a fornire evidenze scientifiche. Limiti connessi ai database e distorsioni da cui possono essere affetti questi studi, possono compromettere i risultati. Questa tesi analizza i metodi di correzione da utilizzare in fase di disegno e di analisi statistica. Alcune di essi sono stati applicati ad uno studio volto a valutare il rischio di sviluppare un evento raro, danno renale acuto (DRA) da somministrazione di mezzo di contrasto iodato (MCI). A tal fine sono stati applicati il disegno di coorte e di caso-controllo innestato nella coorte, utilizzando le schede di dimissioni ospedaliere della regione Marche. La coorte comprendeva 29925 soggetti a cui era stata somministrato il MCI durante il 2008-2011; sono stati individuati 324 casi di DRA in totale, per 129 di questi il tempo trascorso dalla data di somministrazione di MCI era <7 giorni, perciò associati al DRA. Il rischio di sviluppare DRA da MCI risultava 0.43%. Soggetti di età superiore a 65 anni, che soffrivano di una malattia del sistema genitourinario sono risultati a maggior rischio. Nello studio caso-controllo innestato, i 324 casi sono stati appaiati a 1258 controlli. L’esposizione al MCI e le malattie del sistema genitourinario erano significativamente associate ad un maggior rischio di DRA. L’effetto dell’esposizione sullo sviluppo del DRA riduceva il rischio nei soggetti con età superiore a 65 anni e in quelli con più di una somministrazione, mentre aumentava in quelli con una patologia diversa dalle malattie genitourinarie e del sistema circolatorio. Lo studio ha permesso di stimare il rischio di un evento raro e l’effetto dei fattori ad esso associati; rappresenta, altresì, una concreta applicazione della metodologia epidemiologica attuale, particolarmente attenta alle problematiche connesse all’utilizzo di una fonte di dati potente ma che al contempo richiede cautela e cognizione di causa nella sua applicazione.A proliferated number of electronic healthcare databases has increased the role of observational studies as a tool to provide scientific evidence. Challenges in conducting observational studies based on Electronic Databases (ED) include concern about errors that can compromise the validity of the results. This thesis analyses methods and approaches to manage analytical challenges with regard to the study design and the statistical analysis of observational studies based on ED. Some of these techniques are performed in a study aimed to estimate the risk of a rare event, acute kidney injury (AKI) after contrast media (CM) administration. For that purpose, a cohort and a nested case-control study were performed using the discharged hospital database of Marche region. The cohort included 29925 subjects with a CM administration during 2008-2011. AKI occurred in 324 subjects; for 129 of them the time period after the CM administration was <7 days, considered therefore associated to AKI. The overall risk of AKI after CM administration was 0.43%. Subjects over 65 years old, suffering from a renal disease were at higher risk. In the nested case-control study all 324 cases were matched to 1258 controls. CM exposure and renal disease were significantly associated with a higher risk of AKI. A reduction of the exposure effect on AKI risk was found in those aged >65 years and with more than one CM administration, while an increased risk was found in subjects suffering from diseases different from renal and circulatory diseases. The study allowed us to estimate the risk of a rare event and the risk factors. Furthermore, it represents a concrete application of the current epidemiological methodology concerning problems related to the use of a potential data source but in the meantime should be cautiously applied

Bayesian calibration for forensic age estimation.

Forensic medicine is increasingly called upon to assess the age of individuals. Forensic age estimation is mostly required in relation to illegal immigration and identification of bodies or skeletal remains. A variety of age estimation methods are based on dental samples and use of regression models, where the age of an individual is predicted by morphological tooth changes that take place over time. From the medico-legal point of view, regression models, with age as the dependent random variable entail that age tends to be overestimated in the young and underestimated in the old. To overcome this bias, we describe a new full Bayesian calibration method (asymmetric Laplace Bayesian calibration) for forensic age estimation that uses asymmetric Laplace distribution as the probability model. The method was compared with three existing approaches (two Bayesian and a classical method) using simulated data. Although its accuracy was comparable with that of the other methods, the asymmetric Laplace Bayesian calibration appears to be significantly more reliable and robust in case of misspecification of the probability model. The proposed method was also applied to a real dataset of values of the pulp chamber of the right lower premolar measured on x-ray scans of individuals of known age

Epidemiology, clinical characteristics, and outcome of candidemia in a tertiary referral center in Italy from 2010 to 2014

PURPOSE: We evaluated the epidemiology, clinical characteristics and outcome of candidemia in a single institution from 2010 to 2014. METHODS: A retrospective observational study of all cases of candidemia was carried out at a University Hospital in Central Italy including five intensive care units (ICUs), 11 medical and 11 surgical wards. Data regarding demographic characteristics and clinical risk factors were collected from the patient's medical records. Antifungal susceptibility testing was performed and MIC results were interpreted according to species-specific clinical breakpoints. RESULTS: A total of 270 episodes of candidemia were identified. Overall incidence rate was 1.5 episodes/1000 hospital admissions. Although Candida albicans represented the most commonly isolated species, its percentage significantly decreased from 68 to 48 % (p = 0.040). The overall 30-day mortality was 35 %. The variables independently associated with a significant higher risk of mortality were: older age; being hospitalized in ICU or in medical wards vs surgical wards; being infected with C. albicans vs other species; the occurrence of septic shock, pneumonia and acute renal failure; the presence of a solid organ tumor or a chronic pulmonary disease. Conversely, an appropriate treatment was confirmed to be significantly associated with a lower risk of mortality. The overall resistance was low and it was noted only among triazoles. CONCLUSIONS: Our study shows that candidemia is a significant source of morbidity and mortality. The identification of risk factors associated with mortality along with the knowledge of local susceptibility may lead to a better management in terms of preventive and therapeutic measures

Functional outcomes after TEM in patients with complete clinical response after neoadjuvant chemoradiotherapy

Background In patients who exhibit a complete clinical response after radio-chemotherapy for rectal cancer, the standard surgical approach might constitute overtreatment. The aim of this study is to analyse the outcomes of anorectal function and quality of life after transanal endoscopic microsurgery (TEM) in irradiated patients with complete clinical response. Patients and methods Between 2007 and 2014, 84 patients who were diagnosed with stage T2–T3–T4 N0 rectal cancer before chemoradiotherapy showed a complete clinical response to neoadjuvant therapy and underwent TEM. All patients were evaluated before and 1 year after TEM using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) questionnaire to determine the impact of this surgical technique on the degree of faecal continence. To assess the quality of life of patients after surgery, we administered the Fecal Incontinence Quality of Life Scale. Results Twenty-three patients exhibited a worse incontinence status after surgical intervention (27.4; 95% CI 18.2–38.2). These patients experienced a median positive absolute variation in the CCF-FIS of four points (95% CI 3.5–4.5; p\0.001). Female sex and age showed a significant correlation with the worsening of continence status. Scores on the Fecal Incontinence Quality of Life Index Scale did not show a significant difference efore and after TEM. Conclusions TEM may be an alternative treatment for patients with rectal cancer who exhibit a complete clinical response to neoadjuvant chemoradiotherapy because it offers the possibility to achieve a full hickness excision of the rectal wall. TEM also allows the identification of any residual disease and provides optimal quality of life and functional results

Segmented Bayesian calibration approach for estimating age in forensic science

Forensic age estimation is receiving growing attention from researchers in the last few years. Accurate estimates of age are needed both for identifying real age in individuals without any identity document and assessing it for human remains. The methods applied in such context are mostly based on radiological analysis of some anatomical districts and entail the use of a regression model. However, estimating chronological age by regression models leads to overestimated ages in younger subjects and underestimated ages in older ones. We introduced a full Bayesian calibration method combined with a segmented function for age estimation that relied on a Normal distribution as a density model to mitigate this bias. In this way, we were also able to model the decreasing growth rate in juveniles. We compared our new Bayesian-segmented model with other existing approaches. The proposed method helped producing more robust and precise forecasts of age than compared models while exhibited comparable accuracy in terms of forecasting measures. Our method seemed to overcome the estimation bias also when applied to a real data set of South-African juvenile subjects

Laparoscopic transperitoneal adrenalectomy: a comparative study of different techniques for vessel sealing

Laparoscopic adrenalectomy is the standard surgical approach to adrenal lesions. Adrenal vessel sealing is the critical surgical phase of laparoscopic adrenalectomy. This study aimed at comparing perioperative outcomes of laparoscopic transperitoneal adrenalectomy by means of radiofrequency energy-based device (LARFD) to those performed with traditional clipping device (LACD), while focusing on the different adrenal vessel control techniques

The environmental and occupational influence of pesticides on male fertility: A systematic review of human studies

The environment plays a key role in male infertility, changing the incidence in various populations, and pesticides are one of the most studied hazards. The use of the latter has never decreased, jeopardizing the safety of workers and the general population