Danila Azzolina

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 80years). 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 models.

Acute intraoperative echocardiographic changes after transapical off-pump mitral valve repair with NeoChord implantation

OBJECTIVES Our aim is to investigate the acute intraoperative effects of the NeoChord repair procedure on mitral valve (MV) annular geometry and LV function and the impact of these changes on MR at 1-year follow-up. BACKGROUND Recently transapical off-pump mitral valve repair with NeoChord implantation has been demonstrated to be safe and effective in patients with degenerative mitral regurgitation (DMR). METHODS We retrospectively analyzed baseline and early postoperative 3-dimensional transesophageal echocardiography of 66 patients who underwent NeoChord repair for isolated posterior leaflet MV disease using semiautomatic off-line analysis software. RESULTS We observed a significant acute reduction of indexed LV end diastolic volume (Δ% = 14, p < .001), LV ejection fraction (Δ = 5.7%, p = .002), indexed left atrial volume (Δ = 14.7%, p = .045), and pulmonary artery pressure (Δ = 2.1%, p = .026). Among MV geometric parameters, we observed a significant reduction of MV antero-posterior diameter (Δ = 7%, p < .001), sphericity index (Δ = 8%, p < .001), annulus circumference (Δ = 0.9%, p = .021), and annulus area (Δ = 2.7%, p = .018). At 1-year, 53 patients (85.5%) presented MR ≤ mild, while 9 patients (14.5%) had MR ≥ moderate. Reduction of AP diameter (OR = 0.14, CI -3.83; 0.08, p < .001), annulus circumference (OR = 0.27, CI -2.98; 0.37, p = .005), MV area (OR = 0.39, CI -2.46; 0.61, p = .04), aorto-mitral angle (OR = 0.38, CI -2.49; 0.54, p = .002) and iEDV (OR = 0.44, CI -2.44; 0.81, p = .001) were independent protective factors against recurrence of MR greater than mild at 1-year follow-up. CONCLUSIONS Transapical NeoChord repair produces important acute intraoperative changes in MV anatomy in DMR patients. The acute changes observed were associated with procedure durability at 1-year FU.

Obese children are thin in parents’ eyes: A psychologically, socially, or culturally driven bias?:

Although obesity presents a serious health problem in children, parents often underestimate their children’s overweight and obesity status. Therefore, scientific literature was systematically screened through PubMed and PsycINFO to demonstrate the psychological, social, and cultural processes that underlie this evaluation bias. A total of 37 papers that focused on research conducted in different geopolitical contexts were taken into account. Furthermore, a lexicometric analysis of the papers’ conclusions was performed. The findings showed that education plays a key role in promoting parents’ awareness and their realistic recognition of their children’s weight. Accordingly, adequate educational support for parents should be implemented in all healthcare policies addressing childhood obesity.

Prognostic impact of leaflet-to-annulus index in patients treated with transapical off-pump echo-guided mitral valve repair with NeoChord implantation

BACKGROUND The transapical echo-guided NeoChord repair is a procedure to correct mitral regurgitation (MR) without the need for concomitant annuloplasty for degenerative mitral valve (MV) disease. Lacking strict criteria to define normal annular dimensions for patients undergoing MV repair, we consequently missed having precise selection criteria to identify patients who can benefit from a ringless procedure with respect to who would need a combined annular and leaflet repair. The aim of this study is to identify whether a new preoperative echocardiographic index may predict postoperative outcomes after NeoChord repair. METHODS All consecutive patients with posterior leaflet disease who underwent NeoChord repair between November 2013 and January 2016 presenting complete postoperative echocardiographic assessment up to 1year were included. Leaflet-to-Annulus Index (LAI) was defined as the ratio between the sum of anterior leaflet length (AML) and posterior leaflet length (PML) over antero-posterior length (AP; AML+PML/AP). Measurements were performed with 2D transesophageal echocardiography. RESULTS Sixty-six patients were enrolled. At 1year MR was absent in (24) 38% of patients, mild in (28) 44%, moderate in (10) 16% and severe in (1) 2%. Logistic regression analysis identified LAI as positive prognostic predictor of MR≤mild for values >1.35 at 3months, 1.30 at 6months and 1.25 at 1year. At 30days LAI was not associated with the grade of residual MR. CONCLUSIONS LAI is a positive postoperative predictor of MR≤mild at 1-year follow-up and can be used to identify patients who could benefit from a ringless NeoChord repair procedure for the absence of a leaflet-to-annulus mismatch.

Does Love Really Make Mothers Blind? A Large Transcontinental Study on Mothers' Awareness About Their Children's Weight

The aim of this study was to assess maternal misperception rates (perception as normal or underweight of a child with overweight or obesity) and their role in affecting the chance of implementing actions to change childrens weight.

A novel approach for comparing patterns of foreign body injuries across countries: A case study comparing European Countries and Bosnia and Herzegovina

OBJECTIVES The present study aimed at analyzing the characteristics of FB injuries from Bosnia and Herzegovina (B&H), a rapidly growing newly industrialized country, and to compare them with cases from European countries. METHODS The analysis is based on FB injury cases included in the Susy Safe registry. Cases from the Ear-Nose-Throat (ENT) Clinic, University Clinical Center of Tuzla (B&H) were compared with cases from European countries participating in the Susy Safe project. Multiple Correspondence Analysis (MCA) was performed to elucidate differences within a large data set regarding mechanisms and objects causing injuries. RESULTS The results of the MCA showed that the first three dimensions explained 43% of the variability. The first dimension was identified by children hospitalized for FB ingestion, the second one by children hospitalized for FB aspiration (lower airways), and the third one by children with an FB in the ear or in the upper airways. The analysis of the median of coordinates of factors contributing to each dimension showed that the greatest difference between B&H and European countries regarded the third one. Looking at the profile of these patients, it might be suggested that the proportion of males and females and the type of activity in which they were involved at time of injury occurrence are different among the countries considered CONCLUSIONS: This study proposes a simple tool for assessing differences among countries in the distribution of FB injuries. This case study shows that B&H has different patterns of FB injuries in the upper respiratory tract.

Transcatheter aortic valve implantation in patients younger than 75 years: Guidelines-based patients selection and clinical outcome

BACKGROUND Patients treated by transcatheter aortic valve implantation (TAVI) in all major recent trials are still mostly octogenarians. Aim of this study is to analyze the risk profile and outcome of TAVI patients <75 years. METHODS AND RESULTS We retrospectively analyzed 172 patients <75 years with symptomatic severe native AS or degeneration of surgical aortic bioprosthesis treated with TAVI. The level of surgical risk was reassessed according to multiparametric ACC classification (prohibitive in 68 patients, high in 34, intermediate in 70). Mean age was 69.02 ± 6.18 years, mean STS score 5.56 ± 5.21. The majority of them presented one or more clinical or anatomical characteristics favoring TAVI according to ECS guidelines, despite the young age. Vascular access was transfemoral in 76%. According to the VARC-2 definitions, device success was high (90%) in all groups. The early safety was 89%, clinical recovery was slower in prohibitive risk patients. Bleeding events were more frequent in prohibitive and high surgical risk classes. Clinical efficacy at 1 year was overall 83%, and significantly better in intermediate risk patients (p = 0.004). The functional status remained stable over time as well as prostheses performance. CONCLUSION About 40% of patients <75 years were treated by TAVI due to the presence of a prohibitive risk, mainly related to technical impediments. The remaining was referred to TAVI due to an estimated high or intermediate surgical risk driven by STS score, frailty and/or major organ system compromise. Early and mid-term clinical and hemodynamic outcomes were good, in particular in intermediate risk patients.

Anchoring Vignettes in EQ-5D-5L Questionnaire: Validation of a New Instrument

Background: Health Related Quality of Life (HRQoL) is an indicator of patients physical, psychological and social life. HRQoL is influenced by experience, beliefs, perceptions and expectations, and measures subjective perspective of the patient himself. EQ-5D-5L and SF-12 questionnaires are validated instruments useful to measure HRQoL, increasingly administered in electronic formats. Objective: The main purpose is to evaluate the feasibility of anchoring vignettes for the EQ-5D-5L questionnaire, with the aim to improve intergroup comparability of responses among different subjects. A comparison with SF-12 questionnaire is carried out. Method: This is a cross-sectional study conducted at the ambulatories of cardiology of the University Hospital of Padova, in Italy. Thirty-eight subjects with a diagnosis of cardiovascular disease or at risk of cardiovascular disease were enrolled. A factorial analysis has been performed to assess the convergent validity of EQ-5D-5L questionnaire compared to Sf-12. Moreover, a compound Hierarchical Ordered Probit (Chopit) model has been estimated to evaluate if the questionnaire form affects the subjective evaluation process in order to compare EQ-5D-5L with and without vignettes. Results: Correlation and factor analysis demonstrate that EQ_5D questionnaire is coherent with SF-12 in paper format. Chopit model estimation shows that questionnaire format does not affect the subjective question interpretation. Moreover, in a parametric model including vignettes, education attainment, disease severity, and gender are predictors of HRQoL status. Conclusion: The EQ-5D including vignettes in electronic format seems to be a valid tool to measure HRQoL as compared to EQ-5D without vignettes in paper format and to SF-12 questionnaire.

Research in nursing and nutrition: Is randomized clinical trial the actual gold standard?

The aim of this study was to assess the quality of reporting of nurse-driven randomized controlled trials involving a direct nutritional intervention. A bibliometric search for randomized controlled trials involving a direct nutritional intervention from 1991 to 2011 in nursing research was conducted. Both quality of the study and design aspects were evaluated. The prevalent randomized controlled trial design used is 2-arm parallel, individual, and randomized with a continuous primary endpoint. Global numbers of randomized controlled trials and the proportion of good-quality randomized controlled trials began a steady and marked rise, more than doubling, from the 1990s to about 2001 and increased slowly thereafter. Studies are overall sufficiently well designed, although there is still room for quality improvement. Additionally, implementation of new randomized controlled trial designs exists and should be advocated.

A survey on Biostatisticians Serving in the Italian Ethics Committees

Background. Italian ethics committees (ECs) have the responsibility for evaluating and monitoring clinical research. Methods. An electronic survey targeted to the biostatisticians operating in the 95 ECs in Italy, was launched in November 2016. Several aspects were explored such as education, job title, training in biostatistics and experience in the evaluation of protocols within the EC. Results. Seventy case report forms were returned (74%), and the response rate was highest for ECs located in the South (78%) and lowest in the North (51%). The biostatisticians in the respondent ECs were prevalently male, aged 50-60 years, with postgraduate education in medical specialties and statistics. The annual workload varied depending on the type of institution and geographical area, with an annual median number of protocols examined ranging from 80 in hospital ECs to 198 in university hospital ECs, and from 80 to 108, in the South and the Centre, respectively. Of these, 40% were observational study protocols. The EC biostatisticians proposed to reject 5% of protocols and to suspend with the request of clarification or amendments 10%. Only 61% and 79% of these opinions, respectively, were regarded as binding by the other EC members. Conclusion. The biostatistician will not be able to play a significant role in the EC as long as the required skill-set remains vague and his/her opinion on a protocol is underrated.