Osteoradionecrosis incidence in pre-radiation teeth extractions: A prospective study.

AIMS: To evaluate osteoradionecrosis (ORN) incidence in a cohort of patients undergoing tooth extraction (TE) before radiotherapy (RT) for head and neck cancers. METHODS: The study protocol was approved by the Ethics Committee of Università Cattolica del Sacro Cuore (ID-2132) and registered at clinicaltrials.gov (ID: NCT04009161). TE was performed in case of signs of pericoronitis, periapical lesions, restorative impossibility, severe periodontitis. ORN was defined as exposed bone at an unhealed post-extraction socket in the absence of oncological recurrence. The RT plans were reviewed, and each post-extractive socket was contoured to calculate the received radiation dose. RESULTS: In total, 156 patients with 610 TE were enrolled. The mean follow-up was 567 days. ORN was diagnosed in four patients (2.6% of patients and 0.7% of TE). Need for osteotomy and radiation dose at the extraction site were associated with ORN (OR for osteotomy: 21.9, 95% CI: 2.17-222.2, p = 0.009; OR for RT dose: 1.1, 95% CI: 1-1.15, p = 0.05). CONCLUSIONS: TE appears to be a significant risk factor for ORN, particularly when osteotomy is required, and post-extraction sockets receive a high RT dosage. This study proposes a decision-making algorithm for TE and outlines a straightforward surgical protocol.

A cost-effectiveness analysis of an integrated clinical-radiogenomic screening program for the identification of BRCA 1/2 carriers (e-PROBE study).

Current approach to identify BRCA 1/2 carriers in the general population is ineffective as most of the carriers remain undiagnosed. Radiomics is an emerging tool for large scale quantitative analysis of features from standard diagnostic imaging and has been applied also to identify gene mutational status. The objective of this study was to evaluate the clinical and economic impact of integrating a radiogenomics model with clinical and family history data in identifying BRCA mutation carriers in the general population. This cost-effective analysis compares three different approaches to women selection for BRCA testing: established clinical criteria/family history (model 1); established clinical criteria/family history and the currently available radiogenomic model (49% sensitivity and 87% specificity) based on ultrasound images (model 2); same approach used in model 2 but simulating an improvement of the performances of the radiogenomic model (80% sensitivity and 95% specificity) (model 3). All models were trained with literature data. Direct costs were calculated according to the rates currently used in Italy. The analysis was performed simulating different scenarios on the generation of 18-year-old girls in Italy (274,000 people). The main outcome was to identify the most effective model comparing the number of years of BRCA-cancer healthy life expectancy (HLYs). An incremental cost-effectiveness ratio (ICER) was also derived to determine the cost in order to increase BRCA carriers-healthy life span by 1 year. Compared to model 1, model 2 increases the detection rate of BRCA carriers by 41.8%, reduces the rate of BRCA-related cancers by 23.7%, generating over a 62-year observation period a cost increase by 2.51 €/Year/Person. Moreover, model 3 further increases BRCA carriers detection (+ 68.3%) and decrease in BRCA-related cancers (- 38.4%) is observed compared to model 1. Model 3 increases costs by 0.7 €/Year/Person. After one generation, the estimated ICER in the general population amounts to about 3800€ and 653€ in model 2 and model 3 respectively. Model 2 has a massive effect after only one generation in detecting carriers in the general population with only a small cost increment. The clinical impact is limited mainly due to the current low acceptance rate of risk-reducing surgeries. Further multicentric studies are required before implementing the integrated clinical-radiogenomic model in clinical practice.

Insights on DRGs, guideline compliance and economic sustainability. The case of mastectomy with immediate breast reconstruction.

Background: Immediate breast reconstruction is recommended for eligible patients undergoing mastectomy, raising the issue of economic sustainability of both mastectomy and breast reconstruction performed within the same hospitalization, as opposed to two surgical procedures in two different hospitalizations. Study design: A retrospective analysis was conducted to compare economic sustainability of mastectomies with or without immediate breast reconstruction. Methods: Economic data on hospitalizations for mastectomy in a Teaching Hospital between 1 January 2019 and 31 March 2021 were analyzed to assess their sustainability. Results: 338 admissions were selected (63.9% with immediate breast reconstruction (CI 99%: 57.2% to 70.6%). Compared to mastectomy alone, mastectomy with immediate breast reconstruction had higher cost of € 2,245 (p < 0.001), with operating rooms and devices as main cost drivers. Current reimbursements rates (which are the same for mastectomy alone and for mastectomy with immediate breast reconstruction) led to an average loss of € 1,719 for each mastectomy with immediate breast reconstruction. Conclusion: Current DRGs reimbursement rates for hospital admissions for breast cancer surgery do not guarantee immediate breast reconstruction's economic sustainability. DRGs system should be revised, or other solutions as bundled payment should be implemented in the light of the costs of innovation in healthcare, considering mastectomy and breast reconstruction steps in a path of linked actions aimed at improving patients' health.

Hospital networks in Italy: state of the art and future pespectives. Insights from a qualitative research study.

Background Hospitals have undergone important that changes that have led, in recent decades at the international level, to the need for greater integration between hospitals and local healthcare services. The main institutional networks that have been developed in Italy are, as commended by the institutional levels, of 4 main types: the Emergency-Urgency Network, the Time-Dependent Networks, the Oncological Networks, and the Networks with primary care settings. It was important to assess the state of the art and analyze it in relation to possible future developments. Objective The aim of the study was to collect insights from both evidence-based knowledge and personal experience gained by experts in the field regarding the current condition and possible future developments of hospital networks. Material and methods A qualitative research methodology was chosen. Four mini-focus group meetings were organized among participants with proven expertise on the subject. Discussions were guided by four open-ended questions corresponding to the four areas of interest. Directed content analysis was chosen as the methodology for data analysis and final reporting of results. Results Four main categories were explored: "hospital networks and complexity", "hospital networks complexity and the need for integration", "levers for hospital networks governance" and "the COVID-19 challenge and future developments for hospital networks". In particular, the participants found that it is important to understand healthcare systems as complex systems and, therefore, to study the properties of complex systems. In this way it is possible to achieve value-based healthcare in complex contexts. It is also necessary to keep in mind that complexity represents a challenge for coordination/ integration in hospital networks. Mintzberg identified specific mechanisms to achieve it. Of them, mutual adaptation is the key to self-organization. Valentijn showed the organizational levels on which coordination/integration has to be obtained. Hospital network governance should include both hierarchy and self-determination logic to achieve integration in each of the four levels. The participants identified three key levers for governing complex organizations: "education", which consists of multi-professional and multi-level training in governance in complex systems; "information" consisting in considering the data registering as an integral part of the clinical care process to informative value; "leadership", which consists in convincing actors, directed towards personal gains, to achieve valuable goals. Finally, the challenge that COVID-19 served as an incentive for future developments of hospital networks. Discussion Various common points between the definitions of network and complex systems can be found. It is important to study the properties of complex systems in order to achieve value-based healthcare in the hospital networks context. The insights gained should be useful for all professionals from and across all levels of healthcare organizational responsibility, being able to orient roles and actions to achieve coordination/integration inside hospital networks. Conclusions Complexity literature can help understand how to achieve coordination/integration in healthcare settings and find levers for effective governance. It is important to study the current situation to anticipate and, possibly govern, future developments. In conclusion, governance of hospital networks should be interpreted as coordination/integration inside and across multiple organizational levels of co-responsibility.

Disinvestment in healthcare: an overview of HTA agencies and organizations activities at European level.

BACKGROUND: In an era of a growing economic pressure for all health systems, the interest for "disinvestment" in healthcare increased. In this context, evidence based approaches such as Health Technology Assessment (HTA) are needed both to invest and to disinvest in health technologies. In order to investigate the extent of application of HTA in this field, methodological projects/frameworks, case studies, dissemination initiatives on disinvestment released by HTA agencies and organizations located in Europe were searched. METHODS: In July 2015, the websites of HTA agencies and organizations belonging to the European network for HTA (EUnetHTA) and the International Network of Agencies for HTA (INAHTA) were accessed and searched through the use of the term "disinvestment". Retrieved deliverables were considered eligible if they reported methodological projects/frameworks, case studies and dissemination initiatives focused on disinvestment in healthcare. RESULTS: 62 HTA agencies/organizations were accessed and eight methodological projects/frameworks, one case study and one dissemination initiative were found starting from 2007. With respect to methodological projects/frameworks, two were delivered in Austria, one in Italy, two in Spain and three in U.K. As for the case study and the dissemination initiative, both came from U.K. The majority of deliverables were aimed at making an overview of existing disinvestment approaches and at identifying challenges in their introduction. CONCLUSIONS: Today, in a healthcare context characterized by resource scarcity and increasing service demand, "disinvestment" from low-value services and reinvestment in high-value ones is a key strategy that may be supported by HTA. The lack of evaluation of technologies in use, in particular at the end of their lifecycle, may be due to the scant availability of frameworks and guidelines for identification and assessment of obsolete technologies that was shown by our work. Although several projects were carried out in different countries, most remain constrained to the field of research. Disinvestment is a relatively new concept in HTA that could pose challenges also from a methodological point of view. To tackle these challenges, it is necessary to construct experiences at international level with the aim to develop new methodological approaches to produce and grow evidence on disinvestment policies and practices.

Emergency Department crowding and hospital bed shortage: is Lean a smart answer? A systematic review.

OBJECTIVE: Emergency Departments (EDs) worldwide face the challenges of crowding, waiting times, and cost containment. This review aims to provide a synthesis of the current literature focused on how Lean Thinking Principles and tools can be applied in an ED to address overcrowding and hospital admissions. MATERIALS AND METHODS: Primary studies showing Lean interventions and implementation in ED visits, not requiring additional resources measuring specific outcomes (i.e. length of stay, patient volume, patient satisfaction, waiting times for the first visit, waiting times for diagnostic results, left without being seen) were selected. PubMed, Scopus, CINAHL, EconLit, NHS Economic Evaluation Database, Business Sources Complete, and Health Technology Assessment were used to conduct searches. Full-text articles of all potentially relevant publications were reviewed for eligibility. Discrepancies were resolved through discussion by all reviewers. Quality assessment and critical appraisal of selected studies were also evaluated by applying the Quality Improvement Minimum Quality Criteria Set. RESULTS: Nine before-and-after studies met these eligibility criteria. Management of patient flow was the main intervention. Almost all studies showed EDs performance improvement: increased patient volume, decreased length of stay and number of patients left without being seen, reduced costs, and increased patient satisfaction. Only one case reported worse results after Lean intervention implementation. CONCLUSIONS: Though Lean Principals have been used in healthcare for many years conclusion of their effects could still not be drawn. Surely, human-centered approach, top management support, work standardization, resources allocation and adaptation to the local context seem to be crucial for success. Furthermore, higher quality studies are needed: specific research design, appropriate statistical tests and outcome measures are needed. Before large-scale implementation, further studies are needed to evaluate the true ability of Lean interventions to improve healthcare delivery.

[Implementation of the stewardship model in public health: proposal of an assessment tool for the Italian national prevention plan]. / Implementazione della stewardship in sanità pubblica: proposta di una metodologia valutativa applicabile al piano nazionale della prevenzione.

The stewardship model has been adopted as a system of governance in several countries. In Italy, the Ministry of Health has proposed the use of the stewardship model for implementing the activities of the National Prevention Plan 2010-2012. The authors present the conceptual foundations and methodology used in the development of an assessment tool (audit tool) for evaluating the level of implementation of the stewardship model with regards to the activities of the national prevention plan in all Italian regions.

Economic impact of childhood obesity on health systems: a systematic review.

The primary purpose of this study is to analyse the costs related to childhood obesity (CO) with reference to different models of healthcare systems. A systematic review of the economic impact of CO on healthcare systems was conducted by searching the main electronic scientific databases. Cost-of-illness (COI) analyses of children aged under 18 years who had been diagnosed as overweight or obese published up to July 2010 were considered. Short- and long-term consequences of CO were taken into account. In order to appraise the quality of the included studies, the British Medical Journal referees' checklist was used. About 3,844 COI analyses were initially found and 10 were finally considered in the current review: two studies referred to Beveridge and eight referred to Voluntary health insurance models. No studies have been conducted within a Bismarck model. Six studies considered in-patient costs, four studies estimated outpatient and primary care costs and seven studies considered pharmaceutical costs. The average quality of the included analyses was medium. The analysis confirmed the significance of CO related costs and the heterogeneity among available studies, which made it impossible to compare the different healthcare models.

Lack of association of CCR gene polymorphisms and left ventricular hypertrophy in essential hypertension.

Left ventricular hypertrophy (LVH) is a major determinant of heart damage. Scientific evidence suggests the influence of genetic factors, but these have yet to be completely clarified. This study investigates a possible relationship between LVH and two chemokine receptor (CCR) gene polymorphisms: CCR5delta32 and CCR264I. Essential hypertensive out-patients (n=118, grade I-II, age 27-54) were recruited from the Catholic University Hypertension Centre. For each subject, clinical data on office blood pressure and M-mode/2D echocardiography were collected. Statistical analysis did not show a significant association between the CCR polymorphisms and LVH in the study population.

Epidemiology of essential hypertension: the role of genetic polymorphism.

Over the past 20 years, the interest of the scientific community was increasingly placed in the field of genetic epidemiology and molecular genetics of blood pressure control. This paper explores references related to essential hypertension, gene and genetic epidemiology indexed in the MedLine health science database during the period 1980-2001. A systematic literature search was performed using selected keywords, such as 'genetic', 'genome' or a combination of words. We considered the study heading and evaluated the time profile of published articles. A total number of 3116 publications was collected and analyzed. Allelic distribution for the most studied polymorphisms of the renin-angiotensin system in different world populations was reviewed and reported together with a detection of their frequency in Italy: essential hypertensive patients (n = 90), healthy unrelated subjects (n = 300). Molecular variants at angiotensinogen (M and T), angiotensin II type 1 receptor (A and C) and angiotensin-converting enzyme (D and I) genes were analyzed by amplified fragment length polymorphism. A significant association was detected by chi2 analysis for angiotensinogen and angiotensin II-type I receptor allele distribution in hypertensive patients, in accordance with previous reports. Genetic data and methods are contributing more and more to epidemiological studies of complex diseases, and their application is influenced by information availability and Genome Project results.

CCR5 and CCR2 gene polymorphisms in hypertensive patients.

Essential hypertension is a complex trait under polygenic control. Evidences suggests immune system involvement during pathogenesis. CC-chemokine receptor (CCR)5 and CCR2 are characterised by gene polymorphism. Variant alleles are derived from a deletion in the CCR5 gene (CCR5delta32) and a substitution mutation at the CCR2 locus (CCR264I). CCR polymorphic forms have been studied extensively as invasion cofactors for HIV-1, but they have also been implicated in immuno-related disorders. Here, we evaluate the allelic distribution of CCR5 and CCR2 genes in essential hypertension in a case-control study. Genotype frequency in a group of essential hypertensive patients (stage I-II; n=120) and a group of unrelated, healthy Caucasian subjects (n=340) is compared. CCR gene polymorphism is analysed by polymerase chain reaction and restriction enzyme digestion. A statistically significant difference was observed for CCR5 and CCR2 mutant alleles in essential hypertensive patients, compared with the controls (P=0.004 and P=0.003, respectively). CCR5delta32 and CCR264I alleles showed a 0.096 and 0.10 frequency among cases. To date, a role for the immune system in hypertension has not been clarified, nor has the predictive value of CCR polymorphisms.

Angiotensin-related genes involved in essential hypertension: allelic distribution in an Italian population sample.

BACKGROUND: Blood pressure is a quantitative multifactorial trait influenced by environmental and genetic determinants. Although several candidate genes have been associated with the development of essential hypertension, the mechanisms of individual susceptibility still remain unclear. Knowledge on the distribution of genetic polymorphisms in different populations is fundamental for the assessment of the predictive value of genetic variation. METHODS: We genotyped 300 healthy normotensive subjects from the Italian population for three polymorphisms, at the angiotensinogen (AGT, M and T), angiotensin II type 1 receptor (ATIR, A and C) and angiotensin-converting enzyme (ACE, D and I) genes. Polymorphisms were analyzed by polymerase chain reaction and restriction enzyme digestion. Statistical analysis was performed to verify the agreement with the Hardy-Weinberg equilibrium. RESULTS: The observed allelic distribution was in accordance with estimates reported for Caucasian populations. Variant allelic frequencies were 0.36 for the T and C alleles at the AGT andAT1R locus and 0.47 for the I allele of the ACE gene. AT1R and ACE genotype frequencies were in Hardy-Weinberg equilibrium, while there was a deviation of the AGT genotypes from those predicted by the equation. CONCLUSIONS: The studied polymorphisms are largely distributed in the Italian population sample, with a frequency of homozygous subjects for mutant alleles ranging from 9 to 22%. Epidemiology of mutations in the genes involved in blood pressure regulation provides tools to evaluate susceptibility to hypertension.

Microalbuminuria as a marker of cardiac damage in essential hypertension.

A subclinical elevation in urinary albumin excretion (UAE) microalbuminuria is frequently seen in essential hypertension. The level of blood pressure appears to be an important factor in the development of microalbuminuria. Moreover there is some evidence to indicate that microalbuminuria may be an early marker of increased cardiovascular risk. Aim of this study was to evaluate the prevalence of UAE in hypertensives with normal left ventricular mass and to study any association with blood pressure level and with possible modification in left ventricular function. A group of 112 subjects diagnosed as having stage 1-2 essential hypertension were included in the study. Patients underwent urinary collection to evaluate UAE and to 24/hours arterial blood pressure monitoring. Moreover a complete echocardiography was performed. According with UAE levels patients were divided into three groups: A: UAE 0-15 mg/24 h, B: UAE 16-29 mg/24 h, C: UAE 30-300 mg/24 h. We found a significant correlation between 24/h SBP, 24/h DBP and UAE. We observed a significant correlation between impaired diastolic function and UAE. UAE is influenced by BP levels with better correlation with 24/h systolic values. UAE is associated with subclinical decrease of left ventricular function and may be an early marker of cardiac involvement.