Caesarean delivery (CD) rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this ...study was to evaluate whether the Ten Group classification system (TGCS) can be used in case-mix adjustment.
Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index), obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight) and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC) curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC) were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction.
Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS) identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively). In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024).
The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the predictive discrimination of the risk adjusted model.
It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass ...index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia.
A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample included 14109 women with complete records. Associations between exposure variables and newborn macrosomia were analyzed using Pearson's chi squared test. Multiple logistic regression models were built to assess the independent association between potential predictors and macrosomia.
Maternal obesity (adjusted OR 1.7, 95% CI 1.4-2.2), excessive gestational weight gain (adjusted OR 1.9, 95% CI 1.6-2.2) and diabetes (adjusted OR 2.1, 95% CI 1.5-3.0 for gestational; adjusted OR 3.0, 95% CI 1.2-7.6 for pre-gestational) resulted to be independent predictors of macrosomia, when adjusted for other recognized risk factors. Since no significant interaction was found between pre-gestational BMI and gestational weight gain, excessive weight gain should be considered an independent risk factor for macrosomia. In the sub-group of women affected by gestational or pre-gestational diabetes, pre-gestational BMI was not significantly associated to macrosomia, while excessive pregnancy weight gain, maternal height and gestational age at delivery were significantly associated. In this sub-population, pregnancy weight gain less than recommended was not significantly associated to a reduction in macrosomia.
Our findings indicate that maternal obesity, gestational weight gain excess and diabetes should be considered as independent risk factors for newborn macrosomia. To adequately evaluate the clinical evolution of pregnancy all three variables need to be carefully assessed and monitored.
Although the evaluation of caesarean delivery rates has been suggested as one of the most important indicators of quality in obstetrics, it has been criticized because of its controversial ability to ...capture maternal and neonatal outcomes. In an "ideal" process of labor and delivery auditing, both caesarean (CD) and assisted vaginal delivery (AVD) rates should be considered because both of them may be associated with an increased risk of complications. The aim of our study was to evaluate maternal and neonatal outcomes according to the outlier status for case-mix adjusted CD and AVD rates in the same obstetric population.
Standardized data on 15,189 deliveries from 11 centers were prospectively collected. Multiple logistic regression was used to estimate the risk-adjusted probability of a woman in each center having an AVD or a CD. Centers were classified as "above", "below", or "within" the expected rates by considering the observed-to-expected rates and the 95% confidence interval around the ratio. Adjusted maternal and neonatal outcomes were compared among the three groupings.
Centers classified as "above" or "below" the expected CD rates had, in both cases, higher adjusted incidence of composite maternal (2.97%, 4.69%, 3.90% for "within", "above" and "below", respectively; p = 0.000) and neonatal complications (3.85%, 9.66%, 6.29% for "within", "above" and "below", respectively; p = 0.000) than centers "within" CD expected rates. Centers with AVD rates above and below the expected showed poorer and better composite maternal (3.96%, 4.61%, 2.97% for "within", "above" and "below", respectively; p = 0.000) and neonatal (6.52%, 9.77%, 3.52% for "within", "above" and "below", respectively; p = 0.000) outcomes respectively than centers with "within" AVD rates.
Both risk-adjusted CD and AVD delivery rates should be considered to assess the level of obstetric care. In this context, both higher and lower-than-expected rates of CD and "above" AVD rates are significantly associated with increased risk of complications, whereas the "below" status for AVD showed a "protective" effect on maternal and neonatal outcomes.
Caesarean delivery (CD) rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this ...study was to evaluate whether the Ten Group classification system (TGCS) can be used in case-mix adjustment. Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index), obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight) and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC) curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC) were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS) identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively). In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024). The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the predictive discrimination of the risk adjusted model.
The aim of the study was to identify which groups of women contribute to interinstitutional variation of caesarean delivery (CD) rates and which are the reasons for this variation. In this regard, ...15,726 deliveries from 11 regional centers were evaluated using the 10-group classification system. Standardized indications for CD in each group were used. Spearman’s correlation coefficient was used to calculate (1) relationship between institutional CD rates and relative sizes/CD rates in each of the ten groups/centers; (2) correlation between institutional CD rates and indications for CD in each of the ten groups/centers. Overall CD rates correlated with both CD rates in spontaneous and induced labouring nulliparous women with a single cephalic pregnancy at term (P=0.005). Variation of CD rates was also dependent on relative size and CD rates in multiparous women with previous CD, single cephalic pregnancy at term (P<0.001). As for the indications, “cardiotocographic anomalies” and “failure to progress” in the group of nulliparous women in spontaneous labour and “one previous CD” in multiparous women previous CD correlated significantly with institutional CD rates (P=0.021, P=0.005, and P<0.001, resp.). These results supported the conclusion that only selected indications in specific obstetric groups accounted for interinstitutional variation of CD rates.
The European Medicines Agency (EMA) has adopted assessment systems and drug registration procedures to respond to the needs for rapid patient access to therapies, such as Conditional Marketing ...Approval (CMA) and Under Exceptional Circumstances approval (UEC). The Italian Medicine Agency (AIFA) has introduced tools for governing prescriptive behaviour in order to promote appropriateness and correct use of drugs and to manage the uncertainty of financial impact, including Managed Entry Agreements (MEAs). The MEAs are conditional access agreements to the market for new drugs aimed at managing the uncertainty on the clinical and economic effects of the drugs themselves. The aim of this study is to analyse, through the use of the information systems of the AIFA and the institutional website of the EMA, how the drugs authorised by EMA with CMA or UEC have been managed on the access side to the Italian NHS. This in order to understand how the uncertainty deriving from the authorisation processes was subsequently reflected on the reimbursement processes to be borne by the NHS. From the analyses carried out, it emerges that 64% of the drugs approved with CMA were admitted to reimbursement and 68% of those approved with the UEC procedure. Furthermore, it can be noted that approval with CMA is predictive for the application of a financial-based or outcome-based MEA (61%), with the application of a monitoring register, unlike the drugs approved UEC for which no conditional reimbursement arrangements have been applied at the patient level. Furthermore, by carrying out a comparative analysis of the time of access to market following negotiation, from the positive opinion of the CHMP to the decision published in the Official Gazette of the Italian Republic, it emerged that the drugs approved by the UEC procedure take on average more time (897 days) to arrive at the price and reimbursement (P&R) compared to CMA drugs (636 days). Considering instead only the period from the request for P&R to the determination of P&R for the same group of drugs, the process seems to be on average faster for the drugs classified as UEC than for those with CMA (329 vs. 510 days).
Background & Aims
Advances in direct‐acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only ...diagnosed and linked‐to‐care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030.
Methods
Using a modelling approach grounded in Italian real‐life data of diagnosed and treated patients, different linkage‐to‐care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals.
Results
Under the 40% linked‐to‐care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948‐1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0‐F3 cases. Under the 60% linked‐to‐care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958‐1978 birth cohorts could capture 55% of F0‐F3 individuals. Under the 80% linked‐to‐care scenario, screening limited in 1968‐1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals.
Conclusion
In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.
Background & Aims
This study aimed to assess the real‐life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within ...the Italian compassionate use program.
Methods
Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks.
Results
Of 100 transplanted patients, 51 were HCV‐RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for <4 weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%). 98 patients completed SOF/R without LT (SVR12: 73%). In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C‐P ≥B8), a marked improvement of the scores occurred in about 50% of cases and almost 20% of decompensated patients without HCC reached a condition suitable for inactivation and delisting.
Conclusions
These real‐life data indicate that in waitlisted patients: (i) bridging antiviral therapy can be an option for patients still viraemic or negative <4 weeks at LT; and (ii) clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis.
Summary
Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with ...sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real‐world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.
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