A519 days; In KPI5 58% of patients received adjuvant chemotherapy within 60 days after surgery; In KPI6 57% of patients performed radiotherapy within 90 days after surgery (who did not receive adjuvant chemotherapy) and 69% within 180 days after surgery (who received adjuvant chemotherapy); In KPI7 74% of the patients with tumor stage I and II performed one diagnostic examinations within 365 months after surgery. ConClusions: This study sustains the replicability of E.Pic.A. in different realities, the use of the KPIs to measure the performance is a way to guarantee a homogenous level of care regardless where the treatment is performed. Potentially, the improvement of these KPIs could lead to cost savings coming from inefficiencies that could be relocated to higher-value interventions for patients. References: 1. Massa et al., The Breast 34 (2017) 103-107. Disease-specific stuDies inDiviDual's HealtH-clinical Outcomes studies piH1 cOmparing tHe effect Of prOgressive relaxatiOn anD perineal strengHtening interval exercises amOng WOmen WitH primaer DysmenOrrHOea tO reDuce menstrual cramps

Objective: The aim of this study was to assess the pattern of cardiovascular diseases (CVDs), their clinical characteristics, and associated factors in the outpatient department of the chronic illness clinic of Gondar University Referral Hospital. Method: A retrospective cross-sectional study was conducted among patients on follow-up at the outpatient chronic illness clinic of the hospital from October 2010 to October 2015. The source population for the study included patients with a diagnosis of CVD whose medical records have the required socio-demographic information during the study period. The data were collected from August 2015 to December 2015. Chi-square and binary logistic regression tests were performed to test the significance of difference among predictive variables and CVDs. Results: Of 1105 patient medical records, 862 fulfilled the inclusion criteria. The majority of the patients were females (65%) and living in urban areas (62.7%). Hypertension accounted for the majority (62.3%) of CVDs followed by heart failure (HF) (23.9%). Headache was the leading chief complaint among the patients (37.7%) upon diagnosis and was the prominent clinical feature in more than half of the patients during their course of follow-up. Higher proportions of dyslipidemia (85.7%), hypertension (72.8%), and ischemic heart disease (IHD) (73.2%) were associated with urban residency (P<0.01). Conclusion:Hypertension was found to be the most frequent CVD followed by HF, and hypertensive heart disease was the leading cause of cardiac diseases. Most of the patients had improved assessment in the last follow-up, but patients from rural regions and those with comorbidty had higher likelihood of poor cardiovascular outcome.

studies, respectively, was conducted. Methods: A Bayesian ITC was performed on efficacy and safety on the non-gBRCA data from NOVA (niraparib) and gBRCA wild type data from S19 (olaparib). Efficacy analyses compared investigator (INV) and independent review committee (IRC) assessed PFS hazard ratios (HR) and TFST HR. Safety analyses included odds ratios (OR) of any grade ≥ 3 adverse event (AE), AEs leading to dose interruption, reduction, and discontinuation. Results: HRs comparing olaparib and niraparib were 0.94 (95% credible interval 0.54-1.65) for investigator-assessed PFS, and 1.25 (0.67-2.30) for IRC PFS. TFST HR was 0.78 (0.47-1.30). No significant difference in efficacy between PARPi was observed. The corresponding ORs for AE were 0.34 (0.13-0.90), 0.54 (0.16-2.06), 0.16 (0.01-2.18) and 0.21 (0.04-1.21) for any grade ≥ 3 AE, and AE leading to dose interruption, discontinuation, and reduction, respectively. There was a significant reduction in the odds of any grade ≥ 3 AE. No significant difference in AE leading to dose interruption, reduction, and discontinuation. ConClusions: ITC shows no significant difference in efficacy between olaparib capsules and niraparib tablets as maintenance therapy in patients with non-gBRCAm PSROC following response to chemotherapy. Olaparib shows significantly reduced odds compared with niraparib for any grade ≥ 3 AE. No significant difference was observed in AEs leading to modification in drug administration.

data" in 2015 public availability of such evidence has been highlighted. However, publication of clinical data is not a new issue and has been practiced before by HTA agencies like G-BA and IQWiG in Germany. The aim of this study is to determine the information provided in both, German dossiers/benefit assessments and the EMA database, comparing reporting quality. Methods: All documents were retrieved from the G-BA homepage and the EMA database until March 15th 2017. The following sources for extraction had to be available: Dossier module 4 and benefit assessment (G-BA), any clinical data available on the EMA database. Extraction included 16 study methods and 8 results items (method used by Koehler et al. BMJ 2015; 350: h796). Reporting quality was rated as "completely reported", "partly reported" or "not reported". Results: Overall only 2 drugs had both available, G-BA dossier/ assessment and EMA clinical data (Elotuzumab and Carfilzomib). For these 2 drugs 15 clinical studies were assessed. Both sources reached high grades of completeness. G-BA dossiers/assessments (2 studies) were 100% completely reported for methods (32 out of 32 items) and 87.5% completely reported for results (14 out of 16 items). For EMA clinical data (13 studies), the rate was 86.1% for methods (179 out of 208 items) and 97.1% for results (101 out of 104 items). ConClusions: Regarding reporting quality, no major differences between G-BA dossiers/assessments and EMA clinical data was observed. Both publicly available sources provide sufficient information on new drugs. Nevertheless, each datasource has advantages and deficits. AMNOG documents are available in German language only and the EMA database currently only contains a very limited number of newly approved drugs.