RIMASaud Institutional Repository of the Regional Health System
Not a member yet
61753 research outputs found
Sort by
Safety and quality of life with maintenance olaparib plus bevacizumab in older patients with ovarian cancer: subgroup analysis of PAOLA‑1/ENGOT-ov25.
No full text20.500.12530/87908In PAOLA-1/ENGOT-ov25, the addition of olaparib to bevacizumab maintenance improved overall survival in patients with newly diagnosed advanced ovarian cancer. We describe the safety profile and quality of life (QoL) of this combination in older patients in PAOLA-1. Safety (CTCAE v4.03) and QoL (EORTC QoL Questionnaires Core 30 and Ovarian 28) data were collected. We compared safety by age (≥70 vs Of 806 patients randomized, 142 were ≥70 years old (olaparib-containing arm: n = 104; placebo arm: n = 38). Older patients treated with olaparib exhibited a similar safety profile to younger patients, except for higher rates of all grades of lymphopenia and grade ≥3 hypertension (31.7% vs 21.6%, P =.032 and 26.9% vs 16.7%, P =.019, respectively). No hematological malignancy was reported. Two years after randomization, mean Global Health Status and cognitive functioning seemed better with olaparib than bevacizumab alone (adjusted mean difference: +4.47 points [95% CI, -0.49 to 9.42] and +4.82 [-0.57 to 10.21], respectively), and other QoL items were similar between arms. In the olaparib-containing arm, older patients with baseline GVS ≥ 1 (n = 48) exhibited increased toxicity and poorer QoL than those with GVS of 0 (n = 34). Among older patients in PAOLA-1, olaparib plus bevacizumab had a manageable safety profile and no adverse impact on QoL. Additional data are required to confirm these results in more vulnerable patients.(ClinicalTrials.gov Identifier: NCT02477644)
Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks.
No full text20.500.12530/87854To evaluate the long-term effectiveness, persistence and tolerability of dolutegravir (DTG)/lamivudine (3TC), compared with the most frequently prescribed first-line treatment regimens, among antiretroviral-naive people with HIV from CoRIS, a multicentre cohort in Spain, in 2018-23. We used multivariable regression models to compare viral suppression (VS) (HIV RNA viral load Of 2359 participants, DTG/3TC was prescribed in 472 (20.0%), bictegravir/tenofovir alafenamide (TAF)/emtricitabine (FTC) in 1134 (48.1%), DTG + tenofovir disoproxil fumarate/FTC in 300 (12.7%), DTG/abacavir/3TC in 273 (11.6%) and darunavir/cobicistat/TAF/FTC in 180 (7.6%). At 96 weeks from treatment initiation, 94.0% of participants initiating with DTG/3TC achieved VS, and the mean increase in CD4 cell counts was 295.5 cells/μL (95% CI: 269.9-321.1). During the first 96 weeks after DTG/3TC initiation, 9.8% and 1.3% discontinued their initial regimen, overall and due to AEs, respectively. In multivariable analyses, we did not find significant differences in VS or increase in CD4 cell counts among participants initiating with DTG/3TC compared with other regimens. Initiating ART with a regimen other than DTG/3TC was associated with a higher risk of treatment discontinuation, overall and due to AEs. Among treatment-naive people with HIV from this large multicentre cohort, DTG/3TC had similar effectiveness and better persistence and tolerability than those of the most frequently prescribed first-line regimens at 96 weeks
Integrating automated dispensing cabinets into the medication dispensing process: feedback from the practice in European hospitals.
No full text20.500.12530/87910Automated dispensing cabinets (ADCs) offer improved medication safety, greater efficiency and return on investment. However, integrating ADCs into medication dispensing processes can be challenging in complex hospital environments. This study aimed to draft suggestions to help hospitals adopt ADCs. Two-day visits were organised in seven European hospitals operating ADCs. Investigators used an observational grid, a questionnaire and interviews, each divided into the themes of medication processes before and after the introduction of ADCs, the major steps followed and the resources involved, ergonomics and staff perceptions. ADCs were integrated into four global hospital medication dispensing systems (packs of drugs are distributed from the central pharmacy to wards for dispensing) and three nominative systems-that is, patient-specific ones (drug doses prescribed for individuals are distributed from the central pharmacy to wards with ADC as supplementary stock). A general ADC project implementation timeline was shaped: main drivers of automation to initiate the project, visit of other sites, pilot test (with IT integration and staff training), and evaluation phase (satisfaction, safety, efficiency) to justify a possible expansion. Users (7 pharmacists, 21 nurses, 7 data engineers) identified facilitators (such as a dedicated project manager, a pilot phase, an intuitive device), barriers and any improvements needed (training for incoming staff, reorganisation of ward workflow, dynamic inventories). Despite their diverse pharmacy organisations, each hospital raised similar challenges and reported analogous major steps in project implementation. Although integration processes are complex, ADCs rapidly provide users with benefits. By following the practical advice and recommendations from these hospitals, new adopters might reduce the risks of failed ADC projects and accelerate their integration
Comprehensive diagnosis in chronic coronary syndromes combining angiography and intracoronary testing: the AID-ANGIO study
No full text20.500.12530/87873BACKGROUND: The diagnostic yield of invasive coronary angiography (ICA) in patients with chronic coronary syndromes (CCS) in contemporary practice is uncertain. AIMS: We investigated the value of an advanced invasive diagnosis (AID) strategy combining angiography and intracoronary testing. METHODS: AID-ANGIO is an all-comers, prospective, multicentre study enrolling CCS patients referred for ICA. Obstructive coronary artery disease (CAD) was investigated with angiography and pressure guidewires. In the absence of obstructive CAD, intracoronary testing for ischaemia with non-obstructive coronary arteries (INOCA) was performed. The primary endpoint was the proportion of patients with a cause of ischaemia identified by the AID strategy. To assess the effect of AID on decision-making, an initial therapeutic plan was first prepared by clinical cardiologists based on ICA and medical information. Subsequently, based on AID data, a final therapeutic plan was drafted by clinical and interventional cardiologists (Ischaemia Team). RESULTS: We enrolled 317 patients (44.2% female). Based on ICA, obstructive CAD was diagnosed in 32.2% of patients. With the AID strategy, a cause of myocardial ischaemia was identified in 84.2% (
Can Morphology and Immune Infiltration Predict the Homologous Recombination Deficiency Status in Newly Diagnosed High-Grade Serous Ovarian Carcinoma?: Lessons From the PAOLA-1/ENGOT-ov25 Trial, a GINECO Study.
No full text20.500.12530/87854A correlation between the morphology of ovarian high-grade serous carcinomas (HGSOCs) and BRCA mutations has been previously reported. To investigate, beyond BRCA, the association between the morphology of HGSOC and the presence of homologous recombination deficiency (HRD). We reviewed 522 of 806 cases of HGSOC from the PAOLA-1 clinical trial, including 163 cases with tumor BRCA mutation, 345 cases without tumor BRCA mutation, and 14 cases with inconclusive BRCA tests. Regarding HRD status (myChoice HRD Plus assay), 269 cases (52%) were positive (HRD+), 198 (38%) negative (HRD-), and 55 (10%) inconclusive. Morphologic analysis included tumor architecture (with more than 25% of solid, pseudoendometrioid, and transitional patterns defining a SET architecture), tumor-infiltrating intraepithelial lymphocytes (ieTILs), and tumor stromal lymphocytes (sTILs). SET architecture (51% versus 40%, P = .02), high number of ieTILs (16% versus 8%, P = .007), and more than 10% of sTILs (27% versus 18%, P = .02) were associated with tumor BRCA mutation, mostly for tumors with a BRCA1 mutation. These criteria were also associated with HRD status: 54% versus 33% (P The morphology of HGSOC correlates with HRD status and BRCA status but cannot substitute for molecular analysis in daily practice
Patient safety in general practice during COVID-19: a descriptive analysis in 38 countries (PRICOV-19).
No full text20.500.12530/87858This article aims to examine patient safety in general practice during COVID-19. In total, 5489 GP practices from 37 European countries and Israel filled in the online self-reported PRICOV-19 survey between November 2020 and December 2021. The outcome measures include 30 patient safety indicators on structure, process, and outcome. The data showed that structural problems often impeded patient safety during COVID-19, as 58.6% of practices (3209/5479) reported limitations related to their building or infrastructure. Nevertheless, GP practices rapidly changed their processes, including the appointment systems. Implementation proved challenging as, although 76.1% of practices (3751/4932) developed a protocol to answer calls from potential COVID patients, only 34.4% (1252/3643) always used it. The proportion of practices reported having sufficient protected time in general practitioners' schedules to review guidelines remained consistent when comparing the pre-COVID (34.2%,1647/4813) with the COVID period (33.2%,1600/4813). Overall, 42.8% of practices (1966/4590) always informed home care services when patients were diagnosed with COVID-19, while this decreased to 30.1% for other major infectious diseases (1341/4458). Most practices reported at least one incident of delayed care in patients with an urgent condition, most often because the patient did not come to the practice sooner (60.4%, 2561/4237). Moreover, 31.1% of practices (1349/4199) always organized a team discussion when incidents happened. Overall, large variations were found across countries and patient safety indicators. The results demonstrated that European GP practices adopted numerous measures to deliver safe care during COVID-19. However, multilayered interventions are needed to improve infection control and GP practice accessibility in future pandemics
Pituitary Apoplexy: Comorbidities, Management, and Outcomes-A Spanish Observational Multicenter Study.
No full textPituitary apoplexy (PA) is the paradigm of endocrine and neurosurgical emergency. To evaluate the comorbidities, risk factors, clinical presentation, pituitary apoplexy score (PAS), and the outcomes of surgical vs conservative management of PA in Spain. Spanish multicenter, observational study of 301 patients with acute PA. Statistical analyses compared risk factors, clinical presentation, and outcomes between surgical and conservative treatment groups, adjusting for potential confounders. The prevalence of cardiovascular risk factors in patients with PA was compared with the Spanish population and with patients with nonfunctioning pituitary adenomas. Median age was 59.3 years, 201 (66.8%) were men; nonfunctioning adenomas (77.9%) were the most common tumor type. The prevalence of diabetes (20.3% vs 13.9%, P There is a high burden of cardiovascular risk factors among patients with PA, suggesting that metabolic factors may play a potential role in the development of PA. This underscores the need for comprehensive management of these conditions in addition to treating the apoplexy itself in this population. Surgical management has a relevant place in PA approach mainly in patients with higher PAS. However, it leads a permanent vasopressin deficit more frequently than a conservative approach
Comparative efficacy and safety of talazoparib plus enzalutamide and other first-line treatments for metastatic castration-resistant prostate cancer.
No full textTalazoparib plus enzalutamide (TALA + ENZA) has demonstrated antitumor activity in the phase 3 clinical trial (TALAPRO-2; NCT03395197) as first-line (1L) therapy in men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC). Although many active interventions are available, randomized controlled trials (RCTs) involving talazoparib have only been conducted to assess its efficacy and safety compared to enzalutamide. To estimate comparisons between all relevant interventions, indirect comparisons are needed. To estimate the comparative efficacy and safety of TALA + ENZA in 1L patients with mCRPC by conducting a systematic literature review and network meta-analyses (NMAs). Databases were searched using Ovid, along with several gray literature sources to identify RCTs evaluating treatments in 1L mCRPC (PROSPERO registration: CRD42021283512). Feasibility assessment evaluated trial suitability for NMA inclusion and Bayesian or frequentist NMAs were conducted for evaluable efficacy and safety outcomes, respectively. Thirty-three RCTs met the eligibility criteria and were feasible for NMAs. Across multiple efficacy outcomes assessed, except for overall survival (OS), TALA + ENZA was ranked the most efficacious treatment. For OS, TALA + ENZA showed the second-highest probability of being the most effective treatment; second to docetaxel 50 mg plus prednisolone 10 mg. With respect to safety outcomes, TALA + ENZA, in general, showed increased rates of hematological adverse events. TALA + ENZA showed favorable results across multiple efficacy endpoints, but not across hematological toxicities compared with other 1L treatments in asymptomatic or mildly symptomatic mCRPC in the all-comers patient population
Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks.
No full text20.500.12530/87908To evaluate the long-term effectiveness, persistence and tolerability of dolutegravir (DTG)/lamivudine (3TC), compared with the most frequently prescribed first-line treatment regimens, among antiretroviral-naive people with HIV from CoRIS, a multicentre cohort in Spain, in 2018-23. We used multivariable regression models to compare viral suppression (VS) (HIV RNA viral load Of 2359 participants, DTG/3TC was prescribed in 472 (20.0%), bictegravir/tenofovir alafenamide (TAF)/emtricitabine (FTC) in 1134 (48.1%), DTG + tenofovir disoproxil fumarate/FTC in 300 (12.7%), DTG/abacavir/3TC in 273 (11.6%) and darunavir/cobicistat/TAF/FTC in 180 (7.6%). At 96 weeks from treatment initiation, 94.0% of participants initiating with DTG/3TC achieved VS, and the mean increase in CD4 cell counts was 295.5 cells/μL (95% CI: 269.9-321.1). During the first 96 weeks after DTG/3TC initiation, 9.8% and 1.3% discontinued their initial regimen, overall and due to AEs, respectively. In multivariable analyses, we did not find significant differences in VS or increase in CD4 cell counts among participants initiating with DTG/3TC compared with other regimens. Initiating ART with a regimen other than DTG/3TC was associated with a higher risk of treatment discontinuation, overall and due to AEs. Among treatment-naive people with HIV from this large multicentre cohort, DTG/3TC had similar effectiveness and better persistence and tolerability than those of the most frequently prescribed first-line regimens at 96 weeks
Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series.
No full text20.500.12530/87908Bullous pemphigoid (BP) affects elderly individuals with multiple comorbidities, making conventional treatments unsuitable. Evaluate the effectiveness and safety of dupilumab in the treatment of BP. A multicentre ambispective cohort study was conducted across 34 hospitals. Patients with BP treated with dupilumab were included. Most of the patients (97.1%) received an initial 600-mg dose followed by 300 mg every 2 weeks. The primary outcome was the proportion of patients achieving complete remission (CR) within 4 weeks, defined as an Investigator's Global Assessment score of 0 or 1. CR at weeks 16, 24 and 52, adverse events (AEs), reductions in Peak Pruritus Numerical Rating Scale (PP-NRS) and systemic glucocorticoid use were also assessed. The study included 103 patients with a median age of 77.3 years; 58.3% were male. CR was achieved by 53.4% within 4 weeks and 95.7% by week 52. The PP-NRS score reduced by 70.0% by week 4 and was completely controlled by week 24. Thirteen patients presented with AEs, most of which were mild. Systemic glucocorticoid use reduced by 82.1% by week 52. Shorter disease duration and exclusive cutaneous involvement predicted better response at 16 weeks. No differences in response rates to dupilumab were observed between drug-associated BP and idiopathic cases. No significant difference in response rates was observed between patients treated with dupilumab in monotherapy and those receiving dupilumab with concomitant treatments. Dupilumab is effective, rapid and safe in managing BP, reducing the need for corticosteroids and other treatments. Early initiation and exclusive skin involvement predict better outcomes