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We compared patient-reported outcomes (PROs) with once-weekly carfilzomib 70 mg/m 2 (Kd70 mg/m 2 ) vs. twice-weekly carfilzomib 27 mg/m 2 (Kd27 mg/m 2 ) plus dexamethasone in relapsed or refractory multiple myeloma (RRMM). Patient-reported convenience/satisfaction collected at Cycle 2, Day 1 was compared between groups using logistic regression. European Organization for Research and Treatment of Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires were administered at baseline, then every other cycle. PROs were compared between groups using mixed models for repeated measures. Times from randomization to first deterioration (TTD) in scores were analyzed using Cox regression. PRO analyses included 469 patients. Once-weekly Kd70 mg/m 2 patients reported greater convenience (odds ratio [OR], 4.98; p  < 0.001) and satisfaction (OR, 2.41; p  = 0.059) vs. twice-weekly Kd27 mg/m 2 . The mixed models for repeated measures demonstrated no clinically meaningful differences in scores between treatment arms. Clinically meaningful deterioration in QLQ-C30 Global Health Status/QOL rates were 34.2% (once-weekly Kd70 mg/m 2 ) vs. 40.3% (twice-weekly Kd27 mg/m 2 ). TTD was longer for once-weekly Kd70 mg/m 2 vs. twice-weekly Kd27 mg/m 2 for QLQ-C30 fatigue (HR, 0.79; p  = 0.035), QLQ-MY20 disease symptoms (HR, 0.67; p  = 0.008), EQ-5D-5L index score (HR, 0.58; p  = 0.002), and EQ-5D-5L Visual Analog Scale (HR, 0.75, p  = 0.031). Once-weekly Kd70 mg/m 2 improved convenience/satisfaction, and reduced HRQOL deterioration vs. twice-weekly Kd27 mg/m 2 , supporting convenient, once-weekly Kd70 mg/m 2 dosing in RRMM.

Aims Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. Methods We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. Results The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. Discussion Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. Systematic review registration PROSPERO No. CRD42018103179

Background: Antimicrobial resistance is a global health crisis associated with high mortality and economic burden. Patients with renal dysfunction and obesity have increased susceptibility to infections and may experience different real-world outcomes, including clinical success and mortality, but are often under-represented in clinical trials. Ceftolozane/tazobactam (C/T) is an innovative therapy used to treat resistant Gram-negative infections. We aimed to describe real-world clinical outcomes in hospitalized adults treated with C/T across categories of renal function and BMI in the SPECTRA study. Methods: SPECTRA was a multi-national observational study on 617 patients who received C/T for ≥48 h. Outcomes included clinical success, all-cause in-hospital mortality, readmission, and ICU admission and length of stay (LOS), with sub-analysis of patients across BMI and renal function strata. Results: Renal function and weight were reported in 597 and 469 patients, respectively, of which 51.9% had lower creatine clearance (<80 mL/min) and 50.7% were overweight. Clinical success and all-cause in-hospital mortality ranged at 59.1–77.8% and 11.1–29.2% across renal function strata and 64.6–68.6% and 18.6–21.4% across weight subgroups. Across renal function and weight subgroups, 38.9–54.2% and 45.9–53.5% of patients were admitted to ICU. Median ICU LOS was 8–21.5 and 14–20 days, respectively. Readmission (30-day all-cause) occurred in 4.5–11.8% and 8.2–11.9% of patients across renal function and weight strata. Conclusions: Results from this sub-analysis suggest real-world clinical effectiveness of C/T across patients with renal impairment and obesity, highlighting C/T as a component within treatment guidelines for resistant Gram-negative infections.

Effects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) who received their first stem cell transplant (SCT) within 1 year of initial MM diagnosis were estimated using a large US claims database. Disease progression was defined as advancement to the next LOT, bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, acute kidney disease, or death within 12 months of LOT initiation. Annual HRU and costs in the first three LOTs (L1–L3) were compared for patients with versus without disease progression using inverse probability of treatment weighting to adjust for differences between groups in baseline characteristics. In all LOTs, mean annual hospitalizations and healthcare costs were greater for patients with versus without progression. Total incremental annual costs among patients with versus without progression in L1–L3 were $18,359, $87,055, and $71,917, respectively, among LOTs initiated between 2006 and 2018. In LOTs initiated between 2013 and 2018, the figures were $46,024, $100,329, and $101,942 in L1–L3, respectively. The economic burden of disease progression is substantial in this population of MM patients who underwent SCT and received systemic anti-myeloma therapy.

Background Several options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients’ perspectives of and satisfaction with different G-CSF options. Results Three oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF–related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items). Conclusions The SEQ-G-CSF is a novel instrument that quantifies a patient’s experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

This study assessed the clinical burden of carbapenemase-producing Enterobacterales (CPE) infections according to different resistance mechanisms among Enterobacterales isolates in Spain. This retrospective study was conducted in five Spanish hospitals from the National Mapping of Carbapenemases in Spain study. Patients were included if they were 18 years or older; had a diagnosis of complicated intraabdominal infection (cIAI), complicated urinary tract infection (cUTI), bloodstream infection (BSI), or hospital-acquired or ventilator-acquired bacterial pneumonia (HABP/VABP) between 2017 and 2018; and had a confirmed CPE isolate. In total, 118 patients were evaluable for clinical outcomes. The most common mechanism of carbapenem resistance was carbapenemase (KPC; n = 82, 69.5%), followed by OXA-48 (n = 27, 22.9%) and metallo-β-lactamases (MBL; n = 9, 7.6%). Overall, 75 patients (63.6%) died from any cause, including 21 deaths (28.0% of all deaths) attributable to the current infection. Clinical cure was achieved in 92 patients (78.0%) and microbiological cure in 59 (54.6%). Among the 92 patients discharged alive, 29 (31.5%) were readmitted for an infectious disease, and relapse within 30 days occurred in 10 patients (10.9%). Data suggest that CPE infections are associated with a high disease burden, low rates of clinical cure, and high rates of relapse and mortality in Spain. However, results should be interpreted with caution due to the limited sample size which may have restricted the precision of these estimates and gaps in minimal inhibitory concentration data availability.

Background: Antimicrobial resistance is a major global public health challenge, particularly with the rise of carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa (CRPA). This study aimed to describe the characteristics of CRE and CRPA infections in Eastern Europe, focusing on Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Serbia, Slovakia, and Slovenia. Methods: Following MOOSE and PRISMA guidelines, a systematic literature review of articles published between 1 November 2017 and 1 November 2023 was conducted using the MEDLINE, Embase, Web of Science, CDSR, DARE, and CENTRAL databases. The search strategy used a combination of free text and subject headings to gather pertinent literature regarding the incidence and treatment patterns of CRE and CRPA infections. A total of 104 studies focusing on infections in both children and adults were included in this review. Results: This review revealed a significant prevalence of carbapenem-resistant Gram-negative isolates and underscored the effectiveness of imipenem/relebactam and ceftazidime/avibactam (CAZ/AVI) against Klebsiella pneumoniae carbapenemase-producing Enterobacterales and of ceftolozane/tazobactam, imipenem/relebactam and ceftazidime/avibactam against non-metallo-β-lactamase-producing CRPA strains. Conclusions: This study highlights the urgent need for comprehensive measures to combat the escalating threat of CRE and CRPA infections in Eastern European countries. At the same time, it shows the activity of the standard of care and new antimicrobials against carbapenem-resistant Gram-negative pathogens in Eastern Europe. Clinical real-world data on the treatment of carbapenem-resistant infections in Eastern Europe are needed.

Introduction: The emergence and spread of multidrug-resistant infections has resulted in significant clinical and economic burdens. To address these infections, novel therapy combinations are needed. Ceftolozane/tazobactam is a treatment option that targets multidrug-resistant pathogens and may offer improved patient outcomes compared to traditional antibiotics that are now often ineffective. Objectives: Our objective was to collate findings from comparative efficacy studies to assess the efficacy of ceftolozane/tazobactam for the indications of complex intra-abdominal infection, complex urinary tract infection, ventilated hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Methods: Two systematic literature reviews were conducted, including randomized controlled trials comparing ceftolozane/tazobactam with other interventions for complex intra-abdominal infection, complex urinary tract infection, ventilated hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia indications. The outcomes of interest were mortality, clinical cure and microbiological eradication. Results: Ceftolozane/tazobactam was determined to be non-inferior to comparators for all outcomes of interest. All-cause mortality for ceftolozane/tazobactam displayed non-inferiority to meropenem, with the largest numerical differences in all-cause mortality displayed in susceptible patients, such as those with severe renal impairment. Similarly, the clinical cure and microbiological eradication for ceftolozane/tazobactam demonstrated non-inferiority compared to meropenem or levofloxacin. Conclusions: These reviews support the role of ceftolozane/tazobactam as an alternative option, particularly when MDR pathogens are suspected or documented. Their findings may contribute to the standardization of treatment guidelines, ultimately helping to reduce the clinical and economic burdens associated with these infections.

Background: AMR is a public health concern which leads to high global morbidity and mortality. Immunocompromised patients, who are more susceptible to contracting potentially life-threatening infections, are faced with reduced treatment options due to emerging AMR. Ceftolozane/tazobactam is a novel β-lactam/β-lactamase inhibitor which displays effectiveness against resistant Gram-negative infections. Methods: SPECTRA was a multinational, observational study conducted in seven countries including 617 patients who received ≥48 h of ceftolozane/tazobactam. Medical-record data were collected up to 6 months before treatment and 30 days after the final dose or until death. This analysis describes clinical outcomes and healthcare resource use in patients with sepsis or who were immunocompromised, specifically in patients with hematologic malignancy with and without solid tumor, febrile neutropenia, and solid organ transplant patients. Results: Clinical success ranged from 50.0% in patients with hematologic malignancy and solid tumor to 69.4% in 38 patients with febrile neutropenia. All-cause in-hospital mortality was 23.1–42.9%, with the lowest rates in patients with solid organ transplant. ICU admission was 46.4–68.2% across subpopulations (excluding febrile neutropenia) with the lowest rates in patients with hematologic malignancy. ICU length of stay was lowest within transplant patients (9 days) and highest within the hematologic malignancy and solid tumor population (32 days). Conclusions: The results from this sub analysis of SPECTRA showed that ceftolozane/tazobactam was associated with clinical success in the selected immunocompromised and sepsis patient populations and may lead to reduced morbidity, mortality, and healthcare-resource use. Further research is required to standardize treatment protocols and improve patient outcomes.

Introduction: Infections attributed to multidrug-resistant organisms have resulted in a significant clinical burden, high mortality, and excessive costs. Identifying the most appropriate and efficacious treatments will aid in reducing these burdens. Imipenem/cilastatin + relebactam (I/R) is used against multidrug-resistant infections providing an alternative option which may support patients where traditional treatments are no longer effective. Objective: The objective was to evaluate the efficacy of I/R for complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia, based on data aggregated from randomized controlled trials. Method: Two systematic literature reviews were conducted to include randomized controlled trials which aligned with the inclusion criteria reporting on the efficacy of I/R against placebo or other comparators such as piperacillin/tazobactam or colistin. The outcomes of interest were mortality, clinical response, and microbiological response. Results: The results found reduced mortality and comparable clinical and microbiological response with I/R versus its comparators. I/R displayed the largest favorable clinical and microbiological responses within high-risk populations, including those with severe renal impairment when compared with piperacillin/tazobactam. Conclusions: These findings support the efficacy of I/R for key Gram-negative infections, particularly within vulnerable patient populations. Despite the favorable outcomes reported, there is a need for further real-world evidence generation to support the efficacy of I/R to aid in standardizing treatment guidelines and reducing the clinical and economic burden associated with multidrug-resistant bacterial infections.