Prevalence and factors associated with poor sleep quality in inflammatory bowel disease outpatients.

INTRODUCTION: sleep disorders are common in the general population and have obvious repercussions on quality of life. Poor sleep quality is associated to inflammatory activity and fatigue in inflammatory bowel disease (IBD) patients. This study aimed to analyze the prevalence of poor sleep quality and the factors associated with it, in IBD outpatients. METHODS: an observational and prospective study was performed in which epidemiological, clinical and laboratory data were collected from clinical records and patients who consecutively attended an outpatient clinic. Pittsburgh Sleep Quality index (PSQI), Hospital Anxiety and Depression Scale (HADS) and International Physical Activity Questionnaire (IPAQ) were used to measure sleep quality, anxiety, depression and physical activity, respectively. Treatment optimizations, hospital admissions or surgery were prospectively verified three months after the baseline visit. RESULTS: one hundred and two patients were included and 54.9 % had poor sleep quality (PSQI score > 5). No association was found between poor sleep quality and IBD-related variables such as type of disease, ulcerative colitis (UC) extent, Crohn's disease (CD) location or behavior, time from diagnosis, treatment, prior admissions or surgery and laboratory values. Rotating night shift job (OR 6.116, 95 % CI: 1.312-28.514), HAD score for depression (OR 1.125, 95 % CI: 1.062-1.490) and frequency (days per week) of vigorous physical activity (OR 0.783, 95 % CI: 0.619-0.991) were independent predictors of poor sleep quality. A Pittsburgh questionnaire score higher than 5 was not significantly associated to treatment optimization in the total patient cohort (15.2 % vs 18.2 %, p = 0.451), in UC patients (18.2 % vs 10.7 %, p = 0.362) or CD patients (12.5 % vs 25.9 %, p = 0.198). CONCLUSIONS: poor sleep quality is present in more than half of IBD patients. Aspects not directly related to IBD are associated to poor sleep quality.

[The chest x-ray in acute bronchiolitis: Technical quality, findings, and an assessment of its reliability]. / La radiografía de tórax en la bronquiolitis aguda: calidad técnica, hallazgos y evaluación de su fiabilidad.

INTRODUCTION: Despite the recommendations of the current Clinical Practice Guidelines, the chest x-ray continues to be a widely used diagnostic test in the assessment of infants with acute bronchiolitis (AB). However, there have not been many studies that have assessed its reproducibility in these patients. In the present study, an evaluation is made on the radiographs, describing their quality, their radiological findings, and provides new evidence on the agreement between observers. METHOD: Out of a total of 281 infants admitted due to acute bronchiolitis, 140 chest x-rays were performed. Twelve doctors from different specialities evaluated the presence or absence of 10 radiological signs previously agreed by consensus. The level of agreement between 2 observers, and in groups of 3 or more, were analysed using the Cohen and Fleiss kappa index, respectively. RESULTS: Only 8.5% of the radiographs showed evidence of a complicated AB. The between-observer agreement in groups of 3 or more was medium, and with little variability (kappa: 0.20-0.40). However, between 2 observers, each observer against radiologist, the variability was wider, (kappa: -0.20-0.60). This level of agreement was associated with factors including, the sign to evaluate, the medical specialty, and level of professional experience. CONCLUSION: The low levels of agreement between observers and the wide variability, makes the chest x-ray an unreliable diagnostic tool, and is not recommended for the assessment of infants with AB.

Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study.

This randomized multicenter phase III trial evaluated the role of maintenance therapy with pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m(2)) followed by three cycles of docetaxel (100 mg/m(2)) both every 21 days, were randomized to PLD (40 mg/m(2)) every 28 days for six cycles or to observation. Time to progression (TTP) was the primary endpoint. 288 patients were enrolled and received induction first-line chemotherapy. One hundred and fifty-five achieved response or stable disease and were randomized to maintenance PLD (n = 78) or observation (n = 77). With a median follow-up of 20 months from randomization (range 1-56), disease progression occurred in 94% of patients. PLD significantly improved TTP by 3.3 months (8.4 vs. 5.1 months; hazard ratio [HR] = 0.54, 95% CI: 0.39 to 0.76, P = 0.0002) compared with observation. Overall survival was not significantly prolonged with PLD (24.8 vs. 22.0 months, respectively; HR = 0.86, 95% CI: 0.58-1.27, P = 0.44). PLD-induced toxicity was mild and manageable with up to 5% of patients experiencing grade 3/4 non-hematologic events (fatigue, mucositis, palmar-plantar erythrodysesthesia). Grade 3/4 neutropenia occurred in 12% of patients; two patients developed febrile neutropenia. This phase III trial demonstrated that maintenance chemotherapy with PLD is well tolerated and offers improved TTP in patients with MBC following first-line chemotherapy.

GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer.

Response to polyadenosine diphosphate ribose polymerase (PARP) inhibitors in platinum-resistant ovarian cancer and in the absence of BRCA mutations is very low. Combining PARP inhibitors with other agents might overcome this lack of activity. Here we describe the rationale and design of GEICO1601-ROLANDO (resistant ovarian cancer treated with olaparib and pegylated liposomal doxorubin; NCT03161132). ROLANDO is a Phase II single-arm multicenter trial in which patients are treated with a combination of olaparib and pegylated liposomal doxorubicin (PLD) in platinum-resistant epithelial ovarian, primary peritoneal, or Fallopian tube cancer regardless of the BRCA mutation status. The primary end point is progression-free survival at 6 months. Other secondary end points are response rate, disease control rate, quality of life and overall survival.