Chronic ecologically relevant stress effects on reverse-translated touchscreen assays of reward responsivity and attentional processes in male rats: Implications for depression.

Stagnation in the development of novel therapeutic strategies for treatment-resistant depression has encouraged continued interest in improving preclinical methods. One tactic prioritizes the reverse translation of behavioral tasks developed to objectively quantify depressive phenotypes in patient populations for their use in laboratory animals via touchscreen technology. After cross-species concordance in task outcomes under healthy conditions is confirmed, construct validity can be further enhanced by identifying environmental stressors that reliably produce deficits in task performance that resemble those in depressive participants. The present studies characterized in male rats the ability of two chronic ecologically relevant stressors, inescapable ice water or isolated restraint, to produce depressive-like behavioral phenotypes in the Probabilistic Reward Task (PRT) and Psychomotor Vigilance Task (PVT). These tasks previously have been reverse-translated using touchscreen technology for rodents and nonhuman primates to objectively quantify, respectively, reward responsivity (anhedonia) and attentional processes (impaired cognitive function), each of which are core features of major depressive disorder. In the PRT, both inescapable ice water and isolated restraint produced persistent anhedonic phenotypes compared to non-stressed control performance (i.e., significantly blunted response bias for the richly rewarded stimulus). In the PVT, both chronic stressors impaired attentional processing, revealed by increases in titrated reaction times; however, these deficits largely subsided by the end of the chronic condition. Taken together, these findings confirm the ability of reverse-translated touchscreen tasks to effectively generate behavioral phenotypes that exhibit expected deficits in performance outcomes following exposure to chronic ecologically relevant stress. In turn, this approach is well positioned to appraise the ability of candidate therapeutics to attenuate or reverse such behavioral deficits and, thereby, contribute to preclinical medications development for treatment-resistant depression.

Unveiling the intersection: exploring obstetric violence in the Era of COVID-19 in Ecuador.

INTRODUCTION: Changes to healthcare delivery organization that have occurred to protect people from the virus COVID-19 may have led to harmful consequences to pregnant women intensifying obstetric violence. Prevalence of obstetric violence in Ecuador is high with a range between 30 and 70% approximately. METHODS: This cross-sectional study was performed with the participation of 1298 women who answered EPREVO questionnaire from June 2021 to January 2022. Obstetrics characteristics' relationship before and during COVID-19 were examined using Fisher exact test. RESULTS: From 1598 respondents, 1284 (80.4%) gave birth before March 2020 Most of the participants (73.6%; CI:73.59-73.61) experienced obstetric violence during childbirth. Vaginal examination, enemas and genital shaving, episiotomy and cesarean section decreased significantly as well as rooming with the baby during the pandemic. Half of the women did not breastfeed the baby in the first hour but there were not statistically significant differences between giving birth before or during the infection from COVID-19. CONCLUSIONS: Levels of obstetric violence in Ecuador remains high but without major differences due to the COVID-19 pandemic, however some harmful medical practices considered as obstetric violence decreased but maybe to the fear to be infected by the virus.

Actinic keratoses in subjects from la Mitad del Mundo, Ecuador.

BACKGROUND: Quito, the capital of Ecuador due to its geographical location, has a high skin cancer incidence. Actinic keratoses, as premalignant lesions, are precursors of nonmelanoma skin cancer, and the prevalence of this medical condition in the country is unknown. METHODS: An observational, cross-sectional study was performed to assess the prevalence of actinic keratoses (AKs) in a rural area of Quito. Visual skin exams, dermoscopy and biopsy of suspicious lesions were performed. RESULTS: A total of 254 subjects older than 40 years old (71.3% female) were enrolled. The general AK prevalence was 22.4%; in women, the prevalence was 23.6%, while in men, it was 19.4%. The prevalence rates of basocellular and squamous cell carcinomas and Bowen disease were 1.6, 0.8 and 0.4%, respectively. No statistical associations were found between AKs and the studied variables. CONCLUSIONS: This study was the first reporting the prevalence of premalignant lesions in Ecuador. We could not demonstrate a relationship between the presence of AKs and any of the known risk factors for their development.

Validity of the Fitzpatrick Skin Phototype Classification in Ecuador.

BACKGROUND: The Fitzpatrick Skin Phototype Classification (FSPC) is the most common tool used to assess skin phototype in White populations according to the amount of pigment the skin has and its reaction to sun exposure. Scientific evidence about the use of this scale for persons with darker skin is limited. OBJECTIVE: To assess the internal consistency, reliability, and construct validity of the FSPC for Ecuadorians. METHODS: This observational cross-sectional study recruited participants of both sexes between 40 and 90 years of age living in a rural area of Quito, Ecuador. Cronbach α values were used to assess the internal consistency of the scale. Construct validity was assessed with confirmatory factor analysis. RESULTS: The internal consistency coefficients indicated that the reliability of the responses to the scale was fair. Total α value was .515, whereas the α values of the two factors were .42 and .67. Most item-to-factor correlations had a low to moderate magnitude, ranging from r = 0.30 to 0.37. Confirmatory factor analysis supported a two-factor solution and achieved good overall fit as indicated by root mean square error of approximation = 0.08, and nonnormed fit index = 0.88 was mediocre. Goodness-of-fit χ = 177.10, P < .001. The factor loads were greater than 0.30, ranging from 0.30 to 0.99. CONCLUSIONS: The FSPC showed an acceptable construct validity and a fair internal consistency. The five-item scale could potentially be used as an effective instrument for assessing skin phototype in non-White people.

The relationship between conformity to male and female gender norms and depression during pregnancy.

To analyze whether there is an association between conformity to male and female gender norms and the Edinburgh Postnatal Depression Scale (EPDS) score as an indicator of depression during pregnancy, a cross-sectional study was made to a sample of 200 pregnant women being seen at any of the public primary care centers in Segovia (Spain) for the prenatal care. A score of 13 points or higher on the Spanish version of the EPDS is considered to be an indicator of antenatal depression. The Conformity to Feminine Norms Inventory (CFNI-84) and the Conformity to Masculine Norms Inventory (CMNI-94) were used to determine the degree of conformity to gender norms. Descriptive and inferential statistics, as well as multivariate analysis, were carried out. Logistic regression analysis showed the Nice in Relationships Subscale score to be associated with a decreased risk of depression (OR = 0.88; 95%CI 0.79-0.98; p = 0.029). In addition, the CMNI total score, as well as the Self-Reliance subscale, were associated with an increased risk of depression (OR = 1.04; 95%CI 1.01-1.07; p = 0.022; OR = 1.30; 95%CI 1.08-1.55; p = 0.004, respectively). An association between conformity to male gender norms and nonconformity to some female gender norms in pregnant women and a score on the EPDS indicating depression during pregnancy was found. Particularly, an increase in the CMNI total score was associated to increased risk of suffering depression in the pregnant women studied.

[Factors associated with the anxiety level and knowledge about childcare and lactation in first-time pregnant women]. / Factores asociados al nivel de ansiedad y de conocimientos sobre puericultura y lactancia de embarazadas primerizas.

OBJECTIVE: To know the level of anxiety and knowledge of childcare and lactation of the current pregnant women, and the clinical-demographic variables with which they are related. DESIGN: Cross-sectional study. SETTING: Seven health centers of Area V (Asturias). PARTICIPANTS: First-time pregnant women who completed preparatory courses from 01.06.2015 to 31.10.2015, excluding multiple gestation, risk pregnancy, contraindicated breastfeeding and language problems. INTERVENTIONS: Sociodemographic variables questionnaire, STAI state anxiety questionnaire and 23 questions about childcare and lactation. MAIN MEASUREMENTS: We performed descriptive and multivariate analysis (program R) of the variables of the questionnaire. RESULTS: We captured 104 pregnant women; average age 34.2(SD: 4.5), 94.2% Spanish, 61.5% university, 17.3% smokers in pregnancy, 23.1% with psychopathological antecedents; 88.4% planned to give breastfeeding. The mean STAI-S was 18.1(SD: 7.4) and scored 4.5(SD: 2.3) mean errors. The most faulty ones were on causes of fever (56.7%), fever measurement (54.8%) and physiological stools (55.7%). The multivariate analysis between knowledge and profile showed statistically significant associations with: being foreign, university, pregnancy planning and matron. In relation to the STAI-S was significant for being a smoker, receiving breastfeeding, psychopathological antecedents and matron. CONCLUSIONS: The current pregnant women who complete preparatory courses are mainly mature, university and Spanish. They have good concepts about breastfeeding but many are unaware of basic concepts of fever and stool of the infant. Foreign mothers with unwanted pregnancy and primary education seem to have more confusing concepts. Smoking mothers with psychopathological antecedents and who have not received breastfeeding present more anxiety. The matron significantly influences anxiety and acquired concepts.

Epidemiological characteristics of a Zika outbreak in Portoviejo, Ecuador, 2016.

OBJECTIVE: To estimate the number and percentage of cases with Zika diagnosis at a hospital in Portoviejo, Manabí, Ecuador. METHODS: This was a hospital-based, retrospective, observational, descriptive, cross-sectional study conducted at the Dr. Verdi Cevallos Balda Hospital from January - August 2016. A secondary analysis of a database was performed to estimate the number and percentage of patients positive for Zika virus, by sex, age group, ethnicity, and type of medical care. Prevalence and odds ratios with 95% Confidence Intervals were calculated using the Mantel and Haenszel method. Laboratory diagnostics included assays for the detection of Zika, chikungunya, dengue, and others. RESULTS: In all, 467 suspected cases of Zika were identified based on clinical criteria. Of these, 148 cases (31.7%) were confirmed by detection of ZIKV RNA. The peak of the outbreak was documented in May - July 2016 during the rainy season, following the earthquake of April 2016. The adjusted odds ratios indicated that Zika virus was less likely in men and in subjects < 20 years of age. Most of the infected pregnant women (61%) were in the second trimester of pregnancy. No cases of microcephaly were reported. CONCLUSIONS: Because Zika was more likely to occur among women and those ≥ 20 years of age, surveillance of these groups is imperative to avoid transmission to newborns. Future studies that address the research gap and inform the country's Zika control efforts are recommended.

Sex-specific associations of different anthropometric indices with acute and chronic insomnia.

Background: Sleep disorders, including insomnia, are risk factors for weight gain. However, few epidemiological studies have investigated the association of anthropometric markers with insomnia as an outcome. Methods: In this observational, cross-sectional study, we assessed the association of 3 different anthropometric indices with acute and chronic insomnia. We used data from 13 389 French adults (mean age= 51.9 ± 13.1 years; 70.3% women) enrolled in the NutriNet-Santé-Biobank cohort. Body weight, height, waist and hip circumference were measured once during a clinic visit (2011-14). Body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) were the main predictors. Acute (past 8 days) and chronic (≥3 months) insomnia were assessed in 2014 via a self-report questionnaire. We fit multivariable logistic regression models providing odds ratios (OR) and 95% confidence intervals (CI). Results: Overweight (25.0 ≤ BMI < 30.0 kg/m2) and general obesity (BMI ≥ 30.0 kg/m2) appeared to have an inverse association with acute insomnia only among men (overweight: OR= 0.80, 95% CI: 0.70, 0.92; obesity: OR= 0.78, 95% CI: 0.63, 0.98). Obesity assessed by BMI and WHR appeared to be positively associated with chronic insomnia only among women (BMI: OR= 1.23, 95% CI: 1.04, 1.45; WHR: OR= 2.24, 95% CI: 1.07, 4.72). WC did not display any significant associations in either sex. Conclusions: These cross-sectional results revealed sex-specific associations of overweight/obesity with different types of insomnia, and merit confirmation longitudinally with objectively assessed sleep parameters. Nonetheless, the findings reinforce the critical importance of joint health behaviour promotion.

Major Change in Body Weight over 5 Years and Total Sleep Time: Investigation of Effect Modification by Sex and Obesity in a Large e-Cohort.

PURPOSE: We assessed the association of long-term weight change ≥5 kg with total sleep time (TST), investigating effect modification by sex and overweight/obesity. METHOD: In a cross-sectional context, we studied 41,610 adults from the general population-based NutriNet-Santé e-cohort. A sleep questionnaire was self-administered in 2014. It included sleep logs for the estimation of average TST at night, and items for the calculation of major weight change as experienced over the previous 5 years. We fit multivariate polytomous logistic regression models. RESULTS: Overall, women with major weight loss had an increased likelihood of short TST (≤6 h) when compared with women with stable weight (OR = 1.15, 95% CI: 1.05-1.25). Individuals with major weight gain had an increased likelihood of short TST compared with their counterparts with stable weight (men: OR = 1.20, 95% CI: 1.05-1.37; women: OR = 1.24, 95% CI: 1.15-1.33). Men with major weight gain were less likely to report long TST compared with men with stable weight (OR = 0.83, 95% CI: 0.70-0.97). Overweight or obesity did not moderate the associations. CONCLUSIONS: The study advances knowledge in the fields of public health and nutrition by providing some evidence of a sex-specific association of major weight change with both short and long TST. These associations merit future investigation in a longitudinal context with repeated, objective measures of both weight and sleep time, while applying more stringent interaction test criteria and accounting for changes in health behaviors.

Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial.

IMPORTANCE: Studies of mechanically ventilated critically ill patients that combine populations that are at high and low risk for reintubation suggest that conditioned high-flow nasal cannula oxygen therapy after extubation improves oxygenation compared with conventional oxygen therapy. However, conclusive data about reintubation are lacking. OBJECTIVE: To determine whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for preventing reintubation in mechanically ventilated patients at low risk for reintubation. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted between September 2012 and October 2014 in 7 intensive care units (ICUs) in Spain. Participants were 527 adult critical patients at low risk for reintubation who fulfilled criteria for planned extubation. Low risk for reintubation was defined as younger than 65 years; Acute Physiology and Chronic Health Evaluation II score less than 12 on day of extubation; body mass index less than 30; adequate secretions management; simple weaning; 0 or 1 comorbidity; and absence of heart failure, moderate-to-severe chronic obstructive pulmonary disease, airway patency problems, and prolonged mechanical ventilation. INTERVENTIONS: Patients were randomized to undergo either high-flow or conventional oxygen therapy for 24 hours after extubation. MAIN OUTCOMES AND MEASURES: The primary outcome was reintubation within 72 hours, compared with the Cochran-Mantel-Haenszel χ2 test. Secondary outcomes included postextubation respiratory failure, respiratory infection, sepsis and multiorgan failure, ICU and hospital length of stay and mortality, adverse events, and time to reintubation. RESULTS: Of 527 patients (mean age, 51 years [range, 18-64]; 62% men), 264 received high-flow therapy and 263 conventional oxygen therapy. Reintubation within 72 hours was less common in the high-flow group (13 patients [4.9%] vs 32 [12.2%] in the conventional group; absolute difference, 7.2% [95% CI, 2.5% to 12.2%]; P = .004). Postextubation respiratory failure was less common in the high-flow group (22/264 patients [8.3%] vs 38/263 [14.4%] in the conventional group; absolute difference, 6.1% [95% CI, 0.7% to 11.6%]; P = .03). Time to reintubation was not significantly different between groups (19 hours [interquartile range, 12-28] in the high-flow group vs 15 hours [interquartile range, 9-31] in the conventional group; absolute difference, -4 [95% CI, -54 to 46]; P = .66]. No adverse effects were reported. CONCLUSIONS AND RELEVANCE: Among extubated patients at low risk for reintubation, the use of high-flow nasal cannula oxygen compared with conventional oxygen therapy reduced the risk of reintubation within 72 hours. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01191489.

Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial.

Importance: High-flow conditioned oxygen therapy delivered through nasal cannulae and noninvasive mechanical ventilation (NIV) may reduce the need for reintubation. Among the advantages of high-flow oxygen therapy are comfort, availability, lower costs, and additional physiopathological mechanisms. Objective: To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients at high risk of reintubation. Design, Setting, and Participants: Multicenter randomized clinical trial in 3 intensive care units in Spain (September 2012-October 2014) including critically ill patients ready for planned extubation with at least 1 of the following high-risk factors for reintubation: older than 65 years; Acute Physiology and Chronic Health Evaluation II score higher than 12 points on extubation day; body mass index higher than 30; inadequate secretions management; difficult or prolonged weaning; more than 1 comorbidity; heart failure as primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease; airway patency problems; or prolonged mechanical ventilation. Interventions: Patients were randomized to undergo either high-flow conditioned oxygen therapy or NIV for 24 hours after extubation. Main Outcomes and Measures: Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Noninferiority margin was 10 percentage points. Secondary outcomes included respiratory infection, sepsis, and multiple organ failure, length of stay and mortality; adverse events; and time to reintubation. Results: Of 604 patients (mean age, 65 [SD, 16] years; 388 [64%] men), 314 received NIV and 290 high-flow oxygen. Sixty-six patients (22.8%) in the high-flow group vs 60 (19.1%) in the NIV group were reintubation (absolute difference, -3.7%; 95% CI, -9.1% to ∞); 78 patients (26.9%) in the high-flow group vs 125 (39.8%) in the NIV group experienced postextubation respiratory failure (risk difference, 12.9%; 95% CI, 6.6% to ∞) [corrected]. Median time to reintubation did not significantly differ: 26.5 hours (IQR, 14-39 hours) in the high-flow group vs 21.5 hours (IQR, 10-47 hours) in the NIV group (absolute difference, -5 hours; 95% CI, -34 to 24 hours). Median postrandomization ICU length of stay was lower in the high-flow group, 3 days (IQR, 2-7) vs 4 days (IQR, 2-9; P=.048). Other secondary outcomes were similar in the 2 groups. Adverse effects requiring withdrawal of the therapy were observed in none of patients in the high-flow group vs 42.9% patients in the NIV group (P < .001). Conclusions and Relevance: Among high-risk adults who have undergone extubation, high-flow conditioned oxygen therapy was not inferior to NIV for preventing reintubation and postextubation respiratory failure. High-flow conditioned oxygen therapy may offer advantages for these patients. Trial Registration: clinicaltrials.gov Identifier: NCT01191489.

Nursing diagnoses and hospital readmission of patients with respiratory diseases: Findings from a case-control study.

AIM: The rate of readmission after hospitalisation for respiratory diseases has become a common and challenging clinical problem. Social and functional patient variables could help identify cases at high risk of readmission. The aim was to identify the nursing diagnoses that were associated with readmission after hospitalisation for respiratory disease in Spain. DESIGN: Case-control study within the cohort of patients admitted for respiratory disease during 2016-19 in a tertiary public hospital in Spain (n = 3781). METHODS: Cases were patients who were readmitted within the first 30 days of discharge, and their controls were the remaining patients. All nursing diagnoses (n = 130) were collected from the electronic health record. They were then grouped into 29 informative diagnostic categories. Clinical confounder-adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated using logistic regression models. RESULTS: The readmission rate was 13.1%. The nursing diagnoses categories 'knowledge deficit' (OR: 1.61; 95%CI: 1.13-2.31), 'impaired skin integrity and risk of ulcer infection' (OR: 1.45; 95%CI: 1.06-1.97) and 'activity intolerance associated with fatigue' (OR: 1.56; 95%CI: 1.21-2.01) were associated with an increased risk of suffering an episode of hospital readmission rate at 30% after hospital discharge, and this was independent of sociodemographic background, care variables and comorbidity. PATIENT OR PUBLIC CONTRIBUTION: The nursing diagnoses assigned as part of the care plan of patients during hospital admission may be useful for predicting readmissions.

Thyroid abnormalities in patients with Hodgkin lymphoma: The importance of close surveillance.

INTRODUCTION: Survival in paediatric patients with Hodgkin lymphoma (HL) has increased over the last decades. However, these patients are at increased risk of developing late thyroid sequelae due to the treatment with irradiation and alkylating agents. METHODS: We conducted an observational and retrospective study in patients with a diagnosis of HL between 2007 and 2022, in a hospital that is a paediatric oncology reference centre, through the review of electronic health records. We collected data on demographic (age, sex), clinical, radiological and histopathological variables, the dosage of alkylating agents and radiotherapy (RT) and on thyroid disorders using Microsoft Excel. The data analysis was conducted with SPSS version 17, using the Fisher exact test for qualitative data, a nonparametric test for quantitative data and Kaplan-Meier curves. RESULTS: Sixty patients received a diagnosis of HL from 2007 to 2022. The median duration of follow-up was 78.5 months. There were 4 detected cases of hypothyroidism, 5 of thyroid nodules and 1 of subclinical hyperthyroidism. Treatment with RT was significantly associated with the development of hypothyroidism (P= .026), thyroid nodules (P= .01) and thyroid disease overall (P= .003). We estimated that the risk of thyroid disease increased 8-fold with each additional Grey received (hazard ratio, 1.081; 95% CI, 1.014-1.152; P= .017). CONCLUSION: Hodgkin lymphoma patients treated with RT are at increased risk of late thyroid disorders, mainly hypothyroidism and malignancy. This risk is greater the higher the RT dosage and the longer the follow-up. We did not find evidence of an association between the use of alkylating agents and an increase in the risk of thyroid disease.

Effect of different soil amendments on soil buffering capacity.

The buffering capacity of the soil is a very important property of the soil, which determines the ability of the soil to resist external influences, especially changes in pH and thus create good living conditions for plants and microorganisms in the soil. The buffering capacity thus significantly contributes to maintaining the health and quality of the soil. Buffering capacity is an important indicator of soil quality, because it is related to the overall condition of the soil ecosystem and other soil properties. The goal of this paper is to determine the effect of applying different soil amendments on the soils, 10 years after application. We compared the effect of 6 different treatments in closed plots: Natural conditions (N = control); Bare soil (B); Straw mulching (S); Pine mulch (P); TerraCottem hydroabsorbent polymers (H); Prescribed burn (F); and Sewage sludge (M). Our results have shown that the application of different amedments leads to an effect on the plowing capacity of the soil. While in the case of the control variant (Natural conditions, N) the buffering capacity of the soil was measured at 144.93 ± 0.25, the addition of different amendments decreased the buffering capacity in the following order: Bare soil (B) 142.73±0.21 > TerraCotem hydroaborbent polymer (H) 142.23±.15 > Pine mulch (P) 140.40±0.30, Prescribed burn (F) 138.20±0.30, Sludge (S) 127.47±0.15. In the case of all variants, these are statistically significant differences (p ≤ 0.05). Thus, soil amendments have been shown to have a statistically significant effect on soil buffering capacity.

The use of quality-adjusted life-years in the economic evaluation of health technologies in Spain: a review of the 1990-2009 literature.

OBJECTIVE: To appraise economic evaluations of health technologies that included quality-adjusted life-years (QALYs) as an outcome measure conducted over the past 20 years in Spain. METHODS: A systematic review of the literature was conducted. Economic evaluations that included QALYs as an outcome measure, conducted in Spain and published between January 1990 and December 2009 were identified. Primary and gray literature sources were reviewed. RESULTS: A total of 60 articles and 4 health technology assessment reports were included. Key findings were 1) the vast majority of articles (77.1%) referred to therapeutic interventions; 2) 63.2% dealt with pharmaceutical products and much fewer with preventive strategies, medical devices, or diagnostic interventions; 3) most evaluations referred to cardiovascular- (19.8%), respiratory- (16.3%), and cancer- (13.0%) related processes; 4) 80.3% were based on a theoretical model, most commonly Markov models (71.4%); 5) 67.3% adopted the National Health System perspective; 6) information on the methods used to describe the health states was given in 45.1% of studies; 7) 40.3% used the EuroQoL-5D to elicit preferences, whereas 66.1% gave no details on the methods applied to determine patients' choices; 8) it was possible to state who completed the questionnaires in only 17.7% of studies; 9) 77.1% of the interventions assessed were below the €30,000/QALY suggested affordable threshold in Spain. CONCLUSIONS: An increasing number of economic evaluations using QALYs had been conducted. Most of them relied on theoretical models. Several methodological issues remain unsolved. Great disparity exists regarding the reporting of the methods used to determine health states and utility values.

Cost-effectiveness of sacral neuromodulation compared to botulinum neurotoxin a or continued medical management in refractory overactive bladder.

OBJECTIVES: This study assessed the cost-effectiveness and health-care budget impact of sacral neuromodulation (SNM) in refractory idiopathic OAB-wet patients in Spain. METHODS: A 10-year Markov analytic model was developed to estimate quality-adjusted life-years (QALYs) gained and incontinence episode avoided associated with SNM therapy compared with botulinum neurotoxin A (BoNT-A) or continued optimized medical treatment (OMT). RESULTS: At 10 years, the cumulative costs of SNM, BoNT-A, and OMT were €29,166, €29,458, and €29,370, respectively, whereas the QALYs for SNM, BoNT-A, and OMT are 6.89, 6.38, and 5.12, respectively. Consequently, incremental cost-effectiveness ratios (ICERs) for SNM demonstrate that although the initial costs for SNM are higher than those for the other treatments, decreasing follow-up costs coupled with consistently greater effectiveness in the long term make SNM the economically dominant option at 10 years. Sensitivity analyses suggest that 99.7% and 99.9% (for SNM vs. BoNT-A and OMT, respectively) of the 1000 Monte Carlo iterations fall within the €30,000 cost-effectiveness threshold, considered to be acceptable in Spain. The 10-year incremental cost per incontinence episode avoided for SNM also makes this therapy the dominant option compared to BoNT-A or OMT. Additionally, the estimated budget impact of the gradually increased referral for SNM for the management of OAB patients in Spain is small. CONCLUSIONS: As a treatment option for refractory idiopathic OAB, at 10 years, SNM provides a considerable possibility of symptom and quality-of-life improvement and is cost-effective compared to BoNT-A or continued OMT.

Current status of Bayesian clinical trials for oncology, 2020.

Bayesian methods had established a foothold in developing therapies in oncology trials. METHODS: We identified clinical trials posted on the ClinicalTrials.gov database focused on Oncology trials with a Bayesian approach in their design. Differences in study characteristics such as design, study phase, randomization, masking, purpose of study, main outcomes, gender, age and funding involvement according to Bayesian approach were assessed using Chi-squared or Fisher's exact tests. RESULTS: We identified 225 studies with Bayesian components in their design addressing oncological diseases. The most common designs were Bayesian Toxicity Monitoring (26.4%), Model-based designs (36%) Model-assisted designs (8%). Statistical methods such as Bayesian logistic regression model (59.4%), Bayesian piecewise exponential survival regression (10.9%) and the Continual reassessment method (9.4%) were the most used. CONCLUSIONS: Bayesian trials are more common in the early phases of drug development specifically in phase II trials (43.6%). Cancer institutes or Hospitals funded most of the studies retrieved. This type of design has increased over time and represent an innovative means of increasing trial efficiency.

Internal Consistency of Yesavage Geriatric Depression Scale (GDS 15-Item Version) in Ecuadorian Older Adults.

The present study aimed to assess the validity of a Spanish version of the Geriatric Depression-15 Scale (GDS-15) in Ecuadorian adults. Cross-sectional study to validate GDS-15 in its short version (GDS-15). Internal consistency and factor structure were assessed through Kuder Richardson 20 and Confirmatory Factor Analysis. A total of 211 subjects 65 years of age and older participated in the validation process. Internal consistency was adequate, the Kuder Richardson 20 coefficient for the total scale was 0.73. Three factor structure was found for the scale. This study highlights the importance of having a validated scale for screening depression in the elderly. This study provides an evidence for the use of GDS-15 in Ecuadorian elderly population to screen for depression.

Cost-effectiveness analysis of sunitinib in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) after progression or intolerance with imatinib.

INTRODUCTION: Sunitinib is a multiselective oral inhibitor of several tyrosine-kinase receptors that has demonstrated its efficacy in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) who were resistant to or intolerant to previous treatment with imatinib. The purpose of this study is to assess the cost-effectiveness of sunitinib vs. best supportive care (BSC) in GIST as a second- line treatment, from the perspective of the Spanish National Health System. MATERIALS AND METHODS: A Markov model was used to assess the cost effectiveness of sunitinib (50 mg/day, 4 weeks "on" and 2 weeks "off") vs. BSC in GIST as a second-line treatment. Transition probabilities between the three health states considered in the model (progression-free survival (PFS), progression and death) were obtained from a clinical trial [Demetri et al. (2006) Lancet 368:1329-1338]. Health resource data (drugs, medical visits, laboratory and radiology tests, palliative care and adverse events) were obtained from an expert panel. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Projected PFS years, life years (LY) and quality of life adjusted years (QALYs) were higher for sunitinib compared with BSC: 0.50 vs. 0.24, 1.59 vs. 0.88 and 1.00 vs. 0.55. Mean costs per patient were 23,259 euros with sunitinib and 1,622 euros with BSC. The incremental cost-effectiveness ratios (ICERs) obtained were: 4,090 euros/month PFS, 30,242 euros/LY and 49,090 euros/QALY gained. The most influential variables for the results were the efficacy and unit cost of sunitinib. CONCLUSIONS: According to the efficiency thresholds for oncology patients in developed countries, sunitinib is considered cost-effective vs. BSC with acceptable costs per LY and QALY gained.

Cultural adaptation, validation and development of a spanish brief version of the diabetes fear of injecting and self-testing questionnaire.

OBJECTIVE: To develop and validate in Spain a test to measure fear of injecting and selftesting [HIAT-I](c) in diabetic patients by translating and adapting the original English version of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). PATIENTS AND METHOD: Forward-backward translations in duplicate were carried out and were revised by an expert and a nonexpert panel. Men and women with type 1 and type 2 diabetes aged more than 18 years old were enrolled in three primary care centers. The Spanish version of the D-FISQ was administered on two separate occasions at a 15-day interval. The trait-anxiety scale of the Stait-Trait Anxiety Inventory (STAI) and five specific questions on glycemic control, insulin injection, pain and worry were administered. Sociodemographic and clinical data were also collected. Feasibility, construct validity, concept validity and reliability were assessed. RESULTS: A 32-item version of the D-FISQ was developed by an expert panel and was administered to 93 (35 Type 1, 58 Type 2) insulin-treated diabetic patients. Ninetynine per cent of the patients answered all items in 5 minutes (median). Item-total correlation and factor analysis led to an abridged, 19-item version, maintaining the two original dimensions, and explaining 47.4% percent of the total variance: fear of self-injecting (FSI), accounting for 29.5% of the variance, and fear of self-testing (FST), accounting for 17.9%. Test-retest correlation coefficients were 0.85 (FSI) and 0.94 (FST). The correlations between STAI and FSI and FST were not statistically significant (p=0.771). The correlation coefficient between FSI and time under insulin treatment was -0.546 (p=0.023). CONCLUSIONS: We developed a newrecalibrated version of the Spanish D-FISQ called the MIAT-D. The feasibility, dimensionality, construct validity and reliability of this questionnaire were accurate. The concept validity of this test should be explored in further studies.