Economic Burden of Idiopathic Pulmonary Fibrosis in Spain: A Prospective Real-World Data Study (OASIS Study).

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal lung disease associated with dyspnoea, cough and impaired quality of life affecting around 7500 patients in Spain. OBJECTIVE: Our aim was to estimate the economic impact of IPF according to forced vital capacity (FVC) % predicted level in adult patients. METHODS: We conducted a prospective, observational, multicentric study of patients with confirmed IPF in Spain. Total annual IPF-related costs were estimated per patient, and categorised according to the FVC% predicted value (FVC < 50%, FVC 50-80%, FVC > 80%) and total sample. Incurred direct health- and non-health-related costs and indirect costs were calculated considering the IPF-related healthcare resource use and the corresponding unitarian costs. Results were updated to 2023 euros. RESULTS: Two hundred and four consecutive patients with IPF were included: 77% male, average age (standard deviation) 70.8 (7.6) years. At baseline, FVC% was < 50%, 50-80% and > 80% of predicted value in 10.8%, 74.5% and 14.7% of patients, respectively. The final cost-evaluable population included 180 subjects. The mean (standard deviation) total annual IPF-related cost was €26,997 (17,555), with statistically significant differences (p = 0.0002) between groups: €44,412 (33,389) for the FVC < 50%, €25,803 (14,688) for the FVC 50-80% and €23,242 (13,642) for the FVC > 80%. Annual direct health costs had the greatest weight and included pharmacological treatments [€22,324 (13,773)] and hospitalisation days [€1659 (7362)]. 14 patients had ≥ 1 acute exacerbation of IPF during the study; mean total cost of an acute exacerbation of IPF was €10,372. According to the multivariate analysis, an impaired lung function (FVC < 50%) and use of antifibrotic treatment were determinants of cost (p < 0.0001 both). CONCLUSIONS: We observed a significantly higher annual IPF-related cost at a lower level of predicted FVC%, the direct cost having the greatest weight to the total costs. Maintaining patients at early disease stages by slowing IPF progression is relevant to reduce the economic impact of IPF. CLINICAL TRIAL REGISTRATION: EU PAS register number EUPAS19387 (1 June, 2017).

Association of Race and Ethnicity with Pediatric Postoperative Pain Outcomes.

INTRODUCTION: Inequitable variability in healthcare practice negatively affects patient outcomes. Children of color may receive different analgesic medications in the perioperative period, resulting in different outcomes. METHODS: Medical records of children 0 to ≤ 18 years old from May 2014 to August 2019 were reviewed. The exposure was racial or ethnic groups: Asian, Black, Hispanic, Pacific Islander, and White non-Hispanic (reference). PRIMARY OUTCOME: post-anesthesia care unit mean pain score. SECONDARY OUTCOMES: inpatient mean pain score; opioid, antiemetic, and antipruritic administration in the post-anesthesia care unit and inpatient ward. The association of race or ethnicity with outcomes was modeled using multilevel logistic regression, adjusting for confounders and covariates. RESULTS: Twenty-nine thousand six hundred fourteen cases are included. In the post-anesthesia care unit, Black, Hispanic, and Pacific Islander children had no significant difference in the odds of receiving opioids or having moderate-severe pain as compared to White non-Hispanic patients; Asian children had lower odds of receiving opioids and lower odds of having a moderate-severe mean pain score. In the inpatient setting, Black, Hispanic, and Pacific Islander children had no significant difference in the odds of receiving opioids or having moderate severe-pain as compared to White non-Hispanic children, but Asian children had lower odds of receiving opioids and of having a moderate-severe mean pain score. CONCLUSIONS: Asian children had lower odds of receiving opioids and having moderate-severe pain postoperatively compared to the White non-Hispanic children. These differences may be a function of variation in patient/caregivers culture or healthcare provider care and warrant further investigation.

Food and beverage can coatings: A review on chemical analysis, migration, and risk assessment.

The internal surface of food and beverage cans is generally covered with polymeric coatings to preserve food and protect metal substrate from corrosion. Coating materials are complex formulations that contain different starting substances (e.g., monomers, prepolymers, additives, etc.) and in addition during the manufacture of the material several compounds can be formed (e.g., reaction products, degradation products, etc.). These substances have the potential to migrate into the food. Many of them have not been identified and only some have been toxicologically evaluated. This article aims to provide a comprehensive review on the analytical methods used for the identification of potential migrants in can coatings. The migration and exposure to chemicals migrating from can coatings are also reviewed and discussed so far, which is essential for risk assessment. Moreover, a brief section on the current status of the legislation on varnishes and coatings for food contact in Europe is also presented. Liquid chromatography coupled to diode array and fluorescence detectors and particularly to mass spectrometry and gas chromatography-tandem mass spectrometry seem to be the techniques of choice for the identification of potential migrants in can coatings. Some studies have reported migration levels of BPA (bisphenol A) and BADGE (bisphenol A diglycidyl ether) and derivatives exceeding the specific migration limits set in the European legislation. On the whole, low dietary exposure to migrants from can coatings has been reported. However, it is interesting to highlight that in these studies the combined exposure to multiple chemicals has not been considered.

Lower 24-Month Relative Survival among Black Patients with Non- Hodgkin's Lymphoma: An Analysis of the SEER Data 1997-2015.

Background: Recent progress in the therapies used in patients with Non- Hodgkin's lymphoma has improved survival. The incidence has been reported to be decreasing in the last few years, accounting for 4% of all cancers. This study analyzed time trends for incidence, mortality, and prevalence of NHL. Methods: We analyzed the SEER Cancer Database from 1997 to 2015. Join point regression analysis was used to determine age-adjusted incidence rates, 24-month relative survival rate, and to identify racial/ethnic groups with a lower survival. Results: The trend in incidence of NHL decreased between 2008 and 2011 at an annual percentage change rate of 3.74%. The male predominance among NHL patients between 1997-2015 was 57%. The number of male patients affected with NHL has been similar in the last 20 years. Female predominance with NHL was higher in 1998 at 46 %, and lower in 2010 at 42.85%. The 24-month relative survival rate was higher among white patients as compared to black patients with NHL. Conclusions: Our analysis demonstrated that the incidence of Non-Hodgkin's Lymphoma has decreased among minorities; however, the outcomes are inferior in terms of survival. This analysis showed an inferior 24-month relative survival rate among black patients compared with white patients. This analysis demonstrates the need for further research in NHL to determine the biological differences and social factors that influence the lower survival among black patients with NHL.

Ubiquity, Hazardous Effects, and Risk Assessment of Fragrances in Consumer Products.

PURPOSE OF REVIEW: The main aims of fragrances are to create pleasing scents or to mask unpleasant odors. We hereby review their main exposure sources, presumed benefits, and unwanted effects, with special attention to allergic contact dermatitis (prevalence, regulatory environment, risk assessment methodology, and preventive measures). RECENT FINDINGS: Fragrances elicit positive emotions and presumably have therapeutic benefits related to stress reduction and memory enhancement. However, they also cause detrimental health or environmental effects including contact dermatitis (irritant and/or allergic), non-eczematous contact reactions, photosensitivity, photo-allergy, and immediate contact reactions, which can negatively impact the quality of life. Fragrances are the most frequent chemicals causing contact dermatitis. Their main sources are cosmetics, household products, industrial substances, food flavorings, oral hygiene products, and topical medications. It is difficult for sensitized patients to avoid contact with fragrances, due to their ubiquity and because manufacturers are not willing to volunteer information regarding fragrance ingredients. SUMMARY: The treatment of contact dermatitis relies on allergens avoidance which does not "cure" the disease (sensitization persists for life) but prevents disabling illness. The patient should understand that avoiding perfume means to avoid all scented goods and not just perfumes.Labeling fragrances is key in primary prevention (by giving the healthy individual the chance to make an informed choice to avoid risky substances), diagnosis (by helping the practitioner to plan and interpret patch tests), secondary prevention, and prognosis (by allowing the sensitized patient to follow the avoidance instructions). However, only 26 fragrances are mandatory to be declared in cosmetics. The vague labeling of other fragrance ingredients as "perfume" or "fragrance" hampers the diagnostic and preventive approaches. Therefore, in our opinion, declaration should be mandatory for all fragrance ingredients as well as straightforward so most consumers can understand it. Moreover, legislation should be improved to prevent inappropriately high exposures by forbidding stronger allergens, restricting maximum concentrations in the finished product or fields of application, delivering information regarding the risks to the general public, and controlling the compliance of manufacturers with the regulations. Besides, manufacturers should share information regarding the composition in the final products and provide physicians with samples of all fragrance chemicals whenever needed for patch test investigations.

Study of early childhood development and its relationship with parenting practices in poverty contexts within the city of Córdoba.

INTRODUCTION: This study addresses the relationship between social determinants in poverty contexts, parenting practices, and the psychomotor development of children aged 0 to 5 in the city of Córdoba. METHODS: The Screening for psychomotor development problems at primary care level (PRUNAPE, Prueba Nacional de Pesquisa), the Parenting Practices Instrument (Instrumento de Prácticas de Crianza), and the Family Environment Questionnaire (Cuestionario de Ambiente Familiar) were applied to the mother-child coupling (246 cases). The data were analyzed based on the frequency of the categorical variables, and the summary measures of assessable variables and associations were evaluated with the chi-squared test for categorical variables, ANOVA and non-parametric test for the assessable ones. RESULTS: A 95% confidence level was considered. Children have a close relationship with their social and environmental determinants, the development of 3 out of 10 children is at risk. The father's educational level (p<0.001) and the mother's employment status (or father's) (p<0.001) were associated. The parenting practice risk was predominant in cases where the adult does not interpret the child's signals 16.66%; does not interact with songs, stories nor games 16.66%, and does not receive parenting help 20.73%. Children whose parents do not perceive their autonomy have approximately twice the risk of not passing the PRUNAPE (p<0.02, OR: 1.96; IC: 1.11-3.49). CONCLUSION: It may be assumed that the course of development, as a process, is associated with adult-child interaction, mother-child communication and the visualization that parents have of the children' autonomy.

Association of Anticholinergic Risk Score With Functional Status in Patients Preparing for Pelvic Reconstructive Surgery.

OBJECTIVES: Anticholinergic medication use has been associated with cognitive impairment and other functional limitations, particularly in older patients. The anticholinergic risk score (ARS) can be used to measure a patient's cumulative exposure to medications with anticholinergic properties. Our primary objective was to evaluate the correlation between ARS and functional status, as measured by instrumental activities of daily living (IADL), in patients preparing to undergo urogynecologic surgery. The secondary objective was to examine the correlation between ARS and physical function in this same cohort. METHODS: This was a planned cross-sectional analysis of a prospective cohort study to evaluate the impact of urogynecologic surgery on functional status. The ARS was calculated by summing the ARSs of each patient's medications and classified as high (ARS > 5) or low (ARS ≤ 5). A patient's ability to live independently was determined using the IADL questionnaire. The patient's physical function status was determined using the functional comorbidity index. RESULTS: One hundred twenty-two patients were evaluated. A total of 89.3% of subjects had a low and 10.7% had a high ARS score. For our primary outcome, high ARS was associated with low IADL in logistic regression controlling for age and formal education level (odds ratio, 8.0; 95% confidence interval, 1.4-46.9). For our secondary outcome, ARS was not associated with the functional comorbidity index (P = 0.24). CONCLUSIONS: These data support recognition of ARS as a potential risk factor for low functional status in patients planning urogynecologic surgery.

Workforce Analysis of Female Pelvic Medicine and Reconstructive Surgery, 2015 to 2045.

OBJECTIVES: The aim of this study was to assess how the projected increase in prevalence of pelvic floor disorders (PFDs) will impact the number of patients per female pelvic medicine and reconstructive surgery (FPMRS) subspecialist between 2015 and 2045. METHODS: We performed a workforce analysis of FPMRS subspecialists in the United States by developing a model to predict the number of FPMRS subspecialists in 5-year increments from 2015 to 2045. Our model allowed for selection of the number of current FPMRS subspecialists, the number and sex of new FPMRS subspecialists added per year, and retirement age of FPMRS subspecialists. The number of women with PFDs from 2015 to 2045 was then predicted by applying published, age-specific prevalence rates to the 2012 US Census Projections for women aged 20 years or older. For our primary outcome, we divided the projected number of patients by the projected number of FPMRS subspecialists every 5 years from 2015 to 2045. RESULTS: The model predicts the number of FPMRS subspecialists will increase from 1133 to 1514 with a sex shift from 46% female to 81% female between 2015 and 2045. The number of women with ≥1 PFD is predicted to increase from 31.4 million in 2015 to 41.9 million in 2045. For our primary outcome, the number of patients per FPMRS subspecialist is projected to range from 27,870 in 2015 to 27,650 in 2045. CONCLUSIONS: The current ratio of patients per FPMRS subspecialist appears high and is predicted to remain near current levels over the next 30 years. These projections support the need for continued training of physicians skilled in treating PFDs.

The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

UNLABELLED: : On September 20, 2012, a marketing authorization valid throughout the European Union (EU) was issued for decitabine for the treatment of adult patients aged 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy. Decitabine is a pyrimidine analog incorporated into DNA, where it irreversibly inhibits DNA methyltransferases through covalent adduct formation with the enzyme. The use of decitabine was studied in an open-label, randomized, multicenter phase III study (DACO-016) in patients with newly diagnosed de novo or secondary AML. Decitabine (n = 242) was compared with patient's choice with physician's advice (n = 243) of low-dose cytarabine or supportive care alone. The primary endpoint of the study was overall survival. The median overall survival in the intent-to-treat (ITT) population was 7.7 months among patients treated with decitabine compared with 5.0 months for those in the control arm (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.69-1.04; p = .1079). Mature survival data after an additional year of follow-up were consistent with these results, with a median overall survival of 7.7 months in patients treated with decitabine and 5.0 months in the control arm (HR, 0.82; 95% CI, 0.68-0.99; p = .0373). Secondary endpoints, including response rates, progression-free survival, and event-free survival, were increased in favor of decitabine when compared with control treatment. The most common adverse drug reactions reported during treatment with decitabine are pyrexia, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, and diarrhea. This paper summarizes the scientific review of the application leading to approval of decitabine in the EU. The detailed scientific assessment report and product information (including the summary of product characteristics) for this product are available on the EMA website (http://www.ema.europa.eu). IMPLICATIONS FOR PRACTICE: Acute myeloid leukemia (AML) remains an area of significant unmet need, especially in older patients. Older patients and those with comorbidities are often considered ineligible for standard induction therapy, and outcome for these patients is poor. Decitabine has favorable effects in terms of overall survival, which were considered clinically meaningful in the context of a manageable toxicity profile and after consideration of the lack of therapeutic alternatives for these patients. Decitabine is widely used in the treatment of AML in patients aged >60 years, as per current guidelines, including the European LeukemiaNet and the U.S. National Cancer Comprehensive Network.

The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

On June 14, 2010, the European Commission issued a conditional marketing authorization valid throughout the European Union for pazopanib for the treatment of advanced renal cell carcinoma. Pazopanib is an antineoplastic agent that inhibits multiple receptor tyrosine kinases. The recommended oral dose is 800 mg once daily. The benefit of pazopanib is an increased progression-free survival. In the pivotal trial VEG105192, the median progression-free survival was 9.2 months (95% confidence interval, 7.4-12.9) in the pazopanib arm compared with 4.2 months (95% confidence interval, 2.8-4.2) in the placebo arm. The most common side effects include diarrhea, hair color change, hypertension, nausea, fatigue, anorexia, vomiting, dysgeusia, elevated alanine aminotransferase, elevated aspartate aminotransferase, and abdominal pain. The objective of this article is to summarize the scientific review of the application that led to approval in the European Union.

The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

On 11(th) March 2010, the European Commission issued a marketing authorization valid throughout the European Union for Revolade for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura. Revolade is an orphan medicinal product indicated for splenectomized patients with immune (idiopathic) thrombocytopenic purpura who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) and as second-line treatment for non-splenectomized patients where surgery is contraindicated. The active substance of Revolade is eltrombopag (ATC code B02BX05). Eltrombopag increases platelet production through activation of the thrombopoietin receptor. The recommended oral dose is 50 mg once daily to achieve and maintain a platelet count of the 50×10(9)/L or more necessary to reduce or prevent the risk of bleeding. The benefit of Revolade is a durable response in maintaining platelet levels. The most common side effects include headache, nausea, hepatobiliary toxicity, diarrhea, fatigue, paresthesia, constipation, rash, pruritus, cataract, arthralgia and myalgia. The decision to grant the marketing authorization was based on the favorable recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency. The objective of this paper is to describe the data submitted to the European Medicines Agency and to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (www.ema.europa.eu).

Cognitive status and physical function in older african americans.

OBJECTIVES: To investigate the relationship between global cognition, three specific domains of cognition, and lower extremity function in community-dwelling elderly African Americans (AAs) from two community settings. DESIGN: Cross-sectional study. SETTING: Community. PARTICIPANTS: Ninety-six AA men and women aged 60 and older from two community settings, enrolled in the Boosting Minority Involvement (BMI) study, a community-based cohort study designed to increase research participation of older low-income AAs. MEASUREMENTS: Physical performance was assessed using Short Physical Performance Battery score, which is composed of three timed tests: a 4-m walking task, static balance assessment, and a chair stand test. The Bushke Memory Impairment Screen (MIS) and Mini-Mental State Examination were used to assess global memory and global cognition, respectively. For domain-specific performance, three z-score composite scores (attention, verbal memory, and executive function) were developed using the Computer-based Assessment of Mild Cognitive Impairment. RESULTS: All domains of cognition were significant predictors of lower extremity function except for verbal memory. Executive function and MIS were the best predictors of lower extremity function in adjusted models. Participants with poor executive function were more than four times as likely to have poorer lower extremity function (odds ratio=4.96, 95% confidence interval=1.07-23.0). CONCLUSION: Global memory and executive function were the best predictors of lower extremity function in a sample of community-dwelling AA adults. Deficits in lower extremity function may depend on multifaceted higher executive function control processes.