A new paradigm evaluating cost per cure of HCV infection in the UK

Background: New interferon (IFN)-free treatments for hepatitis C are more effective, safer but more expensive than current IFN-based therapies. Comparative data of these, versus current first generation protease inhibitors (PI) with regard to costs and treatment outcomes are needed. We investigated the real-world effectiveness, safety and cost per cure of 1st generation PI-based therapies in the UK. Methods: Medical records review of patients within the HCV Research UK database. Patients had received treatment with telaprevir or boceprevir and pegylated interferon and ribavirin (PR). Data on treatment outcome, healthcare utilisation and adverse events (AEs) requiring intervention were collected and analysed overall and by subgroups. Costs of visits, tests, therapies, adverse events and hospitalisations were estimated at the patient level. Total cost per cure was calculated as total median cost divided by SVR rate. Results: 154 patients from 35 centres were analysed. Overall median total cost per cure was £44,852 (subgroup range,: £35,492 to £107,288). Total treatment costs were accounted for by PI: 68.3 %, PR: 26.3 %, AE management: 5.4 %. Overall SVR was 62.3 % (range 25 % to 86.2 %). 36 % of patients experienced treatment-related AEs requiring intervention, 10 % required treatment-related hospitalisation. Conclusions: This is the first UK multicentre study of outcomes and costs of PI-based HCV treatments in clinical practice. There was substantial variation in total cost per cure among patient subgroups and high rates of treatment-related discontinuations, AEs and hospitalisations. Real world safety, effectiveness and total cost per cure for the new IFN free combinations should be compared against this baseline

The prevention of lower urinary tract symptoms (PLUS) research consortium: A transdisciplinary approach toward promoting bladder health and preventing lower urinary tract symptoms in women across the life course

Lower urinary tract symptoms (LUTS) are highly prevalent in women, and are expected to impose a growing burden to individuals and society as the population ages. The predominance of research related to LUTS has focused on underlying pathology, disease mechanisms, or the efficacy of treatments for women with LUTS. Although this research has been vital for helping to reduce or ameliorate LUTS conditions, it has done little to prevent the onset of LUTS. Health promotion and prevention require an expansion of scientific inquiry beyond the traditional paradigm of studying disease mechanisms and treatment to the creation of an evidence base to support recommendations for bladder health promotion and, in turn, prevention of LUTS. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) introduced the concept of prevention as an important priority for women's urologic research as a prelude to supporting the formation of the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium. In this article, we introduce the PLUS research consortium to the scientific community; share the innovative paradigms by which the consortium operates; and describe its unique research mission: to identify factors that promote bladder health across the life course and prevent the onset of LUTS in girls and women

Anxiety and attentional bias to threat in children at increased familial risk for Autism Spectrum Disorder

Anxiety and threat bias were examined in 6-8-year-old children at familial-risk for Autism Spectrum Disorder (ASD) and low-risk (LR, n = 37) controls. The high-risk (HR) group was divided into those who met diagnostic criteria for ASD (HR-ASD, n = 15) and those who did not (HR-non ASD, n = 24). The HR-ASD group had highest levels of parent-reported anxiety. The HR-non ASD group exhibited increased threat bias on a spatial-cueing task, while the HR-ASD group did not. Anxiety symptoms were associated with both threat bias and ASD severity. These findings suggest that the mechanisms underlying anxiety in HR siblings without ASD are similar to those in non-ASD populations. However, among children with ASD, hypersensitivity to threat may not underlie anxiety symptoms

Early Nutrition and Weight Gain in Preterm Newborns and the Risk of Retinopathy of Prematurity

Objective: To identify nutritional and weight gain limitations associated with retinopathy of prematurity (ROP) severity among very preterm newborns. Patients and Methods 1180 infants <28 weeks GA at birth with ROP examination results were grouped and analyzed by quartile of weekly total calorie, carbohydrate, protein, and lipid intake, as well as growth velocity between postnatal days 7 and 28 (adjusted for GA and birth weight Z-score). ROP was categorized by development of no, mild (<prethreshold), type 2, or type 1 ROP, as well as markers of ROP severity including stage 3 ROP, zone 1 disease, and plus disease. Associations between nutritional intake and ROP severity were compared. Results: Greater risk for Type 1 ROP (risk/95% confidence intervals) was found for infants with lowest quartile receipt of lipids (2.1/1.1, 3.8), total calories (2.2/1.4, 3.6), and carbohydrates (1.7/1.1, 2.9). Development of zone 1 ROP was associated with lipid or total calorie intake in the lowest quartile, and development of stage 3 ROP was associated with lowest quartile of total calorie intake. Growth velocity in the lowest quartile was associated with increased risk of any ROP, including type 1 ROP. Conclusion: The risk of developing severe ROP in extremely premature infants might be reduced by improving nutritional support, specifically targeting lipids and total calories, and perhaps by improving weight gain

Association between Sleep Duration and 24-Hour Urine Free Cortisol in the MrOS Sleep Study

Context Short sleep duration is associated with adverse health outcomes, but the mechanisms involved are unknown. It has been postulated that short sleep duration may elevate cortisol levels, but studies have had conflicting results. It is unclear whether these differing findings may be due to methodological issues, such as assessment of sleep duration. Specifically, objective versus subjective methods of measuring habitual sleep duration may account for the conflicting results found in epidemiological studies. Objective: Our goal was to determine whether habitual sleep duration, measured objectively (by actigraphy) and subjectively (by self-report), was associated with 24-hour urine free cortisol (UFC), a measure of integrated cortisol secretion. Our secondary goal was to determine whether slow wave sleep (SWS, determined by polysomnography) was associated with 24-hour UFC. Design/Setting Cross sectional study of community dwelling older men. Patients/Participants 325 men (mean age = 76.6 years, SD = 5.5) from the Portland site of the MrOS Sleep Study, who underwent 24-hour urine collection, polysomnography, actigraphy and sleep questionnaire. Primary Outcome 24-hour UFC. Results: In this study of community dwelling older men, self-reported sleep duration was inversely related to 24-hour UFC levels. Participants reporting 5 to 8 hours of habitual sleep. However, sleep duration determined by actigraphy was not associated with 24-hour UFC in either univariable or multivariable regression models. SWS was not associated with 24-hour UFC. Conclusion: Objectively measured (i.e., actigraphic) sleep duration is not associated with 24-hour UFC in these community dwelling older men. This finding, together with prior studies, suggests that elevated levels of integrated cortisol secretion is not the mechanisms by which short sleep duration leads to adverse health outcomes

Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions

PRISMA 2009 Checklist. (DOC 63 kb

Hospice care in the Netherlands: who applies and who is admitted to inpatient care?

BACKGROUND: Ten percent of non-sudden deaths in the Netherlands occur in inpatient hospice facilities. To investigate differences between patients who are admitted to inpatient hospice care or not following application, how diagnoses compare to the national population, characteristics of application, and associations with being admitted to inpatient hospice care or not. METHODS: Data from a database representing over 25 % of inpatient hospice facilities in the Netherlands were analysed. The study period spanned the years 2007–2012. Multivariate regression analyses were performed to study associations between demographic and application characteristics, and admittance. RESULTS: Ten thousand two hundred fifty-four patients were included. 84.1 % of patients applying for inpatient hospice care had cancer compared to 37.0 % of deaths nationally. 52.4 % of applicants resided in hospital at the time of admission. Most frequent reasons for application were the wish to die in an inpatient hospice facility (70.5 %), needing intensive care or support (52.2 %), relieving caregivers (41.4 %) and needing pain/symptom control (39.9 %). Living alone (OR 1.68, 95 % CI 1.46–1.94), having cancer (OR 1.40, 95 % CI 1.11–1.76), relieving caregivers (OR 1.18, 95 % CI 1.01–1.38), needing pain/symptom control (OR1.72, 95 % CI 1.46–2.03) wanting inpatient hospice care until death (vs respite care) (OR 3.59, 95 % CI 2.11–6.10), wanting to be admitted as soon as possible (OR 1.64, 95 % CI 1.42–1.88), and being referred by a primary care professional (OR 1.36, 95 % CI 1.17–1.59) were positively associated with being admitted. Wishing to die in an inpatient hospice facility was negatively associated with being admitted (OR 0.85, 95 % CI 0.72–1.00). CONCLUSIONS: This study suggests that when applying for inpatient hospice care, patients who seem most urgently in need of inpatient hospice care are more frequently admitted. However, non-cancer patients seem to be an under-represented population. Staff should consider application based on need for palliation, irrespective of diagnosis

Motor onset and diagnosis in Huntington disease using the diagnostic confidence level

Huntington disease (HD) is a neurodegenerative disorder characterized by motor dysfunction, cognitive deterioration, and psychiatric symptoms, with progressive motor impairments being a prominent feature. The primary objectives of this study are to delineate the disease course of motor function in HD, to provide estimates of the onset of motor impairments and motor diagnosis, and to examine the effects of genetic and demographic variables on the progression of motor impairments. Data from an international multisite, longitudinal observational study of 905 prodromal HD participants with cytosine-adenine-guanine (CAG) repeats of at least 36 and with at least two visits during the followup period from 2001 to 2012 was examined for changes in the diagnostic confidence level from the Unified Huntington's Disease Rating Scale. HD progression from unimpaired to impaired motor function, as well as the progression from motor impairment to diagnosis, was associated with the linear effect of age and CAG repeat length. Specifically, for every 1-year increase in age, the risk of transition in diagnostic confidence level increased by 11% (95% CI 7-15%) and for one repeat length increase in CAG, the risk of transition in diagnostic confidence level increased by 47% (95% CI 27-69%). Findings show that CAG repeat length and age increased the likelihood of the first onset of motor impairment as well as the age at diagnosis. Results suggest that more accurate estimates of HD onset age can be obtained by incorporating the current status of diagnostic confidence level into predictive models

Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities

OBJECTIVE: To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality. STUDY DESIGN: In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/medications, and procedures including cesarean section. RESULTS: The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals. CONCLUSIONS: Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.Fil: Manasyan, Albert. Centre for Infectious Disease Zambia; Zambia. University of Alabama at Birmingahm; Estados UnidosFil: Saleem, Sarah. Aga Khan University; PakistánFil: Koso Thomas, Marion. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Althabe, Fernando. Instituto de Efectividad Clínica y Política de Salud. Departamento de Investigación en Salud Madre e Infantil. Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Pasha, Omrana. Aga Khan University; PakistánFil: Chomba, Elwyn. Centre for Infectious Disease Zambia; Zambia. University of Alabama at Birmingahm; Estados Unidos. University of Zambia; ZambiaFil: Goudar, Shivaprasad S.. KLE; IndiaFil: Patel, Archana. Indira Gandhi Government Medical College; IndiaFil: Esamai, Fabian. Moi University; KeniaFil: Garces, Ana. Francisco Marroquin University; GuatemalaFil: Kodkany, Bhala. KLE; IndiaFil: Belizan, Jose. Instituto de Efectividad Clínica y Política de Salud. Departamento de Investigación en Salud Madre e Infantil. Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: McClure, Elizabeth M.. Research Triangle Institute; Estados UnidosFil: Derman, Richard J.. Christiana Health Care; Estados UnidosFil: Hibberd, Patricia. Indiana University; Estados UnidosFil: Liechty, Edward A.. Massachusetts General Hospital for Children; Estados UnidosFil: Hambidge, K. Michael. State University of Colorado Boulder; Estados UnidosFil: Carlo, Waldemar A.. Centre for Infectious Disease Zambia; ZambiaFil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Moore, janet. Research Triangle Institute; Estados UnidosFil: Wright, Linda L.. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Goldenberg, Robert L.. Columbia University; Estados Unido

Short and long-term lifestyle coaching approaches used to address diverse participant barriers to weight loss and physical activity adherence

Background: Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program, a randomized trial with 3.2 years average treatment duration, have not been previously reported. Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large, diverse participant cohort can inform dissemination efforts. Methods: Lifestyle coaches documented barriers and approaches after each session (mean session attendance = 50.3 ± 21.8). Subjects were 1076 intensive lifestyle participants (mean age = 50.6 years; mean BMI = 33.9 kg/m2; 68% female, 48% non-Caucasian). Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied. Barrier groupings were also analyzed in relation to baseline demographic characteristics. Results: Top weight loss barriers reported were problems with self-monitoring (58%); social cues (58%); holidays (54%); low activity (48%); and internal cues (thought/mood) (44%). Top activity barriers were holidays (51%); time management (50%); internal cues (30%); illness (29%), and motivation (26%). The percentage of the cohort having any type of barrier increased over the long-term intervention period. A majority of the weight loss barriers were significantly associated with younger age, greater obesity, and non-Caucasian race/ethnicity (p-values vary). Physical activity barriers, particularly thought and mood cues, social cues and time management, physical injury or illness and access/weather, were most significantly associated with being female and obese (p 90% long term) and regularly reviewed self-monitoring skills. More costly approaches were used infrequently during the first 16 sessions (≤10%) but increased over 3.2 years. Conclusion: Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers. Given minimal resources, increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted