Accruing patients in a timely manner represents a significant challenge to early phase cancer clinical trials. The NCI
BackgroundThere is a lack of validated instruments to measure the level of burden of Alzheimer’s disease (AD) on caregivers. The Impact of Alzheimer’s Disease on Caregiver Questionnaire (IADCQ) is a 12-item instrument with a seven-day recall period that measures AD caregiver’s burden across emotional, physical, social, financial, sleep, and time aspects. Primary objectives of this study were to evaluate psychometric properties of IADCQ administered on the Web and to determine most appropriate scoring algorithm.MethodsA national sample of 200 unpaid AD caregivers participated in this study by completing the Web-based version of IADCQ and Short Form-12 Health Survey Version 2 (SF-12v2™). The SF-12v2 was used to measure convergent validity of IADCQ scores and to provide an understanding of the overall health-related quality of life of sampled AD caregivers.The IADCQ survey was also completed four weeks later by a randomly selected subgroup of 50 participants to assess test-retest reliability. Confirmatory factor analysis (CFA) was implemented to test the dimensionality of the IADCQ items. Classical item-level and scale-level psychometric analyses were conducted to estimate psychometric characteristics of the instrument. Test-retest reliability was performed to evaluate the instrument’s stability and consistency over time.ResultsVirtually none (2%) of the respondents had either floor or ceiling effects, indicating the IADCQ covers an ideal range of burden. A single-factor model obtained appropriate goodness of fit and provided evidence that a simple sum score of the 12 items of IADCQ can be used to measure AD caregiver’s burden. Scales-level reliability was supported with a coefficient alpha of 0.93 and an intra-class correlation coefficient (for test-retest reliability) of 0.68 (95% CI: 0.50–0.80). Low-moderate negative correlations were observed between the IADCQ and scales of the SF-12v2.ConclusionsThe study findings suggest the IADCQ has appropriate psychometric characteristics as a unidimensional, Web-based measure of AD caregiver burden and is supported by strong model fit statistics from CFA, high degree of item-level reliability, good internal consistency, moderate test-retest reliability, and moderate convergent validity. Additional validation of the IADCQ is warranted to ensure invariance between the paper-based and Web-based administration and to determine an appropriate responder definition.
tions were based in Asia (kϭ4), North America (kϭ3), Africa (kϭ3) and Europe (kϭ2). The target population of these publications were the general public (kϭ7), patients (kϭ4) or both (kϭ1). A slight majority of the 12 primary evidence publications (kϭ7) and a larger majority of the 5 secondary evidence publications (kϭ4) reported a SP bias on the results of the BG. Various parameters such as male gender, higher education and higher income levels were, in some instances, associated with higher WTP amounts. Other factors analysed are the population surveyed (patients vs. general population), and the location of the study. Association between these factors and the occurrence of starting point bias is examined and will be reported. CONCLUSIONS: There is evidence in the literature of a SP bias on the results of BGs, without however a full consensus on the matter. Further research is warranted in order to evaluate the conditions under which such bias appears.OBJECTIVES: Patient reported outcomes (PROs) have become an important component of many clinical studies. The use of ePRO as a data collection method can alleviate the potential burden experienced by patients and/or sites. The purpose of this survey study was to capture current PRO data collection trends and summarize these findings side-by-side with results from a previous PRO data collection survey. METHODS: Industry professionals were invited to complete a web-based survey fielded in late 2011 and early 2012. This survey included questions on professional demographics, experience using PROs (and ePROs) by study type and experience with ePRO technologies. Responses were analyzed descriptively. RESULTS: To date, 54 industry professionals completed the 2011-2012 survey. Fifty nine percent of respondents were from pharmaceutical companies, biotech (26%), medical device (9%), and other (6%). While 49% of respondents in the 2010 survey had previous PRO study experience, 60% of respondents in the current survey had previous PRO experience. The proportion of respondents with prior ePRO experience, however, was similar across the two surveys (51% in 2010 and 54% in 2011-2012). Hand-held device (tablet, PDA) was the most common ePRO technology (71% in 2011, 64% in 2010), followed by interactive voice response (47% in 2011, 60% in 2010), and interactive web-response (29% in 2011, 51% in 2010). Among those with prior ePRO exposure in 2011 and 2010, respectively, 59% and 86% strongly agreed/agreed they would use ePRO in future studies. Among those who never used ePROs, 58% in 2011 and 50% in 2010 indicated they would likely use ePROs in future studies. CONCLUSIONS: Results from this survey suggest that ePRO use continues to gain moderate acceptance among industry professionals. These findings, however, were based on a limited sample size. Future surveys should be administered to allow future trends in ePRO use to be observed over time.
1970. Mortality inequalities continue to exist between population sub-groups. Methods Ecological study using data about mortality of the Improvement Program of Information on Mortality of São Paulo and population estimates by demographic census (IBGEe2000). Areas were drawn from the Social Inclusion Map for the City. The outline was based on territorial classification of the 96 administrative districts in five areas, according to the index of social districts: Areas 1 and 2 (inclusion) and 3, 4, 5 areas (exclusion). We examined cardiovascular mortality rates calculated for 3-year averages age-standardised, relative to differences and rates ratio between areas (CI of 95%). Results Cardiovascular mortality declined in all areas and both male and female sexes in these periods. It was observed major decline (30%) between 1996e1998 and 2003e2005 in rich areas and it was smaller in poor areas (5%). The highest differential was among male, with rate ratio (A5/A1) that it changed from 1.02 (95% CI 0.99 to 1.05) in first period for 1.38 in the last period (95% CI 1.34 to 1.42). In the women this ratio changed from 0.79 (95% CI 0.77 to 0.81) for 1.07 (95% CI 1.03 to 1.09). Conclusion Although overall decline in cardiovascular mortality in all socioeconomic status, it was observed increasing of the inequality in reduction of this death rates, which may reflect worsening living conditions or less access to the health services and to the development diagnostic and therapeutic methods. Introduction Rheumatic heart disease (RHD) is still prevalent in developing countries, with 332.000 annual deaths estimated worldwide. In Brazil, RHD remains a major problem, responsible for high mortality/morbidity and great social impact, with many patients requiring surgical intervention during childhood. Our aim was to investigate the time and risk factors leading to valve surgery in children and adolescents with RHD in a tertiary center in Rio de Janeiro. Methods Data were reviewed on 137 patients followed-up between 1988 and 2007. RHD diagnosis was assigned with revised Jones criteria and/or Doppler-echocardiography indicating chronic mitral/aortic lesions. KaplaneMeier method was used to determine time until surgery and Cox model to evaluate potential risk factors: age; gender; clinical status (acute; recurrence; chronic heart disease); recurrence rate; secondary prophylactic status and endocarditis. SP1-100 SURVIVAL ANALYSIS AND RISK FACTORS FOR VALVE SURGERY IN BRAZILIAN CHILDREN AND ADOLESCENTS WITH RHEUMATIC HEART DISEASEResults The studied population was 52.5% female, median age 11.2 years. Median follow-up time 7.3 years. The proportions were 33.5% for non-adherence to prophylaxis, 31.4% for recurrence rate, 8.8% for endocarditis where most underwent surgery (83.3%). Surgical rate (41%) was different between male (53.8%) and female (29.2%). Survival curves showed most events on the first 2 years and none after 10 years. Cox analysis confirmed the male gender and endocarditis as significant factors. Conclusion Brazilian RHD children...
and SG outcomes from members of the general public who were asked to evaluate hypothetical health states. Two researchers, with a third acting as adjudicator, independently undertook the review of the literature, the inclusion/exclusion process and data extraction. Statistical analyses were performed on study arms (studies) for differences and/or correlation between utility scores derived from TTO and SG. RESULTS: Of the 170 publications yielded by the initial literature search, 19 pertinent articles were included in the present analysis, covering 24 disease categories, 77 studies and 17,515 subjects. The overall weighted mean health utility scores were 0.82 with TTO and 0.83 with SG. Studies reporting a greater than 10% absolute difference between the two measurement tools represented 13% (kϭ10), while 22% reported greater than 10% relative difference (kϭ17), 51% reported overall higher utility scores with SG (kϭ39) and 13% reported equal scores (kϭ10). The most common disease category, discussed in 8 studies covering 2,490 participants, was ocular disease. Spearman's rank test yielded significant positive correlation (r ϭ 0.924). CONCLUSIONS: The majority of studies displayed little difference in scores between the TTO and SG methods collected from the general public. A high positive correlation was observed between utility scores reported by the two methods.
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