363 research outputs found

    Acquiescence and Extremity in Cross-National Surveys: Domain Dependence and Country-Level Correlates

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    Likert-type rating scales are susceptible to response styles, such as acquiescence and extremity scoring. Although it is widely acknowledged that response styles can seriously invalidate findings of cross-cultural research, their theoretical underpinnings are hardly explored. The current study analyzed domain-dependency and country differences in acquiescence and extremity scoring in a large dataset of the International Social Survey Program. The hypothesis that response styles are more likely in domains with a high personal relevance compared to domains with a low personal relevance was tentatively confirmed. Correlations with various cultural, psychological, and economic variables were investigated. We found that acquiescence was negatively related to affluence, individualism, and well-being, while extremity was only negatively related to well-being. Positive associations were found between uncertainty avoidance and both acquiescence and extremity

    Comparison of a dietary record using reported portion size versus standard portion size for assessing nutrient intake

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    Objective: Because the percentage of missing portion sizes was large in the Aerobics Center Longitudinal Study (ACLS), careful consideration of the accuracy of standard portion sizes was necessary. The purpose of the present study was to investigate the consequences of using standard portion size instead of reported portion sizes on subjects\u27 nutrient intake. Methods: In 2307 men and 411 women, nutrient intake calculated from a 3-day dietary record using reported portion sizes was compared with nutrient intake calculated from the same record in which standard portion sizes were substituted for reported portion sizes. Results: The standard portion sizes provided significantly lower estimates (≥ 20%) of energy and nutrient intakes than the reported portion sizes. Spearman correlation coefficients obtained by the two methods were high, ranging from 0.67 to 0.93. Furthermore, the agreement between both methods was fairly good. Thus, in the ACLS the use of standard portion sizes rather than reported portion sizes did not appear to be suitable to assess the absolute intake at the group level, but appeared to lead to a good ranking of individuals according to nutrient intake. These results were confirmed by the Continuing Survey of Food Intake by Individuals (CSFII), in which the assessment of the portion size was optimal. When the standard portion sizes were adjusted using the correction factor, the ability of the standard portion sizes to assess the absolute nutrient intake at the group level was considerably improved. Conclusions: This study suggests that the adjusted standard portion sizes may be able to replace missing portion sizes in the ACLS database

    Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication

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    Background: Claudication secondary to peripheral artery disease (PAD) is associated with substantial functional impairment. Phosphodiesterase (PDE) inhibitors have been shown to increase walking performance in these patients. K-134 is a selective PDE 3 inhibitor being developed as a potential treatment for claudication. The use of K-134, as with other PDE 3 inhibitors, in patients with PAD raises important safety and tolerability concerns, including the induction of cardiac ischemia, tachycardia, and hypotension. We describe the design, oversight, and implementation of an adaptive, phase II, dose-finding trial evaluating K-134 for the treatment of stable, intermittent claudication. Methods: The study design was a double-blind, multi-dose (25 mg, 50 mg, and 100 mg of K-134), randomized trial with both placebo and active comparator arms conducted in the United States and Russia. The primary objective of the study was to compare the highest tolerable dose of K-134 versus placebo using peak walking time after 26 weeks of therapy as the primary outcome. Study visits with intensive safety assessments were included early in the study period to provide data for adaptive decision making. The trial used an adaptive, dose-finding strategy to efficiently identify the highest dose(s) most likely to be safe and well tolerated, based on the side effect profiles observed within the trial, so that less promising doses could be abandoned. Protocol specified criteria for safety and tolerability endpoints were used and modeled prior to the adaptive decision making. The maximum target sample size was 85 subjects in each of the retained treatment arms. Results: When 199 subjects had been randomized and 28-day data were available from 143, the Data Monitoring Committee (DMC) recommended termination of the lowest dose (25 mg) treatment arm. Safety evaluations performed during 14- and 28-day visits which included in-clinic dosing and assessments at peak drug concentrations provided core data for the DMC review. At the time of review, no subject in any of the five treatment arms (placebo, three K-134-containing arms, and cilostazol) had met pre-specified definitions for resting tachycardia or ischemic changes on exercise ECG. If, instead of dropping the 25-mg K-134 treatment arm, all arms had been continued to full enrollment, then approximately 43 additional research subjects would have been required to complete the trial. Conclusions: In this phase II, dose-finding trial of K-134 in the treatment of stable intermittent claudication, no concerning safety signals were seen at interim analysis, allowing the discontinuation of the lowest-dose-containing arm and the retention of the two highest-dose-containing arms. The adaptive design facilitated safe and efficient evaluation of K-134 in this high-risk cardiovascular population

    The development and implementation of a regional network of physiotherapists for exercise therapy in patients with peripheral arterial disease, a preliminary report

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    BACKGROUND: Exercise therapy (ET) is the main conservative and proven effective treatment of patients with intermittent claudication. Currently, the most frequent exercise prescription is a single 'go home and walk' advise, without supervision or follow-up. There is no evidence to support the efficacy of this advise and compliance is known to be low. Therefore, a systematic approach was used to guarantee quality and standardisation of treatment, optimal guideline adherence and improved of inter-professional communication between vascular surgeons and physiotherapists. In this preliminary report we would like to outline the steps taken for the development and implementation of the Network Exercise Therapy Parkstad METHODS: In October 2003 all 59 regional physiotherapy practices were invited to attend a symposium regarding ET in a physiotherapeutic setting. Attending physiotherapists interested in providing ET and willing to follow a certified course on ET, were asked to register. Three tastkgroups were formed to accomplish the set targets: Exercise therapy education, Exercise therapy implementation and continuity, and Inter-professional communication in the Parkstad region. RESULTS: In total 27 physiotherapists, from 22 different practices followed the educational program and are now trained and accredited to provide ET according to the guideline of the Royal Dutch Society for Physiotherapy. A web-based database wasdesigned to contain information on disease specific items provided by the vascular surgery department, and aspects with respect to ET registered by the physiotherapist. The information is regularly updated and available online. Access tothe database is restricted to vascular surgeons and physiotherapists in the network. The secondary purpose of the database is to register essential benchmark data for future analysis of ET in a physiotherapeutic setting in the Netherlands and to enable physiotherapists continuous feedback on patient performance. A triage system was developed to detect patients with a compromised cardiac history. This group receives ET at the in-hospital department of revalidation with the possibility of immediate consultation of a cardiologist in case of cardiac complications or even CPR. CONCLUSION: The Network Exercise Therapy Parkstad of supervised ET is the first initiative in the Netherlands to provide ET close to the patient's home environment. With the implementation of supervised ET in an outpatient physiotherapeutic setting for all eligible patients with symptomatic PAD, the access to care has been improved. A web-based communication system provides physiotherapists and vascular surgeons with all the necessary and continues updated patient information. Future research, currently in progress, will investigate the therapeutic benefits and cost-effectiveness of exercise therapy in a physiotherapeutic setting

    Childhood prediction models for hypertension later in life:A systematic review

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    BACKGROUND: Hypertension, even during childhood, increases the risk of developing atherosclerosis and cardiovascular disease. Therefore, starting prevention of hypertension early in the life course could be beneficial. Prediction models might be useful for identifying children at increased risk of developing hypertension, which may enable targeted primordial prevention of cardiovascular disease. OBJECTIVE: To provide an overview of childhood prediction models for future hypertension. METHODS: Embase and Medline were systematically searched. Studies were included that were performed in the general population, and that reported on development or validation of a multivariable model for children to predict future high blood pressure, prehypertension or hypertension. Data were extracted using the CHARMS checklist for prediction modelling studies. RESULTS: Out of 12 780 reviewed records, six studies were included in which 18 models were presented. Five studies predicted adulthood hypertension, and one predicted adolescent prehypertension/hypertension. BMI and current blood pressure were most commonly included as predictors in the final models. Considerable heterogeneity existed in timing of prediction (from early childhood to late adolescence) and outcome measurement. Important methodological information was often missing, and in four studies information to apply the model in new individuals was insufficient. Reported area under the ROC curves ranged from 0.51 to 0.74. As none of the models were validated, generalizability could not be confirmed. CONCLUSION: Several childhood prediction models for future hypertension were identified, but their value for practice remains unclear because of suboptimal methods, limited information on performance, or the lack of external validation. Further validation studies are indicated.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0
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