Modified informed consent procedure: consent to postponed information

How do you obtain a valid assessment of subjective outcomes in a trial in which the participants cannot be blinded to the intervention? Bias is inevitable from unblinded patients, but trials that have not told patients about treatment in all arms have been heavily criticised. Asking participants to consent to postponed information could be a solutio

Predictive validity of a frailty measure (GFI) and a case complexity measure (IM-E-SA) on healthcare costs in an elderly population

Objectives: Measures of frailty (Groningen Frailty Indicator, GFI) and case complexity (INTERMED for the Elderly, IM-E-SA) may assist healthcare professionals to allocate healthcare resources. Both instruments have been evaluated with good psychometric properties. Limited evidence has been published about their predictive validity. Thus, our aim is to evaluate the predictive validity of both instruments on healthcare costs. Methods: Multivariate linear regression models were developed to estimate associations between the predictors frailty (GFI) and/or case complexity (IM-E-SA) and the healthcare costs (in log transformed) in the following year. All models were adjusted for demographics and the presence of morbidity. Results: In the multivariate regression analyses the continuous scores of the GFI and IM-E-SA remained significant predictors for total healthcare costs. Adjusted beta s for GFI and IM-E-SA were respectively 0.14 (95% CI 0.10-0.18) and 0.06 (95% CI 0.04-0.07). The corresponding explained variance (R-2) for both models was 0.40. Frailty remained a significant predictor of long-term care costs (adjusted beta 0.13 [95% CI 0.09-0.16]), while case complexity was a significant predictor of curative care costs (adjusted beta 0.03 195% CI 0.02-0.05]). Conclusions: The GFI and IM-E-SA both accurately predict total healthcare costs in the following year. (C) 2015 Elsevier Inc. All rights reserved

Data from: Comparing the Health State Preferences of Older Persons, Informal Caregivers and Healthcare Professionals: A Vignette Study

The Older Persons and Informal Caregivers Survey- Minimum Dataset (TOPICS-MDS) collects uniform information from research projects funded under the Dutch National Care for the Elderly Programme. To compare the effectiveness of these projects a reference-weighted outcome measure that combined multidimensional TOPICS-MDS outcomes into a composite endpoint (TOPICS-CEP) was developed based on the health state preferences of olde persons and informal caregivers. Vignette studies were conducted. Participants assessed the general wellbeing of older persons described in vignettes on a scale (0-10). Mixed linear analyses were used to obtain and compare the preference weights of the eight TOPICS-CEP components: morbidities, functional limitations, emotional wellbeing, pain experience, cognitive problems, social functioning, self-perceived health, and self-perceived quality of life (QOL). Overall, 330 healthcare professionals, 124 older persons and 76 informal caregivers participated