International Regulations and Recommendations for Utility Data for Health Technology Assessment

Recommendations and guidelines for the collection, generation, source and usage of utility data for health technology assessment (HTA) vary across different countries, with no international consensus. Many international agencies generate their own guidelines providing details on their preferred methods for HTA submissions, and there is variability in both what they recommend and the clarity and amount of detail provided in their guidelines. This article provides an overview of international regulations and recommendations for utility data in HTA for a selection of key HTA countries: Australia, Canada, France, Germany, the Netherlands, Spain (Catalonia), Sweden and the UK (England/Wales and Scotland). International guidelines are typically clear and detailed for the selection of countries assessed regarding the source description of health states (e.g. generic preference-based measure) and who should provide preference weights for these health states (e.g. general population for own country). Many guidelines specify the use of off-the-shelf generic preference-based measures, and some further specify a measure, such as EQ-5D. However, international guidelines are either unclear or lack detailed guidance regarding the collection (e.g. patients report own health), source (e.g. clinical trial) and usage (e.g. adjusting for comorbidities) of utility values. It is argued that there is a need for transparent and detailed international guidelines on utility data recommendations to provide decision makers with the best possible evidence. Where this is not possible it is recommended that best practice should be used to inform the collection, source and usage of utility values in HTA

The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial

<p>Abstract</p> <p>Background</p> <p>The objective of this article is to describe the design of a study to evaluate the clinical and economic effects of a Disease Management model on functional health, quality of care and quality of life of persons living in homes for the elderly.</p> <p>Methods</p> <p>This study concerns a cluster randomized controlled clinical trial among five intervention homes and five usual care homes in the North-West of the Netherlands with a total of over 500 residents. All persons who are not terminally ill, are able to be interviewed and sign informed consent are included. For cognitively impaired persons family proxies will be approached to provide outcome information. The Disease Management Model consists of several elements: (1) Trained staff carries out a multidimensional assessment of the patients functional health and care needs with the interRAI Long Term Care Facilities instrument (LTCF). Computerization of the LTCF produces immediate identification of problem areas and thereby guides individualized care planning. (2) The assessment outcomes are discussed in a Multidisciplinary Meeting (MM) with the nurse, primary care physician, nursing home physician and Psychotherapist and if necessary other members of the care team. The MM presents individualized care plans to manage or treat modifiable disabilities and risk factors. (3) Consultation by an nursing home physician and psychotherapist is offered to the frailest residents at risk for nursing home admission (according to the interRAI LTCF). Outcome measures are Quality of Care indicators (LTCF based), Quality Adjusted Life Years (Euroqol), Functional health (SF12, COOP-WONCA), Disability (GARS), Patients care satisfaction (QUOTE), hospital and nursing home days and mortality, health care utilization and costs.</p> <p>Discussion</p> <p>This design is unique because no earlier studies were performed to evaluate the effects and costs of this Disease Management Model for disabled persons in homes for the elderly on functional health and quality of care.</p> <p>Trail registration number</p> <p>ISRCTN11076857</p

A new test of the construct validity of the CarerQol instrument: measuring the impact of informal care giving

Purpose: Most economic evaluations of health care programmes do not consider the effects of informal care, while this could lead to suboptimal policy decisions. This study investigates the construct validity of the CarerQol instrument, which measures and values carer effects, in a new population of informal caregivers. Methods: A questionnaire was distributed by mail (n = 1,100, net response rate = 21%) to regional informal care support centers throughout the Netherlands. Two types of construct validity, i.e., convergent and clinical validity, have been analyzed. Convergent validity was assessed with Spearman's correlation coefficients and multivariate correlation between the burden dimensions (CarerQol-7D) and the valuation component (CarerQol-VAS) of the CarerQol. Additionally, convergent validity was analyzed with Spearman's correlation coefficients between the CarerQol and other measures of subjective caregiver burden (SRB, PU). Clinical validity was evaluated with multivariate correlation between CarerQol-VAS and CarerQol-7D, characteristics of caregivers, care recipients and care situation among the whole sample of caregivers and subgroups. Results: The positive (negative) dimensions of CarerQol-7D were positively (negatively) related to CarerQol-VAS, and almost all had moderate strength of convergent validity. CarerQol-VAS was positively associated with PU and negatively with SRB. The CarerQol-VAS reflects differences in important background characteristics of informal care: type of relationship, age of the care recipient and duration of care giving were associated with higher CarerQol-VAS scores. These results confirmed earlier tests of the construct validity of the CarerQol. Furthermore, the dimensions of CarerQol-7D significantly explained differences in CarerQol-VAS scores among subgroups of carers. Conclusion: Notwithstanding the limitations of our study, such as the low response rate, this study shows that the CarerQol provides a valid means to measure carer effects for use in economic evaluations. Future research should derive a valuation set for the CarerQol and further address the instrument's content validity, sensitivity and reliability