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Objective: We explored the effectiveness of preventive home visits on the health-related quality-of-life (HRQoL) and mortality among independently community-dwelling older adults. Design: A randomised controlled trial. Subjects: Independently home-dwelling older adults 75 years and older, consisting of 211 in the intervention and 211 in the control group. Setting: Hyvinkää town municipality, Finland. Main outcome measures: We used the change in HRQoL measured by the 15D scale as our primary outcome. Mortality at two years was retrieved from central registers. Results: At the one-year time point, the HRQoL according to the 15D scores deteriorated in the control group, whereas we found no change in the intervention group. The difference between the 15D score changes between the groups was −0.015 (95% CI −0.029 to −0.0016; p = 0.028, adjusted for age, sex, and baseline value). At the two-year time point as the visits ended, that difference diminished. There was no difference in mortality between the groups during the 24-month follow-up. Conclusion: Preventive home visits implemented by a multidisciplinary team with CGA appear to help slow down the decline in HRQoL among older adults, although the effect diminishes when the visits end.Key points We are exploring preventive home visits as means to support the health-related quality-of-life (HRQoL) of home-dwelling older adults Multiprofessional preventive home visits in this intervention study helped to maintain the HRQoL when measured using 15D The effects on HRQoL diminished when the intervention ended, so could further benefits be attained with a longer intervention?The clinical trial registration number: ACTRN12616001411437

Background: We use data from a randomized controlled trial on preventive home visits exploring effectiveness on health-related quality of life. In this article, we examine the intervention's cost-effectiveness and effects on quality-adjusted life years in older home-dwelling adults., Methods: There were 422 independently home-dwelling participants in the randomized, controlled trial, all aged more than 75 years, with equal numbers in the control and intervention groups. The intervention took place in a municipality in Finland and consisted of multiprofessional preventive home visits. We gathered the data on health care and social services use from central registers and medical records during 1 year before the intervention and 2 years after the intervention. We analyzed the total health care and social services use and costs per person-years and the difference in change in health-related quality of life as measured using the 15D measure. We calculated quality-adjusted life years and incremental cost-effectiveness ratios., Results: There was no significant difference in baseline use of services or in the total use and costs of health care and social services during the 2-year follow-up between the two groups. In the intervention group, health-related quality of life declined significantly more slowly compared with the control group (-0.015), but there was no significant difference in quality-adjusted life years gained between the groups. The cost-effectiveness plane showed 60% of incremental cost-effectiveness ratios lying in the dominant quadrant, representing additional effects with lower costs., Conclusions: This multiprofessional preventive home visit intervention appears to have positive effects on health-related quality of life without accruing additional costs., The Clinical Trial Registration Number: ACTRN12616001411437., (© The Author(s) 2019. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: We explored the effectiveness of preventive home visits on the health-related quality-of-life (HRQoL) and mortality among independently community-dwelling older adults., Design: A randomised controlled trial., Subjects: Independently home-dwelling older adults 75 years and older, consisting of 211 in the intervention and 211 in the control group., Setting: Hyvinkää town municipality, Finland., Main Outcome Measures: We used the change in HRQoL measured by the 15D scale as our primary outcome. Mortality at two years was retrieved from central registers., Results: At the one-year time point, the HRQoL according to the 15D scores deteriorated in the control group, whereas we found no change in the intervention group. The difference between the 15D score changes between the groups was -0.015 (95% CI -0.029 to -0.0016; p = 0.028, adjusted for age, sex, and baseline value). At the two-year time point as the visits ended, that difference diminished. There was no difference in mortality between the groups during the 24-month follow-up., Conclusion: Preventive home visits implemented by a multidisciplinary team with CGA appear to help slow down the decline in HRQoL among older adults, although the effect diminishes when the visits end. Key points We are exploring preventive home visits as means to support the health-related quality-of-life (HRQoL) of home-dwelling older adults Multiprofessional preventive home visits in this intervention study helped to maintain the HRQoL when measured using 15D The effects on HRQoL diminished when the intervention ended, so could further benefits be attained with a longer intervention?The clinical trial registration number: ACTRN12616001411437.

Objectives: The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007., Methods: The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied., Results: Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products., Conclusions: Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent., (Copyright © 2013 John Wiley & Sons, Ltd.)

Even though the regulatory authorities to some extent accept the extrapolation of efficacy data from adults to paediatric patients, it is often the case that differences in the disease process and the developmental stage of the children prevent the extrapolation of efficacy in these populations. Where efficacy studies are needed, the development, validation, and employment of different endpoints for specific age and developmental subgroups become necessary. Children are in continuous development and any measure to assess the efficacy of an intervention should take carefully into account how this development affects the endpoints, including the performance capacity of the child and differences in the condition and symptoms presented. Clinical endpoints that are used in the adult trials to evaluate treatment effect may not be suitable in paediatric studies. The development of surrogate endpoints for benefit and risk assessment in children is necessary. Collaboration between the academic researchers, pharmaceutical industry, and regulatory authorities is needed to meet the challenges in proper validation of biomarkers and surrogate endpoints in paediatric trials.

Objective: The objective of this paper was to analyse opioid consumption in a number European countries using different sources of data., Methods: Data were extracted from the United Nations' International Narcotics Control Board Report (INCB) 2003 and from the registers of the national health authorities in seven countries where data were available for 2002. The amount of opioid used was calculated as daily defined doses per 1000 inhabitants per day (DDD/1000/day). Danish Register of Medicinal Products Statistics was further explored for characteristics of opioid consumption (age, gender, type of opioids consumed) by patients in primary care. Total opioid consumption and consumption of 11 selected opioids (7 strong and 4 weak) were analysed. The amount of opioids consumed by outpatients was also examined., Results: There were considerable differences in the number of opioids reported and significant discrepancies in the amounts of opioids consumed between the national data and the INCB report. The source of data for the national registers on drug consumption varied (pharmacies or wholesale). The INCB data provide information on opioid import and estimated need rather than on medical consumption., Conclusions: Caution is required when interpreting the data on opioid consumption between countries because of differences in the collection and reporting of data. Better recording of opioid consumption is needed for meaningful analysis of opioid consumption and its possible effect on pain management in different countries. Data on opioids consumed for cancer-related pain in comparison with chronic non-malignant pain are needed. A uniform method of collection of data on analgesic consumption should be established for all European countries.