Interventions are crucial as they offer simple and inexpensive public health solutions that will be useful over the long term use. A Task Force on designing trials of nutritional interventions to slow cognitive decline in older adults was held in Toulouse in September 2012. The aim of the Task Force was to bring together leading experts from academia, the food industry and regulatory agencies to determine the best trial designs that would enable us to reach our goal of maintaining or improving cognitive function in apparently healthy aging people. An associated challenge for this Task Force was to determine the type of trials required by the Public Food Agencies for assessing the impact of nutritional compounds in comparison to well established requirements for drug trials. Although the required quality of the study design, rationale and statistical analysis remains the same, the studies designed to show reduction of cognitive decline require a long duration and the objectives of this task force was to determine best design for these trials. Two specific needs were identified to support trials of nutritional interventions: 1- Risk- reduction strategies are needed to tackle the growing burden of cognitive decline that may lead to dementia, 2- Innovative study designs are needed to improve the quality of these studies.
This double-blind, randomized multi-centre study was designed to compare efficacy and tolerability of 120 mg terfenadine taken once daily (in the morning) with the established regimen of 60 mg terfenadine taken twice daily in the treatment of seasonal rhinitis. Two comparable groups, a total of 191 hay fever patients, were treated for 1 week. Symptom severity was assessed by the investigators before and at the end of the treatment (visual analogue scale), and daily by the patient (four-point rating scale). All symptoms improved to a similar degree in both groups. Differences between the two groups were not statistically significant, except for nasal symptoms in three cases as assessed by the visual analogue scale in one centre (better relief in the group given 120 mg terfenadine once daily). Tolerability was good and similar in both groups. The data presented show that in the treatment of hay fever 120 mg terfenadine given once daily is an effective, convenient and well tolerated alternative to the regimen of 60 mg terfenadine given twice daily.
This study was a double-blind, parallel group comparison of terfenadine (TRF) 60 mg b.i.d. and mequitazine (MQZ) 5 mg b.i.d. for 7 days in the symptomatic treatment of acute pollinosis. The trial took place in the same geographic area and during the same pollen season (May-July 85), to ensure homogeneity of the study population. The fourteen investigators participating in this multicentre trial recruited 141 patients (69 TRF; 72 MQZ) suffering from well-documented pollinosis, mainly hay fever and sometimes allergy to tree pollens. Symptoms (nasal itching, sneezing, rhinorrhoea, obstruction, conjunctivitis) and possible somnolence were rated daily using a 4-point rating-scale of 0 to 3 by the patient on a diary card. Assessment of over-all efficacy and tolerability - focusing on atropinic side-effects - was made at the end of the seven-days treatment period by the physician, after reviewing the diary card and questioning the patient. The means score profile of each symptom for the study period was similar with the two treatments. Both had a fast onset of action with the regression of the total symptoms' score being already significant at day 1. Over-all assessment of efficacy at day 7 showed no significant difference between the two treatments. The daily somnolence scores however showed a clear and significant difference between the two drugs: the frequency of moderate to marked somnolence from day 2 to 7 was around 15% with MQZ and around 5% on days 2 to 5 and 0% on days 6 and 7 with TRF, the difference being significant on days 2, 5, 6 and 7.(ABSTRACT TRUNCATED AT 250 WORDS)
Cet article présente la version franç aise de la DAD-6, un outil validé dans l'évaluation des capacités à réaliser les IADL (instrumental activities of daily living) ou activités intentionnelles et complexes de la vie quotidienne. L'évaluation du degré de perte d'autonomie demeure un critère majeur de différenciation entre trouble cognitif léger, démence et sujets normaux. Il existe plusieurs échelles évaluant les IADL, mais la vérification de leurs propriétés psychométriques s'est souvent révélée insuffisante. C'est dans un contexte d'amélioration du diagnostic précoce de la démence que la DAD-6 a été conç ue. Cet outil est fondé sur la mise en exergue des fonctions cognitives requises dans la réalisation des IADL et essentiellement les fonctions exécutives. Le travail actuel montre la fidélité de l'outil. Une utilisation du questionnaire avec les mêmes informants par un neurologue et deux neuropsychologues, séparément, ont montré une excellente concordance entre les différents évaluateurs (alpha de Krippendorff > 0,80). Le présent travail a aussi permis d'identifier et de classer les principaux biais inhérents aux évaluations subjectives. Les auteurs proposent de clarifier les liens théoriques entre fonctions cognitives et IADL et suggèrent une définition précise des IADL. Ils soulignent l'intérêt d'une évaluation des IADL par des professionnels formés à la neuropsychologie.Mots clés : fonctions exécutives, IADL, activités de vie quotidienne, perte d'autonomie Abstract. This paper presents the French version of DAD-6, a validated instrument for the assessment of IADL (instrumental activities of daily living) considered as intentional and complex activities. A loss of autonomy remains a major criterion in the diagnosis of dementia. In addition, IADL assessment is recommended as a primary outcome in dementia drug trials. Since the publication in 1969 by Lawton and Brody of an IADL scale, manyinstruments have been developed. However, their psychometric properties remain to be improved. The need for improving the early diagnosis yielded to the design of DAD-6, an instrument allowing capturing subtle difficulties in IADL management. The DAD-6 scale emphasizes the role of the cognitive function, mainly the executive function in early IADL impairment. DAD-6 requires the participation of an informant (a patient's proxy). Relative to patients' self-reports or performance-based methods, informant-based questionnaires are the most common and practical methods used in memory clinics. In previous work, DAD-6 score gradually decreased with increasing severity of the cognitive status. The present work shows the inter-rater reliability of DAD-6. The use of the scale with the same informants by one neurologist and two neuropsychologists, separately, indicated a high agreement between raters (alpha of Krippendorff > 0.80).This work also highlights the main sources of bias in the context of evaluation based on subjective judgement. The authors stress the necessity of: 1 -a clarification of the relationship between cognitive funct...
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