Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study

<p>Abstract</p> <p>Background</p> <p>Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.</p> <p>Methods</p> <p>This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.</p> <p>Results</p> <p>Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (<it>P </it>< .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.</p> <p>Conclusion</p> <p>GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.</p> <p>Trial Registration</p> <p>D9614C00098; ClinicalTrials.gov Identifier NCT00241501</p

Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis

Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33% over 4 years, confirming the role of strontium ranelate as an effective long-term treatment in osteoporosis. INTRODUCTION: Osteoporotic vertebral fractures are associated with increased mortality, morbidity, and loss of quality-of-life (QoL). Strontium ranelate (2 g/day) was shown to prevent bone loss, increase bone strength, and reduce vertebral and peripheral fractures. The preplanned aim of this study was to evaluate long-term efficacy and safety of strontium ranelate. METHODS: A total of 1,649 postmenopausal osteoporotic women were randomized to strontium ranelate or placebo for 4 years, followed by a 1-year treatment-switch period for half of the patients. Primary efficacy criterion was incidence of patients with new vertebral fractures over 4 years. Lumbar bone mineral density (BMD) and QoL were also evaluated. RESULTS: Over 4 years, risk of vertebral fracture was reduced by 33% with strontium ranelate (risk reduction = 0.67, p < 0.001). Among patients with two or more prevalent vertebral fractures, risk reduction was 36% (p < 0.001). QoL, assessed by the QUALIOST(R), was significantly better (p = 0.025), and patients without back pain were greater (p = 0.005) with strontium ranelate than placebo over 4 years. Lumbar BMD increased over 5 years in patients who continued with strontium ranelate, while it decreased in patients who switched to placebo. Emergent adverse events were similar between groups. CONCLUSION: In this 4- and 5-year study, strontium ranelate is an effective and safe treatment for long-term treatment of osteoporosis in postmenopausal women

Quantitative aspects of an operational procedure to assess cross cultural equivalence: description and applications

National audienc

Detection of Differential Item Functioning with Ordinal Response Format: Application of Ordinal Log-Linear Models

International audienc

Le fonctionnement différentiel de l'item dans la démarche d'évaluation de la validité transculturelle des questionnaires patients

National audienceThe search for Differential Item Functioning (DIF) is pursued in many domains and can be part of the assessment of cross-cultural equivalence of Patient-Reported Outcome (PRO) questionaires. This paper presents methods allowing to detect DIF: Cochran-Mantel-Haenszel test, loglinear models, partial correlation coefficients, logistic and item response theory models. Moreover this paper shows how the evaluation of DIF can take part in a rigorous procedure to evaluate cross-cultural equivalence of PRO questionnaires.Le pilotage de tout système complexe n'est pas chose aisée, le système de santé en est un excellent exemple. Sa finalité est double, il s'agit de conserver, d'améliorer la santé du patient mais également de conserver et d'améliorer la santé de tous les patients. Comme dans la plupart des systèmes, la somme des parties n'est pas égale au tout et une optimisation locale peut aboutir à défavoriser d'autres parties du système. Par ailleurs ce système évolue parmi de nombreuses contraintes : économiques, éthiques, sociales. Un pilotage de qualité exige donc d'avoir accès à une excellente information et de pouvoir utiliser des méthodes d'aide à la décision performantes. Information et décision au service du patient rassemble un ensemble de contributions dédiées aux méthodes et techniques permettant d'acquérir, de structurer, d'analyser et de rendre lisible une information sur le ou les patients, dense, spatialement répartie, hétérogène, ainsi qu'aux méthodes et techniques d'aide à la décision médico-économique, que ce soit pour aider le couple patient-médecin, le médecin ou encore les institutions représentant les intérêts de la société