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Wyszukujesz frazę ""confirmatory studies"" wg kryterium: Temat


Tytuł :
Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study.
Autorzy :
Lexchin J; School of Health Policy and Management, York University, Toronto, Ontario, Canada.; Emergency Department, University Health Network, Toronto, Ontario, Canada.
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Źródło :
BMJ open [BMJ Open] 2018 Apr 28; Vol. 8 (4), pp. e020377. Date of Electronic Publication: 2018 Apr 28.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Research Design*
Aged ; Canada ; Female ; Humans ; Male ; Medical Oncology ; Randomized Controlled Trials as Topic ; Retrospective Studies ; United States
Czasopismo naukowe
Tytuł :
A population-based survey to assess troublesome symptoms in gastroesophageal reflux disease
Index Terms :
Udgivelsesdato: 2009-null
OBJECTIVE: A simple frequency and severity threshold for categorizing reflux symptoms as troublesome has been suggested, but there is a lack of confirmatory studies for this threshold. The objectives of this study were to examine the characteristics for troublesome symptoms and to compare different ways of categorizing reflux symptoms as troublesome. MATERIAL AND METHODS: Members of a web panel responding to an e-mail invitation (1623/3506, median age interval 40-44 years, 51% female) who reported reflux symptoms during the preceding 4 weeks (n=1284) were linked to the full questionnaire. Associations between self-reported troublesome symptoms (10-graded VAS) and troublesome symptoms (mild symptoms >1 day/week or moderate/severe symptoms > or = 1 day/week) and clinical characteristics were analyzed. RESULTS: Out of 1284 subjects, 482 (38%) reported reflux symptoms. Agreement on the classification of troublesome symptoms based on frequency and severity and self-reported troublesome symptoms was poor to fair. Using 4 as the cut-off point on the VAS showed the best agreement (kappa = 0.35). Of the 482 symptomatic respondents, 266 (55%) had troublesome symptoms based on frequency and severity and 274 (57%) had self-reported troublesome symptoms. Subjects (n=80) who had self-reported troublesome symptoms, but were not categorized as having troublesome symptoms based on frequency and severity, reported health concerns, work productivity loss and medical treatment significantly more often (p< or =0.03) than subjects (n=194) with troublesome symptoms according to both categorizations. CONCLUSIONS: Classification of troublesome reflux symptoms based on frequency and severity is too simplistic. Health concerns, disrupted work productivity and night-time symptoms add to the perception of symptoms as troublesome.
URL :
http://curis.ku.dk/portal/da/publications/a-populationbased-survey-to-assess-troublesome-symptoms-in-gastroesophageal-reflux-disease(35633fd0-333e-11df-8ed1-000ea68e967b).html">http://curis.ku.dk/portal/da/publications/a-populationbased-survey-to-assess-troublesome-symptoms-in-gastroesophageal-reflux-disease(35633fd0-333e-11df-8ed1-000ea68e967b).html
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