Tuyển tập các báo cáo nghiên cứu về hóa học được đăng trên tạp chí hóa học đề tài : A review of methods used in assessing nonserious adverse drug events in observational studies among type 2 diabetes mellitus patients | Hakobyan et al. Health and Quality of Life Outcomes 2011 9 83 http content 9 1 83 HEALTH AND QUALITY OF LIFE OUTCOMES REVIEW Open Access A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients Liana Hakobyan1 Flora M Haaijer-Ruskamp1 2 Dick de Zeeuw1 Daniela Dobre1 and Petra Denig1 2 Abstract Clinical drug trials are often conducted in selective patient populations with relatively small numbers of patients and a short duration of follow-up. Observational studies are therefore important for collecting additional information on adverse drug events ADEs . Currently there is no guidance regarding the methodology for measuring ADEs in such studies. Our aim was to evaluate whether the methodology used to assess non-serious ADEs in observational studies is adequate for detecting these ADEs and for addressing limitations from clinical trials in patients with type 2 diabetes mellitus. We systematically searched MEDLINE and EMBASE for observational studies reporting non-serious ADEs 1999-2008 . Methods to assess ADEs were classified as 1 medical record review 2 surveillance by health care professionals HCP 3 patient survey 4 administrative data 5 laboratory clinical values 6 not specified. We compared the range of ADEs identified number and selection of patients included and duration of follow-up. Out of 10 125 publications 68 studies met our inclusion criteria. The most common methods were based on laboratory clinical values n 25 and medical record review n 18 . Solicited surveillance by HCP n 17 revealed the largest diversity of ADEs. Patient surveys n 15 focused mostly on hypoglycaemia and gastrointestinal ADEs laboratory values based studies on hepatic and metabolic ADEs and administrative database studies n 5 on cardiovascular ADEs. Four studies presented ADEs that were identified with the use of more than one method. The patient population was restricted to a lower risk .
