title: Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting.
abstract: BACKGROUND
  Adverse drug reactions (ADRs) have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system.
  
  
  METHODS
  Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261) completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history.
  
  
  RESULTS
  Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found between rheumatology patients with and without neurological comorbidities regarding their awareness of ADRs. The majority of patients reported ADRs of cytotoxic drugs. The most reported ADRs were moderate gastrointestinal discomforts.
  
  
  CONCLUSIONS
  We may draw a profile of rheumatological patients willing to report ADRs: 1) The majority of them suffer from systemic inflammatory diseases and are slightly more prone to neurological comorbidities. 2) They are predominantly aware of their diagnosis but less able to identify the drugs that may cause their ADRs. 3) They tend to report mainly moderate gastrointestinal ADRs; that is, other cohorts of patients and other types of ADRs remain mainly undetected in such a reporting, which could represent a bias. Counseling and education of patients as well as developing a network for online communication might improve patients' reporting of potential ADRs.
authors.affiliation: Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Dragana
authors.initials: D
authors.lastname: Protić
authors.affiliation: Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Nada
authors.initials: N
authors.lastname: Vujasinović-Stupar
authors.affiliation: Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Zoran
authors.initials: Z
authors.lastname: Bukumirić
authors.affiliation: Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Slavica
authors.initials: S
authors.lastname: Pavlov-Dolijanović
authors.affiliation: Department 5, Institute of Rheumatology, Belgrade, Serbia.
authors.forename: Snežana
authors.initials: S
authors.lastname: Baltić
authors.affiliation: Institute of Physiology "Rihard Burjan", Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Slavica
authors.initials: S
authors.lastname: Mutavdžin
authors.affiliation: Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Ljiljana
authors.initials: L
authors.lastname: Marković-Denić
authors.affiliation: Department of Cardiology, Medical Center "Bežanijska kosa", Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Marija
authors.initials: M
authors.lastname: Zdravković
authors.affiliation: Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Zoran
authors.initials: Z
authors.lastname: Todorović
keywords: adverse drug reactions; bias; patient reporting system; rheumatology