Agreement between patients' self-report and medical records for vaccination: the PGRx database
ABSTRACT PURPOSE: Patients' self-reported vaccine exposure (PS) may be subject to memory errors and other biases. Physicians' prescription records and other medical records (MR) do not capture noncompliance with vaccination. This study compared PS with MR for influenza, 23-valent pneumococcal, and human papillomavirus (HPV) vaccines. METHODS: The Pharmacoepidemiologic General Research Extension (PGRx) database uses a network of over 300 general practitioners across France, who systematically recruit an age- and sex-stratified sample of patients (≥ 14 years old), without reference to their diagnoses or prescriptions. Patients received a structured telephone interview, combined with an interview guide listing vaccines commonly given. Patients' self-reported vaccination in the 3 years before their recruitment was compared with medical records kept by the physician or the patient. RESULTS: Concordance between PS and MR was assessed for 7613 patients for whom both sources of information were available. Agreement within 3 years before the recruitment date was substantial for influenza vaccines (prevalence and bias-adjusted kappa [PABAK] = 0.74, sensitivity PS relative to MR 81.5%) and high for 23-valent pneumococcal vaccines (PABAK = 0.98, sensitivity PS 49.6) and HPV vaccines (PABAK = 0.92, sensitivity PS 91.6). In adjusted analyses, agreement varied with sociodemographic and health-related factors, particularly for influenza and 23-valent pneumococcal vaccines. CONCLUSIONS: The PGRx method for drug exposure assessment is a new tool in pharmacoepidemiology that shows substantial to high agreement between PS and MR for exposure to various vaccines. Our finding of high agreement between PS and MR for HPV vaccination status in young women is a significant addition to the literature. Copyright © 2013 John Wiley & Sons, Ltd.
- Pharmacoepidemiology and Drug Safety 06/2013; 22(6):668-9. DOI:10.1002/pds.3425
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ABSTRACT: The aim of this study was to investigate whether the quadrivalent human papillomavirus (HPV) vaccine Gardasil is associated with a change in the risk of autoimmune disorders (ADs) in young female subjects. Systematic case-control study of incident ADs associated with quadrivalent HPV vaccination in young women across France. A total of 113 specialised centres recruited (from December 2007 to April 2011) females aged 14 to 26 years with incident cases of six types of ADs: idiopathic thrombocytopenic purpura (ITP), central demyelination/multiple sclerosis (MS), Guillain-Barré syndrome, connective tissue disorders (systemic lupus erythematosus, rheumatoid arthritis/juvenile arthritis), type 1 diabetes mellitus and autoimmune thyroiditis. Control subjects matched to cases were recruited from general practice. Multivariate conditional logistic regression analysis; factors included age, geographic origin, smoking, alcohol consumption, use of oral contraceptive(s) or vaccine(s) other than Gardasil received within 24 months before the index date and personal/family history of ADs. Overall, 211 definite cases of AD were matched to 875 controls. The adjusted odds ratio (OR) for any quadrivalent HPV vaccine use was 0.9 [95% confidence interval (CI) 0.5-1.5]. The individual ORs were: 1.0 (95% CI 0.4-2.6) for ITP; 0.3 (95% CI 0.1-0.9) for MS; 0.8 (95% CI 0.3-2.4) for connective disorders; and 1.2 (95% CI 0.4-3.6) for type 1 diabetes. No exposure to HPV vaccine was observed in cases with either Guillain-Barré syndrome or thyroiditis. No evidence of an increase in risk of the studied ADs was observable following vaccination with Gardasil within the time periods studied. There was insufficient statistical power to allow conclusions to be drawn regarding individual ADs. This article is protected by copyright. All rights reserved.Journal of Internal Medicine 11/2013; DOI:10.1111/joim.12155
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ABSTRACT: Immunosuppressive agents used to treat inflammatory bowel disease (IBD) can increase the risk for infections, several of which are preventable through vaccination. Our study aimed to describe vaccine utilization by immunosuppression status, examine reasons for vaccine refusal, and identify characteristics associated with lack of influenza vaccination in patients with IBD. We administered an online survey between February 2012 and April 2012 to an internet-based cohort of patients with IBD in the Crohn's and Colitis Foundation of America Partners program. During this time, 958 individuals completed the survey. The median age was 45, 72.8% were female, and 62.0% had Crohn's disease. Self-reported vaccination rates were low. Those on immunosuppression (n = 514) were more likely to be counseled to avoid live vaccines (P < 0.01). However, counseling rates were low (3.5%-19.1% for various live vaccines). Among the 776 individuals who received the influenza vaccine, maintaining health (74.1%), importance of prevention (66.1%), and provider recommendation (38%) were the most frequently cited motivations. Factors associated with lack of influenza vaccine included lower education level (P = 0.01), younger age (P = 0.02), and no chronic immunosuppression use (P < 0.01). Five hundred seventy (59.5%) individuals thought that patients were responsible for keeping track of their vaccines, whereas 428 (44.7%) placed responsibility on their gastroenterologist and 595 (62.1%) on their primary care physician. Vaccine utilization remains suboptimal in patients with IBD. Educational interventions may increase vaccination rates by clarifying misconceptions. Gastroenterologists can play a more active role in health care maintenance in patients with IBD by counseling patients on which vaccines to receive or avoid.Inflammatory Bowel Diseases 12/2013; 20(2). DOI:10.1097/01.MIB.0000437737.68841.87