The experience of accommodating privacy restrictions during implementation of a large‐scale surveillance study of an osteoporosis medication. Issue 8 (19th April 2016)

• Record Type: Journal Article
• Authors: Midkiff, Kirk D.; Andrews, Elizabeth B.; Gilsenan, Alicia W.; Deapen, Dennis M.; Harris, David H.; Schymura, Maria J.; Hornicek, Francis J.
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 25:Issue 8(2016)
• Page Start: 960
• Page End: 968
• Publication Date: 2016-04-19
• Subjects: epidemiology -- oncology -- postmarketing product surveillance -- privacy -- public health -- survey -- retrospective studies -- pharmacoepidemiology; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.4008
• Languages: English
• ISSNs: 1053-8569

Abstract

Abstract: Purpose: To explore whether privacy restrictions developed to protect patients have complicated research within a 15‐year surveillance study conducted with US cancer registries. Methods: Data from enrolling 27 cancer registries over a 10‐year period were examined to describe the amount of time needed to obtain study approval. We also analyzed the proportion of patients that completed a research interview out of the total reported by the registries and examined factors thought to influence this measure. Results: The average length of the research review process from submission to approval of the research was 7 months (range, <1 to 24 months), and it took 6 months or more to obtain approval of the research at 41% of the cancer registries. Most registries (78%) required additional permission steps to gain access to patients for research. After adjustment for covariates, the interview response proportion was 110% greater (ratio of response proportion = 2.1; 95% confidence interval: 1.3, 3.3) when the least restrictive versus the most restrictive permission steps were required. An interview was more often completed for patients (or proxies) if patients were alive, within a year of being diagnosed, or identified earlier in the study. Conclusions: Lengthy research review processes increased the time between diagnosis and provision of patient information to the researcher. Requiring physician permission for access to patients was associated with lower subject participation. A single national point of entry for use of cancer registry data in health research is worthy of consideration to make the research approval process efficient. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.