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	Institution: STANFORD Univ Med Center  | My Account | E-mail Alerts | Access Rights | Sign In Vol. 9 No. 10, November 2000   Archives  •  Online Features Original Contribution  This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (42)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Medical Practice  • Medical Ethics  • Statistics and Research Methods  • Alert me on articles by topic Selection Bias From Requiring Patients to Give Consent to Examine Data for Health Services Research Steven H. Woolf, MD, MPH; Stephen F. Rothemich, MD; Robert E. Johnson, PhD; David W. Marsland, MD Arch Fam Med. 2000;9:1111-1118. Background  New rulings nationwide require health services researchers to obtain patient consent before examining personally identifiable data. A selection bias may result if consenting patients differ from those who do not give consent. Objective  To compare patients who consent, refuse, and do not answer. Design  Patients completing an in-office survey were asked for permission to be surveyed at home and for their records to be reviewed. Survey responses and practice billing data were used to compare patients by consent status. Setting  Urban family practice center. Patients  Of 2046 eligible patients, 1106 were randomly selected for the survey, were approached by staff, and agreed to participate. Approximately 87% of the nonparticipants were eliminated through a randomization process. Main Outcome Measure  Consent status. Results  A total of 33% of patients did not give consent: 25% actively refused, and 8% did not answer. Consenting patients were older, included fewer women and African Americans, and reported poorer physical function than those who did not give consent (P<.05). Patients who did not answer the question were older, included more women and African Americans, and were less educated than those who answered (P<.02). Visits for certain reasons (eg, pelvic infections) were associated with lower consent rates. On multivariate analysis, older age, male sex, and lower functional status were significant predictors of consent. Conclusions  Patients who release personal information for health services research differ in important characteristics from those who do not. In this study, older patients and those in poorer health were more likely to grant consent. Quality and health services research restricted to patients who give consent may misrepresent outcomes for the general population. From the Department of Family Practice, Virginia Commonwealth University (Drs Woolf, Rothemich, and Marsland), and the Department of Mathematical Sciences (Dr Johnson), Virginia Commonwealth University, Richmond. Dr Johnson is now with the Department of Biostatistics. THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES Up to a quarter of the Australian population may have suboptimal health literacy depending upon the measurement tool: results from a population-based survey Barber et al. HEALTH PROMOT INT 2009;24:252-261. ABSTRACT | FULL TEXT   Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research Noble et al. J Health Serv Res Policy 2009;14:77-81. ABSTRACT | FULL TEXT   Evaluating Predictors of Geographic Area Population Size Cut-offs to Manage Re-identification Risk El Emam et al. J. Am. Med. Inform. Assoc. 2009;16:256-266. ABSTRACT | FULL TEXT   Holding personal information in a disease-specific register: the perspectives of people with multiple sclerosis and professionals on consent and access Baird et al. J. Med. Ethics 2009;35:92-96. ABSTRACT | FULL TEXT   Regulatory Challenges for the Resuscitation Outcomes Consortium Tisherman et al. Circulation 2008;118:1585-1592. FULL TEXT   The effect of privacy legislation on observational research Gershon and Tu CMAJ 2008;178:871-873. FULL TEXT   Extracting information from hospital records: what patients think about consent Campbell et al. Qual Saf Health Care 2007;16:404-408. ABSTRACT | FULL TEXT   Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial. Trevena et al. J. Med. Ethics 2006;32:473-477. ABSTRACT | FULL TEXT   Mother's consent to linkage of survey data with her child's birth records in a multi-ethnic national cohort study Tate et al. Int J Epidemiol 2006;35:294-298. ABSTRACT | FULL TEXT   Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies Junghans et al. BMJ 2005;331:940. ABSTRACT | FULL TEXT   Cluster Randomized Trials of Professional and Organizational Behavior Change Interventions in Health Care Settings Grimshaw et al. The ANNALS of the American Academy of Political and Social Science 2005;599:71-93. ABSTRACT   Practice-Based Research Network Studies in the Age of HIPAA Pace et al. Ann Fam Med 2005;3:S38-S45. ABSTRACT | FULL TEXT   Patterns of Consent in Epidemiologic Research: Evidence from Over 25,000 Responders Dunn et al. Am J Epidemiol 2004;159:1087-1094. ABSTRACT | FULL TEXT   Impracticability of Informed Consent in the Registry of the Canadian Stroke Network Tu et al. NEJM 2004;350:1414-1421. ABSTRACT | FULL TEXT   The privacy paradox: laying Orwell's ghost to rest Upshur et al. CMAJ 2001;165:307-309. FULL TEXT   Protecting the Privacy of Family Members in Research Levinson et al. JAMA 2001;285:1960-1963. FULL TEXT   HOME | CURRENT ISSUE | PAST ISSUES | TOPIC COLLECTIONS | CME | PHYSICIAN JOBS | HELP CONDITIONS OF USE | PRIVACY POLICY | CONTACT US | SITE MAP   © 2000 American Medical Association. All Rights Reserved.