To the Editor:
We read with interest the article by O'Herrin et al1 in which they described the increase in workload for healthcare centers and researchers and the increase of dropout rate for proposed studies when investigators are unable or unwilling to meet the regulatory requirements as the result of the current privacy regulation. The requirements of the Health Insurance Portability and Accountability Act (HIPAA), implemented in the United States on April 14, 2003, have changed the use of identifiable private health information (PHI).2 Research affected by the HIPAA regulations includes medical record review. Although intentioned to protect patient privacy, the privacy rule assembles significant barriers to the use or disclosure of general health information.
As coordinating quality control and assurance center for an international multicenter phase III trial on the safety and efficacy of a neuroprotective agent in traumatic brain injury (TBI), we have noted significant differences in completion of screening logs between European and U.S. centers as a result of the HIPAA requirements. All European, but only 5 of 15 U.S. sites report age in actual years, with the remaining 10 U.S. sites only dividing patients into 3 categories: <18 years, 18–65 years, and >65 years of age, the middle category being an inclusion criteria and the other 2 exclusion criteria. Actual age is considered PHI. European screening logs indicate the exact time of injury in hours and minutes; 10 American sites only mentioned the date of injury. Information on the occurrence of hypoxic or hypotensive episode is requested in the screening logs, but many American sites do not complete this for reasons of PHI, and likewise, the admission Glasgow Coma Scale is often omitted. These features are pertinent toward enrollment criteria, and whether or not exclusion of the patient from the trial was appropriate can only be determined from fully completed screening logs.
Furthermore, comparison of participating and nonparticipating screened patients, or comparison of basic population characteristics between countries and regions, is not possible when all characteristics with some relation to PHI are withheld on the screening logs.
The original CONSORT (Consolidated Standards of Reporting Trials) statement was developed by investigators, epidemiologists, statisticians, and editors of peer-reviewed biomedical journals in the mid-1990s and revised recommendations published in 2001.3,4
The CONSORT statement outlines procedures for reporting results of a randomized, controlled clinical trial in a transparent manner, and includes a checklist and flow diagram for reporting clinical trials. This includes the number of patients excluded and reasons for exclusion. As a result of the strict HIPAA requirements, we are certain that the data of screening logs from U.S. sites in this phase III trial preclude possibilities for checking accuracy of exclusion and are not compatible with the outlines for reporting a well-conducted trial according to CONSORT. It is further remarkable that two thirds of U.S. sites do not provide any PHI, but one third appear to apply the regulations less strictly.
We hold the opinion that the use of some PHI for completion of screening logs should be permitted under an alternation or waiver of authorization requirements with approval from an Institutional Review Board.
There is a minimal risk to the privacy of individual subjects when these data are used in screening logs, but the quality of the trial is negatively affected if such data are not provided.
Only high-standard trials can prove the potential benefit of new treatments, and, in this specific scenario, the defense of the privacy collides with the quality of research.
Andrew I. R. Maas, MD, PhD
Erwin J. O. Kompanje, PhD
François J. A. Slieker
Department of Neurosurgeryand Department of Intensive Care Erasmus Medical Center Rotterdam, The Netherlands e.j.o.kompanje@erasmusmc.nl
Nino Stocchetti, MD
Milan University Ospedale Policlinico IRCCS Milan, Italy
REFERENCES
- 1.O'Herrin JK, Fost N, Kudsk KA. Health insurance accountability act (HIPAA) regulations. Effect on medical record research. Ann Surg. 2004;239:772–778. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Kulynych J, Korn D. The effect of the new federal medical-privacy rule on research. N Engl J Med. 2002;346:201–204. [DOI] [PubMed] [Google Scholar]
- 3.Begg CB, Cho MK, Eastwood S. Improving the quality of reporting of randomised controlled trials: the CONSORT statement. JAMA. 1996;276:637–639. [DOI] [PubMed] [Google Scholar]
- 4.Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomised trials. Lancet. 2001;357:1191–1194. [PubMed] [Google Scholar]