As part of our commitment to the continued well-being of our patients, we established a program to monitor the health of patients involved in the hydraulic fluid incident. The program was designed to detect any unusual patterns of symptoms and illnesses among these patients. No such patterns have been found.

Active participation in the program was voluntary, and all patient information was kept confidential.

Program overview

PharmaLinkFHI (PharmaLink) was selected to manage the long-term monitoring program as part of Duke’s commitment to provide an independent analysis of the long-term health data collected from patients involved in the hydraulic fluid incident.

PharmaLink, a full-service Clinical Research Organization based in Durham, North Carolina, has significant experience in collecting and analyzing information relating to the medical management of patients. Over the last several years, PharmaLink has managed similar programs involving up to 250,000 patients. The company has a clear commitment to quality in all aspects of its work and its quality management system has been certified to global standards (ISO 9001:2000). PharmaLink is affiliated with Durham-based Family Health International (www.fhi.org), a not-for-profit public health research and services organization with offices in over 40 countries.

The long-term monitoring program did not involve patient treatment. Rather, the focus was on tracking the ongoing health of patients based on review of medical records. PharmaLink’s staff independently managed the collection, review, analysis and reporting of the patient outcomes data. The review focused on identification of outcomes of concern after potential hydraulic fluid exposure.

The analysis further compared rates of medical problems of patients included in the program to the expected rates among the general population.

How did Duke’s program collect information?

Since this program was established by Duke, internal Duke University Health System (DUHS) medical records were used in the program to identify new illnesses, post-surgery complications, or unusual complaints. Some patients received care from private-practice physicians following the incident, and their consent was required before those records could be included in the study.

Sources of information included:

• Patient records from Duke-affiliated office practices
• Duke Hospital records
• Durham Regional Hospital records
• Duke Health Raleigh Hospital records
• Medical records submitted by patients
• Medical records submitted by non-Duke doctors, but only with patient permission
• Calls made to the hotline (919-286-3232, ext. 223) if patients provided medical information not already available from the sources above
• News reports and other public records if no other source available for that patient

Did everyone participate?

No. Participation of patients who received follow-up care outside DUHS was completely voluntary and subject to each patient’s consent to participate and share their information. While we encouraged patients to participate to help us obtain the most comprehensive data, Duke respects the privacy of patients who have requested that they not be contacted further, and followed their wishes. Only information available from Duke-affiliated medical records and public reports was included in the study for these patients.

How can I be sure my information was included?

Any visit to a Duke-affiliated hospital or clinic for medical care since the hydraulic fluid incident, including the original surgery and/or hospitalization, was automatically included in the monitoring program. De-identified patient information from visits to the medical consultation clinic with Drs. Darcey and Epling was also included.

Some patients received care elsewhere for new illnesses or symptoms. These patients were able to provide information to the Duke monitoring program in three ways:

1. Patients sent medical records and/or descriptions of their illness or complication directly to the PharmaLink monitoring program at:

   Long-Term Monitoring Program/Project 240
   c/o PharmaLinkFHI
   P.O. Box 528
   Morrisville, NC 27560

2. Patients provided consent to their personal physician to send the medical record of their illness or complication to the program.
3. Patients completed a “Release of Information” form that allowed the Duke follow-up program to obtain a copy of the non-Duke physician or hospital records.

Patients involved in the hydraulic fluid incident may still contact the Duke hotline at: 919-286-3232 ext. 223. Both this hotline and the Medical Consultation Clinic remain available to meet your needs.

Will my health information remain confidential?

All patient medical information will be held in a secure setting accessible only to PharmaLink employees involved in the program.

Are the results available?

Yes. Results are posted in the Scientific Reports section and communicated via this Web site and e-mail as promised.