ALBERT

Description: The Internet is a potentially useful tool for recruiting patients with rare diseases to clinical trials. It facilitates the rapid and efficient recruitment of subjects, allowing patients to participate in minimal risk clinical trials who may not otherwise enroll because of lack of available studies, age, health, or proximity to a major medical center. In this study we recruited patients with the myeloproliferative disorders polycythemia vera (PV), essential thrombocytosis (ET) and agnogenic myeloid metaplasia (AMM) through the aid of an Internet support group. Our goal was to test the feasibility of using an internet-based support group to recruit 600 patients to a national cohort that collected clinical, demographic, and quality of life data as well as blood samples for tissue banking. Information on the trial was emailed to the mailing list and posted on the website of the MPD support group www.mpdinfo.org. Participants emailed the study investigator with their interest in the study, their diagnoses and mailing addresses. Information packets with consent forms, questionnaires, and release of medical records were sent through the U.S. postal service to participants. Once signed informed consents and questionnaires were returned, patients were mailed blood sample kits with pre-paid return postage to obtain blood samples. Patients were eligible if they had a diagnosis of PV, ET or AMM, lived in the United States, were 〉18 years old, and had not had a stem cell transplant. From January – July 2004, 497 people responded with initial interest. At each stage of the enrollment process there was a decrease in the number of participants: 23 were excluded because they lived outside of the United States. 474 were sent information packets, of which 360 were returned. Of these, 2 patients were excluded because of prior stem cell transplant and 12 opted out of the study. 344 patients consented to having blood samples drawn and 247 of these samples have been received in our tissue bank to date. Thus, the overall retention rate from initial response to receipt of blood sample is 52%. The median age of the cohort is 58 (range 20– 84 years) and the majority (58%) are female, in contrast to recent clinical trials in PV, ET and AMM where the majority of participants are older and male. Similar to recent studies 98% are white; and the median duration of disease for these patients is 63 months (range 3–543). The Internet recruitment method did select for a highly educated and more affluent population than in other series: 60% of participants are college graduates and 47% reported annual incomes 〉$75,000/year. PV was the most common self reported diagnosis (50%) followed by ET (35%) and then AMM (14%). Of 269 participants on whom we have received medical records thus far, we have been able to verify diagnosis on 136 participants; 53/136 (39%) have PV; 58/136 (42%) have ET; and 25/136 (18%) have AMM or myelofibrosis. Despite provision of a signed medical records releases, HIPAA restrictions have interfered with our ability to obtain medical records in some cases. In conclusion we have found that using the Internet for recruiting participants with rare diseases was efficient and feasible, and has produced a large cohort willing to provide self-reported information, medical records and research specimens. Issues of incomplete data collection, selection bias, and HIPAA restrictions remain barriers to optimal use of the Internet for minimal risk studies.

Description: Purpose: Previous studies of patient-physician communication have noted that patients (pts) want to know “as much information as possible” about their diseases, but very little is known about successful ways to communicate this information. Patients and Methods: We report interim results of an ongoing, longitudinal study of patient-physician communication among people with hematologic malignancies. 83 pts seeing 15 physicians were studied at the Dana-Farber Cancer Institute (DFCI), Boston, MA between 9/02-9/03. After informed consent, subjects were interviewed qualitatively and quantitatively prior to their consultations, the consultation was audiotaped, and pts were interviewed between 1–10 days after their consultations. 83/176 (47%) of invited patients participated. Results: Interim results from the pre-consultation and post-consultation interviews for evaluable pts (n=72) are presented. Overall, the population was well-educated (53% college graduates), married (74%), White (81%), and reported high social support and relatively little anxiety and depression. The median age was 58 yrs (range 20–80 yrs), 46% were female, and the median time from diagnosis to study was 69 days (range 7–1512 d). The primary diagnoses were non-Hodgkin’s lymphoma (n=22, 31%) and multiple myeloma (n=21, 29%). Most wanted to be an equal partner in decision making (41%) or take primary responsibility for the decision (36%). Almost everyone wanted to discuss treatment options, treatment goals, and physician treatment recommendations (96–100%), but fewer wanted to discuss average patient survival (86%), likelihood of treatment success (70%), likelihood of cure (60%) or clinical trials (49%). 70% wanted prognostic information in percentages and 64% wanted to hear about previous pts, while fewer desired fractions (43%) or qualitative expressions of probability (44%). When asked to estimate prognosis (chance of cure and life expectancy) before the consultation, pts were much more optimistic compared to their physicians. After the consultation, most pts’ prognostic estimates were unchanged although a few (14–24%) became more optimistic and 7–19% became less optimistic. Most pts were satisfied with their consultations and “very likely” to recommend their physicians to other pts (88%). Pts were completely (69%) or somewhat (28%) satisfied with the amount of information they were given. Most reported the same or improved depression, anxiety and hope after their consultations. Conclusions: Patients in our study are interested in most but not all information about their diseases. In particular, they want information about treatment options and recommendations, but less information about the likely course of the disease. While physicians appear to be communicating with patients in ways that result in high degrees of satisfaction, maintain hope, and do not diminish patients’ sense of depression or anxiety, patients are retaining their overoptimistic prognostic expectations after their consultations.