Conducting research on the Internet: medical record data integration with patient-reported outcomes.

BACKGROUND: The growth in the number of patients seeking health information online has given rise to new direct-to-patient research methods, including direct patient recruitment and study conduct without use of physician sites. While such patient-centric designs offer time and cost efficiencies, the absence of physician-reported data is a key concern, with potential impact on both scientific rigor and operational feasibility. OBJECTIVE: To (1) gain insight into the viability of collecting patient-reported outcomes and medical record information in a sample of gout patients through a direct-to-patient approach (ie, without the involvement of physician sites), and (2) evaluate the validity of patient-reported diagnoses collected during a patient-reported outcomes plus medical record (PRO+MR) direct-to-patient study. METHODS: We invited a random sample of MediGuard.org members aged 18 to 80 years to participate via email based on a gout treatment or diagnosis in their online profiles. Interested members clicked on an email link to access study information, consent to participate electronically, and be screened for eligibility. The first 50 consenting participants completed an online survey and provided electronic and wet signatures on medical record release forms for us to obtain medical charts from their managing physicians. RESULTS: A total of 108 of 1250 MediGuard.org members (8.64%) accessed study information before we closed the study at 50 completed surveys. Of these 108 members who took the screener, 50 (46.3%) completed the study, 19 (17.6%) did not pass the screening, 5 (4.6%) explicitly declined to participate due to the medical record requirement, and 34 (31.5%) closed the browser without completing the survey screener. Ultimately, we obtained 38 of 50 charts (76%): 28 collected using electronic signature and 10 collected based on wet signature on a paper form. Of the 38 charts, 37 cited a gout diagnosis (35 charts) or use of a gout medication (2 charts). Only 1 chart lacked any mention of gout. CONCLUSIONS: Patients can be recruited directly for observational study designs that include patient-reported outcomes and medical record data with over 75% data completeness. Although the validity of self-reported diagnosis is often a concern in Internet-based studies, in this PRO+MR study pilot, nearly all (37 of 38) charts confirmed patient-reported data.

Impact of comorbidity on health-related quality of life in men undergoing radical prostatectomy: data from CaPSURE.

OBJECTIVES: Comorbidity is one of many factors that may affect health-related quality of life (HRQOL) in men with prostate cancer. We hypothesized that the number and type of comorbidities negatively affect HRQOL in men undergoing radical prostatectomy. METHODS: We reviewed HRQOL outcomes before and up to 2 years after radical prostatectomy for men with localized prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a longitudinal disease registry. This analysis focused on 856 men who completed a pretreatment survey and at least one posttreatment survey. HRQOL was assessed using the University of California, Los Angeles, Prostate Cancer Index (six subscales) and the Medical Outcomes Study 36-Item Short Form questionnaire (eight subscales and two summary scales). The associations between HRQOL and the number and type of comorbidities were analyzed using repeated measures during a 2-year follow-up period. RESULTS: Preoperatively, men with no comorbidities had greater HRQOL scores than did men with comorbidities for physical health and disease-specific measures, but not for mental health measures. Only sexual function and the physical component summary scores showed a significant interaction between the number of comorbidities and time (P < 0.01 and P = 0.03, respectively). Significant interactions with time were observed for other urinary conditions, gastrointestinal disease, heart disease, and hypertension on at least one HRQOL domain. CONCLUSIONS: Men with comorbidities had worse HRQOL scores than men without comorbidities, both before and after radical prostatectomy. However, with two exceptions, the scores declined at similar rates after surgery. Specific comorbidities also had an association with certain HRQOL domains. Therefore, during preoperative counseling, clinicians should consider a patient's number and type of comorbidities.

Comorbidity and primary treatment for localized prostate cancer: data from CaPSURE.

PURPOSE: The optimal approach for treating localized prostate cancer remains controversial, leading to a multifactorial decision making process. We characterized the extent to which the presence and number of comorbidities affects treatment for localized prostate cancer. MATERIALS AND METHODS: Data were abstracted from a longitudinal observational database of men with prostate cancer. A total of 5,149 men diagnosed with localized prostate cancer between 1995 and 2001 were included in this analysis if they had been treated with RP, external beam radiation, brachytherapy, hormonal therapy or surveillance. Comorbidity was assessed through a patient reported checklist of conditions. Multinomial logistic regression was used to determine the OR of the likelihood of receiving each type of therapy. The number of comorbidities and specific comorbidities in patients receiving RP were compared with comorbidities in patients receiving other treatment. RESULTS: The adjusted OR showed a dose response between the number of comorbidities and an increasing probability of any nonRP treatment. In addition, heart disease, stroke or another urinary condition were found to be associated with treatment. CONCLUSIONS: Patient comorbidities affect decision making regarding treatment for localized prostate cancer. Urologists and other physicians treating this disease appear to evaluate patient comorbidities when selecting treatment options.