COLLECTING PROS IN PATIENT REGISTRIES- THE NEED FOR AND POTENTIAL IMPACT OF PROVIDING PRO DATA TO THE TREATING PHYSICIAN – AND WHEN
Author(s)
Gemmen E1, Leavy MB2
1Quintiles, Rockville, MD, USA, 2Quintiles Real World & Late Phase, Cambridge, MA, USA
The advent of ePROs and direct-to-patient reporting has enabled patients participating in registries to report their symptom or treatment experiences between physician visits, with minimal patient burden. These independent reporting approaches are often used to support patient retention over long follow-up periods, and/or to collect patient-reported data outside of typical physician visit schedules. When a patient completes PROs independent of a physician’s presence (i.e., not completed at the physician’s office and not entered by the registry site), the treating physician may not be aware of the patient’s responses and may need to either proactively ask for this information or wait to obtain this information at the end of the study. The move toward independent reporting of PRO data introduces several competing concerns. First, physician knowledge of the PRO responses could potentially alter the naturalistic follow-up in an observational study, if, for example, the physician’s knowledge of the PRO response prompts him/her to alter the patient’s treatment. As a result, patient reporting independence may be preferred from a research purity perspective. However, any PRO response that may be a safety signal would carry ethical considerations; in such a case, reporting independence would not be preferred. If patient care is always paramount to the benefits of research, then it could be argued that the optimization of patient care is only possible when the physician has all available patient information (e.g., PROs) at his/her disposal, in as close to real-time as possible. In addition, some research indicates that patients are more likely to complete PROs when their physician is aware of and using the PRO data to inform treatment decisions. Further discussion will focus on sponsor and researcher responsibilities for funneling observed data on a patient’s experience back to the treating physician, drawing on examples from the literature and registry protocols.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PRM152
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Multiple Diseases