By Jim Kremidas, VP of market development, Quintiles’ Digital Patient Unit
Patients are taking an increasingly active role in managing their own healthcare. This continues a trend that 65% of physicians believe is linked to better outcomes. In this environment, online communities are becoming a powerful tool for clinical research — even raising the interesting possibility of carrying out elements of clinical trials without involving physicians.
This radical shift, where patients are becoming their own advocates rather than relying on their healthcare provider’s advice for managing their health, is largely the product of the Internet and the wide availability of medical information. The role of patient advocacy groups is also evolving, often focusing on driving traditional biopharma research to benefit their constituents, while individual patients are seeking practical guidance online to help manage their health. Online patient communities, which may be sponsored by a variety of groups, provide many benefits to patients, including connections with other people coping with similar conditions, advice on disease management, and information about clinical trials. These communities — for example, MediGuard.org and ClinicalResearch.com — also have the potential to improve trials and accelerate patient recruitment by prescreening potential participants online and by allowing protocol feasibility and messaging to be tested directly with patients.
During a trial, online tools, such as email communications providing disease updates and appointment reminders, can keep patients engaged with the study, help optimize participant retention, and may allow patients to have virtual visits (for example, submitting patient-reported outcomes, the contents of a patient diary, or progress on lifestyle changes). Virtual visits can reduce the burden of trial participation for both patient and physician and can also reduce costs such as site monitoring and investigator grant fees. Once the trial is complete, creation of “alumni communities” can keep participants informed about the findings of the trial and may provide a pool of engaged and willing volunteers for future research.
Digital Observational Research
Much experience to date with patient communities has involved observational research. A recent study aimed to test the perception that patients who are highly engaged in their healthcare have better outcomes than those who are not engaged in their healthcare. The study needed 500 patients with a chronic ambulatory disease to fill out a patient-reported outcome questionnaire indicating their level of engagement and motivation to take care of their health. The participants were recruited online through patient communities. As an indication of the promise of this approach, the first patient was recruited in six minutes, and all 500 were signed up within six business days. To recruit this many patients through the traditional physician-based approach would have taken months.
As part of the study, all participants were asked to give informed consent and were asked to fill out an online psychodemographic survey, which segmented them by behavioral characteristics related to control, emotion, and agency/action. With permission from these patients, the researchers then examined the patients’ medical records (MR). The actual medical outcomes for each patient were compared with the segmentation results of survey, allowing researchers to determine whether there was a correlation between the MR and the patient-reported outcome (PRO). Although concerns exist regarding the validity of self-reported diagnosis, this pilot showed that nearly all data collected by physicians confirmed the data provided by the patients, with those who are highly engaged in their healthcare recording the most positive outcomes. The study broadly validated PRO instruments used to evaluate adherence to medications, treatment satisfaction, and other drivers of actively managing a patient’s health.
This interesting result illustrates the promise of obtaining data directly from patients and comparing this with the outcome recorded in their health record, requiring minimal involvement from physicians. This approach has particular promise in postmarketing surveillance of products that are taken over extended periods, such as products for diabetes or pain, and could come close to real-time clinical research. Alumni communities could be helpful in risk evaluation and mitigation strategies (REMS) programs required by the FDA, allowing immediate feedback from trial participants. If used in the appropriate setting, online communities may be a rapid and relatively inexpensive source of essential data in the future.