Patient Engagement and Consumerism - Translational Informatics: Realizing the Promise of Knowledge-Driven Healthcare - page 150

A side effect of participation in an interventional clinical trial for a patient is that
the patient is receiving an intervention that is not part of standard care, and may not
be coordinated with other care received. For example, if a patient is recruited to a
trial that is not directed by the patient's primary physician, other clinicians will be
providing interventional care for that patient independent of their primary physi-
cian. Because the clinical trial information system is usually separate from the EHR,
information about the treatment received may not be accessed as part of regular
clinical care. For example, a patient may receive an intervention as part of a clinical
trial that is not indicated in the patient record, and the treating physicians in an
emergency department may not know about the intervention unless the patient
informs them of the intervention. Integrating information from the research data
system to the EHR to notify treating clinicians is thus important to reduce unantici-
pated interactions between care provided, and improve patient safety.
Patient engagement can directly infl uence research in the area of data collection,
because a result of increased patient engagement in health and healthcare is greater
data about patients. Consumer health and social media sites like PatientsLikeMe.
com have emerged as more patients are using electronic tools for support. Studies
of such electronic health data sources have identifi ed the potential of using these
data for research [ 14 , 15 ]. A benefi t of such sources is that participants collect data
more frequently than other clinical sources. Extreme data collection by patients
with such engagement initiatives as Quantifi ed Self provide opportunities for analy-
sis of a high level of self-data collection, and can also lead to innovations for
advancements in increased data collection for the general population [ 16 ].

9.2.4 Providing Results

In most clinical trials, there is no patient engagement beyond recruitment, consent
and data collection. Once the data are collected, contact with subjects ends, as the
research moves to analysis and dissemination phases. Much of the disconnect is due
to cost - research funds usually only cover what is needed for the study. The prob-
lem is that patients participating in a trial are among the most interested in the
results of a study, but standard dissemination methods are (a) slow and (b) directed
at the medical community rather than the patient. This can have a dampening effect
on the enthusiasm of both subjects and a community for participation in clinical
trials, where they are less willing to participate in other trials. It can also create
distrust between the patient and research communities. One study of community
engagement showed that less than a quarter of studies had meaningful engagement
with the community, in either advising the direction of the research, facilitating
recruitment, or having fi ndings shared [ 17 ]. Unfortunately, the effects of non-
engagement have been seen most strongly in minority and underserved populations,
the same populations where more research is needed to address health disparities.
Community-based participatory research (CBPR) has emerged as an approach
to improve engagement in research at the community level. CBPR is a form of