Format

Send to

Choose Destination
Med Care. 2018 Oct;56 Suppl 10 Suppl 1:S11-S15. doi: 10.1097/MLR.0000000000000949.

Exploring Meaningful Patient Engagement in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness).

Author information

1
Department of Epidemiology and Biostatistics, University of California, San Francisco, CA.
2
Duke Clinical Research Institute, Durham, NC.
3
Department of Medicine, Division of General Internal Medicine, University of California, San Francisco, CA.

Abstract

BACKGROUND:

Genuine patient engagement can improve research relevance, impact and is required for studies using the National Patient-Centered Clinical Research Network including major multicenter research projects. It is unclear, however, how best to integrate patients into governance of such projects.

METHODS:

ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) is the first major multicenter research project to be conducted in National Patient-Centered Clinical Research Network. Here, we provide a description of how we implemented patient engagement in ADAPTABLE thus far, including a description of committee structures and composition, first-hand patient testimonials, specific contributions, and lessons learned during the planning and early implementation of ADAPTABLE.

RESULTS:

We recruited 1 patient leader from 6 of the 7 enrolling networks to serve on a Patient Review Board for ADAPTABLE, supported the Board with an experienced patient engagement team including an "investigator-advocate" not otherwise involved in the trial, and facilitated bidirectional communication between the Board and ADAPTABLE Coordinating Center. The Board has reviewed and provided substantial input on the informed consent procedure, recruitment materials, patient portal design, and study policy including compensation of participants. Although it was "too late" for some suggested modifications, most modifications suggested by the patient leaders have been implemented, and they are enthusiastic about the study and their role. The patient leaders also attend Steering and Executive Committee calls; these experiences have been somewhat less productive.

CONCLUSIONS:

With adequate support, a cadre of committed patient leaders can provide substantial value to design and implementation of a major multicenter clinical trial.

PMID:
30074943
PMCID:
PMC6143214
DOI:
10.1097/MLR.0000000000000949
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wolters Kluwer Icon for PubMed Central
Loading ...
Support Center