Improving Real-World Evidence on Shared Decision Making Through Joint Clinician and Patient Reported Outcomes

OBJECTIVES: Clinical outcomes assessments can be a powerful tool in generating real-world-data (RWD). Research consistently demonstrates that shared-decision making between patients and clinicians and agreement on the dyadic exchanges of patient/provider clinical communication can lead to improved patient care and associated outcomes (e.g., treatment, adherence). Our understanding of patient-provider clinical communication and its associated outcomes is limited by the lack of validated instruments that measure clinician reported outcomes (ClinRO). This gap creates a challenge in generating generalizable RWD to effectively inform how to improve patient outcomes. This study aims to describe literature where both ClinROs and PROs are measured, methods used, and to identify areas for improving measurement of clinical dyadic communication.

METHODS: A targeted review of recent literature with both ClinROs and PROs was conducted. Methodology and instruments are described and evaluated for future relevant research.

RESULTS: Studies employing both ClinRO and PRO measures are largely qualitative with small sample sizes. They rely heavily on PROs with minimal contribution from ClinROs. Shared-decision making is the construct most frequently measured using PROs and ClinROs. Other constructs measured dyadically often use custom designed questions that are not validated (e.g., barriers, access).

CONCLUSIONS: The dearth of validated ClinROs and PROs integrated into RWD data suggests a considerable gap in the measurement of clinical dyadic communication. Assessed studies were generally qualitative, with small sample sizes, used non-validated measurement, and therefore, not generalizable. RWD are used to inform stakeholder (clinicians/industry/payers) decision-making and transform patient care. Studies employing validated PROs and ClinROs provide more meaningful data on the patient journey. These data can inform the design of interventions and programs to improve patient care.

Researchers have an opportunity to build a roadmap for the development of validated tools to measure ClinROs and PROs simultaneously to maximize the full impact of these dyadic exchanges to generate valuable RWD.