PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.
Understanding patient experiences, values, and preferences for health care and treatment is essential to patient-centered care. PCORI’s Methodology Standards advocate using patient-centered outcomes (PCOs) wherever possible. Researchers explored whether it was applicable and feasible to use the Patient-Reported Outcomes Measurement Information System (PROMIS®), a set of generic PCOs querying common symptoms/impacts, during routine visits with patients with rheumatoid arthritis (RA) to enhance communication and shared decision making (SDM).
Study objectives were to (1) evaluate the feasibility, acceptability, relevance, and psychometric performance of PROMIS PCOs for patients with RA in routine visits; (2) estimate the effect of PCOs on communication and SDM; and (3) integrate into the study team a diverse group of stakeholders (e.g., patients, advocates, industry, government, and professional organizations) to identify new opportunities for further PCO research and implementation.
Pragmatic implementation trial.
Participants, Interventions, Settings, and Outcomes
Participants included RA patients, the clinical and research teams, and stakeholders. All participants were seen in a tertiary RA clinic in Baltimore, Maryland, at an academic medical center.
Patients used tablets and paper forms to complete PCOs at three or more consecutive visits for up to two years. Results were provided to patients and providers during clinical encounters.
Clinical outcome measures included PCOs (e.g., pain interference, physical function, fatigue, sleep, depression, anxiety, and participation), RA status, and satisfaction and impact surveys. Process measures included questionnaire completion time, visit length, domains discussed, and technology acceptability.
Researchers conducted focus groups and interviews with patients, providers, and research and clinical staff to explore each group’s experiences with the process of PCO collection and use of results. The research team developed standardized qualitative interview guides. Interviews were conducted and coded by two or more experienced qualitative researchers.
Clinical data were abstracted from medical charts. Process data were collected by the study team. Qualitative data sources included focus groups and interviews with patients, providers, and research and clinical staff.
To analyze quantitative data, researchers compared descriptive statistics for sociodemographics, PCOs, satisfaction, SDM, and process measures. In addition, researchers evaluated PROMIS construct validity, reliability, and responsiveness along with baseline and longitudinal relationships between PCOs and RA disease activity. To analyze qualitative data, the research team used pragmatic thematic analysis of interview transcripts and survey text. Discrepancies between researchers were resolved collaboratively and results were reviewed by stakeholders.
RA participants (n = 196 enrolled) were mostly female (82 percent) and white (83 percent) with a mean (SD) age of 56 (13) years. In addition, 24 percent had ≤ high school education, 29 percent had RA ≤5 years, and 22 percent were disabled.
Feasibility, Acceptability, and Domain Coverage: Routine PCO collection/use at visits was feasible and acceptable. The minimal additional time required was not viewed as burdensome to patients, providers, or clinic flow. Many patients preferred completing PCOs on tablets; modifications were necessary for a minority of patients with considerable deforming hand arthritis. Computerized administration of PCOs reduced missing data. Results were rated somewhat relevant to highly relevant by >85 percent of patients and providers.
Performance of PROMIS in RA: PROMIS measures overcame known floor and ceiling effects of other existing RA PCOs and provided precise symptom levels across the entire measurement continuum. PROMIS measures correlated moderately to strongly (rho’s ≥0.68) with corresponding measures. People with RA had higher levels of symptoms as other markers of disease activity increased. Short-term test-retest reliability for PROMIS was strong, and measures detected improvement or worsening over time.
Communication: Even when patients had reached clinical “targets” of therapy, PROMIS showed substantial residual impacts in many areas of physical, social, and emotional health. Doctors and patients reported that PROMIS results were useful indicators to quickly assess and monitor overall health-related quality of life (HRQL). Addressing additional symptoms not traditionally queried (e.g., fatigue, mood) impacted discussions and SDM and helped focus conversations, identify new problems, trigger referrals, and adjust medications. Although population norms were helpful, patients and clinicians noted that RA norms and thresholds for action would significantly enhance the meaningfulness of results.
Stakeholder Integration: Stakeholders helped to improve study design (e.g., recruit more minority participants), interpret results, and disseminate findings including advocating the use of PCOs in self-management, program development, treatment and program evaluation, and policy making.
Patients and clinicians at this single site may not be representative of all patients with RA. Most patients had relatively well-controlled RA at enrollment. There was no control group. Use of PROMIS computer adaptive tests required Internet access.
Results suggest that using PROMIS to assess a broad range of symptoms and impacts at arthritis care visits is feasible, acceptable, and minimally burdensome. There was strong evidence of construct validity, reliability, responsiveness, and relevance of PROMIS measures for RA. Expanded PCO collection facilitated monitoring of symptoms and impacts on HRQL, communication, and SDM.
The researchers have published several manuscripts and presented their findings at numerous professional meetings. They received additional PCORI funding to work with patient stakeholders to “tell the story” of the project through text and videos that included patients, clinicians, and researchers.
The researchers applied for and received PCORI funding for an additional research project based on this study. This study includes a more diverse patient sample and online patient community, and will establish norms and clinically important thresholds/changes for PROMIS among RA patients.