PCORI funded the development of PCORnet®, the National Patient-Centered Clinical Research Network, to make research faster, easier, and less costly to conduct. PCORnet is made up of Partner Networks of healthcare systems, patients and communities, and health plans that harness the power of large amounts of health data.
PCORI supports brief, descriptive projects to assess the feasibility of conducting research using data gathered and shared securely through PCORnet. This project is one of several designed to test the network while addressing priorities identified by PCORI and its stakeholders.
To incorporate patient-reported outcome measures (PROMs) collected during routine clinical care for patients with heart failure into the PCORnet Common Data Model (CDM) and conduct descriptive analytics of the relationship between these data and other patient characteristics
||Implementation and evaluation of PROMs as part of clinical care for patients with heart failure
|Data Sources and
|Data from 2019–2020 for 1,054 adult patients from 3 clinical sites in 2 PCORnet networks
||Qualitative interviews of patients and clinicians using PROMs, descriptive analytics of PROM data and patient characteristics extracted through a PCORnet query
Aim 1: Qualitative analysis of patient and clinician experiences with PROM implementation
Aim 2: Descriptive analytics of the generalizability of patients with heart failure who completed PROMs compared with patients who did not
Aim 3: Descriptive analytics of the relationship between PROM data and demographic and clinical characteristics
The project team had three aims:
- Aim 1. Implement data collection for PROMs through the electronic health records (EHRs) of three academic health centers across the United States using the PCORnet CDM and interview patients and clinicians about their experiences using these PROM data during clinical encounters.
- Aim 2. Use a PCORnet query from the three medical centers to compare demographic and clinical characteristics of patients who completed PROMs with patients who did not.
- Aim 3. Using data from the PCORnet query, evaluate the association of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores with patient comorbidities.
PROMs are surveys that ask patients how they feel and what activities they can do. The team integrated three PROMs into the EHRs of three academic health centers: the KCCQ-12, which focuses on heart failure symptoms; the Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health scale, which focuses on general health status; and the Patient Health Questionnaire (PHQ-2), which focuses on depression. The team incorporated PROMs into the PCORnet infrastructure using the PCORnet CDM, which organizes data into a standard structure for use by researchers. The team then interviewed a group of 10 patients and 8 clinicians to understand their experiences in using PROM data as part of clinical care.
Next, the project team ran a PCORnet query of PROM data collected from 1,054 adult patients at the three medical centers between 2019 and 2020. The team compared the characteristics of patients who completed the three PROMs with 3,126 patients who did not. The team also examined the association between patients’ PROM scores and patient characteristics, including patient demographics and clinical comorbidities.
Aim 1. The team successfully implemented PROMs at each academic health center and uploaded PROM data to PCORnet. The team assigned PROMs to be completed by 4,180 patients at the three centers, and 1,054 patients completed the questionnaires. Based on the qualitative interviews, patients felt that PROMs helped them communicate their symptoms to their doctors, and doctors found the information from PROMs to be useful for clinical care.
Aim 2. The team successfully ran a PCORnet query and compared patients who completed PROMs with patients who did not. At one of the three medical centers, patients who completed PROMs were significantly younger (p<0.05) than patients who did not complete PROMs; no other statistically significant differences in demographics were seen. Patients who did not complete PROMs had a higher burden of clinical comorbidities, including ischemic heart disease, valvular heart disease, peripheral vascular disease, renal failure, and depression.
Aim 3. The team successfully ran a PCORnet query and found that a significantly larger proportion of female patients had severe heart failure symptoms, defined as a KCCQ-12 score less than 25. Patients with KCCQ-12 scores less than 25 also had a higher burden of clinical comorbidities, including chronic obstructive pulmonary disease, obesity, and depression. Lastly, patients with KCCQ-12 scores less than 25 had significantly lower general health status as defined by the PROMIS Global Health scale and significantly higher depressive symptoms as defined by the PHQ-2.
The timeframe of the project and data latency related to the PCORnet query limited the number of patients with PROM data, which precluded more advanced quantitative analysis such as linear and logistic regression.
Conclusions and Relevance
The project team successfully integrated three PROMs into EHRs at three academic health centers and queried these data using the PCORnet CDM. Patients who did not complete PROMs were generally more ill than those that did, raising the importance of optimizing PROM completion rates. The team found that the PCORnet CDM was a useful tool for extracting and analyzing PROM data.
Future projects could use PROM data from more patients, allowing for an analysis of the association between PROM data and outcomes such as hospitalizations and mortality.