Use of Patient-Reported Outcomes Measurement Information System Measures in Clinical Research in Patients With Stroke: A Systematic Literature Review.

OBJECTIVE

To systematically describe the use and outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in clinical studies in populations with stroke.

DATA SOURCES

A systematic search on the use of PROMIS measures in clinical stroke studies in 9 electronic databases.

STUDY SELECTION

Studies had to be original, reporting on outcome data using PROMIS measures in populations with stroke (ischemic and/or hemorrhagic), from January 1st, 2007. Initially, 174 unique studies met the inclusion criteria. In 2 steps, titles, abstracts and full-text articles were screened for eligibility (2 authors independently).

DATA EXTRACTION

From the selected articles, study characteristics, type of PROMIS measures, and its outcomes were extracted by 2 authors independently. The authors discussed their views to achieve consensus. A third author was consulted if necessary.

DATA SYNTHESIS

In total, 27 studies (24,366 patients) were included, predominantly from the United States (22); most study populations were hospital-based (20); the number of patients ranged from 30-3283. In general, patients had no or mild symptoms (median modified Rankin scale 1). Two different generic PROMIS measures were reported (PROMIS Global Health, PROMIS 29) and 9 PROMIS measures focusing on specific domains (sleep, pain, physical functioning, self-efficacy, satisfaction with social roles, depression, anxiety, cognition, fatigue). These match the International Classification of Functioning, Disability, and Health (ICF) domains mentioned in the Core Set for Stroke. The measures were administered 1-55 months after stroke. Outcome data are provided. Pooling of data was not achieved because of a large variety in study characteristics (inclusion criteria, follow-up moments, data processing).

CONCLUSIONS

The PROMIS measures in this review could be relevant from a patient's perspective, covering ICF core set domains for patients with stroke. The large variety in study characteristics hampers comparisons across populations. Many different outcome measures are used to report results of stroke rehabilitation studies.