Validity and reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using computerized adaptive testing in patients with advanced chronic kidney disease

Abstract

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has been recommended for computerized adaptive testing (CAT) of health-related quality of life. This study compared the content, validity, and reliability of seven PROMIS CATs to the 12-item Short-Form Health Survey (SF-12) in patients with advanced chronic kidney disease.

Methods: Adult patients with chronic kidney disease and an estimated glomerular filtration rate under 30 mL/min/1.73 m2 who were not receiving dialysis treatment completed seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and the ability to participate in social roles and activities), the SF-12, and the PROMIS Pain Intensity single item and Dialysis Symptom Index at inclusion and 2 weeks. A content comparison was performed between PROMIS CATs and the SF-12. Construct validity of PROMIS CATs was assessed using Pearson's correlations. We assessed the test-retest reliability of all patient-reported outcome measures by calculating the intraclass correlation coefficient and minimal detectable change.

Results: In total, 207 patients participated in the study. A median of 45 items (10 minutes) were completed for PROMIS CATs. All PROMIS CATs showed evidence of sufficient construct validity. PROMIS CATs, most SF-12 domains and summary scores, and Dialysis Symptom Index showed sufficient test-retest reliability (intraclass correlation coefficient ≥ 0.70). PROMIS CATs had a lower minimal detectable change compared with the SF-12 (range, 5.7-7.4 compared with 11.3-21.7 across domains, respectively).

Conclusion: PROMIS CATs showed sufficient construct validity and test-retest reliability in patients with advanced chronic kidney disease. PROMIS CATs required more items but showed better reliability than the SF-12. Future research is needed to investigate the feasibility of PROMIS CATs for routine nephrology care.

Keywords: chronic kidney disease (CKD); minimal detectable change; patient-reported outcome measures (PROMs); reliability; validity.

Graphical Abstract

FIGURE 1:

Flow diagram of patient inclusion for baseline and 2-week measurements. All patients who completed the baseline measurement constitute the study sample for validity analyses. All patients who completed the 2-week measurement within 28 days after baseline are included for reliability analyses. The patient indicated the reason for exclusion. Patients who were not digitally skilled were offered participation by telephone but were not willing to participate in that manner.

FIGURE 2:

Score distributions of PROMIS CATs and SF-12 domains and summary scores. The figure's background color gives an indication of the interpretation of scores, ranging from good (green) to worse (red) HRQOL [31]. Note that the first five PROMIS CATs use a reverse scale compared with the other PROMIS CATs and the SF-12.