Country-specific reference values for PROMIS ^® pain, physical function and participation measures compared to US reference values

Abstract

Introduction Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is commonly used across medical conditions. To facilitate interpretation of scores across countries, we calculated Dutch reference values for PROMIS Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), Pain Behavior (PROMIS-PB), Ability to Participate in Social Roles and Activities (PROMIS-APSRA), and Satisfaction with Social Roles and Activities (PROMIS-SSRA), as compared to US reference values. Patients and methods A panel completed full PROMIS-PF ( n =1310), PROMIS-PI and PROMIS-PB ( n =1052), and PROMIS-APSRA and PROMIS-SSRA ( n =1002) item banks and reported their level of health per domain (no, mild, moderate, severe limitations). T-scores were calculated by sample and subgroups (age, gender, self-reported level of domain). Distribution-based and anchor-based thresholds for mild, moderate, and severe scores were determined. Results Mean T-scores were close to the US mean of 50 for PROMIS-PF (49.8) and PROMIS-APSRA (50.6), lower for PROMIS-SSRA (47.5) and higher for PROMIS-PI (54.9) and PROMIS-PB (52.0). Distribution-based thresholds for mild, moderate, and severe scores were comparable to US recommended cut-off values (except for PROMIS-PI) but participants reported limitations ‘earlier’ than suggested thresholds. Conclusion Dutch reference values were close to US reference values for some PROMIS domains but not all. We recommend country-specific reference values to facilitate worldwide PROMIS use. KEY MESSAGES PROMIS offers universally applicable IRT-based efficient and patient-friendly measures to assess commonly relevant patient-reported outcomes across medical conditions. To support the use of PROMIS in daily clinical practice and research across the world, country-specific general population reference values should be obtained. More research is necessary to obtain reliable and valid cut-off values for what constitutes mild, moderate and severe scores from the patients’ perspective.

The challenges of classical galactosemia: HRQoL in pediatric and adult patients

“… N sample size, SD standard deviation, P = P value. D Cohen’s D; ≥ 0.20 = small effect, ≥ 0.50 = medium effect, ≥ 0.80 = large effect * P < 0.05, ** P < 0.01, *** P < 0.001 ^ Higher scores indicate more symptoms + Higher scores indicate better functioning # Non-parametric test $ Effect size calculated with median and median absolute deviation a Normative sample of 1002 Dutch adults [ 24 ] b PROMIS reference sample of the US general population c Normative sample of 1006 Dutch adults [ 25 ] d Normative sample of 1310 Dutch adults [ 26 ] e Normative sample of 1002 Dutch adults [ 26 ] …”

“…Ten PROMIS adult measures translated into Dutch [ 60 ] were completed by adult patients: CAT V1.0—Anxiety [ 24 , 61 , 62 ], CAT V1.0—Depression [ 24 , 62 , 63 ], Short Form V2.0—Cognitive function [ 50 , 64 ] 8a, Short Form V1.0—Fatigue 8a [ 25 , 65 ], CAT V2.0—Physical function [ 26 , 66 ], CAT V2.0—Ability to participate in social roles and activities [ 26 , 67 ], CAT V2.0—Satisfaction with social roles and activities [ 26 , 67 ], Short Form V2.0 Companionship 6a [ 68 , 69 ], Short Form V2.0—Emotional Support 8a [ 68 , 70 ] and Short Form V2.0—Social isolation 8a [ 68 , 71 ]. Anxiety, depression, fatigue, physical function and participation- and satisfaction with social roles were validated in the Dutch general population [ 24 – 26 ]. Representatives of adult patients with severe cognitive disabilities completed the PROMIS adult measures avoiding the items addressing emotions and personal feelings [ 44 ].…”

Enhancing the evaluation of physical function following orthopaedic trauma care: comparison of PROMIS Computerized Adaptive Testing and Short Musculoskeletal Function Assessment (SMFA)

“…PROMIS scores are expressed on a T score metric with a mean of 50 and an SD of 10 in the US population (the mean T score in the Dutch population is also 50). 27 Higher scores represent more of the construct measured, in other words, better physical function for PF and increased pain interference for PI.…”

Psychometrics of patient-reported outcomes measurement information system in von Willebrand disease, inherited platelet function disorders, and rare bleeding disorders

“…For all measures, higher scores represent more of the construct (eg, more anger or better physical function). Dutch thresholds for categorizing the T-scores according to severity of the symptoms are available for all PROMIS measures except the short form v1.1 anger [ [35] , [36] , [37] , [38] ].…”