Construct Validity of the Promis-29 in Systemic Sclerosis: Results from the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort

Linda Kwakkenbos¹, Brett D. Thombs¹, Susan J. Bartlett², Marie-Eve Carrier³, Marie Hudson¹, Luc Mouthon⁴, Vanessa L. Malcarne⁵, Maureen Sauvé⁶, Dinesh Khanna⁷ and SPIN investigators, ¹McGill University, Montreal, QC, Canada, ²Medicine, McGill University, Montreal, QC, Canada, ³Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada, ⁴Paris Descartes University, UPRES-EA 4058, Department of Internal Medicine, Cochin Hospital, Paris, France, ⁵SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, ⁶Scleroderma Societies of Canada and Ontario, Hamilton, QC, Canada, ⁷Division of Rheumatology, University of Michigan, Ann Arbor, MI

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: measure, PROMIS, Quality of life and scleroderma

Session Information

Date: Tuesday, November 10, 2015

Title: Research Methodology Poster (ARHP)

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The Patient-Reported Outcomes
Measurement Information System (PROMIS¨) initiative is a cooperative research
program designed to develop, evaluate, and standardize item banks to measure
patient-reported outcomes across medical conditions. The PROMIS-29 measure
contains 29 items, which include four items each for domains reflecting physical
function, anxiety, depression, fatigue, sleep disturbance, pain interference, and
ability to perform social roles, plus a single item on pain intensity. Scores
are standardized with a mean of 50 and standard deviation (SD) of 10. Higher scores represent more of the domain
being measured (e.g., greater sleep disturbance, greater ability to perform
social roles). The purpose of this study was to examine feasibility and construct
validity of the PROMIS29 in patients with systemic sclerosis (SSc) enrolled in a large multinational study.

Methods: English-speaking patients with SSc and ³18 years of age were enrolled in
the Scleroderma Patient-centered Intervention Network (SPIN) Cohort between July
2014 and June 2015 from 19 centers across Canada, the USA and the UK. Baseline medical data are provided by the enrolling physician,
and SPIN Cohort patients completed the PROMIS-29 at baseline. Floor and ceiling
effects were defined as >15% of patients having the lowest or highest
possible domain score, respectively. To examine convergent validity of domains,
hypotheses were formulated a-priori about the associations of domains and
legacy measures. The magnitude of the correlations was interpreted as small (|r|
² 0.3), moderate (0.3 < |r| < 0.5), or
large (|r| ³ 0.5).

Results: In total, 473 patients were included in
analyses. Mean age was 55 years (SD=11.9) and mean time since onset of the
first non-Raynaud symptom was 11.8 years (SD= 8.7). Most patients were female
(n=411, 86.9%) and diagnosed with limited SSc (n=277,
59.1%). Means for the PROMIS-29 domains were: function 42.8 (SD=8.7), anxiety 51.5 (SD=9.6), depression 50.9 (SD=9.2), fatigue 55.9
(SD=11.2), sleep 51.8 (SD=5.0), roles 47.5 (SD=9.6), pain interference 55.9
(SD=9.8), and pain intensity 3.7 (SD=2.7). There was a floor effect for anxiety
(33.6%) and depression (37.6%), and ceiling effects for function (20.5%), roles
(15.2%) and pain interference (23.7%). Most hypotheses were confirmed (7 of 9)
and all were in the hypothesized direction (Table 1).

Conclusion: Results of our study support the
construct validity of the PROMIS-29 in patients with SSc.
Future studies should examine the influence of floor- and ceiling effects for
some domains, as well as other psychometric properties of the measure.

Table 1. Hypotheses and correlations of
PROMIS-29 domains and legacy instruments

PROMIS-29 domain	Legacy instrument(s)	Hypothesis for correlation¹	Pearson correlation [95% CI]
Function	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Large, negative	-0.79 [-0.82, -0.75]
Function	Cochin Hand Function Scale	Large, negative	-0.57 [-0.63, -0.50]
Anxiety	Brief Fear of Negative Evaluation	Moderate, positive	0.49 [0.42, 0.55]
Depression	Patient Health Questionnaire (PHQ)-8	Large, positive	0.72 [0.68, 0.76]
Fatigue	PHQ-8 item 4 (Feeling tired)	Large, positive	0.80 [0.76, 0.83]
Sleep disturbance	PHQ-8 item 3 (Trouble sleeping)	Large, positive	0.55 [0.48, 0.61]
Social roles	HAQ-DI	Moderate, negative	-0.64 [-0.69, -0.59]
Pain interference	Pain interference numeric rating scale	Large, negative	-0.82 [0.79, 0.85]
Pain intensity	Pain severity numeric rating scale	Large, positive	0.89 [0.87, 0.91]

¹The magnitude of the
correlations was interpreted as small (|r| ² 0.3),
moderate (0.3 < |r| < 0.5), or large (|r| ³
0.5).

Disclosure: L. Kwakkenbos, None; B. D. Thombs, None; S. J. Bartlett, None; M. E. Carrier, None; M. Hudson, None; L. Mouthon, None; V. L. Malcarne, None; M. Sauvé, None; D. Khanna, None.

To cite this abstract in AMA style:

Kwakkenbos L, Thombs BD, Bartlett SJ, Carrier ME, Hudson M, Mouthon L, Malcarne VL, Sauvé M, Khanna D. Construct Validity of the Promis-29 in Systemic Sclerosis: Results from the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/construct-validity-of-the-promis-29-in-systemic-sclerosis-results-from-the-scleroderma-patient-centered-intervention-network-spin-cohort/. Accessed .

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