The Promis-29 in Systemic Sclerosis: Associations with Clinical Characteristics in the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort

Linda Kwakkenbos^1,2, Brett D. Thombs¹, Susan J. Bartlett^3,4, Marie-Eve Carrier², Marie Hudson¹, Luc Mouthon⁵, Vanessa L. Malcarne⁶, Maureen Sauvé⁷, Dinesh Khanna⁸ and SPIN investigators, ¹McGill University, Montreal, QC, Canada, ²Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada, ³Medicine , Divisions of Clinical Epidemiology, Rheumatology, Respirology, McGill University, Montreal, QC, Canada, ⁴Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, ⁵Paris Descartes University, UPRES-EA 4058, Department of Internal Medicine, Cochin Hospital, Paris, France, ⁶SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, ⁷Scleroderma Societies of Canada and Ontario, Hamilton, QC, Canada, ⁸Division of Rheumatology, University of Michigan, Ann Arbor, MI

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Quality of life and scleroderma

Session Information

Date: Wednesday, November 11, 2015

Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud's - Clinical Aspects and Therapeutics III

Session Type: ACR Concurrent Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: Systemic sclerosis (SSc) has far-reaching physical consequences and impacts health-related quality of life. The
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 measure
includes 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 (range 0-10). The
objective was to explore associations of PROMIS-29 domains with clinical
variables in subjects with SSc.

Methods: Adult SSc
subjects were enrolled in the Scleroderma Patient-centered Intervention Network
(SPIN) Cohort from 19 centers across Canada, the USA and the UK between July
2014 and May 2015. Baseline medical data are provided by the
enrolling physician, and SPIN Cohort participants completed the
PROMIS-29 at baseline. For all PROMIS-29 domains, t-tests were conducted for
gender and dichotomous clinical variables. The standardized mean effect size
[95% CI] was calculated to assess the magnitude of the difference between
groups. Correlations and effect sizes were interpreted as small (²0.3),
moderate (between 0.3 and 0.5), or large (³0.5).

Results: In total, 473 subjects were included in
the 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 subjects were female
(n=411, 86.9%) with lcSSc (n=277, 59.1%). The
PROMIS-29 domains were 0.1-0.8 SD below general population. The involvement of
the gastrointestinal tract was consistently associated with worse outcomes
across PROMIS-29 domains (lower scores for function and roles, higher scores
for fatigue, pain interference, pain intensity, anxiety and depression), with
moderate to large effect sizes in 7 of 8 domains. Other clinical variables with
decrements in at least 5 domains included: more skin thickening, diffuse
disease, and presence of contractures (Tables 1 and 2). Conclusion: SSc is associated with
significant impairment in PROMIS-29 domains, with certain disease
characteristics more commonly associated than others. These data inform
priorities for future patient-centered research.

Table 1. Mean differences of PROMIS-29v2
function, fatigue, and pain domains between subjects with different disease characteristics

	N	Function M (SD)	Effect size [95% CI]	Fatigue M (SD)	Fatigue effect size [95%CI]	Pain interference M (SD)	Effect size [95% CI]	Pain intensity M (SD)	Effect size [95% CI]
Sex:
Female	411	43.01 (8.73)	0.16 [-0.10, 0.43]	56.08 (11.24)	0.10 [-0.17, 0.36]	55.74 (9.97)	-0.16 [-0.43, 0.11]	3.68 (2.72)	-0.04 [-0.31, 0.23]
Male	62	41.58 (8.72)	0.16 [-0.10, 0.43]	55.00 (10.77)	0.10 [-0.17, 0.36]	57.3 (8.22)	-0.16 [-0.43, 0.11]	3.79 (2.45)	-0.04 [-0.31, 0.23]
Disease subtype:
Limited/Sine	277	43.93 (8.74)	0.30 [0.11, 0.48]	55.55 (11.47)	-0.08 [-0.26, 0.11]	54.93 (9.59)	-0.24 [-0.42, -0.06]	3.54 (2.63)	-0.13 [-0.31, 0.06]
Diffuse	192	41.36 (8.5)	0.30 [0.11, 0.48]	56.41 (10.76)	-0.08 [-0.26, 0.11]	57.24 (9.68)	-0.24 [-0.42, -0.06]	3.88 (2.71)	-0.13 [-0.31, 0.06]
Raynauds:
No	4	39.98 (11.66)	-0.32 [-1.31, 0.66]	61.78 (12.31)	0.52 [-0.46, 1.51]	61.28 (7.47)	0.55 [-0.44, 1.53]	6.00 (2.94)	0.87 [-0.12, 1.85]
Yes	463	42.80 (8.71)	-0.32 [-1.31, 0.66]	55.91 (11.2)	0.52 [-0.46, 1.51]	55.94 (9.76)	0.55 [-0.44, 1.53]	3.68 (2.68)	0.87 [-0.12, 1.85]
Puffy fingers:
No	172	42.03 (8.91)	-0.10 [-0.29, 0.09]	56.86 (10.65)	0.06 [-0.13, 0.25]	56.47 (9.8)	0.05 [-0.14, 0.24]	3.73 (2.69)	-0.03 [-0.22, 0.16]
Yes	273	42.87 (8.47)	-0.10 [-0.29, 0.09]	56.19 (11.07)	0.06 [-0.13, 0.25]	56 (9.73)	0.05 [-0.14, 0.24]	3.80 (2.69)	-0.03 [-0.22, 0.16]
Sclerodactyly:
No	74	42.68 (8.32)	-0.02 [-0.27, 0.22]	56.82 (11.81)	0.10 [-0.15, 0.34]	56.47 (9.56)	0.07 [-0.18, 0.31]	3.86 (2.64)	0.08 [-0.17, 0.33]
Yes	395	42.90 (8.85)	-0.02 [-0.27, 0.22]	55.74 (11.1)	0.10 [-0.15, 0.34]	55.83 (9.84)	0.07 [-0.18, 0.31]	3.66 (2.70)	0.08 [-0.17, 0.33]
Skin thickening:
No	218	43.73 (8.58)	0.19 [0.01, 0.37]	55.13 (11.88)	-0.13 [-0.31, 0.05]	54.19 (9.85)	-0.34 [-0.52, -0.16]	3.39 (2.68)	-0.21 [-0.39, -0.03]
Yes	253	42.09 (8.82)	0.19 [0.01, 0.37]	56.57 (10.53)	-0.13 [-0.31, 0.05]	57.45 (9.48)	-0.34 [-0.52, -0.16]	3.96 (2.68)	-0.21 [-0.39, -0.03]
Digital ulcers:
No	302	43.38 (8.57)	0.17 [-0.02, 0.36]	55.71 (11.16)	-0.06 [-0.25, 0.13]	55.33 (9.82)	-0.18 [-0.37, 0.01]	3.48 (2.63)	-0.22 [-0.41, -0.03]
Yes	167	41.86 (9.06)	0.17 [-0.02, 0.36]	56.39 (11.17)	-0.06 [-0.25, 0.13]	57.11 (9.61)	-0.18 [-0.37, 0.01]	4.07 (2.74)	-0.22 [-0.41, -0.03]
Joint contractures:
No	333	43.88 (8.67)	0.49 [0.28, 0.71]	55.54 (11.04)	-0.16 [-0.38, 0.05]	54.75 (9.66)	-0.46 [-0.67, -0.25]	3.39 (2.59)	-0.42 [-0.64, -0.21]
Yes	115	39.66 (8.20)	0.49 [0.28, 0.71]	57.33 (10.60)	-0.16 [-0.38, 0.05]	59.16 (9.29)	-0.46 [-0.67, -0.25]	4.50 (2.70)	-0.42 [-0.64, -0.21]
Telangiactasias:
No	116	43.37 (7.78)	0.07 [-0.14, 0.28]	55.65 (10.7)	-0.03 [-0.24, 0.18]	54.94 (8.77)	-0.13 [-0.34, 0.08]	3.59 (2.49)	-0.05 [-0.26, 0.16]
Yes	354	42.72 (9.02)	0.07 [-0.14, 0.28]	55.99 (11.36)	-0.03 [-0.24, 0.18]	56.21 (10.04)	-0.13 [-0.34, 0.08]	3.73 (2.75)	-0.05 [-0.26, 0.16]
Overlap syndrome:
No	371	42.74 (8.52)	0.10 [-0.13, 0.33]	55.95 (11.00)	-0.17 [-0.40, 0.06]	56.06 (9.36)	-0.07 [-0.30, 0.16]	3.70 (2.61)	-0.12 [-0.35, 0.10]
Yes	91	41.9 (9.09)	0.10 [-0.13, 0.33]	57.84 (10.58)	-0.17 [-0.40, 0.06]	56.75 (10.97)	-0.07 [-0.30, 0.16]	4.03 (2.89)	-0.12 [-0.35, 0.10]
GI involvement:
No	60	47.19 (7.92)	0.58 [0.31, 0.86]	49.4 (9.79)	-0.69 [-0.96, -0.41]	52.37 (9.93)	-0.42 [-0.7, -0.15]	3.02 (2.67)	-0.29 [-0.56, -0.02]
Yes	413	42.19 (8.67)	0.58 [0.31, 0.86]	56.88 (11.06)	-0.69 [-0.96, -0.41]	56.47 (9.64)	-0.42 [-0.7, -0.15]	3.8 (2.67)	-0.29 [-0.56, -0.02]
Lung disease:
No	287	43.73 (8.82)	0.30 [0.11, 0.49]	55.41 (11.12)	-0.09 [-0.28, 0.09]	55.41 (9.83)	-0.15 [-0.34, 0.04]	3.63 (2.71)	-0.05 [-0.24, 0.13]
Yes	172	41.14 (8.42)	0.30 [0.11, 0.49]	56.48 (11.36)	-0.09 [-0.28, 0.09]	56.9 (9.57)	-0.15 [-0.34, 0.04]	3.77 (2.62)	-0.05 [-0.24, 0.13]
Pulmonary hypertension:
No	358	43.18 (8.9)	0.51 [0.20, 0.81]	55.71 (11.41)	-0.17 [-0.47, 0.13]	55.59 (9.86)	-0.29 [-0.59, 0.02]	3.64 (2.70)	-0.15 [-0.45, 0.15]
Yes	48	38.67 (8.65)	0.51 [0.20, 0.81]	57.60 (10.92)	-0.17 [-0.47, 0.13]	58.41 (9.90)	-0.29 [-0.59, 0.02]	4.04 (2.59)	-0.15 [-0.45, 0.15]

Table 2. Mean differences of
PROMIS-29v2 anxiety, depression, sleep, and role domains between subjects with
different disease characteristics

	N	Anxiety M (SD)	Effect size [95% CI]	Depression M (SD)	Effect size [95% CI]	Sleep M (SD)	Effect size [95% CI]	Roles M (SD)	Effect size [95% CI]
Sex:
Female	411	51.63 (9.71)	0.07 [-0.2, 0.33]	50.78 (9.19)	-0.09 [-0.35, 0.18]	51.75 (5.04)	-0.05 [-0.32, 0.21]	47.75 (9.55)	0.17 [-0.1, 0.44]
Male	62	50.99 (9.27)	0.07 [-0.2, 0.33]	51.57 (8.95)	-0.09 [-0.35, 0.18]	52.03 (4.78)	-0.05 [-0.32, 0.21]	46.13 (10.22)	0.17 [-0.1, 0.44]
Disease subtype:
Limited/Sine	277	50.66 (9.48)	-0.21 [-0.40, -0.03]	50.15 (8.77)	-0.18 [-0.37, 0.00]	51.57 (4.99)	-0.09 [-0.27, 0.1]	48.62 (9.58)	0.27 [0.08, 0.45]
Diffuse	192	52.71 (9.71)	-0.21 [-0.40, -0.03]	51.84 (9.57)	-0.18 [-0.37, 0.00]	52.01 (5.02)	-0.09 [-0.27, 0.1]	46.1 (9.43)	0.27 [0.08, 0.45]
Raynauds:
No	4	60.05 (13.58)	0.00 [-0.98, 0.98]	58.75 (4.7)	0.87 [-0.12, 1.85]	55.1 (5.88)	0.66 [-0.32, 1.65]	39.2 (9.23)	-0.87 [-1.86, 0.11]
Yes	463	51.48 (9.57)	0.00 [-0.98, 0.98]	50.83 (9.15)	0.87 [-0.12, 1.85]	51.78 (5.01)	0.66 [-0.32, 1.65]	47.57 (9.59)	-0.87 [-1.86, 0.11]
Puffy fingers:
No	172	51.99 (9.19)	0.03 [-0.16, 0.22]	50.85 (8.92)	-0.05 [-0.24, 0.14]	51.38 (4.98)	-0.16 [-0.35, 0.03]	47.35 (9.58)	0.03 [-0.17, 0.22]
Yes	273	51.72 (9.92)	0.03 [-0.16, 0.22]	51.29 (9.3)	-0.05 [-0.24, 0.14]	52.17 (5.01)	-0.16 [-0.35, 0.03]	47.11 (9.49)	0.03 [-0.17, 0.22]
Sclerodactyly:
No	74	51.64 (11.05)	0.01 [-0.23, 0.26]	51.22 (9.39)	0.04 [-0.21, 0.29]	51.84 (5.18)	0.01 [-0.24, 0.25]	47.23 (9.25)	-0.04 [-0.29, 0.21]
Yes	395	51.51 (9.42)	0.01 [-0.23, 0.26]	50.83 (9.13)	0.04 [-0.21, 0.29]	51.8 (4.98)	0.01 [-0.24, 0.25]	47.63 (9.75)	-0.04 [-0.29, 0.21]
Skin thickening:
No	218	49.86 (9.84)	-0.32 [-0.51, -0.14]	49.43 (8.99)	-0.29 [-0.47, -0.11]	51.42 (4.99)	-0.14 [-0.32, 0.04]	48.89 (9.9)	0.26 [0.08, 0.44]
Yes	253	52.95 (9.28)	-0.32 [-0.51, -0.14]	52.07 (9.14)	-0.29 [-0.47, -0.11]	52.12 (5.01)	-0.14 [-0.32, 0.04]	46.4 (9.32)	0.26 [0.08, 0.44]
Digital ulcers:
No	302	51.2 (9.6)	-0.10 [-0.29, 0.09]	50.31 (8.75)	-0.18 [-0.37, 0.01]	51.71 (4.92)	-0.04 [-0.23, 0.15]	47.71 (9.56)	0.05 [-0.14, 0.24]
Yes	167	52.19 (9.78)	-0.10 [-0.29, 0.09]	51.95 (9.81)	-0.18 [-0.37, 0.01]	51.91 (5.20)	-0.04 [-0.23, 0.15]	47.24 (9.89)	0.05 [-0.14, 0.24]
Joint contractures:
No	333	51.14 (9.77)	-0.16 [-0.38, 0.05]	50.42 (8.89)	-0.22 [-0.43, -0.01]	51.29 (4.82)	-0.35 [-0.56, -0.14]	48.26 (9.46)	0.32 [0.11, 0.53]
Yes	115	52.73 (9.25)	-0.16 [-0.38, 0.05]	52.43 (9.58)	-0.22 [-0.43, -0.01]	53.08 (5.89)	-0.35 [-0.56, -0.14]	45.23 (9.68)	0.32 [0.11, 0.53]
Telangiactasias:
No	116	52.90 (9.61)	0.19 [-0.02, 0.40]	51.52 (8.95)	0.09 [-0.12, 0.3]	51.65 (4.65)	-0.04 [-0.24, 0.17]	47.34 (8.29)	-0.04 [-0.25, 0.17]
Yes	354	51.09 (9.64)	0.19 [-0.02, 0.40]	50.66 (9.23)	0.09 [-0.12, 0.3]	51.83 (5.14)	-0.04 [-0.24, 0.17]	47.69 (10.03)	-0.04 [-0.25, 0.17]
Overlap syndrome:
No	371	51.94 (9.41)	0.09 [-0.14, 0.32]	51.11 (9.16)	0.02 [-0.21, 0.25]	51.87 (4.99)	0.04 [-0.19, 0.27]	47.53 (9.38)	0.16 [-0.07, 0.39]
Yes	91	51.06 (10.53)	0.09 [-0.14, 0.32]	50.95 (9.2)	0.02 [-0.21, 0.25]	51.67 (5.2)	0.04 [-0.19, 0.27]	46.05 (9.96)	0.16 [-0.07, 0.39]
GI involvement:
No	60	49.03 (9.15)	-0.30 [-0.57, -0.03]	47.95 (8.13)	-0.37 [-0.64, -0.10]	51.45 (4.95)	-0.08 [-0.35, 0.19]	51.7 (8.62)	0.50 [0.23, 0.77]
Yes	413	51.91 (9.68)	-0.30 [-0.57, -0.03]	51.31 (9.23)	-0.37 [-0.64, -0.10]	51.84 (5.02)	-0.08 [-0.35, 0.19]	46.94 (9.64)	0.50 [0.23, 0.77]
Lung disease:
No	287	51.22 (9.44)	-0.08 [-0.27, 0.11]	50.1 (8.56)	-0.20 [-0.38, -0.01]	51.67 (4.94)	-0.04 [-0.23, 0.15]	48.22 (9.83)	0.21 [0.02, 0.40]
Yes	172	51.99 (9.96)	-0.08 [-0.27, 0.11]	51.87 (9.87)	-0.20 [-0.38, -0.01]	51.87 (5.05)	-0.04 [-0.23, 0.15]	46.22 (9.11)	0.21 [0.02, 0.40]
Pulmonary hypertension:
No	358	51.63 (9.82)	-0.03 [-0.33, 0.27]	50.86 (9.22)	-0.08 [-0.38, 0.22]	51.75 (4.89)	0.06 [-0.24, 0.36]	47.79 (9.71)	0.39 [0.09, 0.70]
Yes	48	51.88 (8.47)	-0.03 [-0.33, 0.27]	51.58 (7.88)	-0.08 [-0.38, 0.22]	51.45 (5.09)	0.06 [-0.24, 0.36]	43.96 (9.66)	0.39 [0.09, 0.70]

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. The Promis-29 in Systemic Sclerosis: Associations with Clinical Characteristics in the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/the-promis-29-in-systemic-sclerosis-associations-with-clinical-characteristics-in-the-scleroderma-patient-centered-intervention-network-spin-cohort/. Accessed .

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