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Abstract Number: 455

Validity, Reliability and Sensitivity to Change of Four Different Patient-Reported Outcomes (PROs) to Measure the Domains Pain, Fatigue, Experienced Disease Activity and General Well-Being in Patients with Rheumatoid Arthritis

Lisanne Renskers1, Piet L.C.M. van Riel2,3 and Ron J.J.C. van Uden1, 1IQ healthcare, Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, Netherlands, 2Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, Netherlands, 3Bernhoven, Department of Rheumatology, Uden, Netherlands

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: patient preferences, patient-reported outcome measures and rheumatoid arthritis (RA), Validity

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Session Information

Date: Sunday, November 13, 2016

Session Title: Quality Measures and Quality of Care - ARHP Poster

Session Type: ACR Poster Session A

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

Background/Purpose: With Patient-Reported Outcomes (PROs), the patient’s perspective can be assessed. Several forms can be used; Verbal Rating Scale (VRS), Numerical Rating Scale (NRS), Visual Analog Scale (VAS) and Likert-scale. Since contradictory findings exist with regard to advantages and disadvantages of these scales, the aim of this study was to assess the clinimetric properties (using OMERACT 2.0 filter) of these scales for the measurement of pain, fatigue, experienced disease activity (DA) and general well-being and to ask patients which scale they prefer most.

Methods: Patients (all fulfilling ACR criteria for RA) visiting the rheumatology outpatient clinic Bernhoven (Uden, the Netherlands) were included. They filled in a questionnaire directly after their visit, consisting of 21 items in 4 domains using VRS, NRS, VAS and 5-point Likert scale. They were asked to fill in the same questionnaire 5 days after their visit and return it in a self-addressed envelope. DAS28(3) scores were calculated (absence of VAS global rating). Regarding truth, Pearson correlations with DAS28(3) were used for validity analysis. Regarding discrimination, Pearson correlations were used for reliability analysis and paired sample t-tests for sensitivity to change (patients in this group were treated with 120 mg methylprednisolone). Regarding feasibility, patients indicated which scale they preferred most.

Results: Two hundred fifty-seven patients (63% female) filled in the first questionnaire, of which 184 patients filled in questionnaire two. Mean DAS28(3) score was 3.16 (±1.15). Concerning truth, 211 stable patients were included for validity analysis. The highest correlation coefficient was found for NRS in the domain pain (r = 0.41, p < 0.001). On fatigue and DA VAS scored best, while Likert scored best on general well-being. With regard to discrimination, 153 patients were eligible for the reliability analysis, 31 patients for the sensitivity to change analysis. For fatigue NRS was most reliable (r = 0.853, p < 0.001). VAS was most reliable to measure pain and DA, while Likert scored best on general well-being. Regarding sensitivity to change, VAS pain was most sensitive (t = 2.843, p < 0.005), followed by Likert pain and NRS pain (t = 2.340 and t = 2.151 respectively, both p < 0.05). Patient indicated NRS as overall scale preference (first questionnaire 47.9%, second questionnaire 48.4%). Besides that, NRS was most preferred for every domain separately (45.1 to 50.0%) (Table1).

Conclusion: Mixed results exist with regard to the clinimetric properties of 4 scales to measure the 4 domains. The great majority of patients preferred NRS and NRS showed reasonable to good clinimetric properties for most domains. Therefore we might consider using NRS as the preferable scale for these PROs except may be for general well-being for which the Likert scale has some advantages.

OMERACT aspect Domain Scale Values
r p-value
Truth Pain 1. NRS 0.41 <0.001
  2. VAS 0.40 <0.001
  3. VRS 0.37 <0.001
  4. Likert 0.34 <0.001
  Fatigue 1. VAS 0.16 <0.05
2. Likert 0.14 0.05
3. NRS 0.14 0.05
4. VRS 0.11 0.10
DA 1. VAS 0.35 <0.001
2. NRS 0.32 <0.001
3. Likert 0.31 <0.001
4. VRS 0.28 <0.001
General well-being 1. Likert -0.29 <0.001
2. VRS -0.28 <0.001
3. NRS -0.25 <0.001
4. VAS -0.25 <0.001
Discrimination
Reliability Pain 1. VAS 0.850 <0.001
2. NRS 0.83 <0.001
3. VRS 0.77 <0.001
4. Likert 0.76 <0.001
Fatigue 1. NRS 0.853 <0.001
2. VAS 0.83 <0.001
3. VRS 0.77 <0.001
4. Likert 0.76 <0.001
DA 1. VAS 0.81 <0.001
2. NRS 0.79 <0.001
3. Likert 0.68 <0.001
4. VRS 0.67 <0.001
General well-being 1. Likert 0.57 <0.001
2. VRS 0.53 <0.001
3. NRS 0.50 <0.001
4. VAS 0.49 <0.001
t
Sensitivity to change Pain VAS 2.84 <0.05
Likert 2.34 <0.05
NRS 2.15 <0.05
%
Feasibility
Questionnaire 1 NRS 47.9
Questionnaire 2 NRS 48.4

Table1: Results of best scoring PROs according to OMERACT 2.0 filter


Disclosure: L. Renskers, None; P. L. C. M. van Riel, None; R. J. J. C. van Uden, None.

To cite this abstract in AMA style:

Renskers L, van Riel PLCM, van Uden RJJC. Validity, Reliability and Sensitivity to Change of Four Different Patient-Reported Outcomes (PROs) to Measure the Domains Pain, Fatigue, Experienced Disease Activity and General Well-Being in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/validity-reliability-and-sensitivity-to-change-of-four-different-patient-reported-outcomes-pros-to-measure-the-domains-pain-fatigue-experienced-disease-activity-and-general-well-being-in-patients/. Accessed February 5, 2023.
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