Background/Purpose: Changes in skin are a cardinal feature of systemic sclerosis (SSc). However, there are no SSc specific patient reported outcome measures validated for use to measure changes in skin. Some of the current measures used for SSc are the Modified Rodnan Skin Score (MRSS), SHAQ, SF-36, and PROMIS-29. In addition, several PROs have been developed for use in other skin diseases such as Skindex-29. Our goal was to evaluate some of these current measures to determine their correlations with specific skin symptoms and skin pathology in diffuse cutaneous systemic sclerosis patients.  

Methods: Patients were recruited from the Boston University Scleroderma Center. Data collection occurred between December 2005 to April 2014 and data collected included the SHAQ, Skindex-29, MRSS, and a skin symptom assessment questionnaire developed for this study.  The Skin Symptom Assessment (SSA) consisted of patients’ self-evaluation of six skin symptoms over the past week, each scored on a 5-level Likert Scale (tight, painful, red, rigid/stiff, itchy and overall). Correlations using Spearman’s rho were assessed between SSA, SHAQ, MRSS, and Skindex-29, only when the compared measures were completed on the same date.  A subgroup of patients had a skin biopsy from the same visit as the MRSS, SSA, and SHAQ (n=20), and the relationships between these measures, histological features and myofibroblast staining were evaluated. The first time point the subject completed each patient reported outcome measure was used for analysis.  

Results: 99, 42, 99, and 45 patients completed the SHAQ, Skindex-29, MRSS, and SSA, respectively.  In the 99 patients who had a SHAQ and MRSS from the same date, the SHAQ moderately correlated with MRSS (r=0.403, p<0.001).  SSA had weak to moderate correlations with the MRSS (n=45): the MRSS correlated most highly with tight (r= 0.410, p=0.0052), rigid/stiff (r=0.535, p=0.0002), and overall skin symptoms (r=0.389, p=0.0083). In contrast, the SHAQ correlated most highly with painful (r=0.524, p=0.0003) skin symptoms (n=43).  In the 20 patients with skin biopsies along with concurrent measures, the MRSS correlated strongly with hyalinized collagen (r=0.679, p=0.001), but the SHAQ did not correlate significantly with any of the histologic measures (inflammation, myofibroblast infiltration, or hyalinized collagen).                              

With the SSA, tight skin moderately correlated with myofibroblast infiltration (r=0.485, p=0.030), while rigid/stiff skin moderately correlated with inflammation (r=0.514, p=0.02), myofibroblast infiltration(r=0.450, p=0.036) and hyalinized collagen(r=0.539, p=0.014).                                        

The three domains of Skindex-29, Symptoms, Emotions and Functioning did not correlate significantly with MRSS but did so moderately with SHAQ (r=0.464, r=0.502, and r=0.472 respectively all with p<0.05). 

Conclusion: Patient reported skin symptoms correlate with both clinical and pathological measures. However, this Skin Symptom Assessment was exploratory, as it was not developed through the formal methodology needed for validation of a patient reported outcome measure. Further research is required to develop a patient reported skin symptom measure that is both validated and sensitive to change.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-relationship-of-patient-reported-skin-symptoms-to-the-scleroderma-haq-the-modified-rodnan-skin-score-and-skin-pathology/