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COVID-19 pandemic heralds the biggest challenge faced by health services worldwide and remote consultations are now widely implemented. Evaluation of skin involvement with modified Rodnan Skin Score (mRSS) is central in systemic sclerosis (SSc) as it is associated with internal organ manifestations and mortality, and an increase in mRSS requires attention in all SSc subsets.1 To monitor skin activity remotely during this pandemic we developed the PASTUL (Patient self-Assessment of Skin Thickness in Upper Limb) questionnaire. The questionnaire specifies a grading of skin (normal (0), mild (1), moderate (2), severely (3) thickened) at eight sites corresponding to mRSS with maximum score assigned to each site.2
We evaluated the PASTUL questionnaire on feasibility and validity in patients with SSc who had either a remote or face-to-face appointment at the Royal Free Hospital London, UK. Informed consent was obtained and patient instructions were provided.
Scleroderma Skin Patient Reported Outcome (SSPRO),3 Scleroderma Health Assessment (SHAQ),4 the Scleroderma Functional Score (SFS)5 and the mRSS were collected to evaluate construct validity. The mRSS was done by an experienced rheumatologist without referring to the self-assessed score. Content validity was evaluated in a subgroup of patients by scoring relevance, clarity and practical difficulty of the PASTUL questionnaire on a 5-point Likert scale using Surveymonkey software. Patients were also asked to do the assessment 2 weeks later and to record the time required to complete the self-assessment. Data were analysed using SPSS V.25 (IBM). Construct validity was evaluated using Pearson’s correlation coefficient. Test–retest reliability was estimated using intraclass correlation coefficient (ICC). Coefficients were interpreted as follows: 0–0.19=negligible, 0.2–0.39=weak, 0.4–0.59=moderate, 0.6–0.79=strong, 0.8–1.0=very strong.
Hundred and thirty patients were invited of which 104 (80%) completed all questionnaires. Mean age of participants was 57 years (SD 12), 87% was women, 55 (53%) had limited cutaneous systemic sclerosis (lcSSc) and 49 (47%) diffuse cutaneous systemic sclerosis (dcSSc). PASTUL was completed by patients (86%) or a partner/relative (14%). For characteristics see online supplemental table S1. Mean PASTUL score was 11 (SD 7), SHAQ 1.41 (SD 0.77), SFS 13 (SD 9) and SSPRO 48 (SD 27). PASTUL strongly correlated with total SSPRO and SSPRO subdomain physical limitations (r=0.60 and 0.62, respectively). Seventy-eight (75%) patients completed mRSS. PASTUL and mRSS total and mRSS of upper limbs were moderately correlated (r=0.56 and 0.58, respectively). Table 1 shows the correlations of PASTUL scores with other outcome measures.
Similar approaches have been reported of physician-directed mRSS and patients’ assessment of full mRSS.6 Here, we refined this approach with a simplified instrument scoring only the upper limbs but still demonstrated good correlations with key outcome measures. Interestingly, correlation between PASTUL and mRSS was stronger in lcSSc compared with dcSSc (r=0.53 vs 0.43) and when assessed by a partner/relative compared with patients themselves (r=0.90 vs 0.54). Test–retest reliability, assessed in 21 patients, was excellent (ICC of 0.93, p<0.001). Participants (N=21) scored relevance with a mean score of 4.0 out of 5.0 (SD 1.0), clarity of instructions 4.3 out of 5.0 (SD 0.7) and practicability with 4.1 out of 5.0 (SD 0.9). The mean time to do the self-assessment was 4 min (SD 3).
As the pandemic continues, we need new ways to assess skin in our patients with SSc. Correlations with SSPRO and mRSS support usefulness of PASTUL as an outcome measure. Moreover, our questionnaire empowers patients to help us delivering safe and effective care. Further research is needed to validate the PASTUL questionnaire in other groups, assess responsiveness, explore the role partners in assessment of skin and ways to implement PASTUL in daily practice.
The authors would like to thank the patients who participated in this project. JS acknowledges EUSTAR, EULAR and Catharine van Tussenbroek Fonds for supporting her fellowship.
Handling editor Josef S Smolen
Contributors Study design: all authors. Data collection: JS. Data analysis and interpretation: all authors. Statistical analysis: JS. Drafting of manuscript: all authors.
Funding JS is supported by travel awards from EUSTAR, EULAR and the Catharine van Tussenbroek Fonds.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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