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Severity and Area Score for Hidradenitis (SASH): a novel outcome measurement for hidradenitis suppurativa.

ABSTRACT:

Background

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease with a large impact on patients' health-related quality of life. However, reliable and consistent outcome measures to assess body surface area (BSA) of HS have not been established.

Objectives

To develop and assess the reliability and validity of a novel outcome instrument for assessment of HS BSA in a clinical trial setting.

Methods

Qualitative interviews and focus groups were conducted from July to August 2015 and October 2017 to January 2018. Evaluation of the measurement was assessed during a single-day grading session with patients in April 2018. Participants, who included clinicians or patients, were recruited from academic medical centres in the U.S. mid-Atlantic region.

Results

Concept elicitation included input from 10 providers, of which 60% (n = 6) were female, 80% (n = 8) dermatology specialists and 20% (n = 2) gynaecology specialists. Cognitive debriefing was conducted with 11 providers, of which 82% (n = 9) were dermatologists and 18% (n = 2) gynaecologists. The evaluation stage included 10 clinicians and 23 patients. The intraclass correlation coefficient (ICC) for inter-rater reliability was 0·60 [95% confidence interval (CI) 0·44-0·74]. The ICC for intrarater reliability was 0·98 (95% CI 0·94-1·00). Transformation of the BSA score resulted in an increase in inter-rater reliability to 0·75 (95% CI 0·62-0·85) or 0·76 (95% CI 0·62-0·85). Scores all demonstrated concurrent validity, with statistically significant correlations with extant scoring methods.

Conclusions

This novel scale is a reliable and valid HS outcome instrument and may capture a wide range of patients by assessing BSA. Future research is necessary to demonstrate its responsiveness. What's already known about this topic? The major HS disease activity scales rely on lesions counts and have moderate-to-good reliability. Body surface area (BSA) is one of the physical signs included in the Core Outcome Set for HS, but is not a part of existing HS disease activity scales. What does this study add? A novel disease severity scale, the Severity and Area Score for Hidradenitis (SASH), was developed and the psychometric properties assessed. There was high inter-rater reliability of 0·75 and 0·76 when BSA was scored on an ordinal scale, and an excellent intrarater reliability of 0·98. The SASH score also demonstrated convergent validity with extant instruments. What are the clinical implications of this work? The ability of clinicians to accurately assess disease status will be improved. Implementation of the SASH score will help guide and assess the effectiveness of appropriate treatment choice.

SUBMITTER: Kirby JS

PROVIDER: S-EPMC6928447 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceThe variation in both clinical appearance and responses to diverse treatment options emphasize the importance of an accurate, clinically relevant, yet easy-to-use scoring system in hidradenitis suppurativa.ObjectiveTo propose and provide validation data for the newly designed Severity Assessment of Hidradenitis Suppurativa score.Design, setting, and participantsWe prospectively assessed disease severity using Hurley staging and the modified Hidradenitis Suppurativa Score in 355 patients referred to Ruhr-University Bochum Department of Dermatology between March 2016 and June 2017. We also assessed disease severity via the Severity Assessment of Hidradenitis Suppurativa score.Main outcomes and measuresEvaluation and assessment of convergent validity and responsiveness to treatment of the Severity Assessment of Hidradenitis Suppurativa score.ResultsEighty-eight of the 355 patients (134 [37.7%] men and 221 [62.3%] women with a median [IQR] age of 40 [30-49] years) were classified as Hurley stage I, 221 were Hurley stage II, and 46 were Hurley stage III, with an overall median modified Hidradenitis Suppurativa Score of 31 (interquartile range [IQR], 19.3-53). The median total Severity Assessment of Hidradenitis Suppurativa score was 6 (IQR, 4-9), significantly different among the 3 Hurley groups. The median SAHS score for patients in Hurley stage I was 5 (IQR, 3-6), 6 (IQR, 5-9) for patients in Hurley stage II, and 9 (IQR, 7-12) for patients in Hurley stage III (P < .001, Kruskal-Wallis test). Correlation analysis showed a significant correlation between the modified Hidradenitis Suppurativa Score and the Severity Assessment of Hidradenitis Suppurativa score (r = 0.79, P < .001). Disease severity assessment before and after 3 months of conservative systemic treatment showed a significant correlation between the Severity Assessment of Hidradenitis Suppurativa score and modified Hidradenitis Suppurativa Score. Both the mHSS (P = .001) and the SAHS score (P < .001) significantly differed between the baseline visit (median mHSS, 33 [IQR, 24-52]; median SAHS score, 6 [IQR, 5-9]) and the 3-month visit (median mHSS, 28 [IQR, 15-43.5]; median SAHS score, 5 [IQR, 4-6.3]). The 2 patient-reported items demonstrated excellent test-retest reliability with intraclass correlation coefficient values greater than 0.8.Conclusions and relevanceOur validation data demonstrated that the Severity Assessment of Hidradenitis Suppurativa score is a disease severity instrument that significantly correlates with Hurley staging and the modified Hidradenitis Suppurativa Score, and is responsive enough to measure treatment outcome.

Project description:IntroductionHidradenitis suppurativa (HS) is considered to be the most burdensome dermatosis, with a well-documented negative influence on quality of life (QoL). The patient's perception of the disorder, assessed as the self-reported severity, has been used in other dermatoses but not in HS. The aim of this study was to evaluate the usefulness of self-reported HS severity in clinical practice.MethodsThe study was performed on a group of 130 Spanish HS patients. HS severity was assessed for all the subjects. Hurley staging and patient self-reported severity were used. Moreover, QoL impairment was evaluated using the Dermatology Life Quality Index (DLQI) and the Hidradenitis Suppurativa Quality of Life 24 (HSQoL-24) questionnaire.ResultsThe severity of HS according to the Hurley staging was most commonly assessed as Hurley II (47.7%), indicating moderate disease, followed by severe disease (Hurley III, 26.9%) and mild disease (Hurley I, 25.4%). According to the patient self-reported HS severity, most of the patients reported having mild disease (76 patients, 58.5%), followed by moderate disease (31 patients, 23.8%). Only 23 patients (17.7%) assessed their disease as severe. Moreover, men reported mild disease significantly more frequently than women (70.9% and 49.3%, respectively; p = 0.014). The self-reported HS severity correlated positively with the effect of the disease on patient QoL assessed with DLQI (r = 0.288, p < 0.001). Likewise, a strong positive correlation was found between self-reported HS severity and QoL impairment assessed with HSQoL-24 (r = 0.404, p = 0.001). No statistically significant correlation between Hurley severity stage and DLQI or HSQoL-24 was found. Moreover, there were significant differences in both DLQI and HSQoL-24 total score between different self-reported HS severities. This was not seen for any of the QoL instruments or for Hurley severity staging.ConclusionThe results show that self-assessment severity may reflect patients' subjective feelings more adequately than popular objective instruments, and there should be a place for its use in daily clinical practice.

Project description:Hidradenitis suppurativa (HS) leads to disfigurement and painful eruptions in terminal hair follicles of the intertriginous skin, mainly of axillary, genitofemoral, and perianal sites. It is associated with an excessive impairment of quality of life, psychiatric disorders, and sexual distress. Body image impairment has been linked to depression and anxiety and has been described for some dermatologic disorders but has not yet been investigated in patients with HS.To investigate whether body image is diminished in patients with HS and whether disease severity, age at onset, disease duration, obesity, depression, and anxiety are linked to body image impairment.This 12-month (August 1, 2009, to August 31, 2010) case-control study with a prospective, observational, cross-sectional design recruited 47 consecutive patients with HS entering a tertiary care center and 45 healthy control individuals matched for age, sex, and body mass index (BMI). One patient and 4 controls failed to complete the questionnaire and were excluded from the evaluation. Data analysis was performed from December 1, 2013, to February 15, 2014.The Frankfurt Body Concept Scale (FKKS) and the Hospital Anxiety and Depression Scale (HADS) were given to patients and controls. Correlations among FKKS, HADS, and disease features were calculated.Of the 46 patients and 41 controls included in the evaluation (mean [SD] age, 35.6 [1.6] years; 40 [46%] male and 47 [54%] female), HS significantly reduced body image (mean FKKS score, 234.2 [5.4] in patients and 276.9 [5.7] in controls; P < .001), even when controlled for BMI. A correlation was found for the extent of body image disruption and BMI (r = -0.589; P < .001), HADS-depression score (r = -0.619; P < .001), and HADS-anxiety score (r = -0.340; P = .03). No association was found for the body image score and the severity of HS, age at onset of disease, and duration of disease. The body contact subscale score was the only subscale score that was not different between patients with HS and controls.Patients with HS have major body image impairment, which might lead to depression and anxiety, disorders that have been largely acknowledged in HS. This study identified another element of the psychosocial burden of patients with HS and reveals that body image could potentially be used as an outcome measure in future studies of HS.