Background

The HiSQOL™ is an HS-specific quality-of-life instrument that is of particular importance as it is sensitive to the unique symptoms and experiences of patients with HS.

The HiSQOL™ is a validated and reliable tool for the assessment of HS-specific quality-of-life.

Instrument

The HiSQOL™ is a 17-item HS-specific questionnaire used to assess participants’ QOL, with a recall period of seven days. Each item is structured as a Likert-type scale with five or seven response levels and, for all items, the score ranges from 0 (not at all) to 4 (extremely). Some items also have response options for when an item is not performed, either because it’s not relevant or due to HS severity. The HiSQOL items address HS symptoms, psychosocial and emotional impacts, as well as activities and adaptations related to HS.

The HiSQOL is available in 70 languages.

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Development

A mixed methods design was utilized and included four phases aligned with guidance from the U.S. Food and Drug Administration. The development of the HiSQOL™ was overseen by an international group of investigators, which included patient research partners, clinicians with expertise in HS and researchers with expertise in instrument development. The initial psychometric properties of the HiSQOL were studied in a cross-sectional observational study of 215 participants with moderate-to-severe HS. Subsequently, the psychometric properties of the HiSQOL were confirmed and expanded through analysis of HiSQOL data collected from two Phase III pivotal trials.

The HiSQOL instrument has been validated for use of the total score as well as subscale scores, determined clinically meaningful within-patient change thresholds for the HiSQOL subscale and total scores and established score categories. Details of the development of the HiSQOL can be found in the References.

Scoring

The total score for the HiSQOL is calculated from the sum of the 17 item scores, which has a total score range of 0 to 68. Additionally, the HiSQOL has three validated subscale scores that can be derived from the item scores: symptoms (with a score range of 0 to 16), psychosocial (with a score range of 0 to 20) and activities-adaptations (with a score range of 0 to 32), with a higher score indicating a higher level of symptomology in all subscales.

The following ranges are recommended to represent a marked clinically meaningful within-patient improvement.

• Symptoms subscale: 5- to 6-point decrease (i.e., 31% to 38% of the score range)
• Psychosocial subscale: 4- to 5-point decrease (i.e., 20% to 25% of the score range)
• Activities-adaptations subscale: 10- to 11-point decrease (i.e., 31% to 34% of the score range)
• Total score: 20- to 21-point decrease (i.e., 29% to 31% of the score range).

Additional details of scoring and interpretation of the HiSQOL scores can be found in the References.

References

Kirby JS, Thorlacius L, Villumsen B, et al. The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials. Br J Dermatol. Aug 2020;183(2):340-348. doi:10.1111/bjd.18692.

Kursawe Larsen C, Kjaersgaard Andersen R, Kirby JS, Tan J, Saunte DML, Jemec GBE. Convergent Validity of Suffering and Quality of Life as Measured by The Hidradenitis Suppurativa Quality of Life. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1577-1581. doi: 10.1111/jdv.17148.

Kirby JS, Ingram JR, Lambert J, Rolleri R, Muller E, Pansar I, Pelligra C. Determination of Bands of HiSQOL Scores Defining Clinically Meaningful Within-Patient Improvement Threshold and Severity Levels. ISPOR-EU 2023; November 12-15, 2023; Copenhagen, Denmark.

Languages

Background

Hidradenitis suppurativa (HS) can have a large negative impact on health-related quality of life (HRQOL). Thus, HS-Specific HRQOL assessment is recommended for measurement in clinical trials. The Hidradenitis Suppurativa Quality Of Life (HiSQOL) scale was developed to validly and reliably measure HS-specific HRQOL for adults (18 years of age and older) with HS. Thus, there was a need for a scale for use with adolescents with HS. The objective of our work study has been to investigate the validity and reliability of the adaptation of the HiSQOL for adolescents with moderate-to-severe HS.

Instrument

The HiSQOL-Adolescent is an HS-specific quality of life instrument that has been adapted for use in adolescents, specifically patients 12 years of age to less than 18 years of age. The HiSQOL-Adolescent is also sensitive to the unique symptoms and experiences of patients with HS. The HiSQOL-Adolescent demonstrates face validity and convergent validity. Its responsiveness to change and score interpretation have not been established.

The HiSQOL is available in 70 languages; however, the HiSQOL-Adolescent adaptations have not been incorporated into languages other than English.

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Development

A qualitative study was conducted and following relevant ethics board approval. Interviews were conducted with HS patients aged 11 to <18 years-old at a center in the United States and a second site in Cardiff, United Kingdom. Details of the development of the HiSQOL can be found in the References. The face validity of the HiSQOL was confirmed in the cognitive debriefings as participants indicated the instrument was exciting and assessed relevant symptoms and impacts of the condition. Quantitative analyses on the subset showed positive results. Content validity was supported by a strong Pearson correlation between the HiSQOL and CDLQI (r=0.92; p=0.01). The reliability for HiSQOL, using the Cronbach alpha, was also strong (a=0.98). Based on feedback, two items related to sexual activity and desire were removed and one item related to exercise was re-worded.

Scoring

Score methodology is conserved from the adult version, with modifications for the reduced number of items. The total score for the HiSQOL-Adolescent is calculated from the sum of the 15 item scores, which has a total score range of 0 to 60. The construct validity of the subscores has not been validated, and interpretation of scores will need to be confirmed. As with the HiSQOL, a higher score indicates a higher level of symptomology.

References

Kirby JS, Thorlacius L, Villumsen B, et al. The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials. Br J Dermatol. Aug 2020;183(2):340-348. doi:10.1111/bjd.18692

Background

Hidradenitis suppurativa (HS) can have a large negative impact on health-related quality of life (HRQOL). The Hidradenitis Suppurativa Quality Of Life (HiSQOL)-Mini™ is an HS-specific quality-of-life instrument that is a reduced version of the original HiSQOL scale.

There was a need for a more efficient scale for use with adults and adolescents with HS in clinical care, health services research, survey research, quality assessment and other approaches to clinical research.

Instrument

The HiSQOL-Mini™ is a 4-item HS-specific questionnaire used to assess participants’ QOL, with a recall period of seven days. Each item is structured as a Likert-type scale with five or seven response levels and, for all items, the score ranges from 0 (not at all) to 4 (extremely). Some items also have response options for when an item is not performed, either because it’s not relevant or due to HS severity. The HiSQOL-Mini items address all three subscales from the original HiSQOL™ scale, including symptoms, psychosocial impacts, as well as activities and adaptations related to HS.

The HiSQOL-Mini™ is available in 70 languages.

Development

The items are derived from the original HiSQOL, which was developed based on the rigorous mixed methods. The face validity of the HiSQOL-Mini was confirmed by patient research partners. Quantitative analyses on the subset showed positive results. Content validity of the HiSQOL-Mini was supported by a strong Pearson correlation with DLQI, Pain NRS, EQ-5D-5L, and original HiSQOL.

Scoring

Score methodology is conserved from the HiSQOL, with modifications for the reduced number of items. The total score for the HiSQOL-Mini is calculated from the sum of the 4 item scores, which has a total score range of 0 to 16. The interpretation of scores will need to be confirmed. As with the HiSQOL, a higher score indicates a higher level of symptomology.

References

Submitted, pending publication.

Background

Single-item assessments such as a global assessment have been effective in assessing and tracking dermatologic disease severity over time. Simplicity in its use can result in a high compliance rate. Specifically, a patient global assessment (PtGA) can assess a construct comprehensively, such as disease impact on QOL, and allows the patient to consider all contributory factors (such as multiple symptoms, treatments, etc.) related to the condition or disease.

Instrument

The HS PtGA is available in English.

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Development

Similar to the HiSQOL, a mixed methods design was utilized and included four phases aligned with guidance from the U.S. Food and Drug Administration. The development of the PtGA was overseen by an international group of investigators, which included patient research partners, clinicians with expertise in HS, and researchers with expertise in instrument development. The psychometric properties of the PtGA were studied in a cross-sectional observational study of 215 participants with moderate-to-severe HS. Details of the development of the HS PtGA can be found in the References.

Scoring

A 2-grade reduction has been shown in a cross-sectional study to represent a marked clinically meaningful within-patient improvement. Additional investigation will confirm the score interpretation of the PtGA.

References

Kirby JS, Hereford B, Thorlacius L, Villumsen B, Ingram JR, Garg A, Butt M, Esmann S, King T, Tan J, Jemec GBE. Validation of global item for assessing impact on quality of life of patients with hidradenitis suppurativa. Br J Dermatol. 2021 Apr;184(4):681-687. doi: 10.1111/bjd.19344.

Background

Clinician-reported outcome measures (CROs) that are valid, reliable, feasible and sensitive to change are critical for evaluating response of HS to therapy. While most CRO for HS are based on lesion counts, which can have problematic inter-rater reliability, the HASI-R is based on body surface area assessment, similar to other validated tools such as the PASI and EASI.

Instrument

The HASI-R assesses HS activity at ten body sites including: head/neck, left axilla, right axilla, chest, abdomen, back, buttocks including intergluteal cleft, right thigh, left thigh, and pubic area/genitals. Extent of HS is assessed using BSA for each body site. Raters were asked to only score active disease. At each site, the rater also grades the severity of four domains: inflammatory color change, inflammatory induration, open skin surface and extent of tunnels.

The HASI-R is only available in English.

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Development

Development of the HASI-R was based off the concurrent development of the original Hidradenitis Suppurativa Activity and Severity Index (HASI) and the Severity and Area Score for Hidradenitis Suppurativa (SASH). Subsequently, the two groups collaborated to develop the HASI-R through included semi-structured physician interviews, a review of the literature on severity assessment tools, and suggestions from the U.S. Food and Drug Administration (FDA).

The inter-rater and intra-rater reliability as well as construct and known groups validity were evaluated in a multi-rater study with assessment of multiple patients with HS, that represented a broad range of HS severity and affected body sites. Details of the development of the HASI-R can be found in the References section.

Training online or in-person is encouraged to ensure valid use in studies.

Scoring

Each item of the HASI-R should be scored by the clinician if it is judged to be due to active HS. Skin findings due to other conditions, including previously active disease, skin damage, infection or comorbidity should not be included in the clinical assessment for the HASI-R.

Each of the four severity domains is scored on a Likert scale from 0 to 3 (0 = none; 1 = limited/mild, 2 = moderate, 3 = severe/extensive) based on the average intensity across the lesions at each body site. The maximum intensity score for each body site is 12 (maximum score of 3, across 4 components). The BSA score for each HS-specific site is calculated as the proportion of the site involved by HS. This is converted to a 0–6 ordinal scale, (0 points = 0 BSA, 1 point =1–3%, 2 points = 4–9%, 3 points= 10–20%, 4 points= 21–29%, 5 points= 30–50%, 6 points= >51%). To calculate HASI-R, the site-specific score is calculated by multiplying the BSA ordinal score by the sum of the four intensity scores. The maximum score for each body site is 72, thus the score range for the total body HASI-R score is 0 to 720, with higher scores indicating more severe disease activity.

References

Goldfarb N, Lowes MA, Butt M, King T, Alavi A, Kirby JS. Hidradenitis Suppurativa Area and Severity Index Revised (HASI-R): psychometric property assessment. Br J Dermatol. 2021 May;184(5):905-912. doi: 10.1111/bjd.19565.

Goldfarb N, Ingram JR, Jemec GBE, Naik HB, Piguet V, Hyde MJ, Freese R, Lowes MA, Alavi A. Hidradenitis Suppurativa Area and Severity Index (HASI): a pilot study to develop a novel instrument to measure the physical signs of hidradenitis suppurativa. Br J Dermatol. 2020 Jan;182(1):240-242. doi: 10.1111/bjd.18335.

Kirby JS, Butt M, King T. Severity and Area Score for Hidradenitis (SASH): a novel outcome measurement for hidradenitis suppurativa. Br J Dermatol. 2020 Apr;182(4):940-948. doi: 10.1111/bjd.18244.

Bellefeuille G, Paiewonsky B, Khalid B, Freese RL, Lowes MA, Kirby JS, Alavi A, Goldfarb N. Worst area local Hidradenitis suppurativa Activity and Severity Index-Revised (W-HASI-R): a study evaluating construct validity. Br J Dermatol. 2023 Aug 24;189(3):338-354. doi: 10.1093/bjd/ljad138.

Background

Hidradenitis suppurativa (HS), a chronic, inflammatory skin condition, can cause drainage. This drainage significantly impacts patients’, contributing to skin irritation, odor, social stigma, and emotional distress.

The HiSTORIC (Hidradenitis SuppuraTiva cORe outcomes set International Collaboration) initiative identified drainage as a critical symptom to be measured in clinical trials, yet no validated outcome measurement instrument (OMI) for HS drainage had been developed. The HS Drainage Scale™ is an HS-specific instrument to evaluate the HS drainage in HS.

Instrument

The HS Drainage Scale™ is a 2-item HS-specific patient-reported questionnaire used to assess drainage with a recall period of seven days. Each item is structured as a numerical rating scale (NRS)-type scale from zero to 10 response levels for each item. The HS Drainage items address both “overall” and “worst” drainage levels, as these dimensions provided a more comprehensive understanding of patients’ experiences. The final scale demonstrated comprehensibility, comprehensiveness, and relevance, and was iteratively refined based on patient feedback. The Numeric Rating Scale (NRS) was ultimately selected for its precision, feasibility, and alignment with existing HS measures.

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Development

An international workgroup, comprising researchers, clinicians, and patient research partners was formed to guide development of the drainage instrument. The workgroup conducted a narrative review and designed candidate instruments based on insights from both existing wound drainage scales and HS-specific literature. Multiple versions of the scale were created and tested in a two-phase qualitative study, involving concept elicitation and pilot testing. Patients from dermatology clinics in Denmark and US participated in cognitive interviews to assess the scales’ content validity. The face validity of the HS Drainage scale was confirmed in the cognitive debriefings. Quantitative analyses are needed in the trial setting to investigate other aspects of validity and reliability. Details of the development of can be found in the references.

Scoring

Additional investigation will confirm the score interpretation of the HS Drainage Scale.

References

Linnea Thorlacius, Bente Villumsen, Mina Shereen Khaled, Terri Shih, et al. The development and content validation of an instrument to measure drainage in hidradenitis suppurativa:
The HiSTORIC Drainage Scale for HS. 2024. [Submitted, pending publication.]