Responsiveness to Change and Establishment of the Minimal Clinically Important Difference for the Cutaneous Sarcoidosis Activity and Morphology Instrument | Allergy and Clinical Immunology | JAMA Dermatology | JAMA Network
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Table 1.  Assessing the Responsiveness of Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) Score Compared With Other Sarcoidosis Instruments
Assessing the Responsiveness of Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) Score Compared With Other Sarcoidosis Instruments
Table 2.  Determination of the Minimal Clinically Important Difference in Cutaneous Sarcoidosis Activity and Morphology Instrument Score
Determination of the Minimal Clinically Important Difference in Cutaneous Sarcoidosis Activity and Morphology Instrument Score
1.
Rosenbach  M, Yeung  H, Chu  EY,  et al.  Reliability and convergent validity of the Cutaneous Sarcoidosis Activity and Morphology Instrument for assessing cutaneous sarcoidosis.  JAMA Dermatol. 2013;149(5):550-556. doi:10.1001/jamadermatol.2013.60PubMedGoogle ScholarCrossref
2.
Finlay  AY, Khan  GK.  Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use.  Clin Exp Dermatol. 1994;19(3):210-216. doi:10.1111/j.1365-2230.1994.tb01167.xPubMedGoogle ScholarCrossref
3.
Judson  MA, Mack  M, Beaumont  JL, Watt  R, Barnathan  ES, Victorson  DE.  Validation and important differences for the Sarcoidosis Assessment Tool: a new patient-reported outcome measure.  Am J Respir Crit Care Med. 2015;191(7):786-795. doi:10.1164/rccm.201410-1785OCPubMedGoogle ScholarCrossref
4.
Wells  G, Li  T, Maxwell  L, MacLean  R, Tugwell  P.  Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis.  J Rheumatol. 2007;34(2):280-289.PubMedGoogle Scholar
5.
Basra  MK, Salek  MS, Camilleri  L, Sturkey  R, Finlay  AY.  Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.  Dermatology. 2015;230(1):27-33. doi:10.1159/000365390PubMedGoogle ScholarCrossref
6.
Wells  G, Beaton  D, Shea  B,  et al.  Minimal clinically important differences: review of methods.  J Rheumatol. 2001;28(2):406-412.PubMedGoogle Scholar
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    Research Letter
    November 13, 2019

    Responsiveness to Change and Establishment of the Minimal Clinically Important Difference for the Cutaneous Sarcoidosis Activity and Morphology Instrument

    Author Affiliations
    • 1Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
    • 2Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
    • 3Department of Psychology, University of Arizona, Tucson
    • 4Division of Pulmonary and Critical Care Medicine, Department of Medicine, Albany Medical College, Albany, New York
    • 5Deputy Editor, JAMA Dermatology
    JAMA Dermatol. 2020;156(1):98-99. doi:10.1001/jamadermatol.2019.3519

    The Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) is a reliable and valid instrument to objectively measure disease activity in cutaneous sarcoidosis.1 To our knowledge, its responsiveness to changes in disease activity over time has not been established. The objective of this study was to measure the responsiveness of the CSAMI to changes in disease activity over time and establish a minimal clinically important difference (MCID).

    Methods

    Patients 18 years and older were recruited from the cutaneous sarcoidosis clinic at the University of Pennsylvania between March 1, 2014, and December 31, 2016. Their demographic characteristics can be found in the eTable in the Supplement. This study was reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline. A diagnosis of cutaneous sarcoidosis was based on clinical presentation and skin biopsy results consistent with the diagnosis. Treatments and follow-up visits were recommended as appropriate for routine clinical care. Written informed consent was obtained from all participants prior to participation, and this study was approved by the institutional review board at the University of Pennsylvania.

    Standard physician- and patient-reported instruments were used to measure disease activity and health-related quality of life at each appointment. Physician-reported CSAMI was used to measure cutaneous sarcoidosis activity.1 Patients completed a visual analog scale as a self-assessment of disease, the Dermatology Life Quality Index2 to measure health-related quality of life, and the Sarcoidosis Assessment Tool—skin concerns module.3 Additionally, at follow-up appointments the physician change rating (PCR) was documented as improved, no change, or worsened (Table 1).

    Descriptive statistics were used to characterize the demographic information, disease severity, and health-related quality of life at baseline. The median change in CSAMI score between baseline and follow-up was calculated for each PCR group (improved, no change, or worsened) and in those who met the MCID for the other standard instruments. An anchor-based approach was used to establish the MCID for the CSAMI, using PCR as the criterion standard for determining correct classification.6 A receiver operating characteristic curve analysis was performed to determine the sensitivity, specificity, and percentage of patients correctly classified as showing improvements in the CSAMI score. The final determination of MCID was chosen based on the percentage of patients correctly classified and maximizing both the sensitivity and specificity (Table 2).

    Results

    The median (interquartile range [IQR]) age of the 41 patients included was 54 (46-52) years, and 29 patients (68%) were women. Most patients (n = 30; 73%) were African American. The median (IQR) baseline CSAMI score was 14.0 (9.0-23.0), and the median (IQR) baseline Dermatology Life Quality Index score was 3 (1-9). Patients categorized as improved had a median (range) improvement of 6.5 (−20 to 8) points in the CSAMI score, and those categorized as worsened had a median (range) worsening of 5 (0-10) points (Table 1). To examine the construct validity of the CSAMI to measure changes in disease severity, the median change between CSAMI score at follow-up visits and baseline was also calculated for patients who achieved the MCID for the other standard instruments (Table 1). A receiver operating characteristic curve analysis was performed to determine the MCID in CSAMI score using PCR as the criterion standard. A 5-point decrease in CSAMI score was 61.9% sensitive and 63.6% specific for improvement in skin disease, resulting in correct classification of 63% of the patients (Table 2).

    Discussion

    In this single-institution case series study, we found that the CSAMI was responsive to changes in cutaneous sarcoidosis disease activity over time. The analysis suggests that an absolute CSAMI score improvement of 5 points reflects the MCID and could be used as a benchmark in future clinical trials. Limitations of this analysis include the small sample size, performance in a specialty clinic at an academic medical center, and use of a single investigator to measure disease activity. Additional multicenter research is necessary to extrapolate these results to larger cohorts with cutaneous sarcoidosis, differing phenotypes, and a variety of physician groups and clinics.

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    Article Information

    Accepted for Publication: September 18, 2019.

    Corresponding Author: Megan H. Noe, MD, MPH, MSCE, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA 02115 (mnoe2@bwh.harvard.edu).

    Published Online: November 13, 2019. doi:10.1001/jamadermatol.2019.3519

    Author Contributions: Dr Noe had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Noe, Rosenbach.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Noe, Judson.

    Critical revision of the manuscript for important intellectual content: Gelfand, Bryer, Price, Judson, Rosenbach.

    Statistical analysis: Noe.

    Obtained funding: Gelfand.

    Administrative, technical, or material support: Bryer, Price, Rosenbach.

    Supervision: Gelfand, Judson, Rosenbach.

    Conflict of Interest Disclosures: Dr Noe reports receiving grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr Judson reports receiving grants from Mallinckrodt Pharmaceuticals. Dr Rosenbach has received honoraria from aTyr Pharma, Merck, Processa Pharmaceuticals, and JAMA Dermatology as well as grant support from Processa Pharmaceuticals. No other disclosures were reported.

    Funding/Support: This study was supported by a generous gift from the Siegel family to the trustees of the University of Pennsylvania.

    Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Disclaimer: Dr Rosenbach is a deputy editor of JAMA Dermatology, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.

    Additional Information: The CSAMI instrument was developed at the University of Pennsylvania, but the authors have never patented, copyrighted, or financially profited from it.

    References
    1.
    Rosenbach  M, Yeung  H, Chu  EY,  et al.  Reliability and convergent validity of the Cutaneous Sarcoidosis Activity and Morphology Instrument for assessing cutaneous sarcoidosis.  JAMA Dermatol. 2013;149(5):550-556. doi:10.1001/jamadermatol.2013.60PubMedGoogle ScholarCrossref
    2.
    Finlay  AY, Khan  GK.  Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use.  Clin Exp Dermatol. 1994;19(3):210-216. doi:10.1111/j.1365-2230.1994.tb01167.xPubMedGoogle ScholarCrossref
    3.
    Judson  MA, Mack  M, Beaumont  JL, Watt  R, Barnathan  ES, Victorson  DE.  Validation and important differences for the Sarcoidosis Assessment Tool: a new patient-reported outcome measure.  Am J Respir Crit Care Med. 2015;191(7):786-795. doi:10.1164/rccm.201410-1785OCPubMedGoogle ScholarCrossref
    4.
    Wells  G, Li  T, Maxwell  L, MacLean  R, Tugwell  P.  Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis.  J Rheumatol. 2007;34(2):280-289.PubMedGoogle Scholar
    5.
    Basra  MK, Salek  MS, Camilleri  L, Sturkey  R, Finlay  AY.  Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.  Dermatology. 2015;230(1):27-33. doi:10.1159/000365390PubMedGoogle ScholarCrossref
    6.
    Wells  G, Beaton  D, Shea  B,  et al.  Minimal clinically important differences: review of methods.  J Rheumatol. 2001;28(2):406-412.PubMedGoogle Scholar
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