Development of a Measuring App for Systemic Sclerosis-related Digital Ulceration (SALVE: Scleroderma App for Lesion VErification)

Overview

Journal Rheumatology (Oxford)

Publisher Oxford University Press

Specialty Rheumatology

Date 2024 Jul 19

PMID 39029921

Authors

Adrian K Davison

Ashma Krishan

Robert P New

Andrea Murray

Graham Dinsdale

Joanne Manning

Frances Hall

John D Pauling

Andy Vail

Kathryn Kearney

Helen Patrick

Michael Hughes

William Dixon

Mark Dickinson

Chris Taylor

Ariane L Herrick

Affiliations

Soon will be listed here.

Abstract

Objectives: To test the hypothesis that photographs (in addition to self-reported data) can be collected daily by patients with SSc using a smartphone app designed specifically for digital lesions, and could provide an objective outcome measure for use in clinical trials.

Methods: An app was developed to collect images and patient-reported outcome measures including Pain score and the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU) questionnaire. Participants photographed their lesion(s) each day for 30 days and uploaded images to a secure repository. Lesions were analysed both manually and automatically, using a machine learning approach.

Results: Twenty-five patients with SSc-related digital lesions consented, of whom 19 completed the 30-day study, with evaluable data from 27 lesions. Mean (s.d.) baseline Pain score was 5.7 (2.4) and HDISS-DU 2.2 (0.9), indicating high lesion- and disease-related morbidity. A total of 506 images were used in the analysis [mean number of used images per lesion 18.7 (s.d. 8.3)]. Mean (s.d.) manual and automated lesion areas at day 1 were 11.6 (16.0) and 13.9 (16.7) mm2, respectively. Manual area decreased by 0.08 mm2 per day (2.4 mm2 over 30 days) and automated area by 0.1 mm2 (3.0 mm2 over 30 days). Average gradients of manual and automated measurements over 30 days correlated strongly (r = 0.81). Manual measurements were on average 40% lower than automated ones, with wide limits of agreement.

Conclusion: Even patients with significant hand disability were able to use the app. Automated measurement of finger lesions could be valuable as an outcome measure in clinical trials.

References

Zhang J, Mihai C, Tushaus L, Scebba G, Distler O, Karlen W . Wound Image Quality From a Mobile Health Tool for Home-Based Chronic Wound Management With Real-Time Quality Feedback: Randomized Feasibility Study. JMIR Mhealth Uhealth. 2021; 9(7):e26149. PMC: 8367165. DOI: 10.2196/26149. View

Steen V, Medsger Jr T . The value of the Health Assessment Questionnaire and special patient-generated scales to demonstrate change in systemic sclerosis patients over time. Arthritis Rheum. 1997; 40(11):1984-91. DOI: 10.1002/art.1780401110. View

Mouthon L, Poiraudeau S, Vernon M, Papadakis K, Perchenet L, Khanna D . Psychometric validation of the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®) patient-reported outcome instrument. Arthritis Res Ther. 2020; 22(1):3. PMC: 6945532. DOI: 10.1186/s13075-019-2087-4. View

Dinsdale G, Moore T, Manning J, Murray A, Atkinson R, Ousey K . Tracking digital ulcers in systemic sclerosis: a feasibility study assessing lesion area in patient-recorded smartphone photographs. Ann Rheum Dis. 2018; 77(9):1382-1384. DOI: 10.1136/annrheumdis-2017-212829. View

Kuang B, Pena G, Szpak Z, Edwards S, Battersby R, Cowled P . Assessment of a smartphone-based application for diabetic foot ulcer measurement. Wound Repair Regen. 2021; 29(3):460-465. DOI: 10.1111/wrr.12905. View

Hughes M, Roberts C, Tracey A, Dinsdale G, Murray A, Herrick A . Does the Clinical Context Improve the Reliability of Rheumatologists Grading Digital Ulcers in Systemic Sclerosis?. Arthritis Care Res (Hoboken). 2016; 68(9):1340-5. PMC: 5006886. DOI: 10.1002/acr.22833. View

Davison A, Dinsdale G, New P, Manning J, Patrick H, Taxiarchi V . Feasibility study of mobile phone photography as a possible outcome measure of systemic sclerosis-related digital lesions. Rheumatol Adv Pract. 2022; 6(3):rkac105. PMC: 9757677. DOI: 10.1093/rap/rkac105. View

Suliman Y, Bruni C, Johnson S, Praino E, Alemam M, Borazan N . Defining Skin Ulcers in Systemic Sclerosis: Systematic Literature Review and Proposed World Scleroderma Foundation (WSF) definition. J Scleroderma Relat Disord. 2018; 2(2):115-120. PMC: 6296474. DOI: 10.5301/jsrd.5000236. View

Castellvi I, Eguiluz S, Escudero-Contreras A, Rios J, Calvo-Alen J, Callejas-Rubio J . LAUDES Study: impact of digital ulcers on hand functional limitation, work productivity and daily activities, in systemic sclerosis patients. Rheumatol Int. 2019; 39(11):1875-1882. DOI: 10.1007/s00296-019-04436-z. View

10.

Hughes M, Tracey A, Bhushan M, Chakravarty K, Denton C, Dubey S . Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design. J Scleroderma Relat Disord. 2018; 3(2):170-174. PMC: 5986081. DOI: 10.1177/2397198318764796. View

11.

Hachulla E, Hatron P, Carpentier P, Agard C, Chatelus E, Jego P . Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Ann Rheum Dis. 2015; 75(6):1009-15. PMC: 4893100. DOI: 10.1136/annrheumdis-2014-207001. View

12.

Madenidou A, Dinsdale G, Samaranayaka M, Muir L, Dixon W, Herrick A . Smartphone images of digital ulcers provide a clear picture of disease progression for the first rheumatology visit. Rheumatology (Oxford). 2022; 62(5):e153-e154. DOI: 10.1093/rheumatology/keac561. View

13.

Hachulla E, Clerson P, Launay D, Lambert M, Morell-Dubois S, Queyrel V . Natural history of ischemic digital ulcers in systemic sclerosis: single-center retrospective longitudinal study. J Rheumatol. 2007; 34(12):2423-30. View

14.

Baron M, Chung L, Gyger G, Hummers L, Khanna D, Mayes M . Consensus opinion of a North American Working Group regarding the classification of digital ulcers in systemic sclerosis. Clin Rheumatol. 2013; 33(2):207-14. DOI: 10.1007/s10067-013-2460-7. View

15.

Hughes M, Allanore Y, Chung L, Pauling J, Denton C, Matucci-Cerinic M . Raynaud phenomenon and digital ulcers in systemic sclerosis. Nat Rev Rheumatol. 2020; 16(4):208-221. DOI: 10.1038/s41584-020-0386-4. View

16.

Khanna D, Denton C, Merkel P, Krieg T, Le Brun F, Marr A . Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis: DUAL-1 and DUAL-2 Randomized Clinical Trials. JAMA. 2016; 315(18):1975-88. DOI: 10.1001/jama.2016.5258. View

17.

Simpson V, Hughes M, Wilkinson J, Herrick A, Dinsdale G . Quantifying Digital Ulcers in Systemic Sclerosis: Reliability of Computer-Assisted Planimetry in Measuring Lesion Size. Arthritis Care Res (Hoboken). 2017; 70(3):486-490. DOI: 10.1002/acr.23300. View

18.

McLean K, Mountain K, Shaw C, Drake T, Ots R, Knight S . Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery.... BMJ Open. 2019; 9(10):e029620. PMC: 6797297. DOI: 10.1136/bmjopen-2019-029620. View

19.

van den Hoogen F, Khanna D, Fransen J, Johnson S, Baron M, Tyndall A . 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2013; 65(11):2737-47. PMC: 3930146. DOI: 10.1002/art.38098. View

20.

Matucci-Cerinic M, Krieg T, Guillevin L, Schwierin B, Rosenberg D, Cornelisse P . Elucidating the burden of recurrent and chronic digital ulcers in systemic sclerosis: long-term results from the DUO Registry. Ann Rheum Dis. 2015; 75(10):1770-6. PMC: 5036212. DOI: 10.1136/annrheumdis-2015-208121. View