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1. A comprehensive framework for navigating patient care in systemic sclerosis: A global response to the need for improving the practice of diagnostic and preventive strategies in SSc

Author

Saketkoo, LA, Frech, T, Varju, C, Domsic, R, Farrell, J, Gordon, JK, Mihai, C, Sandorfi, N, Shapiro, L, Poole, J, Volkmann, ER, Lammi, M, McAnally, K, Alexanderson, H, Pettersson, H, Hant, F, Kuwana, M, Shah, AA, Smith, V, Hsu, V, Kowal-Bielecka, O, Assassi, S, Cutolo, M, Kayser, C, Shanmugam, VK, Vonk, MC, Fligelstone, K, Baldwin, N, Connolly, K, Ronnow, A, Toth, B, Suave, M, Farrington, S, Bernstein, EJ, Crofford, LJ, Czirjak, L, Jensen, K, Hinchclif, M, Hudson, M, Lammi, MR, Mansour, J, Morgan, ND, Mendoza, F, Nikpour, M, Pauling, J, Riemekasten, G, Russell, A-M, Scholand, MB, Seigart, E, Rodriguez-Reyna, TS, Hummers, L, Walker, U, Steen, V, Saketkoo, LA, Frech, T, Varju, C, Domsic, R, Farrell, J, Gordon, JK, Mihai, C, Sandorfi, N, Shapiro, L, Poole, J, Volkmann, ER, Lammi, M, McAnally, K, Alexanderson, H, Pettersson, H, Hant, F, Kuwana, M, Shah, AA, Smith, V, Hsu, V, Kowal-Bielecka, O, Assassi, S, Cutolo, M, Kayser, C, Shanmugam, VK, Vonk, MC, Fligelstone, K, Baldwin, N, Connolly, K, Ronnow, A, Toth, B, Suave, M, Farrington, S, Bernstein, EJ, Crofford, LJ, Czirjak, L, Jensen, K, Hinchclif, M, Hudson, M, Lammi, MR, Mansour, J, Morgan, ND, Mendoza, F, Nikpour, M, Pauling, J, Riemekasten, G, Russell, A-M, Scholand, MB, Seigart, E, Rodriguez-Reyna, TS, Hummers, L, Walker, U, and Steen, V

Abstract

Systemic sclerosis (SSc), the most lethal of rheumatologic conditions, is the cause of death in >50% of SSc cases, led by pulmonary fibrosis followed by pulmonary hypertension and then scleroderma renal crisis (SRC). Multiple other preventable and treatable SSc-related vascular, cardiac, gastrointestinal, nutritional and musculoskeletal complications can lead to disability and death. Vascular injury with subsequent inflammation transforming to irreversible fibrosis and permanent damage characterizes SSc. Organ involvement is often present early in the disease course of SSc, but requires careful history-taking and vigilance in screening to detect. Inflammation is potentially reversible provided that treatment intensity quells inflammation and other immune mechanisms. In any SSc phenotype, opportunities for early treatment are prone to be under-utilized, especially in slowly progressive phenotypes that, in contrast to severe progressive ILD, indolently accrue irreversible organ damage resulting in later-stage life-limiting complications such as pulmonary hypertension, cardiac involvement, and malnutrition. A single SSc patient visit often requires much more physician and staff time, organization, vigilance, and direct management for multiple organ systems compared to other rheumatic or pulmonary diseases. Efficiency and efficacy of comprehensive SSc care enlists trending of symptoms and bio-data. Financial sustainability of SSc care benefits from understanding insurance reimbursement and health system allocation policies for complex patients. Sharing care between recognised SSc centers and local cardiology/pulmonary/rheumatology/gastroenterology colleagues may prevent complications and poor outcomes, while providing support to local specialists. As scleroderma specialists, we offer a practical framework with tools to facilitate an optimal, comprehensive and sustainable approach to SSc care. Improved health outcomes in SSc relies upon recogntion, management and, to the

Published
2021

2. Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients

Author

Thombs, BD, Kwakkenbos, L, Carrier, M-E, Bourgeault, A, Tao, L, Harb, S, Gagarine, M, Rice, D, Bustamante, L, Ellis, K, Duchek, D, Wu, Y, Bhandari, PM, Neupane, D, Carboni-Jimenez, A, Henry, RS, Krishnan, A, Sun, Y, Levis, B, He, C, Turner, KA, Benedetti, A, Culos-Reed, N, El-Baalbaki, G, Hebblethwaite, S, Bartlett, SJ, Dyas, L, Patten, S, Varga, J, Fortune, C, Gietzen, A, Guillot, G, Lewis, N, Nielsen, K, Richard, M, Sauve, M, Welling, J, Baron, M, Furst, DE, Gottesman, K, Malcarne, V, Mayes, MD, Mouthon, L, Nielson, WR, Riggs, R, Wigley, F, Assassi, S, Boutron, I, Ells, C, van den Ende, C, Fligelstone, K, Frech, T, Godard, D, Harel, D, Hinchcliff, M, Hudson, M, Johnson, SR, Larche, M, Leite, C, Nguyen, C, Pope, J, Portales, A, Rannou, F, Rodriguez Reyna, TS, Schouffoer, AA, Suarez-Almazor, ME, Agard, C, Albert, A, Andre, M, Arsenault, G, Benzidia, I, Bernstein, EJ, Berthier, S, Bissonnette, L, Boire, G, Bruns, A, Carreira, P, Casadevall, M, Chaigne, B, Chung, L, Cohen, P, Correia, C, Dagenais, P, Denton, C, Domsic, R, Dubois, S, Dunne, J, Dunogue, B, Fare, R, Farge-Bancel, D, Fortin, PR, Gill, A, Gordon, J, Granel-Rey, B, Gyger, G, Hachulla, E, Hatron, P-Y, Herrick, AL, Hij, A, Hoa, S, Ikic, A, Jones, N, Fernandes, AJDB, Kafaja, S, Khalidi, N, Lambert, M, Launay, D, Liang, P, Maillard, H, Maltez, N, Manning, J, Marie, I, Martin, M, Martin, T, Masetto, A, Maurier, F, Mekinian, A, Melchor, S, Nikpour, M, Olagne, L, Poindron, V, Proudman, S, Regent, A, Riviere, S, Robinson, D, Rodriguez, E, Roux, S, Smets, P, Smith, D, Sobanski, V, Spiera, R, Steen, V, Stevens, W, Sutton, E, Terrier, B, Thorne, C, Wilcox, P, Ayala, MC, Ostbo, N, Thombs, BD, Kwakkenbos, L, Carrier, M-E, Bourgeault, A, Tao, L, Harb, S, Gagarine, M, Rice, D, Bustamante, L, Ellis, K, Duchek, D, Wu, Y, Bhandari, PM, Neupane, D, Carboni-Jimenez, A, Henry, RS, Krishnan, A, Sun, Y, Levis, B, He, C, Turner, KA, Benedetti, A, Culos-Reed, N, El-Baalbaki, G, Hebblethwaite, S, Bartlett, SJ, Dyas, L, Patten, S, Varga, J, Fortune, C, Gietzen, A, Guillot, G, Lewis, N, Nielsen, K, Richard, M, Sauve, M, Welling, J, Baron, M, Furst, DE, Gottesman, K, Malcarne, V, Mayes, MD, Mouthon, L, Nielson, WR, Riggs, R, Wigley, F, Assassi, S, Boutron, I, Ells, C, van den Ende, C, Fligelstone, K, Frech, T, Godard, D, Harel, D, Hinchcliff, M, Hudson, M, Johnson, SR, Larche, M, Leite, C, Nguyen, C, Pope, J, Portales, A, Rannou, F, Rodriguez Reyna, TS, Schouffoer, AA, Suarez-Almazor, ME, Agard, C, Albert, A, Andre, M, Arsenault, G, Benzidia, I, Bernstein, EJ, Berthier, S, Bissonnette, L, Boire, G, Bruns, A, Carreira, P, Casadevall, M, Chaigne, B, Chung, L, Cohen, P, Correia, C, Dagenais, P, Denton, C, Domsic, R, Dubois, S, Dunne, J, Dunogue, B, Fare, R, Farge-Bancel, D, Fortin, PR, Gill, A, Gordon, J, Granel-Rey, B, Gyger, G, Hachulla, E, Hatron, P-Y, Herrick, AL, Hij, A, Hoa, S, Ikic, A, Jones, N, Fernandes, AJDB, Kafaja, S, Khalidi, N, Lambert, M, Launay, D, Liang, P, Maillard, H, Maltez, N, Manning, J, Marie, I, Martin, M, Martin, T, Masetto, A, Maurier, F, Mekinian, A, Melchor, S, Nikpour, M, Olagne, L, Poindron, V, Proudman, S, Regent, A, Riviere, S, Robinson, D, Rodriguez, E, Roux, S, Smets, P, Smith, D, Sobanski, V, Spiera, R, Steen, V, Stevens, W, Sutton, E, Terrier, B, Thorne, C, Wilcox, P, Ayala, MC, and Ostbo, N

Abstract

Objective Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.

Published
2020

3. Development and validation of the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI): a novel instrument to quantify organ damage in systemic sclerosis

Author

Ferdowsi, N, Huq, M, Stevens, W, Hudson, M, Wang, M, Tay, T, Burchell, JL, Mancuso, S, Rabusa, C, Sundararajan, V, Prior, D, Proudman, SM, Baron, M, Nikpour, M, Frech, T, Proudman, S, Chatterjee, S, Chung, L, Gordon, JK, Haemel, A, Johnson, SR, Khanna, D, Medsger, TA, Merkel, P, Pauling, J, Pope, JE, Rodriguez-Reyna, T, Saketkoo, L, Seibold, JR, Shah, A, Steen, V, Strickland, G, Ngian, G-S, Rischmueller, M, Roddy, J, Sahhar, J, Walker, J, Youssef, P, Pope, J, Markland, J, Robinson, D, Jones, N, Khalidi, N, Docherty, P, Kaminska, E, Masetto, A, Sutton, E, Mathieu, J-P, Ligier, S, Grodzicky, T, LeClercq, S, Thorne, C, Gyger, G, Smith, D, Fortin, PR, Larche, M, Abu-Hakima, M, Rodriguez-Reyna, TS, Cabral, AR, Fritzler, M, Ferdowsi, N, Huq, M, Stevens, W, Hudson, M, Wang, M, Tay, T, Burchell, JL, Mancuso, S, Rabusa, C, Sundararajan, V, Prior, D, Proudman, SM, Baron, M, Nikpour, M, Frech, T, Proudman, S, Chatterjee, S, Chung, L, Gordon, JK, Haemel, A, Johnson, SR, Khanna, D, Medsger, TA, Merkel, P, Pauling, J, Pope, JE, Rodriguez-Reyna, T, Saketkoo, L, Seibold, JR, Shah, A, Steen, V, Strickland, G, Ngian, G-S, Rischmueller, M, Roddy, J, Sahhar, J, Walker, J, Youssef, P, Pope, J, Markland, J, Robinson, D, Jones, N, Khalidi, N, Docherty, P, Kaminska, E, Masetto, A, Sutton, E, Mathieu, J-P, Ligier, S, Grodzicky, T, LeClercq, S, Thorne, C, Gyger, G, Smith, D, Fortin, PR, Larche, M, Abu-Hakima, M, Rodriguez-Reyna, TS, Cabral, AR, and Fritzler, M

Abstract

OBJECTIVE: We sought to develop the first Damage Index (DI) in systemic sclerosis (SSc). METHODS: The conceptual definition of 'damage' in SSc was determined through consensus by a working group of the Scleroderma Clinical Trials Consortium (SCTC). Systematic literature review and consultation with patient partners and non-rheumatologist experts produced a list of potential items for inclusion in the DI. These steps were used to reduce the items: (1) Expert members of the SCTC (n=331) were invited to rate the appropriateness of each item for inclusion, using a web-based survey. Items with >60% consensus were retained; (2) Using a prospectively acquired Australian cohort data set of 1568 patients, the univariable relationships between the remaining items and the endpoints of mortality and morbidity (Physical Component Summary score of the Short Form 36) were analysed, and items with p<0.10 were retained; (3) using multivariable regression analysis, coefficients were used to determine a weighted score for each item. The DI was externally validated in a Canadian cohort. RESULTS: Ninety-three (28.1%) complete survey responses were analysed; 58 of 83 items were retained. The univariable relationships with death and/or morbidity endpoints were statistically significant for 22 items, with one additional item forced into the multivariable model by experts due to clinical importance, to create a 23-item weighted SCTC DI (SCTC-DI). The SCTC-DI was predictive of morbidity and mortality in the external cohort. CONCLUSIONS: Through the combined use of consensus and data-driven methods, a 23-item SCTC-DI was developed and retrospectively validated.

Published
2019

4. Subsets in systemic sclerosis: One size does not fit all

Author

Leclair, V, Hudson, M, Proudman, SM, Stevens, WM, Fritzler, MJ, Wang, M, Pope, J, Baron, M, Markland, J, Robinson, D, Khalidi, N, Masetto, A, Sutton, E, Thorne, C, Gyger, G, Smith, D, Fortin, PR, Larché, M, Rodriguez-Reyna, TS, Fritzler, M, Nikpour, M, Sahhar, J, Zochling, J, Roddy, J, Walker, J, Youssef, P, Leclair, V, Hudson, M, Proudman, SM, Stevens, WM, Fritzler, MJ, Wang, M, Pope, J, Baron, M, Markland, J, Robinson, D, Khalidi, N, Masetto, A, Sutton, E, Thorne, C, Gyger, G, Smith, D, Fortin, PR, Larché, M, Rodriguez-Reyna, TS, Fritzler, M, Nikpour, M, Sahhar, J, Zochling, J, Roddy, J, Walker, J, and Youssef, P

Abstract

Purpose: Systemic sclerosis (SSc) is a heterogeneous disease that is often divided into subsets to stratify patients and predict prognosis. We hypothesized that individual methods of subsetting would not prognosticate equally well for different outcomes or in patients at different stages of disease. Methods: We subsetted subjects with SSc using three approaches: limited versus diffuse cutaneous SSc (lcSSc, dcSSc); grouped by SSc-specific antibodies; and, grouped using unsupervised clustering. We studied patients with <2 years or between 2–4 years of disease duration, separately. Outcomes were time to death and time to development of (a) SF-36 Physical Component Score <40, (b) forced vital capacity <70% predicted, (c) echocar-diographic pulmonary hypertension, and (d) interstitial lung disease. We used Cox proportional hazards models to determine the ability of the subsets to predict the outcomes of interest, and Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC) to compare the performance of the models. Results: In this international, multicentered cohort of over 500 SSc subjects with less than four years of disease duration, none of the three methods of subsetting studied was able to predict all of the outcomes of interest. Different subsetting methods predicted different outcomes within and between each disease duration group. In general, subsetting by skin performed somewhat better than the two other methods, but this was not consistent and there was considerable variability in the models. Conclusions: Subsetting SSc to consistently predict morbidity and mortality in subjects at different stages of disease remains an important challenge.

Published
2016

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