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2. Drug Therapy

Author

Herrick, Ariane L., Wigley, Fredrick M., Pope, Janet, Wigley, Fredrick M., editor, Herrick, Ariane L., editor, and Flavahan, Nicholas A., editor

Published
2024
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3. Lower Limb Ulceration

Author

Samaranayaka, Muditha, Herrick, Ariane L., O’Donoghue, Nuala, Allanore, Yannick, editor, Varga, John, editor, Denton, Christopher P., editor, Kuwana, Masataka, editor, Chung, Lorinda, editor, and Shah, Ami A., editor

Published
2024
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7. Patients’ perspectives on systemic sclerosis-related Raynaud's phenomenon in the feet: A qualitative study from the OMERACT Foot and Ankle Working Group

Author

Chapman, Lara S., Alcacer-Pitarch, Begonya, Pauling, John D., Flurey, Caroline A., Redmond, Anthony C., Richards, Pamela, Herrick, Ariane L., Merkel, Peter A., Proudman, Susanna, Menz, Hylton B., Helliwell, Philip S., Hannan, Marian T., Domsic, Robyn T., Saketkoo, Lesley A., Shea, Beverley, and Siddle, Heidi J.

Published
2024
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16. Development of a measuring app for systemic sclerosis-related digital ulceration (SALVE: Scleroderma App for Lesion VErification).

Author

Davison, Adrian K, Krishan, Ashma, New, Robert P, Murray, Andrea, Dinsdale, Graham, Manning, Joanne, Hall, Frances, Pauling, John D, Vail, Andy, Kearney, Kathryn, Patrick, Helen, Hughes, Michael, Dixon, William, Dickinson, Mark, Taylor, Chris, and Herrick, Ariane L

Subjects
WOUND healing, MOBILE apps, SELF-evaluation, PAIN measurement, SMARTPHONES, RESEARCH funding, QUESTIONNAIRES, PILOT projects, CLINICAL trials, TRAUMATOLOGY diagnosis, PHOTOGRAPHY, DESCRIPTIVE statistics, SYSTEMIC scleroderma, SOFTWARE architecture, HEALTH outcome assessment, MACHINE learning, AUTOMATION, SKIN ulcers, NAIL diseases, DISEASE complications
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. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index.

Author

Ross, Laura, Hansen, Dylan, Proudman, Susanna, Khanna, Dinesh, Herrick, Ariane L., Stevens, Wendy, Baron, Murray, Nikpour, Mandana, Assassi, Shervin, Bruni, Cosimo, Chatterjee, Soumya, Chung, Lorinda, Derk, Chris, Foeldvari, Ivan, Ferdowsi, Nava, Fernandez‐Codina, Andreu, Frech, Tracy, Gordon, Jessica, Hant, Faye, and Hudson, Marie

Subjects
CONSENSUS (Social sciences), MORTALITY, MULTITRAIT multimethod techniques, RESEARCH methodology evaluation, CLINICAL trials, RESEARCH evaluation, DESCRIPTIVE statistics, EXPERIMENTAL design, DISEASES, KAPLAN-Meier estimator, RESEARCH methodology, SYSTEMIC scleroderma, QUALITY of life, TEST validity, DELPHI method, SURVIVAL analysis (Biometry), DATA analysis software, PROPORTIONAL hazards models, REGRESSION analysis
Abstract

Objective: Accurate measurement of disease activity in systemic sclerosis (SSc) remains a significant clinical challenge. The Scleroderma Clinical Trials Consortium (SCTC) convened an Activity Index (AI) Working Group (WG) to develop a novel measure of disease activity (SCTC‐AI). Methods: Using consensus methodology, we developed a conceptual definition of disease activity. Literature review and expert consensus generated provisional SCTC‐AI items, which were reduced by Delphi survey. Provisional items were weighted against a combined endpoint of morbidity and mortality, using time‐dependent Cox proportional hazards regression analysis of the Australian Scleroderma Cohort Study (ASCS) (n = 1,254). External validation of the SCTC‐AI was performed using data collected from 1,103 Canadian Scleroderma Research Group Study participants. Results: Disease activity in SSc was defined using consensus methodology as "aspects of disease that are reversible, or can be arrested, with time and, or effective therapy." One‐hundred and forty‐one provisional SCTC‐AI items were generated and reduced using three rounds of Delphi survey and statistical reduction and weighting, against mortality and quality of life measures, yielding a final 24‐item index with a maximum possible score of 140. Survival analysis in an external cohort showed a graded relationship between disease activity scores and survival (P < 0.01). Conclusion: We present a novel instrument to quantify the burden of disease activity in SSc. We have employed a rigorous consensus‐based process in combination with data‐driven methods to develop an instrument that has face, content, and criterion validity. Further work is required to fully validate and confirm the construct and discriminative validity of the SCTC‐AI. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Calcinosis

Author

Herrick, Ariane L., Samaranayaka, Muditha, Matucci-Cerinic, Marco, editor, and Denton, Christopher P., editor

Published
2021
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20. Complement component C4 structural variation and quantitative traits contribute to sex-biased vulnerability in systemic sclerosis

Author

Kerick, Martin, Acosta-Herrera, Marialbert, Simeón-Aznar, Carmen Pilar, Callejas, José Luis, Assassi, Shervin, Proudman, Susanna M., Nikpour, Mandana, Hunzelmann, Nicolas, Moroncini, Gianluca, de Vries-Bouwstra, Jeska K., Orozco, Gisela, Barton, Anne, Herrick, Ariane L., Terao, Chikashi, Allanore, Yannick, Fonseca, Carmen, Alarcón-Riquelme, Marta Eugenia, Radstake, Timothy R. D. J., Beretta, Lorenzo, Denton, Christopher P., Mayes, Maureen D., and Martin, Javier

Published
2022
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24. Pain levels and associated factors in the Scleroderma Patient-centered Intervention Network (SPIN) cohort: a multicentre cross-sectional study

Author

Henry, Richard S., Gottesman, Karen, Hudson, Marie, Hummers, Laura K., Malcarne, Vanessa L., Mayes, Maureen D., Nielson, Warren R., Riggs, Robert, Assassi, Shervin, El-Baalbaki, Ghassan, Ells, Carolyn, Fligelstone, Kim, Fortuné, Catherine, Frech, Tracy, Gietzen, Amy, Guillot, Geneviève, Harel, Daphna, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Nielsen, Karen, Pope, Janet, Rannou, François, Richard, Michelle, Rodriguez-Reyna, Tatiana Sofia, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Ait Abdallah, Nassim, Albert, Alexandra, André, Marc, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Correia, Chase, Crichi, Benjamin, Denton, Christopher, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gordon, Jessica, Granel-Rey, Brigitte, Gyger, Genevieve, Hachulla, Eric, Herrick, Ariane L, Hoa, Sabrina, Ikic, Alena, Jones, Niall, Kafaja, Suzanne, Khalidi, Nader, Lambert, Marc, Launay, David, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Martin, Maria, Martin, Thierry, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Smets, Perrine, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Wilcox, Pearce, Bourgeault, Angelica, Cañedo Ayala, Mara, Carboni Jiménez, Andrea, Discepola, Marie-Nicole, Gagarine, Maria, Nordlund, Julia, Østbø, Nora, Lee, Yvonne C, Fox, Rina S, Kwakkenbos, Linda, Levis, Brooke, Carrier, Marie-Eve, Welling, Joep, Sauvé, Maureen, Mouthon, Luc, Benedetti, Andrea, Bartlett, Susan J, Varga, John, and Thombs, Brett D

Published
2021
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27. Factors associated with fears due to COVID-19: A Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 cohort study

Author

Fortuné, Catherine, Gietzen, Amy, Guillot, Geneviève, Lewis, Nancy, Richard, Michelle, Sauvé, Maureen, Welling, Joep, Fligelstone, Kim, Gottesman, Karen, Leite, Catarina, Pérez, Elisabet, Baron, Murray, Malcarne, Vanessa, Mayes, Maureen D., Nielson, Warren R., Riggs, Robert, Assassi, Shervin, Ells, Carolyn, van den Ende, Cornelia, Frech, Tracy, Harel, Daphna, Hinchcliff, Monique, Hudson, Marie, Johnson, Sindhu R., Larche, Maggie, Nguyen, Christelle, Pope, Janet, Rannou, François, Reyna, Tatiana Sofia Rodriguez, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Albert, Alexandra, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Carreira, Patricia, Chaigne, Benjamin, Chung, Lorinda, Correia, Chase, Denton, Christopher, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Farge-Bancel, Dominique, Fortin, Paul R., Gordon, Jessica, Granel-Rey, Brigitte, Hatron, Pierre-Yves, Herrick, Ariane L., Hoa, Sabrina, Jones, Niall, Fernandes, Artur Jose de B., Kafaja, Suzanne, Khalidi, Nader, Launay, David, Manning, Joanne, Marie, Isabelle, Martin, Maria, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Sobanski, Vincent, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Wilcox, Pearce, Ayala, Mara Cañedo, Carboni-Jiménez, Andrea, Gagarine, Maria, Nordlund, Julia, Østbø, Nora, Rice, Danielle B., Turner, Kimberly A., Culos-Reed, Nicole, Dyas, Laura, El-Baalbaki, Ghassan, Hebblethwaite, Shannon, Bustamante, Laura, Duchek, Delaney, Ellis, Kelsey, Wu, Yin, Kwakkenbos, Linda, Henry, Richard S., Carrier, Marie-Eve, Harb, Sami, Bourgeault, Angelica, Tao, Lydia, Negeri, Zelalem, Patten, Scott, Bartlett, Susan J., Mouthon, Luc, Varga, John, Benedetti, Andrea, and Thombs, Brett D.

Published
2021
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28. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, Herrick, Ariane L, Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, and Herrick, Ariane L

Abstract

OBJECTIVE Our objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP. METHODS Patients with systemic sclerosis (SSc) and ≥7 RP attacks during the last screening week prior to a baseline visit were randomised to four weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud’s Condition Score, with change in RP attacks/week as primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory endpoints included patients’ and physicians’ global impression of change, Assessment of Scleroderma-associated Raynaud’s Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites. RESULTS Sixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). Mean weekly number of RP attacks (baseline; vipoglanstat 14.4[SD 6.7], placebo 18.2[12.6]) decreased by 3.4[95% CI -5.8;-1.0] and 4.2[-6.5;-2.0] attacks per week (p= 0.628) respectively. All patient reported outcomes improved, with no difference between the groups. Mean change in recovery of peripheral blood flow after cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in urine. Vipoglanstat was safe and well tolerated. CONCLUSION Although vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.

Published
2024

32. Changes in mental health symptoms from pre-COVID-19 to COVID-19 among participants with systemic sclerosis from four countries: A Scleroderma Patient-centered Intervention Network (SPIN) Cohort study

Author

Fortuné, Catherine, Gietzen, Amy, Guillot, Geneviève, Lewis, Nancy, Richard, Michelle, Sauvé, Maureen, Welling, Joep, Fligelstone, Kim, Gottesman, Karen, Leite, Catarina, Pérez, Elisabet, Baron, Murray, Malcarne, Vanessa, Mayes, Maureen D., Nielson, Warren R., Riggs, Robert, Assassi, Shervin, Ells, Carolyn, van den Ende, Cornelia, Frech, Tracy, Harel, Daphna, Hinchcliff, Monique, Hudson, Marie, Johnson, Sindhu R., Larche, Maggie, Nguyen, Christelle, Pope, Janet, Rannou, François, Reyna, Tatiana Sofia Rodriguez, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Albert, Alexandra, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Carreira, Patricia, Chaigne, Benjamin, Chung, Lorinda, Correia, Chase, Denton, Christopher, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Farge-Bancel, Dominique, Fortin, Paul R., Gordon, Jessica, Granel-Rey, Brigitte, Hatron, Pierre-Yves, Herrick, Ariane L., Hoa, Sabrina, Jones, Niall, Fernandes, Artur Jose de B., Kafaja, Suzanne, Khalidi, Nader, Launay, David, Manning, Joanne, Marie, Isabelle, Martin, Maria, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Sobanski, Vincent, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Wilcox, Pearce, Ayala, Mara Cañedo, Carboni-Jiménez, Andrea, Gagarine, Maria, Nordlund, Julia, Østbø, Nora, Rice, Danielle B., Turner, Kimberly A., Culos-Reed, Nicole, Dyas, Laura, El-Baalbaki, Ghassan, Hebblethwaite, Shannon, Bustamante, Laura, Duchek, Delaney, Ellis, Kelsey, Thombs, Brett D., Kwakkenbos, Linda, Henry, Richard S., Carrier, Marie-Eve, Patten, Scott, Harb, Sami, Bourgeault, Angelica, Tao, Lydia, Bartlett, Susan J., Mouthon, Luc, Varga, John, and Benedetti, Andrea

Published
2020
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33. 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

Fortuné, Catherine, Gietzen, Amy, Guillot, Geneviève, Lewis, Nancy, Nielsen, Karen, Richard, Michelle, Sauvé, Maureen, Welling, Joep, Baron, Murray, Furst, Daniel E., Gottesman, Karen, Malcarne, Vanessa, Mayes, Maureen D., Mouthon, Luc, Nielson, Warren R., Riggs, Robert, Wigley, Fredrick, Assassi, Shervin, Boutron, Isabelle, Ells, Carolyn, van den Ende, Cornelia, Fligelstone, Kim, Frech, Tracy, Godard, Dominique, Harel, Daphna, Hinchcliff, Monique, Hudson, Marie, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Pope, Janet, Portales, Alexandra, Rannou, François, Reyna, Tatiana Sofia Rodriguez, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Albert, Alexandra, André, Marc, Arsenault, Guylaine, Benzidia, Ilham, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Boire, Gilles, Bruns, Alessandra, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Cohen, Pascal, Correia, Chase, Dagenais, Pierre, Denton, Christopher, Domsic, Robyn, Dubois, Sandrine, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gill, Anna, Gordon, Jessica, Granel-Rey, Brigitte, Gyger, Genevieve, Hachulla, Eric, Hatron, Pierre-Yves, Herrick, Ariane L., Hij, Adrian, Hoa, Sabrina, Ikic, Alena, Jones, Niall, de B. Fernandes, Artur Jose, Kafaja, Suzanne, Khalidi, Nader, Lambert, Marc, Launay, David, Liang, Patrick, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Martin, Maria, Martin, Thierry, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Smets, Perrine, Smith, Doug, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Stevens, Wendy, Sutton, Evelyn, Terrier, Benjamin, Thorne, Carter, Varga, John, Wilcox, Pearce, Ayala, Mara Cañedo, Ostbo, Nora, Thombs, Brett D., Kwakkenbos, Linda, Carrier, Marie-Eve, Bourgeault, Angelica, Tao, Lydia, Harb, Sami, Gagarine, Maria, Rice, Danielle, Bustamante, Laura, Ellis, Kelsey, Duchek, Delaney, Wu, Yin, Bhandari, Parash Mani, Neupane, Dipika, Carboni-Jiménez, Andrea, Henry, Richard S., Krishnan, Ankur, Sun, Ying, Levis, Brooke, He, Chen, Turner, Kimberly A., Benedetti, Andrea, Culos-Reed, Nicole, El-Baalbaki, Ghassan, Hebblethwaite, Shannon, Bartlett, Susan J., Dyas, Laura, and Patten, Scott

Published
2020
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35. Standardisation of nailfold capillaroscopy for the assessment of patients with Raynaud's phenomenon and systemic sclerosis

Author

Smith, Vanessa, Herrick, Ariane L., Ingegnoli, Francesca, Damjanov, Nemanja, De Angelis, Rossella, Denton, Christopher P., Distler, Oliver, Espejo, Karinna, Foeldvari, Ivan, Frech, Tracy, Garro, Boris, Gutierrez, Marwin, Gyger, Genevieve, Hachulla, Eric, Hesselstrand, Roger, Iagnocco, Annamaria, Kayser, Cristiane, Melsens, Karin, Müller-Ladner, Ulf, Paolino, Sabrina, Pizzorni, Carmen, Radic, Mislav, Riccieri, Valeria, Snow, Marcus, Stevens, Wendy, Sulli, Alberto, van Laar, Jacob M., Vonk, Madelon C., Vanhaecke, Amber, and Cutolo, Maurizio

Published
2020
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37. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, primary, Edenius, Charlotte, additional, Pauling, John D, additional, Denton, Christopher P, additional, Olsson, Anna, additional, Kowalski, Jan, additional, Murray, Andrea, additional, Anderson, Marina, additional, Bhat, Smita, additional, Del Galdo, Francesco, additional, Hall, Frances, additional, Korkosz, Mariusz, additional, Krasowska, Dorota, additional, Olas, Jacek, additional, Smith, Vanessa, additional, van Laar, Jacob M, additional, Vonk, Madelon C, additional, Wojteczek, Anna, additional, and Herrick, Ariane L, additional

Published
2024
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40. Fast track algorithm: How to differentiate a “scleroderma pattern” from a “non-scleroderma pattern”

Author

Smith, Vanessa, Vanhaecke, Amber, Herrick, Ariane L., Distler, Oliver, Guerra, Miguel G., Denton, Christopher P., Deschepper, Ellen, Foeldvari, Ivan, Gutierrez, Marwin, Hachulla, Eric, Ingegnoli, Francesca, Kubo, Satoshi, Müller-Ladner, Ulf, Riccieri, Valeria, Sulli, Alberto, van Laar, Jaap M., Vonk, Madelon C., Walker, Ulrich A., and Cutolo, Maurizio

Published
2019
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43. Non-invasive imaging and clinical skin scores in juvenile localized scleroderma.

Author

Pain, Clare E, Murray, Andrea, Dinsdale, Graham, Marsden, Antonia, Manning, Joanne, Riley, Phil, Leone, Valentina, Amin, Tania, Zulian, Francesco, and Herrick, Ariane L

Subjects
SKIN temperature, RESEARCH funding, SKIN, SCLERODERMA (Disease), LONGITUDINAL method, REACTIVE oxygen species, OXYGEN in the body
Abstract

Objectives To evaluate whether in juvenile localized scleroderma (JLS), non-invasive imaging can differentiate affected from non-affected skin and whether imaging correlates with a validated skin score [Localised Scleroderma Cutaneous Assessment Tool (LoSCAT)]. Methods A total of 25 children with JLS were recruited into a prospective study and a single 'target' lesion was selected. High-frequency ultrasound (HFUS, measuring skin thickness), infrared thermography (IRT, skin temperature), laser Doppler imaging (LDI, skin blood flow) and multispectral imaging (MSI, oxygenation) were performed at four sites: two of affected skin (centre and inner edge of lesion) and two of non-affected skin (1 cm from the edge of the lesion 'outer' and contralateral non-affected side) at four visits at 3 month intervals. Results Differences between affected and non-affected skin were detected with all four techniques. Compared with non-affected skin, affected skin was thinner (P  < 0.001), with higher temperature (P  < 0.001–0.006), perfusion (P  < 0.001–0.039) and oxygenation (P  < 0.001–0.028). Lesion skin activity (LoSCAT) was positively correlated with centre HFUS [ r  = 0.32 (95% CI 0.02, 0.61), P  = 0.036] and negatively correlated with centre LDI [ r  = −0.26 (95% CI −0.49, −0.04), P  = 0.022]. Lesion skin damage was positively correlated with centre and inner IRT [ r  = 0.43 (95% CI 0.19, 0.67), P  < 0.001 and r  = 0.36 (95% CI 0.12, 0.59), P  = 0.003, respectively] and with centre and inner LDI [ r  = 0.37 (95% CI 0.05, 0.69), P  = 0.024 and r  = 0.41 (95% CI 0.08, 0.74), P  = 0.015, respectively]. Conclusion Non-invasive imaging can detect differences between affected and non-affected skin in JLS and may help to differentiate between activity (thicker, less well-perfused skin) and damage (thinner, highly perfused skin). [ABSTRACT FROM AUTHOR]

Published
2024
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44. Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) questionnaire.

Author

Pauling, John D, Yu, Lan, Frech, Tracy M, Herrick, Ariane L, Hummers, Laura K, Shah, Ami A, Denton, Christopher P, Saketkoo, Lesley Ann, Withey, Jane, Khanna, Dinesh, and Domsic, Robyn T

Subjects
MULTITRAIT multimethod techniques, PAIN measurement, RAYNAUD'S disease, HEALTH status indicators, RESEARCH funding, QUESTIONNAIRES, RESEARCH methodology evaluation, VISUAL analog scale, DISABILITY evaluation, SEVERITY of illness index, DESCRIPTIVE statistics, CALCINOSIS, SYSTEMIC scleroderma, PSYCHOMETRICS, RESEARCH methodology, RESEARCH, HEALTH outcome assessment, CONFIDENCE intervals, PHENOTYPES, EVALUATION, DISEASE complications
Abstract

Objectives Assessment of construct validity and reliability of a novel patient-reported outcome (PRO) instrument for assessing the severity and impact of RP in SSc. Methods An international multicentre study validation study of the 27-item Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) and 10-item short-form (ASRAP-SF) questionnaires. The relationship between ASRAP questionnaires and demographics, clinical phenotype and legacy instruments for assessing SSc-RP severity, disability and pain was assessed. Repeatability was evaluated at 1 week. Anchor-based statements of health status facilitated assessment of ASRAP thresholds of meaning. Results A total of 420 SSc subjects were enrolled. There was good correlation between ASRAP (and ASRAP-SF) with RP visual analogue scale (VAS) and Scleroderma Health Assessment Questionnaire RP VAS (rho range 0.648–0.727, P  < 0.001). Correlation with diary-based assessment of SSc-RP attack frequency and duration was lower (rho range 0.258–0.504, P  < 0.001). ASRAP questionnaires had good correlation with instruments for assessing disability, hand function, pain and global health assessment (rho range 0.427–0.575, P  < 0.001). Significantly higher ASRAP scores were identified in smokers, patients with active digital ulceration (DU), previous history of DU and calcinosis (P  < 0.05 for all comparisons). There was excellent repeatability at 1 week among patients with stable SSc-RP symptoms (intra-class coefficients of 0.891 and 0.848, P  < 0.001). Patient-acceptable symptom state thresholds for ASRAP and ASRAP-SF were 45.34 and 45.77, respectively. A preliminary Minimally Important Clinical Difference threshold of 4.17 (95% CI 0.53, 7.81, P  = 0.029) was estimated. Conclusion ASRAP and ASRAP-SF questionnaires are valid and reliable novel PRO instruments for assessing the severity and impact of SSc-RP. [ABSTRACT FROM AUTHOR]

Published
2024
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