8 results on '"Welling, Joep"'
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2. Additional file 3 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana Sof��a, Larche, Maggie, van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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3. Good health - Abstract
Additional File 3. Participant consent form (English version)
3. Additional file 2 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana Sof��a, Larche, Maggie, van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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behavioral disciplines and activities ,3. Good health - Abstract
Additional File 2. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents
4. Additional file 2 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana Sof��a, Larche, Maggie, van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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behavioral disciplines and activities ,3. Good health - Abstract
Additional File 2. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents
5. The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana S., Larche, Maggie, Van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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3. Good health - Abstract
Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ��� 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020
6. Additional file 1 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana Sof��a, Larche, Maggie, van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION ,behavioral disciplines and activities ,3. Good health - Abstract
Additional File 1. Items from the World Health Organization Trial Registration Data Set
7. Additional file 1 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
- Author
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Nordlund, Julia, Henry, Richard S., Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R., Bartlett, Susan J., Dyas, Laura, Tao, Lydia, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Pope, Janet, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R., Piotrowski, Pamela, Jewett, Lisa R., Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Levis, Alexander W., Turner, Kimberly A., Cumin, Julie, Welling, Joep, Fortun��, Catherine, Leite, Catarina, Gottesman, Karen, Sauve, Maureen, Rodr��guez-Reyna, Tatiana Sof��a, Larche, Maggie, van Breda, Ward, Suarez-Almazor, Maria E., Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L., Mayes, Maureen D., Boutron, Isabelle, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D.
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ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION ,behavioral disciplines and activities ,3. Good health - Abstract
Additional File 1. Items from the World Health Organization Trial Registration Data Set
8. Update of EULAR recommendations for the treatment of systemic sclerosis
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Kowal-Bielecka O., Fransen J., Avouac J., Becker M., Kulak A., Allanore Y., Distler O., Clements P., Cutolo M., Czirjak L., Damjanov N., Del Galdo F., Denton C. P., Distler J. H. W., Foeldvari I., Figelstone K., Frerix M., Furst D. E., Guiducci S., Hunzelmann N., Khanna D., Matucci-Cerinic M., Herrick A. L., Van Den Hoogen F., Van Laar J. M., Riemekasten G., Silver R., Smith V., Sulli A., Tarner I., Tyndall A., Welling J., Wigley F., Valentini G., Walker U. A., Zulian F., Muller-Ladner U., Daikeler T., Lanciano E., Becvar R., Tomcik M., Gindzienska-Sieskiewicz E., Cuomo G., Iudici M., Rednic S., Vlachoyiannopoulos P. G., Caporali R., Carreira P. E., Novak S., Minier T., Kucharz E. J., Gabrielli A., Moroncini G., Airo' P., Hesselstrand R., Martinovic D., Radic M., Marasovic-Krstulovic D., Braun-Moscovici Y., Balbir-Gurman A., Lo Monaco A., Caramaschi P., Morovic-Vergles J., Henes J., Ortiz Santamaria V., Heitmann S., Krasowska D., Seidel M. F., Hasler P., Pereira Da Silva J. A., Salvador M. J., Stamenkovic B., Stankovic A., Tikly M., Ananieva L. P., Beretta L., Szucs G., Szamosi S., de la Puente Bujidos C., Midtvedt O., Hoffmann-Vold A. -M., Launay D., Hachulla E., Riccieri V., Ionescu R., Opris D., Mihai C., Herrgott I., Beyer C., Ingegnoli F., von Muhlen C. A., Alegre-Sancho J. J., Beltran-Catalan E., Aringer M., Fantana J., Leuchten N., Tausche A. -K., De Langhe E., Vanthuyne M., Anic B., Baresic M., Mayer M., Uprus M., Otsa K., Yavuz S., Granel B., Azevedo V. F., Muller C., Jimenez S. A., Popa S., Agachi S., Zenone T., Stebbings S., Dockerty J., Vacca A., Schollum J., Veale D. J., Toloza S., Xu D., Olas J., Rosato E., Foti R., Adler S., Dan D., Wiesik-Szewczyk E., Olesinska M., Kayser C., Fathi N., de la Pena Lefebvre P. G., Imbert B., Kowal-Bielecka, O., Fransen, J., Avouac, J., Becker, M., Kulak, A., Allanore, Y., Distler, O., Clements, P., Cutolo, M., Czirjak, L., Damjanov, N., Del Galdo, F., Denton, C. P., Distler, J. H. W., Foeldvari, I., Figelstone, K., Frerix, M., Furst, D. E., Guiducci, S., Hunzelmann, N., Khanna, D., Matucci-Cerinic, M., Herrick, A. L., Van Den Hoogen, F., Van Laar, J. M., Riemekasten, G., Silver, R., Smith, V., Sulli, A., Tarner, I., Tyndall, A., Welling, J., Wigley, F., Valentini, G., Walker, U. A., Zulian, F., Muller-Ladner, U., Daikeler, T., Lanciano, E., Becvar, R., Tomcik, M., Gindzienska-Sieskiewicz, E., Cuomo, G., Iudici, M., Rednic, S., Vlachoyiannopoulos, P. G., Caporali, R., Carreira, P. E., Novak, S., Minier, T., Kucharz, E. J., Gabrielli, A., Moroncini, G., Airo', P., Hesselstrand, R., Martinovic, D., Radic, M., Marasovic-Krstulovic, D., Braun-Moscovici, Y., Balbir-Gurman, A., Lo Monaco, A., Caramaschi, P., Morovic-Vergles, J., Henes, J., Ortiz Santamaria, V., Heitmann, S., Krasowska, D., Seidel, M. F., Hasler, P., Pereira Da Silva, J. A., Salvador, M. J., Stamenkovic, B., Stankovic, A., Tikly, M., Ananieva, L. P., Beretta, L., Szucs, G., Szamosi, S., de la Puente Bujidos, C., Midtvedt, O., Hoffmann-Vold, A. -M., Launay, D., Hachulla, E., Riccieri, V., Ionescu, R., Opris, D., Mihai, C., Herrgott, I., Beyer, C., Ingegnoli, F., von Muhlen, C. A., Alegre-Sancho, J. J., Beltran-Catalan, E., Aringer, M., Fantana, J., Leuchten, N., Tausche, A. -K., De Langhe, E., Vanthuyne, M., Anic, B., Baresic, M., Mayer, M., Uprus, M., Otsa, K., Yavuz, S., Granel, B., Azevedo, V. F., Muller, C., Jimenez, S. A., Popa, S., Agachi, S., Zenone, T., Stebbings, S., Dockerty, J., Vacca, A., Schollum, J., Veale, D. J., Toloza, S., Xu, D., Olas, J., Rosato, E., Foti, R., Adler, S., Dan, D., Wiesik-Szewczyk, E., Olesinska, M., Kayser, C., Fathi, N., de la Pena Lefebvre, P. G., Imbert, B., UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service de rhumatologie, Kowal Bielecka, Otylia, Fransen, Jaap, Avouac, Jerome, Becker, Mike, Kulak, Agnieszka, Allanore, Yannick, Distler, Oliver, Clements, Philip, Cutolo, Maurizio, Czirjak, Laszlo, Damjanov, Nemanja, del Galdo, Francesco, Denton, Christopher P., Distler, Jörg H. W., Foeldvari, Ivan, Figelstone, Kim, Frerix, Marc, Furst, Daniel E., Guiducci, Serena, Hunzelmann, Nicola, Khanna, Dinesh, Matucci Cerinic, Marco, Herrick, Ariane L., van den Hoogen, Frank, van Laar, Jacob M., Riemekasten, Gabriela, Silver, Richard, Smith, Vanessa, Sulli, Alberto, Tarner, Ingo, Tyndall, Alan, Welling, Joep, Wigley, Frederic, Valentini, Gabriele, Walker, Ulrich A., Zulian, Francesco, Müller Ladner, Ulf, Daikeler, Thoma, Lanciano, Elisabetta, Becvã¡r, Radim, Tomcik, Michal, Gindzienska Sieskiewicz, Ewa, Iudici, Michele, Rednic, Simona, Vlachoyiannopoulos, Panayiotis G., Caporali, Roberto, Carreira, Patricia E., Novak, Srdan, Minier, Tã¼nde, Kucharz, Eugene J., Gabrielli, Armando, Moroncini, Gianluca, Airo, Paolo, Hesselstrand, Roger, Martinovic, Duska, Radic, Mislav, Marasovic Krstulovic, Daniela, Braun Moscovici, Yolanda, Monaco, Andrea Lo, Morovic Vergles, Jadranka, Culo, Melanie I., Henes, Jã¶rg, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Michalska Jakubus, Malgorzata, Seidel, Matthias F., Klinik III, Medizinische, Hasler, Paul, Da Silva, José A. Pereira, Salvador, Maria J., Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Ananieva, Lidia P., Beretta, Lorenzo, Szucs, Gabriella, Szamosi, Szilvia, de la Puente Bujidos, Carlo, Midtvedt, Øyvind, Hoffmann Vold, Anna Maria, Launay, David, Hachulla, Eric, Riccieri, Valeria, Ionescu, Ruxandra, Opris, Daniela, Mihai, Carina, Herrgott, Ilka, Beyer, Christian, Ingegnoli, Francesca, von Mühlen, Carlos Alberto, Alegre Sancho, Juan José, Beltran Catalan, Emma, Aringer, Martin, Fantana, Julia, Leuchten, Nicolai, Tausche, Anne Kathrin, Langhe, Ellen De, Vanthuyne, Marie, Anic, Branimir, Bareå¡ic, Marko, Mayer, Miroslav, Ãœprus, Maria, Otsa, Kati, Yavuz, Sule, Granel, Brigitte, Jimenez, Sergio A., Popa, Serghei, Agachi, Svetlana, Zenone, Thierry, Stebbings, Simon, Dockerty, Joanne, Vacca, Alessandra, Schollum, Joanna, Veale, Douglas J., Toloza, Sergio, Xu, Dong, Olas, Jacek, Rosato, Edoardo, Foti, Rosario, Adler, Sabine, Dan, Diana, Wiesik Szewczyk, Ewa, Olesinska, Marzena, Kayser, Cristiane, Fathi, Nihal, de la Peña Lefebvre, Paloma GarcÃa, Imbert, Bernard, and Cuomo, Giovanna
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Endothelin Receptor Antagonists ,Lung Diseases ,Kidney Disease ,Delphi Technique ,Gastrointestinal Diseases ,systemic sclerosis ,Scleroderma Renal Crisis ,Placebo-controlled study ,Angiotensin-Converting Enzyme Inhibitors ,Lung Disease ,Scleroderma ,0302 clinical medicine ,Glucocorticoid ,Phosphodiesterase 5 Inhibitor ,Immunology and Allergy ,skin and connective tissue diseases ,BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina ,integumentary system ,treatment ,genetics and molecular biology (all) ,Hematopoietic Stem Cell Transplantation ,cyclophosphamide ,methotrexate ,Pulmonary ,Orvostudományok ,Serotonin Uptake Inhibitor ,3. Good health ,Europe ,Systematic review ,Hypertension ,Serotonin Uptake Inhibitors ,Cyclophosphamide ,Methotrexate ,Systemic Sclerosis ,Treatment ,Fingers ,Fluoxetine ,Glucocorticoids ,Humans ,Hypertension, Pulmonary ,Kidney Diseases ,Phosphodiesterase 5 Inhibitors ,Prostaglandins I ,Pyrazoles ,Pyrimidines ,Raynaud Disease ,Rheumatology ,Scleroderma, Systemic ,Ulcer ,Immunology ,Biochemistry, Genetics and Molecular Biology (all) ,030211 gastroenterology & hepatology ,Endothelin Receptor Antagonist ,Selective Serotonin Reuptake Inhibitors ,medicine.drug ,Human ,medicine.medical_specialty ,Gastrointestinal Disease ,Klinikai orvostudományok ,Riociguat ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,medicine ,Finger ,biochemistry ,Intensive care medicine ,BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine ,Systemic Sclerosi ,030203 arthritis & rheumatology ,business.industry ,Systemic ,Angiotensin-Converting Enzyme Inhibitor ,medicine.disease ,Transplantation ,Clinical research ,Pyrimidine ,immunology and allergy ,rheumatology ,immunology ,Pyrazole ,Physical therapy ,business ,Rheumatism - Abstract
The aim was to update the 2009 European League against Rheumatism (EULAR) recommendations for the treatment of systemic sclerosis (SSc), with attention to new therapeutic questions. Update of the previous treatment recommendations was performed according to EULAR standard operating procedures. The task force consisted of 32 SSc clinical experts from Europe and the USA, 2 patients nominated by the pan-European patient association for SSc (Federation of European Scleroderma Associations (FESCA)), a clinical epidemiologist and 2 research fellows. All centres from the EULAR Scleroderma Trials and Research group were invited to submit and select clinical questions concerning SSc treatment using a Delphi approach. Accordingly, 46 clinical questions addressing 26 different interventions were selected for systematic literature review. The new recommendations were based on the available evidence and developed in a consensus meeting with clinical experts and patients. The procedure resulted in 16 recommendations being developed (instead of 14 in 2009) that address treatment of several SSc-related organ complications: Raynaud's phenomenon (RP), digital ulcers (DUs), pulmonary arterial hypertension (PAH), skin and lung disease, scleroderma renal crisis and gastrointestinal involvement. Compared with the 2009 recommendations, the 2016 recommendations include phosphodiesterase type 5 (PDE-5) inhibitors for the treatment of SSc-related RP and DUs, riociguat, new aspects for endothelin receptor antagonists, prostacyclin analogues and PDE-5 inhibitors for SSc-related PAH. New recommendations regarding the use of fluoxetine for SSc-related RP and haematopoietic stem cell transplantation for selected patients with rapidly progressive SSc were also added. In addition, several comments regarding other treatments addressed in clinical questions and suggestions for the SSc research agenda were formulated. These updated data-derived and consensus-derived recommendations will help rheumatologists to manage patients with SSc in an evidence-based way. These recommendations also give directions for future clinical research in SSc.
- Published
- 2017
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