Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials

Journal article


Décary, Simon, de Wit, Maarten, Naye, Florian, Barton, Jennifer L., Fraenkel, Liana, Li, Linda C., Brooks, Peter, Stacey, Dawn, Maxwell, Lara J., Campbell, Willemina, Hofstetter, Cathie, Voshaar, Marieke, Meara, Alexa, Christensen, Robin, Boonen, Annelies, Suarez-Almazor, Maria E., Meade, Tanya, March, Lyn, Jull, Janet Elizabeth, Alten, Rieke, Morgan, Esi M., Hazlewood, Glen, Barber, Claire, Guillemin, Francis, El-Miedany, Yasser, Mittoo, Shikha, Robertson, Tiffany Westrich, Bartlett, Susan J., Singh, Jasvinder A., Mannion, Melissa, Nasef, Samah Ismail, Boel, Anne, Adebajo, Adewale, Arnaud, Laurent, Gill, Tiffany K., Moholt, Ellen, Burt, Jennifer, Jayatilleke, Arundathi, Hmamouchi, Ihsane, Berthelsen, Dorthe B, Blanco, Francisco J., Mather, Kate, Maharaj, Ajesh, Sharma, Saurab, Caso, Francesco, Beaton, Dorcas, Shea, Beverly, Fong, Christopher, Fernandez, Anthony P., Mackie, Sarah, Nikiphorou, Elena, Jones, Allyson, Greer-Smith, Regina, Sloan, Victor S., Akpabio, Akpabio, Strand, Vibeke, Lee, Rebecca R., Umaefulam, Valerie, Monti, Sara, Abaza, Nouran, Schultz, Grayson, Stones, Simon, Gossec, Laure, Nielsen, Sabrina Mai, Cavallo, Sabrina, Srinivasalu, Hemalatha, Constien, Deb, Evans, Vicki, Tugwell, Peter and Toupin-April, K. 2024. Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials. Seminars in Arthritis and Rheumatism. 65, p. 152381. https://doi.org/10.1016/j.semarthrit.2024.152381
AuthorsDécary, Simon, de Wit, Maarten, Naye, Florian, Barton, Jennifer L., Fraenkel, Liana, Li, Linda C., Brooks, Peter, Stacey, Dawn, Maxwell, Lara J., Campbell, Willemina, Hofstetter, Cathie, Voshaar, Marieke, Meara, Alexa, Christensen, Robin, Boonen, Annelies, Suarez-Almazor, Maria E., Meade, Tanya, March, Lyn, Jull, Janet Elizabeth, Alten, Rieke, Morgan, Esi M., Hazlewood, Glen, Barber, Claire, Guillemin, Francis, El-Miedany, Yasser, Mittoo, Shikha, Robertson, Tiffany Westrich, Bartlett, Susan J., Singh, Jasvinder A., Mannion, Melissa, Nasef, Samah Ismail, Boel, Anne, Adebajo, Adewale, Arnaud, Laurent, Gill, Tiffany K., Moholt, Ellen, Burt, Jennifer, Jayatilleke, Arundathi, Hmamouchi, Ihsane, Berthelsen, Dorthe B, Blanco, Francisco J., Mather, Kate, Maharaj, Ajesh, Sharma, Saurab, Caso, Francesco, Beaton, Dorcas, Shea, Beverly, Fong, Christopher, Fernandez, Anthony P., Mackie, Sarah, Nikiphorou, Elena, Jones, Allyson, Greer-Smith, Regina, Sloan, Victor S., Akpabio, Akpabio, Strand, Vibeke, Lee, Rebecca R., Umaefulam, Valerie, Monti, Sara, Abaza, Nouran, Schultz, Grayson, Stones, Simon, Gossec, Laure, Nielsen, Sabrina Mai, Cavallo, Sabrina, Srinivasalu, Hemalatha, Constien, Deb, Evans, Vicki, Tugwell, Peter and Toupin-April, K.
Abstract

Objective
To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions.

Methods
Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains.

Results
WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains.

Conclusion
Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set.

Clinical significance
The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.

KeywordsOMERACT; Outcome Measures in Rheumatology ; SDM; Shared decision making; PRPs; Patient research partners; WG; Working group
Year2024
JournalSeminars in Arthritis and Rheumatism
Journal citation65, p. 152381
PublisherElsevier
ISSN00490172
Digital Object Identifier (DOI)https://doi.org/10.1016/j.semarthrit.2024.152381
Official URLhttps://www.sciencedirect.com/science/article/pii/S0049017224000222
Publication dates
PrintApr 2024
Publication process dates
Deposited18 Jan 2024
Output statusPublished
Permalink -

https://repository.canterbury.ac.uk/item/96x07/consensus-on-the-definitions-and-descriptions-of-the-domains-of-the-omeract-core-outcome-set-for-shared-decision-making-interventions-in-rheumatology-trials

  • 18
    total views
  • 0
    total downloads
  • 0
    views this month
  • 0
    downloads this month

Export as

Related outputs

Defining criteria for disease activity states in systemic juvenile idiopathic arthritis based on the systemic Juvenile Arthritis Disease Activity Score
Rosina, Silvia, Rebollo‐Gimenez, Ana I., Tarantola, Letizia, Pistorio, Angela, Vyzhga, Y., El Miedany, Yasser, Lotfy, Hala M., Abu‐Shady, Hend, Eissa, M., Osman, Naglaa S., Hassan, Waleed, Mahgoub, Marwa Y., Fouad, Nermeen A., Mosa, D., Adel, Yasmin, Mohamed, Sheren E. M., Radwan, Ahmed R., Abu-Zaid, M., Tabra, Samar A. A., Shalaby, Radwa H., Nasef, S., Khubchandani, Raju, Khan, A., Maldar, Naziya P., Ozen, S., Bayindir, Yagmur, Alsuweiti, Motasem, Alzyoud, Raed, Almaaitah, Hiba, Vilaiyuk, Soamarat, Lerkvaleekul, Butsabong, Alexeeva, Ekaterina, Dvoryakovskaya, Tatyana, Kriulin, Ivan, Bracaglia, C., Pardeo, M., De Benedetti, F., Licciardi, F., Montin, Davide, Robasto, Francesca, Minoia, F., Filocamo, Giovanni, Rossano, Martina, Simonini, Gabriele, Marrani, Edoardo, Abu‐Rumeleih, S., Kostik, M., Belozerov, Konstantin E., Pal, P., Bathia, Jigna N., Katsicas, María M., Villarreal, Giselle, Marino, Achille, Costi, Stefania, Sztajnbok, Flavio, Silva, Rodrigo M., Maggio, Maria C., El‐Ghoneimy, Dalia H., El Owaidy, R., Civino, Adele, Diomeda, Federico, Al‐Mayouf, Sulaiman M., Al‐Sofyani, Fuad, Dāvidsone, Zane, Patrone, Elisa, Saad‐Magalhães, Claudia, Consolaro, A. and Ravelli, A. 2024. Defining criteria for disease activity states in systemic juvenile idiopathic arthritis based on the systemic Juvenile Arthritis Disease Activity Score. Arthritis & Rheumatology. https://doi.org/10.1002/art.42865
Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: A scoping review to identify candidate instruments
Naye, Florian, Toupin-April, Karine, de Wit, Maarten, LeBlanc, Annie, Dubois, Olivia, Boonen, Annelies, Barton, Jennifer L., Fraenkel, Liana, Li, Linda C., Stacey, Dawn, March, Lyn, Barber, Claire E.H., Hazlewood, Glen Stewart, Guillemin, Francis, Bartlett, Susan J., Berthelsen, Dorthe B., Mather, Kate, Arnaud, Laurent, Akpabio, Akpabio, Adebajo, Adewale, Schultz, Grayson, Sloan, Victor S., Gill, Tiffany K., Sharma, Saurab, Scholte-Voshaar, Marieke, Caso, Francesco, Nikiphorou, Elena, Nasef, Samah Ismail, Campbell, Willemina, Meara, Alexa, Christensen, Robin, Suarez-Almazor, Maria E., Jull, Janet Elizabeth, Alten, Rieke, Morgan, Esi M., El-Miedany, Yasser, Singh, Jasvinder A., Burt, Jennifer, Jayatilleke, Arundathi, Hmamouchi, Ihsane, Blanco, Francisco J., Fernandez, Anthony P., Mackie, Sarah, Jones, Allyson, Strand, Vibeke, Monti, Sara, Stones, Simon R., Lee, Rebecca R., Nielsen, Sabrina Mai, Evans, Vicki, Srinivasalu, Hemalatha, Gérard, Thomas, Demers, Juliette LeBlanc, Bouchard, Roxanne, Stefan, Théo, Dugas, Michèle, Bergeron, Frédéric, Beaton, Dorcas, Maxwell, Lara J., Tugwell, Peter and Décary, Simon 2023. Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: A scoping review to identify candidate instruments. Seminars in Arthritis and Rheumatism. 65, p. 152344. https://doi.org/10.1016/j.semarthrit.2023.152344
Beyond the symptoms: Personalizing giant cell arteritis care through multidimensional patient reported outcome measure
El Miedany, Y., El Gaafary, M, Toth, M, Palmer, D., Ali, Ayman, Bahlas, S., Mahran, S., Hassan, W., Abu-Zaid, M H, Saber, S. and Elwakil, W. 2023. Beyond the symptoms: Personalizing giant cell arteritis care through multidimensional patient reported outcome measure. Seminars in Arthritis and Rheumatism. 63, p. 152285. https://doi.org/10.1016/j.semarthrit.2023.152285
Prevalence of glucocorticoid-induced osteoporosis among rheumatology patients in Africa: a systematic review and meta-analysis.
Hmamouchi, I., Paruk, Farhanah, Tabra, Samar, Maatallah, Kaouther, Bouziane, Amal, Abouqal, Redouane, El Maidany, Yasser, El Maghraoui, Abdellah and Kalla, Asgar Ali 2023. Prevalence of glucocorticoid-induced osteoporosis among rheumatology patients in Africa: a systematic review and meta-analysis. Archives of Osteoporosis. 18 (1), p. 59. https://doi.org/10.1007/s11657-023-01246-6
Consensus evidence-based clinical practice recommendations for the diagnosis and treat-to-target management of osteoporosis in chronic kidney disease stages G4-G5D and post-transplantation: An initiative of Egyptian Academy of Bone Health
El Miedany, Yasser, Gadallah, Naglaa Ali, Sarhan, Eman, Toth, Mathias, Hasab El Naby, Mona Mansour, Elwy, Mohamed, Ganeb, Sahar, El Gaafary, Maha, Mortada, Mohamed, Nasef, Samah Ismail, Mohannad, Nevine, Mahran, Safaa Ali, Abu-Zaid, Mohammed Hassan, Eissa, Mervat, Hassan, Waleed, Medhat, Basma M, Ghaleb, Rasha, Tabra, Samar Abdelhamed, Saber, Heba Gamal, Ibrahim, Rehab Ali, Saber, Sally and Galal, Salwa 2022. Consensus evidence-based clinical practice recommendations for the diagnosis and treat-to-target management of osteoporosis in chronic kidney disease stages G4-G5D and post-transplantation: An initiative of Egyptian Academy of Bone Health. Kidney Diseases. 8 (5), pp. 392-407. https://doi.org/10.1159/000526492
001 Egyptian consensus-based recommendations for the diagnosis and targeted management of Kawasaki disease. An initiative by the Egyptian College of Pediatric Rheumatology
El Miedany, Y, Lotfy, H, Salah, S, Abu-Zaid, M. H, Mohamed, S. S, Esam Maher, S, El Gaafary, M, Abdulhady, H, Hassan, W. A, Mortada, M, Amer, Y, Osman, N. S, Medhat, B. M, Farag, Y, Eissa, M, Radwan, A, Nasef, S. I, Elkaraly, N. E, El-Shanawany, Amira T, El Mikkawy, D, Mosa, D. M, El Deriny, G, Fouad, N. A and Tabra, S. A 2022. 001 Egyptian consensus-based recommendations for the diagnosis and targeted management of Kawasaki disease. An initiative by the Egyptian College of Pediatric Rheumatology. Rheumatology. 61 (Supplement_2). https://doi.org/10.1093/rheumatology/keac495.001
43 Egyptian evidence-based consensus recommendations for diagnosis and targeted management of childhood-onset systemic lupus erythematosus. An initiative by the Egyptian College of Pediatric Rheumatology
Lotfy, H, El Miedany, Y, Salah, S, Tabra, S. A, Salaby, R. A, Amer, Y, Adel, Y, Osman, N. S, Medhat, B. M, El Gaafary, M, Abdulhady, H, Hassan, W. A, Farag, Y, Eissa, M, Maher, S. Esam, Radwan, A, El-Shanawany, Amira T, El Mikkawy, D, Mosa, D. M, El Deriny, G, Mortada, M, Fouad, N. A, Nasef, S. I, Elkaraly, N. E, Mohamed, S. S and Abu-Zaid, M. H 2022. 43 Egyptian evidence-based consensus recommendations for diagnosis and targeted management of childhood-onset systemic lupus erythematosus. An initiative by the Egyptian College of Pediatric Rheumatology. Rheumatology. 61 (Supplement_2). https://doi.org/10.1093/rheumatology/keac496.039
Regenerative medicine : Challenges and opportunities
Plummer, S. and El Miedany, Y. 2022. Regenerative medicine : Challenges and opportunities. in: El Miedany, Y. (ed.) Musculoskeletal Ultrasound-Guided Regenerative Medicine Springer. pp. 539 -548
Rheumatology-led pregnancy clinic: patient-centred approach
El Miedany, Y. and Palmer, D. 2021. Rheumatology-led pregnancy clinic: patient-centred approach. Clinical Rheumatology. 40 (10), pp. 3875-3882. https://doi.org/10.1007/s10067-021-05690-y
Consensus evidence-based recommendations for treat-to-target management of immunoglobulin A vasculitis
Abu-Zaid, M., Salah S., Lotfy H., El Gaafary, M., Abdulhady, H., Tabra, S., Salah, H., Farag, Y., Eissa, M., Maher, S., Radwan, A., El-Shanawany, A., Medhat, B., El Mikkawy, D., Mosa D., El Deriny, G., Mortada M., Osman, N., Fouad, N., Elkaraly, N., Mohamed, S., Hassan, W., Amer, Y., Nasef, S. and El Miedany, Y. 2021. Consensus evidence-based recommendations for treat-to-target management of immunoglobulin A vasculitis. Therapeutic Advances in Musculoskeletal Disease. https://doi.org/10.1177/1759720X211059610
Egyptian consensus on treat-to-target approach for osteoporosis: a clinical practice guideline from the Egyptian Academy of bone health and metabolic bone diseases
El Miedany, Y., Abu-Zaid, M., El Gaafary, M., El Naby, M., Fathi N., Saber H., Hassan, W., Eissa M., Mohannad N., Khaled H., Mortada M., Nasef S., Galal, S., Ghaleb R., Tabra S., Mohamed S., Medhat B., Aly H., Elolemy G., Fouad N., Ganeb S., Adel Y., Ibrahim M., Farouk O. and Gadallah N. 2021. Egyptian consensus on treat-to-target approach for osteoporosis: a clinical practice guideline from the Egyptian Academy of bone health and metabolic bone diseases. Egyptian Rheumatology and Rehabilitation. 48 (5). https://doi.org/10.1186/s43166-020-00056-9
Consensus evidence-based clinical practice guidelines for the diagnosis and treat-to-target management of osteoporosis in Africa: an initiative by the African Society of Bone Health and Metabolic Bone Diseases.
El Miedany, Y., Paruk, F., Kalla, A., Adebajo, A., El Gaafary, M., El Maghraoui, A., Ngandeu, M., Dey, D., Gadallah, Naglaa, Elwy, Mohamed, Moosajee, F., Abu-Zaid, M., Galal, S., Miladi, S., Hassan, W., Fadlelmola, Abubaker and Saber, S. 2021. Consensus evidence-based clinical practice guidelines for the diagnosis and treat-to-target management of osteoporosis in Africa: an initiative by the African Society of Bone Health and Metabolic Bone Diseases. Archives of Osteoporosis. 16 (1), p. 176. https://doi.org/10.1007/s11657-021-01035-z
Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia?
Miedany, Yasser El, Gaafary, Maha El, Toth, Mathias, Hegazi, Mohamed Osama, Aroussy, Nadia El, Hassan, Waleed, Almedany, Samah, Nasr, Annie, Bahlas, Sami, Galal, S. and Egyptian Academy of Bone Health, Metabolic Bone Diseases 2021. Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia? Clinical Rheumatology. https://doi.org/10.1007/s10067-021-05757-w
Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.
Toupin-April, K., Décary, S., de Wit, M., Meara, A., Barton, J. L., Fraenkel, L., Li, L. C., Brooks, P., Shea, B., Stacey, D., Légaré, F., Lydiatt, A., Hofstetter, C., Proulx, L., Christensen, R., Voshaar, M., Suarez-Almazor, M. E, Boonen, A., Meade, T., March, L., Jull, J. E., Campbell, W., Alten, R., Morgan, E.M., Kelly, A., Kaufman, J., Hill, S., Maxwell, L. J., Guillemin, F., Beaton, D., El-Miedany, Y., Mittoo, S., Westrich Robertson, T., Bartlett, S. J., Singh, J. A., Mannion, M., Nasef, S. I., de Souza, S., Boel, A., Adebajo, A., Arnaud, L., Gill, T. K., Moholt, E., Burt, J., Jayatilleke, A., Hmamouchi, I., Carrott, D., Blanco, F. J., Mather, K., Maharaj, A., Sharma, S., Caso, F., Fong, C., Fernandez, A. P., Mackie, S., Nikiphorou, E., Jones, A., Greer-Smith, R., Sloan, V. S., Akpabio, A., Strand, V., Umaefulam, V., Monti, S., Melburn, C., Abaza, N., Schultz, K., Stones, S., Kiwalkar, S., Srinivasalu, H., Constien, D., King, L. K. and Tugwell, P. 2021. Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach. Seminars in Arthritis and Rheumatism. 51 (3). https://doi.org/10.1016/j.semarthrit.2021.03.017
Rheumatology-led pregnancy clinic: enhancing the care of women with rheumatic diseases during pregnancy
El Miedany, Y. and Palmer, D. 2020. Rheumatology-led pregnancy clinic: enhancing the care of women with rheumatic diseases during pregnancy. Clinical Rheumatology. 39 (12), pp. 3593-3601. https://doi.org/10.1007/s10067-020-05173-6
Widespread lytic lesions—A metastatic or vasculitic process?
Fahd Khan, Srinivasan Srirangan, Yasser El Miedany and Sanjeev Madaan 2016. Widespread lytic lesions—A metastatic or vasculitic process? International Journal of Surgery Case Reports. 18, pp. 18-20. https://doi.org/10.1016/j.ijscr.2015.11.023