Toward consensus in defining and handling contextual factors within rheumatology trials:an initial qualitative study from an OMERACT Working Group
| Autor: | Sabrina Mai Nielsen, Josef S Smolen, Marieke Voshaar, Annelies Boonen, Marianne Uggen Rasmussen, Peter Tugwell, Torkell Ellingsen, Lyn March, Reuben Escorpizo, Thasia G. Woodworth, Beverley Shea, Karine Toupin-April, Dorcas E. Beaton, Daniëlle A W M van der Windt, Maarten Boers, Maarten de Wit, Caroline A Flurey, Barnaby C Reeves, Daniel E. Furst, George A. Wells, Robin Christensen |
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| Přispěvatelé: | Psychology, Health & Technology, Epidemiology and Data Science, General practice, Ethics, Law & Medical humanities, APH - Methodology, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, MUMC+: MA Reumatologie (9) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Outcome Assessment CHECKLIST Applied psychology GUIDELINES Terminology 0302 clinical medicine Outcome Assessment Health Care Health care Formerly Health & Social Sciences Immunology and Allergy Medicine 030212 general & internal medicine Qualitative Research OUTCOMES Clinical Trials as Topic HEALTH EQUITY Outcome measures Focus Groups Middle Aged health care Research Personnel arthritis Research Design GUIDELINE Female CLINICAL-TRIALS medicine.medical_specialty Consensus Immunology systematic reviews PATIENT General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Rheumatology Rheumatic Diseases Terminology as Topic Internal medicine Qualitative research Humans Treatment effect Patient Reported Outcome Measures outcome assessment 030203 arthritis & rheumatology business.industry Arthritis CARE Focus group Clinical trial Health Care patient reported outcome measures Rheumatologists business |
| Zdroj: | Nielsen, S M, Rasmussen, M U, Boers, M, van der Windt, D, de Wit, M, Woodworth, T G, Flurey, C A, Beaton, D E, Shea, B, Escorpizo, R, Furst, D E, Smolen, J S, April, K T, Boonen, A, Voshaar, M, Ellingsen, T, Wells, G A, Reeves, B C, March, L, Tugwell, P S & Christensen, R 2020, ' Toward consensus in defining and handling contextual factors within rheumatology trials : an initial qualitative study from an OMERACT Working Group ', Annals of the Rheumatic Diseases . https://doi.org/10.1136/annrheumdis-2020-217895 Nielsen, S M, Rasmussen, M U, Boers, M, van der Windt, D A, de Wit, M, Woodworth, T G, Flurey, C A, Beaton, D, Shea, B, Escorpizo, R, Furst, D E, Smolen, J S, Toupin-April, K, Boonen, A, Voshaar, M, Ellingsen, T, Wells, G A, Reeves, B C, March, L, Tugwell, P & Christensen, R 2021, ' Towards consensus in defining and handling contextual factors within rheumatology trials : An initial qualitative study from an OMERACT working group ', Annals of the Rheumatic Diseases, vol. 80, no. 2, 217895, pp. 242-249 . https://doi.org/10.1136/annrheumdis-2020-217895 Annals of the rheumatic diseases, 80(2), 242-249. BMJ Annals of the Rheumatic Diseases, 80(2):217895, 242-249. BMJ Publishing Group Annals of the Rheumatic Diseases, 80(2), 242-249. BMJ Publishing Group Nielsen, S M, Rasmussen, M U, Boers, M, van der Windt, D A, de Wit, M, Woodworth, T G, Flurey, C A, Beaton, D, Shea, B, Escorpizo, R, Furst, D E, Smolen, J S, Toupin-April, K, Boonen, A, Voshaar, M, Ellingsen, T, Wells, G A, Reeves, B C, March, L, Tugwell, P & Christensen, R 2021, ' Towards consensus in defining and handling contextual factors within rheumatology trials : An initial qualitative study from an OMERACT working group ', Annals of the rheumatic diseases, vol. 80, no. 2, pp. 242-249 . https://doi.org/10.1136/annrheumdis-2020-217895 |
| ISSN: | 0003-4967 1468-2060 |
| Popis: | ObjectivesThe Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term ‘contextual factors’ exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor’ and its related terminology, identifying such factors and accounting for them in trials across rheumatology.MethodsWe conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis.ResultsWe interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The ‘treatment effect’ theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The ‘outcome measurement’ theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types.ConclusionsTwo main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders. |
| Databáze: | OpenAIRE |
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