The OMERACT Contextual Factors Working Group (CFWG) aims to update the current OMERACT definition* of contextual factors to make it useful for OMERACT working groups and rheumatology clinical trials. At the moment, the definition is felt to be unclear and unspecific by many. We interviewed patients, clinicians and researchers about contextual factors, and their descriptions tended to group into separate types of contextual factors:
1) Effect Modifying Contextual Factors
2) Measurement Affecting Contextual Factors
3) Outcome Explaining Contextual Factors
We need your input on a suggested update of the current OMERACT definition to make it operational (i.e. understandable, useful and applicable) by describing each of the three types of contextual factors in detail and how they should be handled within OMERACT and in rheumatology research.
On the following pages, each contextual factor type will be explained. You will be asked to what extent you agree with a statement on a scale from 1 to 9: ‘Disagree’ (1-3), ‘Undecided’ (4-6), and ‘Agree’ (7-9). It will be possible to provide feedback where necessary or choose ‘Unable to score’.
After this first Delphi round, your ratings will be anonymously** summarized with the ones of your stakeholder group. Consensus will be present if ≥70% rate ‘agree’ (or ‘disagree’) for a statement. You will be invited for the next Delphi round (likely in a modified version), where you will be presented with the results from the previous round, and you will rate the survey again. A total of three Delphi rounds are anticipated for this study.
What can we offer?
To express our gratitude, we will write your name (with your permission) in the acknowledgment section, if you complete all Delphi rounds. Furthermore, you will have the chance to win a traditional Danish souvenir. But more importantly, you will have a chance to explore our proposed definitions and have a say in how contextual factors should be understood and considered within OMERACT in the future.
CLICK ‘REGISTER’ TO CONTINUE
*The current OMERACT definition: OMERACT currently defines a contextual factor as a “variable that is not an outcome of the study, but needs to be recognized (and measured) to understand the study results. This includes potential confounders and effect modifiers” (OMRACT filter 2.0, Boers et al, 2014; similar description in filter 2.1)
**Ethics and data protection: This study will be carried out in accordance with the Helsinki Declaration. The Danish Data Protection Agency has approved the study and data will be handled according to agreements (ID 06081, BFH-2017-127). Your contact data will only be used to sent emails regarding this study. As a default, your answers in the survey will be anonymous. A participant ID code will be auto-generated for each participant to be able to analyse your data across rounds, but it will not be linked to your personal details. Your email will only be linked to your survey answers, if you while signing up allowed this so we can contact you if any of your comments provided in the survey seem unclear to us.
All DelphiManager data is stored on a secure server in the University of Liverpool data centre. For more information please contact firstname.lastname@example.org