OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Nielsen, Sabrina Mai; Boers, Maarten; Wit, Maarten de; Shea, Beverly; Windt, Daniëlle A. van der; Reeves, Barnaby C; Beaton, Dorcas; Alten, Rieke; April, Karine Toupin; Boonen, Annelies; Escorpizo, Reuben; Flurey, Caroline; Fürst, Daniel E.; Guillemin, Françis; Leong, Amye; Pohl, Christoph; Rasmussen, Marianne Uggen; Singh, Jasvinder A; Smolen, Josef S.; Strand, Vibeke; Verstappen, Suzanne; Voshaar, Marieke; Woodworth, Thasia; Ellingsen, Torkell; March, Lyn; Wells, George A.; Tugwell, Peter; Christensen, Robin

doi:10.1016/j.semarthrit.2021.03.013

Cited by 8 publications

(7 citation statements)

References 13 publications

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“…Discussion during stage three highlighted the inconsistent domains involved in the role of cultural versus political versus power imbalances, whether contextual factors were a measurable mechanism, whether placebo/ nocebo effects were a necessity within the definition, if a contextual factor was a "nonspecific" finding, and its role as a prognostic mediator/moderator. Thus, the emerging findings mirror the Kaplan et al, 2010;Testa and Rossettini, 2016;Nielsen et al, 2019Nielsen et al, , 2021Rollet et al, 2021;Sevilla Guerra et al, 2022;Sherriff et al, 2022). Our work acknowledged and established an initial synthesis of these complex and important domains, which may in turn be fruitful to consider in future work.…”

Section: Discussionsupporting

confidence: 71%

“…This suggests that who is enrolled in a study, who provides care in a study, and where that study is performed may influence clinical outcomes. The OMERACT group ( Nielsen et al, 2021 ) defined contextual factors as personal factors, disease-related factors, and environmental factors, each with a possibility of being effect modifying, outcome influencing, and measurement affecting ( Nielsen et al, 2021 ). Similarities between the two definitions include the multidimensional aspect of the definitions and the role of contextual factors in influencing clinical outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…The ecological landscape in which the clinical encounter occurs, which is sometimes referred to as therapeutic context, consists of a range of factors increasingly referred to as contextual factors ( McLaren and Hawe, 2005 ). Although increasingly well studied, contextual factors/effects are defined differently across a majority of studies ( Kaplan et al, 2010 ; Kelley et al, 2014 ; Testa and Rossettini, 2016 ; Nielsen et al, 2019 , 2021 ; Rollet et al, 2021 ; Sevilla Guerra et al, 2022 ; Sherriff et al, 2022 ). Definitions have included sociodemographic variables ( Nielsen et al, 2019 ), person-related factors (race, age, patient beliefs and characteristics) ( Nielsen et al, 2019 ), and physical and social environments ( Sevilla Guerra et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

“…At a micro-level, contextual factors have been defined by seemingly disparate terms such as therapeutic alliance ( Kelley et al, 2014 ), one’s role in the environment ( Kaplan et al, 2010 ), treatment characteristics ( Sherriff et al, 2022 ), healthcare processes ( Rollet et al, 2021 ), placebo or nocebo effects ( Testa and Rossettini, 2016 ), government agencies ( Kaplan et al, 2010 ), and cultural beliefs. Occasionally, at a macro-level, they are described as confounders or effect modifiers that are not an outcome of the study, but need to be recognized (and measured) ( Nielsen et al, 2021 ; Sevilla Guerra et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

“…Recently, through a multi-step process (semi-structured interviews and a Delphi method), the Outcome Measures in Rheumatology (OMERACT) initiative created a consensus definition for contextual factors ( Nielsen et al, 2021 ). The principal goal of OMERACT was to identify contextual factors that were relevant for clinical trials.…”

Section: Introductionmentioning

confidence: 99%

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An international consensus definition for contextual factors: findings from a nominal group technique

et al. 2023

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ObjectiveEmerging literature suggests contextual factors are important components of therapeutic encounters and may substantially influence clinical outcomes of a treatment intervention. At present, a single consensus definition of contextual factors, which is universal across all health-related conditions is lacking. The objective of this study was to create a consensus definition of contextual factors to better refine this concept for clinicians and researchers.DesignThe study used a multi-stage virtual Nominal Group Technique (vNGT) to create and rank contextual factor definitions. Nominal group techniques are a form of consensus-based research, and are beneficial for identifying problems, exploring solutions and establishing priorities.SettingInternational.Main outcome measuresThe initial stages of the vNGT resulted in the creation of 14 independent contextual factor definitions. After a prolonged discussion period, the initial definitions were heavily modified, and 12 final definitions were rank ordered by the vNGT participants from first to last.ParticipantsThe 10 international vNGT participants had a variety of clinical backgrounds and research specializations and were all specialists in contextual factors research.ResultsA sixth round was used to identify a final consensus, which reflected the complexity of contextual factors and included three primary domains: (1) an overall definition; (2) qualifiers that serve as examples of the key areas of the definition; and (3) how contextual factors may influence clinical outcomes.ConclusionOur consensus definition of contextual factors seeks to improve the understanding and communication between clinicians and researchers. These are especially important in recognizing their potential role in moderating and/or mediating clinical outcomes.

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