Article type
Year
Abstract
Background: variability of use and reporting of outcome measures leads to challenges in comparison between trials and inclusion in systematic reviews and clinical guidelines. Initiatives such as COMET (Core Outcome Measures in Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) aim to further the development of standardised core outcome sets. Whilst the benefits of these core sets are clear, their uptake has been variable.
Objectives: to explore the choice of outcomes in recent rheumatoid arthritis guidelines, their consistency with the OMERACT core set, and how the application of this set differs between guideline developers.
Methods: we identified a convenience sample of recent updated guidelines for rheumatoid arthritis and Cochrane Systematic Reviews on the topic and assessed protocols of the intervention reviews included; extracting details of the outcomes considered, and comparing to each other and the OMERACT core set.
Results: we included systematic reviews from three clinical guidelines and Cochrane reviews and compared them with the OMERACT core set of:
- tender joint count
- swollen joint count
- patient’s assessment of pain
- patient’s global assessment of disease activity
- physician’s global assessment of disease activity
- patient’s assessment of physical function
- acute-phase reactant value
- imaging (in trials of DMARDS > 1 year duration)
Analysis indicated that systematic reviews only report 50% of the outcomes from the core set. On average an additional five outcomes are included. These additional outcomes include; stiffness, fatigue and adverse events. Composite measures of disease activity are also frequently reported, which incorporate the individual elements, rather than measuring each individually. Only one of the systematic reviews reported on all of the core set outcomes individually, with no additions to the outcome list.
Conclusions: outcome selection in guidelines and systematic reviews is variable, and infrequently agrees with reporting guidelines. Increased use of core outcome sets in systematic reviews and consistency in outcomes reported would aid sharing of data and the incorporation of high-quality systematic reviews in guidelines. Furthermore it would help ensure recommendations are based on outcomes deemed to be important to both clinicians and patients. Understanding the choice of outcomes in reviews may help inform updates of core sets. It was noted, for example, that fatigue, which was frequently included in protocols, was recommended at OMERACT 8 as an additional outcome that should be added in addition to the core set.
Further research to explore rationales for these decisions therefore could have an impact on both guideline development and updates of the core outcome set, ultimately improving prioritisation of outcomes for decision making.
Patient or healthcare consumer involvement: patients were involved in the guideline committees.
Objectives: to explore the choice of outcomes in recent rheumatoid arthritis guidelines, their consistency with the OMERACT core set, and how the application of this set differs between guideline developers.
Methods: we identified a convenience sample of recent updated guidelines for rheumatoid arthritis and Cochrane Systematic Reviews on the topic and assessed protocols of the intervention reviews included; extracting details of the outcomes considered, and comparing to each other and the OMERACT core set.
Results: we included systematic reviews from three clinical guidelines and Cochrane reviews and compared them with the OMERACT core set of:
- tender joint count
- swollen joint count
- patient’s assessment of pain
- patient’s global assessment of disease activity
- physician’s global assessment of disease activity
- patient’s assessment of physical function
- acute-phase reactant value
- imaging (in trials of DMARDS > 1 year duration)
Analysis indicated that systematic reviews only report 50% of the outcomes from the core set. On average an additional five outcomes are included. These additional outcomes include; stiffness, fatigue and adverse events. Composite measures of disease activity are also frequently reported, which incorporate the individual elements, rather than measuring each individually. Only one of the systematic reviews reported on all of the core set outcomes individually, with no additions to the outcome list.
Conclusions: outcome selection in guidelines and systematic reviews is variable, and infrequently agrees with reporting guidelines. Increased use of core outcome sets in systematic reviews and consistency in outcomes reported would aid sharing of data and the incorporation of high-quality systematic reviews in guidelines. Furthermore it would help ensure recommendations are based on outcomes deemed to be important to both clinicians and patients. Understanding the choice of outcomes in reviews may help inform updates of core sets. It was noted, for example, that fatigue, which was frequently included in protocols, was recommended at OMERACT 8 as an additional outcome that should be added in addition to the core set.
Further research to explore rationales for these decisions therefore could have an impact on both guideline development and updates of the core outcome set, ultimately improving prioritisation of outcomes for decision making.
Patient or healthcare consumer involvement: patients were involved in the guideline committees.
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