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Outcome measures in rheumatoid arthritis randomised trials over the last 50 years.

Kirkham JJ, Boers M, Tugwell P, Clarke M, Williamson PR - Trials (2013)

Bottom Line: Since the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains.The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Biostatistics, University of Liverpool, L69 3GA, Liverpool, United Kingdom. prw@liv.ac.uk.

ABSTRACT

Background: The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology.

Methods: An observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study.

Results: Since the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.

Conclusions: This observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.

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Related in: MedlinePlus

Flow diagram of rheumatoid arthritis Cochrane systematic reviews included in study. DMARD, disease-modifying anti-rheumatic drugs; SAARD, slow-acting anti-rheumatic drugs; SMARD, symptom-modifying anti-rheumatic drugs.
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Figure 1: Flow diagram of rheumatoid arthritis Cochrane systematic reviews included in study. DMARD, disease-modifying anti-rheumatic drugs; SAARD, slow-acting anti-rheumatic drugs; SMARD, symptom-modifying anti-rheumatic drugs.

Mentions: Up to and including the September 2012 issue, we found 56 eligible reviews in The Cochrane Library. Eight were excluded: four did not identify any randomised trials, two were overviews, one focussed on safety only and one had been withdrawn (Figure 1). Of the remaining 48 reviews, 31 focussed on a pharmacological intervention and 17 on a non-pharmacological intervention (Figure 1).


Outcome measures in rheumatoid arthritis randomised trials over the last 50 years.

Kirkham JJ, Boers M, Tugwell P, Clarke M, Williamson PR - Trials (2013)

Flow diagram of rheumatoid arthritis Cochrane systematic reviews included in study. DMARD, disease-modifying anti-rheumatic drugs; SAARD, slow-acting anti-rheumatic drugs; SMARD, symptom-modifying anti-rheumatic drugs.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3852710&req=5

Figure 1: Flow diagram of rheumatoid arthritis Cochrane systematic reviews included in study. DMARD, disease-modifying anti-rheumatic drugs; SAARD, slow-acting anti-rheumatic drugs; SMARD, symptom-modifying anti-rheumatic drugs.
Mentions: Up to and including the September 2012 issue, we found 56 eligible reviews in The Cochrane Library. Eight were excluded: four did not identify any randomised trials, two were overviews, one focussed on safety only and one had been withdrawn (Figure 1). Of the remaining 48 reviews, 31 focussed on a pharmacological intervention and 17 on a non-pharmacological intervention (Figure 1).

Bottom Line: Since the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains.The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Biostatistics, University of Liverpool, L69 3GA, Liverpool, United Kingdom. prw@liv.ac.uk.

ABSTRACT

Background: The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology.

Methods: An observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study.

Results: Since the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.

Conclusions: This observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.

Show MeSH
Related in: MedlinePlus