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Quality of randomised trials in COPD
B Bausch1, A Spaar, J Kleijnen
1Horten Centre for Patient-oriented Research and Knowledge Transfer, University of Zurich, Switzerland.
The European Respiratory Journal
|July 4, 2009
Summary
The quality of many chronic obstructive pulmonary disease (COPD) trials is low, but improved after 2000, especially for non-pharmacological interventions and general medical journals. This trend aligns with the adoption of the CONSORT statement.
Area of Science:
- Clinical Research
- Respiratory Medicine
- Evidence-Based Medicine
Background:
- Randomized trials are crucial for informing treatment decisions in respiratory medicine.
- The quality of randomized controlled trials (RCTs) in chronic obstructive pulmonary disease (COPD) has not been extensively evaluated.
- Assessing trial quality is essential for interpreting research findings and guiding clinical practice.
Purpose of the Study:
- To evaluate the quality of randomized trials in chronic obstructive pulmonary disease (COPD).
- To identify factors associated with higher trial quality, including intervention type, journal type, and publication year.
- To understand trends in COPD trial quality over time.
Main Methods:
- A systematic assessment of 344 COPD randomized trials published between 1957 and 2006.
- Quality markers included: appropriate random allocation, concealment of allocation, and intention-to-treat analysis.
- Ordered logistic regression was used to analyze associations between quality and study characteristics.
Main Results:
- Only 27.0% of trials reported appropriate randomization, 11.6% concealed allocation, and 21.8% used intention-to-treat analysis.
- Higher quality was associated with non-pharmacological interventions (OR 2.49), general medical journals (OR 2.25), and publication after 2000 (OR 2.28).
- A trend towards improved quality was observed, particularly following the adoption of the CONSORT statement.
Conclusions:
- Many COPD randomized trials exhibit low methodological quality.
- Trial quality has improved over time, especially for non-pharmacological interventions and in general medical journals.
- The CONSORT statement appears to have positively influenced the quality of COPD trial reporting.
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