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Clinical trial variability: quality control in a randomized clinical trial.
Marion McGregor1, Jerrilyn A Cambron, James Jedlicka
1Canadian Memorial Chiropractic College, Toronto, Ontario, Canada. mmcgregor@cmcc.ca
Contemporary Clinical Trials
|September 17, 2008
Summary
Treatment variability in manual medicine trials is a challenge. This study found high agreement on treatment location but poor reliability in the number of repetitions for flexion-distraction procedures, impacting clinical trial generalizability.
Area of Science:
- Manual Medicine
- Clinical Trials
- Chiropractic Research
Background:
- Treatment variability poses a significant challenge in manual medicine clinical trials.
- Ensuring treatment options are representative of field practice and consistent among researchers is crucial.
Purpose of the Study:
- To assess treatment comparability between field and research clinicians for flexion-distraction procedures.
- To provide quality control insights for a randomized clinical trial.
Main Methods:
- A vignette-based study was used to evaluate treatment protocols.
- Clinician agreement was assessed for treatment location, range of motion, and repetitions.
- Comparison included field clinicians, research clinicians, and a reference clinician.
Main Results:
- High reliability was found for decision-making regarding the location of spinal treatment (ICC=0.88 for research clinicians).
- Agreement on treatment direction was moderate (kappa=0.64 for research clinicians).
- Reliability for the number of repetitions was poor, ranging from ICC=0.18 to 0.34.
Conclusions:
- Understanding treatment protocol disparities is vital for quality control in randomized clinical trials.
- Further research into clinical trial preparation and decision-making is recommended.
- Disparities in treatment can significantly impact the generalizability of clinical trial findings.
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