Chapter 1

The Specific Challenges of Conducting High Quality Clinical Trials to Assess Conservative Non Pharmacological Treatments of Osteoarthritis

M. Marty

Abstract

There is a need for health providers to disseminate the results of high quality trials to justify health care policy. Non pharmacological treatments (NPT) are recommended for the treatment of osteoarthritis (OA). NPT (including medical devices, technical interventions, participative interventions, and nutraceuticals) represent a wide range of treatments for OA. While the reference study design to evaluate the effects of NPT is the randomized controlled trial (RCT), other study designs are also appropriate. Specific methodological issues are associated with RCTs designed for the assessment of the efficacy of NPTs in OA. The key points of a high quality clinical trial protocol to assess the efficacy of NPT for the treatment of OA are presented and justified. The methodology proposed is mostly in line with the International Conference of Harmonization (ICH) guidelines, European Agency for the Evaluation of Medicinal Products (EMEA) recommendations and the recommended efficacy core sets for assessment of OA. Grading quality for RCT assessing NPT in OA is challenging. Four features represent specific challenges to conducting high quality RCTs assessing NPT in comparison with those assessing pharmacological treatment : 1) the potential influence of care providers on treatment (e.g. experience of a therapist for a physical therapy intervention), 2) the choice of comparator (waiting list, usual care, sham intervention, another NPT, or a pharmacological treatment), 3) the blinding of the intervention and 4) the methods of randomization and assignation of the intervention. Depending on the nature of the NPT, bias can be limited using adapted methodological issues but are often not fully avoided.

Total Pages: 3-12 (10)

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