Is time to joint replacement a valid outcome measure in clinical trials of drugs for osteoarthritis?

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Hip osteoarthritis

Hip OA is a common disorder that frequently leads to significant handicap and disability. Its prevalence increases with age and ranges from 1% to 10% at age 55 to 64 years to 3.5% to 15% at age 65 to 74 years [7], [8], [9], [10], [11], [12], [13]. There is no universally accepted definition of disease progression, which has been defined with reference to clinical parameters, the need for joint replacement surgery, and changes in structural parameters of OA pathology; however, whatever the

Outcome measures used in clinical trials of disease-modifying osteoarthritis drugs in patients who have hip osteoarthritis

As the frequency of hip OA increases as a result of the aging of the population, this disorder will become an increasingly major health problem. Consequently, it is important to optimize treatment and to evaluate interventions that might prevent or delay the progression of the disease. Several outcome measures have been recommended for use in studies to evaluate potential DMOADs [1], [2], [3], [4], [5], [6]. Variables related to symptoms are reliable, clinically relevant outcome measures, but

Obtaining a dichotomous outcome variable for use in trials of hip osteoarthritis

Evaluation of the interbone distance in radiographs provides a continuous variable. At a group level the results are usually presented as the mean change in this variable, which is a powerful parameter for use in a statistical analysis of trial results, but it is difficult for the clinician to interpret because it does not present the results as “the percentage of patients with or without a key event,” “time to a key event,” or “the number of patients needed to treat to prevent a key event,” an

The five sets of criteria for total hip arthroplasty

To the authors' knowledge, five sets of criteria for THA have been proposed (Table 1) [44], [53], [61], [62], [63].

Summary

Each of the five sets of criteria for THA mentioned in this article should be regarded as preliminary. They require validation in future studies conducted in various cohorts of patients and in different countries. Moreover, a set of generally accepted criteria is badly needed. The number of proposed sets of criteria listed in this article indicates clearly that no consensus presently exists with respect to the optimal time for a patient who has hip OA to undergo THA.

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    • Health economics in the field of osteoarthritis: An Expert's consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)

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      Thus, to be able to capture QALY gain/difference at the “time of treatment failure” should be investigated and included in new analytical models. The surrogate endpoint in OA of “time to treatment failure” or “need for joint replacement surgery” based on the structural changes and symptomatic thresholds has been proposed previously [115,116], but due to regional differences as to when to perform surgery and the inconsistencies in the decision process, this proposition has still to convince the clinical opinion leaders [14]. Due to the major cost implications of TJA, delaying such a step (where possible) has a significant effect on health budgets.

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