Session Information
Date: Sunday, November 8, 2015
Title: Health Services Research Poster I: Diagnosis, Management and Treatment Strategies
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
Outcomes Measures in Rheumatology Trials (OMERACT) has developed a framework based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) conceptual model. It proposes four core areas to assess the impact of disease, namely Death, Life Impact, Resource Use/Economic Impact and Pathophysiological Manifestations and within each area to select one or more domains applicable to every condition of interest. The objective of this study was to perform a survey of important stakeholders to develop preliminary recommendations for core domains to be reported in TJR clinical trials.
Methods:
We surveyed two groups of experts, who rated potential core domains (mapped to Outcomes Measures in Rheumatology Trials (OMERACT) filter 2.0 framework) for their relevance to TJR clinical trials during the 2014 American Academy of Orthopaedic surgeons [AAOS] and the 2014 OMERACT meetings. Ratings were on a 1 to 9 scale, 1-3 indicating domain of limited importance, 4-6 being important, but not critical domain, and 7-9 being critical domain.
Results:
17 stakeholders at the AAOS and 19 stakeholders at OMERACT meeting completed the survey. At the two meetings, 86% and 36% were arthroplasty researcher/surgeons, 0% and 10% were patients and 58% and 31% were 55 years and older, respectively. The following domains were rated as candidates for critical core domains by both groups, with a median score of 7 and above (median score from AAOS vs. OMERACT): Joint pain (9 vs. 9), functional ability (8 vs. 9), joint-specific quality of life (8 vs. 7), patient satisfaction (7 vs. 8), revision surgery (8 vs. 7), adverse events (9 vs. 8), death (9 vs. 7.5), serious adverse events (8.5 vs. 8), reoperation (8 vs. 8), and cost (7 vs. 7).
|
Table 1. Preliminary Core Areas/Domains for TJR Clinical Trials |
AAOS Median [IQR] |
OMERACT Median [IQR] |
Both combined Median [IQR] |
|
Ratings for the Main Domains to be reported in every TJR clinical trial
|
|||
|
Joint Pain |
9 [8, 9] |
9 [9, 9] |
9 [8, 9] |
|
Function or functional ability (ability to function in society, work; work productivity, employability; disability; work disability) |
8 [8, 9] |
9 [8, 9] |
9 [7, 9] |
|
Generic Quality of life (including fatigue, sleep, mood, stress, anxiety, depression) |
6 [4, 9] |
7 [5.75, 8.25] |
7 [5, 8] |
|
Joint-specific Quality of life |
8 [7, 9] |
7 [5, 7.25] |
7 [6, 8] |
|
Patient Satisfaction (satisfaction with the outcome, satisfaction with the procedure) |
7 [5, 8] |
8 [7, 9] |
7.5 [5.75, 9] |
|
Patient expectation of surgical outcome |
5 [4, 8] |
5 [4, 7] |
5 [4, 7] |
|
Revision surgery |
8 [6, 9] |
7 [7, 9] |
8 [6, 9] |
|
Adverse events |
9 [8, 9] |
8 [7, 9] |
8 [7, 9] |
|
Death |
9 [8, 9] |
7.5 [5, 9] |
8 [6, 9] |
|
Ratings for Additional domains for consideration
|
|||
|
Serious Adverse events |
8.5 [7, 9] |
8 [8, 9] |
8 [7, 9] |
|
Cardiac Adverse events (e.g. Myocardial infarction, unstable angina, worsening of congestive heart failure) |
7.5 [5.75, 8] |
6 [5.5, 7.5] |
6 [6, 8] |
|
Pulmonary Adverse events (e.g. Pneumonia, Pulmonary Embolism) |
7 [5.75, 8] |
6 [5.5, 7] |
7 [6, 8] |
|
Reoperation |
8 [5.5, 9] |
8 [7, 8] |
8 [6.25, 8] |
|
Cost |
7 [4, 8] |
7 [6, 7] |
7 [6, 8] |
|
Health care utilization (e.g. length of stay) |
5 [3, 7.25] |
7 [6, 7] |
6 [5, 7] |
|
Readmission (e.g. 90-day readmission) |
6.5 [5, 8.75] |
7 [6, 7] |
7 [6, 9] |
|
|
|
|
|
Conclusion:
This study lays the foundation for future work by identifying preliminary core domain set for TJR clinical trials. This core domain set will be further vetted with multi-stakeholder input. It will be used for the development of TJR clinical trial core measurement set.
To cite this abstract in AMA style:
Singh JA, Dohm M. A Preliminary Consensus on Core Outcome Domains for Total Joint Replacement Clinical Trials: An Omeract-Based Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/a-preliminary-consensus-on-core-outcome-domains-for-total-joint-replacement-clinical-trials-an-omeract-based-study/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-preliminary-consensus-on-core-outcome-domains-for-total-joint-replacement-clinical-trials-an-omeract-based-study/