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Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review.

ABSTRACT: (1) Background: We have updated knowledge of the psychometric qualities of patient-reported outcome measures and, for the first time, systematically reviewed and compared the psychometric qualities of physical tests for patients with knee osteoarthritis who are undergoing total knee arthroplasty. This work was conducted to facilitate the choice of the most appropriate instruments to use in studies and clinical practice. (2) Methods: A search of medical databases up to December 2019 identified the studies and thus the instruments used. The quality of the measurement properties was assessed by the Bot et al. criteria. (3) Results: We identified 20 studies involving 25 instruments. Half of the instruments were questionnaires (n = 13). Among the condition-specific instruments, the Oxford knee score, Knee injury and Osteoarthritis Outcomes Score, and the Western Ontario and McMaster Universities Osteoarthritis index had the highest overall scores. Concerning generic tools, the Medical Outcomes Study Short-Form 36 (SF-36) or SF-12 obtained the highest overall score. For patient-specific tools, the Hospital Anxiety and Depression Scale ranked the highest. Some physical tests seemed robust in psychometric properties: 6-min Walk Test, five times Sit-To-Stand test, Timed Up and Go test strength testing of knee flexor/extensor by isometric or isokinetic dynamometer and Pressure Pain Threshold. (4) Conclusion: To make stronger recommendations, key areas such as reproducibility, responsiveness to clinical change, and minimal important change still need more rigorous evaluations. Some promising physical tests (e.g., actimetry) lack validation and require rigorous studies to be used as a core set of outcomes in future studies.

SUBMITTER: Reynaud V

PROVIDER: S-EPMC7463550 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review.

Reynaud Vivien V Verdilos Anargyros A Pereira Bruno B Boisgard Stéphane S Costes Frédéric F Coudeyre Emmanuel E

Journal of clinical medicine 20200730 8

(1) Background: We have updated knowledge of the psychometric qualities of patient-reported outcome measures and, for the first time, systematically reviewed and compared the psychometric qualities of physical tests for patients with knee osteoarthritis who are undergoing total knee arthroplasty. This work was conducted to facilitate the choice of the most appropriate instruments to use in studies and clinical practice. (2) Methods: A search of medical databases up to December 2019 identified th ...[more]

PMID: 32751523

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Project description:PurposeStability in the sagittal plane, particularly regarding anterior cruciate ligament compensation, and postoperative functionality and satisfaction remain issues in total knee arthroplasty. Therefore, this prospective study compared the clinical outcomes between medial-pivot-based and posterior-stabilised total knee arthroplasty based on anterior translation and clinical scores.MethodsTo assess outcomes of total knee arthroplasty for varus osteoarthritis, the anterior translation distance of the tibia relative to the femur was measured at 30 and 60° of flexion using a KS measure Arthrometer at 6 months postoperatively. The 2011 Knee Society Score, Forgotten Joint Score, visual analogue scale for pain, and range of motion were assessed at 6 months and 1 year postoperatively. The correlations among each score, anterior translation distance, range of motion, and visual analogue scale score for pain were investigated.ResultsThe medial-pivot and posterior-stabilised groups comprised 70 and 51 patients, respectively. The medial-pivot group exhibited a significantly shorter anterior translation distance at 60° flexion than the posterior-stabilised group. Furthermore, the medial-pivot group achieved significantly better outcomes regarding the visual analogue scale for pain, 2011 Knee Society Score, and Forgotten Joint Score than the posterior-stabilised group. A significant negative correlation was observed between the anterior translation distance and the function score of the 2011 Knee Society Score, whereas a significant positive correlation was found between the anterior translation distance and flexion angle, and between the extension angle and score of the Forgotten Joint Score or 2011 Knee Society Score. Significant negative correlations were also found between the pain visual analogue scale and both the 2011 Knee Society Score and Forgotten Joint Score.ConclusionIn total knee arthroplasty for osteoarthritis, the medial-pivot group displayed a shorter anterior translation distance than the posterior-stabilised group at 6 months postoperatively. The visual analogue scale score for pain was also significantly lower in the medial-pivot group than that in the posterior-stabilised group at both 6 months and 1 year postoperatively. Because a correlation was observed between the anterior translation distance and the function score, medial-pivot-based total knee arthroplasty was considered to significantly improve postoperative function compared to posterior-stabilised total knee arthroplasty.

Project description:BackgroundAn increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outcome measurement instruments has produced little evidence for traditional Chinese medicine in treating NVAF because many trials cannot be included in a meta-analysis. The majority of the trials did not report endpoint outcomes, side effects or other important outcomes for patients, which makes it difficult to evaluate the efficacy and safety of traditional Chinese medicine. Therefore, it is important to develop a core outcome set (COS). Although there are two related COSs for clinical trials of atrial fibrillation, the methodology is limited, and the perspectives of Chinese experts and patients are unclear. Therefore, we will develop a COS and recommend outcome measurement instruments after finishing the COS, which can be used for clinical trials of traditional Chinese medicine in NVAF.Methods/designThe method of the study will include eight stages led by a national multidisciplinary Steering Committee: (1) A systematic review will be developed to identify currently reported outcomes and traditional Chinese medicine syndromes in clinical trials of NVAF, (2) Semi-structured interviews of patients will be conducted to fill gaps in potential outcomes, (3) Traditional Chinese medicine syndrome names will be identified from medical records, (4) A dataset of traditional Chinese medicine syndrome names will be developed, (5) The investigation of traditional Chinese medicine syndromes will be conducted from cross-sectional study, (6) Two rounds of Delphi surveys will be carried out, (7) A consensus meeting will be conducted to develop a COS, and (8) Recommendations of outcome measurement instruments (OMIs), which should be used in the COS, will be developed.DiscussionThe COS will improve the consistency of outcome reporting and reduce the reporting bias in NVAF clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials.Trial registrationThis study is not a clinical trial, so it is registered in Core Outcome Measures in Effectiveness Trials Initiative (COMET). Registration number: 941 . Registered on 22 December 2016.

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Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review.

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Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review.

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