| 1. |
- Allen, K. D., et al.
(författare)
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Osteoarthritis: Models for appropriate care across the disease continuum
- 2016
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Ingår i: Best Practice and Research: Clinical Rheumatology. - : Elsevier BV. - 1521-6942. ; 30:3, s. 503-535
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Tidskriftsartikel (refereegranskat)abstract
- Osteoarthritis (OA) is a leading cause of pain and disability worldwide. Despite the existence of evidence-based treatments and guidelines, substantial gaps remain in the quality of OA management. There is underutilization of behavioral and rehabilitative strategies to prevent and treat OA as well as a lack of processes to tailor treatment selection according to patient characteristics and preferences. There are emerging efforts in multiple countries to implement models of OA care, particularly focused on improving nonsurgical management. Although these programs vary in content and setting, key lessons learned include the importance of support from all stakeholders, consistent program delivery and tools, a coherent team to run the program, and a defined plan for outcome assessment. Efforts are still needed to develop, deliver, and evaluate models of care across the spectrum of OA, from prevention through end-stage disease, in order to improve care for this highly prevalent global condition. © 2016
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| 2. |
- Losina, E, et al.
(författare)
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OARSI Clinical Trials Recommendations: Key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis.
- 2015
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 23:5, s. 677-685
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Forskningsöversikt (refereegranskat)abstract
- To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Investigators may use the findings and recommendations advanced in this paper to guide design and conduct of randomized controlled trials of interventions for osteoarthritis.
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| 3. |
- Katz, J N, et al.
(författare)
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OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.
- 2015
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 23:5, s. 798-802
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Forskningsöversikt (refereegranskat)abstract
- To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies for addressing these challenges.
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| 4. |
- Kraus, V B, et al.
(författare)
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OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.
- 2015
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 23:5, s. 686-697
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Forskningsöversikt (refereegranskat)abstract
- The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification.
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