| 1. General |
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Considerations should be relevant to the design of all forms of interventional study following joint injury, unless otherwise stated
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CONSORT or STROBE criteria should be adopted in the design and reporting of any interventional or cohort study in this area
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Patients and the public should be involved throughout the process of study design and delivery
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| 2. Regulatory |
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Current and future regulatory considerations and requirements in this area should be considered in design of future studies
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The community should work closely with regulatory bodies to establish evidence and precedent for outcomes and design of interventional trials
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Responder criteria, the number needed to treat for benefit (NNT), and cost-effectiveness should be measured
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| 3. Feasibility |
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Feasibility, patient burden and cost considerations of, for example, type of imaging, or intervening near to the injury should be carefully weighed against the scientific/therapeutic benefits of the proposed approach
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For any given study, a balance should be found between scientific rigour in design and pragmatic considerations regarding recruitment and generalizability to clinical practice
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| 4. Specific targets |
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Some of the considerations around study design (including eligibility criteria, outcomes and time-window of intervention) may be different, depending on the nature of the intervention
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There may be particular biomarker(s) which are specific and sensitive for a particular intervention
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| 5. Stratification |
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The assessment of personal or individualized risk was noted to be important
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Novel molecular or imaging biomarkers might be used in the future as stratifiers at the point of entry to the study, or as intermediate (surrogate) outcomes, but none are validated for these purposes currently
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Effective stratification of an individual's personal risk of post-traumatic OA is not yet possible based on current knowledge
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