From: A consensus-based framework for conducting and reporting osteoarthritis phenotype research
General study characteristics | |
Availability of a prespecified research protocol | |
Study design: observational cohort, case-control, clinical trial, animal study, other | |
Primary goal and setup of the original study, when the phenotype approach is not the primary goal of the study. Cite references/registrations when available | |
Intended goal(s) and context(s) of the pursued phenotype classification (e.g., to have prognostic or therapeutic consequences) | |
Position of the study with respect to its stage in phenotyping (i.e., study of assessment method, hypothesis-setting, hypothesis-testing, narrow validation, broad validation or impact analysis) | |
Study population | |
Setting: general population, general practitioner, rheumatological and/or orthopedic practice, etc. | |
Flow diagram of participants selection process/sampling | |
Sample size, dropouts | |
Demographics | |
Clinical OA characteristics (e.g., pain, function) | |
Structural OA characteristics (e.g., radiographic parameters) | |
Data collection | |
Variable(s) for the assumed pathobiological and/or pain mechanisms under study • Explanation of how and why the variable(s) is (are) anticipated to reflect the mechanism(s) • Statement of the quality of the variable(s), when available | |
Follow-up time points for each of the variables (longitudinal studies) | |
Outcome parameter(s) (i.e., structural and functional consequences of the phenotype(s)) | |
Statistical analysis | |
Availability of a prespecified statistical analysis plan | |
Analytical approach (supervised, unsupervised*) and rationale | |
Power, sample size considerations | |
Methods to adjust for potential confounders/effect modifiers and to handle missing data | |
Criteria for the distinction between phenotypes and whether these were predefined | |
Criteria for clinical relevance and/or applicability and whether these were predefined | |
Any sensitivity analyses | |
Methods to determine reproducibility/consistency | |
Availability of datasets and syntaxes to other investigators (e.g., website, contact details) | |
Appraisal | |
Underlying pathobiological and/or pain mechanisms | |
Potential clinical relevance and applicability | |
Internal validity, potential sources of bias | |
External validity, generalizability | |
Comparison with other phenotype classifications/literature data, when possible | |
Relevance and consequences of the present work for future research | |
Financial/commercial interests, funding sources |