Study design
Prospective, longitudinal. Initial assessment of all variables should be as close to time of injury as possible. Multiple assessment time points for examining change in pain. Assessments should correspond to medical and psychological diagnoses, eg, orthopedic healing (3 months), persistent pain (2 months), and posttraumatic stress disorder (1 month), following date of injury. Sample
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Participant samples should be clearly described in terms of
○ Age (mean, range, standard deviation). ○ Mechanism of injury (eg, motor vehicle accident, fall). ○ Injury type (eg, upper or lower extremity injury, single or multiple injury).
Sample size should be adequate to have enough power to include all variables being studied in, for example, a logistic regression or hierarchical regression analysis. Attrition rates and missing data at each assessment interval. Pain assessment
Follow Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines for comprehensive measures of pain.44 Measure the type, amount, and frequency of pain interventions at every pain assessment interval. These may include, but are not limited to, pharmacological interventions (eg, opioid use, nonsteroidal antiinflammatory medications, acetaminophen), psychological (eg, cognitive behavioral therapy, acceptance and commitment therapy), and physical (eg, physiotherapy, ice/heat, massage). Pain disability or pain interference must be measured using a reliable, validated measure. Reported statistics
Means, standard deviations, and confidence intervals for all variables, where possible. Odds ratios (relative risk) and confidence intervals for all models. Other assessment tools
All other assessment tools should be well validated and appropriate for assessment among participants who have experienced a traumatic musculoskeletal injury. Assessments should be conducted at the time of the initial assessment and at more than one follow-up time point.
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