Table 3 Summary of objectives, outcomes, success criteria, and analyses
Primary | |||
Objective | Outcome | Success criteria | Analysis |
Feasibility | Recruitment | Each site should recruit 50 participants in 12 months or less | Descriptive—proportions with 95% CI |
Adherence to visit windows | At least 75% of study visits should be within the defined windows | ||
Participant retention | Loss to follow-up should remain under 15% | ||
Data completeness | Questionnaire completion rates should remain over 80% | ||
Secondary | |||
Objective | Outcome | Analysis | |
Determine how a history of IPV affects injury-related complications | Injury-related complications | Proportions of patients experiencing injury-related complications by group with 95% CI; logistic regression. | |
Determine how a history of IPV affects return to pre-injury function | Return to pre-injury function | Proportion of patients achieving return to pre-injury level of function in each group at baseline, 3Â months, 6Â months, and 12Â months with 95% CI; logistic regression. | |
Determine incident cases of IPV | New IPV disclosures | Incidence statistic with 95% CI. | |
Determine how a history of IPV affects health care and support service use | Utilization and associated costs of support services and hospitalizations | Proportions of women using each service per group over 12Â months, median number of times that participants used each service with IQR. Estimated mean costs with 95% CI in each group and bootstrap differences between those with a history of IPV and those without with 95% CI. | |
Determine how patterns of IPV change over time | Changes in abuse severity/frequency and type | Proportion of patients who experienced no abuse, a stable level of abuse, escalating abuse, and de-escalating abuse over 12Â months with 95% CI; graphically. | |
Determine how a history of IPV affects HRQL after a musculoskeletal injury | EuroQuol-5 Dimensions (EQ-5D) | Mean change in HRQL from baseline to the 3Â month, 6Â month, and 12Â month visits, by group with 95% CI. | |
Determine how abused women’s stage of change changes over time | Domestic Violence Survivor Assessment (DVSA) | Change in stage of change from baseline at 3 months, 6 months, 9 months, and 12 months. | |