Skip to main content

Table 2 Feasibility outcome metrics and traffic light system progression criteria

From: Investigating and defining outcomes of suprapatellar versus infrapatellar intramedullary nailing of tibial shaft fractures: a protocol for a pilot randomised controlled trial

Outcome

Red: major revision prior to full trial

Amber: continue to full trial with changes

Green: continue to full trial without changes

Enrolment rate (target: 60 enrolled after 18 months)

< 60 % of eligible patients enrolled

60–80% of eligible patients enrolled

> 80% of eligible patients enrolled

Retention rate

< 70% complete 18-month follow-up

70–80% complete 18-month follow-up

> 80% complete 18-month follow-up

Questionnaire and assessment compliance

< 80% completion of all questionnaires and assessments

80–90% completion of all questionnaires and assessments

> 90% completion of all questionnaires and assessments

Adverse events

Score of < 3 on a 7-point Likert scale indicating total impact of all adverse events

Score of 3 or 4 on a 7-point Likert scale

Score of ≥ 5 on a 7-point Likert scale.