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Table 3 Quantitative progression criteria for the TEMPO study

From: Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial

Criteria

Green (Go)

Amber (Amend)

Red (Stop)

Recruitment

At least 50 eligible participants are identified and agree to take part over 9 months

Between 35 and 49 eligible participants are identified and agree to participation over 9 months

 < 35 eligible participants are identified and agree to participation over 9 months

Consent

At least 40% of eligible potential participants consent to be randomised

20–39% of eligible potential participants consent to be randomised

 < 20% of eligible potential participants consent to be randomised

Proportion of randomised participants providing 14-week outcome dataa

At least 85% of participants provide outcome data at 14 weeks

60 to 84% of participants provide outcome data at 14 weeks

 < 60% of participants provide outcome data at 14 weeks

Intervention fidelity

At least 75% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks)

50 to 74% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks)

 < 50% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks)

  1. aFollow-up would be at least 6 months in the definitive RCT so this is a proxy