Table 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule

Study period
EnrolmentAllocationPostallocation
Time point-t1 0 Baselinet1 3 monthst2 6 monthst3 12 months
Enrolment
 Eligibility screenX
  Individual informed consentX
  AllocationX
Interventions
  (Standard treatment)XX
  (Experimental treatment)XX
Assessments
  DemographicsXXXX
  Physical functioning*XXXX
  Knee pain†XXXX
  HRQoL‡XXXX
  Self-reported function§XXXX
  Physical activity¶XXXX
  PASSXXX
  Absenteeism**X
  Presenteeism††XXXX
  Healthcare costs‡‡X

  • *30 s chair stand test.

  • †Numeric rating scale (NRS) 0–10.

  • ‡HRQoL, health-related quality of life measured using the EQ-5D-5L.

  • §KOOS-PS (Knee injury and Osteoarthritis Outcome Score–Physical Function Shortform).

  • ¶The Swedish Board of Health and Welfare indicator questions. 

  • **Productivity loss measured using data from the Social Insurance Agency’s Register.

  • ††Productivity loss while working, measured using the Work Productivity and Activity Impairment Questionnaire (WPAI).

  • ‡‡Estimated using data from the Swedish patient register, medication register and data from each participant’s primary care provider.

  • PASS, patient acceptable symptom state.