Table 1

GRADE evidence profile: real foot orthoses compared with sham foot orthoses

Quality assessmentLimitationsInconsistencyIndirectnessImprecisionPublication biasSummary of findingsEffect size
(95% CI)
GRADE
OutcomeNo of trialsParticipants
Foot orthosesSham
Pain
  Short term325 27 50 Serious limitations*Serious inconsistency No serious indirectnessSerious imprecision Undetected10370SMD −0.13
(−0.94 to 0.68)
Very low
  Medium term325–27 No serious limitationsNo serious inconsistencyNo serious indirectnessSerious imprecision § Undetected173106SMD −0.27
(−0.51 to −0.02)
Moderate
  Longer term225 26 No serious limitationsSerious inconsistency Serious indirectness ** Serious imprecision Undetected12783SMD −0.23
(−0.82 to 0.37)
Very low
Function
  Short termNil
  Medium term325–27 No serious limitationsNo serious inconsistencyNo serious indirectnessSerious imprecision Undetected15899SMD −0.17
(−0.41 to 0.08)
Moderate
  Longer term225 26 No serious limitationsNo serious inconsistencySerious indirectness ** Serious imprecision Undetected12783MD −0.21
(−0.49 to 0.07)
Low
  • *>25% of the participants from trials at high risk of bias.

  • †CIs show no overlap.

  • ‡Wide confidence intervals with the upper and lower boundaries representing different conclusions regarding the true effect.

  • §The upper and lower boundaries represent different conclusions regarding the true effect.

  • ¶Point estimates vary with high I2.

  • **Trial endpoints vary with one trial ending at 24 weeks and the other 52 weeks.

  • GRADE, Grading Recommendations, Assessment, Development and Evaluation; MD, mean difference; SMD, standardised mean difference.