Table 4

Examples of specific matches, general matches, and non-matches between outcomes in regulatory guidance documents and corresponding relevant core outcome sets

Clinical areaOutcome in EMA/FDA guidelineOutcome in COSType of matchComparative assessment of breadth of outcomes
Back painPain intensityPain intensitySpecific
Back painQuality of lifeHealth related quality of lifeSpecific
NeurodisabilitySleep disturbanceSleepSpecific
NeurodisabilityBehavioural reactionsBehaviourSpecific
Back painEmotional functioningDepressionGeneralOutcome in COS is narrower
NeurodisabilityActivities of daily livingToiletingGeneralOutcome in COS is narrower
Coronary artery diseaseSymptomatic improvementAnginaGeneralOutcome in COS is narrower
Type 1 diabetesQuality of lifeDiabetes related quality of lifeGeneralOutcome in COS is narrower
Prostate cancerOverall survivalDeath from prostate cancerGeneralOutcome in COS is narrower
Type 1 diabetesNocturnal hypoglycaemiaHypoglycaemiaGeneralOutcome in COS is broader
Prostate cancerTime to need of radical treatmentTreatment failureGeneralOutcome in COS is broader
Rolandic epilepsyCoordinationGross motor functionGeneralOutcome in COS is broader
Multiple sclerosisRelapseEmploymentNot a match
RheumatologyAnalgesic UseUtilityNot a match
Type 1 diabetesBody weightPerceived level of control over diabetesNot a match
  • COS=core outcome set; EMA=European Medicines Agency; FDA=US Food and Drug Administration.