Table 1

Examples of overlap in scope between core outcome sets and matched guidance documents

Scenario*PopulationInterventionExample title of COSExample title of guidance documentRegulator
ACOS is narrowerCOS is narrowerHow to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome setGuideline on clinical investigation of medicinal products used in the treatment of osteoarthritisEMA
BCOS is narrowerExact matchNoneNoneN/A
CCOS is narrowerCOS is broaderSelecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type two diabetesGuideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitusEMA
EExact matchCOS is narrowerNoneNoneN/A
FExact matchExact matchAchieving consensus on minimum data items (including core outcome domains) for a longitudinal observational cohort study in rheumatoid arthritisClinical development programmes for drugs, devices, and biological products for the treatment of rheumatoid arthritisFDA
GExact matchCOS is broaderToward establishing core outcome domains for trials in kidney transplantation: report of the standardised outcomes in nephrology-kidney transplantation consensus workshopsDelayed graft function in kidney transplantation: developing drugs for preventionFDA
ICOS is broaderCOS is narrowerNoneNoneN/A
JCOS is broaderExact matchNoneNoneN/A
KCOS is broaderCOS is broaderChronic rhinosinusitis outcome Measures (CHROME) – developing a core outcome set for trials of interventions in chronic rhinosinusitisNon-allergic rhinitis: developing drug products for treatmentFDA
  • COS=core outcome set; EMA=European Medicines Agency; FDA=US Food and Drug Administration; N/A=not applicable.

  • *Letters relate to those in figure 1, top panel.