Table FCore dataset elements for local hepatic therapy registry by PICOTS

PopulationInterventionComparatorsOutcomesTimingSetting
Patient Characteristics
 Age
 Sex
 Race
 Ethnicity
 Performance status
 LDH
 CEA
 Clinical risk scores (e.g., Fong)95

Tumor Characteristics
 Location of tumor
 Size of lesions
 Number of lesions
 Tumor volume
 Portal vein obstruction
 Course of disease (stabilization, rapid progression)

Other Treatments
 Number, dose, and duration for lines of prior therapy by drug

 Number, dose, and duration for lines of adjunctive therapy by drug

 Previous liver-directed therapy
Type of Local Hepatic Therapy
 Cryosurgical ablation
 RFA
 MWA
 TAE
 TACE
 HAI
 RE
 DEB
 3D-CRT
 IMRT
 SBRT

Characteristics of Local Hepatic Therapy
 Dose
 Duration
 Surgical site
Same as InterventionOverall survival

Quality of life

Response (e.g., complete, partial, no response)

Recovery time

Length of stay

Adverse effects (Short-term and long-term harms)

Treatment holidays*
OngoingHospital type

Number of procedures by practitioner

Type of practitioner

Local hepatic therapy availability

Inpatient or outpatient procedure

3D-CRT = three-dimensional conformal radiation therapy; CEA = carcinoembryonic antigen; DEB = drug-eluting bead; HAI = hepatic artery infusion; IMRT = intensity-modulated radiation therapy; LDH = lactate dehydrogenase; RE = radioembolization; RFA = radiofrequency ablation; SBRT = stereotactic body radiation therapy; TACE = transarterial chemoembolization; TAE = transarterial embolization

*

Treatment holidays refer to time away from systemic chemotherapy and may vary based on the success of treatment with a local hepatic therapy.

From: Executive Summary

Cover of Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer
Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer [Internet].
Comparative Effectiveness Reviews, No. 93.
Belinson S, Chopra R, Yang Y, et al.

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