TABLE 3-2Summary of Ontario Field Evaluations

Technology (n)Field Evaluation Overseen byType of StudyReason for Field EvaluationResultPolicy Decision
Drug eluting stents (DES) (21,000)PATH, with ICESProspective pragmatic registryGeneralizability of RCT evidence and cost effective analysisOnly effective in patients at high risk for restenosisFunded; 30% conversion from bare-metal to DES (90% in U.S.A.)
Endovascular abdominal aortic aneurysm repair (160)PATH and single AHSCProspective observationSafety assessment of endoleakNo endoleak; CE only for high surgical riskFunded for high but not low surgical risk
Multifaceted primary care diabetes programPATH, with Oxford UniversityBefore-after study using micro simulation economic modelPrioritize investments according to downstream effects and CE following systemic review of diabetes strategyMost CE were bariatric surgery, MDT; Least, insulin infusion pumps for type IIBariatric program funded and additional funding for MDT; Insulin infusion pumps for type 2 on hold
64-slice CT angiography (CTA) v coronary angiography (CA) (175)PATH, with cardiologists, radiologists, selected AHSCsPatients for CA also underwent CTAUncertainty regarding indications for use, CE and QA parametersSensitivity lower than reported, reducing CEOHTAC recommended slow diffusion until sensitivity issue resolved
PET to stage locally advanced NSCLC (310)OCOGRCTClinical utility in decisions regarding combined modality therapeuticsTerminated by efficacy & safety committeePET insured for this indication
PET to stage early NSCLC (322)OCOGRCTResolve inconsistencies to inform decision regarding accessPET reduces futile thoracotomy ratesPET insured for this indication
PET to stage breast cancer (320)OCOGProspective cohortCompare PET to sentinel lymph node biopsyNo utility in stagingNot insured
PET for colorectal cancer metastatic to liver (400)OCOGRCTClinical utility in decision for metastatectomyAccrual completed February 2010Awaiting results
PET for head and neck cancer (400)OCOGProspective cohortClinical utility presurgery following radiation therapyNo clinical utilityNot insured
Extracorporeal photopheresis (120)PATH with AHSCProspective observationalBasis for decision regarding funding for GvH and SezaryEffective in GvH; Inconclusive for SezaryInsured for GvH; Inconclusive for Sezary -small vol. after backlog dealt with

Abbreviations: AHSC (academic health science center); CE (cost effectiveness); DES (drug eluting stent); GvH (graft vs host); ICES (Institute for Clinical Evaluative Sciences); MDT (multi-disciplinary teams); NSCLC (non-small cell lung cancer); OCOG (Ontario Clinical Oncology Group); OHTAC (Ontario Health Technology Advisory Committee); PATH (Programs for Assessment of Technology in Health); PET (positron emission tomography); QA (quality assurance); RCT (randomized controlled trial).

SOURCE: As updated from Levin et al., 2007, by Levin in IOM workshop presentation on November 17, 2010.

From: 3, Approaches to Evidence Generation

Cover of Generating Evidence for Genomic Diagnostic Test Development
Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary.
Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health.
Washington (DC): National Academies Press (US); 2011.
Copyright © 2011, National Academy of Sciences.

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