Retrieval Code (field 12)
GETretrieve full copy
DNGdo not retrieve full copy
UNCuncertain; needs check by second reviewer
Selection Decision Code (field 12)
EXCexclude (with codes for exclusion reasons)
Full Review Codes (field 42)
I. Key Question Codes
Q1breast tissue HER2, accuracy/concordance,
Q2Abreast tissue HER2 discrepant, trastuzumab therapy
Q2Bbreast tissue HER2 negative, trastuzumab therapy
Q2ABeither/both Q2A and Q2B
Q3Abreast tissue HER2 status, chemotherapy
Q3Bbreast tissue HER2 status, hormonal therapy
Q3ABeither/both Q3A and Q3B
Q4breast serum HER2
Q5Sserum HER2, non-breast solid tumors
Q5Ttissue HER2, non-breast solid tumors
Q5STserum & tissue HER2, non-breast solid tumors
NRQnot relevant question (note if NDE, INV, ANM, HNM, NRD, NRO, NRT, NRS, NIT)
Q#?unclear if relevant to any key question
II. Study Design Codes
RCTrandomized controlled trial
PROprospective single-arm study
PIphase I trial
PIIphase II trial
QEXquasi-experimental study (nonrandomized comparative)
DACdiagnostic accuracy/concordance study
ADSassay development study
RETretrospective study
CRcase report (n≤5)
CScase series
PRGprognostic study
ADBadministrative database
SRsystematic review
NPDno primary data
NRAnarrative review article (GET only if helps for Intro; DNG if 2002 or earlier)
CEAcost-effectiveness analysis
D?design unclear/possibly relevant
NDEnot relevant design
ICTincomplete cross-tabluation of assay results
HNMHER-2 not measured
INVin vitro study
ANManimal model study
III. Sample Size Code (single-arm only)
FEWn < 25
N2525 ≤ n ≤ 49
N5050 ≤ n ≤ 99
N100n ≥ 100
N?n unclear
IV. Disease/Outcome/Intervention Codes
BCbreast cancer
OSTother solid tumor
NSTnon-solid tumor
DS?disease unclear
NRDnot relevant disease
O?outcome unclear
NROnot relevant outcome (or no follow-up)
NRSno relevant subgroup analysis for outcomes
FU?follow-up uncertain
TRZtrastuzumab-based treatment
HThormonal therapy
T?treatment unclear
NRTnot relevant treatment
NITnot identically treated
IT?uncertain whether identically treated
PCprostate cancer
LClung cancer
HNChead & neck cancer
OCovarian cancer
V. HER2 Assay Method Codes
IHCimmunohistochemistry, one antibody or antiserum
WBLWestern blot (measures HER2 protein)
MABIHC comparing ≥2 antibodies or antisera
FISfluorescence in-situ hybridization
CISchromogenic in-situ hybridization
PCRpolymerase chain reaction
RNAdot-blot or other methods for mRNA assay (including rt-PCR)
OTHany other HER2 assay methods
TMAtissue micro-array methods
MNVassay method not adequately validated, quality assured, etc.
MV?uncertain assay method validation, quality assurance
OBFother body fluid (not serum or plasma)
HM?HER2 assay method unclear
ELSELISA or other enzyme assay
CTCcirculating tumor cells
SBLSouthern blot

From: Appendix B. Listing of Excluded Studies

Cover of HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors
HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors.
Evidence Reports/Technology Assessments, No. 172.
Seidenfeld J, Samson DJ, Rothenberg BM, et al.

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