ROADMAP Dictionary

A

AE

Adverse event

ACSQH

Australian Commission on Safety and Quality in Healthcare

ACT

Australian Capital Territory

AEs

Adverse Events

AGAR

Australian Group on Antimicrobial Resistance

AKI

Acute Kidney Injury

ALI

Acute Liver Injury

ALT

Alanine Transaminase Test

AOANJRR

Australian Orthopaedic Association National Joint Replacement Registry

AR

Adverse reaction

ASID CRN

Australasian Society for Infectious Diseases Clinical Research Network

AST

Aspartate Transferase Test

AURA

Antimicrobial Use and Resistance Surveillance System

AUS RTSC

Australian Regional Trial Steering Committee

AGAR

Australian Trial Management Group

B

BC

Blood Culture

C

CDAD

C. difficile Associated Diarrhoea

CPI

Coordinating Principal Investigator

CQRs

Clinical Quality Registries

CRF

Case Report Form

CRG

Collaborative or Cooperative Research Group

CRP

C-reactive Protein

CTA

Clinical Trial Approval

CTMS

Clinical Trial Management System

CTN

Clinical Trial Notification

CTRA

Clinical Trials Research Agreement

D

D/C

Discharge

DAIR

Debridement, Antibiotics and Implant Retention

DATIPO

Duration of Antibiotic Treatment in Prosthetic Joint Infection trial

DOOR

Desirability Of Outcome Ranking

DSA

Domain-Specific Appendix

DSMC

Data Safety and Monitoring Committee

DSWG

Domain-Specific Working Group

E

EBJIS

The European Bone and Joint Infection Society

eCRF

Electronic Case Report Form

EOS

Early Oral Switch

EQ-5D-5L

European Quality of Life Questionnaire, 5 Dimensions, 5 Level version

ESBL

Extended-spectrum β-lactamases

G

G+ve

Gram Positive

GCP

Good Clinical Practice

GTSC

Global Trial Steering Committee

H

HDU

High Dependency Unit

HE

Health Economic(s)

HEWG

Health Economics Working Group

HITH

Hospital in the home

HR

Heart Rate

HREC

Human Research Ethics Committee

I

ICER

Incremental Cost-Effectiveness Ratios

ICH GCP

International Conference and Harmonisation Good Clinical Practice

ICMJE

International Committee of Medical Journal Editors

ICU

Intensive Care Unit

ID physician

Infectious Disease physician

IDSA

Infectious Diseases Society of America

IIG

International Interest Group

IPCW

Inverse Probability of Censoring Weights

IQR

Interquartile Range

IRB

Institutional Review Board

ITT

Intention-to-treat

IV

Intravenous

K

KDIGO

Kidney Disease: Improving Global Outcomes

M

MA

Medicine Australia

MCMC

Markov Chain Monte Carlo

MoU

Memorandum of Understanding

MRSA

Methicillin-Resistant Staphylococcus aureus

MSSA

Methicillin-Susceptible Staphylococcus aureus

N

NAAT

Nucleic Acid Amplification Test

NHMRC

National Health and Medical Research Council

NMA

National Mutual Acceptance

NMB

Net Monetary Benefits

NSW

New South Wales

NT

Northern Territory

O

OHS

Oxford Hip Score

OKS

Oxford Knee Score

OPAT

Outpatient Parenteral Antimicrobial Therapy

OR

Odds Ratio

P

PCR

Polymerase Chain Reaction

PI

Principle Investigator

PJI

Prosthetic Joint Infection

Platform

Patients in the platform are those who meet all core eligibility criteria and consent to inclusion in the platform. Occasional patients in the platform will not receive any randomised intervention (if they are not eligible for any available domain).

Platform entry

“Platform entry” is the timepoint when the patient has met core eligibility criteria, given informed consent for the platform, and been randomised

PO

Oral Administration

PPP

Purchasing Power Parity

PROMS

Patient-Reported Outcome Measures

PROSPERO

The International Prospective Register of Systematic Reviews

PSSA

Penicillin-Susceptible Staphylococcus aureus

Q

QALY

Quality-adjusted Life Year

QLD

Queensland

QoL

Quality of Life

R

RAR

Response Adaptive Randomisation

RCT

Randomised Controlled Trial

Registry

Patients in the registry include all those in the platform (as defined above) PLUS the “registry only” patients. Registry only patients are those who are not in the platform, but who have consented to being in the registry.

REMAP

Randomised Embedded Multifactorial Adaptive Platform

RGO

Research Governance Office

ROADMAP

RandOmised Arthroplasty infection worlDwide Multidomain Adaptive  Platform trial

ROADMAP-SS

ROADMAP Statistical Subcommittee

RSA

Region-Specific Appendix

RSWG

Region-Specific Working Group

SWG

ROADMAP Statistics Working Group

RTSC

Regional Trial Steering Committee

RWG

ROADMAP Registry working group

S

SA

South Australia

SAB

Staphylococcus aureus Bacteraemia

SAE

Serious Adverse Event

SAP

Statistical Analysis Appendix

SAR

Serious Adverse Reaction

SEBS

Southeastern Border States

SF12

The 12-item Short Form Survey is a patient-reported general health questionnaire

SIG

Statistical Implementation Guide (current state of the analytic plan based on any previous platform adaptations)

SOP

Standard Operating Procedures

SSA

Site specific assessment

SSI

Significant Safety Issue

SUSAR

Suspected Unexpected Serious Adverse Reactions

T

TAS

Tasmania

TGA

Therapeutic Goods Administration

TMG

Trial Management Group

U

ULN

Upper Limit Normal

UoN

University of Newcastle

USM

Urgent Safety Measure

V

VIC

Victoria

W

WA

Western Australia

WTP

Willingness to Pay

X

XDR

Extensively Drug Resistant