Cost-effectiveness and
QALY Assessment
Ilana F. Gareen, Ph.D.
Brown University
Center for Statistical Sciences
igareen@stat.brown.edu
ACRIN Cardiovascular Committee
RESCUE AIMS
Primary Aim
Compare outcomes of participants with symptoms of stable angina undergoing CCTA
as initial method of CAD diagnosis (Group A) to SPECT MPI (Group B) as a guide to
OMT.
Secondary Aims
1. To evaluate the ability of available prognostic indices to predict revascularization or
MACE using CCTA information and to develop new indices using the RESCUE trial
data.
2. To determine the cost, effectiveness, and incremental cost-effectiveness of CCTA
versus SPECT MPI in the evaluation of participants with symptoms of stable
angina.
3. To compare angina symptoms and self-reported health status of participants with
symptoms of stable angina undergoing CCTA as initial method of CAD diagnosis
(Group A) to SPECT MPI (Group B) as a guide to OMT.
ACRIN Cardiovascular Committee
For Images/Graphics
For Images/Graphics
For Images/Graphics
For Images/Graphics
For Images/Graphics
For Images/Graphics
Triggering Medical Record
Abstraction
• Medical chart abstraction will be triggered by
participant responses during telephone follow up
ForCCTA
Images/Graphics
and by initial
and SPECT MPI results.
Triggering Medical Record
Abstraction
• All records relating to the following will be
abstracted:
For Images/Graphics
– MACE/revascularization
events;
– Medical care for cardiac issues;
– Medical care for OMT;
– Medical care related to incidental findings
on the CCTA or SPECT MPI examinations.
Centralized Process
• HIM staff at the ACR will collect, prepare records
for shipment to the centralized abstraction facility
• Medical records abstraction and coding will be
For
Images/Graphics
performed by a single central medical record
abstraction company.
• Centralizing the abstraction process with a single
group of abstractors simplifies quality control,
ensuring consistent and reliable coding of medical
conditions and care.
Collection of Abstraction Data
• All abstraction will be done directly onto forms on
laptop computers. These computer forms
incorporate range checks and International
For ofImages/Graphics
Classification
Disease (ICD) and Current
Procedural Terminology (CPT) look-ups which
ensure that data are as error-free as possible.
• The data on the laptops are routinely backed up
and uploaded to the central computer at the
conclusion of the abstraction assignment at each
site.
For Images/Graphics
Patient Reported Outcomes
• The importance of patient self-reported outcomes is widely
recognized in the literature and by the US Food and Drug
Administration.
For Images/Graphics
– Global measures of health, such as the 36-Item Short Form
Survey Instrument, version 2 (SF-36 v2), are useful to compare
participant health status across studies of different health
conditions as well as to derive health utilities for use in costeffectiveness analyses.
– Disease-specific measures of participant health status, such as
the Seattle Angina Questionnaire (SAQ), are useful to collect
detailed information regarding the specific disease outcome of
interest.
Quality of Life Measurement Tools
• Both the SF-36 and the SAQ have been used to assess
health-related QoL in patients with angina and have been
demonstrated to be internally consistent with good testretest reliability.
For Images/Graphics
• Selected subscales from both tools have been correlated
with patient angina severity measured using the CCS
Classification
• Both of these tools have been used to measure participant
health status in a prior large clinical trial of PCI and OMT
interventions for patients with angina.
For Images/Graphics
For Images/Graphics
For Images/Graphics
Administration of QoL Tools:
• Administered at the sites at the Baseline
examination prior to randomization.
For Images/Graphics
• Administered by the ACRIN Outcomes and
Economics Unit (AOEU) located within the
ACRIN Biostatistics Center at the Brown
University Center for Statistical Sciences at 12
months post-randomization.
Ensuring Completion of QoL
Tools:
• The site will fax Participant Contact Information
Forms to the AOEU following the baseline visit.
For Images/Graphics
• AEOU personnel
will mail copies of QoL tools to
participants along with pre-addressed, stamped
envelopes for return mailing to the AOEU.
Participants will be provided with a toll-free
number (which is answered by the AOEU RA)
should they require assistance with reading
questionnaires.
Ensuring Completion of QoL
Tools:
• If the questionnaires are not received at the AOEU within
10 working days of the date of the mailing, an AOEU RA
will telephone the participant
– To determine whether the questionnaires were received
– If the participant has the questionnaires, the participant will
be asked to complete and return them.
– If the participant has not received the questionnaires, the
AOEU RA will confirm the delivery address and send the
tools to the participant.
For Images/Graphics
Ensuring Completion of QoL
Tools:
• If questionnaires are not returned within 20 working days
thereafter, the AOEU RA will attempt to complete the
questionnaires in a telephone interview.
– Telephone interviews will be conducted only as a final
measure to avoid any biases introduced by differences in
the method of administration of the questionnaires, and the
mode of administration of all such questionnaires will be
documented in the trial database.
– The AOEU RA will not attempt to interpret a question;
training will be provided to help ensure that the AOEU
RAs facilitate completion of the QoL questionnaires in a
standardized fashion.
For Images/Graphics