Project Report:
HIT2continued
relevant patient data and putting it into
a standardized format for eventual
analysis by the MediClass program.
This task has proven to be a major
challenge, since each health system has
idiosyncratic forms of encounter data.
For HIT 2, we chose to use a clinical
document architecture (CDA) written
in HTML format. The HTML format
is required by the Java processing
design of MediClass. It can also be
exported as a WORD document for
the team of MediClass evaluators to
use for the validity study coding.
To test the validity of the MediClass
program, we have trained medical
record abstractors at each site in the
use of a common coding protocol. To
date they have coded 500 primary care
encounters and we are currently in the
process of comparing their coding to
that done by the MediClass program.
The results of this test will be used to
refine the MediClass program and
produce the final version which will
be used in the second phase of HIT 2.
This second phase of the study will
include a clinical trial testing the effect
of feedback on the delivery of
tobacco cessation services by primary
care physicians.
Baseline data collection for the provider
feedback study will cover the first six
months of 2004 and providers will be
randomized in July. We will also be
sending questionnaire to patients of
study providers. We will use the
questionnaire results to gauge the
delivery of the 5A's as perceived by
the patients and use it to evaluate the
effectiveness of our feedback study in
changing provider behavior.
Sabina Smith, KPNW
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Collaborating CRN sites include KPSC
(Ann Geiger and Shelley Enger), GHC
(Diana Buist), Health Partners (FeiFei
Wei), HFHS (Marianne Ulcickas Yood),
and Fallon (Terry Field, CRN principal
investigator). Lovelace Health System
(Floyd Frost) from the HMO Research
Network is the sixth site. The project
is using a historical cohort design to
study over 2000 older women for 10
years to answer treatment effective- ness
questions among those with early stage
disease. To maximize study efficiency,
all eligible stage II, minority group, and
80+ year old women are being enrolled;
a sampling strategy is being used for
Stage I, white, and younger women.
The project uses a Microsoft Accessbased
data collection system (DCS),
pre-loaded with SEER/administrative
data when available, for data collection.
This system was created by BUMC
research staff Soe Soe Thwin and Kerri
Clough-Gorr. Special features of the
system include range checks for all
numeric data fields, extensive logic
check for data quality assurance, a check
for whether the site-specific sampling
quota for stage I, younger, white
women has been achieved, and a check
for data completeness. The DCS was
designed to incorporate real-time data
quality checks so that the medical
record abstractors are prompted
whenever there are illogical datadiscrepancies
which otherwise would
not be caught until after data entry.
Because the DCS is laptop-based and
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mobile, a single person provided onsite
training for all sites. The common
data collection problems that are
usually associated with project startup
were minimized because project
resources were "front loaded" early
in the data collection planning process.
Meticulous attention was paid to
achieving consensus on inclusion/
exclusion criteria and data elements/
coding; the interface between SEER/
Tumor Registry sites and those
without; procedure manual creation;
extensive system pre-testing; and indepth
on site training. Because of these
efforts, roll-out of the DCS was
smooth. The few problems encountered
have been minor and most
have been attributable to the user
rather than the system. Due to the
geographic separation of the project
sites, an important challenge is
managing these technical issues
remotely.
We are using the existing CRN internet
technology to transfer data files
between the study sites and BUMC
securely, eliminating the need for
physical transfer of data, thus reducing
potential for loss and inefficiency.
Data are transferred to BUMC on a
monthly basis via the CRN website.
As of the end of March, data have
been collected on 581 subjects (27%
of the total). We have also modified
the DCS by creating a "stripped
down" version which has automated
our quality control strategies. We are
assessing intra- and inter-rater reliability
electronically and have automated data
comparisons and transfer, thereby
providing additional project efficiencies.
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