AN INTEGRATED CLINICAL PROTOCOL MANAGEMENT SYSTEM
Richard B. Friedman, M.D., Steven Entine, G. Malcolm Murray,
David Holladay, and Carol E. Steinhart
Department of Human Oncology, University of Wisconsin
Madison, Wisconsin
The rapid increase in the number and
complexity of combined modality and multiple
therapeutic agent therapy in protocol based
treatment of disease has resulted in increased
reliance on manual and automated data base
management systems. At many clinical research
centers multiple computerized data base systems
are used to keep track of patients on various
treatment protocols. This has resulted in
redundant data entry and often hinders cross
data base correlations.
An integrated protocol management system
is described which utilizes a common minimal
data set to facilitate patient identification,
eliminate duplicate data entry, and promote
cross data base correlations. The system
is currently in use at a clinical cancer
center and has resulted in significant savings
in data entry and data manipulation and has
assisted in monitoring protocol compliance.
The increasing number of clinical protocols
available for the treatment of various diseases
has resulted in the rapid proliferation of
systems for the entry, manipulation, storage,
and retrieval of clinical data. This in turn
has brought about the large scale introduction
of computerized data base systems in clinical
data management. This has been particularly
apparent in the area of cancer treatment
protocols since a major cancer research cen-
ter may at one time have hundreds of patients
under treatment on as many as fifty to one
hundred different protocols.
While the introduction of computer data base
management systems into this area has resulted
in substantial savings to the clinicians and
data managers who must collect, store, and then
analyze this data; the unchecked proliferation
of multiple independent data systems at a single
center can result in redundant data entry and
a loss of ability to correlate across data
systems. To eliminate data redundancy and
facilitate cross data base retrievals we have
instituted an integrated cancer data system
which utilizes a centralized minimal data set
which is common to all components and in turn
contains pointers to individual data files.
81
The integrated protocol management system
is composed of a number of individual systems
linked through a central minimal data set
(figure 1). The individual components include:
1) a tumor registry; 2) an outpatient clinic
appointment system; 3) a hospital admission
notification system; 4) a chemistry and
hematology laboratory results storage and
retrieval system; 5) a clinical protocol
scheduling system; 6) clinical data recording
system; and 7) research data bases. These
are all linked through pointers in a minimal
data set which includes the following infor-
mation on each patient:
1) name
2) history number
3) date of birth
4) sex
5) date first seen
6) site of tumor
7) laterality of tumor
8) histology of tumor (including morphol-
ogy, behavior, and grade)
9) stage of tumor
10) whether this is an analytic case (i.e.,
initial course of therapy given at this
hospital)
11) followup information
12) current status (i.e., alive or dead)
The component data bases can each be
accessed separately or through the minimal data
set. This-promotes individual data base
integrity as well as permitting additional
clinical research data bases to be added to the
system without the necessity of re-entering
all the identifying information in the minimal
data set or information already contained in
other data bases.
Tumor Registry
The hospital tumor registry contains over
seventy pieces of information on each cancer
patient seen at the medical center. In addition
to the information contained in the minimal
data set the registry contains information on
sites of tumor metastases, contact addresses,
mode of therapy, etc. The registry is main-
tained as an independent data base and all
retrievals can be done utilizing only this
CH1480-3/79/0000-0081$00.75 ©) 1979 IEEE
data base. Entries and updates are communicated
automatically to the central file (where
appropriate).
Clinic Appointment System
The clinic appointment system is maintained
as a wholly independent system to permit com-
puter based clinic scheduling in the oncology
outpatient clinic. A complex and highly sophis-
ticated system permits scheduling of appoint-
ments by date, hour, and clinician. It provides
flexible appointment blocks depending on a
clinician's work output as well as the require-
ments of an individual patient visit. The
system automatically generates daily, weekly,
and monthly physician and clinic appointment
schedules so the clinicians can review his/her
schedule prior to the start of a clinic (figure
2). In addition, it provides administrative
data to the clinic director to facilitate
patient load equalizing and work load reschedul-
ing in the event that a clinician must cancel
a clinic.
In addition, by integrating this system
with the minimal data set one can facilitate
positive patient identification, treatment
protocol planning, and order protocol mandated
tests or therapies prior to the clinic visit.
In cmnjutnction with the separate protocol
scheduling and tumor registry data systems it
permits the automatic notification of
physicians involved in a protocol study or those
looking for patients with a specific tumor when
those patients are due to return for a clinic
visit.
Hospital Admission Notification System
When an oncology patient is admitted to the
hospital the patient's name and history number
are checked against the minimal data set and if
not found a new patient entry is made. In
addition to the information in the minimal data
set the referring physiciads name as well as
the patient¶s -ward and the attending physician
are recorded. If the patient has been pre-
viously seen in the clinic or hospital, only the
current ward and attending physician are added.
The system then automatically generates a letter
to the referring physician (figure 3) notifying
him of the patient's admission and detailing
the patient's room number, the attending
physician's name, and a toll free number to call
for further information. If the patient has
been previously admitted, letters are automat-
ically generated to all attending physicians
at the center who had previously taken care of
the patient notifying them of the current
admission. Periodic reports are generated
indicating referral patterns to the medical
center over sequential six month periods. These
reports indicate referrals by physicians, city,
and health service area. These reports are
useful to determine the impact of various out-
reach programs. Referral pattern information
82
can be combined with information on stage and
histology contained in the tumor registry for
detailed evaluations. By combining the infor-
mation in these two data bases one can determine
if, for example, a particular community based
program on the early detection of breast cancer
has resulted in the subsequent referral of the
breast cancer patients from that area at an
earlier stage of disease.
Laboratory Test Result Data Base
All chemistry and hematology test results
on patients seen at the medical center are
stored on magnetic tapes. This information
is identified by patient history number and
result date and can be retrieved using a 4
specially built hierarchical data base system
This system is integrated with the other data
bases using information contained in the minimal
data set. Therefore, retrievals of laboratory
data by individual patient name, history number,
tumor site, histology, stage, etc. are possible.
Protocol Schedule System
During the past five years there has been
a marked shift towards the use of combined
modality and multiple chemotherapeutic agent
therapy in the treatment of disseminated
malignancies. The development of these multiple
therapy regimens has necessitated the intro-
duction of strictly controlled treatment
protocols to permit comparison of different
treatment programs. The introduction of in-
creasingly complex rules for modifying drug
dosages on the basis of changing test parameters
has further enhanced the need for strict
protocol management. At the major cancer cen-
ters patients on as many as 50 to 100 different
treatment protocols may be followed simultan-
eously. In addition, most of these patients
will be treated during frequent clinic visits
during which their contact with the oncology
staff may be quite brief. This large number
of differing and complex treatment protocols
places a large burden on those persons who are
responsible for scheduling clinic visits,
ordering the appropriate tests, modifying
therapy dosages and recording appropriate
clinical and research data. Errors in drug
dosage could prove detrimental; failure to
order appropriate studies can result in pro-
longing important clinical studies.
A clinical protocol scheduling system has
been developed which facilitates handling of
protocol patients on both an inpatient and
outpatient basis. The system utilizes the
minimal data base to permit unique patient
identification based on history number, full
name or soundex name matching. The integrated
clinic appointment and hospital admission
systems facilitate both patient and laboratory
test scheduling. This permits the clinic staff
to determine work schedules, length of time
for an appointment, and laboratory test
requirements.
When a patient is placed on a cancer pro-
tocol, a unique test requirement and therapy
schedule is generated for that patient based
on the date he began therapy (figure 4a,4b).
(Provision is made for the staff to adjust
cycle dates if a patient's treatment program
requires modification due to the patient's
condition, drug reactions, etc.) Copies of
this schedule are then used to plan clinic
visits and to determine what test must be order-
ed at each visit and when therapies must be
altered. A list of tests to be compiled as well
as an identification for the study protocol
appears on the daily clinic schedule and the
doctor's appointment list. Individual lists
for patients to be admitted to the hospital or
those scheduled to have tests are also printed.
The system itself is table driven so new
protocols can be added without any additional
programming.
In linking the appointment and protocol
systems in an integrated data management system,
we can automatically notify staff personnel
whenever an appointment is made for a study
patient, whether that appointment results from
a scheduled protocol visit or is patient
initiated due to a change in clinical condition.
This prior notification permits the staff to
carefully review the patient's chart before the
visit to determine that all protocol dictated
tests are ordered and correct drug dosages
administered. The system is also interfaced
with specialized data sets and the hospital
tumor registry to assure early and comprehensive
case finding.
Protocol Data Recording System
As the results of tests or therapy modifi-
cations required by a clinical protocol are
available, they can be entered and stored in
a separate protocol data recording system.
Through the minimal data set this data is
linked with the patient and the data and therapy
requirements of that patient's treatment pro-
tocol. If tests or therapy modifications
indicated by the protocol are not completed
by the specified date, the system's tabular
display (figure 5) makes it easy for the data
manager to spot this deficiency and contact the
appropriate clinician.
Since the laboratory data system could be
linked directly with this data recording system,
data could be passed directly from the labora-
tory data base to the protocol recording system
without the need for manual re-entry of the
data.
83
Research Data Bases
Individual research data bases can be con-
structed utilizing the WISAR data base system .
This highly flexible system permits easy data
base definition, generation storage and re-
trieval. Researchers can develop their own
special data bases to study particular clinical
problems. Data bases dealing with hormonal
markers, bone density, ancillary clinical data
etc., have already been developed. By inte-
grating these data bases through the central
minimal data system the need to re-enter patient
identification data is negated and positive
identification for each patient is facilitated.
Equipment
The system is programmed in MIIS dialect
of MUMPS language. The system resides on a
Data General C-330 computer with direct inter-
face to the University's UNIVAC 1100/80 for
large scale data storage and manipulation.
The minimal data set is hierarchical in nature
with the overall physical disk storage strategy
dictated by the B-tree scheme inherent in the
MIIS language. The overall computer config-
uration consists of two identical Data General
C-330 computers supporting a total of 45
terminal ports of which approximately 20 are
dedicated to this integrated data management
system.
Discussion
The integration of multiple data bases
into a unified data system linked through a
minimal data set has multiple advantages:
1) it permits positive patient data identi-
fication for each data system since the minimal
data set allows identification by name, history
number, or soundex search. It contains date
of birth and sex information for further
positive confirmation; 2) it eliminates data
entry redundancy by locating the most frequently
repeated information in a central minimal data
set which contains pointers to the individual
data bases; 3) it facilitates data searches
across data bases by linking data elements
through the common centralized data core.. In
this way the power of the individual systems
are greatly enhanced and multiple clinical
correlations facilitated; 4) it greatly
facilitates clinic treatment scheduling by
automatically generating a list of protocol
requirements for each study patient's visit;
and 5) it makes it possible to easily monitor
protocol compliance by making it possible for
clerical personnel to keep track of the tests
or therapies required at each stage of protocol
management.
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lr et vsamte
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Th attendin,g p ys icia is / Dr. rieUmi...
.h. c.. Lbe --ahed at (508)-263-2345. The -eident on he -ad
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Yo
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Il.tter
the. cnlso
etil-ng the.
of
n pt.1 cours
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a

time. 1978 MUMPS User's Group Meeting,

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of t4dicine.
..d H.... Onlcology
FltCURE

This work was supported in part by NIH-NCI- PPC:miis

CA-14520 from the National Cancer Institute.

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