A NATIONAL TRAUMATIC COMA DATA BANK
Selma C. Kunitz, Cynthia Gross,
Barbara Nichols and Sylvia Edelstein
Computer Applications Section, Office of Biometry and Field Studies, NINCDS/NIH
Bethesda, Maryland 20014
ABSTRACT
A number of university hospital centers are par-
ticipating in the pilot of a national computeriz-
ed clinical data bank for traumatic coma. Pa-
tient data including history, symptoms, treat-
ment, and outcome are collected prospectively
during the patient care and follow up process
according to common definitions. The data bank
was implemented to demonstrate its usefulness
for clinical research and patient management. To
achieve these goals, a clinical data bank requires
research methodology and computer technology
linked with the needs of the patient environment.
This paper describes the research design, the
implementation, and the computer system of the
Traumatic Coma Data Bank, which began in 1979.
INTRODUCTION
Traumatic head injury is a major health problem
in the United States. Accidental head injuries
affect over four hundred thousand Americans each
year, and many of these persons will experience
periods of unconsciousness. Motor vehicles are
the major cause of these accidents, and the
majority of these victims are young.40 A number
of therapies have recently been introduced to im-
prove the management of traumatic coma victims,
and further study is needed to assess the impact
of these therapies on survival, recovery of
function, and quality of life.
As with many other neurologic disorders, clinical
research in traumatic coma is hampered by a lack
of useful data. Data from large numbers of pa-
tients, carefully and prospectively collected,
according to precise definitions, are needed to
identify and elucidate the course of traumatic
coma and its sequelae. Data are needed to des-
cribe the complexities of management and the
patterns of survival and recovery. Multidi-
mensional assessment batteries are needed to
characterize short and long term patient outcome
during follow-up periods.
1333
U.S. Government work not protected
by U.S. copyright.
The medical record, which contains data routinely
collected as a part of the care of patients, has
long been recognized as a potential resource for
research.4-
However, the data contained in
these records have frequently not been useful for
research purposes for the following reasons. The
data elements are not consistently defined
among hospital centers or even among physicians
at the same center; they are not uniformly col-
lected on each patient; and they are generally
difficult to retrieve from the medical record.
In the 1970's, clinical data banks for lung,
cardiovascular,8 and rheumatic diseases were
introduced.0' , 8These data banks store
information on the course of illness for large
numbers of patients and provide rapid access to
a dynamic "textbook of chronic disease" to ait
the decision-making process of the physician.
In addition, these data banks provide the computer
systems technology required to store the temporal
relationships among items of information which
collectively constitute the patients' clinical
course. To be useful for research, however, a
clinical data bank requires both the appropriate
computer technology and a workable research
strategy.
The National Institute of Neurological and Commu-
nicative Disorders and Stroke (NINCDS) of the
National Institutes of Health (NIH) has developed
a national collaborative pilot data bank program*,
which combines the clinical data bank concept
with the formal structure of research methodology.
Within the context of the pilot data bank program,
a clinical data bank is defined as a collection
of data bases from several hospital centers,
each containing patients' medical history, des-
cription of the onset of the disease (or precip-
itating accident), the therapy, and the outcome,
recorded throughout the patients' clinical course
according to an established set of definitions.
These data are entered, stored and retrieved in
a rapid, flexible manner through the use of a
computer system which retains information on
the data's temporal relationships.
Many academic hospital centers are actively par-
ticipating in the collaborative data banks, whose
two major goals are to provide a data resource
for clinical research and to aid in patient
*An NINCDS Stroke Data Bank Network is also part
of this program,
management. If the pilot data banks are success-
ful, they will provide models for similar data
banks for other diseases and other purposes.
The Traumatic Coma Data Bank is discussed in the
following sections with a focus on its goals,
research design, uses, and the computer system
which makes it operational.
GOALS OF PILOT DATA BANK
A primary goal of the NINCDS data banks is to
demonstrate their utility for clinical research.
Adaptation or development of research designs and
methodological guidelines appropriate to the
data banks are necessary to achieve this goal.
Careful study design, which can provide data
that are useful for clinical research, requires
that data are collected in a manner which is
consistent over time among both data collectors
and subjects.10 The NINCDS data bank research
design specifies systematic, organized methods
for the implementation and operation of the
clinical data bank; for data identification and
collection; and for determining the limitations
of the data for clinical studies.
Studies arising from the clinical data bank are
observational. An observational study seeks to
describe what is happening in an environment,
and is an important method for research on human
problems in situations where one is unable to
ethically experiment. Observational studies can
incorporate epidemiologic procedures for the se-
lection of cases and the collection of data. The
carefully planned observational study, which
utilizes statistical methods for data analysis
can provide descriptive information concerning
disease stages, associations among symptoms,
intervention, complication and outcome, and
generate leads for clini al experimentation.
Dambrosia and Ellenbergil have recently described
their views on the utility and and limitations
arising from medical data bases.
A second goal of the pilot data banks is to offer,
through the computer system, administrative aids
for patient management such as structured medical
records, automated discharge notes, and tickler
lists designed to assist in scheduling follow-up
visits. It is hoped that these benefits will pro-
vide continuous motivation to collect consistent
data. Consistent, accurately recorded data are
necessary for good clinical research. It has
been shown that physicians are more likely to ad-
here to protocols, to utilize computers, and to
collect consistent data if they are provided rap-
id and useful feedback from these systems.12
The development and use of data collection forms
which can serve as the medical record and which
are also compatible with data entry into the com-
puter for research purposes is an objective of
the pilot data bank. In most clinical studies
data are abstracted from existing medical records
or are collected by means of a form developed and
utilized for a single, specific study. In con-
trast, most currently automated patient record
1334
systems have provided a formatted medical record
but have not attempted to develop and adhere to
uniform definitions which are a requirement of
clinical research. They have also not provided
the ability to access or manipulate user-chosen
subgroups of patients; an ability which is re-
quired for data analysis. Although direct en-
hancement of patient care is not a primary ob-
jective of these data banks, some benefit may be
derived in this area by the introduction of
structured, computer retrievable medical records13
for review and use by the attending physician.
DATA BANK DESIGN AND OPERATION
The pilot Traumatic Coma Data Bank consists of
four federally-funded university hospital centers
(Appendix I), called Clinical Data Bank Centers.
(clinical centers) Each center has as Principal
Investigator, a neurosurgeon who is primarily
responsible for all activities involved in the
data bank. The Principal Investigator leads a
team composed of other physicians, nurse practi-
tioners, research assistants, and data entry
persons. A separate federally funded Data Bank
Maintenance Center, which is at the Stanford
University Medical Center, provides the computer
support to store and retrieve data. The Clinical
Data Bank Centers, the Data Bank Maintenance
Center, and the Office of Biometry and Field
Studies (OBFS) in NINCDS collaborate on all
phases of the projects. OBFS, which sponsers
this program, also offers technical expertise
in systems design, computer science, biosta-
tistics and epidemiology.
The design of the Traumatic Coma Data Bank in-
cludes specification of research questions; of
data element definitions; of data collection -
protocol ,s and procedures; and of quality assurance
methods. Each of these elements is essential
to an effective collaborative observational study
useful for clinical research.
The research questions for traumatic coma concern
issues of patient management; specifically the
relationships among types of emergency care,
early symptom presentation and outcome; the
association of intensive care monitoring, treat-
ment and outcome; and identification of the
determinants of prognosis.
Vocabulary
The research questions provide a strategy for
the selection of data elements to be included in
the data bank, which is termed the vocabulary.
The vocabulary includes data elements which
describe the patients' background, accident
details, transport modes, emergency room care,
clinical history, symptoms, laboratory tests,
interventions, and outcome. In addition, the
Clinical Data Bank Center staffs have concentrat-
ed on detailed data capture of the complex,
often simultaneous events occurring during inten-
sive care, and on developing a more comprehensive
set of outcome measures than are currently util-
ized. The Principal Investigators have mutually
defined and agreed to the of definition for each
 item in the vocabulary.
Data Collection Forms
The order in which data are routinely collected
in the patient care setting provide a structure
for the data collection forms. Some of the forms
are in a format similar o the Time-Oriented Re-
cord developed by Fries , in which data are col-
lected in columns, by date and time (Figure 1).
TRAUMATIC COMA DATA BANK
EVALUATION AND TREATMENT
FORM TYPE 3
DATE
3 TiME
6 i OBSERvER Flosp tai Keeps List of Codes)
PLACE OF EVALUATION
1 = Pldce of njirv 4 =
2 In Tr&isitrv Forst Hospital 5 =
3 = At Ernergensc Room of
|Fist HospItai
-%ELACL^;CGCAL EVALUATION
20 , BEST EYE OPEN/NG EChoose One)
I -"Nre
2= To Pan
6
7
=
=
3 To Sound
4 - Spoitaneous B =
5 - Pe:x!ie Tarsorrhaphy
B:ST MrOTOR RESPONSE (Choose One}
1= None
2 - Extensor
7 - Limb iniury;lmmobilization
B - Spinal Cord lbjury
Time-oriented records are used for data collected
in a repetitive manner during the hospital stay.
Other forms are formatted for a single encounter
or procedure, such as demographic histoW, pa-
tient history, and surgery (Figure 2). For an-
TRAUMATIC COMA DATA BANK
PATIENT INFORMATION (Cont'd.)
DETAILS OF PATIENT ADMITTANCErrRANSFER
H45 PATIENT ADMITTED/TRANSFERRED TO DATA BANK HOSPITAL
00. = Direct From Scene of Accident
002 = From Home (Not Scene of Accident1
003 = From Non-Hospital Provider
= From Other Huspital
elevated 30 degrees. Protocols requiring specit-
ic tests or other medical interventions that
would change the standard care of patients are
not appropriate for the Traumatic Coma Data Bank.
The development of the collection protocols was
a difficult task; it was found that if cominon
goals were shared and fostered among investiga-
tors, the development was easier.
The data element codes, definitions, instructions,
and data collection protocols comprise the Data
Dictionary which is a part of the Administrative
TOR NO
Manual for each of the centers. Eligibility cri-
teria and informed consent procedures are outlin-
ed in Administrative Manuals along with flow
I = Emergency Room diagrams to decribe case ascertainment, follow-up
3-9 = Nurse
10-20 = Physician
procedures, and personnel rosters. The Admini-
strative Manuals are reviewed at six month inter-
In Transit to Data Bank Hospital' vals for possible revision.
At Emergency Room of Data
Bank Hospital'
Data Collection
In each clinical center all patients who are el-
Injur.ediSwollen
barbiturites, Narcotics. or
igible for the study are followed for two years,
Pharmacologic Paraiyss or until the project ends, patient dies, or is
O-her otherwise lost to follow-up.
All data are collected by examination of the
Fti.9'sL l
patient or other original source by, or under
the supervision of the Principal Investigator.
Data are collected at specific time intervals
depending on the patient's status. For example,
data are collected every eight hours during
intensive care, and then daily during in-pat'ient
care. In addition, an event triggered data col-
lection method is utilized. For example, if in-
tracranial pressure or blood pressure is elevated
beyond a specific range, additional data are col-
lected for a specific time period. Event trigger-
ed data collection helps to organize the many
patient changes and interventions which occur
in a short time frame in an intensive care unit.

H56 COLLABORATING HOSP!TAL Training

(See Code List irn Ad-ministrative Manual)
H46 TRANSPORT MODE TO FiRST HOSP!TAL
- Self
2 = HeletiveiFriend
= Ambulance
H57 TRAINING OF TRANSPORTER TO FIRST HOSPITAL
0 =None
1 = Police/Firenmen (if less than EMT 1 training)
2 = EMT 1 (Bas;c EMS)
3 = EMlT 2 (Advanced EMS)
4 = Nurse
5- Physician
6 =Other.__ _
7 = Unknown
F.i
alytic purposes, it is important that the forms
contain conventions which deal with categories
of missing responses such as "no data", "unavail-
able data", and "not applicable".
Procedures and Operations Manual
Where appropriate, specifications for the method
of data collection are expressed by collaborative-
ly defined protocols. For example, intracranial
pressure, if monitored, must be with the head
Training programs were developed to teach data
4 = Helicopter/Plane l entry procedures at each of the clinical centers.
5 = Police
6 = Other Data collection personnel have attended meetings
with the Principal Investigators in order to
become thoroughly familiar with the data defini-
tions, instructions, and data collection pro-
cedures. Workshops on evaluating patient sta-
tus on follow-up and on data retrieval methods
occurred.
Quality Assurance
Quality assurance methods are desi.gned for pa-
tient selection, data collection, data entry, and
data retrieval. Some methods are objective and
staightforward, such as computer edits and com-
prehensive forms design. For example, a computer
edit might prevent an illogical relationship,
e.g., pregnant male. Other methods are more sub-
jective and approximate, requiring on-site moni-
toring and frequent problem-sharing. Specific
methods include the option of central reading of
CT scans; compilation of data summaries to check
for anomalous results within and among centers;

1335
use of common diagnostic criteria; standardized
protocols for patient evaluation; agreement on
specific times for patient observation and col-
lection of data; determination of compliance
to th data definitions; and patient management
aids. 4During the data collection test phase,
cases were reviewed and discussed among all of
the Principal Investigators and their staff.
This collaboration served to identify areas
of ambiguity in the instructions and definitions
and many items were revised or clarified.
During the operational phase of the pilot, sam-
ples of the completed forms are periodically
compared with items stored in the computer. An
external observer will visit each of the Data
Bank Centers to independently examine and dia-
gnose patients and record information.
COMPUTER TECHNOLOGY
The computer system utilized in the pilot data
bank integrates the storage and retrieval cap-
abilities of a Data Base Management System (DBMS)
which are useful for research with the benefits
of a local computer which can serve the patient
management needs of each clinical Data Bank
Center (Figure 3). The specific attributes re-
Data Bank
Center Daow Bank
'N
CGntam
Dapdnt 180
Mloproc_o
ViuRee 3
quired of a DBMS for the clinical data bank
include: ease of use by nontechnical personnel;
adaptability to change; flexibility in access
and retrieval of changing subsets of data; modes
of linkage to statistical packages and higher
order programming languages; and security with
respect to system intergrity and confidentiality.
The clinical data base management system utilized
is a modified version of the Time Oriented Data
(TOD) System and is maintained by a subgroup
of the American Rheumatism Association Medical
Information System (ARAMIS). TOD-ARAMIS, which
was developed specifically for the clinical
environment, is housed on an IBM 3033 at Stanford
University Medical Center, and is managed by
ORVYL, a powerful operating system.
1336
Each Data Bank Center has a Datapoint 1800 intel-
ligent CRT processor with dual floppy disk drives
and printer, for communication with the Stanford
computer. The Datapoint 1800's are microproces-
sors. To take full advantage of their potential,
each center is encouraged to use them for admin-
istrative assistance to their patient care process,
as well as for the data entry and retrieval
needs of the data bank.
The TOD System
TOD is programmed for data entry and editing ei-
ther online or through batch transmission via
commercial communications lines such as Telenet
and Tymshare. Central to the TOD system is a
schema which is composed of the attributes of
each data element. The TOD system was designed
for an out-patient setting and is based upon a
patient-clinician encounter which is called a
VISIT. Data collected in the first and subse-
quent encounters, as well as laboratory tests
and therapies, are stored by VISIT number and
date. Background and demographic data which do
not change over time are stored in a separate
file. All patient medical history data are
collapsed into a single visit, called VISIT 0.
The Traumatic Coma Data Banks, however, must con-
sider the handling of patients in an acute care
hospital setting. In the hospital, patients are
examined, treated, and evaluated several times a
day. A patient's status, as well as therapy, may
change dramatically within a few hours, especial-
ly in an intensive care unit. In order to accu-
rately describe a patient's course, these changes
must be collected and stored. In addition, a
specific event type, such as a surgical procedure,
or arteriogram, is more relevant to hospital data
collection than the VISIT concept. For these
reasons, the TOD system was modified to record
data elements by time, date, and event type as
well as VISIT.
DATAPOINT INTERFACE
While the TOD system manages data in the central
data bank in a timely and flexible manner, it
was not designed to meet the needs of acute care
environments in geographically dispersed centers.
However, a microprocessor or intelligent terminal,
which itself is a small computer, is an appropri-
ate tool for the patient care setting. Rather
than choosing "dumb" terminals, which can only
transmit and receive data, the Datapoint intelli-
gent terminals were selected for the Data Bank
Centers. A "front-end" general purpose software
package was developed for the Datapoint, which
allows data to be entered, edited, and stored
locally by time and date. This software package
also sorts the collected data and prepares it for
subsequent transmission in a batch mode over a
conunercial line to the TOD system which accom-
plishes more complex editing.
The microprocessor software operates with menu
processing, in which a non-programmer such as
the data entry person can choose the relevant
form(s) for data entry from a list of options.
It produces screen images which replicate the
order of the data on the the data collection
record (Figure 4). During data entry, data are
PATIENT OFFLINE DATA ENTRY AND UPDATE
PAGE Past History Fl = JUMP F3= ABORT F5 = WRITE
M.R.N. 00001 PAGE NO. 2A ENTRY DATE 01 Jan 1980
P11 Location in Community ........................ 1
P435 Mental Status Problem ......................... 2
P18 Employment Status ..........................
P19 Unemployed/Retired for Medical Reason ......... 0
P425 Performance Class ...........................
P426 Placement Clss ............................
F 94i.e LI
edited for valid numeric ranges, alpha/numeric
field consistency, code lists, and special for-
mats such as dates. Data are protected by a
password system and confidential items such as
name and address are never transmitted to the
central data bank. Changes to the TOD schema
update a local Datapoint program which automat-
ically generates changes to the local entry
program. The data collected locally are stored
on a diskette by patient, data element, date,
and time. The data housed on the diskette are
useful for generating information on an individual
patient such as course during hospital stay,
discharge and referral notes. These data will
also be used to produce lists of patients such
as those needing follow-up visits, and simple
patient counts.
When data are received by TOD from the local
system, they are stored in an ENTRY file. Data
are then transposed into the central data bank
and maintained separately for each Data Bank
Center; that is, arranged in a matrix ordered by
data item, patient, date, and time within center.
Transposed data are accessed to generate subsets
of patients for research purposes. Data analyses
can be run on the Stanford system or data can be
sent back to the local centers for use with sta-
tistical packages and higher order programming
languages.
An aspect of the computer system which may be
addressed during the latter stage of the pilot, is
the feasibility of establishing an automated link
between the microprocessor and monitoring equip-
ment used during intensive care.
MULTIDISCIPLINARY PROJECT TEAM
The implementation and operation of the Traumatic
Coma Data Bank has involved a multidisciplinary
team of neurosurgeons, biostatistians, computer
scientists, and epidemiologists. The team has
had to:
1. Develop standard data element defi-nitions
and
protocols;
2. Design new patient record forms to aid the
clinicians and to facilitate the process
of data entry into the computer;
3. Require follow-up data such as long-range
outcome on patients to permit estimates of
TIME 1200 prognosis; and
4. Develo% quality control procedures for data
collection for clinical research.
OLD CHANGE
In the early stages of the data bank planning and
development, a communication barrier existed
among the various disciplines, partly because of
the subject-specific jargon that tends to pervade
2 one's professional speech patterns. Numerous
- meetings, perserverance, and increased confidence
in the data banks dissipated these barriers and
1 2 common goals emerged which replaced stereotyped
1 -
discipline viewpoints.
The data bank projects have taken advantage of
the specific definitions required by DBMS to
integrate the computer technology with research
methodology. As with many medical applications
of DBMS, this planned integration might have been
overlooked, if the project did not involve a mul-
tidisciplinary team.
ASSESSMENT AND FUTURE DIRECTIONS
The Traumatic Coma Data Bank is a pilot effort.
During the three-year pilot, each Data Bank
Center will collect and enter data on a minimum
of fifty patients annually. At the end of the
pilot, NINCDS will carry out a heuristic assess-
ment of the data bank according to the following
goal s:
a. Ability of diverse institutions to partici-
pate, collaborate, and benefit from a
computer data bank network.
b. Ability to collect data of high quality in
the data bank.
c. Preliminary utility of data for (1) deter-
mining new research leads and (2) patient
management.
d. Ability to provide guidelines and protocols
for expansion to additional centers and
other neurologic disorders, if appropriate.
In addition, the biostatisticians involved in the
pilot program will examine the consistency of
the relationships among variables across the clin-
ical centers in order to determine the appropri-
ateness of aggregating the data for research
studies.
The computer system aspects of the data bank are
also being assessed under an independent contract
which will eventually outline specifications for
an optimal clinical data bank system.
Long Range Goals
If the pilot data bank is successful, a full-phase
clinical data bank will be supported so that the
long range goals of the data bank may be realized.
1337
Long range goals include evaluation of the con-
tribution and effectiveness of the clinical data
banks with respect to improvements in patient
care, research, and teaching; a determination of
whether the clinical data banks can provide ex-
perienced-based computer consultation; evaluation
of the overall costeffectiveness of the network;
determination of whether a significant part of
the data bank system's cost can be defrayed by
providing reports required by various components
of the patient care system.
The computer system used for the Traumatic Coma
Data Bank can, and most likely will, be utilized
to collect and retrieve the data for clinical ex-
periments such as clinical trials. The clinical
trial involves the standardization and randomiza-
tion of the treatment regimens among the study
patients. A long term goal of the data bank
program is to incorporate clinical trials when
the efficacy of a specific treatment or therapy
is under question and the requirements for ran-
domization and protocol can be met.
Another long term goal is to determine the use-
fulness of the clinical data bank in the develop-
ment and application of prognostic information.
The usefulness of data bank prognostic information
will depend upon the completeness and validity
of the data as well as on the ability to develop
rules in using the data.
CONCLUSION
Carefully collected data on the clinical history
of head trauma and other neurologic disorders,
in general, is a scarce commodity. The clinical
data bank can provide descriptive information
concerning disease stages, and associations
between symptoms, intervention, and outcome.
Through observational studies, the Traumatic Coma
Data Bank may provide leads for clinical experi-
mentation and has the potential for supporting
clinical trials.
The computer aspect of the Traumatic Coma Data
Bank, while based upon existing technology, is
innovative. The system integrates a modified
version of a clinical data base management system
with a software package for the Datapoint 1800
in order to edit, store, and access data in
dispersed geographic areas and aid in providing
patient records, discharge notes, and other
administrative aids to patient care.
The development of a uniform vocabulary used by
several centers is a beneficial product of the
data bank program. Several other neurosurgical
centers have requested the data collection forms
and operations manuals for use in their centers.
Recent articles17'18 have stated that research
in chronic disease can benefit greatly from the
technology of data base systems. In order to be
useful for clinical research, however, a clinical
data bank requires an appropriate data base
technology integrated with the requirements of
research methodology and the needs of the clinical
environment. It is hoped that the current data
1338
bank developments will add a new and much needed
dimension to the clinical research of not only
traumatic coma but to other neurological
disorders as well.
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