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OCR for page 1
Executive Summary
On August 2, 1990, Iraq invaded the independent nation of Kuwait and the
Persian Gulf War began. Within 5 days the United States began to deploy
troops, the number of which would ultimately reach almost 700,000, in
Operation Desert Shield. Intense air attacks against Iraqi forces began on
January 16, 1991 (Operation Desert Stonn), and a ground attack was launched
on February 24, 1991. Within 4 days Iraqi resistance crumbled. Following the
fighting the number of U.S. troops in the area began to decline, and by June
1991 fewer then 50,000 U.S. troops remained.
Most troops returned home and resumed their normal activities. However,
a number of those who had been deployed to the Persian Gulf began to report
health problems that they believed were connected to their deployment. These
problems included the symptoms of fatigue, memory loss, severe headaches,
muscle and joint pain, and rashes.
In 1992 the Department of Veterans Affairs (VA) developed a Persian Gulf
Registry to assist in addressing questions about the health concerns of Persian
Gulf veterans. Queries about exposures, particularly those associated with oil
well fires, were included as part of the history taking. With continuing concern
about the potential health consequences of service in the Persian Gulf, the
Department of Defense (DoD) and VA met in 1994, revised the clinical
program, and implemented this revised approach to diagnose veterans' health
complaints, called the Comprehensive Clinical Evaluation Program (CCEP) by
OCR for page 2
2
ADEQUACY OF THE VA PERSL4N GULFREGISTRY AND UCAP
DoD and the Persian Gulf Registry and Uniform Case Assessment Protocol
(UCAP) by VA.
The Persian Gulf Registry is a basic initial examination aimed at diagnosing
veterans' health problems. If a veteran's complaint cannot be diagnosed
through the Registry examination, he or she is referred to UCAP for specialty
consultation and testing.
The President's Advisory Committee, the General Accounting Office, and
the Office of Technology Assessment have evaluated these programs and have
made recommendations on the basis of their reviews. In addition, the Institute
of Medicine (IOM) has conducted assessments of and made recommendations
regarding CCEP.
In September 1996 VA asked IOM to evaluate the adequacy of the UCAP
and its implementation with specific emphasis on (1) the protocol, (2) its
implementation and administration, (3) outreach efforts to inform veterans of
available services, and (4) education of providers. A committee of experts met;
heard presentations from many groups and individuals including VA, the
President's Advisory Committee, the General Accounting Office, the American
Legion, and the Disabled American Veterans; conducted site visits of VA health
care facilities; and solicited written testimony from VA health care facilities and
veterans service organizations.
A great deal of time and a great deal of effort were expended by VA in
developing and implementing a diagnostic program for Persian Gulf veterans
that could be conducted in all VA facilities, from small rural primary care
facilities to large urban tertiary complexes. This effort was begun immediately
upon the cessation of hostilities and attempted to build on lessons learned from
past program efforts, for example, those directed toward Vietnam veterans'
health concerns. The initial program was implemented in 1992 and the revised
program was implemented in 1994, veterans were examined, and information
about their symptoms and conditions was collected.
The information that has emerged from the diagnostic program, from
research studies, and from the veterans themselves has helped indicate where
changes and improvements in the Registry and UCAP can be made. Change is
part of a natural evolutionary process in developing good screening instruments
for diagnosis. This is not to imply that the first efforts were inappropriate but,
rather, that time leads to new knowledge, which leads to the ability to improve.
Such is the case with the VA Persian Gulf protocol. Over time, information
has been obtained that can be used to help identify areas where change in the
protocol and its implementation will be of benefit. This report is intended to
assist VA in that effort to improve. As an operational system, the Persian Gulf
Registry arid UCAP have provided the opportunity for observation, evaluation,
and feedback aimed at improvement. That is what the committee has done-
observed, evaluated, and reported.
OCR for page 3
EXECUTIVE SUMMARY
3
The committee's first recommendations address the process for diagnosing
Persian Gulf veterans' health complaints. These are followed by recommenda-
tions regarding implementation and administration and the quality of services
rendered. Next come recommendations related to outreach efforts and provider
education. Broad recommendations appear in boldface type, with the subentries
indicating recommendations following from these broader recommendations.
FINDINGS AND RECOMMENDATIONS
Diagnostic Process
The diagnostic and referral process specified in VA Manual M-10 is laid out
as a two-stage protocol. The protocol specifies that if, after an initial history and
physical with minimal laboratory testing (Registry; Phase b, a diagnosis is not
made, the veteran is referred to the UCAP for specialist consultation and
additional testing (Phase II). The division of the diagnostic process into two
phases is, however, an artificial designation that does not accurately reflect the
way in which medicine is traditionally practiced.
The committee found that the diagnostic process followed in some facilities
does not adhere to the written protocol, rather it is more clinically based. For
example, it was found that Registry (Phase I) evaluations are supplemented in
some facilities by selected consultations and tests from He UCAP (Phase II).
Although this approach may be clinically more appropriate and should be
encouraged, it is not Be process specified by the current protocol. Such
deviation introduces the problem of inconsistency in evaluations across facilities
as well as variation in data recording and reporting. This failure, in turn, works
against achieving one of the purposes for which the system was developed, Hat
is, to identify previously unrecognized major diagnostic entities that could
provide an explanation for the symptoms commonly reported in Persian Gulf
veterans with unexplained illnesses (FA Manual M-10; see Chapter 3~.
The committee believes that He goal of implementing a uniform~approach
to the diagnosis of Persian Gulf veterans' health problems is admirable and
should be encouraged. To accomplish that goal, the committee makes several
recommendations.
1. The committee recommends that the diagnostic pathway, illustrated
in Figure 1, for the evaluation and referral of Persian Gulf veterans' health
problems be adopted and followed by providers in each VA facility.
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4
ADEQUACY OF THE VA PERSL4N GULFREGISTRY AND UCAP
No symptoms and
negative findings
| Primaly Care Provider I
1
Definable
disorder consistent
with symptoms
-
~=:
periodic evaluation ~
Definable Definable
disorder consistent disorder inconsistent
with symptoms with symptoms
1 1
-
_
Refer for treatment,
periodic evaluator
~ _ ,
Definable
disorder inconsistent Unexplained
with symptoms findings
-
Unexplained
symptom
~ r
f
SPECIALIST EVALUATION
1 1 1
| Unexplained
| findings
l
Unexplained
symptoms
. .
PROFESSIONAL DECISION
Refer for treatment, l
periodic reevaluation
required
1
1
Refer to special center
for further evaluation
FIGURE 1. Pathway for diagnosing health problems of Persian Gulf veterans in the VA
system.
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EXECUTIVE SUMMARY
s
The major differences between the current written protocol and the pathway
recommended by the committee are (1) the primary care provider is encouraged
to order additional tests and consultations beyond those specified in Phase I for
a patient, based on symptoms and complaints, without Me requirement of
initiating a Phase II evaluation, (2) patients should be referred to a designated
referral center only when the resources necessary to provide appropriate
evaluation of presenting complaints are unavailable at the originating facility,
and (3) there must be a defined approach to be used for patients who remain
undiagnosed or whose major symptoms have not been accounted for (for
example, periodic reevaluation, treatment, or referral to a referral center).
Adoption of the described pathway necessitates changes to specific
elements of the Registry and UCAP protocols.
l.a. Use of the pathway eliminates the need to designate phases of
evaluation; therefore, the distinction between Phase I and Phase II (with all
accompanying specifications for specialty examination and referral) should
be eliminated.
l.a.~1) The Persian Gulf Registry Code Sheet needs to be redesigned
to reflect the elimination of Phase I and Phase II from the protocol.
l.a.~2) The redesign should accommodate the need to aggregate data
from the original data collection system with that of the redesigned
system.
A minority of patients with persistent symptoms will not receive a
definitive diagnosis. Some of these patients could have disease processes that
cannot be diagnosed at present because of limitations in scientific understanding
and diagnostic testing. They may not benefit from further evaluation now but
may receive benefit from reassessment at a later date. This undiagnosed patient
cohort, some of whom are designated as having an "unexplained illness," will
contain a diversity of individuals who will require monitoring and periodic
reassessment.
l.b. VA should plan for and include periodic reevaluations of the
clinical needs ofthese undiagnosed patients.
The pathway specifies an initial evaluation by a primary care provider for
both the veteran presenting with complaints and those with no complaints. In
traditional medical practice, the comprehensive clinical evaluation of a patient
presenting to any physician includes a complete history, physical examination,
and laboratory tests. This should be no different for Persian Gulf veterans. The
committee believes, however, that VA should consider using an expanded set of
tests for the initial laboratory evaluation.
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6
ADEQUACYOF THE VA PERSIAN GULFREGISTRYAND UCAP
2. The committee recommends that both patients presenting with and
those presenting without complaints should receive an initial evaluation
which includes (1) a comprehensive history and physical as defined in the
American Medical Association publication Physicians' Current Procedural
Terminology (1998), (2) a very specific set of questions related to the Gulf
War setting, and (3) a standardized laboratory evaluation.
2.a. A national panel of experts should be convened to (1) review the
current set of Gulf War-related questions contained on the Persian Gulf
Registry Code Sheet to determine whether additions or deletions are
needed, (2) identify the set of standardized laboratory tests to be used in
the initial evaluation, and (3) conduct periodic reevaluations of the
usefulness of each element in the initial evaluation.
Specific Gulf War-related questions to which veterans are asked to respond
include the exposure questions contained on the Persian Gulf Registry Code
Sheet (see Appendix H). Given the importance placed by veterans and
clinicians on the potential contribution of exposures to health complaints of
Persian Gulf veterans, the committee decided to examine the exposure questions
in detail.
At some facilities the questionnaire portion of this Code Sheet is given to
the veteran to complete as a self-report form, whereas at other facilities this is
completed during an interview with the provider. The committee believes that
many of these questions are appropriate if administered by an interviewer but
are not optimal as a self-report. The information collected with this question-
naire is not intended to be used for research purposes. Rather, the purpose of
the questionnaire is to provide information to the clinician that might be used to
assist in the diagnosis of health problems. It is important, therefore, that the
patient understand what is being asked of him or her so as to provide the
clinician with accurate information.
In addition, the questions related to traumatic experiences may miss
important experiences that can affect physical and mental health and about
which the physician should know when conducting the patient's evaluation.
2.b. The section on traumatic experiences on the Persian Gulf Registry
Code Sheet (Question 19) should be expanded by the addition of (1)
specific questions inquiring about experiences not presently assessed that
have been reported by Persian Gulf veterans, and (2) an open-ended
questioners) that Clowns) the veteran to report idiosyncratic or particularly
distressing experiences that may play a role in the veteran's current health
status.
2.c. The questionnaire should be administered in an interview format. If
the information on environmental exposure, immunizations, and exposure
OCR for page 7
EXECUTIVE SUMAI4RY
7
to traumatic situations cannot be collected in an interview format, all yes
and don't know responses should be reviewed with the patient in a face-to-
face evaluation.
When the Registry and UCAP protocols were developed, they were
designed to be very broad and to capture as much information as possible about
potential health concerns that could affect Persian Gulf veterans. The
information collected through that system as well as the information obtained
from other providers and through scientific studies allows efforts to be more
appropriately focused on identifying and diagnosing Persian Gulf veterans'
health problems. One mechanism that can aid these efforts is the development
of clinical practice guidelines which are statements developed for the purpose of
assisting the provider and the patient in making decisions about appropriate
health care.
3. The committee recommends that VA, to the extent possible, use an
evidence-based approach to develop and continuously reevaluate clinical
practice guidelines for the most common presenting symptoms and the
difficult-to-diagnose, ill-defined, or medically unexplained conditions of
Persian Gulf veterans.
Because the Persian Gulf War was the first engagement in which women
formed such a large proportion of deployed troops (7%) and because potential
exposure of this group of women to stressors, reproductive system toxicants,
and other health hazards may produce disorders distinct from those seen in prior
conflicts, the committee believes that VA has a unique opportunity to examine
the health of women deployed under such conditions. Therefore, there should
be increased examination of and attention directed toward women's health
issues. The current Registry and UCAP do investigate infertility or subLertility.
However, evaluation of miscarriages, stillbirths, and congenital malformations
and the evaluation of genitourinary or other hormonally related diseases are
limited.
3.a. Clinical practice guidelines for the evaluation and management of
women's health issues should be developed.
A major principle in the development and use of clinical practice guidelines
is that there must be a mechanism that encourages feedback on the adequacy of
the guidelines and their ease of implementation.
3.b. VA should develop a formal mechanism that enables practitioners to
provide feedback on the practice guidelines and the diagnostic process
used in the VA clinical program for Persian Gulf veterans.
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8
ADEQUACY OF THE VA PERSIAN GULFREGISTRY AND UCAP
Implementation and Administration
The committee focused its examination of the implementation and
administration of the Registry and UCAP on four elements that it believes are of
prime importance to the adequate functioning of the program. These four areas
are (1) referral for specialty consultation both within and across facilities, (2)
quality of services provided, (3) patient satisfaction, and (4) data collection and
reporting.
Referrals
The committee found that problems often exist with referrals for specialty
consultations. Within facilities, consultant practices are often booked weeks in
advance resulting in long delays for specialty services. The referral specialist is
frequently unaware that the referred patient is a Persian Gulf veteran, and the
specialist may have little experience with the special needs and concerns of this
group of patients. In addition, veterans undergoing this tertiary level of
evaluation frequently have unrealistic expectations about the process and the
outcome of their visit. One approach to addressing this problem is the use of
clinical pathways which are clinical management tools that organize, sequence,
and specify the timing of the major patient care activities and interventions of
the entire interdisciplinary team for a particular diagnosis, procedure, or process.
4. The committee recommends that the process and procedures for
referral be modified.
4.a. In those facilities where specialist consultations are provided, certain
individuals within each specialty should be designated as the one~s) who
will provide the consultative services to Persian Gulf veterans.
4.b. Clinical pathways should be developed to specify the events and
processes involved in referrals for specialty consultation.
4.c. In the case of an inpatient evaluation, a site-specific clinical pathway
should be used to facilitate the timely and efficient evaluation of patients.
4.d. The diagnostic pathway should specify that a patient be referred to
another facility for evaluation only when the resources necessary to
provide appropriate evaluation of the patient's presenting complaints are
unavailable at the originating facility.
4.e. VA should develop a transfer protocol that specifies procedures for
initial contact and scheduling as well as the materials and processes
necessary for a transfer, for example, a full copy of the veteran's record to
date including all laboratory tests and consultations, the differential
diagnosis, and a procedure for the transfer of records from the tertiary
OCR for page 9
EXECUTIVE SUMMARY
9
institution to the originating provider upon completion of the diagnostic
workup.
Quality
There is a great deal of interest in and concern about the quality of care that
Persian Gulf veterans are receiving in VA facilities. Although the VA has
developed procedures for what it terms the Quality Management/Assessment
Monitor (see Appendix K), this information is not adequate to evaluate the
quality of care provided to Persian Gulf veterans. The committee believes that,
overall, the clinicians involved in the VA Persian Gulf Registry and UCAP
examinations are practicing medicine according to acceptable standards but
there does not appear to be, across facilities, a systematic approach to
documenting the quality of care provided or to identifying areas where
improvement is needed.
Traditional quality improvement programs examined the structure within
which care is provided, the process for providing care, or the outcomes of care
in an attempt to identify the outliers or "bad apples." More recent approaches
focus on performance improvement and are aimed at involving practitioners in
the use of nonpunitive efforts that result in more effective changes and
improvements to the system than was the case with approaches aimed at
identifying practitioners with deficiencies.
The development and use of clinical practice guidelines, as recommended
earlier, can be an important tool in a program for continuous quality
improvement. Additionally, the participation of a multidisciplinary group of
providers in the development of such guidelines increases the likelihood that
needed changes will be more readily accepted.
5. The committee recommends that VA should establish an evaluation
feedback mechanism that includes the elements of a performance
improvement system.
Patient Satisfaction
The VA has implemented a well-developed and structured approach for
assessing general patient satisfaction with VA care. However, there is no
system in place specifically addressing the substantial number of issues and
concerns specific and relevant to Persian Gulf veterans, or the special Persian
Gulf diagnostic program.
6. The committee recommends that VA design and implement a brief
yet comprehensive questionnaire to survey patient satisfaction with the
special program for Persian Gulf veterans.
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10
Data Collection and Reporting
ADEQUACY OF THE VA PERSIAN GULF REGISTRYAND UCAP
An adequate and accurate data collection and reporting system is crucial to
the understanding of Persian Gulf veterans' health problems. Such a system is
needed to understand the extent of services provided, to contribute to
assessments of the quality of services, to examine overall patterns in health
status, and to contribute ideas for potential research studies that could be
conducted on the health problems of Persian Gulf veterans. These data are not
appropriate, however, for the conduct of scientific research.
Data collection foes need to be standardized and easily computerized.
Those completing the forms should be doing so in a consistent manner from
facility to facility. The committee found variation across sites in the diagnostic
categories that practitioners used to identify their patients' health problems; for
example, some practitioners use Chronic Fatigue Syndrome as a diagnosis and
some do not. Additionally, the methods used to determine primary versus
secondary diagnoses also appear to vary. Such variation has implications for the
consistency and accuracy of data collection and reporting.
7. The committee recommends that VA facilitate the consistency of
data reporting in the following ways.
7.a. There should be agreement nationally, within VA, on the definition
and use of specific diagnostic categories.
7.b. Clear decision rules for determining and recording the primary
diagnosis should be developed.
The committee also found that there was no opportunity for updating the
database information gathered for each patient, even though a patient's
condition can change in ways that are important for the analysis of information
collected.
8. The committee recommends that there be established a mechanism
by which individual patient information can be updated and incorporated
in the database in a systematic fashion.
Outreach
The committee commends VA for Me extensive effort it has put forth to
inform Persian Gulf veterans of the services available to them. In only two
areas has the committee identified needs.
OCR for page 11
EXECUTIVE SUMAL4RY
11
9. The committee recommends that VA develop informational pam-
phlets for veterans. These pamphlets could be placed in facility treatment
areas and could address common concerns such as the purpose and process
of the VA Persian Gulf program, health effects of low-level exposure to
chemical warfare agents, research activities related to Persian Gulf
veterans and their results to date, and so forth.
When first entering a VA health care facility to receive services, all
veterans complete an intake form that requests infonnation about their service in
the military. This presents an opportunity for the identification of Persian Gulf
veterans who may not yet have participated in the special VA program for
Persian Gulf veterans but who may wish to do so.
10. The committee recommends that VA consider redesigning intake
forms so that the veteran is asked to identify whether or not she or he was
deployed to the Persian Gulf War (or any other specific engagement).
Provider Education
VA has designed a number of high-quality programs to educate its
designated Persian Gulf providers. These programs would be more effective if
they reached a broader audience.
11. The committee recommends that primary care providers, in
addition to the Registry practitioners, as well as the specialists who see
Persian Gulf veterans, be provided the opportunity and encouraged to
participate in the educational programs.
1 l.a. The audience for whom existing educational activities are developed
related to providing health care for Persian Gulf veterans should be
expanded to include other providers involved in the evaluation process, for
example, designated specialty consultants.
1 l.b. VA should consider the following options for educating its
providers: periodic team conferences (perhaps quarterly) to be held with
all designated providers (including specialists) to discuss activities and
findings and to provide updates on Persian Gulf issues and concerns, and
the development of site-specific clinical pathways by designated specialists
and Registry providers.
Although reproductive issues have been addressed in VA educational
efforts, other women's health issues have been less thoroughly explored.
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12
ADEQUACYOF THE VA PERSIAN GULFREGISTRY AND UCAP
ll.c. Future educational efforts should place greater emphasis on
women's health concerns.
ll.d. VA should provide resources to establish a repository for
accumulated knowledge of, expertise in, and experience win the health
issues and problems of Persian Gulf veterans. Specialists who possess
such expertise should be identified and available for consultation by
telephone e-mail or telemedicine connections with local providers in all
VA facilities.
TABLE 1. Summary of Recommendations
Topic Recommendation
. .
Diagnostic Process 1. A national diagnostic pathway for evaluation of
Persian Gulf veterans' health problems should be
adopted.
l.a. The distinction between Phase I and Phase II
should be eliminated.
l.a(1~. The Persian Gulf Registry Code
Sheet needs to be redesigned to reflect the
elimination of Phase I and Phase II.
l.a.~2) Provision should be made for the
aggregation of data from both the original
arid the revised systems.
l.b. There should be a pearl for periodic
reevaluation of patients without a diagnosis.
2. All patients entering the special VA program for
Persian Gulf veterans should receive an expanded
initial evaluation.
2.a. A national panel of experts should be con
vened to determine the specific questions arid tests
to be included in this expanded evaluation.
2.b. The section on exposures should be
expanded to include additional questions about
traumatic experiences.
2.c. The questionnaire should be administered in
art interview format, but at a minimum, all yes and
don't know responses should be reviewed with the
patient.
3. Clinical practice guidelines should be developed
for the most common presenting symptoms and the
difficult-to-diagnose, ill-defined, or medically unex
plained conditions.
Continued
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EXECUTIVE SUMMARY
TABLE 1 Continued
-
Topic Recommendation
13
-
Diagnostic Process 3.a. Clinical practice guidelines for the investi
(cont'd.) gation of women's health issues should be
developed.
3.b. A formal mechanism that enables
practitioners to provide feedback on the practice
guidelines and their implementation should be
developed.
Referral 4. The committee recommends that the process and
procedures for referral be modified.
4.a. Within facilities providing specialty
consultation, certain individuals within each
specialty should be designated to provide
consultative services to Persian Gulf veterans.
4.b. Clinical pathways should be developed to
specify the events and processes involved in
referrals for specialty consultation.
4.c. If an inpatient evaluation is conducted, a site
specif~c clinical pathway should be used to
facilitate timely arid efficient evaluation.
4.d. Patients should be referred to another facility
for evaluation only when the necessary resources
are unavailable at the originating facility.
4.e. A transfer protocol should be developed to
facilitate referral to another facility.
5. VA should establish an evaluation feedback
mechanism that includes the elements of a
performance improvement system.
6. VA should design and implement a brief yet
comprehensive questionnaire to survey patient
satisfaction with the special program for Persian
Gulf veterans.
Quality
Patient Satisfaction
Data
7. VA should facilitate the consistency of data
reporting in the following ways:
a. There should be agreement nationally, within
VA, on the definition and use of specific
diagnostic categories.
b. Decision rules for determining arid recording
the primal and the secondary diagnoses should
be developed
8. A mechanism to allow updating of individual
patient information should be developed.
Continued
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14
ADEQUACYOF THE VA PERSIAN GULFREGISTRYAND UCAP
TABLE 1 Continued
Topic Recommendation
Outreach 9. VA should develop for veterans informational
pamphlets that address their concerns.
10. Intake forms should be redesigned to more
easily identify the war or conflict in which veterans
served.
11. Primary care providers, in addition to the
Registry practitioners, as well as the specialists who
see Persian Gulf veterans, should be provided the
opportunity and encouraged to participate in the
educational programs.
ll.a. The audience for whom existing Persian
Gulf educational activities are developed should
be expanded to include other providers involved
in the evaluation process.
ll.b. VA should consider as educational
activities team conferences that include spe
cialists and should consider development of site
specif~c clinical pathways.
ll.c. Future efforts should place greater
emphasis on women's health concerns.
1 l.d. Resources should be provided to establish
a repository for accumulated knowledge, exper
tise, and experience in Persian Gulf health issues
alla problems.
Education
SUMMARY
Change is inevitable and as such, it is important to plan for that change on
the basis of new information and techniques that have emerged from past
experiences. The committee believes that the changes recommended in this
report build on the strengths and lessons learned through research, the
implementation of the Registry and UCAP, and advances made in the field of
clinical practice evaluation. It is with the intent to assist VA with better serving
Persian Gulf veterans as well as facilitating the practice of VA practitioners that
these recommendations are offered.
The committee believes that the recommendations contained in this report
will clarify areas of confusion and engage VA practitioners in efforts to design
practice guidelines and pathways that will result in the rendering of better, more
timely diagnostic services to Persian Gulf veterans. The committee urges VA to
make the implementation of these recommendations a priority.
Representative terms from entire chapter:
gulf veterans
