VA Health Care
Progress and Challenges in Conducting the National Vietnam Veterans Longitudinal Study Gao ID: GAO-10-658T May 5, 2010This testimony discusses the National Vietnam Veterans Longitudinal Study (NVVLS). According to the Department of Veterans Affairs (VA), experts estimate that up to 30 percent of Vietnam veterans have experienced post-traumatic stress disorder (PTSD), an anxiety disorder that can occur after a person is exposed to a life-threatening event. Veterans suffering from PTSD may experience problems sleeping, maintaining relationships, and returning to their previous civilian lives. Additionally, studies have shown that many veterans suffering from PTSD are more likely to be diagnosed with cardiovascular disease and other diseases. After the Vietnam War, Congress wanted information about the psychological effects of the war on Vietnam veterans to inform the need for PTSD services at VA. Consequently, in 1983, Congress mandated that VA provide for the conduct of a study on PTSD and related postwar psychological problems among Vietnam veterans. VA contracted with an external entity, the Research Triangle Institute, to conduct the National Vietnam Veterans Readjustment Study (NVVRS). According to VA, the NVVRS was a landmark study and is the only nationally representative study of PTSD in Vietnam veterans. PTSD is an ongoing concern for Vietnam veterans, and today, Vietnam-era veterans still constitute the largest group of veterans receiving VA care for PTSD. Congress and others have been concerned about the continued prevalence of PTSD and VA's capacity to meet the needs of Vietnam veterans. In section 212 of the Veterans Benefits and Health Care Improvement Act of 2000, Congress required that VA contract with an appropriate entity to conduct a follow-up study to the NVVRS. The law specifies certain requirements that the follow-up study must meet, including that the study must use the database and sample of the NVVRS and be designed to yield information on the long-term effects of PTSD and whether particular subgroups were at greater risk of chronic or more severe problems with PTSD. In 2001, VA awarded another contract to the Research Triangle Institute to plan and conduct a follow-up study, the NVVLS. However, in 2003, before data collection for the study began, VA terminated the contract and the study was not completed. In September 2009, the Secretary of Veterans Affairs announced that the agency planned to award a new contract to an external entity to conduct the NVVLS.
We found that since September 2009, VA has taken a number of steps toward conducting the NVVLS. VA convened a project team for the NVVLS consisting of VA officials and PTSD experts both within VA and outside of VA. According to VA officials, the NVVLS project team developed a performance work statement, which outlines VA's requirements for the contractor selected to conduct the NVVLS. VA expects to select a contractor for the NVVLS in the summer of 2010 and for the NVVLS to be completed in 2013. VA officials stated that they plan for the NVVLS to meet all of the requirements of the law where scientifically feasible. In addition, VA is conducting studies of PTSD in male twin Vietnam-era veterans and female Vietnam-era veterans, and VA officials maintain that these studies will also provide useful information in response to the law. VA reported that it faces several challenges in restarting the NVVLS. However, in several instances, the researchers and methodologists we interviewed offered suggestions for how these challenges could be addressed. The challenges reported by VA included the following: (1) Locating and gaining consent from NVVLS participants, (2) Mitigating possible bias in a follow-up study, and (3) Assessing PTSD in the NVVLS. Overall, VA officials do not know whether, given the challenges they face, the NVVLS can be completed. VA's NVVLS draft performance work statement includes an initial phase during which VA expects the contractor to assess the feasibility of the study. All 10 researchers we interviewed said that restarting the study soon is important because as the study participants continue to age, an increasing number will be lost for follow-up because of illness or death. Nine of the researchers told us that they believe it is important for VA to complete the NVVLS because it will potentially provide important, nationally representative information on PTSD and related issues in Vietnam-era veterans. In responding to a draft of the report from which this testimony is based, VA explained its position on the ownership of the NVVRS and NVVLS study data. VA stated that the NVVRS contract provided that the study data was the property of the agency and did not provide that the identifying information be kept from VA. The agency also stated that the NVVRS consent documents did not restrict VA from possessing the identifying information of participants. VA confirmed that the agency intends to receive all the NVVLS study data, including participants' identifying information, upon completion of the study, and stated that the NVVLS consent form will explain to participants that VA does not intend to use the data to determine eligibility for VA benefits.
GAO-10-658T, VA Health Care: Progress and Challenges in Conducting the National Vietnam Veterans Longtitudinal Study
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Testimony:
Before the Committee on Veterans' Affairs, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 10:00 a.m. EDT:
Wednesday, May 5, 2010:
VA Health Care:
Progress and Challenges in Conducting the National Vietnam Veterans
Longitudinal Study:
Statement of Randall B. Williamson:
Director, Health Care:
GAO-10-658T:
[End of section]
Mr. Chairman and Members of the Committee:
I am pleased to be here today as you discuss the National Vietnam
Veterans Longitudinal Study (NVVLS). According to the Department of
Veterans Affairs (VA), experts estimate that up to 30 percent of
Vietnam veterans have experienced post-traumatic stress disorder
(PTSD), an anxiety disorder that can occur after a person is exposed
to a life-threatening event.[Footnote 1] Veterans suffering from PTSD
may experience problems sleeping, maintaining relationships, and
returning to their previous civilian lives.[Footnote 2] Additionally,
studies have shown that many veterans suffering from PTSD are more
likely to be diagnosed with cardiovascular disease and other diseases.
After the Vietnam War, Congress wanted information about the
psychological effects of the war on Vietnam veterans to inform the
need for PTSD services at VA. Consequently, in 1983, Congress mandated
that VA provide for the conduct of a study on PTSD and related postwar
psychological problems among Vietnam veterans.[Footnote 3] VA
contracted with an external entity, the Research Triangle Institute,
to conduct the National Vietnam Veterans Readjustment Study (NVVRS).
[Footnote 4] According to VA, the NVVRS was a landmark study and is
the only nationally representative study of PTSD in Vietnam veterans.
PTSD is an ongoing concern for Vietnam veterans, and today, Vietnam-
era veterans still constitute the largest group of veterans receiving
VA care for PTSD.[Footnote 5] Congress and others have been concerned
about the continued prevalence of PTSD and VA's capacity to meet the
needs of Vietnam veterans. In section 212 of the Veterans Benefits and
Health Care Improvement Act of 2000, Congress required that VA
contract with an appropriate entity to conduct a follow-up study to
the NVVRS.[Footnote 6] The law specifies certain requirements that the
follow-up study must meet, including that the study must use the
database and sample of the NVVRS and be designed to yield information
on the long-term effects of PTSD and whether particular subgroups were
at greater risk of chronic or more severe problems with PTSD. In 2001,
VA awarded another contract to the Research Triangle Institute to plan
and conduct a follow-up study, the NVVLS.[Footnote 7] However, in
2003, before data collection for the study began, VA terminated the
contract and the study was not completed.[Footnote 8] In September
2009, the Secretary of Veterans Affairs announced that the agency
planned to award a new contract to an external entity to conduct the
NVVLS.
My testimony is based on our May 2010 report,[Footnote 9] which is
being released today, and discusses two issues related to VA's current
efforts to address the law: (1) the recent progress VA has made in
conducting the NVVLS and (2) the challenges VA faces in its plans to
conduct the NVVLS.
To obtain information about VA's progress in conducting the NVVLS and
its challenges, we interviewed VA officials responsible for managing
VA's PTSD research, including officials on the project team
responsible for restarting the NVVLS.[Footnote 10] We also interviewed
VA officials who are conducting VA's studies of PTSD in male twin
Vietnam-era veterans and female Vietnam-era veterans. In addition, we
obtained and reviewed relevant documents regarding VA's PTSD research
studies, including a draft performance work statement[Footnote 11] and
progress report for the NVVLS, study protocols for the studies on male
twin Vietnam-era veterans and female Vietnam-era veterans,[Footnote
12] and other documents related to the study methodologies. In order
to understand how the NVVLS will be conducted, we also obtained and
reviewed information about the NVVRS and the 2001 NVVLS attempt.
To provide context for the information we obtained from VA,
particularly about VA's reported challenges in conducting the NVVLS,
we interviewed 10 researchers who are currently involved in or have
previously been involved in managing or conducting PTSD research.
[Footnote 13] The criteria we used to select the researchers we
interviewed included expertise in PTSD, as indicated, for example, by
service on national committees focused on veterans and PTSD, and
knowledge of or involvement with the NVVRS, the 2001 NVVLS attempt, or
the NVVLS. We chose these researchers to represent a range of
perspectives on the studies we examined: for example, we interviewed
both researchers who are currently employed by VA and researchers who
are not employed by VA. To obtain additional perspectives on study
design techniques and feasibility issues, we also interviewed three
Department of Health and Human Services methodologists: two from its
Agency for Healthcare Research and Quality and one from its Centers
for Disease Control and Prevention.[Footnote 14]
We conducted this performance audit from October 2009 through April
2010 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
In summary, we found that since September 2009, VA has taken a number
of steps toward conducting the NVVLS. VA convened a project team for
the NVVLS consisting of VA officials and PTSD experts both within VA
and outside of VA. According to VA officials, the NVVLS project team
developed a performance work statement, which outlines VA's
requirements for the contractor selected to conduct the NVVLS.
[Footnote 15] VA expects to select a contractor for the NVVLS in the
summer of 2010 and for the NVVLS to be completed in 2013. VA officials
stated that they plan for the NVVLS to meet all of the requirements of
the law where scientifically feasible. In addition, VA is conducting
studies of PTSD in male twin Vietnam-era veterans[Footnote 16] and
female Vietnam-era veterans,[Footnote 17] and VA officials maintain
that these studies will also provide useful information in response to
the law.
VA reported that it faces several challenges in restarting the NVVLS.
However, in several instances, the researchers and methodologists we
interviewed offered suggestions for how these challenges could be
addressed. The challenges reported by VA included the following:
* Locating and gaining consent from NVVLS participants. VA officials
stated that they did not know how many of the NVVRS participants can
be located and would agree to participate in the NVVLS, which could
impact the feasibility of the study. While 6 of the 10 researchers and
the 3 methodologists we interviewed agreed that it could be
challenging to locate the original participants, 9 of the researchers
offered suggestions for overcoming this challenge, such as using the
data sources and methods from previous successful efforts to reconnect
with study participants and taking advantage of current technology.
[Footnote 18] All 10 researchers and 3 methodologists stated that to
encourage participation, it was important for NVVLS participants to
receive assurances of confidentiality--that is, assurances regarding
use of their identifying information, as was done with the NVVRS
participants.[Footnote 19] According to VA's draft performance work
statement for the NVVLS, the NVVLS consent form will not contain these
assurances of confidentiality but it will state that study
participation will not affect participants' VA benefits or VA health
care. However, the draft performance work statement also states that
the agency plans to take possession of study participants' identifying
data at the conclusion of the NVVLS. While nine of the researchers
commented that this requirement could impact whether veterans would
agree to participate in the NVVLS, VA stated that it conducts many
internal research studies and has no material issues recruiting study
participants due to mistrust of VA.
* Mitigating possible bias in a follow-up study. VA officials said
that there could be bias in the NVVLS because the NVVRS was not
designed to accommodate a follow-up study. The three methodologists we
interviewed stated that this challenge was closely related to the
challenges of locating the original participants and obtaining their
agreement to participate in the study--that is, bias will be present
in the NVVLS if representative participation across the subgroups
included in the NVVRS is not achieved.[Footnote 20] The methodologists
stated that if bias in the NVVLS is a concern, VA could survey
additional individuals from the general Vietnam-era population to
supplement the original NVVRS cohort or develop a new sample of
participants from the general Vietnam-era population for the NVVLS.
VA's draft NVVLS performance work statement states that the contractor
can choose to examine all or some of the NVVRS participants, but does
not address the question of whether the contractor could propose to
survey other Vietnam-era veterans.
* Assessing PTSD in the NVVLS. VA officials were concerned about
appropriately assessing PTSD in the NVVLS. Because there was no widely
accepted PTSD screening method at the time the NVVRS was conducted,
the study's estimates of PTSD prevalence were based on a multimeasure
approach involving the use of 10 PTSD assessment instruments
administered to a subset of NVVRS participants by doctoral-level
mental health professionals. VA officials stated that this complex
approach has not been used in other PTSD studies and would not be
desirable to replicate. Nine of the 10 researchers we interviewed
stated that the multimeasure method used to identify PTSD in the
original study was not of concern.[Footnote 21] In order to provide
comparable longitudinal data, 9 of the researchers and 2 of the
methodologists we interviewed recommended that the NVVLS contractor
use PTSD assessment instruments similar or identical to those used in
the NVVRS in addition to more current approaches.[Footnote 22]
According to the NVVLS draft performance work statement, the PTSD
instruments used in the NVVRS should be used in the NVVLS, when
appropriate, to enhance consistency and facilitate long-term analyses.
The draft performance work statement also recommends that newer
measures should be included when possible.
Overall, VA officials do not know whether, given the challenges they
face, the NVVLS can be completed. VA's NVVLS draft performance work
statement includes an initial phase during which VA expects the
contractor to assess the feasibility of the study. All 10 researchers
we interviewed said that restarting the study soon is important
because as the study participants continue to age, an increasing
number will be lost for follow-up because of illness or death.
[Footnote 23] Nine of the researchers told us that they believe it is
important for VA to complete the NVVLS because it will potentially
provide important, nationally representative information on PTSD and
related issues in Vietnam-era veterans.
In responding to a draft of the report from which this testimony is
based, VA explained its position on the ownership of the NVVRS and
NVVLS study data. VA stated that the NVVRS contract provided that the
study data was the property of the agency and did not provide that the
identifying information be kept from VA. The agency also stated that
the NVVRS consent documents did not restrict VA from possessing the
identifying information of participants. VA confirmed that the agency
intends to receive all the NVVLS study data, including participants'
identifying information, upon completion of the study, and stated that
the NVVLS consent form will explain to participants that VA does not
intend to use the data to determine eligibility for VA benefits.
Mr. Chairman, this concludes my statement. I would be pleased to
respond to any questions you or other members of the committee may
have.
Contacts and Acknowledgments:
For further information about this testimony, please contact Randall
B. Williamson at (202) 512-7114 or williamsonr@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this testimony. Individuals who made key
contributions to this testimony include Mary Ann Curran, Assistant
Director; Susannah Bloch; Stella Chiang; Martha R. W. Kelly; Lisa
Motley; Rebecca Rust; and Suzanne Worth.
[End of section]
Footnotes:
[1] Unless otherwise noted, Vietnam veterans refers to those who
served in Vietnam during the Vietnam era, from February 28, 1961,
through May 7, 1975. See 38 U.S.C. § 101(29). Estimates for Vietnam
veterans who have experienced PTSD vary. For example, according to the
Centers for Disease Control and Prevention's 1989 Vietnam Experience
Study, about 15 percent of Vietnam veterans have experienced PTSD.
American Psychiatric Association, Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision (Washington, D.C.,
2000).
[2] Those diagnosed with PTSD may also suffer from other ailments,
such as depression and substance abuse.
[3] Veterans' Health Care Amendments of 1983, Pub. L. No. 98-160, §
102, 97 Stat. 993, 994-95. This law defined Vietnam veterans as those
who served in Vietnam or elsewhere in the Vietnam theater of
operations from August 5, 1964, through May 7, 1975, the Vietnam era.
See 38 U.S.C. § 101(29) (1982).
[4] Other collaborators, such as Louis Harris and Associates, Inc.,
and The Graduate Center of the City University of New York, were also
involved in conducting the NVVRS.
[5] When we use "Vietnam-era veteran" in this testimony, we are using
the current governing definition: from February 28, 1961, through May
7, 1975, for veterans who served in Vietnam, and from August 5, 1964,
through May 7, 1975, for veterans who served in any other location.
See 38 U.S.C. § 101(29).
[6] Pub. L. No. 106-419, § 212, 114 Stat. 1822, 1843-44. Throughout
this testimony, we refer to section 212 as the law.
[7] A longitudinal study approach involves the repeated examination of
a set of study participants over time.
[8] In this testimony, we use "2001 NVVLS attempt" to refer to the
efforts that began in 2001 to complete the NVVLS. After the contract
was terminated, VA's Office of Inspector General investigated the 2001
NVVLS attempt. The resulting 2005 report found that VA did not
properly plan or administer the study contract. It recommended that VA
use appropriate contracting processes to complete the mandated follow-
up study. See Department of Veterans Affairs, Office of Inspector
General, Audit of VA Acquisition Practices for the National Vietnam
Veterans Longitudinal Study (2005).
[9] GAO, VA Health Care: Status of VA's Approach in Conducting the
National Vietnam Veterans Longitudinal Study, [hyperlink,
http://www.gao.gov/products/GAO-10-578R] (Washington, D.C.: May 5,
2010).
[10] The NVVLS project team is composed of 14 individuals, including 7
VA officials who are handling various aspects of the study, 3 VA
representatives who are subject matter experts, 2 non-VA
representatives who are subject matter experts, and 2 facilitators.
[11] A performance work statement, also known as a statement of work,
is a description of the work the government expects the contractor to
perform.
[12] A study protocol is a document that describes the formal design
of a research study.
[13] We contacted a total of 13 researchers, but 3 researchers
declined to speak with us. Two of them felt unable to provide specific
comments on our issues, and the third stated that he did not have time
to speak with us.
[14] In addition, we interviewed representatives of two veteran
service organizations, the Vietnam Veterans of America and Disabled
American Veterans, in order to obtain their perspectives on the
concerns and needs of veterans with PTSD. We also contacted
representatives from the American Legion.
[15] We reviewed a draft version of this performance work statement.
[16] This study, officially titled "A Twin Study of the Course and
Consequences of PTSD in Vietnam Era Veterans," began in 2006 and is
projected to finish in 2013. The objectives of the study are (1) to
estimate the longitudinal course and current prevalence of PTSD; (2)
to identify the relationships between the longitudinal course of PTSD
and veterans' current mental and physical health conditions, such as
cardiovascular disease, diabetes, depression, and substance use
disorders; and (3) to identify the relationships between PTSD and
veterans' current functional status and disability. VA estimates that
5,306 men will participate in the study. This study defines the
Vietnam era as 1965 through 1975.
[17] This study, officially titled "Long Term Health Outcomes of
Women's Service During the Vietnam Era," began in 2008 and is
projected to conclude in 2014. The study will examine the following
issues in Vietnam-era female veterans: (1) the prevalence of lifetime
and current psychiatric conditions, including PTSD; (2) physical
health; and (3) the level of current disability. According to VA,
approximately 7,000 women will participate in the study. This study
defines the Vietnam era as July 4, 1965, through March 28, 1973.
[18] The one researcher who did not offer a suggestion stated that VA
may not be able to overcome the challenge.
[19] The NVVRS provided participants with assurances of
confidentiality via the NVVRS consent form, which stated that their
identifying information would not be disclosed in any government
proceedings.
[20] The NVVRS was required by law to provide information on certain
subgroups, specifically veterans with service-connected disabilities,
female veterans, and minorities.
[21] One researcher thought the method used to identify PTSD in the
NVVRS was of concern because the PTSD assessment instruments used in
the method lacked validity. However, this researcher acknowledged that
these instruments may have been the best available at the time.
[22] One researcher said that this approach would not necessarily be
recommended because it may burden the participants and reduce
participation rates.
[23] The youngest Vietnam-era veterans still living today would be
approximately in their early 50s. During the 2001 NVVLS attempt, the
researchers estimated that 8.5 percent of the Vietnam-era veterans who
originally participated had died.
[End of section]
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