Treatment of Posttraumatic Stress Disorder An Assessment of the Evidence (2008) / Chapter Skim
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5 Issues in PTSD Treatment Research
5 Issues in PTSD Treatment Research
Pages 137-158
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From page 137... ...
ISSUES IDENTIFIED IN REVIEWING THE EVIDENCE In its review of the PTSD treatment literature, a number of common themes and important questions emerged. These include: methodological problems, especially attrition and subsequent handling of missing data; funding of pharmacotherapy studies by pharmaceutical companies, raising concern about publication bias and investigator independence; applicability of the PTSD treatment outcome studies in civilian populations to the Depart ment of Veterans Affairs (VA)
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From page 138... ...
The committee excluded a large volume of studies that were case reports and case-series, and controlled studies without randomization. The remaining studies varied in their adherence to current standards of design quality, had problems with sample size, assessor blinding or independence, high dropout rates, and had short or no follow-up after treatment concluded.
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From page 139... ...
. Unfortunately, the most common way missing data were handled in the literature reviewed was to use the last recorded outcome as the final outcome in a patient who dropped out -- also known as the "last observation carried forward"
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From page 140... ...
Recommendation 1. The committee recommends that VA and other funders of PTSD research take steps to identify and require investi gators to use methods that will improve the internal validity of the research, with particular attention to standardization of treatment and outcome measures, follow-up of individuals dropping out of clinical trials, and handling of missing data.
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From page 141... ...
The committee recommends that VA and other funders of PTSD treatment research seek ways to give opportunities to a broad and diverse group of investigators to ensure that studies are conducted by individuals and in settings without potential financial or intellectual conflicts of interest. Special Veteran Populations PTSD Comorbid with Traumatic Brain Injury (TBI) A high percentage of returning soldiers with PTSD also have sustained concussive TBI (Seal et al., 2007)
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From page 142... ...
PTSD Comorbid with Major Depression and Substance Abuse The committee noted that major depression, other anxiety disorders, and substance abuse are common among patients with PTSD, and yet some research systematically excludes such patients from the clinical trials. The result is that the literature is almost completely uninformative about how best to treat the substantial proportion of veterans who have an important comorbid condition.
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From page 143... ...
may be minimally informative about treatment efficacy in veterans of the recent conflicts. Acknowledging the heterogeneity of trauma types associated with cases of PTSD, and the question of applicability of evidence regarding treatments for PTSD across different contexts, the current report considers the range of contexts, highlighting the evidence of applicability to the veteran population where it is possible to do so.
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From page 144... ...
The committee noted that type of trauma, recurrence or frequency of trauma (as in current combat situations) , gender, ethnicity and cultural differences, comorbidities (especially substance abuse and depression)
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From page 145... ...
Finally, the population of veterans is heterogeneous, including older veterans with chronic PTSD and younger returning veterans; they also include women and members of various ethnic and racial groups. Little is known from systematic research on the potential response to various treatments or the acceptability of various treatment modalities across the groups identified.
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From page 146... ...
Reviews of the empirical evidence such as the one contained in this report take into consideration studies and data emerging over years and even decades. ISSUES DEFINED IN THE STATEMENT OF TASK In addition to assessing the quality and direction of the empirical evidence on various PTSD treatment modalities, the committee discussed the following issues, as requested by the sponsor: • What are the goals of PTSD treatment?
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From page 147... ...
multiple domain measures used to determine good or high end-state functioning, and (3) a clinically meaningful threshold for "symptom improvement." Not all studies seeking to show symptom improvement also reported PTSD diagnostic status, but almost all studies reporting loss of diagnosis did so by showing changes on PTSD symptom measures such as the Clinician administered PTSD Scale (CAPS)
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From page 148... ...
may report significant improvement in a post-treatment score drop of 2 SDs or 50 percent (to the 36th percentile, for example) while still troubled by PTSD symptoms, albeit in a milder form. Should many patients in a study have a severe form of the condition, these criteria would mask their continuing dysfunction and invalidate a positive conclusion based on these criteria, meaning, in these cases, the statistical
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From page 149... ...
Studies in the second category, those with the outcome of good or high end-state functioning, defined recovery by specific levels on multiple domain measures, including one or more PTSD specific measures (such as CAPS; other examples from the literature reviewed by the committee are provided below) in combination with specific levels on other types of measures of depression (Hamilton Rating Scale for Depression and Beck Depression Inventory)
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From page 150... ...
diagnosis, PTSD symptom improvement, and end state functioning. The committee further recommends the following three principles be considered in the selection of outcome measures: • validity in research; • convergence on a core of common outcomes for the purpose of comparability; and • usefulness to clinicians to assess patients over time as symp toms and function change.
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From page 151... ...
in PTSD. The committee further recommends that future research specify both time since trauma expo sure and duration of PTSD diagnosis, and that interventions be tested for efficacy at specific clinically meaningful intervals, as interventions might be expected to vary in effectiveness related to time since exposure and duration of diagnosis.
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From page 152... ...
The impact of periodic reexamination for asymptomatic patients is also difficult to ascertain from the literature reviewed by the committee. Although a number of pharmacotherapy and psychotherapy studies conducted follow-up after the completion of treatment, most of the studies did not assess patients' symptom status specifically, but rather, identified scores on various measures, such as measures of PTSD, depression, and anxiety.
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From page 153... ...
The literature examined by the committee was limited in providing long-term follow-up. The committee understands that follow-up beyond treatment is uncommon in drug studies aimed at addressing efficacy, regardless of clinical condition, but nonetheless observed that only 11 of 36 drug studies followed patients beyond treatment cessation, and none longer than 6 months.
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From page 154... ...
CONCLUDING OBSERVATIONS In this report the committee sought to describe the evidence regarding the efficacy of available treatment modalities for PTSD, identify some of the major issues in the field, and make recommendations to help guide further research in PTD treatment. The committee's findings, conclusions, and recommendations about the evidence for the treatment modalities reviewed in this report are not clinical practice guidelines.
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From page 155... ...
1999. The relative efficacy and treatment distress of EMDR and a cognitive-behavior trauma treatment protocol in the amelioration of posttraumatic stress disorder.
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From page 156... ...
2000. Randomized clinical trial of brief eclectic psychotherapy for police officers with posttraumatic stress disorder.
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From page 157... ...
, fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: Treatment effects and long-term maintenance. Journal of Clinical Psy chiatry 68(1)
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