In consultation with a technical advisory panel (clinical or research experts working in the areas of pain, polytrauma or TBI, primarily within the Veterans Affairs (VA) system), we identified five key questions for the review. These questions addressed 1) methods of assessment of pain among patients with cognitive deficits due to TBI; 2) effectiveness of treatment approaches for pain related to polytrauma; 3) the phenomenology and management of blast-related headache; 4) patient factors associated with pain-related outcomes among polytrauma patients; and 5) clinician and systems factors associated with pain-related outcomes among polytrauma patients. The specific key questions are included with the results below.
Polytrauma was defined for this review as concurrent injury to two or more body parts or systems resulting in cognitive, physical, psychological, or other psychosocial impairments. Consistent with VHA's definition, TBI of moderate or greater severity was considered polytrauma (head injury itself plus associated cognitive sequelae). Combat-related mental conditions co-occurring with injury to at least one other system also constituted polytrauma.
The scope of this review included the assessment and treatment in rehabilitation and post-rehabilitation care settings of persistent pain or exacerbations of pain resulting from polytraumatic injuries. We included studies measuring pain-related outcomes, specifically pain intensity and pain-related function or interference, 3 months or more from the date of injury. Studies examining battlefield/emergency or assessment and care within 3 months of injury were not included unless they also examined pain outcomes 3 months following injury. We also did not include studies examining choice of specific surgical strategy, perioperative management of traumatic (including burn) injuries, or use of particular procedures or devices for specific orthopedic injuries. We excluded studies describing functional outcomes of polytrauma unless a pain measure was also included. Finally, we excluded studies of post-traumatic/post-concussive headache unless the sample included patients with moderate or severe head injury or included a majority of patients with blast-related head injury. There have been a number of narrative reviews of assessment and treatment of post-traumatic headache among patients with mild-TBI or post-concussive syndrome; we felt that inclusion of these studies was beyond the scope of our key questions. illustrates the analytic framework that guided our review.
Two research librarians independently designed search strategies based on the key questions, and conducted searches in PubMed and Ovid MEDLINE of literature published from 1950 through July 2008. Appendix A
provides the search strategies in detail. The results of both searches were combined into a single reference library. Additional articles were identified from reference lists of studies, review articles, editorials, and by consulting experts; some of these articles were published prior to 1950. We also searched for relevant studies in the following databases: PsychINFO; the PILOTS Database (the VA PTSD bibliographic database); REHABDATA, the bibliographic database of the National Rehabilitation Information Center; DOD Technical Information Center; and the Cochrane Database of controlled clinical trials. All citations were imported into an electronic database (EndNote X1).
Three investigators (SD, RC, MF) reviewed the titles and abstracts identified from the searches. Full-text articles of potentially relevant abstracts were retrieved for further review. Reference lists from pertinent articles were reviewed to find additional articles for inclusion. Eligible articles had English-language abstracts and provided primary data relevant to the key questions. For a study to be eligible for Key Questions 1, 2, 4, and 5, the sample had to have all or a majority of patients with polytrauma, or analyses and findings had to be stratified by whether the patients had polytrauma, such that readers could discern outcomes for the polytrauma group.
Eligible study designs included controlled clinical trials, systematic reviews, as well as prospective and retrospective cohort studies, case-control design studies, and qualitative studies using rigorous qualitative research methods. Due to a limited number of studies that included a comparator group, we also considered relevant cross-sectional and case report/case series studies for inclusion for some of the key questions. To rate the quality of studies we used criteria developed by the U.S. Preventive Services Task Force for rating randomized controlled trials, cohort studies, and case control studies (Appendix B
]. We did not rate the quality of cross-sectional studies, case reports, or case series. We assessed the overall quality of evidence for outcomes using a method developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group (Appendix C
], which classified the grade of evidence across outcomes according to the following criteria: High = Further research is very unlikely to change our confidence on the estimate of effect; Moderate = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; Low = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate; Very Low = Any estimate of effect is very uncertain. Finally, a draft version of our findings was sent to technical reviewers who provided comments, suggested additional pertinent references, and prioritized future research topics and study designs.