Lessons learned in a clinical trial for military sexual trauma-related posttraumatic stress disorder.

Abstract

A large body of literature exists describing the challenges associated with implementing randomized controlled clinical trials (RCTs) [1]. However, when clinical trials are conducted within Department of Veterans Affairs (VA) Medical Center (VAMC) settings, several additional and unique factors contribute to the difficulty of conducting RCTs. The challenges and strategies to address them, described in this editorial, are based on an RCT conducted to determine the effectiveness of an evidence-based therapy to treat Veterans with military sexual trauma (MST)-related posttraumatic stress disorder (PTSD) [2]. Logistical and Environmental Challenges at VAMCs The number of Veterans that VAMCs serve has increased substantially since they were built [3]. Due to the design and age of many VAMCs and the increased demand for care, physical space within many VAMCs is at a premium, often necessitating updates and reorganization that require construction. Some examples of difficulties that were experienced during our study included (1) a large construction project to add needed parking spaces (temporarily reducing existing parking); (2) space issues that required frequent VAMC reorganization and changes in office locations for study therapists and personnel; (3) ongoing construction that produced frequent loud noises; and (4) due to space limitations, female Veterans with MST-related PTSD had to share small waiting rooms with male Veterans prior to study visits, often resulting in distress. Frustration and distress related to these experiences may have affected the way participants completed self-report outcome measures relating to PTSD, anger, depression, and anxiety symptoms. For example, although assessments asked participants to consider a discrete time period encompassing at a minimum the past few days, changes in current affect and anxiety can influence participants' responses [4-5]. Variability in participation could also have been affected by loud construction noise and encounters with male Veterans in small waiting rooms. These events are similar to exposure elements prominent in some therapies for PTSD, and this unintentional form of exposure could interfere with self-report accuracy. Proposed Strategies to Address Logistical and Environmental Challenges We recommend researchers anticipate logistical and environmental challenges by acquiring information about construction schedules; informing participants about construction challenges before starting the study; considering construction-related appointment delays during scheduling; and attempting to create quiet, private waiting areas. To further address space and parking limitations, reducing visits to the medical center can be helpful. For example, we encourage researchers to be flexible with follow-up data collection, such as offering phone assessments. Challenges with Documentation in the VAMC Electronic Medical Record Documentation of the diagnosis and treatment of PTSD in the electronic medical record (EMR) raised several concerns for our study, including (1) confusion about participation affecting VA disability claims; (2) perception that the diagnosis will create barriers to employment, government security clearances, and/or reenlistment; and (3) concerns about how participation in the study would affect access to other VA treatment. Proposed Strategies to Address Challenges with Charting in the VAMC EMR Researchers should address Veteran-specific concerns related to documentation during the informed consent (IC) process. Researchers should provide information on what exactly is documented (e.g., attendance and procedures at a study visit) and not documented (e.g., outcome data that could show improvement or worsening of symptoms). Researchers should also be knowledgeable about how information documented in a participant's EMR may or may not affect obtaining a security clearance, disability, and additional treatment. …