Psychotropic Medication Use among Medicare Beneficiaries Following Traumatic Brain Injury.

OBJECTIVES: To characterize psychotropic medication use before and after traumatic brain injury (TBI) hospitalization among older adults. A secondary objective is to determine how receipt of indicated pharmacologic treatment for anxiety and post-traumatic stress disorder (PTSD) differs following TBI. DESIGN: Retrospective cohort. SETTING: United States. PARTICIPANTS: Medicare beneficiaries aged ≥65 years hospitalized with TBI between 2006 and 2010 with continuous drug coverage for 12 months before and after TBI (N = 60,276). MEASUREMENTS: We obtained monthly psychotropic medication use by drug class and specific drugs from Medicare Part D drug event files.ICD-9 codes were used to define anxiety (300.0x) and PTSD (309.81). RESULTS: Average monthly prevalence of psychotropic medication use among all patients hospitalized for TBI was 44.8%; antidepressants constituted 73%. Prevalence of psychotropic medication use increased from 2006 to 2010. Following TBI, psychotropic medication use increased slightly (OR: 1.05; 95% CI: 1.03, 1.06.) Tricyclic antidepressant use decreased post-TBI (OR: 0.76; 95% CI: 0.73, 0.79) whereas use of the sedating antidepressants mirtazapine (OR: 1.31; 95% CI: 1.25, 1.37) and trazadone (OR: 1.11; 95% CI: 1.06, 1.17) increased. Antipsychotic (OR: 1.15; 95% CI: 1.12, 1.19) use also increased post-TBI. Beneficiaries newly diagnosed with anxiety (OR: 0.42; 95% CI: 0.36, 0.48) and/or PTSD (OR: 0.39; 95% CI: 0.18, 0.84) post-TBI were less likely to receive indicated pharmacologic treatment. CONCLUSIONS: Older adults hospitalized with TBI have a high prevalence of psychotropic medication use yet are less likely to receive indicated pharmacological treatment for newly diagnosed anxiety and PTSD following TBI.

Use of a Qualitative Story Deck to Create Scenarios and Uncover Factors Associated with African American Participation in Genomics Research.

To gain a complex understanding of willingness to participate in genomics research among African Americans, we developed a technique specifically suited to studying decision making in a relaxed social setting. The "Qualitative Story Deck," (QSD) is a gamified, structured elicitation technique that allows for the spontaneous creation of scenarios with variable attributes. We used the QSD to create research scenarios that varied on four details (race/ethnicity of the researcher; research goal; biospecimen requested; and institutional affiliation). Participants created scenarios by randomly choosing cards from these categories and provided: (1) a judgement about their willingness to participate in the research project represented; and (2) their thought process in reaching a decision. The QSD has applicability to topics involving decision making or in cases where it would be beneficial to provide vignettes with alternate attributes. Additional benefits include: rapid establishment of rapport and engagement and the facilitation of discussion of little known or sensitive topics.

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.