Sequenced treatment effectiveness for posttraumatic stress (STEPS) trial: A protocol for a pragmatic comparative effectiveness trial with baseline results.

BACKGROUND: There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments. METHOD: Patients screening positive for PTSD (n = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5). RESULTS: Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline. CONCLUSION: Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.

High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL): A Randomized Controlled Trial - Background, Aims, and Study Protocol.

BACKGROUND: Hypoxic-ischemic encephalopathy (HIE) remains an important cause of neonatal death and frequently leads to significant long-term disability in survivors. Therapeutic hypothermia, while beneficial, still leaves many treated infants with lifelong disabilities. Adjunctive therapies are needed, and erythropoietin (Epo) has the potential to provide additional neuroprotection. OBJECTIVES: The aim of this study was to review the current incidence, mechanism of injury, and sequelae of HIE, and to describe a new phase III randomized, placebo-controlled trial of Epo neuroprotection in term and near-term infants with moderate to severe HIE treated with therapeutic hypothermia. METHODS: This article presents an overview of HIE, neuroprotective functions of Epo, and the design of a double-blind, placebo-controlled, multicenter trial of high-dose Epo administration, enrolling 500 neonates ≥36 weeks of gestation with moderate or severe HIE diagnosed by clinical criteria. RESULTS AND CONCLUSIONS: Epo has robust neuroprotective effects in preclinical studies, and phase I/II trials suggest that multiple high doses of Epo may provide neuroprotection against brain injury in term infants. The High Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) Trial will evaluate whether high-dose Epo reduces the combined outcome of death or neurodevelopmental disability when given in conjunction with hypothermia to newborns with moderate/severe HIE.

Primary care and urology patients with the male pelvic pain syndrome: symptoms and quality of life.

PURPOSE: We assessed symptoms and health related quality of life in men who received prostatitis-prostatodynia diagnoses at primary care and urology visits, and compared those in whom pain-discomfort had versus had not resolved approximately 1 month later. MATERIALS AND METHODS: Telephone interviews were done with 357 men an average of 1 month after a prostatitis-prostatodynia diagnosis was made at a health maintenance organization visit. The interview included the National Institutes of Health Chronic Prostatitis Symptom Index, and pain and health related quality of life measures. RESULTS: The most common pain location was the pubic-bladder area. Mean scores on most health related quality of life measures were below average, and higher pelvic pain and urinary symptom scores were associated with worse quality of life. This episode of pelvic pain was the first lifetime episode in fewer urology (22%) than primary care (38%) patients (p = 0.02). Urology patients had longer symptom episodes (p = 0.000), more days with pain in the last month (p = 0.002) and higher National Institutes of Health Chronic Prostatitis Symptom Index pain scores (p = 0.002). Men with pain in the testicles, penis or between the rectum and testicles at the visit, and with longer symptom duration before the visit were significantly more likely to have continued pain between the visit and interview. CONCLUSIONS: Pelvic pain is often a persistent, recurrent condition that can have a significant negative impact on quality of life. The average symptom severity in men with pelvic pain in primary care and urology settings is lower than that in tertiary care samples.