Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

2018-01-01

This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

Comparison of eye movement desensitization and reprocessing therapy, cognitive behavioral writing therapy, and wait-list in pediatric posttraumatic stress disorder following single-incident trauma: a multicenter randomized clinical trial.

PubMed

de Roos, Carlijn; van der Oord, Saskia; Zijlstra, Bonne; Lucassen, Sacha; Perrin, Sean; Emmelkamp, Paul; de Jongh, Ad

2017-11-01

Practice guidelines for childhood posttraumatic stress disorder (PTSD) recommend trauma-focused psychotherapies, mainly cognitive behavioral therapy (CBT). Eye movement desensitization and reprocessing (EMDR) therapy is a brief trauma-focused, evidence-based treatment for PTSD in adults, but with few well-designed trials involving children and adolescents. We conducted a single-blind, randomized trial with three arms (n = 103): EMDR (n = 43), Cognitive Behavior Writing Therapy (CBWT; n = 42), and wait-list (WL; n = 18). WL participants were randomly reallocated to CBWT or EMDR after 6 weeks; follow-ups were conducted at 3 and 12 months posttreatment. Participants were treatment-seeking youth (aged 8-18 years) with a DSM-IV diagnosis of PTSD (or subthreshold PTSD) tied to a single trauma, who received up to six sessions of EMDR or CBWT lasting maximally 45 min each. Both treatments were well-tolerated and relative to WL yielded large, intent-to-treat effect sizes for the primary outcomes at posttreatment: PTSD symptoms (EMDR: d = 1.27; CBWT: d = 1.24). At posttreatment 92.5% of EMDR, and 90.2% of CBWT no longer met the diagnostic criteria for PTSD. All gains were maintained at follow-up. Compared to WL, small to large (range d = 0.39-1.03) intent-to-treat effect sizes were obtained at posttreatment for negative trauma-related appraisals, anxiety, depression, and behavior problems with these gains being maintained at follow-up. Gains were attained with significantly less therapist contact time for EMDR than CBWT (mean = 4.1 sessions/140 min vs. 5.4 sessions/227 min). EMDR and CBWT are brief, trauma-focused treatments that yielded equally large remission rates for PTSD and reductions in the severity of PTSD and comorbid difficulties in children and adolescents seeking treatment for PTSD tied to a single event. Further trials of both treatments with PTSD tied to multiple traumas are warranted. © 2017 Association for Child and Adolescent Mental Health.

Moderators of treatment response to trauma-focused cognitive behavioral therapy among youth in Zambia.

PubMed

Kane, Jeremy C; Murray, Laura K; Cohen, Judith; Dorsey, Shannon; Skavenski van Wyk, Stephanie; Galloway Henderson, Jennica; Imasiku, Mwiya; Mayeya, John; Bolton, Paul

2016-10-01

The effectiveness of mental health interventions such as trauma-focused cognitive behavioral therapy (TF-CBT) may vary by client, caregiver, and intervention-level variables, but few randomized trials in low- and middle-income countries (LMIC) have conducted moderation analyses to investigate these characteristics. This study explores moderating factors to TF-CBT treatment response among a sample of orphans and vulnerable children (OVC) in Zambia. Data were obtained from a completed randomized trial of TF-CBT among 257 OVC in Zambia. Trauma symptoms and functioning were measured at baseline and following the end of treatment. Mixed effects regression models were estimated for each moderator of interest: gender, age, number of trauma types experienced, history of sexual abuse, orphan status, primary caretaker, school status, and parental involvement in treatment. Treatment effectiveness was moderated by history of sexual abuse with greater reductions in both outcomes (trauma, p < .05; functioning, p < .01) for those that experienced sexual abuse. Primary caretaker was also a moderator with greater trauma reductions in those who identified their mother as the primary caretaker (p < .01), and better functioning in those that identified their father as the primary caretaker (p < .05). Nonorphans and single orphans (mother alive) showed greater reduction in functional impairment (p < .01) compared with double orphans. There was no significant moderator effect found by gender, age, number of trauma types, school status, or caregiver participation in treatment. This study suggests that TF-CBT was effective in reducing trauma symptoms and functional impairment among trauma-affected youth overall and that it may be particularly effective for survivors of child sexual abuse and children whose primary caretaker is a biological parent. Scale-up of TF-CBT is warranted given the wide range of effectiveness and prevalence of child sexual abuse. Future randomized trials of interventions in LMIC should power for moderation analyses in the study design phase when feasible. © 2016 Association for Child and Adolescent Mental Health.

Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma.

PubMed

Stengel, Dirk; Bauwens, Kai; Rademacher, Grit; Ekkernkamp, Axel; Güthoff, Claas

2013-07-31

Ultrasonography is regarded as the tool of choice for early diagnostic investigations in patients with suspected blunt abdominal trauma. Although its sensitivity is too low for definite exclusion of abdominal organ injury, proponents of ultrasound argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of computed tomography scans and cut costs. To assess the effects of trauma algorithms that include ultrasound examinations in patients with suspected blunt abdominal trauma. We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EBSCO), publishers' databases, controlled trials registers and the Internet. Bibliographies of identified articles and conference abstracts were searched for further elligible studies. Trial authors were contacted for further information and individual patient data. The searches were updated in February 2013. randomised controlled trials (RCTs) and quasi-randomised trials (qRCTs). patients with blunt torso, abdominal or multiple trauma undergoing diagnostic investigations for abdominal organ injury. diagnostic algorithms comprising emergency ultrasonography (US). diagnostic algorithms without ultrasound examinations (for example, primary computed tomography [CT] or diagnostic peritoneal lavage [DPL]). mortality, use of CT and DPL, cost-effectiveness, laparotomy and negative laparotomy rates, delayed diagnoses, and quality of life. Two authors independently selected trials for inclusion, assessed methodological quality and extracted data. Where possible, data were pooled and relative risks (RRs), risk differences (RDs) and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed- or random-effects modelling, as appropriate. We identified four studies meeting our inclusion criteria. Overall, trials were of moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. We pooled mortality data from three trials involving 1254 patients; relative risk in favour of the US arm was 1.00 (95% CI 0.50 to 2.00). US-based pathways significantly reduced the number of CT scans (random-effects RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result is unclear. Given the low sensitivity of ultrasound, the reduction in CT scans may either translate to a number needed to treat or number needed to harm of two. There is currently insufficient evidence from RCTs to justify promotion of ultrasound-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma.

Trauma-informed Temporary Assistance for Needy Families (TANF): A Randomized Controlled Trial with a Two-Generation Impact.

PubMed

Booshehri, Layla G; Dugan, Jerome; Patel, Falguni; Bloom, Sandra; Chilton, Mariana

2018-01-01

Temporary Assistance for Needy Families (TANF) has limited success in building self-sufficiency, and rarely addresses exposure to trauma as a barrier to employment. The objective of the Building Wealth and Health Network randomized controlled trial was to test effectiveness of financial empowerment combined with trauma-informed peer support against standard TANF programming. Through the method of single-blind randomization we assigned 103 caregivers of children under age six into three groups: control (standard TANF programming), partial (28-weeks financial education), and full (same as partial with simultaneous 28-weeks of trauma-informed peer support). Participants completed baseline and follow-up surveys every 3 months over 15 months. Group response rates were equivalent throughout. With mixed effects analysis we compared post-program outcomes at months 9, 12, and 15 to baseline. We modeled the impact of amount of participation in group classes on participant outcomes. Despite high exposure to trauma and adversity results demonstrate that, compared to the other groups, caregivers in the full intervention reported improved self-efficacy and depressive symptoms, and reduced economic hardship. Unlike the intervention groups, the control group reported increased developmental risk among their children. Although the control group showed higher levels of employment, the full intervention group reported greater earnings. The partial intervention group showed little to no differences compared with the control group. We conclude that financial empowerment education with trauma-informed peer support is more effective than standard TANF programming at improving behavioral health, reducing hardship, and increasing income. Policymakers may consider adapting TANF to include trauma-informed programming.

Recombinant activated factor VII for bleeding in patients without inherited bleeding disorders.

PubMed

Selin, S; Tejani, A

2006-03-01

(1) Recombinant activated factor VII (rFVIIa) is licensed in Canada for the prevention and treatment of bleeding in hemophiliacs, but it is increasingly used to control bleeding in non-hemophilic patients during surgery, or during treatment for severe trauma or intracerebral hemorrhage (ICH). (2) In one clinical trial, there was a significant reduction in mortality among patients with ICH treated with rFVIIa. In another trial, administration of rFVIIa significantly reduced the number of trauma patients needing massive blood transfusions although there was no significant difference in mortality. (3) Adequately powered randomized controlled trials are needed to clarify the efficacy and safety of rFVIIa for non-bleeding disorder indications. Phase III trials in ICH and trauma are underway. (4) There is potential for non-hemophilic use, particularly if clinical efficacy and cost effectiveness are established.

Surveyed opinion of American trauma, orthopedic, and thoracic surgeons on rib and sternal fracture repair.

PubMed

Mayberry, John C; Ham, L Bruce; Schipper, Paul H; Ellis, Thomas J; Mullins, Richard J

2009-03-01

Rib and sternal fracture repair are controversial. The opinion of surgeons regarding those patients who would benefit from repair is unknown. Members of the Eastern Association for the Surgery of Trauma, the Orthopedic Trauma Association, and thoracic surgeons (THS) affiliated with teaching hospitals in the United States were recruited to complete an electronic survey regarding rib and sternal fracture repair. Two hundred thirty-eight trauma surgeons (TRS), 97 orthopedic trauma surgeons (OTS), and 70 THS completed the survey. Eighty-two percent of TRS, 66% of OTS, and 71% of THS thought that rib fracture repair was indicated in selected patients. A greater proportion of surgeons thought that sternal fracture repair was indicated in selected patients (89% of TRS, 85% of OTS, and 95% of THS). Chest wall defect/pulmonary hernia (58%) and sternal fracture nonunion (>6 weeks) (68%) were the only two indications accepted by a majority of respondents. Twenty-six percent of surgeons reported that they had performed or assisted on a chest wall fracture repair, whereas 22% of surgeons were familiar with published randomized trials of the surgical repair of flail chest. Of surgeons who thought rib fracture or sternal fracture repair was rarely, if ever, indicated, 91% and 95%, respectively, specified that a randomized trial confirming efficacy would be necessary to change their negative opinion. A majority of surveyed surgeons reported that rib and sternal fracture repair is indicated in selected patients; however, a much smaller proportion indicated that they had performed the procedures. The published literature on surgical repair is sparse and unfamiliar to most surgeons. Barriers to surgical repair of rib and sternal fracture include a lack of expertise among TRS, lack of research of optimal techniques, and a dearth of randomized trials.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Mind-Body Training for At-Risk Populations: Preventive Medicine at its Best.

PubMed

Elder, Charles

2017-01-01

This article is a companion to "Transcendental meditation and reduced trauma symptoms in female inmates: A randomized controlled pilot study," available at: www.thepermanentejournal.org/issues/2017/6290-meditation.html, and on page 39 and to "Reduced trauma symptoms and perceived stress in male prison inmates through the Transcendental Meditation program: A randomized controlled trial," available at: www.thepermanentejournal.org/issues/2016/fall/6227-incarcerated-healthcare.html and in the Fall 2016 issue of The Permanente Journal.

Preventing perineal trauma during childbirth: a systematic review.

PubMed

Eason, E; Labrecque, M; Wells, G; Feldman, P

2000-03-01

To review systematically techniques proposed to prevent perineal trauma during childbirth and meta-analyze the evidence of their efficacy from randomized controlled trials. MEDLINE (1966-1999), the Cochrane Library (1999 Issue 1), and the Cochrane Collaboration: Pregnancy and Childbirth Database (1995); and reference lists from articles identified. Search terms included childbirth or pregnancy or delivery, and perineum, episiotomy, perineal massage, obstetric forceps, vacuum extraction, labor stage-second. No language or study-type constraints were imposed. Randomized controlled trials (RCTs) of interventions affecting perineal trauma were reviewed. If no RCTs were available, nonrandomized research designs such as cohort studies were included. Studies were selected by examination of titles and abstracts of more than 1,500 articles, followed by analysis of the methods sections of studies that appeared to be RCTs. INTEGRATION AND RESULTS: Eligible studies used random or quasirandom allocation of an intervention of interest and reported perineal outcomes. Further exclusions were based on failure to report results by intention to treat, or incomplete or internally inconsistent reporting of perineal outcomes. Final selection of studies and data extraction was by consensus of the first two authors. Data from trials that evaluated similar interventions were combined using a random effects model to determine weighted estimate of risk difference and number needed to treat. Effects of sensitivity analysis and quality scoring were examined. Results indicated good evidence that avoiding episiotomy decreased perineal trauma (absolute risk difference -0.23, 95% confidence interval [CI] -0.35, -0.11). In nulliparas, perineal massage during the weeks before giving birth also protected against perineal trauma (risk difference -0.08, CI -0.12, -0.04). Vacuum extraction (risk difference -0.06, CI -0.10, -0.02) and spontaneous birth (-0.11, 95% CI -0.18, -0.04) caused less anal sphincter trauma than forceps delivery. The mother's position during the second stage has little influence on perineal trauma (supported upright versus recumbent: risk difference 0.02, 95% CI -0.05, 0.09). Factors shown to increase perineal integrity include avoiding episiotomy, spontaneous or vacuum-assisted rather than forceps birth, and in nulliparas, perineal massage during the weeks before childbirth. Second-stage position has little effect. Further information on techniques to protect the perineum during spontaneous delivery is sorely needed.

Preventing Epilepsy after Traumatic Brain Injury

DTIC Science & Technology

2007-02-01

the standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized clinical trial to determine if TPM can...than the current standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized clinical trial to...dose of phenytoin within several hours of being admitted to the trauma/neurosurgical unit, as part of the standard of care for such individuals. The

A Pilot Randomized Controlled Trial of Combined Trauma-Focused CBT and Sertraline for Childhood PTSD Symptoms

ERIC Educational Resources Information Center

Cohen, Judith A.; Mannarino, Anthony P.; Perel, James M.; Staron, Virginia

2007-01-01

Objective: To examine the potential benefits of adding a selective serotonin reuptake inhibitor, sertraline, versus placebo, to trauma-focused cognitive-behavioral therapy (TF-CBT) for improving posttraumatic stress disorder and related psychological symptoms in children who have experienced sexual abuse. Method: Twenty-four 10- to 17-year-old…

Reduced Trauma Symptoms and Perceived Stress in Male Prison Inmates through the Transcendental Meditation Program: A Randomized Controlled Trial.

PubMed

Nidich, Sanford; O'connor, Tom; Rutledge, Thomas; Duncan, Jeff; Compton, Blaze; Seng, Angela; Nidich, Randi

2016-01-01

Trauma events are four times more prevalent in inmates than in the general public and are associated with increased recidivism and other mental and physical health issues. To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in male inmates. One hundred eighty-one inmates with a moderate- to high-risk criminal profile were randomly assigned to either the TM program or to a usual care control group. The Trauma Symptom Checklist and the Perceived Stress Scale were administered at baseline and four-month posttest. Significant reductions in total trauma symptoms, anxiety, depression, dissociation, and sleep disturbance subscales, and perceived stress in the TM group were found compared with controls (all p values < 0.001). The high-trauma subgroup analysis further showed a higher magnitude of effects in the TM group compared with controls on all outcomes, with Cohen effect sizes ranging from 0.67 to 0.89. Results are consistent with those of prior studies of the TM program in other populations and its effects on trauma symptoms and perceived stress.

Change in Parental Depressive Symptoms in Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Trial.

PubMed

Tutus, Dunja; Keller, Ferdinand; Sachser, Cedric; Pfeiffer, Elisa; Goldbeck, Lutz

2017-03-01

Depressive symptoms are frequently described in parents whose children have been exposed to traumatic events. Hence, including nonoffending parents in trauma-focused cognitive-behavioral therapy (TF-CBT) for children and adolescents may help both children and their parents to cope with the trauma. Up to now, three randomized controlled trials have investigated parental depressive symptoms after TF-CBT. Given the ambiguous results, further effectiveness trials are needed to investigate parental benefit from TF-CBT. The aim of this study is to determine whether TF-CBT is superior to waitlist (WL) regarding change in parental depressive symptoms. Parents, N = 84, whose children (age 6-17 years) were randomly assigned to either 12 sessions of TF-CBT (n = 40) or to WL condition (n = 44) completed the Beck Depression Inventory-Second Edition (BDI-II) for pre-post comparison. The group difference was tested through repeated-measures analyses of variance (ANOVA). The change in parental depressive symptoms was additionally categorized using the reliable change index. Repeated-measures ANOVA indicated a significant time effect F(1, 82) = 2.55, p = 0.02, and no significant time-group interaction F(1, 82) = 1.09, p = 0.30, suggesting a similar reduction in parental depressive symptoms in both groups. Across both conditions, most of the parents remained unchanged (n = 62), some of them improved (n = 17), and a few deteriorated (n = 5). There was no significant difference between the conditions (χ 2 (2) = 1.74; p = 0.42). Contrary to findings of several previous studies, our results suggest no superiority of TF-CBT in comparison with WL regarding change in depressive symptoms in parents. This might be due to different types of the child's trauma. Parental benefit from TF-CBT was found in samples of sexually abused, but not in children and adolescents exposed to diverse trauma types.

Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Archer, Kristin R; Coronado, Rogelio A; Haislip, Lori R; Abraham, Christine M; Vanston, Susan W; Lazaro, Anthony E; Jackson, James C; Ely, E Wesley; Guillamondegui, Oscar D; Obremskey, William T

2015-06-02

Approximately 1 million individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Many trauma survivors with mild TBI have debilitating and long-term physical, emotional, and cognitive impairments that are unrecognized at trauma centers. Early intervention studies are needed to address these impairments, especially cognitive deficits in executive functioning. Goal management training (GMT) is a structured cognitive rehabilitation program that has been found to improve executive functioning in patients with moderate to severe TBI. The current study adapted the GMT program for telephone delivery in order to improve the accessibility of rehabilitation services in a patient population with multiple barriers to care and significant yet unrecognized cognitive impairment. The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, and psychological health in trauma survivors with mild TBI. This study is a three-group randomized controlled trial being conducted at a Level I trauma center. Ninety trauma survivors with mild TBI and cognitive deficits in executive functioning will be randomized to receive telephone-based GMT, telephone-based education, or usual care. GMT and education programs will be delivered by a physical therapist. The first in-person session is 1 h and the remaining six telephone sessions are 30 min. A battery of well-established cognitive tests will be conducted and validated questionnaires will be collected that measure executive functioning, functional status, and depressive and posttraumatic stress disorder symptoms at 6 weeks, 4 months, and 7 months following hospital discharge. This study supports a telephone-delivery approach to rehabilitation services in order to broaden the availability of evidence-based cognitive strategies. This trial was registered with Clinicaltrials.gov on 10 October 2012, registration number: NCT01714531.

Gender-Specific Effects of an Augmented Written Emotional Disclosure Intervention on Posttraumatic, Depressive, and HIV-Disease-Related Outcomes: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Ironson, Gail; O'Cleirigh, Conall; Leserman, Jane; Stuetzle, Rick; Fordiani, Joanne; Fletcher, MaryAnn; Schneiderman, Neil

2013-01-01

Objective: Trauma histories and symptoms of PTSD occur at very high rates in people with HIV and are associated with poor disease management and accelerated disease progression. The authors of this study examined the efficacy of a brief written trauma disclosure intervention on posttraumatic stress, depression, HIV-related physical symptoms, and…

Development of a coping intervention to improve traumatic stress and HIV care engagement among South African women with sexual trauma histories.

PubMed

Sikkema, Kathleen J; Choi, Karmel W; Robertson, Corne; Knettel, Brandon A; Ciya, Nonceba; Knippler, Elizabeth T; Watt, Melissa H; Joska, John A

2018-06-01

This paper describes the development and preliminary trial run of ImpACT (Improving AIDS Care after Trauma), a brief coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We engaged in an iterative process to culturally adapt a cognitive-behavioral intervention for delivery within a South African primary care clinic. This process involved three phases: (a) preliminary intervention development, drawing on content from a prior evidence-based intervention; (b) contextual adaptation of the curriculum through formative data collection using a multi-method qualitative approach; and (c) pre-testing of trauma screening procedures and a subsequent trial run of the intervention. Feedback from key informant interviews and patient in-depth interviews guided the refinement of session content and adaptation of key intervention elements, including culturally relevant visuals, metaphors, and interactive exercises. The trial run curriculum consisted of four individual sessions and two group sessions. Strong session attendance during the trial run supported the feasibility of ImpACT. Participants responded positively to the logistics of the intervention delivery and the majority of session content. Trial run feedback helped to further refine intervention content and delivery towards a pilot randomized clinical trial to assess the feasibility and potential efficacy of this intervention. Copyright © 2018 Elsevier Ltd. All rights reserved.

Change in Posttraumatic Stress Disorder Symptoms: Do Clinicians and Patients Agree?

ERIC Educational Resources Information Center

Monson, Candice M.; Gradus, Jaimie L.; Young-Xu, Yinong; Schnurr, Paula P.; Price, Jennifer L.; Schumm, Jeremiah A.

2008-01-01

This study assessed the longitudinal association between clinician and patient ratings of posttraumatic stress disorder (PTSD) symptoms over the course of 2 different randomized clinical trials of veterans with chronic PTSD. One trial, the Department of Veterans Affairs Cooperative Study 420 (CSP 420; N = 360) compared trauma-focused and…

Western Trauma Association Critical Decisions in Trauma: Management of rib fractures.

PubMed

Brasel, Karen J; Moore, Ernest E; Albrecht, Roxie A; deMoya, Marc; Schreiber, Martin; Karmy-Jones, Riyad; Rowell, Susan; Namias, Nicholas; Cohen, Mitchell; Shatz, David V; Biffl, Walter L

2017-01-01

This is a recommended management algorithm from the Western Trauma Association addressing the management of adult patients with rib fractures. Because there is a paucity of published prospective randomized clinical trials that have generated Class I data, these recommendations are based primarily on published observational studies and expert opinion of Western Trauma Association members. The algorithm and accompanying comments represent a safe and sensible approach that can be followed at most trauma centers. We recognize that there will be patient, personnel, institutional, and situational factors that may warrant or require deviation from the recommended algorithm. We encourage institutions to use this as a guideline to develop their own local protocols.

Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial.

PubMed

Albers, Leah L; Sedler, Kay D; Bedrick, Edward J; Teaf, Dusty; Peralta, Patricia

2005-01-01

Genital tract trauma after spontaneous vaginal childbirth is common, and evidence-based prevention measures have not been identified beyond minimizing the use of episiotomy. This study randomized 1211 healthy women in midwifery care at the University of New Mexico teaching hospital to 1 of 3 care measures late in the second stage of labor: 1) warm compresses to the perineal area, 2) massage with lubricant, or 3) no touching of the perineum until crowning of the infant's head. The purpose was to assess whether any of these measures was associated with lower levels of obstetric trauma. After each birth, the clinical midwife recorded demographic, clinical care, and outcome data, including the location and extent of any genital tract trauma. The frequency distribution of genital tract trauma was equal in all three groups. Individual women and their clinicians should decide whether to use these techniques on the basis of maternal comfort and other considerations.

Midwifery Care Measures in the Second Stage of Labor and Reduction of Genital Tract Trauma at Birth: A Randomized Trial

PubMed Central

Albers, Leah L.; Sedler, Kay D.; Bedrick, Edward J.; Teaf, Dusty; Peralta, Patricia

2005-01-01

Genital tract trauma following spontaneous vaginal childbirth is common, and evidence-based prevention measures have not been identified, beyond minimizing the use of episiotomy. This study randomized 1211 healthy women in midwifery care at the University of New Mexico teaching hospital to one of three care measures late in the second stage of labor:1) warm compresses to the perineal area, 2) massage with lubricant, or 3) no touching of the perineum until crowning of the infant’s head. The purpose was to assess whether any of these measures was associated with lower levels of obstetric trauma. After each birth, the clinical midwife recorded demographic, clinical care, and outcome data, including the location and extent of any genital tract trauma. The frequency distribution of genital tract trauma was equal in all three groups. Individual women and their clinicians should decide whether to use these techniques based on maternal comfort and other considerations. PMID:16154062

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

PubMed Central

2013-01-01

Background Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient. Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma. Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. Methods/design The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later. The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment. In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed. The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner. Discussion This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients. Trial registration This trial has been registered with ClinicalTrials.gov (NCT01850875). PMID:23987561

Animal-Assisted Therapy for Post-traumatic Stress Disorder: Lessons from "Case Reports" in Media Stories.

PubMed

Altschuler, Eric L

2018-01-01

Post-traumatic stress disorder (PTSD) can follow war trauma, sexual abuse, other traumas, and even be experienced by commanders for the PTSD of their subordinates. Medications and counseling are sometimes not effective, so new treatments are needed. Some years ago, I suggested that animal-assisted therapy (AAT) (pet therapy) might be beneficial for PTSD. A large randomized controlled trial is underway of canine-assisted therapy for PTSD. Randomized controlled trials are most useful in assessing the efficacy of a medical intervention as these trials control for known and unknown biases. However, due to their very nature and rigorous requirements, knowledge gained from randomized controlled trials may need to be supplemented from other kinds of studies. Here, I note that media reports of AAT for PTSD may effectively function as case reports and suggest further studies: For PTSD, these demonstrate that (1) AAT can be dramatically effective in improving PTSD symptoms; (2) there is the potential for benefit from AAT by multiple different animals besides canines for PTSD; and (3) AAT may have a role in preventing suicide in patients with PTSD. © Association of Military Surgeons of the United States 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Randomized Controlled Trial of Exposure Therapy and Cognitive Restructuring for Posttraumatic Stress Disorder

ERIC Educational Resources Information Center

Bryant, Richard A.; Moulds, Michelle L.; Guthrie, Rachel M.; Dang, Suzanne T.; Mastrodomenico, Julie; Nixon, Reginald D. V.; Felmingham, Kim L.; Hopwood, Sally; Creamer, Mark

2008-01-01

Previous studies have reported that adding cognitive restructuring (CR) to exposure therapy does not enhance treatment gains in posttraumatic stress disorder (PTSD). This study investigated the extent to which CR would augment treatment response when provided with exposure therapy. The authors randomly allocated 118 civilian trauma survivors with…

Information interventions for recovery following vehicle-related trauma to persons of working age: a systematic review of the literature.

PubMed

Clay, Fiona J; Collie, Alex; McClure, Roderick J

2012-06-01

Given the burden associated with vehicle-related trauma, there is interest in time and cost effective methods of providing information to assist recovery. This systematic review aims to address the question: "Do targeted early information interventions improve outcomes following vehicle--related injuries for persons of working age?" Ovid Medline, EMBASE, PsychINFO and Cochrane databases were searched for studies published between 1990-April 2011. Included studies were randomized or pseudo--randomized controlled trials of information interventions delivered to working age persons following vehicle-related injuries. Two reviewers independently selected and appraised the studies. Sixteen publications (13 primary studies) met the inclusion criteria and were assessed for bias. Hetero-geneity in terms of the information interventions and measured outcomes was encountered. In 4 of the included studies, the intervention was positively associated with at least one outcome reported. Methodological issues limited the conclusions that could be drawn. Following vehicle-related trauma, people often experience difficulties in ongoing functioning. The current evidence neither supports nor fails to support the effectiveness of information interventions in promoting injury recovery. There is a need for larger more methodologically and conceptually rigorous randomized controlled trials that better consider the type and timing of the intervention.

Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials.

PubMed

Steenkamp, Maria M; Litz, Brett T; Hoge, Charles W; Marmar, Charles R

2015-08-04

Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder common among military personnel and veterans. First-line psychotherapies most often recommended for PTSD consist mainly of "trauma-focused" psychotherapies that involve focusing on details of the trauma or associated cognitive and emotional effects. To examine the effectiveness of psychotherapies for PTSD in military and veteran populations. PubMed, PsycINFO, and PILOTS were searched for randomized clinical trials (RCTs) of individual and group psychotherapies for PTSD in military personnel and veterans, published from January 1980 to March 1, 2015. We also searched reference lists of articles, selected reviews, and meta-analyses. Of 891 publications initially identified, 36 were included. Two trauma-focused therapies, cognitive processing therapy (CPT) and prolonged exposure, have been the most frequently studied psychotherapies for military-related PTSD. Five RCTs of CPT (that included 481 patients) and 4 RCTs of prolonged exposure (that included 402 patients) met inclusion criteria. Focusing on intent-to-treat outcomes, within-group posttreatment effect sizes for CPT and prolonged exposure were large (Cohen d range, 0.78-1.10). CPT and prolonged exposure also outperformed waitlist and treatment-as-usual control conditions. Forty-nine percent to 70% of participants receiving CPT and prolonged exposure attained clinically meaningful symptom improvement (defined as a 10- to 12-point decrease in interviewer-assessed or self-reported symptoms). However, mean posttreatment scores for CPT and prolonged exposure remained at or above clinical criteria for PTSD, and approximately two-thirds of patients receiving CPT or prolonged exposure retained their PTSD diagnosis after treatment (range, 60%-72%). CPT and prolonged exposure were marginally superior compared with non-trauma-focused psychotherapy comparison conditions. In military and veteran populations, trials of the first-line trauma-focused interventions CPT and prolonged exposure have shown clinically meaningful improvements for many patients with PTSD. However, nonresponse rates have been high, many patients continue to have symptoms, and trauma-focused interventions show marginally superior results compared with active control conditions. There is a need for improvement in existing PTSD treatments and for development and testing of novel evidence-based treatments, both trauma-focused and non-trauma-focused.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials.

PubMed

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials

PubMed Central

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required. PMID:29695993

A randomized trial of cognitive behavior therapy and cognitive therapy for children with posttraumatic stress disorder following single-incident trauma: Predictors and outcome at 1-year follow-up.

PubMed

Nixon, Reginald D V; Sterk, Jisca; Pearce, Amanda; Weber, Nathan

2017-07-01

The 1-year outcome and moderators of adjustment for children and youth receiving treatment for posttraumatic stress disorder (PTSD) following single-incident trauma was examined. Children and youth who had experienced single-incident trauma (N = 33; 7-17 years old) were randomly assigned to receive 9 weeks of either trauma-focused cognitive behavior therapy (CBT) or trauma-focused cognitive therapy (without exposure; CT) that was administered to them and their parents individually. Intent-to-treat analyses demonstrated that both groups maintained posttreatment gains in PTSD, depression and general anxiety symptoms reductions at 1-year follow-up, with no children meeting criteria for PTSD. A large proportion of children showed good end-state functioning at follow-up (CBT: 65%; CT: 71%). Contrary to 6-month outcomes, maternal adjustment no longer moderated children's outcome, nor did any other tested variables. The findings confirm the positive longer-term outcomes of using trauma-focused cognitive-behavioral methods for PTSD secondary to single-incident trauma and that these outcomes are not dependent on the use of exposure. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Systematic review of multidisciplinary rehabilitation in patients with multiple trauma.

PubMed

Khan, F; Amatya, B; Hoffman, K

2012-01-01

Multiple trauma is a cause of significant disability in adults of working age. Despite the implementation of trauma systems for improved coordination and organization of care, rehabilitation services are not yet routinely considered integral to trauma care processes. MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, Physiotherapy Evidence Database, Latin American and Caribbean Literature on Health Sciences and Cochrane Library databases were searched up to May 2011 for randomized clinical trials, as well as observational studies, reporting outcomes of injured patients following multidisciplinary rehabilitation that addressed functional restoration and societal reintegration based on the International Classification of Functioning, Disability and Health. No randomized and/or controlled clinical trials were identified. Fifteen observational studies involving 2386 participants with injuries were included. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach assessed methodological quality as 'poor' in all studies, with selection and observer bias. Although patients with low functional scores showed improvement after rehabilitation, they were unable to resume their pretrauma level of activity. Their functional ability was significantly associated with motor independence on admission and early acute rehabilitation, which contributed to a shorter hospital stay. Injury location, age, co-morbidity and education predicted long-term functional consequences. Trauma care systems were associated with reduced mortality. The gaps in evidence include: rehabilitation settings, components, intensity, duration and types of therapy, and long-term outcomes for survivors of multiple trauma. Rehabilitation is an expensive resource and the evidence to support its justification is needed urgently. The issues in study design and research methodology in rehabilitation are challenging. Opportunities to prioritize trauma rehabilitation, disability management and social reintegration of multiple injury survivors are discussed. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Cognitive therapy as an early treatment for post-traumatic stress disorder in children and adolescents: a randomized controlled trial addressing preliminary efficacy and mechanisms of action.

PubMed

Meiser-Stedman, Richard; Smith, Patrick; McKinnon, Anna; Dixon, Clare; Trickey, David; Ehlers, Anke; Clark, David M; Boyle, Adrian; Watson, Peter; Goodyer, Ian; Dalgleish, Tim

2017-05-01

Few efficacious early treatments for post-traumatic stress disorder (PTSD) in children and adolescents exist. Previous trials have intervened within the first month post-trauma and focused on secondary prevention of later post-traumatic stress; however, considerable natural recovery may still occur up to 6-months post-trauma. No trials have addressed the early treatment of established PTSD (i.e. 2- to 6-months post-trauma). Twenty-nine youth (8-17 years) with PTSD (according to age-appropriate DSM-IV or ICD-10 diagnostic criteria) after a single-event trauma in the previous 2-6 months were randomly allocated to Cognitive Therapy for PTSD (CT-PTSD; n = 14) or waiting list (WL; n = 15) for 10 weeks. Significantly more participants were free of PTSD after CT-PTSD (71%) than WL (27%) at posttreatment (intent-to-treat, 95% CI for difference .04-.71). CT-PTSD yielded greater improvement on child-report questionnaire measures of PTSD, depression and anxiety; clinician-rated functioning; and parent-reported outcomes. Recovery after CT-PTSD was maintained at 6- and 12-month posttreatment. Beneficial effects of CT-PTSD were mediated through changes in appraisals and safety-seeking behaviours, as predicted by cognitive models of PTSD. CT-PTSD was considered acceptable on the basis of low dropout and high treatment credibility and therapist alliance ratings. This trial provides preliminary support for the efficacy and acceptability of CT-PTSD as an early treatment for PTSD in youth. Moreover, the trial did not support the extension of 'watchful waiting' into the 2- to 6-month post-trauma window, as significant improvements in the WL arm (particularly in terms of functioning and depression) were not observed. Replication in larger samples is needed, but attention to recruitment issues will be required. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

COMBAT: Initial experience with a randomized clinical trial of plasma-based resuscitation in the field for traumatic hemorrhagic shock

PubMed Central

Chapman, Michael P.; Moore, Ernest E.; Chin, Theresa L; Ghasabyan, Arsen; Chandler, James; Stringham, John; Gonzalez, Eduardo; Moore, Hunter B.; Banerjee, Anirban; Silliman, Christopher C; Sauaia, Angela

2015-01-01

The existing evidence shows great promise for plasma as the first resuscitation fluid in both civilian and military trauma. We embarked on the Control of Major Bleeding After Trauma (COMBAT) trial with the support of the Department of Defense, in order to determine if plasma-first resuscitation yields hemostatic and survival benefits. The methodology of the COMBAT study represents not only three years of development work, but the integration of nearly two-decades of technical experience with the design and implementation of other clinical trials and studies. Herein, we describe the key features of the study design, critical personnel and infrastructural elements, and key innovations. We will also briefly outline the systems engineering challenges entailed by this study. COMBAT is a randomized, placebo controlled, semi-blinded prospective Phase IIB clinical trial, conducted in a ground ambulance fleet based at a Level I trauma center, and part of a multicenter collaboration. The primary objective of COMBAT is to determine the efficacy of field resuscitation with plasma first, compared to standard of care (normal saline). To date we have enrolled 30 subjects in the COMBAT study. The ability to achieve intervention with a hemostatic resuscitation agent in the closest possible temporal proximity to injury is critical and represents an opportunity to forestall the evolution of the “bloody vicious cycle”. Thus, the COMBAT model for deploying plasma in first response units should serve as a model for RCTs of other hemostatic resuscitative agents. PMID:25784527

Damage Control Resuscitation: Directly Addressing the Early Coagulopathy of Trauma

DTIC Science & Technology

2007-02-01

FACS, Jay Johannigman, MD, FS, FACS, Peter Mahoney, FRCA, RAMC , Sumeru Mehta, MD, E. Darrin Cox, MD, FACS, Michael J. Gehrke, MD, Greg J. Beilman, MD...opportunity to formally evaluate the immediate and direct treatment of the coagulopathy of trauma is available. Submitted for publication September 22, 2006...the results were not evaluated in randomized human trials.33–35 Additionally, the potential benefits of mitigating ischemia-induced reperfusion injury

Resolving controversies in hip fracture care: the need for large collaborative trials in hip fractures.

PubMed

Bhandari, Mohit; Sprague, Sheila; Schemitsch, Emil H

2009-07-01

Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicate the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip fractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Opportunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial.

PubMed

Holmes, James F; Kelley, Kenneth M; Wootton-Gorges, Sandra L; Utter, Garth H; Abramson, Lisa P; Rose, John S; Tancredi, Daniel J; Kuppermann, Nathan

2017-06-13

The utility of the focused assessment with sonography for trauma (FAST) examination in children is unknown. To determine if the FAST examination during initial evaluation of injured children improves clinical care. A randomized clinical trial (April 2012-May 2015) that involved 975 hemodynamically stable children and adolescents younger than 18 years treated for blunt torso trauma at the University of California, Davis Medical Center, a level I trauma center. Patients were randomly assigned to a standard trauma evaluation with the FAST examination by the treating ED physician or a standard trauma evaluation alone. Coprimary outcomes were rate of abdominal computed tomographic (CT) scans in the ED, missed intra-abdominal injuries, ED length of stay, and hospital charges. Among the 925 patients who were randomized (mean [SD] age, 9.7 [5.3] years; 575 males [62%]), all completed the study. A total of 50 patients (5.4%, 95% CI, 4.0% to 7.1%) were diagnosed with intra-abdominal injuries, including 40 (80%; 95% CI, 66% to 90%) who had intraperitoneal fluid found on an abdominal CT scan, and 9 patients (0.97%; 95% CI, 0.44% to 1.8%) underwent laparotomy. The proportion of patients with abdominal CT scans was 241 of 460 (52.4%) in the FAST group and 254 of 465 (54.6%) in the standard care-only group (difference, -2.2%; 95% CI, -8.7% to 4.2%). One case of missed intra-abdominal injury occurred in a patient in the FAST group and none in the control group (difference, 0.2%; 95% CI, -0.6% to 1.2%). The mean ED length of stay was 6.03 hours in the FAST group and 6.07 hours in the standard care-only group (difference, -0.04 hours; 95% CI, -0.47 to 0.40 hours). Median hospital charges were $46 415 in the FAST group and $47 759 in the standard care-only group (difference, -$1180; 95% CI, -$6651 to $4291). Among hemodynamically stable children treated in an ED following blunt torso trauma, the use of FAST compared with standard care only did not improve clinical care, including use of resources; ED length of stay; missed intra-abdominal injuries; or hospital charges. These findings do not support the routine use of FAST in this setting. clinicaltrials.gov Identifier: NCT01540318.

Sternotomy or drainage for a hemopericardium after penetrating trauma: a randomized controlled trial.

PubMed

Nicol, Andrew J; Navsaria, Pradeep H; Hommes, Martijn; Ball, Chad G; Edu, Sorin; Kahn, Delawir

2014-03-01

To determine if stable patients with a hemopericardium detected after penetrating chest trauma can be safely managed with pericardial drainage alone. The current international practice is to perform a sternotomy and cardiac repair if a hemopericardium is detected after penetrating chest trauma. The experience in Cape Town, South Africa, on performing a mandatory sternotomy in hemodynamically stable patients was that a sternotomy was unnecessary and the cardiac injury, if present, had sealed. A single-center parallel-group randomized controlled study was completed. All hemodynamically stable patients with a hemopericardium confirmed at subxiphoid pericardial window (SPW), and no active bleeding, were randomized. The primary outcome measure was survival to discharge from hospital. Secondary outcomes were complications and postoperative hospital stay. Fifty-five patients were randomized to sternotomy and 56 to pericardial drainage and wash-out only. Fifty-one of the 55 patients (93%) randomized to sternotomy had either no cardiac injury or a tangential injury. There were only 4 patients with penetrating wounds to the endocardium and all had sealed. There was 1 death postoperatively among the 111 patients (0.9%) and this was in the sternotomy group. The mean intensive care unit (ICU) stay for a sternotomy was 2.04 days (range, 0-25 days) compared with 0.25 days (range, 0-2) for the drainage (P < 0.001). The estimated mean difference highlighted a stay of 1.8 days shorter in the ICU for the drainage group (95% CI: 0.8-2.7). Total hospital stay was significantly shorter in the SPW group (P < 0.001; 95% CI: 1.4-3.3). SPW and drainage is effective and safe in the stable patient with a hemopericardium after penetrating chest trauma, with no increase in mortality and a shorter ICU and hospital stay. (ClinicalTrials.gov Identifier: NCT00823160).

Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial

PubMed Central

Farris, Coreen; Fischhoff, Baruch; Rosengart, Matthew R; Angus, Derek C; Yealy, Donald M; Wallace, David J; Barnato, Amber E

2017-01-01

Abstract Objective To determine whether a behavioral intervention delivered through a video game can improve the appropriateness of trauma triage decisions in the emergency department of non-trauma centers. Design Randomized clinical trial. Setting Online intervention in national sample of emergency medicine physicians who make triage decisions at US hospitals. Participants 368 emergency medicine physicians primarily working at non-trauma centers. A random sample (n=200) of those with primary outcome data was reassessed at six months. Interventions Physicians were randomized in a 1:1 ratio to one hour of exposure to an adventure video game (Night Shift) or apps based on traditional didactic education (myATLS and Trauma Life Support MCQ Review), both on iPads. Night Shift was developed to recalibrate the process of using pattern recognition to recognize moderate-severe injuries (representativeness heuristics) through the use of stories to promote behavior change (narrative engagement). Physicians were randomized with a 2×2 factorial design to intervention (game v traditional education apps) and then to the experimental condition under which they completed the outcome assessment tool (low v high cognitive load). Blinding could not be maintained after allocation but group assignment was masked during the analysis phase. Main outcome measures Outcomes of a virtual simulation that included 10 cases; in four of these the patients had severe injuries. Participants completed the simulation within four weeks of their intervention. Decisions to admit, discharge, or transfer were measured. The proportion of patients under-triaged (patients with severe injuries not transferred to a trauma center) was calculated then (primary outcome) and again six months later, with a different set of cases (primary outcome of follow-up study). The secondary outcome was effect of cognitive load on under-triage. Results 149 (81%) physicians in the game arm and 148 (80%) in the traditional education arm completed the trial. Of these, 64/100 (64%) and 58/100 (58%), respectively, completed reassessment at six months. The mean age was 40 (SD 8.9), 283 (96%) were trained in emergency medicine, and 207 (70%) were ATLS (advanced trauma life support) certified. Physicians exposed to the game under-triaged fewer severely injured patients than those exposed to didactic education (316/596 (0.53) v 377/592 (0.64), estimated difference 0.11, 95% confidence interval 0.05 to 0.16; P<0.001). Cognitive load did not influence under-triage (161/308 (0.53) v 155/288 (0.54) in the game arm; 197/300 (0.66) v 180/292 (0.62) in the traditional educational apps arm; P=0.66). At six months, physicians exposed to the game remained less likely to under-triage patients (146/256 (0.57) v 172/232 (0.74), estimated difference 0.17, 0.09 to 0.25; P<0.001). No physician reported side effects. The sample might not reflect all emergency medicine physicians, and a small set of cases was used to assess performance. Conclusions Compared with apps based on traditional didactic education, exposure of physicians to a theoretically grounded video game improved triage decision making in a validated virtual simulation. Though the observed effect was large, the wide confidence intervals include the possibility of a small benefit, and the real world efficacy of this intervention remains uncertain. Trial registration clinicaltrials.gov; NCT02857348 (initial study)/NCT03138304 (follow-up). PMID:29233854

Empirically Assessing Participant Perceptions of the Research Experience in a Randomized Clinical Trial: The Women's Self-Defense Project as a Case Example.

PubMed

Weitlauf, Julie C; Ruzek, Josef I; Westrup, Darrah A; Lee, Tina; Keller, Jennifer

2007-06-01

A growing body of empirical literature has systematically documented the reactions to research participation among participants in traumafocused research. To date, the available data has generally presented an optimistic picture regarding participants' ability to tolerate and even find benefit from their participation. However, this literature has been largely limited to cross-sectional designs. No extant literature has yet examined the perceptions of participants with psychiatric illness who are participating in randomized clinical trials (RCTs) designed to evaluate the efficacy or effectiveness of novel trauma treatments. The authors posit that negative experiences of, or poor reactions to, the research experience in the context of a trauma-focused RCT may elevate the risk of participation. Indeed, negative reactions may threaten to undermine the potential therapeutic gains of participants and promoting early drop out from the trial. Empirically assessing reactions to research participation at the pilot-study phase of a clinical trial can both provide investigators and IRB members alike with empirical evidence of some likely risks of participation. In turn, this information can be used to help shape the design and recruitment methodology of the full-scale trial. Using data from the pilot study of the Women's Self-Defense Project as a case illustration, we provide readers with concrete suggestions for empirically assessing participants' perceptions of risk involved in their participation in behaviorally oriented clinical trials.

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms.

PubMed

Tesarz, Jonas; Gerhardt, Andreas; Leisner, Sabine; Janke, Susanne; Hartmann, Mechthild; Seidler, Günther H; Eich, Wolfgang

2013-08-30

Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient.Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma.Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later.The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0-10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment.In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed.The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner. This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients. This trial has been registered with ClinicalTrials.gov (NCT01850875).

CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media

PubMed Central

Binz, Sophia; McCollester, Jonathon; Thomas, Scott; Miller, Joseph; Pohlman, Timothy; Waxman, Dan; Shariff, Faisal; Tracy, Rebecca; Walsh, Mark

2015-01-01

This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences. PMID:26448897

CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media.

PubMed

Binz, Sophia; McCollester, Jonathon; Thomas, Scott; Miller, Joseph; Pohlman, Timothy; Waxman, Dan; Shariff, Faisal; Tracy, Rebecca; Walsh, Mark

2015-01-01

This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences.

Effects of psychotherapies for posttraumatic stress disorder on sleep disturbances: Results from a randomized clinical trial.

PubMed

Woodward, Elizabeth; Hackmann, Ann; Wild, Jennifer; Grey, Nick; Clark, David M; Ehlers, Anke

2017-10-01

The effectiveness and mechanisms of psychotherapies for posttraumatic stress disorder (PTSD) in treating sleep problems is of interest. This study compared the effects of a trauma-focused and a non-trauma-focused psychotherapy on sleep, to investigate whether 1) sleep improves with psychotherapy for PTSD; 2) the degree of sleep improvement depends on whether the intervention is trauma or nontrauma-focused; 3) the memory-updating procedure in cognitive therapy for PTSD (CT-PTSD) is associated with sleep improvements; 4) initial sleep duration affects PTSD treatment outcome; and 5) which symptom changes are associated with sleep duration improvements. Self-reported sleep was assessed during a randomized controlled trial (Ehlers et al., 2014) comparing CT-PTSD (delivered weekly or intensively over 7-days) with emotion-focused supportive therapy, and a waitlist. Sleep duration was reported daily in sleep diaries during intensive CT-PTSD. CT-PTSD led to greater increases in sleep duration (55.2 min) and reductions in insomnia symptoms and nightmares than supportive therapy and the waitlist. In intensive CT-PTSD, sleep duration improved within 7 days, and sleep diaries indicated a 40-min sleep duration increase after updating trauma memories. Initial sleep duration was not related to CT-PTSD treatment outcome when initial PTSD symptom severity was controlled. The results suggest that trauma-focused psychotherapy for PTSD is more effective than nontrauma-focused therapy in improving self-reported sleep, and that CT-PTSD can still be effective in the presence of reduced sleep duration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.

PubMed

Shakur, Haleema; Roberts, Ian; Bautista, Raúl; Caballero, José; Coats, Tim; Dewan, Yashbir; El-Sayed, Hesham; Gogichaishvili, Tamar; Gupta, Sanjay; Herrera, Jorge; Hunt, Beverley; Iribhogbe, Pius; Izurieta, Mario; Khamis, Hussein; Komolafe, Edward; Marrero, María-Acelia; Mejía-Mantilla, Jorge; Miranda, Jaime; Morales, Carlos; Olaomi, Oluwole; Olldashi, Fatos; Perel, Pablo; Peto, Richard; Ramana, P V; Ravi, R R; Yutthakasemsunt, Surakrant

2010-07-03

Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919. 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077). Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.

Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial

PubMed Central

2014-01-01

Background Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home. Methods/Design This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, ‘Head CT Choice’, to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child’s risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up. Discussion This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs. Trial registration ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014. PMID:24965659

Primary repair of penetrating colon injuries: a systematic review.

PubMed

Singer, Marc A; Nelson, Richard L

2002-12-01

Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

Intranasal Oxytocin to Prevent Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial in Emergency Department Patients.

PubMed

van Zuiden, Mirjam; Frijling, Jessie L; Nawijn, Laura; Koch, Saskia B J; Goslings, J Carel; Luitse, Jan S; Biesheuvel, Tessa H; Honig, Adriaan; Veltman, Dick J; Olff, Miranda

2017-06-15

There are currently few preventive interventions available for posttraumatic stress disorder (PTSD). Intranasal oxytocin administration early after trauma may prevent PTSD, because oxytocin administration was previously found to beneficially impact PTSD vulnerability factors, including neural fear responsiveness, peripheral stress reactivity, and socioemotional functioning. Therefore, we investigated the effects of intranasal oxytocin administration early after trauma on subsequent clinician-rated PTSD symptoms. We then assessed whether baseline characteristics moderated the intervention's effects. We performed a multicenter, randomized, double-blind, placebo-controlled clinical trial. Adult emergency department patients with moderate to severe acute distress (n = 120; 85% accident victims) were randomized to intranasal oxytocin (8 days/40 IU twice daily) or placebo (8 days/10 puffs twice daily), initiated within 12 days posttrauma. The Clinician-Administered PTSD Scale (CAPS) was administered at baseline (within 10 days posttrauma) and at 1.5, 3, and 6 months posttrauma. The intention-to-treat sample included 107 participants (oxytocin: n = 53; placebo: n = 54). We did not observe a significant group difference in CAPS total score at 1.5 months posttrauma (primary outcome) or across follow-up (secondary outcome). Secondary analyses showed that participants with high baseline CAPS scores receiving oxytocin had significantly lower CAPS scores across follow-up than participants with high baseline CAPS scores receiving placebo. Oxytocin administration early after trauma did not attenuate clinician-rated PTSD symptoms in all trauma-exposed participants with acute distress. However, participants with high acute clinician-rated PTSD symptom severity did show beneficial effects of oxytocin. Although replication is warranted, these findings suggest that oxytocin administration is a promising preventive intervention for PTSD for individuals with high acute PTSD symptoms. Copyright © 2016 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

PubMed

Moreno-Alcázar, Ana; Radua, Joaquim; Landín-Romero, Ramon; Blanco, Laura; Madre, Mercè; Reinares, Maria; Comes, Mercè; Jiménez, Esther; Crespo, Jose Manuel; Vieta, Eduard; Pérez, Victor; Novo, Patricia; Doñate, Marta; Cortizo, Romina; Valiente-Gómez, Alicia; Lupo, Walter; McKenna, Peter J; Pomarol-Clotet, Edith; Amann, Benedikt L

2017-04-04

Up to 60% of patients with bipolar disorder (BD) have a history of traumatic events, which is associated with greater episode severity, higher risk of comorbidity and higher relapse rates. Trauma-focused treatment strategies for BD are thus necessary but studies are currently scarce. The aim of this study is to examine whether Eye Movement Desensitization and Reprocessing (EMDR) therapy focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and mood stabilization can reduce episode severity and relapse rates and increase cognitive performance and functioning in patients with BD. This is a single-blind, randomized controlled, multicentre trial in which 82 patients with BD and a history of traumatic events will be recruited and randomly allocated to one of two treatment arms: EMDR therapy or supportive therapy. Patients in both groups will receive 20 psychotherapeutic sessions, 60 min each, during 6 months. The primary outcome is a reduction of affective episodes after 12 and 24 months in favour of the EMDR group. As secondary outcome we postulate a greater reduction in affective symptoms in the EMDR group (as measured by the Bipolar Depression Rating Scale, the Young Mania Rating Scale and the Clinical Global Impression Scale modified for BD), and a better performance in cognitive state, social cognition and functioning (as measured by the Screen for Cognitive Impairment in Psychiatry, The Mayer-Salovey-Caruso Emotional Intelligence Test and the Functioning Assessment Short Test, respectively). Traumatic events will be evaluated by The Holmes-Rahe Life Stress Inventory, the Clinician-administered PTSD Scale and the Impact of Event Scale. The results of this study will provide evidence whether a specific EMDR protocol for patients with BD is effective in reducing affective episodes, affective symptoms and functional, cognitive and trauma symptoms. The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on 3 December 2015.

Cognitive-behavioral therapy for sleep disturbances in treating posttraumatic stress disorder symptoms: A meta-analysis of randomized controlled trials.

PubMed

Ho, Fiona Yan-Yee; Chan, Christian S; Tang, Kristen Nga-Sze

2016-02-01

Sleep disturbances are frequently reported in patients with posttraumatic stress disorder (PTSD). There is evidence that sleep disturbance is not only a secondary symptom but also a risk factor for PTSD. Sleep-specific psychological treatments provide an alternative to conventional trauma-focused psychological treatments. The current meta-analysis evaluated the efficacy of sleep-specific cognitive-behavioral therapy (CBT) in mitigating PTSD, sleep, and depressive symptoms. A total of 11 randomized controlled trials were included in the meta-analytic comparisons between sleep-specific CBT and waiting-list control groups at posttreatment. Random effects models showed significant reduction in self-report PTSD and depressive symptoms and insomnia severity in the sleep-specific CBT group. The corresponding effect sizes, measured in Hedges' g, were 0.58, 0.44, and 1.15, respectively. The effect sizes for sleep diary-derived sleep onset latency, wake after sleep onset, and sleep efficiency were 0.83, 1.02 and 1.15, respectively. The average study attrition rate of sleep-specific CBT was relatively low (12.8%), with no significant difference from the control group (9.4%). In conclusion, sleep-specific CBT appears to be efficacious and feasible in treating PTSD symptoms. Due to the relatively small number of randomized controlled trials available, further research is warranted to confirm its efficacy and acceptability, especially in comparison to trauma-specific psychological treatments. Copyright © 2015 Elsevier Ltd. All rights reserved.

Immediate total-body CT scanning versus conventional imaging and selective CT scanning in patients with severe trauma (REACT-2): a randomised controlled trial.

PubMed

Sierink, Joanne C; Treskes, Kaij; Edwards, Michael J R; Beuker, Benn J A; den Hartog, Dennis; Hohmann, Joachim; Dijkgraaf, Marcel G W; Luitse, Jan S K; Beenen, Ludo F M; Hollmann, Markus W; Goslings, J Carel

2016-08-13

Published work suggests a survival benefit for patients with trauma who undergo total-body CT scanning during the initial trauma assessment; however, level 1 evidence is absent. We aimed to assess the effect of total-body CT scanning compared with the standard work-up on in-hospital mortality in patients with trauma. We undertook an international, multicentre, randomised controlled trial at four hospitals in the Netherlands and one in Switzerland. Patients aged 18 years or older with trauma with compromised vital parameters, clinical suspicion of life-threatening injuries, or severe injury were randomly assigned (1:1) by ALEA randomisation to immediate total-body CT scanning or to a standard work-up with conventional imaging supplemented with selective CT scanning. Neither doctors nor patients were masked to treatment allocation. The primary endpoint was in-hospital mortality, analysed in the intention-to-treat population and in subgroups of patients with polytrauma and those with traumatic brain injury. The χ(2) test was used to assess differences in mortality. This trial is registered with ClinicalTrials.gov, number NCT01523626. Between April 22, 2011, and Jan 1, 2014, 5475 patients were assessed for eligibility, 1403 of whom were randomly assigned: 702 to immediate total-body CT scanning and 701 to the standard work-up. 541 patients in the immediate total-body CT scanning group and 542 in the standard work-up group were included in the primary analysis. In-hospital mortality did not differ between groups (total-body CT 86 [16%] of 541 vs standard work-up 85 [16%] of 542; p=0.92). In-hospital mortality also did not differ between groups in subgroup analyses in patients with polytrauma (total-body CT 81 [22%] of 362 vs standard work-up 82 [25%] of 331; p=0.46) and traumatic brain injury (68 [38%] of 178 vs 66 [44%] of 151; p=0.31). Three serious adverse events were reported in patients in the total-body CT group (1%), one in the standard work-up group (<1%), and one in a patient who was excluded after random allocation. All five patients died. Diagnosing patients with an immediate total-body CT scan does not reduce in-hospital mortality compared with the standard radiological work-up. Because of the increased radiation dose, future research should focus on the selection of patients who will benefit from immediate total-body CT. ZonMw, the Netherlands Organisation for Health Research and Development. Copyright © 2016 Elsevier Ltd. All rights reserved.

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

PubMed

Raaben, Marco; Redzwan, Syaiful; Augustine, Robin; Blokhuis, Taco Johan

2018-04-12

Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

Trauma-Informed Mindfulness-Based Stress Reduction for Female Survivors of Interpersonal Violence: Results From a Stage I RCT.

PubMed

Kelly, Amber; Garland, Eric L

2016-04-01

This pilot randomized controlled trial evaluated a novel trauma-informed model of mindfulness-based stress reduction (TI-MBSR) as a phase I trauma intervention for female survivors of interpersonal violence (IPV). A community-based sample of women (mean age = 41.5, standard deviation = 14.6) with a history of IPV was randomly assigned to an 8-week TI-MBSR intervention (n = 23) or a waitlist control group (n = 22). Symptoms of posttraumatic stress disorder (PTSD) and depression as well as anxious and avoidant attachment were assessed pre- and postintervention. Relative to the control group, participation in TI-MBSR was associated with statistically and clinically significant decreases in PTSD and depressive symptoms and significant reductions in anxious attachment. Retention in the intervention was high, with most participants completing at least 5 of the 8 sessions for the intervention. Minutes of mindfulness practice per week significantly predicted reductions in PTSD symptoms. TI-MBSR appears to be a promising and feasible phase I intervention for female survivors of interpersonal trauma. © 2016 Wiley Periodicals, Inc.

Trauma-related emotions and radical acceptance in dialectical behavior therapy for posttraumatic stress disorder after childhood sexual abuse.

PubMed

Görg, Nora; Priebe, Kathlen; Böhnke, Jan R; Steil, Regina; Dyer, Anne S; Kleindienst, Nikolaus

2017-01-01

Posttraumatic Stress Disorder (PTSD) related to childhood sexual abuse (CSA) is often associated with a wide range of trauma-related aversive emotions such as fear, disgust, sadness, shame, guilt, and anger. Intense experience of aversive emotions in particular has been linked to higher psychopathology in trauma survivors. Most established psychosocial treatments aim to reduce avoidance of trauma-related memories and associated emotions. Interventions based on Dialectical Behavior Therapy (DBT) also foster radical acceptance of the traumatic event. This study compares individual ratings of trauma-related emotions and radical acceptance between the start and the end of DBT for PTSD (DBT-PTSD) related to CSA. We expected a decrease in trauma-related emotions and an increase in acceptance. In addition, we tested whether therapy response according to the Clinician Administered PTSD-Scale (CAPS) for the DSM-IV was associated with changes in trauma-related emotions and acceptance. The data was collected within a randomized controlled trial testing the efficacy of DBT-PTSD, and a subsample of 23 women was included in this secondary data analysis. In a multilevel model, shame, guilt, disgust, distress, and fear decreased significantly from the start to the end of the therapy whereas radical acceptance increased. Therapy response measured with the CAPS was associated with change in trauma-related emotions. Trauma-related emotions and radical acceptance showed significant changes from the start to the end of DBT-PTSD. Future studies with larger sample sizes and control group designs are needed to test whether these changes are due to the treatment. ClinicalTrials.gov, number NCT00481000.

Effectiveness of Phosphodiesterase 5 Inhibitors in the Treatment of Erectile Dysfunction in Patients with Spinal Cord Trauma: Systematic Review and Meta-Analysis.

PubMed

García-Perdomo, Herney Andrés; Echeverría-García, Fernando; Tobías, Aurelio

2017-01-01

To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma. A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed. Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%). PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI. © 2016 S. Karger AG, Basel.

Audit filters for improving processes of care and clinical outcomes in trauma systems.

PubMed

Evans, Christopher; Howes, Daniel; Pickett, William; Dagnone, Luigi

2009-10-07

Traumatic injuries represent a considerable public health burden with significant personal and societal costs. The care of the severely injured patient in a trauma system progresses along a continuum that includes numerous interventions being provided by a multidisciplinary group of healthcare personnel. Despite the recent emphasis on quality of care in medicine, there has been little research to direct trauma clinicians and administrators on how optimally to monitor and improve upon the quality of care delivered within a trauma system. Audit filters are one mechanism for improving quality of care and are defined as specific clinical processes or outcomes of care that, when they occur, represent unfavorable deviations from an established norm and which prompt review and feedback. Although audit filters are widely utilized for performance improvement in trauma systems they have not been subjected to systematic review of their effectiveness. To determine the effectiveness of using audit filters for improving processes of care and clinical outcomes in trauma systems. Our search strategy included an electronic search of the Cochrane Injuries Group Specialized Register, the Cochrane EPOC Group Specialized Register, CENTRAL (The Cochrane Library 2008, Issue 4), MEDLINE, PubMed, EMBASE, CINAHL, and ISI Web of Science: (SCI-EXPANDED and CPCI-S). We handsearched the Journal of Trauma, Injury, Annals of Emergency Medicine, Academic Emergency Medicine, and Injury Prevention. We searched two clinical trial registries: 1) The World Health Organization International Clinical Trials Registry Platform and, 2) Clinical Trials.gov. We also contacted content experts for further articles. The most recent electronic search was completed in December 2008 and the handsearch was completed up to February 2009. We searched for randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series studies that used audit filters as an intervention for improving processes of care, morbidity, or mortality for severely injured patients. Two authors independently screened the search results, applied inclusion criteria, and extracted data. There were no studies identified that met the inclusion criteria for this review. We were unable to identify any studies of sufficient methodological quality to draw conclusions regarding the effectiveness of audit filters as a performance improvement intervention in trauma systems. Future research using rigorous study designs should focus on the relative effectiveness of audit filters in comparison to alternative quality improvement strategies at improving processes of care, functional outcomes, and mortality for injured patients.

Facts and Fiction: The Impact of Hypothermia on Molecular Mechanisms following Major Challenge

PubMed Central

Frink, Michael; Flohé, Sascha; van Griensven, Martijn; Mommsen, Philipp; Hildebrand, Frank

2012-01-01

Numerous multiple trauma and surgical patients suffer from accidental hypothermia. While induced hypothermia is commonly used in elective cardiac surgery due to its protective effects, accidental hypothermia is associated with increased posttraumatic complications and even mortality in severely injured patients. This paper focuses on protective molecular mechanisms of hypothermia on apoptosis and the posttraumatic immune response. Although information regarding severe trauma is limited, there is evidence that induced hypothermia may have beneficial effects on the posttraumatic immune response as well as apoptosis in animal studies and certain clinical situations. However, more profound knowledge of mechanisms is necessary before randomized clinical trials in trauma patients can be initiated. PMID:22481864

Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial.

PubMed

Giese-Davis, Janine; Bliss-Isberg, Caroline; Wittenberg, Lynne; White, Jennifer; Star, Path; Zhong, Lihong; Cordova, Matthew J; Houston, Debra; Spiegel, David

2016-08-01

We conducted a randomized controlled trial of peer-counseling for newly diagnosed breast cancer (BC) patients as a community/research collaboration testing an intervention developed jointly by a community-based-organization serving women with cancer and university researchers. We recruited 104 women newly diagnosed with BC at any disease stage. Prior to randomization, all received a one-time visit with an oncology nurse who offered information and resources. Afterwards, we randomized half to receive a match with a Navigator with whom they could have contact for up to 6 months. We recruited, trained, and supervised 30 peer counselors who became "Navigators." They were at least one-year post-diagnosis with BC. Controls received no further intervention. We tested the effect of intervention on breast-cancer-specific well-being and trauma symptoms as primary outcomes, and several secondary outcomes. In exploratory analyses, we tested whether responding to their diagnosis as a traumatic stressor moderated outcomes. We found that, compared with the control group, receiving a peer-counseling intervention significantly improved breast-cancer-specific well-being (p=0.01, Cohen's d=0.41) and maintained marital adjustment (p=0.01, Cohen's d=0.45) more effectively. Experiencing the diagnosis as a traumatic stressor moderated outcomes: those with a peer counselor in the traumatic stressor group improved significantly more than controls on well-being, trauma and depression symptoms, and cancer self-efficacy. Having a peer counselor trained and supervised to recognize and work with trauma symptoms can improve well-being and psychosocial morbidity during the first year following diagnosis of BC. Cancer 2016;122:2408-2417. © 2016 American Cancer Society. © 2016 American Cancer Society.

Guidelines for the Prevention of Infection After Combat-Related Injuries

DTIC Science & Technology

2008-03-01

randomized con - trol trials or cohort studies that could be incorporated into the guidelines. In addition, civilian trauma articles, primarily randomized...when patients are unable to tolerate oral medication, the TCCC also has pro - vided recommendations for intravenous or intramuscular agents to use in...Level I) is typically provided by a physician assistant or a general medical officer (general med- ical officer ( GMO )—physician with at least 1 year of

Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma.

PubMed

Stengel, Dirk; Rademacher, Grit; Ekkernkamp, Axel; Güthoff, Claas; Mutze, Sven

2015-09-14

Ultrasonography (performed by means of a four-quadrant, focused assessment of sonography for trauma (FAST)) is regarded as a key instrument for the initial assessment of patients with suspected blunt abdominal and thoraco-abdominal trauma in the emergency department setting. FAST has a high specificity but low sensitivity in detecting and excluding visceral injuries. Proponents of FAST argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of unnecessary multi-detector computed tomography (MDCT) scans, and enable quicker triage to surgical and non-surgical care. Given the proven accuracy, increasing availability of, and indication for, MDCT among patients with blunt abdominal and multiple injuries, we aimed to compile the best available evidence of the use of FAST-based assessment compared with other primary trauma assessment protocols. To assess the effects of diagnostic algorithms using ultrasonography including in FAST examinations in the emergency department in relation to the early, late, and overall mortality of patients with suspected blunt abdominal trauma. The most recent search was run on 30th June 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), EMBASE (OvidSP), ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), clinical trials registers, and screened reference lists. Trial authors were contacted for further information and individual patient data. We included randomised controlled trials (RCTs). Participants were patients with blunt torso, abdominal, or multiple trauma undergoing diagnostic investigations for abdominal organ injury. The intervention was diagnostic algorithms comprising emergency ultrasonography (US). The control was diagnostic algorithms without US examinations (for example, primary computed tomography (CT) or diagnostic peritoneal lavage (DPL)). Outcomes were mortality, use of CT or invasive procedures (DPL, laparoscopy, laparotomy), and cost-effectiveness. Two authors (DS and CG) independently selected trials for inclusion, assessed methodological quality, and extracted data. Methodological quality was assessed using the Cochrane Collaboration risk of bias tool. Where possible, data were pooled and relative risks (RRs), risk differences (RDs), and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed-effect or random-effects models as appropriate. We identified four studies meeting our inclusion criteria. Overall, trials were of poor to moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. Strong heterogeneity amongst the trials prompted discussion between the review authors as to whether the data should or should not be pooled; we decided in favour of a quantitative synthesis to provide a rough impression about the effect sizes achievable with US-based triage algorithms. We pooled mortality data from three trials involving 1254 patients; the RR in favour of the FAST arm was 1.00 (95% CI 0.50 to 2.00). FAST-based pathways reduced the number of CT scans (random-effects model RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result was unclear. The experimental evidence justifying FAST-based clinical pathways in diagnosing patients with suspected abdominal or multiple blunt trauma remains poor. Because of strong heterogeneity between the trial results, the quantitative information provided by this review may only be used in an exploratory fashion. It is unlikely that FAST will ever be investigated by means of a confirmatory, large-scale RCT in the future. Thus, this Cochrane Review may be regarded as a review which provides the best available evidence for clinical practice guidelines and management recommendations. It can only be concluded from the few head-to-head studies that negative US scans are likely to reduce the incidence of MDCT scans which, given the low sensitivity of FAST (or reliability of negative results), may adversely affect the diagnostic yield of the trauma survey. At best, US has no negative impact on mortality or morbidity. Assuming that major blunt abdominal or multiple trauma is associated with 15% mortality and a CT-based diagnostic work-up is considered the current standard of care, 874, 3495, or 21,838 patients are needed per intervention group to demonstrate non-inferiority of FAST to CT-based algorithms with non-inferiority margins of 5%, 2.5%, and 1%, power of 90%, and a type-I error alpha of 5%.

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911 PMID:23072576

Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial.

PubMed

Mohan, Deepika; Farris, Coreen; Fischhoff, Baruch; Rosengart, Matthew R; Angus, Derek C; Yealy, Donald M; Wallace, David J; Barnato, Amber E

2017-12-12

To determine whether a behavioral intervention delivered through a video game can improve the appropriateness of trauma triage decisions in the emergency department of non-trauma centers. Randomized clinical trial. Online intervention in national sample of emergency medicine physicians who make triage decisions at US hospitals. 368 emergency medicine physicians primarily working at non-trauma centers. A random sample (n=200) of those with primary outcome data was reassessed at six months. Physicians were randomized in a 1:1 ratio to one hour of exposure to an adventure video game (Night Shift) or apps based on traditional didactic education (myATLS and Trauma Life Support MCQ Review), both on iPads. Night Shift was developed to recalibrate the process of using pattern recognition to recognize moderate-severe injuries (representativeness heuristics) through the use of stories to promote behavior change (narrative engagement). Physicians were randomized with a 2×2 factorial design to intervention (game v traditional education apps) and then to the experimental condition under which they completed the outcome assessment tool (low v high cognitive load). Blinding could not be maintained after allocation but group assignment was masked during the analysis phase. Outcomes of a virtual simulation that included 10 cases; in four of these the patients had severe injuries. Participants completed the simulation within four weeks of their intervention. Decisions to admit, discharge, or transfer were measured. The proportion of patients under-triaged (patients with severe injuries not transferred to a trauma center) was calculated then (primary outcome) and again six months later, with a different set of cases (primary outcome of follow-up study). The secondary outcome was effect of cognitive load on under-triage. 149 (81%) physicians in the game arm and 148 (80%) in the traditional education arm completed the trial. Of these, 64/100 (64%) and 58/100 (58%), respectively, completed reassessment at six months. The mean age was 40 (SD 8.9), 283 (96%) were trained in emergency medicine, and 207 (70%) were ATLS (advanced trauma life support) certified. Physicians exposed to the game under-triaged fewer severely injured patients than those exposed to didactic education (316/596 (0.53) v 377/592 (0.64), estimated difference 0.11, 95% confidence interval 0.05 to 0.16; P<0.001). Cognitive load did not influence under-triage (161/308 (0.53) v 155/288 (0.54) in the game arm; 197/300 (0.66) v 180/292 (0.62) in the traditional educational apps arm; P=0.66). At six months, physicians exposed to the game remained less likely to under-triage patients (146/256 (0.57) v 172/232 (0.74), estimated difference 0.17, 0.09 to 0.25; P<0.001). No physician reported side effects. The sample might not reflect all emergency medicine physicians, and a small set of cases was used to assess performance. Compared with apps based on traditional didactic education, exposure of physicians to a theoretically grounded video game improved triage decision making in a validated virtual simulation. Though the observed effect was large, the wide confidence intervals include the possibility of a small benefit, and the real world efficacy of this intervention remains uncertain. clinicaltrials.gov; NCT02857348 (initial study)/NCT03138304 (follow-up). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Prehospital Use of Cervical Collars in Trauma Patients: A Critical Review

PubMed Central

Asbjørnsen, Helge; Habiba, Samer; Sunde, Geir Arne; Wester, Knut

2014-01-01

Abstract The cervical collar has been routinely used for trauma patients for more than 30 years and is a hallmark of state-of-the-art prehospital trauma care. However, the existing evidence for this practice is limited: Randomized, controlled trials are largely missing, and there are uncertain effects on mortality, neurological injury, and spinal stability. Even more concerning, there is a growing body of evidence and opinion against the use of collars. It has been argued that collars cause more harm than good, and that we should simply stop using them. In this critical review, we discuss the pros and cons of collar use in trauma patients and reflect on how we can move our clinical practice forward. Conclusively, we propose a safe, effective strategy for prehospital spinal immobilization that does not include routine use of collars. PMID:23962031

Performance in a blocked versus randomized emotional Stroop task in an aged, early traumatized group with and without posttraumatic stress symptoms.

PubMed

Wittekind, Charlotte E; Muhtz, Christoph; Moritz, Steffen; Jelinek, Lena

2017-03-01

Attentional biases (AB) for trauma-related stimuli have been examined in many studies assessing different trauma samples. In emotional Stroop tasks (EST), blocked and single-trial formats are used almost interchangeably in clinical research. There is reason to believe that different designs yield different results and assess different processes, which, however, has been hardly examined in studies. Furthermore, there is a dearth of information about AB in older trauma survivors with posttraumatic stress symptoms. Older adults with (n = 20) and without PTSD symptoms (n = 26) as well as non-traumatized controls (n = 21) completed an EST, in which words were presented both blocked and randomized. Analyses revealed that individuals with PTSD symptoms showed AB for trauma- and depression-related words; however, mode of administration did not significantly influence reaction times. The emotional Stroop task cannot disentangle the underlying cognitive mechanism (i.e., facilitation, interference, avoidance). PTSD symptoms in older trauma survivors are associated with AB. Overall, participants with PTSD symptoms did not show greater impairment of cognitive control in comparison to both control groups. Results also illustrate that methodological differences between task versions need to be considered more thoroughly. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pilot randomized controlled trial of Tuning Relationships with Music: Intervention for parents with a trauma history and their adolescent.

PubMed

Colegrove, Vivienne M; Havighurst, Sophie S; Kehoe, Christiane E; Jacobsen, Stine L

2018-05-01

For parents who have experienced childhood interpersonal trauma, the challenges of parenting an adolescent may trigger memories of abuse, intensifying conflict, resulting in negative cycles of relating and poorer responsiveness to emotions when parenting. This study examined whether Tuning Relationships with Music, a dyadic therapy for parents and adolescents, increased responsive parent-adolescent interactions and parent emotion coaching whilst reducing conflict and adolescent mental health difficulties. Twenty-six parent-adolescent dyads were recruited if parents had a trauma history and the dyad were currently having high levels of conflict. Dyads were randomly allocated into intervention or wait-list control and completed questionnaires and observation assessments at baseline and 4-month post-baseline follow-up. Those allocated to the intervention condition participated in 8 sessions of Tuning Relationships with Music. ANZCTR: 12615000814572. Parents and adolescents reported significant reductions in conflict. Parents in the intervention condition were observed to significantly improve their nonverbal communication, emotional responsiveness and non-reactivity toward their adolescent. Although parents reported they were less dismissive and punitive, and more encouraging of their adolescent's emotions, and both parents and adolescents reported improvements in the adolescent's mental health, these were not statistically significant. Findings suggest Tuning Relationships with Music may assist parents with a history of childhood interpersonal trauma and their adolescent to reduce conflict and increase responsive ways of relating that may positively impact the young person's mental health. Future trials with a larger sample are warranted. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effects of advanced life support versus basic life support on the mortality rates of patients with trauma in prehospital settings: a study protocol for a systematic review and meta-analysis

PubMed Central

Kondo, Yutaka; Fukuda, Tatsuma; Uchimido, Ryo; Hifumi, Toru; Hayashida, Kei

2017-01-01

Introduction Advanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature. Methods and analysis We will perform searches in PubMed, Embase and the Cochrane Central Register of Controlled Trials for published observational studies, controlled before-and-after studies, randomised controlled trials and other controlled trials conducted in humans and published until March 2017. We will screen search results, assess study selection, extract data and assess the risk of bias in duplicate; disagreements will be resolved through discussions. Data from clinically homogeneous studies will be pooled using a random-effects meta-analysis, heterogeneity of effects will be assessed using the χ2 test of homogeneity, and any observed heterogeneity will be quantified using the I2 statistic. Last, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to rate the quality of the evidence. Ethics and dissemination Our study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information. Trial registration number PROSPERO (International Prospective Register of Systematic Reviews) registration number CRD42017054389. PMID:29061611

Prolonged Exposure versus Dynamic Therapy for Adolescent PTSD: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Gilboa-Schechtman, Eva; Foa, Edna B.; Shafran, Naama; Aderka, Idan M.; Powers, Mark B.; Rachamim, Lilach; Rosenbach, Lea; Yadin, Elna; Apter, Alan

2010-01-01

Objective: To examine the efficacy and maintenance of developmentally adapted prolonged exposure therapy for adolescents (PE-A) compared with active control time-limited dynamic therapy (TLDP-A) for decreasing posttraumatic and depressive symptoms in adolescent victims of single-event traumas. Method: Thirty-eight adolescents (12 to 18 years old)…

Randomized Trial of Law Enforcement Training on Autism Spectrum Disorders

ERIC Educational Resources Information Center

Teagardin, Jill; Dixon, Dennis R.; Smith, Marlena N.; Granpeesheh, Doreen

2012-01-01

The core symptoms of autism spectrum disorders (ASD) are likely to affect interactions between law enforcement officers and persons with ASD. If law enforcement officers are not trained to identify and appropriately respond to persons with ASD, it is possible that officers may exacerbate a situation, resulting in unnecessary trauma, injury, or…

Does Narrative Exposure Therapy Reduce PTSD in Survivors of Mass Violence?

ERIC Educational Resources Information Center

McPherson, Jane

2012-01-01

Purpose: This review examines the effectiveness of narrative exposure therapy (NET) , a short-term intervention for posttraumatic stress disorder (PTSD) in survivors of mass violence and torture, who have often suffered multiple traumas over several years. Methods: Randomized control trials were reviewed if they measured PTSD outcome and were…

Thromboprophylaxis for trauma patients.

PubMed

Barrera, Luis M; Perel, Pablo; Ker, Katharine; Cirocchi, Roberto; Farinella, Eriberto; Morales Uribe, Carlos Hernando

2013-03-28

Trauma is a leading causes of death and disability in young people. Venous thromboembolism (VTE) is a principal cause of death. Trauma patients are at high risk of deep vein thrombosis (DVT). The incidence varies according to the method used to measure the DVT and the location of the thrombosis. Due to prolonged rest and coagulation abnormalities, trauma patients are at increased risk of thrombus formation. Thromboprohylaxis, either mechanical or pharmacological, may decrease mortality and morbidity in trauma patients who survive beyond the first day in hospital, by decreasing the risk of VTE in this population.A previous systematic review did not find evidence of effectiveness for either pharmacological or mechanical interventions. However, this systematic review was conducted 10 years ago and most of the included studies were of poor quality. Since then new trials have been conducted. Although current guidelines recommend the use of thromboprophylaxis in trauma patients, there has not been a comprehensive and updated systematic review since the one published. To assess the effects of thromboprophylaxis in trauma patients on mortality and incidence of deep vein thrombosis and pulmonary embolism. To compare the effects of different thromboprophylaxis interventions and their effects according to the type of trauma. We searched The Cochrane Injuries Group Specialised Register (searched April 30 2009), Cochrane Central Register of Controlled Trials 2009, issue 2 (The Cochrane Library), MEDLINE (Ovid) 1950 to April (week 3) 2009, EMBASE (Ovid) 1980 to (week 17) April 2009, PubMed (searched 29 April 2009), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to April 2009), ISI Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) (1990 to April 2009). Randomized controlled clinical trials involving people of any age with major trauma defined by one or more of the following criteria: physiological: penetrating or blunt trauma with more than two organs and unstable vital signs, anatomical: people with an Injury Severity Score (ISS) higher than 9, mechanism: people who are involved in a 'high energy' event with a risk for severe injury despite stable or normal vital signs. We excluded trials that only recruited outpatients, trials that recruited people with hip fractures only, or people with acute spinal injuries. Four authors, in pairs (LB and CM, EF and RC), independently examined the titles and the abstracts, extracted data, assessed the risk of bias of the trials and analysed the data. PP resolved any disagreement between the authors. Sixteen studies were included (n=3005). Four trials compared the effect of any type (mechanical and/or pharmacological) of prophylaxis versus no prophylaxis. Prophylaxis reduced the risk of DVT in people with trauma (RR 0.52; 95% CI 0.32 to 0.84). Mechanical prophylaxis reduced the risk of DVT (RR = 0.43; 95% CI 0.25 to 0.73). Pharmacological prophylaxis was more effective than mechanical methods at reducing the risk of DVT (RR 0.48; 95% CI 0.25 to 0.95). LMWH appeared to reduce the risk of DVT compared to UH (RR 0.68; 95% CI 0.50 to 0.94). People who received both mechanical and pharmacological prophylaxis had a lower risk of DVT (RR 0.34; 95% CI 0.19 to 0.60) We did not find evidence that thromboprophylaxis reduces mortality or PE in any of the comparisons assessed. However, we found some evidence that thromboprophylaxis prevents DVT. Although the strength of the evidence was not high, taking into account existing information from other related conditions such as surgery, we recommend the use of any DVT prophylactic method for people with severe trauma.

The efficacy of initial hydrocortisone administration at preventing posttraumatic distress in adult trauma patients: a randomized trial

PubMed Central

Delahanty, Douglas L.; Gabert-Quillen, Crystal; Ostrowski, Sarah A.; Nugent, Nicole R.; Fischer, Beth; Morris, Adam; Pitman, Roger K.; Bon, John; Fallon, William

2013-01-01

Objective/Introduction Secondary pharmacological interventions have shown promise at reducing the development of posttraumatic stress disorder symptoms (PTSS) in preclinical studies. The present study examined the preliminary efficacy of a 10-day low-dose (20 mg bid) course of hydrocortisone at preventing PTSS in traumatic injury victims. Methods Sixty-four traumatic injury patients (34% female) were randomly assigned in a double-blind protocol to receive either a 10-day course of hydrocortisone or placebo initiated within 12 hours of the trauma. One-month and 3-months posttrauma participants completed an interview to assess PTSS and self-report measures of depression and health-related quality of life. Results Hydrocortisone recipients reported fewer PTSD and depression symptoms, and had greater improvements in health-related quality of life during the first 3 months posttrauma than did placebo recipients. Hydrocortisone recipients who had never received prior mental health treatment had the lowest PTSD scores. Conclusion Low-dose hydrocortisone may be a promising approach to the prevention of PTSD in acutely injured trauma patients, and may be particularly efficacious in acutely injured trauma victims without a history of significant psychopathology. PMID:23557627

Effectiveness of an Extended Yoga Treatment for Women with Chronic Posttraumatic Stress Disorder.

PubMed

Price, Maggi; Spinazzola, Joseph; Musicaro, Regina; Turner, Jennifer; Suvak, Michael; Emerson, David; van der Kolk, Bessel

2017-04-01

Yoga has been found to be an effective posttraumatic stress disorder (PTSD) treatment for a variety of trauma survivors, including females with chronic PTSD. Aim/Purpose: The current study builds on extant research by examining an extended trauma-sensitive yoga treatment for women with chronic PTSD. The study sought to optimize the results of a treatment protocol examined in a recent randomized controlled trial with a shorter duration and without assignment or monitoring of home practice. The authors examined a 20-week trauma-sensitive yoga treatment in a non-randomized single-group treatment feasibility study for women with chronic treatment-resistant PTSD (N = 9). The authors examined PTSD and dissociation symptom reduction over several assessment periods. The results indicate that participants experienced significant reductions in PTSD and dissociative symptomatology above and beyond similar treatments of a shorter duration. The findings suggest that more intensive trauma-sensitive yoga treatment characterized by longer duration and intentional assignment and monitoring of home practice may be more advantageous for individuals with severe and chronic PTSD. The implications of the findings for the potentially more substantial role of yoga as an intervention for a subset of adults with chronic treatment-resistant PTSD are discussed.

Gender research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: a summary of findings.

PubMed

Greenfield, Shelly F; Rosa, Carmen; Putnins, Susan I; Green, Carla A; Brooks, Audrey J; Calsyn, Donald A; Cohen, Lisa R; Erickson, Sarah; Gordon, Susan M; Haynes, Louise; Killeen, Therese; Miele, Gloria; Tross, Susan; Winhusen, Theresa

2011-09-01

The National Institute of Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable subgroups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. To review gender-related findings from published CTN clinical trials and related studies from January 2000 to March 2010. CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors; or implemented gender-specific protocols. The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized controlled trials in community settings, of which 4 have been gender-specific. This article summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance-using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods.

Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients - A Multi-Center Trial

DTIC Science & Technology

2015-04-01

threshold are based on a randomized controlled trial by Hébert et al . that showed that critically ill patients who are not actively bleeding should not...causes of increased morbidity and mortality in several studies [23-28]. In a large study, Malone et al . assessed the effect of blood transfusion on...strong independent predictor of mortality. Another study published by Murrell et al . did not find an association between the dose of aged blood and

Radiation dose from initial trauma assessment and resuscitation: review of the literature.

PubMed

Hui, Catherine M; MacGregor, John H; Tien, Homer C; Kortbeek, John B

2009-04-01

Trauma care benefits from the use of imaging technologies. Trauma patients and trauma team members are exposed to radiation during the continuum of care. Knowledge of exposure amounts and effects are important for trauma team members. We performed a review of the published literature; keywords included "trauma," "patients," "trauma team members," "wounds," "injuries," "radiation," "exposure," "dose" and "computed tomography" (CT). We also reviewed the Board on Radiation Effects Research (BEIR VII) report, published in 2005 and 2006. We found no randomized controlled trials or studies. Relevant studies demonstrated that CT accounts for the single largest radiation exposure in trauma patients. Exposure to 100 mSv could result in a solid organ cancer or leukemia in 1 of 100 people. Trauma team members do not exceed the acceptable occupation radiation exposure determined by the National Council of Radiation Protection and Management. Modern imaging technologies such as 16- and 64-slice CT scanners may decrease radiation exposure. Multiple injured trauma patients receive a substantial dose of radiation. Radiation exposure is cumulative. The low individual risk of cancer becomes a greater public health issue when multiplied by a large number of examinations. Though CT scans are an invaluable resource and are becoming more easily accessible, they should not replace careful clinical examination and should be used only in appropriate patients.

Prehospital Blood Product Resuscitation for Trauma: A Systematic Review

PubMed Central

Smith, Iain M.; James, Robert H.; Dretzke, Janine; Midwinter, Mark J.

2016-01-01

ABSTRACT Introduction: Administration of high ratios of plasma to packed red blood cells is a routine practice for in-hospital trauma resuscitation. Military and civilian emergency teams are increasingly carrying prehospital blood products (PHBP) for trauma resuscitation. This study systematically reviewed the clinical literature to determine the extent to which the available evidence supports this practice. Methods: Bibliographic databases and other sources were searched to July 2015 using keywords and index terms related to the intervention, setting, and condition. Standard systematic review methodology aimed at minimizing bias was used for study selection, data extraction, and quality assessment (protocol registration PROSPERO: CRD42014013794). Synthesis was mainly narrative with random effects model meta-analysis limited to mortality outcomes. Results: No prospective comparative or randomized studies were identified. Sixteen case series and 11 comparative studies were included in the review. Seven studies included mixed populations of trauma and non-trauma patients. Twenty-five of 27 studies provided only very low quality evidence. No association between PHBP and survival was found (OR for mortality: 1.29, 95% CI: 0.84–1.96, P = 0.24). A single study showed improved survival in the first 24 h. No consistent physiological or biochemical benefit was identified, nor was there evidence of reduced in-hospital transfusion requirements. Transfusion reactions were rare, suggesting the short-term safety of PHBP administration. Conclusions: While PHBP resuscitation appears logical, the clinical literature is limited, provides only poor quality evidence, and does not demonstrate improved outcomes. No conclusions as to efficacy can be drawn. The results of randomized controlled trials are awaited. PMID:26825635

Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial.

PubMed

Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda

2013-08-13

Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients. Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented. The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms (n=20) (P<.001). Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high-risk individuals who are more likely to benefit from the intervention. International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).

Lifetime trauma victimization and PTSD in relation to psychopathy and antisocial personality disorder in a sample of incarcerated women and men.

PubMed

Gobin, Robyn L; Reddy, Madhavi K; Zlotnick, Caron; Johnson, Jennifer E

2015-01-01

Antisocial personality disorder (ASPD) and psychopathy are similar, but distinct, psychiatric conditions that are common in male and female inmates; a segment of the population with high rates of trauma exposure. It is unclear whether specific types of lifetime trauma are associated with ASPD and psychopathy in incarcerated women and men. Furthermore, the unique roles of post-traumatic stress disorder (PTSD) symptom severity and trauma victimization in antisocial personality disturbance are not well-understood. The paper aims to discuss these issues. This study investigated associations between trauma variables (different kinds of traumatic experiences and PTSD) and antisocial personality variables (ASPD and psychopathy) in a sample of incarcerated women and men who participated in a randomized clinical trial for major depressive disorder. In total, 88 incarcerated men and women were assessed for ASPD diagnosis, psychopathy severity, PTSD symptom severity, and history of physical, sexual, and crime-related trauma. Regression analyses predicted ASPD or psychopathy from trauma variables, controlling for gender. Physical trauma was the only form of trauma that was significantly related to psychopathy. Physical trauma and crime-related trauma were associated with ASPD. PTSD symptom severity was not associated with psychopathy or ASPD. There are associations between some kinds of lifetime trauma exposure and current ASPD/psychopathy in the target sample, but these associations do not appear to be mediated through current PTSD symptoms.

App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial.

PubMed

Friedrich, Mirco; Bergdolt, Christian; Haubruck, Patrick; Bruckner, Thomas; Kowalewski, Karl-Friedrich; Müller-Stich, Beat Peter; Tanner, Michael C; Nickel, Felix

2017-02-06

Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a new training concept comprised of e-learning elements as well as continuous rating using an objective structured assessment of technical skills (OSATS) tool. The study protocol is presented for a randomized trial to evaluate e-learning with app-based serious gaming for chest drain insertion. The proposed randomized trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University in the context of regular curricular teaching for medical students (n = 90, 3rd to 6th year). The intervention group will use e-learning with the serious gaming app Touch Surgery (TM) for chest drain insertion, whereas the control group uses serious gaming for an unrelated procedure. Primary endpoint is operative performance of chest drain insertion in a porcine cadaveric model according to OSATS. The randomized trial will help determine the value of e-learning with the serious gaming app Touch Surgery (TM) for chest drain insertion by using the OSATS score. The study will improve surgical training for trauma situations. Trial Registration Number, DRKS00009994 . Registered on 27 May 2016.

Treating childhood traumatic grief: a pilot study.

PubMed

Cohen, Judith A; Mannarino, Anthony P; Knudsen, Kraig

2004-10-01

To examine the potential efficacy and specific timing of treatment response of individual child and parent trauma-focused cognitive-behavioral therapy for childhood traumatic grief (CTG), a condition in which trauma symptoms impinge on the child's ability to successfully address the normal tasks of grieving. Twenty-two children and their primary caretakers received a manual-based 16-week treatment with sequential trauma- and grief-focused interventions. Children experienced significant improvements in CTG, posttraumatic stress disorder (PTSD), depressive, anxiety, and behavioral problems, with PTSD symptoms improving only during the trauma-focused treatment components and CTG improving during both trauma- and grief-focused components. Participating parents also experienced significant improvement in PTSD and depressive symptoms. The timing of improvements in CTG and PTSD symptoms lends support to providing sequential trauma- and grief-focused interventions and to the concept that CTG is related to but distinct from PTSD. The results also suggest the benefit of individual treatment for CTG and for including parents in the treatment of CTG. Randomized, controlled trials are needed to further test the efficacy of this treatment model.

Responding to the need for sleep among survivors of interpersonal violence: A randomized controlled trial of a cognitive-behavioral insomnia intervention followed by PTSD treatment.

PubMed

Pigeon, Wilfred R; Heffner, Kathi L; Crean, Hugh; Gallegos, Autumn M; Walsh, Patrick; Seehuus, Martin; Cerulli, Catherine

2015-11-01

Sleep disturbance is a common feature of posttraumatic stress disorder (PTSD), but is not a focus of standard PTSD treatments. Psychological trauma exposure is associated with considerable physical and mental health morbidity, possibly due to the alterations in neuroendocrine function and inflammation observed in trauma exposed individuals. Although PTSD treatments are efficacious, they are associated with high drop-out rates in clinical trials and clinical practice. Finally, individuals with PTSD stemming from exposure to interpersonal violence represent an especially under-treated population with significant sleep disturbance. Community-based participatory research was utilized to design and prepare a clinical trial that randomizes recent survivors of interpersonal violence who have PTSD, depression, and insomnia to receive either: (1) Cognitive Behavioral Therapy for Insomnia (CBTi) followed by Cognitive Processing Therapy (CPT) for trauma, or (2) attention control followed by CPT. Outcome measures include subjective and objective measures of sleep, clinician-administered PTSD and depression scales, inflammatory cytokines, and salivary cortisol. Assessments are conducted at baseline, following the sleep or control intervention, and again following CPT. The design allows for: (1) the first test of a sleep intervention in this population; (2) the comparison of sequenced CBTi and CPT to attention control followed by CPT, and (3) assessing the roles of neuroendocrine function, inflammatory processes, and objective sleep markers in mediating treatment outcomes. The study's overarching hypothesis is that treating insomnia will produce reduction in insomnia, PTSD, and depression severity, allowing patients to more fully engage in, and derive optimal benefits from, cognitive processing therapy. Published by Elsevier Inc.

Effectiveness of EMDR in patients with substance use disorder and comorbid PTSD: study protocol for a randomized controlled trial.

PubMed

Schäfer, Ingo; Chuey-Ferrer, Laycen; Hofmann, Arne; Lieberman, Peter; Mainusch, Günter; Lotzin, Annett

2017-03-16

Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based treatment for PTSD. However, it is unclear whether EMDR shows the same effectiveness in patients with substance use disorders (SUD) and comorbid PTSD. In this trial, we examine the effectiveness of EMDR in reducing PTSD symptoms in patients with SUD and PTSD. We conduct a single-blinded RCT among 158 patients with SUD and comorbid PTSD admitted to a German addiction rehabilitation center specialized for the treatment of patients with SUD and comorbid PTSD. Patients are randomized to receive either EMDR, added to SUD rehabilitation and non-trauma-focused PTSD treatment (TAU), or TAU alone. The primary outcome is change from baseline in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale at 6-month follow-up. Secondary outcomes are change from baseline in substance use, addiction-related problems, depressive symptoms, dissociative symptoms, emotion dysregulation and quality of life. Assessments are carried out by blinded raters at admission, at end of treatment, and at 3- and 6-month follow-up. We expect that EMDR plus TAU will be more effective in reducing PTSD symptoms than TAU alone. Mixed models will be conducted using an intention-to-treat and per-protocol approach. This study aims to expand the knowledge about the effectiveness of EMDR in patients with SUD and comorbid PTSD. The expected finding of the superiority of EMDR in reducing PTSD symptoms compared to non-trauma-focused PTSD treatment may enhance the use of trauma-focused treatment approaches for patients with SUD and co-morbid PTSD. German Clinical Trials Register: DRKS00009007 ; U1111-1172-9213. Retrospectively registered 01 Juni 2016.

Coagulation management in trauma-associated coagulopathy: allogenic blood products versus coagulation factor concentrates in trauma care.

PubMed

Klages, Matthias; Zacharowski, Kai; Weber, Christian Friedrich

2016-04-01

Coagulation management by transfusion of allogenic blood products and coagulation factors are competing concepts in current trauma care. Rapid and adequate therapy of trauma-associated coagulopathy is crucial to survival of severely injured patients. Standard coagulation tests such as prothrombin time and activated partial thromboplastin time are commonly used, but these tests are inappropriate for monitoring and guiding therapy in trauma patients. Coagulation factor-based treatment showed promising results, but randomized trials have not yet been performed. In addition, viscoelastic tests are needed to guide therapy, although there is in fact limited evidence for these in tests in trauma care. Regarding transfusion therapy with allogenic blood products, plasma transfusion has been associated with improved survival in trauma patients following massive transfusion. In contrast, patients not requiring massive transfusion seem to be at risk for suffering complications with increasing volumes of plasma transfused. The collective of trauma patients is heterogeneous. Despite the lack of evidence, there are strong arguments for individualized patient treatment with coagulation factors for some indications and to abstain from the use of fresh frozen plasma. In patients with severe trauma and major bleeding, plasma, platelets, and red blood cells should be considered to be administered at a ratio of 1 : 1 : 1.

Changing Beliefs about Trauma: A Qualitative Study of Cognitive Processing Therapy.

PubMed

Price, Jennifer L; MacDonald, Helen Z; Adair, Kathryn C; Koerner, Naomi; Monson, Candice M

2016-03-01

Controlled qualitative methods complement quantitative treatment outcome research and enable a more thorough understanding of the effects of therapy and the suspected mechanisms of action. Thematic analyses were used to examine outcomes of cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) in a randomized controlled trial of individuals diagnosed with military-related PTSD (n = 15). After sessions 1 and 11, participants wrote "impact statements" describing their appraisals of their trauma and beliefs potentially impacted by traumatic events. Trained raters coded each of these statements using a thematic coding scheme. An analysis of thematic coding revealed positive changes over the course of therapy in participants' perspective on their trauma and their future, supporting the purported mechanisms of CPT. Implications of this research for theory and clinical practice are discussed.

Trauma-focused exposure therapy for chronic posttraumatic stress disorder in alcohol and drug dependent patients: A randomized controlled trial.

PubMed

Coffey, Scott F; Schumacher, Julie A; Nosen, Elizabeth; Littlefield, Andrew K; Henslee, Amber M; Lappen, Amy; Stasiewicz, Paul R

2016-11-01

To test whether a modified version of prolonged exposure (mPE) can effectively treat posttraumatic stress disorder (PTSD) in individuals with co-occurring PTSD and substance dependence, an efficacy trial was conducted in which substance dependent treatment-seekers with PTSD (N = 126, male = 54.0%, White = 79.4%) were randomly assigned to mPE, mPE + trauma-focused motivational enhancement session (mPE + MET-PTSD), or a health information-based control condition (HLS). All participants were multiply traumatized; the median number of reported traumas that satisfied DSM-IV Criterion A for PTSD was 8. Treatment consisted of 9-12 60-min individual therapy sessions plus substance abuse treatment-as-usual. Participants were assessed at baseline, end-of-treatment, and at 3- and 6-months posttreatment. Both the mPE and mPE + MET-PTSD conditions achieved significantly better PTSD outcome than the control condition. The mPE + MET-PTSD and mPE conditions did not differ from one another on PTSD symptoms at end of treatment, 3-, or 6-month follow-up. Substance use outcomes did not differ between groups with all groups achieving 85.7%-97.9% days abstinent at follow-up. In regard to clinically significant improvement in trauma symptoms, 75.8% of the mPE participants, 60.0% of the mPE + MET-PTSD participants, and 44.4% of the HLS participants experienced clinically significant improvement at the end-of-treatment. Results indicate mPE, with or without an MET-PTSD session, can effectively treat PTSD in patients with co-occurring PTSD and substance dependence. In addition, mPE session lengths may better suit standard clinical practice and are associated with medium effect sizes. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

PubMed

Engel, Charles C; Bray, Robert M; Jaycox, Lisa H; Freed, Michael C; Zatzick, Doug; Lane, Marian E; Brambilla, Donald; Rae Olmsted, Kristine; Vandermaas-Peeler, Russ; Litz, Brett; Tanielian, Terri; Belsher, Bradley E; Evatt, Daniel P; Novak, Laura A; Unützer, Jürgen; Katon, Wayne J

2014-11-01

War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change. Copyright © 2014 Elsevier Inc. All rights reserved.

Chinese My Trauma Recovery, a Web-based intervention for traumatized persons in two parallel samples: randomized controlled trial.

PubMed

Wang, Zhiyun; Wang, Jianping; Maercker, Andreas

2013-09-30

Guided self-help interventions for PTSD (post-traumatic stress disorder) are a promising tool for the dissemination of contemporary psychological treatment. This study investigated the efficacy of the Chinese version of the My Trauma Recovery (CMTR) website. In an urban context, 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a randomized controlled trial (RCT) with a waiting list control condition. In addition, in a rural context, 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers. Assessment was completed online on a professional Chinese survey website. The primary outcome measure was the Post-traumatic Diagnostic Scale (PDS); secondary outcome measures were Symptom Checklist 90-Depression (SCL-D), Trauma Coping Self-Efficacy Scale (CSE), Post-traumatic Cognitive Changes (PCC), and Social Functioning Impairment (SFI) questionnaires adopted from the My Trauma Recovery website. For the urban sample, findings indicated a significant group×time interaction in post-traumatic symptom severity (F₁,₈₈=7.65, P=.007). CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment (F₁,₄₅=15.13, Cohen's d=0.81, P<.001) and the reduction was sustained over a 3-month follow-up (F₁,₄₅=17.29, Cohen's d=0.87, P<.001). In the rural sample, the group×time interaction was also significant in post-traumatic symptom severity (F₁,₉₁=5.35, P=.02). Post-traumatic symptoms decreased significantly after treatment (F₁,₄₈=43.97, Cohen's d=1.34, P<.001) and during the follow-up period (F₁,₄₈=24.22, Cohen's d=0.99, P<.001). Additional outcome measures (post-traumatic cognitive changes, depression) indicated a range of positive effects, in particular in the urban sample (group×time interactions: F₁,₈₈=5.32-8.37, all Ps<.03), contributing to the positive evidence for self-help interventions. Differences in the effects in the two RCTs are exploratorily explained by sociodemographic, motivational, and setting feature differences between the two samples. These findings give support for the short-term efficacy of CMTR in the two Chinese populations and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons. Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611000951954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000951954 (Archived by WebCite at http://www.webcitation.org/6G7WyNODk).

Staying Connected: A Feasibility Study Linking American Indian and Alaska Native Trauma Survivors to their Tribal Communities

PubMed Central

Tsosie, Ursula; Nannauck, Sweetwater; Buchwald, Dedra; Russo, Joan; Geiss Trusz, Sarah; Foy, Hugh; Zatzick, Douglas

2013-01-01

The objective of this investigation was to assess the feasibility of a culturally tailored care management intervention for physically injured American Indian/Alaska Native (AI/AN) patients. The intervention was initiated at a Level I trauma center and aimed to link AI/AN patients to their distant tribal communities. Thirty AI/AN patients were randomized to the intervention or to usual care. Assessments at baseline, 3 months, and 6 months included self-reported lifetime cumulative trauma burden, Native healing requests, and symptoms of posttraumatic stress, depression, and alcohol use. Generalized estimating equations ascertained differences between groups over time. Ninety-four percent of eligible patients participated; follow-up at 3 and 6 months was 83%. Participants had high numbers of lifetime traumas (mean = 5.1, standard deviation = 2.6). No differences between the intervention and control groups were observed in posttraumatic stress symptoms, depression symptoms, or alcohol use at baseline or follow-up time points. Among intervention patients, 60% either requested or participated in traditional Native healing practices and 75% reported that the intervention was helpful. This effectiveness trial demonstrated the feasibility of recruiting and randomizing injured AI/AN patients. Future efforts could integrate evidence-based interventions and traditional Native healing into stepped collaborative care treatment programs. PMID:22168295

Effectiveness of an Extended Yoga Treatment for Women with Chronic Posttraumatic Stress Disorder

PubMed Central

Price, Maggi; Musicaro, Regina; Turner, Jennifer; Suvak, Michael; Emerson, David; van der Kolk, Bessel

2017-01-01

Abstract Background: Yoga has been found to be an effective posttraumatic stress disorder (PTSD) treatment for a variety of trauma survivors, including females with chronic PTSD. Aim/Purpose: The current study builds on extant research by examining an extended trauma-sensitive yoga treatment for women with chronic PTSD. The study sought to optimize the results of a treatment protocol examined in a recent randomized controlled trial with a shorter duration and without assignment or monitoring of home practice. Materials and Methods: The authors examined a 20-week trauma-sensitive yoga treatment in a non-randomized single-group treatment feasibility study for women with chronic treatment-resistant PTSD (N = 9). The authors examined PTSD and dissociation symptom reduction over several assessment periods. Results: The results indicate that participants experienced significant reductions in PTSD and dissociative symptomatology above and beyond similar treatments of a shorter duration. Conclusions: The findings suggest that more intensive trauma-sensitive yoga treatment characterized by longer duration and intentional assignment and monitoring of home practice may be more advantageous for individuals with severe and chronic PTSD. The implications of the findings for the potentially more substantial role of yoga as an intervention for a subset of adults with chronic treatment-resistant PTSD are discussed. PMID:28121466

Preventing PTSD: A Randomized Controlled Trial of Brief Anxiety Reducation Treatment for Acute Trauma (ARTAT). Addendum

DTIC Science & Technology

2013-08-01

stress disorder. Journal of Psychiatric Research 45(6): 735-41. Galatzer-Levy, I.R., Madan , A., Neylan, T.C, Henn-Haase, C., Marmar, C. R. (2011...Journal of Traumatic Stress 24(5): 557-565. Komarovskaya, I., Maguen, S., McCaslin,S.E., Metzler, T.J., Madan , A., Brown, A.D., Galatzer-Levy, I.R

Training Teachers to Build Resilience in Children in the Aftermath of War: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Baum, Naomi L.; Cardozo, Barbara Lopes; Pat-Horenczyk, Ruth; Ziv, Yuval; Blanton, Curtis; Reza, Avid; Weltman, Alon; Brom, Danny

2013-01-01

Background: There is growing interest in school-based interventions for building resilience in children facing trauma and adversity. Recent studies focus on teacher training as an effective way to enhance resilience in their students, and emphasize the need for additional evidence-based practice. Objective: The aim of this study was to evaluate…

A Randomized Controlled Trial of Cognitive-Behavioral Treatment of Posttraumatic Stress Disorder in Severe Mental Illness

PubMed Central

Mueser, Kim T.; Rosenberg, Stanley D.; Xie, Haiyi; Jankowski, M. Kay; Bolton, Elisa E.; Lu, Weili; Hamblen, Jessica L.; Rosenberg, Harriet J.; McHugo, Gregory J.; Wolfe, Rosemarie

2014-01-01

A cognitive-behavioral therapy (CBT) program for PTSD was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared to treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major mood disorder (85%) or schizophrenia or schizoaffective disorder (15%), of whom 25% also had borderline personality disorder. Eighty-one percent of clients assigned to CBT participated in the program. Intent-to-treat analyses showed that CBT clients improved significantly more than clients in TAU at blinded post-treatment and 3- and 6-month follow-up assessments in PTSD symptoms, other symptoms, perceived health, negative trauma-related beliefs, knowledge about PTSD, and case manager working alliance. The effects of CBT on PTSD were strongest in clients with severe PTSD. Homework completion in CBT predicted greater reductions in symptoms. Changes in trauma-related beliefs in CBT mediated improvements in PTSD. The findings suggest that clients with severe mental illness and PTSD can benefit from CBT, despite severe symptoms, suicidal thinking, psychosis, and vulnerability to hospitalizations. PMID:18377122

Review of Randomized Controlled Trials on Psychological Interventions in Child Sexual Abuse: Current Status and Emerging Needs in the Indian Context.

PubMed

Choudhary, Vandana; Satapathy, Sujata; Sagar, Rajesh

2016-01-01

Child sexual abuse (CSA) is a critical, psychologically traumatic and sometimes life-threatening incident often associated with sequel of adverse physical, behavioral, and mental health consequences. Factors such as developmental age of the child, severity of abuse, closeness to the perpetrator, availability of medico-legal-social support network and family care, gender stereotypes in the community complicate the psychological trauma. Although the research on the effects of CSA as well as psychological intervention to reduce the victimization and promote the mental health of the child is in its infancy stage in India, the global research in the past three decades has progressed much ahead. A search was performed using MEDLINE, PubMed, PsycINFO, and Google Scholar from 1984 to 2015 and only 17 randomized controlled trials (RCTs) out of 96 potentially relevant studies were included. While nonspecific therapies covering a wide variety of outcome variables were prominent till 1999s, the trend changed to specific and focused forms of trauma-focused therapies in next one-and-half decades. Novel approaches to psychological interventions have also been witnessed. One intervention (non-RCT) study on effects on general counseling has been reported from India.

Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial.

PubMed

Larsson, S; Struglics, A; Lohmander, L S; Frobell, R

2017-09-01

Prospectively monitor how treatment of acutely ruptured anterior cruciate ligament (ACL) affects biomarkers of inflammation and proteolytic degradation over 5 years. We studied 119 subjects with acute ACL injury from the randomized controlled knee anterior cruciate ligament, non-surgical versus surgical treatment (KANON)-trial (Clinical trial ISRCTN 84752559) who had synovial fluid, serum and urine samples available from at least two out of six visits over 5 years after acute ACL rupture. All subjects followed a similar rehabilitation protocol where, according to randomization, 60 also had early ACL reconstruction and 59 had the option to undergo a delayed ACL reconstruction if needed. Interleukin (IL)-6, IL-8, IL-10, interferon-gamma (IFNγ), tumor necrosis factor (TNF), amino acids alanine, arginine, glycine, serine (ARGS)-aggrecan, C-terminal crosslinking telopeptide type II collagen (CTX-II) and N-terminal crosslinking telopeptide type I collagen (NTX-I) were quantified by enzyme-linked immunosorbent assays (ELISA). Subjects randomized to early ACL reconstruction had higher cytokine concentrations in index knee synovial fluid at 4 months (IL-6, IL-8, IL-10, TNF), 8 months (IL-6 and TNF) and at 5 years (IFNγ) compared to those randomized to optional delayed reconstruction. Those that underwent delayed ACL reconstruction within 5 years (30 subjects), had higher synovial fluid concentrations of IL-6 at 5 years compared to those treated with rehabilitation alone. No differences between groups were noted for ARGS-aggrecan in synovial fluid and serum or CTX-II and NTX-I in urine over 5 years, neither as randomized nor as treated. Surgical ACL reconstruction constitutes a second trauma to the acutely injured joint resulting in a prolonged elevation of already high synovial fluid levels of inflammatory cytokines. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Cognitive-Behavioral Therapy for PTSD and Depression Symptoms Reduces Risk for Future Intimate Partner Violence among Interpersonal Trauma Survivors

PubMed Central

Iverson, Katherine M.; Gradus, Jaimie L.; Resick, Patricia A.; Suvak, Michael K.; Smith, Kamala F.; Monson, Candice M.

2010-01-01

Objective Women who develop symptoms of posttraumatic stress disorder (PTSD) and depression subsequent to interpersonal trauma are at heightened risk for future intimate partner violence (IPV) victimization. Cognitive-behavioral therapy (CBT) is effective in reducing PTSD and depression symptoms, yet limited research has investigated the effectiveness of cognitive-behavior therapy in reducing risk for future IPV among interpersonal trauma survivors. Method This study examined the effect of CBT for PTSD and depressive symptoms on the risk of future IPV victimization in a sample of women survivors of interpersonal violence. The current sample included 150 women diagnosed with PTSD secondary to an array of interpersonal traumatic events who were participating in a randomized clinical trial of different forms of cognitive processing therapy for the treatment of PTSD. Participants were assessed at nine time points as part of the larger trial: pre-treatment, six times during treatment, post-treatment, and at 6-month follow-up. Results As hypothesized, reductions in both PTSD and depressive symptoms during treatment were associated with a decreased likelihood of IPV victimization at a 6-month follow-up even after controlling for recent IPV (i.e., IPV from a current partner within the year prior to beginning the study) and prior interpersonal traumas. Conclusions These findings highlight the importance of identifying and treating PTSD and depressive symptoms among interpersonal trauma survivors as a method for reducing risk for future IPV. PMID:21341889

Critical care considerations in the management of the trauma patient following initial resuscitation

PubMed Central

2012-01-01

Background Care of the polytrauma patient does not end in the operating room or resuscitation bay. The patient presenting to the intensive care unit following initial resuscitation and damage control surgery may be far from stable with ongoing hemorrhage, resuscitation needs, and injuries still requiring definitive repair. The intensive care physician must understand the respiratory, cardiovascular, metabolic, and immunologic consequences of trauma resuscitation and massive transfusion in order to evaluate and adjust the ongoing resuscitative needs of the patient and address potential complications. In this review, we address ongoing resuscitation in the intensive care unit along with potential complications in the trauma patient after initial resuscitation. Complications such as abdominal compartment syndrome, transfusion related patterns of acute lung injury and metabolic consequences subsequent to post-trauma resuscitation are presented. Methods A non-systematic literature search was conducted using PubMed and the Cochrane Database of Systematic Reviews up to May 2012. Results and conclusion Polytrauma patients with severe shock from hemorrhage and massive tissue injury present major challenges for management and resuscitation in the intensive care setting. Many of the current recommendations for “damage control resuscitation” including the use of fixed ratios in the treatment of trauma induced coagulopathy remain controversial. A lack of large, randomized, controlled trials leaves most recommendations at the level of consensus, expert opinion. Ongoing trials and improvements in monitoring and resuscitation technologies will further influence how we manage these complex and challenging patients. PMID:22989116

Seven Deadly Sins in Trauma Outcomes Research: An Epidemiologic Post-Mortem for Major Causes of Bias

PubMed Central

del Junco, Deborah J.; Fox, Erin E.; Camp, Elizabeth A.; Rahbar, Mohammad H.; Holcomb, John B.

2013-01-01

Background Because randomized clinical trials (RCTs) in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multi-system responses to injury that necessitate highly dynamic treatment regimes like blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Methods Drawing on recent experience in the design, data collection, monitoring and analysis of the 10-site observational PROMMTT study, seven common and sometimes overlapping biases are described through examples and resolution strategies. Results Sources of bias in trauma research include ignoring 1) variation in patients’ indications for treatment (indication bias), 2) the dependency of intervention delivery on patient survival (survival bias), 3) time-varying treatment, 4) time-dependent confounding, 5) non-uniform intervention effects over time, 6) non-random missing data mechanisms, and 7) imperfectly defined variables. This list is not exhaustive. Conclusion The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients. PMID:23778519

The effects of parental components in a trauma-focused cognitive behavioral based therapy for children exposed to interparental violence: study protocol for a randomized controlled trial.

PubMed

Visser, Margreet M; Telman, Machteld D; de Schipper, J Clasien; Lamers-Winkelman, Francien; Schuengel, Carlo; Finkenauer, Catrin

2015-06-23

Interparental violence is both common and harmful and impacts children's lives directly and indirectly. Direct effects refer to affective, behavioral, and cognitive responses to interparental violence and psychosocial adjustment. Indirect effects refer to deteriorated parental availability and parent-child interaction. Standard Trauma Focused Cognitive Behavioral Therapy may be insufficient for children traumatized by exposure to interparental violence, given the pervasive impact of interparental violence on the family system. HORIZON is a trauma focused cognitive behavioral therapy based group program with the added component of a preparatory parenting program aimed at improving parental availability; and the added component of parent-child sessions to improve parent-child interaction. This is a multicenter, multi-informant and multi-method randomized clinical trial study with a 2 by 2 factorial experimental design. Participants (N = 100) are children (4-12 years), and their parents, who have been exposed to interparental violence. The main aim of the study is to test the effects of two parental components as an addition to a trauma focused cognitive behavioral based group therapy for reducing children's symptoms. Primary outcome measures are posttraumatic stress symptoms, and internalizing and externalizing problems in children. The secondary aim of the study is to test the effect of the two added components on adjustment problems in children and to test whether enhanced effects can be explained by changes in children's responses towards experienced violence, in parental availability, and in quality of parent-child interaction. To address this secondary aim, the main parameters are observational and questionnaire measures of parental availability, parent-child relationship variables, children's adjustment problems and children's responses to interparental violence. Data are collected three times: before and after the program and six months later. Both intention-to-treat and completer analyses will be done. The current study will enhance our understanding of the efficacy interparental violence-related parental components added to trauma focused cognitive behavioral group program for children who have been exposed to IPV. It will illuminate mechanisms underlying change by considering multiple dimensions of child responses, parenting variables and identify selection criteria for participation in treatment. Netherlands Trial Register NTR4015 . Registered 4th of June, 2013.

Trauma- and Stress-Induced Response in Veterans with Alcohol Dependence and Comorbid Post-Traumatic Stress Disorder.

PubMed

Ralevski, Elizabeth; Southwick, Steven; Jackson, Eric; Jane, Jane Serrita; Russo, Melanie; Petrakis, Ismene

2016-08-01

Alcohol dependence (AD) and post-traumatic stress disorder (PTSD) commonly co-occur, and the co-occurrence is associated with worse prognosis than either disorder absent the other. Craving is an important construct related to relapse, but the relationship between PTSD symptoms, craving, and relapse is not well understood. Several studies have documented the relationship between stress and craving in individuals without comorbid PTSD, but the effect on those with comorbid PTSD is not well known. A small literature suggests that trauma imagery affects craving. This is the first study to explore the effects of trauma-induced and stress-induced scripts on alcohol craving, affect, cardiovascular, and cortisol responses in the laboratory. Veterans (n = 25) diagnosed with AD and PTSD who were participating in a randomized clinical treatment trial took part in this laboratory study. Baseline assessment included PTSD symptoms and drinking quantity and frequency over 3 months before study initiation. In the laboratory, participants were exposed to neutral, stressful, and trauma scripts randomly assigned. Main outcomes included craving, anxiety, mood states, salivary cortisol, and cardiovascular responses. Both stress and trauma scripts produced greater increases in craving, negative affect, and cardiovascular reactivity, compared to neutral scripts. Trauma scripts produced significantly stronger craving for alcohol and greater cardiovascular reactivity than stress scripts. Also, trauma-induced but not stress-induced craving was positively correlated with baseline levels of drinking. There were no changes in cortisol levels from pre- to postexposure of any scripts. The results highlight that trauma cues are more salient in inducing alcohol craving than stress cues and higher reactivity is related to more baseline drinking. This finding is consistent with clinical observations that show an association between PTSD symptoms and alcohol relapse. It also underscores the importance of adequate treatment of PTSD as reactivity related to trauma cues and reminders may be an important factor in craving and relapse. Copyright © 2016 by the Research Society on Alcoholism.

Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force.

PubMed

Martinowitz, U; Michaelson, M

2005-04-01

Recombinant activated factor VII (rFVIIa) has been approved by the U.S. Food and Drug Administration (FDA) for almost a decade for hemophilic patients with inhibitors. Its off-label use as a hemostatic agent in massive bleeding caused by a wide array of clinical scenarios is rapidly expanding. While evidence-based guidelines exist for rFVIIa treatment in hemophilia, none are available for its off-label use. The aim of this study is to develop expert recommendations for the use of rFVIIa in patients suffering from uncontrolled bleeding (with special emphasis on trauma) until randomized, controlled trials allow for the introduction of more established evidence-based guidelines. A multidisciplinary task force comprising representatives of the relevant National Medical Associations, experts from the Medical Corps of the Army, Ministry of Health and the Israel National Trauma Advisory Board was established in Israel. Recommendations were construed based on the analysis of the first 36 multi-trauma patients accumulated in the prospective national registry of the use of rFVIIa in trauma, and an extensive literature search consisting of published and prepublished controlled animal trials, case reports and series. The final consensus guidelines, together with the data of the first 36 trauma patients treated in Israel, are presented in this article. Results of the first 36 trauma patients: The prolonged clotting assays [prothrombin time (PT) and partial thromboplastin time (PTT)] shortened significantly within minutes following administration of rFVIIa. Cessation of bleeding was achieved in 26 of 36 (72%) patients. Acidosis diminished the hemostatic effect of the drug, while hypothermia did not affect it. The survival rate of 61% (22/36) seems to be favorable compared with published series of similar, or less severe, trauma patients (range 30%-57%). As a result of the lack of controlled trials, our guidelines should be considered as suggestive rather than conclusive. However, they provide a valuable tool for physicians using rFVIIa for the expanding off-label clinical uses.

A Randomised, Double Blind Trial of N-Acetylcysteine for Hearing Protection during Stapes Surgery

PubMed Central

Bagger-Sjöbäck, Dan; Strömbäck, Karin; Hakizimana, Pierre; Plue, Jan; Larsson, Christina; Hultcrantz, Malou; Papatziamos, Georgios; Smeds, Henrik; Danckwardt-Lillieström, Niklas; Hellström, Sten; Johansson, Ann; Tideholm, Bo; Fridberger, Anders

2015-01-01

Background Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies. Methods We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo. Findings One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed) and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting. Conclusions N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy. Trial Registration ClinicalTrials.gov NCT00525551 PMID:25763866

The Applicability of Resilience Training to the Mitigation of Trauma-Related Mental Illness in Military Personnel [Formula: see text].

PubMed

Thompson, Summer R; Dobbins, Sarah

Ongoing participation by the United States in military operations around the world places military personnel at an increased potential for exposure to trauma, which may directly result in an increased risk for mental health issues. It is important to develop and test new approaches to prevent and mitigate the effects of trauma in military personnel. One such area of research is focused on psychological resilience to prevent the sequelae of trauma. This article examines empirical research of resilience training in military personnel and discusses the potential applicability of such training in this population. In this literature review, four randomized control trials and one retrospective, parallel group study were reviewed. Each intervention had the goal of mitigating behavioral health issues after trauma exposure. The results of the various interventions were wide-ranging from no measurable difference in treatment groups to significant differences in outcomes. Despite the inconclusive results of our review, we have determined that resilience training for active duty service members to help prevent the deleterious effects of trauma on mental health is a compelling and necessary avenue for further research.

The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial.

PubMed

Roberts, Ian; Shakur, Haleema; Afolabi, Adefemi; Brohi, Karim; Coats, Tim; Dewan, Yashbir; Gando, Satoshi; Guyatt, Gordon; Hunt, B J; Morales, Carlos; Perel, Pablo; Prieto-Merino, David; Woolley, Tom

2011-03-26

The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. The CRASH-2 trial was undertaken in 274 hospitals in 40 countries. 20,211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health DOH-27-0607-1919. 10,096 patients were allocated to tranexamic acid and 10,115 to placebo, of whom 10,060 and 10,067, respectively, were analysed. 1063 deaths (35%) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0.0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5.3%] events in tranexamic acid group vs 286/3704 [7.7%] in placebo group; relative risk [RR] 0.68, 95% CI 0.57-0.82; p<0.0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4.8%] vs 184/2996 [6.1%]; RR 0.79, 0.64-0.97; p=0.03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4.4%] vs 103/3362 [3.1%]; RR 1.44, 1.12-1.84; p=0.004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial.

PubMed

Beck, Bolette Daniels; Lund, Steen Teis; Søgaard, Ulf; Simonsen, Erik; Tellier, Thomas Christian; Cordtz, Torben Oluf; Laier, Gunnar Hellmund; Moe, Torben

2018-05-30

Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy. A randomized controlled study with a non-inferiority design is carried out in three locations of a regional outpatient psychiatric clinic for refugees. Seventy Arabic-, English- or Danish-speaking adult refugees (aged 18-67 years) diagnosed with PTSD are randomized to 16 sessions of either music therapy or verbal therapy (standard treatment). All participants are offered medical treatment, psychoeducation by nurses, physiotherapy or body therapy and social counseling as needed. Outcome measures are performed at baseline, post therapy and at 6 months' follow-up. A blind assessor measures outcomes post treatment and at follow-up. Questionnaires measuring trauma symptoms (HTQ), quality of life (WHO-5), dissociative symptoms (SDQ-20, DSS-20) and adult attachment (RAAS) are applied, as well as physiological measures (salivary oxytocin, beta-endorphin and substance P) and participant evaluation of each session. The effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration. ClinicalTrials.gov ID number NCT03574228, registered retrospectively on 28 June 2016.

Intraoperative Low-frequency Electroacupuncture under General Anesthesia Improves Postoperative Recovery in a Randomized Trial.

PubMed

Grech, Dennis; Li, Zhifeng; Morcillo, Patrick; Kalyoussef, Evelyne; Kim, David D; Bekker, Alex; Ulloa, Luis

2016-10-01

Neuronal stimulation improves physiological responses to infection and trauma, but the clinical potential of this strategy is unknown. We hypothesized that transdermal neural stimulation through low-frequency electroacupuncture might control the immune responses to surgical trauma and expedite the postoperative recovery. However, the efficiency of electroacupuncture is questioned due to the placebo effect. Here, electroacupuncture was performed on anesthetized patients to avoid any placebo. This is a prospective double-blinded pilot trial to determine whether intraoperative electroacupuncture on anesthetized patients improves postoperative recovery. Patients with electroacupuncture required 60% less postoperative analgesic, even they had pain scores similar to those in the control patients. Electroacupuncture prevented postoperative hyperglycemia and attenuated serum adrenocorticotropic hormone in the older and heavier group of patients. From an immunological perspective, electroacupuncture did not affect the protective immune responses to surgical trauma, including the induction of interleukin-6 and interleukin-10. The most significant immunological effect of electroacupuncture was enhancing transforming growth factor-β1 production during surgery in the older and lighter group of patients. These results suggest that intraoperative electroacupuncture on anesthetized patients can reduce postoperative use of analgesics and improve immune and stress responses to surgery. Copyright © 2016. Published by Elsevier B.V.

The association of childhood trauma and personality disorders with chronic depression: A cross-sectional study in depressed outpatients.

PubMed

Klein, Jan Philipp; Roniger, Antje; Schweiger, Ulrich; Späth, Christina; Brodbeck, Jeannette

2015-06-01

Chronic depression has often been associated with childhood trauma. There may, however, be an interaction between personality pathology, childhood trauma, and chronic depression. This interaction has not yet been studied. This retrospective analysis is based on 279 patients contacted for a randomized trial in an outpatient psychotherapy center over a period of 18 months from 2010 to 2012. Current diagnoses of a personality disorder and presence of chronic depression were systematically assessed using the Structured Clinical Interview for DSM-IV. Retrospective reports of childhood trauma were collected using the short form of the Childhood Trauma Questionnaire (CTQ-SF). DSM-IV-defined chronic depression was the primary outcome. The association between chronic depression, childhood trauma, and personality disorders was analyzed using correlations. Variables that had at least a small effect on correlation analysis were entered into a series of logistic regression analyses to determine the predictors of chronic depression and the moderating effect of childhood trauma. The presence of avoidant personality disorder, but no CTQ-SF scale, was associated with the chronicity of depression (odds ratio [OR] = 2.20, P = .015). The emotional abuse subscale of the CTQ-SF did, however, correlate with avoidant personality disorder (OR = 1.15, P = .000). The level of emotional abuse had a moderating effect on the effect of avoidant personality disorder on the presence of chronic depression (OR = 1.08, P = .004). Patients who did not suffer from avoidant personality disorder had a decreased rate of chronic depression if they retrospectively reported more severe levels of emotional abuse (18.9% vs 39.7%, respectively). The presence of avoidant personality pathology may interact with the effect of childhood trauma in the development of chronic depression. This has to be confirmed in a prospective study. ClinicalTrials.gov identifier: NCT01226238. © Copyright 2015 Physicians Postgraduate Press, Inc.

Gender Research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: A Summary of Findings

PubMed Central

Greenfield, Shelly F.; Rosa, Carmen; Putnins, Susan I.; Green, Carla A.; Brooks, Audrey J.; Calsyn, Donald A.; Cohen, Lisa R.; Erickson, Sarah; Gordon, Susan M.; Haynes, Louise; Killeen, Therese; Miele, Gloria; Tross, Susan; Winhusen, Theresa

2011-01-01

Background The NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable sub-groups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. Objectives To review gender-related findings from published CTN clinical trials and related studies from January, 2000 through March, 2010. Methods CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders and HIV risk behaviors; or implemented gender-specific protocols. Results The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized clinical trials in community settings, of which 4 have been gender-specific. This paper summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. Conclusions These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. Scientific Relevance To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods. PMID:21854272

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

PubMed

Rixen, Dieter; Steinhausen, Eva; Sauerland, Stefan; Lefering, Rolf; Maegele, Marc G; Bouillon, Bertil; Grass, Guido; Neugebauer, Edmund A M

2016-01-25

Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of "damage control orthopedics" (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains. Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.

The influence of large clinical trials in orthopedic trauma: do they change practice?

PubMed

Khan, Hassan; Hussain, Nasir; Bhandari, Mohit

2013-12-01

To evaluate the influence of top fracture trials on the practice of orthopedic surgeons. This is a cross-sectional study. We electronically administered the survey to all members of the Canadian Orthopedic Association. We received responses for 222 surveys, of which, 178 surveys were completed. We distributed a survey that evaluated the influence of 7 important fracture studies (6 randomized controlled trials and 1 prospective cohort study) on practice, patient care and the overall advancement of knowledge in the field of orthopedics. This study was approved by our local ethics review board. The primary outcome measure was the perceived general influence and impact of important fracture studies on the perceptions and practice of orthopedic surgeons. The Clavicular Fixation Trial (2007) and Tibial Fracture Trial (SPRINT, 2008) were perceived by surgeons to have the greatest influence on advancing overall knowledge in the field, improving personal practice, and the most influence on improving patient care. On the other hand, the Bone Stimulation in Fractures Trial (2011) and the recombinant human bone morphogenetic protein-2-BESST Trial (2002) had the lowest mean influence ranks. The probability of changing practice was significantly higher (Odds Ratio, 2.89; 95% confidence interval, 2.16-3.88; P < 0.00001) when studies had positive outcomes in comparison with negative outcomes. Despite the complexity and costs associated with clinical trials in orthopedic trauma, the results from this survey suggest that these studies result in a demonstrable perceived influence and impact on the practice of orthopedic surgeons.

Effects of intranasal oxytocin on amygdala reactivity to emotional faces in recently trauma-exposed individuals.

PubMed

Frijling, Jessie L; van Zuiden, Mirjam; Koch, Saskia B J; Nawijn, Laura; Veltman, Dick J; Olff, Miranda

2016-02-01

There is a need for effective, early post-trauma preventive interventions for post-traumatic stress disorder (PTSD). Attenuating amygdala hyperreactivity early post-trauma, a likely PTSD vulnerability factor, may decrease PTSD risk. Since oxytocin modulates amygdala reactivity to emotional stimuli, oxytocin administration early post-trauma may be a promising candidate for PTSD prevention. In a randomized double-blind placebo-controlled fMRI study, we investigated effects of a single intranasal oxytocin administration (40 IU) on amygdala reactivity to happy, neutral and fearful faces in 41 recently trauma-exposed men and women showing moderate to high distress after initial post-trauma screening. We explored treatment interactions with sex. Participants were scanned within 11 days post-trauma. Compared with placebo, oxytocin significantly increased right amygdala reactivity to fearful faces. There was a significant treatment by sex interaction on amygdala reactivity to neutral faces, with women showing increased left amygdala reactivity after oxytocin. These findings indicate that a single oxytocin administration may enhance fearful faces processing in recently trauma-exposed individuals and neutral faces processing in recently trauma-exposed women. These observations may be explained by oxytocin-induced increased salience processing. Clinical implications of these findings for PTSD prevention should be further investigated. Netherlands Trial Registry; Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related psychopathology (BONDS); NTR3190; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 3190. © The Author (2015). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

PubMed

Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

2013-01-05

Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people. ClinicalTrials.gov Identifier NCT00671099.

Predictors and moderators in the randomized trial of multifamily psychoeducational psychotherapy for childhood mood disorders.

PubMed

MacPherson, Heather A; Algorta, Guillermo Perez; Mendenhall, Amy N; Fields, Benjamin W; Fristad, Mary A

2014-01-01

This study investigated predictors and moderators of mood symptoms in the randomized controlled trial (RCT) of Multi-Family Psychoeducational Psychotherapy (MF-PEP) for childhood mood disorders. Based on predictors and moderators in RCTs of psychosocial interventions for adolescent mood disorders, we hypothesized that children's greater functional impairment would predict worse outcome, whereas children's stress/trauma history and parental expressed emotion and psychopathology would moderate outcome. Exploratory analyses examined other demographic, functioning, and diagnostic variables. Logistic regression and linear mixed effects modeling were used in this secondary analysis of the MF-PEP RCT of 165 children, ages 8 to 12, with mood disorders, a majority of whom were male (73%) and White, non-Hispanic (90%). Treatment nonresponse was significantly associated with higher baseline levels of global functioning (i.e., less impairment; Cohen's d = 0.51) and lower levels of stress/trauma history (d = 0.56) in children and Cluster B personality disorder symptoms in parents (d = 0.49). Regarding moderators, children with moderately impaired functioning who received MF-PEP had significantly decreased mood symptoms (t = 2.10, d = 0.33) compared with waitlist control. MF-PEP had the strongest effect on severely impaired children (t = 3.03, d = 0.47). Comprehensive assessment of demographic, youth, parent, and familial variables should precede intervention. Treatment of mood disorders in high-functioning youth without stress/trauma histories and with parents with elevated Cluster B symptoms may require extra therapeutic effort, whereas severely impaired children may benefit most from MF-PEP.

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

PubMed

Zatzick, Douglas; O'Connor, Stephen S; Russo, Joan; Wang, Jin; Bush, Nigel; Love, Jeff; Peterson, Roselyn; Ingraham, Leah; Darnell, Doyanne; Whiteside, Lauren; Van Eaton, Erik

2015-10-01

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury. Copyright © 2015 Wiley Periodicals, Inc., A Wiley Company.

Setting the stage for chronic health problems: cumulative childhood adversity among homeless adults with mental illness in Vancouver, British Columbia.

PubMed

Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

2014-04-12

It is well documented that childhood abuse, neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults, and that these experiences adversely impact child development and a wide range of adult outcomes. However, few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness. This study examines adverse events in childhood as predictors of duration of homelessness, psychiatric and substance use disorders, and physical health in a sample of homeless adults with mental illness. This study was conducted using baseline data from a randomized controlled trial in Vancouver, British Columbia for participants who completed the Adverse Childhood Experiences (ACE) scale at 18 months follow-up (n=364). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; and vocational functioning. In multivariable regression models, ACE total score independently predicted a range of mental health, physical health, and substance use problems, and marginally predicted duration of homelessness. Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness. Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems, particularly substance use problems. Results are discussed in the context of cumulative adversity and self-trauma theory. This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374.

Effects of advanced life support versus basic life support on the mortality rates of patients with trauma in prehospital settings: a study protocol for a systematic review and meta-analysis.

PubMed

Kondo, Yutaka; Fukuda, Tatsuma; Uchimido, Ryo; Hifumi, Toru; Hayashida, Kei

2017-10-22

Advanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature. We will perform searches in PubMed, Embase and the Cochrane Central Register of Controlled Trials for published observational studies, controlled before-and-after studies, randomised controlled trials and other controlled trials conducted in humans and published until March 2017. We will screen search results, assess study selection, extract data and assess the risk of bias in duplicate; disagreements will be resolved through discussions. Data from clinically homogeneous studies will be pooled using a random-effects meta-analysis, heterogeneity of effects will be assessed using the χ 2 test of homogeneity, and any observed heterogeneity will be quantified using the I 2 statistic. Last, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to rate the quality of the evidence. Our study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information. PROSPERO (International Prospective Register of Systematic Reviews) registration number CRD42017054389. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Engaging foster parents in treatment: a randomized trial of supplementing trauma-focused cognitive behavioral therapy with evidence-based engagement strategies.

PubMed

Dorsey, Shannon; Pullmann, Michael D; Berliner, Lucy; Koschmann, Elizabeth; McKay, Mary; Deblinger, Esther

2014-09-01

The goal of this study was to examine the impact of supplementing Trauma-focused Cognitive Behavioral Therapy (TF-CBT; Cohen et al., 2006) with evidence-based engagement strategies on foster parent and foster youth engagement in treatment, given challenges engaging foster parents in treatment. A randomized controlled trial of TF-CBT standard delivery compared to TF-CBT plus evidence-based engagement strategies was conducted with 47 children and adolescents in foster care and one of their foster parents. Attendance, engagement, and clinical outcomes were assessed 1 month into treatment, end of treatment, and 3 months post-treatment. Youth and foster parents who received TF-CBT plus evidence-based engagement strategies were more likely to be retained in treatment through four sessions and were less likely to drop out of treatment prematurely. The engagement strategies did not appear to have an effect on the number of canceled or no-show sessions or on treatment satisfaction. Clinical outcomes did not differ by study condition, but exploratory analyses suggest that youth had significant improvements with treatment. Strategies that specifically target engagement may hold promise for increasing access to evidence-based treatments and for increasing likelihood of treatment completion. Copyright © 2014 Elsevier Ltd. All rights reserved.

Engaging Foster Parents in Treatment: A Randomized Trial of Supplementing Trauma-focused Cognitive Behavioral Therapy with Evidence-based Engagement Strategies

PubMed Central

Pullmann, Michael D.; Berliner, Lucy; Koschmann, Elizabeth; McKay, Mary; Deblinger, Esther

2014-01-01

The goal of this study was to examine the impact of supplementing Trauma-focused Cognitive Behavioral Therapy (TF-CBT; Cohen, Mannarino, & Deblinger, 2006) with evidence-based engagement strategies on foster parent and foster youth engagement in treatment, given challenges engaging foster parents in treatment. A randomized controlled trial of TF-CBT standard delivery compared to TF-CBT plus evidence-based engagement strategies was conducted with 47 children and adolescents in foster care and one of their foster parents. Attendence, engagement, and clinical outcomes were assessed 1 month into treatment, end of treatment, and 3 months post-treatment. Youth and foster parents who received TF-CBT plus evidence-based engagement strategies were more likely to be retained in treatment through four sessions and were less likely to drop out of treatment prematurely. The engagement strategies did not appear to have an effect on the number of cancelled or no-show sessions or on treatment satisfaction. Clinical outcomes did not differ by study condition, but exploratory analyses suggest that youth had significant improvements with treatment. Strategies that specifically target engagement may hold promise for increasing access to evidence-based practices and for increasing likelihood of treatment completion. PMID:24791605

Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD).

PubMed

Kip, Kevin E; Rosenzweig, Laney; Hernandez, Diego F; Shuman, Amy; Sullivan, Kelly L; Long, Christopher J; Taylor, James; McGhee, Stephen; Girling, Sue Ann; Wittenberg, Trudy; Sahebzamani, Frances M; Lengacher, Cecile A; Kadel, Rajendra; Diamond, David M

2013-12-01

Therapies for post-traumatic stress disorder (PTSD) endorsed by the Department of Defense and Veterans Administration are relatively lengthy, costly, and yield variable success. We evaluated Accelerated Resolution Therapy (ART) for the treatment of combat-related psychological trauma. A randomized controlled trial of ART versus an Attention Control (AC) regimen was conducted among 57 U.S. service members/veterans. After random assignment, those assigned to AC were offered crossover to ART, with 3-month follow-up on all participants. Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle. Mean age was 41 ± 13 years with 19% female, 54% Army, and 68% with prior PTSD treatment. The ART was delivered in 3.7 ± 1.1 sessions with a 94% completion rate. Mean reductions in symptoms of PTSD, depression, anxiety, and trauma-related guilt were significantly greater (p < 0.001) with ART compared to AC. Favorable results for those treated with ART persisted at 3 months, including reduction in aggression (p < 0.0001). Adverse treatment-related events were rare and not serious. ART appears to be a safe and effective treatment for symptoms of combat-related PTSD, including refractory PTSD, and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

The clinical effectiveness of permissive hypotension in blunt abdominal trauma with hemorrhagic shock but without head or spine injuries or burns: a systematic review

PubMed Central

Alsawadi, Abdulrahman

2012-01-01

Background Trauma is a major cause of death and disability. The current trend in trauma management is the rapid administration of fluid as per the Advanced Trauma Life Support guidelines, although there is no evidence to support this and even some to suggest it might be harmful. Some guidelines, protocols, and recommendations have been established for the use of permissive hypotension although there is reluctance concerning its application in blunt injuries. Objectives The aim of this review is to determine whether there is evidence of the use of permissive hypotension in the management of hemorrhagic shock in blunt trauma patients. This review also aims to search for any reason for the reluctance to apply permissive hypotension in blunt injuries. Methods This systematic review has followed the steps recommended in the Cochrane Handbook for Systematic Reviews of Interventions. It is also being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement and checklist. Database searches of MEDLINE, EMBASE, the Centre for Reviews and Dissemination databases and the Cochrane Library were made for eligible studies as well as journal searches. Inclusion criteria included systematic reviews that have similar primary questions to this review and randomized controlled trials where patients with blunt torso injuries and hemorrhagic shock were not excluded. Rapid or early fluid administration was compared with controlled or delayed fluid resuscitation and a significant outcome was obtained. Results No systematic reviews attempting to answer similar questions were found. Two randomized controlled trials with mixed types of injuries in the included patients found no significant difference between the groups used in each study. Data concerning the question of this review was sought after these papers were appraised. Conclusion The limited available data are not conclusive. However, the supportive theoretical concept and laboratory evidence do not show any reason for treating blunt injuries differently from other traumatic injuries. Moreover, permissive hypotension is being used for some nontraumatic causes of hemorrhagic shock and in theater. Therefore, this should encourage interested researchers to continue clinical work in this important field. PMID:27147860

Pentobarbital versus thiopental in the treatment of refractory intracranial hypertension in patients with traumatic brain injury: a randomized controlled trial

PubMed Central

Pérez-Bárcena, Jon; Llompart-Pou, Juan A; Homar, Javier; Abadal, Josep M; Raurich, Joan M; Frontera, Guillem; Brell, Marta; Ibáñez, Javier; Ibáñez, Jordi

2008-01-01

Introduction Experimental research has demonstrated that the level of neuroprotection conferred by the various barbiturates is not equal. Until now no controlled studies have been conducted to compare their effectiveness, even though the Brain Trauma Foundation Guidelines recommend that such studies be undertaken. The objectives of the present study were to assess the effectiveness of pentobarbital and thiopental in terms of controlling refractory intracranial hypertension in patients with severe traumatic brain injury, and to evaluate the adverse effects of treatment. Methods This was a prospective, randomized, cohort study comparing two treatments: pentobarbital and thiopental. Patients who had suffered a severe traumatic brain injury (Glasgow Coma Scale score after resuscitation ≤ 8 points or neurological deterioration during the first week after trauma) and with refractory intracranial hypertension (intracranial pressure > 20 mmHg) first-tier measures, in accordance with the Brain Trauma Foundation Guidelines. Results A total of 44 patients (22 in each group) were included over a 5-year period. There were no statistically significant differences in ' baseline characteristics, except for admission computed cranial tomography characteristics, using the Traumatic Coma Data Bank classification. Uncontrollable intracranial pressure occurred in 11 patients (50%) in the thiopental treatment group and in 18 patients (82%) in the pentobarbital group (P = 0.03). Under logistic regression analysis – undertaken in an effort to adjust for the cranial tomography characteristics, which were unfavourable for pentobarbital – thiopental was more effective than pentobarbital in terms of controlling intracranial pressure (odds ratio = 5.1, 95% confidence interval 1.2 to 21.9; P = 0.027). There were no significant differences between the two groups with respect to the incidence of arterial hypotension or infection. Conclusions Thiopental appeared to be more effective than pentobarbital in controlling intracranial hypertension refractory to first-tier measures. These findings should be interpreted with caution because of the imbalance in cranial tomography characteristics and the different dosages employed in the two arms of the study. The incidence of adverse effects was similar in both groups. Trial Registration (Trial registration: US Clinical Trials registry NCT00622570.) PMID:18759980

A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan.

PubMed

Raskind, Murray A; Peterson, Kris; Williams, Tammy; Hoff, David J; Hart, Kimberly; Holmes, Hollie; Homas, Dallas; Hill, Jeffrey; Daniels, Colin; Calohan, Jess; Millard, Steven P; Rohde, Kirsten; O'Connell, James; Pritzl, Denise; Feiszli, Kevin; Petrie, Eric C; Gross, Christopher; Mayer, Cynthia L; Freed, Michael C; Engel, Charles; Peskind, Elaine R

2013-09-01

The authors conducted a 15-week randomized controlled trial of the alpha-1 adrenoreceptor antagonist prazosin for combat trauma nightmares, sleep quality, global function, and overall symptoms in active-duty soldiers with posttraumatic stress disorder (PTSD) returned from combat deployments to Iraq and Afghanistan. Sixty-seven soldiers were randomly assigned to treatment with prazosin or placebo for 15 weeks. Drug was titrated based on nightmare response over 6 weeks to a possible maximum dose of 5 mg midmorning and 20 mg at bedtime for men and 2 mg midmorning and 10 mg at bedtime for women. Mean achieved bedtime doses were 15.6 mg of prazosin (SD=6.0) and 18.8 mg of placebo (SD=3.3) for men and 7.0 mg of prazosin (SD=3.5) and 10.0 mg of placebo (SD=0.0) for women. Mean achieved midmorning doses were 4.0 mg of prazosin (SD=1.4) and 4.8 mg of placebo (SD=0.8) for men and 1.7 mg of prazosin (SD=0.5) and 2.0 mg of placebo (SD=0.0) mg for women. Primary outcome measures were the nightmare item of the Clinician-Administered PTSD Scale (CAPS), the Pittsburgh Sleep Quality Index, and the change item of the Clinical Global Impressions Scale anchored to functioning. Secondary outcome measures were the 17-item CAPS, the Hamilton Depression Rating Scale, the Patient Health Questionnaire-9, and the Quality of Life Index. Maintenance psychotropic medications and supportive psychotherapy were held constant. Prazosin was effective for trauma nightmares, sleep quality, global function, CAPS score, and the CAPS hyperarousal symptom cluster. Prazosin was well tolerated, and blood pressure changes did not differ between groups. Prazosin is effective for combat-related PTSD with trauma nightmares in active-duty soldiers, and benefits are clinically meaningful. Substantial residual symptoms suggest that studies combining prazosin with effective psychotherapies might demonstrate further benefit.

A model for the development of mothers' perceived vulnerability of preterm infants.

PubMed

Horwitz, Sarah McCue; Storfer-Isser, Amy; Kerker, Bonnie D; Lilo, Emily; Leibovitz, Ann; St John, Nick; Shaw, Richard J

2015-06-01

Some mothers of preterm infants continue to view them as vulnerable after their health has improved. These exaggerated perceptions of vulnerability lead to poor parent-child interactions and, subsequently, to adverse child outcomes. However, there is no theoretical model to explain why these exaggerated perceptions develop in only some mother-child dyads. Data for this study come from a randomized trial of an intervention to reduce distress in mothers of preterm infants. A total of 105 mothers older than 18 years of infants aged 25-34 weeks, weighing >600 g and with clinically significant anxiety, depression, or trauma symptoms, were recruited and randomized. Women were assessed at baseline, after intervention, and at 6 months after birth. The outcome for these analyses was perceptions of infant vulnerability as measured by the Vulnerable Baby Scale (VBS) at 6 months after birth. A theoretical model developed from the extant literature was tested using the MacArthur Mediator-Moderator Approach. A dysfunctional coping style, high depression, anxiety, or trauma symptoms in response to the preterm birth, and low social support were related to 6-month VBS scores. Maternal response to trauma was directly related to VBS, and an important precursor of maternal response to trauma was a dysfunctional coping style. This model suggests that maternal responses to trauma are critical in the formation of exaggerated perceptions of vulnerability as are dysfunctional coping styles and low social support. Women with these characteristics should be targeted for intervention to prevent poor parenting practices that result from exaggerated perceptions of vulnerability.

Trauma-related shame and guilt as time-varying predictors of posttraumatic stress disorder symptoms during imagery exposure and imagery rescripting--A randomized controlled trial.

PubMed

Øktedalen, Tuva; Hoffart, Asle; Langkaas, Tomas Formo

2015-01-01

The specific aims of this study are to examine trauma-related shame and guilt as time-varying predictors of symptoms of posttraumatic stress disorder (PTSD). Sixty-five patients were included in the statistical analyses and the multilevel modeling analyses supported three major findings. (i) Patients with a higher level of shame and guilt at the start of treatment displayed a higher level of PTSD symptoms over the course of treatment compared to other patients. (ii) Time-specific change in shame and guilt predicted the level of PTSD symptoms 3 days later from session to session during treatment. (iii) No significant differences were evident between prolonged exposure (PE) and modified PE to include imagery rescripting in the within-person process of change in PTSD symptoms from session to session during therapy. This trial reports the first evidence that within-person change in shame and guilt predicts change in PTSD symptoms from session to session during treatment.

Episiotomy for vaginal birth

PubMed Central

Carroli, Guillermo; Mignini, Luciano

2014-01-01

Background Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear. Objectives The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (March 2008). Selection criteria Randomized trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy. Data collection and analysis The two review authors independently assessed trial quality and extracted the data. Main results We included eight studies (5541 women). In the routine episiotomy group, 75.15% (2035/2708) of women had episiotomies, while the rate in the restrictive episiotomy group was 28.40% (776/2733). Compared with routine use, restrictive episiotomy resulted in less severe perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49 to 0.91), less suturing (RR 0.71, 95% CI 0.61 to 0.81) and fewer healing complications (RR 0.69, 95% CI 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (RR 1.84, 95% CI 1.61 to 2.10). There was no difference in severe vaginal/perineal trauma (RR 0.92, 95% CI 0.72 to 1.18); dyspareunia (RR 1.02, 95% CI 0.90 to 1.16); urinary incontinence (RR 0.98, 95% CI 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison. Authors’ conclusions Restrictive episiotomy policies appear to have a number of benefits compared to policies based on routine episiotomy. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy. PMID:19160176

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics.

PubMed

Goldbeck, Lutz; Muche, Rainer; Sachser, Cedric; Tutus, Dunja; Rosner, Rita

Trauma-focused cognitive behavioral therapy (Tf-CBT) is efficacious for children and adolescents with posttraumatic stress symptoms (PTSS). Its effectiveness in clinical practice has still to be investigated. To determine whether Tf-CBT is superior to waiting list (WL), and to investigate the predictors of treatment response. We conducted a single-blind parallel-group randomized controlled trial in eight German outpatient clinics with the main inclusion criteria of age 7-17 years, symptom score ≥35 on the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA), and caregiver participation. Patients were randomly assigned to 12 sessions of Tf-CBT (n = 76) or a WL (n = 83). The primary outcome was the CAPS-CA symptom score assessed at 4 months by blinded evaluators. The secondary measures were diagnostic status, the Children's Global Assessment Scale (CGAS), self-reported and caregiver-reported PTSS (UCLA-PTSD Reaction Index), the Child Posttraumatic Cognitions Inventory (CPTCI), the Children's Depression Inventory (CDI), the Screen for Child Anxiety- Related Emotional Disorders (SCARED), the Child Behavior Checklist (CBCL/4-18), and the Quality of Life Inventory for Children. Intention-to-treat analyses showed that Tf-CBT was significantly superior to WL on the CAPS-CA (Tf-CBT: baseline = 58.51 ± 17.41; 4 months = 32.16 ± 26.02; WL: baseline = 57.39 ± 16.05; 4 months = 43.29 ± 25.2; F1, 157 = 12.3; p = 0.001; d = 0.50), in terms of secondary measures of the CGAS, UCLA-PTSD-RI, CPTCI, CDI, SCARED, and CBCL/4-18, but not in terms of quality of life. Age and comorbidity significantly predicted treatment response. Tf-CBT is effective for children and adolescents with heterogeneous trauma types in German service settings. Younger patients with fewer comorbid disorders show most improvement. © 2016 S. Karger AG, Basel.

Randomized Trial of a Social Networking Intervention for Cancer-Related Distress.

PubMed

Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette

2017-10-01

Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).

Treatment of Post-Traumatic Stress Disorders with the Alpha-1 Adrenergic Antagonist Prazosin.

PubMed

Simon, Philippe Yves Rémy; Rousseau, Pierre-François

2017-03-01

The present review aims to assess the clinical efficacy and safety of the α-1-adrenergic antagonist prazosin as primary pharmacologic treatment for post-traumatic stress disorder (PTSD). A systematic review was performed using keywords (i.e., prazosin, α-1-adrenergic antagonist, α-1-blocker, post-traumatic stress disorder) in the databases PubMed/Medline (1966-May 2016), Embase (1966-May 2016), ScienceDirect (1823-May 2016), OvidSP (1946-May 2016) and Nature (1845-May 2016). To be considered for inclusion, studies had to test the efficacy of prazosin either alone or added to ongoing treatment in adults with PTSD, use validated tools to assess and monitor the disorders, allow comparisons on the basis of univariate analyses (i.e., p-values of t-tests and effect sizes) and list the identified adverse reactions. 12 studies were included: 5 randomized controlled trials, 4 open-label prospective trials and 3 retrospective file reviews. The evaluation concerned 276 patients exposed to civilian trauma (19%) or war trauma (81%). Prazosin significantly decreases trauma nightmares, avoidance, hypervigilance and improves patient status in all studies. No significant difference of blood pressure was observed at the end of trials. Beyond the methodological and clinical biases of these studies, the present review not only confirms the effectiveness and good tolerability of prazosin, but also suggests its possible use as primary pharmacologic treatment for PTSD. Uncertainties remain, however, regarding the prescription modalities and dosages.

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq

PubMed Central

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-01-01

ABSTRACT Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein’s government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen’s d, 0.57; P = .02) and dysfunction (Cohen’s d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. PMID:27609624

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq.

PubMed

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-09-28

Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein's government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen's d, 0.57; P = .02) and dysfunction (Cohen's d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. © Bass et al.

Neurocognitive functioning over the course of trauma-focused psychotherapy for PTSD: Changes in verbal memory and executive functioning.

PubMed

Nijdam, Mirjam J; Martens, Irene J M; Reitsma, Johannes B; Gersons, Berthold P R; Olff, Miranda

2018-05-01

Individuals with post-traumatic stress disorder (PTSD) have neurocognitive deficits in verbal memory and executive functioning. In this study, we examined whether memory and executive functioning changed over the course of treatment and which clinical variables were associated with change. Neuropsychological assessments were administered at baseline and endpoint of a randomized controlled trial as secondary outcome. Trauma survivors (n = 88) diagnosed with PTSD received trauma-focused psychotherapy within a 17-week randomized controlled trial. Neuropsychological tests were the California Verbal Learning Test, Rivermead Behavioural Memory Test, Stroop Color Word Test, and Trail Making Test. Significant, small- to medium-sized improvements in verbal memory, information processing speed, and executive functioning were found after trauma-focused psychotherapy (Cohen's d 0.16-0.68). Greater PTSD symptom decrease was significantly related to better post-treatment neurocognitive performance (all p < .005). Patients with comorbid depression improved more than patients with PTSD alone on interference tasks (p < .01). No differences emerged between treatment conditions and between patients on serotonergic antidepressants and those who were not. This study suggests that neurocognitive deficits in PTSD can improve over the course of trauma-focused psychotherapy and are therefore at least partly reversible. Improvements over treatment are in line with previous neuropsychological and neuroimaging studies and effect sizes exceed those of practice effects. Future research should determine whether these changes translate into improved functioning in the daily lives of the patients. Patients with PTSD have difficulties performing verbal memory tasks (e.g., remembering a grocery list, recall of a story) and executive functioning tasks (e.g., shifting attention between two tasks, ignoring irrelevant information to complete a task). Verbal memory, information processing speed, and executive functioning significantly improved in patients with post-traumatic stress disorder over the course of trauma-focused psychotherapy. Improvements were equal in size for two different trauma-focused psychotherapies (Eye movement desensitization and reprocessing therapy and brief eclectic psychotherapy for PTSD). Medium-sized effects were found for recall of a story, whereas effects in other aspects of verbal memory, information processing speed, and executive functioning were small-sized. No causal attributions can be made because we could not include a control group without treatment for ethical reasons. Findings may be more reflective of patients who completed treatment than patients who prematurely dropped out as completers were overrepresented in our sample. © 2018 The British Psychological Society.

Implementation of cognitive therapy for PTSD in routine clinical care: effectiveness and moderators of outcome in a consecutive sample.

PubMed

Ehlers, Anke; Grey, Nick; Wild, Jennifer; Stott, Richard; Liness, Sheena; Deale, Alicia; Handley, Rachel; Albert, Idit; Cullen, Deborah; Hackmann, Ann; Manley, John; McManus, Freda; Brady, Francesca; Salkovskis, Paul; Clark, David M

2013-11-01

Trauma-focused psychological treatments are recommended as first-line treatments for Posttraumatic Stress Disorder (PTSD), but clinicians may be concerned that the good outcomes observed in randomized controlled trials (RCTs) may not generalize to the wide range of traumas and presentations seen in clinical practice. This study investigated whether Cognitive Therapy for PTSD (CT-PTSD) can be effectively implemented into a UK National Health Service Outpatient Clinic serving a defined ethnically mixed urban catchment area. A consecutive sample of 330 patients with PTSD (age 17-83) following a wide range of traumas were treated by 34 therapists, who received training and supervision in CT-PTSD. Pre and post treatment data (PTSD symptoms, anxiety, depression) were collected for all patients, including dropouts. Hierarchical linear modeling investigated candidate moderators of outcome and therapist effects. CT-PTSD was well tolerated and led to very large improvement in PTSD symptoms, depression and anxiety. The majority of patients showed reliable improvement/clinically significant change: intent-to-treat: 78.8%/57.3%; completer: 84.5%/65.1%. Dropouts and unreliable attenders had worse outcome. Statistically reliable symptom exacerbation with treatment was observed in only 1.2% of patients. Treatment gains were maintained during follow-up (M=280 days, n=220). Few of the selection criteria used in some RCTs, demographic, diagnostic and trauma characteristics moderated treatment outcome, and only social problems and needing treatment for multiple traumas showed unique moderation effects. There were no random effects of therapist on symptom improvement, but therapists who were inexperienced in CT-PTSD had more dropouts than those with greater experience. The results support the effectiveness of CT-PTSD and suggest that trauma-focused cognitive behavior therapy can be successfully implemented in routine clinical services treating patients with a wide range of traumas. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Implementation of Cognitive Therapy for PTSD in routine clinical care: Effectiveness and moderators of outcome in a consecutive sample☆

PubMed Central

Ehlers, Anke; Grey, Nick; Wild, Jennifer; Stott, Richard; Liness, Sheena; Deale, Alicia; Handley, Rachel; Albert, Idit; Cullen, Deborah; Hackmann, Ann; Manley, John; McManus, Freda; Brady, Francesca; Salkovskis, Paul; Clark, David M.

2013-01-01

Objective Trauma-focused psychological treatments are recommended as first-line treatments for Posttraumatic Stress Disorder (PTSD), but clinicians may be concerned that the good outcomes observed in randomized controlled trials (RCTs) may not generalize to the wide range of traumas and presentations seen in clinical practice. This study investigated whether Cognitive Therapy for PTSD (CT-PTSD) can be effectively implemented into a UK National Health Service Outpatient Clinic serving a defined ethnically mixed urban catchment area. Method A consecutive sample of 330 patients with PTSD (age 17–83) following a wide range of traumas were treated by 34 therapists, who received training and supervision in CT-PTSD. Pre and post treatment data (PTSD symptoms, anxiety, depression) were collected for all patients, including dropouts. Hierarchical linear modeling investigated candidate moderators of outcome and therapist effects. Results CT-PTSD was well tolerated and led to very large improvement in PTSD symptoms, depression and anxiety. The majority of patients showed reliable improvement/clinically significant change: intent-to-treat: 78.8%/57.3%; completer: 84.5%/65.1%. Dropouts and unreliable attenders had worse outcome. Statistically reliable symptom exacerbation with treatment was observed in only 1.2% of patients. Treatment gains were maintained during follow-up (M = 280 days, n = 220). Few of the selection criteria used in some RCTs, demographic, diagnostic and trauma characteristics moderated treatment outcome, and only social problems and needing treatment for multiple traumas showed unique moderation effects. There were no random effects of therapist on symptom improvement, but therapists who were inexperienced in CT-PTSD had more dropouts than those with greater experience. Conclusions The results support the effectiveness of CT-PTSD and suggest that trauma-focused cognitive behavior therapy can be successfully implemented in routine clinical services treating patients with a wide range of traumas. PMID:24076408

Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial

PubMed Central

Mendelow, A. David; Rowan, Elise N.; Francis, Richard; McColl, Elaine; McNamee, Paul; Chambers, Iain R.; Unterberg, Andreas; Boyers, Dwayne; Mitchell, Patrick M.

2015-01-01

Abstract Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, −4.4–25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed. PMID:25738794

Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

DTIC Science & Technology

2017-01-11

patient- controlled analgesia per the primary treating team. Four subjects in the ketamine group and one subject in the hydromorphone group withdrew...occurred more frequently in the ketamine group , although this was not statistically significant (40% vs. 0%, P=0.090). Ketamine patient- controlled ...breakthrough IV morphine equivalents between groups . 4.0 RESULTS 4.1 Participants Due to unanticipated barriers to enrollment, including a

Implementing the Bounce Back trauma intervention in urban elementary schools: A real-world replication trial.

PubMed

Santiago, Catherine DeCarlo; Raviv, Tali; Ros, Anna Maria; Brewer, Stephanie K; Distel, Laura M L; Torres, Stephanie A; Fuller, Anne K; Lewis, Krystal M; Coyne, Claire A; Cicchetti, Colleen; Langley, Audra K

2018-03-01

The current study provides the first replication trial of Bounce Back, a school-based intervention for elementary students exposed to trauma, in a different school district and geographical area. Participants in this study were 52 1st through 4th graders (Mage = 7.76 years; 65% male) who were predominately Latino (82%). Schools were randomly assigned to immediate treatment or waitlist control. Differential treatment effects (Time × Group Interaction) were found for child-reported posttraumatic stress disorder (PTSD) and parent-reported child coping, indicating that the immediate treatment group showed greater reductions in PTSD and improvements in coping compared with the delayed group. Differential treatment effects were not significant for depression or anxiety. Significant maintenance effects were found for both child-reported PTSD and depression as well as parent-reported PTSD and coping for the immediate treatment group at follow-up. Significant treatment effects were also found in the delayed treatment group, showing reductions in child-reported PTSD, depression, and anxiety as well as parent-reported depression and coping upon receiving treatment. In conclusion, the current study suggests that Bounce Back is an effective intervention for reducing PTSD symptoms and improving coping skills, even among a sample experiencing high levels of trauma and other ongoing stressors. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Empirically supported psychological treatments for adult acute stress disorder and posttraumatic stress disorder: a review.

PubMed

Ponniah, Kathryn; Hollon, Steven D

2009-01-01

Acute stress disorder (ASD) predicts the development of posttraumatic stress disorder (PTSD), which in some sufferers can persist for years and lead to significant disability. We carried out a review of randomized controlled trials to give an update on which psychological treatments are empirically supported for these disorders, and used the criteria set out by Chambless and Hollon [1998: J Consult Clin Psychol 66:7-18] to draw conclusions about efficacy, first irrespective of trauma type and second with regard to particular populations. The PsycINFO and PubMed databases were searched electronically to identify suitable articles published up to the end of 2008. Fifty-seven studies satisfied our inclusion criteria. Looking at the literature undifferentiated by trauma type, there was evidence that trauma-focused cognitive behavioral therapy (CBT) and eye movement desensitization and reprocessing (EMDR) are efficacious and specific for PTSD, stress inoculation training, hypnotherapy, interpersonal psychotherapy, and psychodynamic therapy are possibly efficacious for PTSD and trauma-focused CBT is possibly efficacious for ASD. Not one of these treatments has been tested with the full range of trauma groups, though there is evidence that trauma-focused CBT is established in efficacy for assault- and road traffic accident-related PTSD. Trauma-focused CBT and to a lesser extent EMDR (due to fewer studies having been conducted and many having had a mixed trauma sample) are the psychological treatments of choice for PTSD, but further research of these and other therapies with different populations is needed.

Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial.

PubMed

Innerhofer, Petra; Fries, Dietmar; Mittermayr, Markus; Innerhofer, Nicole; von Langen, Daniel; Hell, Tobias; Gruber, Gottfried; Schmid, Stefan; Friesenecker, Barbara; Lorenz, Ingo H; Ströhle, Mathias; Rastner, Verena; Trübsbach, Susanne; Raab, Helmut; Treml, Benedikt; Wally, Dieter; Treichl, Benjamin; Mayr, Agnes; Kranewitter, Christof; Oswald, Elgar

2017-06-01

Effective treatment of trauma-induced coagulopathy is important; however, the optimal therapy is still not known. We aimed to compare the efficacy of first-line therapy using fresh frozen plasma (FFP) or coagulation factor concentrates (CFC) for the reversal of trauma-induced coagulopathy, the arising transfusion requirements, and consequently the development of multiple organ failure. This single-centre, parallel-group, open-label, randomised trial was done at the Level 1 Trauma Center in Innsbruck Medical University Hospital (Innsbruck, Austria). Patients with trauma aged 18-80 years, with an Injury Severity Score (ISS) greater than 15, bleeding signs, and plasmatic coagulopathy identified by abnormal fibrin polymerisation or prolonged coagulation time using rotational thromboelastometry (ROTEM) were eligible. Patients with injuries that were judged incompatible with survival, cardiopulmonary resuscitation on the scene, isolated brain injury, burn injury, avalanche injury, or prehospital coagulation therapy other than tranexamic acid were excluded. We used a computer-generated randomisation list, stratification for brain injury and ISS, and closed opaque envelopes to randomly allocate patients to treatment with FFP (15 mL/kg of bodyweight) or CFC (primarily fibrinogen concentrate [50 mg/kg of bodyweight]). Bleeding management began immediately after randomisation and continued until 24 h after admission to the intensive care unit. The primary clinical endpoint was multiple organ failure in the modified intention-to-treat population (excluding patients who discontinued treatment). Reversal of coagulopathy and need for massive transfusions were important secondary efficacy endpoints that were the reason for deciding the continuation or termination of the trial. This trial is registered with ClinicalTrials.gov, number NCT01545635. Between March 3, 2012, and Feb 20, 2016, 100 out of 292 screened patients were included and randomly allocated to FFP (n=48) and CFC (n=52). Six patients (four in the FFP group and two in the CFC group) discontinued treatment because of overlooked exclusion criteria or a major protocol deviation with loss of follow-up. 44 patients in the FFP group and 50 patients in the CFC group were included in the final interim analysis. The study was terminated early for futility and safety reasons because of the high proportion of patients in the FFP group who required rescue therapy compared with those in the CFC group (23 [52%] in the FFP group vs two [4%] in the CFC group; odds ratio [OR] 25·34 [95% CI 5·47-240·03], p<0·0001) and increased needed for massive transfusion (13 [30%] in the FFP group vs six [12%] in the CFC group; OR 3·04 [0·95-10·87], p=0·042) in the FFP group. Multiple organ failure occurred in 29 (66%) patients in the FFP group and in 25 (50%) patients in the CFC group (OR 1·92 [95% CI 0·78-4·86], p=0·15). Our results underline the importance of early and effective fibrinogen supplementation for severe clotting failure in multiple trauma. The available sample size in our study appears sufficient to make some conclusions that first-line CFC is superior to FFP. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effectiveness of antenatal perineal massage in reducing perineal trauma and post-partum morbidities: A randomized controlled trial.

PubMed

Ugwu, Emmanuel Onyebuchi; Iferikigwe, Eric Sunday; Obi, Samuel Nnamdi; Eleje, George Uchenna; Ozumba, Benjamin Chukwuma

2018-04-02

The study aimed to evaluate the effectiveness of antenatal perineal massage (APM) in reducing perineal trauma and post-partum morbidities. A randomized controlled trial of 108 primigravidae at the University of Nigeria Teaching Hospital, Enugu, Nigeria, was conducted from January 2013 to May 2014. The intervention group received APM, while the control group did not receive APM. Women who received APM were significantly more likely to have an intact perineum after childbirth [27/53 (50.9%) vs 16/55 (29.1%); RR: 1.75; 95% CI: 1.07-2.86; P = 0.02]. The incidence of episiotomy was lower in the intervention group [20/53 (37.7%) vs 32/55 (58.2%); RR: 0.65; 95% CI: 0.43-0.98; P = 0.03; NNT = 5]. Women who received APM were significantly less likely to develop flatus incontinence [4/53 (8.3%) vs 13/55 (26.0%); RR: 0.32; 95% CI: 0.11-0.91; P = 0.03]. However, the incidences of premature rupture of membranes, preterm labor and birth asphyxia were similar between the two groups (P > 0.05). APM reduces the incidence of episiotomy and increases the incidence of women with an intact perineum after vaginal delivery. It also reduces the risk of flatus incontinence after childbirth without increased maternal or neonatal complications. Women should therefore be counseled on the likely benefits of APM and the information provided during antenatal care. Obstetricians should consider the technique as routine prenatal care for nulliparous women so as to reduce the incidence of perineal trauma during vaginal birth. © 2018 Japan Society of Obstetrics and Gynecology.

Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures.

PubMed

Ingalls, Nichole K; Horton, Zachary A; Bettendorf, Matthew; Frye, Ira; Rodriguez, Carlos

2010-02-01

The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy. Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p < 0.05. Thirty-three patients received the lidocaine patch 5% and 25 received the placebo patch. There were no significant differences in age, number of rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%. The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.

A controlled trial of trauma-focused therapy versus problem-solving in Islamic children affected by civil conflict and disaster in Aceh, Indonesia.

PubMed

Dawson, Katie; Joscelyne, Amy; Meijer, Catherine; Steel, Zachary; Silove, Derrick; Bryant, Richard A

2018-03-01

To evaluate the relative efficacies of trauma-focused cognitive behavior therapy and problem-solving therapy in treating post-traumatic stress disorder in children affected by civil conflict in Aceh, Indonesia. A controlled trial of children with post-traumatic stress disorder ( N = 64) randomized children to either five individual weekly sessions of trauma-focused cognitive behavior therapy or problem-solving therapy provided by lay-counselors who were provided with brief training. Children were assessed by blind independent assessors at pretreatment, posttreatment and 3-month follow-up on post-traumatic stress disorder, depression and anger, as well as caregiver ratings of the child's post-traumatic stress disorder levels. Intent-to-treat analyses indicated no significant linear time × treatment condition interaction effects for post-traumatic stress disorder at follow-up ( t(129.05) = -0.55, p = 0.58), indicating the two conditions did not differ. Across both conditions, there were significant reductions in post-traumatic stress disorder on self-reported ( t(131.26) = -9.26, p < 0.001) and caregiver-reported ( t(170.65) = 3.53, p = 0.001) measures and anger ( t(127.66) = -7.14, p < 0.001). Across both conditions, there was a large effect size for self-reported post-traumatic stress disorder (cognitive behavior therapy: 3.73, 95% confidence interval = [2.75, 3.97]; problem-solving: 2.68, 95% confidence interval = [2.07, 3.29]). These findings suggest that trauma-focused cognitive behavior therapy and problem-solving approaches are comparably successful in reducing post-traumatic stress disorder and anger in treating mental health in children in a post-conflict setting. This pattern may reflect the benefits of non-specific therapy effects or gains associated with trauma-focused or problem-solving approaches.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Memory effects of sedative drugs in children and adolescents--protocol for a systematic review.

PubMed

Viana, Karolline A; Daher, Anelise; Maia, Lucianne C; Costa, Paulo S; Martins, Carolina C; Paiva, Saul M; Costa, Luciane R

2016-02-18

Some sedatives used in children and adolescents can affect memory function. Memory impairment of traumatic experience can minimize the chance of future psychological trauma. Knowledge about the potential of different sedatives to produce amnesia can help in the decision-making process of choosing a sedative regimen. The aim of this systematic review is to evaluate the effect of different sedatives on memory of perioperative events in children and adolescents. Electronic databases and other sources, such as trial registers, gray literature, and conference abstracts will be searched. Randomized controlled trials will be included that assess memory of perioperative events in children and adolescents 2-19 years old receiving sedative drugs as premedication or as agents for procedural sedation in a medical or dental settings. The outcomes will be loss of memory after and before sedative administration (anterograde and retrograde amnesia). Two independent reviewers will perform screening, study selection, and data extraction. Disagreement at all levels will be resolved by consensus or by involving a third reviewer. Assessment of the risk of bias of included studies will be performed according to "Cochrane Collaboration's Tool for Assessing Risk of Bias in Randomized Trials." Clinical and methodological heterogeneity across studies will be evaluated to determine if it is possible to combine or not combine study results in a meta-analysis. To the best of our knowledge, there is no systematic review that specifically addresses this question. Findings from the review will be useful in the decision-making process about the best sedative for minimizing recall of the medical/dental event and possible psychological trauma. PROSPERO CRD42015017559.

Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb-a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST).

PubMed

Achten, Juul; Vadher, Karan; Bruce, Julie; Nanchahal, Jagdeep; Spoors, Louise; Masters, James P; Dutton, Susan; Madan, Jason; Costa, Matthew L

2018-06-07

Patients with closed high-energy injuries associated with major trauma have surprisingly high rates of surgical site infection in incisions created during fracture fixation. One factor that may reduce the risk of surgical site infection is the type of dressing applied over the closed surgical incision. In this multicentre randomised clinical trial, negative-pressure wound therapy will be compared with standard dressings with outcomes of deep infection, quality of life, pain and disability. Adult patients presenting to hospital within 72 hours of sustaining major trauma, requiring a surgical incision to treat a fractured lower limb, are eligible for inclusion. Randomisation, stratified by trial centre, open/closed fracture at presentation and Injury Severity Score (ISS) ≤15 versus ISS ≥16 will be administered via a secure web-based service using minimisation. The random allocation will be to either standard wound management or negative-pressure wound therapy.Trial participants will usually have clinical follow-up at the local fracture clinic for a minimum of 6 months, as per standard National Health Service practice. Diagnosis of deep infection will be recorded at 30 days. Functional, pain and quality of life outcome data will be collected using the Disability Rating Index, Douleur Neuropathique Questionnaire and Euroqol - 5 Dimension - 5 level (EQ-5D-5L) questionnaires at 3 months and 6 months postinjury. Further data will be captured on resource use and any late postoperative complications.Longer term outcomes will be assessed annually for 5 years and reported separately. National Research Ethics Committee approved this study on 16 February 2016 16/WM/0006.The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of this trial. The results of this trial will inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. ISRCTN12702354; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Childhood trauma predicts antidepressant response in adults with major depression: data from the randomized international study to predict optimized treatment for depression.

PubMed

Williams, L M; Debattista, C; Duchemin, A-M; Schatzberg, A F; Nemeroff, C B

2016-05-03

Few reliable predictors indicate which depressed individuals respond to antidepressants. Several studies suggest that a history of early-life trauma predicts poorer response to antidepressant therapy but results are variable and limited in adults. The major goal of the present study was to evaluate the role of early-life trauma in predicting acute response outcomes to antidepressants in a large sample of well-characterized patients with major depressive disorder (MDD). The international Study to Predict Optimized Treatment for Depression (iSPOT-D) is a randomized clinical trial with enrollment from December 2008 to January 2012 at eight academic and nine private clinical settings in five countries. Patients (n=1008) meeting DSM-IV criteria for MDD and 336 matched healthy controls comprised the study sample. Six participants withdrew due to serious adverse events. Randomization was to 8 weeks of treatment with escitalopram, sertraline or venlafaxine with dosage adjusted by the participant's treating clinician per routine clinical practice. Exposure to 18 types of traumatic events before the age of 18 was assessed using the Early-Life Stress Questionnaire. Impact of early-life stressors-overall trauma 'load' and specific type of abuse-on treatment outcomes measures: response: (⩾50% improvement on the 17-item Hamilton Rating Scale for Depression, HRSD17 or on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated, QIDS_SR16) and remission (score ⩽7 on the HRSD17 and ⩽5 on the QIDS_SR16). Trauma prevalence in MDD was compared with controls. Depressed participants were significantly more likely to report early-life stress than controls; 62.5% of MDD participants reported more than two traumatic events compared with 28.4% of controls. The higher rate of early-life trauma was most apparent for experiences of interpersonal violation (emotional, sexual and physical abuses). Abuse and notably abuse occurring at ⩽7 years of age predicted poorer outcomes after 8 weeks of antidepressants, across the three treatment arms. In addition, the abuses occurring between ages 4 and 7 years differentially predicted the poorest outcome following the treatment with sertraline. Specific types of early-life trauma, particularly physical, emotional and sexual abuse, especially when occurring at ⩽7 years of age are important moderators of subsequent response to antidepressant therapy for MDD.

Childhood trauma predicts antidepressant response in adults with major depression: data from the randomized international study to predict optimized treatment for depression

PubMed Central

Williams, L M; Debattista, C; Duchemin, A-M; Schatzberg, A F; Nemeroff, C B

2016-01-01

Few reliable predictors indicate which depressed individuals respond to antidepressants. Several studies suggest that a history of early-life trauma predicts poorer response to antidepressant therapy but results are variable and limited in adults. The major goal of the present study was to evaluate the role of early-life trauma in predicting acute response outcomes to antidepressants in a large sample of well-characterized patients with major depressive disorder (MDD). The international Study to Predict Optimized Treatment for Depression (iSPOT-D) is a randomized clinical trial with enrollment from December 2008 to January 2012 at eight academic and nine private clinical settings in five countries. Patients (n=1008) meeting DSM-IV criteria for MDD and 336 matched healthy controls comprised the study sample. Six participants withdrew due to serious adverse events. Randomization was to 8 weeks of treatment with escitalopram, sertraline or venlafaxine with dosage adjusted by the participant's treating clinician per routine clinical practice. Exposure to 18 types of traumatic events before the age of 18 was assessed using the Early-Life Stress Questionnaire. Impact of early-life stressors—overall trauma ‘load' and specific type of abuse—on treatment outcomes measures: response: (⩾50% improvement on the 17-item Hamilton Rating Scale for Depression, HRSD17 or on the 16-item Quick Inventory of Depressive Symptomatology—Self-Rated, QIDS_SR16) and remission (score ⩽7 on the HRSD17 and ⩽5 on the QIDS_SR16). Trauma prevalence in MDD was compared with controls. Depressed participants were significantly more likely to report early-life stress than controls; 62.5% of MDD participants reported more than two traumatic events compared with 28.4% of controls. The higher rate of early-life trauma was most apparent for experiences of interpersonal violation (emotional, sexual and physical abuses). Abuse and notably abuse occurring at ⩽7 years of age predicted poorer outcomes after 8 weeks of antidepressants, across the three treatment arms. In addition, the abuses occurring between ages 4 and 7 years differentially predicted the poorest outcome following the treatment with sertraline. Specific types of early-life trauma, particularly physical, emotional and sexual abuse, especially when occurring at ⩽7 years of age are important moderators of subsequent response to antidepressant therapy for MDD. PMID:27138798

Trauma and PTSD symptoms in Rwanda: implications for attitudes toward justice and reconciliation.

PubMed

Pham, Phuong N; Weinstein, Harvey M; Longman, Timothy

2004-08-04

The 1994 genocide in Rwanda led to the loss of at least 10% of the country's 7.7 million inhabitants, the destruction of much of the country's infrastructure, and the displacement of nearly 4 million people. In seeking to rebuild societies such as Rwanda, it is important to understand how traumatic experience may shape the ability of individuals and groups to respond to judicial and other reconciliation initiatives. To assess the level of trauma exposure and the prevalence of posttraumatic stress disorder (PTSD) symptoms and their predictors among Rwandans and to determine how trauma exposure and PTSD symptoms are associated with Rwandans' attitudes toward justice and reconciliation. Multistage, stratified cluster random survey of 2091 eligible adults in selected households in 4 communes in Rwanda in February 2002. Rates of exposure to trauma and symptom criteria for PTSD using the PTSD Checklist-Civilian Version; attitudes toward judicial responses (Rwandan national and gacaca local trials and International Criminal Tribunal for Rwanda [ICTR]) and reconciliation (belief in community, nonviolence, social justice, and interdependence with other ethnic groups). Of 2074 respondents with data on exposure to trauma, 1563 (75.4%) were forced to flee their homes, 1526 (73.0%) had a close member of their family killed, and 1472 (70.9%) had property destroyed or lost. Among the 2091 total participants, 518 (24.8%) met symptom criteria for PTSD. The adjusted odds ratio (OR) of meeting PTSD symptom criteria for each additional traumatic event was 1.43 (95% CI, 1.33-1.55). More respondents supported the local judicial responses (90.8% supported gacaca trials and 67.8% the Rwanda national trials) than the ICTR (42.1% in support). Respondents who met PTSD symptom criteria were less likely to have positive attitudes toward the Rwandan national trials (OR, 0.77; 95% CI, 0.61-0.98), belief in community (OR, 0.76; 95% CI, 0.60-0.97), and interdependence with other ethnic groups (OR, 0.71; 95% CI, 0.56-0.90). Respondents with exposure to multiple trauma events were more likely to have positive attitudes toward the ICTR (OR, 1.10; 95% CI, 1.04-1.17) and less likely to support the Rwandan national trials (OR, 0.90; 95% CI, 0.84-0.96), the local gacaca trials (OR, 0.80; 95% CI, 0.72-0.89), and 3 factors of openness to reconciliation: belief in nonviolence (OR, 0.92; 95% CI, 0.87-0.97), belief in community (OR, 0.92; 95% CI, 0.87-0.98), and interdependence with other ethnic groups (OR, 0.86; 95% CI, 0.81-0.92). Other variables that were associated with attitudes toward judicial processes and openness to reconciliation were educational level, ethnicity, perception of change in poverty level and access to security compared with 1994, and ethnic distance. This study demonstrates that traumatic exposure, PTSD symptoms, and other factors are associated with attitudes toward justice and reconciliation. Societal interventions following mass violence should consider the effects of trauma if reconciliation is to be realized.

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

PubMed Central

Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

2014-01-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history. PMID:25506545

Extracorporeal shock waves in the treatment of nonunions.

PubMed

Biedermann, Rainer; Martin, Arho; Handle, Gerhart; Auckenthaler, Thomas; Bach, Christian; Krismer, Martin

2003-05-01

Nonunion remains a major complication after skeletal trauma. In the last decade, extracorporeal shock wave therapy has become a common tool for the treatment of nonunions. To date, no prospective, randomized trial has been conducted to show the efficacy of this form of treatment. This study was performed to determine the value of extracorporeal shock wave therapy for nonunions. Previous published results in the literature and our own clinical results were analyzed and related to the natural history of bony union. No study has proven that extracorporeal shock wave therapy improves bone healing. Clinical studies reporting the acceleration of union after application of shock waves instead seem to misinterpret the natural history of bony union. No evidence supports the treatment of pseudarthroses with extracorporeal shock waves. A randomized, prospective, clinical trial with a control group has to be performed before a final decision can be made regarding this indication for extracorporeal shock wave therapy.

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial.

PubMed

Yadavaia, James E; Hayes, Steven C; Vilardaga, Roger

2014-10-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history.

The Impact of Noise on the Reliability of Heart-Rate Variability and Complexity Analysis in Trauma Patients

DTIC Science & Technology

2013-01-01

endotracheal intubations, 30 transfusions, 18 tube thoracos- tomies, 9 cardiopulmonary resuscitations , 8 needle decompressions, 1 angio-embolization...monitoring in very low birth weight neonates : a randomized trial, J. Pediatr. 6 (2011) 900–906. [11] J.R. Moorman, J.B. Delos, A.A. Flower, H. Cao, B.P...Kovatchev, J.S. Richman, D.E. Lake, Cardiovascular oscillations at the bedside: early diagnosis of neonatal sepsis using heart rate characteristics

Trauma-focused cognitive behavioral therapy a clinical trial to increase self-efficacy in abused the primary school children.

PubMed

Farina, Vahid; Salemi, Safora; Tatari, Faezeh; Abdoli, Nasrin; Jouybari, Touraj Ahmadi; Alikhani, Mostafa; Basanj, Behrad; Zakiei, Ali

2018-01-01

Child abuse and violence toward children has become a complex phenomenon in nowadays societies leaving hurt children with numerous complications such as lowered self-efficacy. Hence, this study was conducted to assess the effect of trauma-focused cognitive behavioral therapy (TF-CBT) in physically abused children self-efficacy. This study was a randomized clinical trial. From this statistical population of all abused children aged 9-12 in Kermanshah in 2016-2017, 40 were divided into intervention and control groups randomly. Tools used in this study were Maurice self-efficacy questionnaire and child abuse questionnaire. Data analysis was done using Chi-square test, paired t -test, and independent t -test. It was revealed that the mean difference between two groups was not meaningful before intervention. After TF-CBT in intervention group, self-efficacy mean scores of social (17.95 vs. 24.20) and emotional (15.05 vs. 19.05) domains showed meaningful differences, whereas academic self-efficacy mean score did not change significantly (14.10 vs. 14.65) ( P < 0.086). In control group, social (16.20 vs. 15.55), emotional (13.90 vs. 14.35), and academic (13.40 vs. 13.90) mean self-efficacy scores were not of significant difference ( P > 0.001). TF-CBT can be used as an appropriate therapy intervention to improve social and emotional self-efficacy in abused children.

Trauma management therapy with virtual-reality augmented exposure therapy for combat-related PTSD: A randomized controlled trial.

PubMed

Beidel, Deborah C; Frueh, B Christopher; Neer, Sandra M; Bowers, Clint A; Trachik, Benjamin; Uhde, Thomas W; Grubaugh, Anouk

2017-08-23

Virtual reality exposure therapy (VRET) realistically incorporates traumatic cues into exposure therapy and holds promise in the treatment of combat-related posttraumatic stress disorder (PTSD). In a randomized controlled trial of 92 Iraq and Afghanistan veterans and active duty military personnel with combat-related PTSD, we compared the efficacy of Trauma Management Therapy (TMT; VRET plus a group treatment for anger, depression, and social isolation) to VRET plus a psychoeducation control condition. Efficacy was evaluated at mid- and post-treatment, and at 3- and 6-month follow-up. Consistent with our hypothesis, VRET resulted in significant decreases on the Clinician Administered PTSD Scale and the PTSD Checklist-Military version for both groups. Also consistent with our hypothesis, significant decreases in social isolation occurred only for those participants who received the TMT group component. There were significant decreases for depression and anger for both groups, although these occurred after VRET and before group treatment. All treatment gains were maintained six-months later. Although not part of the original hypotheses, sleep was not improved by either intervention and remained problematic. The results support the use of VRET as an efficacious treatment for combat-related PTSD, but suggest that VRET alone does not result in optimal treatment outcomes across domains associated with PTSD. Copyright © 2017 Elsevier Ltd. All rights reserved.

Occult pneumothorax in the mechanically ventilated trauma patient

PubMed Central

Ball, Chad G.; Hameed, S. Morad; Evans, Dave; Kortbeek, John B.; Kirkpatrick, Andrew W.

2003-01-01

The term occult pneumothorax (OP) describes a pneumothorax that is not suspected on the basis of clinical examination or plain radiography but is ultimately detected with thoracoabdominal computed tomography (CT). This situation is increasingly common in trauma care with the increased use of CT. The rate is approximately 5% in injured people presenting to hospital, with CT revealing at least twice as many pneumothoraces as suspected on plain radiography. Whereas pneumothorax is a common and treatable cause of mortality and morbidity, there is substantial disagreement regarding the appropriate treatment of OP. The greatest controversy is in patients in the critical care unit who require positive-pressure ventilation. There is little current evidence to direct the proper management of ventilated trauma patients with OP, and no studies have focussed specifically on these patients. Future randomized trials will need to consider the potential effects of OP on pulmonary mechanics and potential influences on the known risks of ventilator-induced lung injury associated with mechanical ventilation. PMID:14577712

Does adding low doses of oral naltrexone to morphine alter the subsequent opioid requirements and side effects in trauma patients?

PubMed

Farahmand, Shervin; Ahmadi, Omid; Dehpour, Ahmadreza; Khashayar, Patricia

2012-01-01

The present study aims to assess the influence of ultra-low doses of opioid antagonists on the analgesic properties of opioids and their side effects. In the present randomized, double-blind controlled trial, the influence of the combination of ultra-low-dose naltrexone and morphine on the total opioid requirement and the frequency of the subsequent side effects was compared with that of morphine alone (added with placebo) in patients with trauma in the upper or lower extremities. Although the morphine and naltrexone group required 0.04 mg more opioids during the study period, there was no significant difference between the opioid requirements of the 2 groups. Nausea was less frequently reported in patients receiving morphine and naltrexone. The combination of ultra-low-dose naltrexone and morphine in extremity trauma does not affect the opioid requirements; it, however, lowers the risk of nausea. Copyright © 2012 Elsevier Inc. All rights reserved.

Effectiveness of Educational Poster on Knowledge of Emergency Management of Dental Trauma - Part 2: Cluster Randomised Controlled Trial for Secondary School Students

PubMed Central

Young, Cecilia; Wong, Kin Yau; Cheung, Lim K.

2014-01-01

Objective To investigate the effectiveness of educational poster on improving secondary school students' knowledge of emergency management of dental trauma. Methods A cluster randomised controlled trial was conducted. 16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention (poster, 8 schools, 364 students) and control groups (8 schools, 305 students) at the school level. Baseline knowledge of dental trauma was obtained by a questionnaire. Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters. Students of both groups completed the same questionnarie after 2 weeks. Results Two-week display of posters improved the knowledge score by 1.25 (p-value = 0.0407) on average. Conclusion Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong. Trial Registration HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457 PMID:25093728

Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial.

PubMed

Dalgleish, Tim; Goodall, Benjamin; Chadwick, Isobel; Werner-Seidler, Aliza; McKinnon, Anna; Morant, Nicola; Schweizer, Susanne; Panesar, Inderpal; Humphrey, Ayla; Watson, Peter; Lafortune, Louise; Smith, Patrick; Meiser-Stedman, Richard

2015-03-25

Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years. This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms. This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information about the feasibility of delivering the treatment in UK National Health Service (NHS) settings, and its acceptability to the children and their families. This study will highlight aspects of the intervention that need improvement or modification in preparation for a full-scale evaluation in a larger sample. ISRCTN35018680 , registered on 18 November 2013.

Childhood traumas as a risk factor for HIV-risk behaviours amongst young women and men living in urban informal settlements in South Africa: A cross-sectional study

PubMed Central

Dunkle, Kristin; Washington, Laura; Willan, Samantha; Shai, Nwabisa; Jewkes, Rachel

2018-01-01

Childhood traumas, in the form of physical, sexual, and emotional abuse and neglect, are globally widespread and highly prevalent, and associated with a range of subsequent poor health outcomes. This study sought to understand the relationship between physical, sexual and emotional childhood abuse and subsequent HIV-risk behaviours amongst young people (18–30) living in urban informal settlements in Durban, South Africa. Data came from self-completed questionnaires amongst 680 women and 677 men comprising the baseline of the Stepping Stones and Creating Futures intervention trial. Men and women were analysed separately. Logistic regression models assessed the relationship between six HIV-risk behaviours and four measures of trauma: the form of trauma, the severity of each trauma, the range of traumas, and overall severity of childhood trauma. Childhood traumas were incredibly prevalent in this population. All childhood traumas were associated with a range of HIV-risk behaviours. This was for the ever/never trauma, as well as the severity of each type of trauma, the range of trauma, and overall severity of childhood trauma. Despite the wider harsh contexts of urban informal settlements, childhood traumas still play a significant role in shaping subsequent HIV-risk behaviours amongst young people. Interventions to reduce childhood traumas for populations in informal settlements need to be developed. In addition, trauma focused therapies need to be considered as part of wider HIV-prevention interventions for young adults. Trial registration: ClinicalTrials.gov NCT03022370 PMID:29624612

The associations of earlier trauma exposures and history of mental disorders with PTSD after subsequent traumas

PubMed Central

Kessler, Ronald C.; Aguilar-Gaxiola, Sergio; Alonso, Jordi; Bromet, Evelyn J.; Gureje, Oye; Karam, Elie G.; Koenen, Karestan C.; Lee, Sing; Liu, Howard; Pennell, Beth-Ellen; Petukhova, Maria V.; Sampson, Nancy A.; Shahly, Victoria L.; Stein, Dan J.; Atwoli, Lukoye; Borges, Guilherme; Bunting, Brendan; de Girolamo, Giovanni; Gluzman, Semyon; Haro, Josep Maria; Hinkov, Hristo; Kawakami, Norito; Kovess-Masfety, Viviane; Navarro-Mateu, Fernando; Posada-Villa, Jose; Scott, Kate M.; Shalev, Arieh Y.; Have, Margreet ten; Torres, Yolanda; Viana, Maria Carmen; Zaslavsky, Alan M.

2017-01-01

Although earlier trauma exposure is known to predict post-traumatic stress disorder (PTSD) after subsequent traumas, it is unclear if this association is limited to cases where the earlier trauma led to PTSD. Resolution of this uncertainty has important implications for research on pre-trauma vulnerability to PTSD. We examined this issue in the WHO World Mental Health (WMH) Surveys with 34,676 respondents who reported lifetime trauma exposure. One lifetime trauma was selected randomly for each respondent. DSM-IV PTSD due to that trauma was assessed. We reported in a previous paper that four earlier traumas involving interpersonal violence significantly predicted PTSD after subsequent random traumas (OR=1.3–2.5). We also assessed 14 lifetime DSM-IV mood, anxiety, disruptive behavior, and substance disorders prior to random traumas. We show in the current report that only prior anxiety disorders significantly predicted PTSD in a multivariate model (OR=1.5–4.3) and that these disorders interacted significantly with three of the earlier traumas (witnessing atrocities, physical violence victimization, rape). History of witnessing atrocities significantly predicted PTSD after subsequent random traumas only among respondents with prior PTSD (OR=5.6). Histories of physical violence victimization (OR=1.5) and rape after age 17 (OR=17.6) significantly predicted only among respondents with no history of prior anxiety disorders. Although only preliminary due to reliance on retrospective reports, these results suggest that history of anxiety disorders and history of a limited number of earlier traumas might usefully be targeted in future prospective studies as distinct foci of research on individual differences in vulnerability to PTSD after subsequent traumas. PMID:28924183

Identifying youth at risk for difficulties following a traumatic event: pre-event factors are associated with acute symptomatology.

PubMed

Goslin, Megan C; Stover, Carla Smith; Berkowitz, Steven; Marans, Steven

2013-08-01

This study examined factors related to children's acute symptoms following a potentially traumatic event (PTE) to more clearly identify domains that should be included in screenings of youth exposed to a PTE. In particular, the authors examined whether trauma category (i.e., sexual abuse/disclosure of abuse, intentionally perpetrated traumas other than sexual abuse, and unintentional traumas) was related to symptoms after controlling for other relevant factors. Participants were 112 youth presenting for clinical evaluation within a month of a PTE and their nonoffending caregivers. Using data from baseline assessments collected as part of a randomized controlled trial of a secondary prevention program, the following factors were tested in 3 hierarchical regression models: index PTE category, history of traumatic exposure, preindex event functioning, and parenting behaviors. Prior trauma exposure, preindex event functioning, and hostile parenting were uniquely related to children's symptoms in the acute posttraumatic period after controlling for time since the event and child age, but trauma category was not. Implications for identifying and referring children at high risk for poor outcomes in the early aftermath of a PTE are discussed. An exclusive focus on the event is insufficient and more comprehensive understanding of the child and family is required. Copyright © 2013 International Society for Traumatic Stress Studies.

Déjà-vu from the nineties: is there a perspective for anti-endotoxin strategies to improve the outcome of multiple trauma patients?

PubMed Central

Menger, Michael D.

2016-01-01

A recent cohort study of Charbonney et al. indicates that multiple trauma patients develop endotoxemia also in the absence of Gram-negative infection. This is most probably due to an increase of gut permeability. Non-survivors as well as patients with cardiovascular dysfunction and multiple organ failure (MOF) show significantly higher endotoxin levels at 24 h after injury compared to survivors and patients without MOF. These results are like a déjà-vu from the nineties of the last century, where several studies reported endotoxemia during the initial 24 h after multiple trauma with development of MOF and death at endotoxin levels >10 and >12 pg/mL, respectively. Of interest, other multiple trauma patient studies in the nineties have shown endogenous anti-endotoxin antibody production in survivors and reduced antibody production in non-survivors, which died from MOF. Although all these studies have pointed towards a mechanistic role of endotoxin in the fatal outcome after multiple injuries, clinical anti-endotoxin studies are still lacking. Thus, the future perspective must be prospective randomized multicenter trials, which have to elucidate the capability of anti-endotoxin treatment strategies to improve outcome in multiple trauma patients. PMID:27620806

Déjà-vu from the nineties: is there a perspective for anti-endotoxin strategies to improve the outcome of multiple trauma patients?

PubMed

Histing, Tina; Menger, Michael D

2016-08-01

A recent cohort study of Charbonney et al. indicates that multiple trauma patients develop endotoxemia also in the absence of Gram-negative infection. This is most probably due to an increase of gut permeability. Non-survivors as well as patients with cardiovascular dysfunction and multiple organ failure (MOF) show significantly higher endotoxin levels at 24 h after injury compared to survivors and patients without MOF. These results are like a déjà-vu from the nineties of the last century, where several studies reported endotoxemia during the initial 24 h after multiple trauma with development of MOF and death at endotoxin levels >10 and >12 pg/mL, respectively. Of interest, other multiple trauma patient studies in the nineties have shown endogenous anti-endotoxin antibody production in survivors and reduced antibody production in non-survivors, which died from MOF. Although all these studies have pointed towards a mechanistic role of endotoxin in the fatal outcome after multiple injuries, clinical anti-endotoxin studies are still lacking. Thus, the future perspective must be prospective randomized multicenter trials, which have to elucidate the capability of anti-endotoxin treatment strategies to improve outcome in multiple trauma patients.

Hotspots in trauma memories and their relationship to successful trauma-focused psychotherapy: a pilot study.

PubMed

Nijdam, Mirjam J; Baas, Melanie A M; Olff, Miranda; Gersons, Berthold P R

2013-02-01

Imaginal exposure is an essential element of trauma-focused psychotherapies for posttraumatic stress disorder (PTSD). Exposure should in particular focus on the "hotspots," the parts of trauma memories that cause high levels of emotional distress which are often reexperienced. Our aim was to investigate whether differences in the focus on hotspots differentiate between successful and unsuccessful trauma-focused psychotherapies. As part of a randomized trial, 45 PTSD patients completed brief eclectic psychotherapy for PTSD. We retrospectively assessed audio recordings of therapy sessions of 20 patients. Frequency of hotspots and the associated emotions, cognitions, and characteristics were compared for the most successful (n = 10) versus the least successful (n = 10) treatments. The mean number of unique hotspots per patient was 3.20, and this number did not differ between successful and unsuccessful treatments. In successful treatments, however, hotspots were more frequently addressed (r = .48), and they were accompanied by more characteristics of hotspots (r = .39), such as an audible change in affect, indicating medium- to large-sized effects. Repeatedly focusing on hotspots and looking for associated characteristics of hotspots may help clinicians to enhance the efficacy of imaginal exposure for patients who would otherwise show insufficient response to treatment. Copyright © 2013 International Society for Traumatic Stress Studies.

Effectiveness of educational poster on knowledge of emergency management of dental trauma--part 2: cluster randomised controlled trial for secondary school students.

PubMed

Young, Cecilia; Wong, Kin Yau; Cheung, Lim K

2014-01-01

To investigate the effectiveness of educational poster on improving secondary school students' knowledge of emergency management of dental trauma. A cluster randomised controlled trial was conducted. 16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention (poster, 8 schools, 364 students) and control groups (8 schools, 305 students) at the school level. Baseline knowledge of dental trauma was obtained by a questionnaire. Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters. Students of both groups completed the same questionnaire after 2 weeks. Two-week display of posters improved the knowledge score by 1.25 (p-value = 0.0407) on average. Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong. HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457.

Testing a videogame intervention to recalibrate physician heuristics in trauma triage: study protocol for a randomized controlled trial.

PubMed

Mohan, Deepika; Rosengart, Matthew R; Fischhoff, Baruch; Angus, Derek C; Farris, Coreen; Yealy, Donald M; Wallace, David J; Barnato, Amber E

2016-11-11

Between 30 and 40 % of patients with severe injuries receive treatment at non-trauma centers (under-triage), largely because of physician decision making. Existing interventions to improve triage by physicians ignore the role that intuition (heuristics) plays in these decisions. One such heuristic is to form an initial impression based on representativeness (how typical does a patient appear of one with severe injuries). We created a video game (Night Shift) to recalibrate physician's representativeness heuristic in trauma triage. We developed Night Shift in collaboration with emergency medicine physicians, trauma surgeons, behavioral scientists, and game designers. Players take on the persona of Andy Jordan, an emergency medicine physician, who accepts a new job in a small town. Through a series of cases that go awry, they gain experience with the contextual cues that distinguish patients with minor and severe injuries (based on the theory of analogical encoding) and receive emotionally-laden feedback on their performance (based on the theory of narrative engagement). The planned study will compare the effect of Night Shift with that of an educational program on physician triage decisions and on physician heuristics. Psychological theory predicts that cognitive load increases reliance on heuristics, thereby increasing the under-triage rate when heuristics are poorly calibrated. We will randomize physicians (n = 366) either to play the game or to review an educational program, and will assess performance using a validated virtual simulation. The validated simulation includes both control and cognitive load conditions. We will compare rates of under-triage after exposure to the two interventions (primary outcome) and will compare the effect of cognitive load on physicians' under-triage rates (secondary outcome). We hypothesize that: a) physicians exposed to Night Shift will have lower rates of under-triage compared to those exposed to the educational program, and b) cognitive load will not degrade triage performance among physicians exposed to Night Shift as much as it will among those exposed to the educational program. Serious games offer a new approach to the problem of poorly-calibrated heuristics in trauma triage. The results of this trial will contribute to the understanding of physician quality improvement and the efficacy of video games as behavioral interventions. clinicaltrials.gov; NCT02857348 ; August 2, 2016.

Influence of a pelvic floor training programme to prevent perineal trauma: A quasi-randomised controlled trial.

PubMed

Leon-Larios, Fatima; Corrales-Gutierrez, Isabel; Casado-Mejía, Rosa; Suarez-Serrano, Carmen

2017-07-01

perineal injury is common after birth and may be caused by tears or episiotomy or both. Perineal massage has been shown to prevent episiotomies in primiparous women. On the other hand, pelvic floor exercises might have an influence by shortening the first and second stages of labour in the primigravida. the aim of this study was to investigate the effects of a pelvic floor training following a birth programme on perineal trauma. a single-blind quasi-randomized controlled trial with two groups: standard care and intervention. a tertiary, metropolitan hospital in Seville, Spain. women (n=466) who were 32 weeks pregnant, having a singleton pregnancy and anticipating a normal birth were randomised. Women in the experimental groups were asked to perform a pelvic floor training programme that included: daily perineal massage and pelvic floor exercises from 32 weeks of pregnancy until birth. They were allocated to an intervention group by clusters (antenatal education groups) randomized 1:1. The control group had standard care that did not involve a perineal/pelvic floor intervention. These women were collected in a labour ward at admission 1:3 by midwives. outcomes were analysed by intention-to-treat. Women assigned to the perineal/pelvic floor intervention showed a 31.63% reduction in episiotomy (50.56% versus 82.19%, p<0.001) and a higher likelihood of having an intact perineum (17.61% versus 6.85%, p<0.003). There were also fewer third (5.18% versus 13.12%, p<0.001) and fourth degree-tears (0.52% versus 2.5%, p<0.001). Women allocated to the intervention group also had less postpartum perineal pain (24.57% versus 36.30%, p<0.001) and required less analgesia in the postnatal period (21.14% versus 30.82%, p<0.001). a training programme composed of pelvic floor exercises and perineal massage may prevent episiotomies and tears in primiparous women. This programme can be recommended to primiparous women in order to prevent perineal trauma. the pelvic floor programme was associated with significantly lower rates of episiotomies and severe perineal trauma; and higher intact perineum when compared with women who received standard care only. the programme is an effective intervention that we recommend to all women at 32nd week of pregnancy to prevent perineal trauma. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Randomized Controlled Dismantling Trial of Post-Workshop Consultation Strategies to Increase Effectiveness and Fidelity to an Evidence-Based Psychotherapy for Posttraumatic Stress Disorder

DTIC Science & Technology

2013-08-01

not eligible for CPT based on the state of research evidence, including those with: current uncontrolled psychotic or bipolar disorder ; substance...among trauma, post-traumatic stress disorder , and health outcomes. Adv Mind Body Med 2004, 20(1):18–29. 10. Kessler RC: Posttraumatic Stress Disorder ...to an evidence-based psychotherapy for Posttraumatic stress disorder Shannon Wiltsey Stirman1, Norman Shields2, Josh Deloriea3, Meredith SH Landy3

A mental health intervention strategy for low-income, trauma-exposed Latina immigrants in primary care

PubMed Central

Kaltman, Stacey; de Mendoza, Alejandra Hurtado; Serrano, Adriana; Gonzales, Felisa A.

2016-01-01

Latinos in the United States face significant mental health disparities related to access to care, quality of care, and outcomes. Prior research suggests that Latinos prefer to receive care for common mental health problems (e.g., depression and anxiety disorders) in primary care settings, suggesting a need for evidence-based mental health services designed for delivery in these settings. This study sought to develop and preliminarily evaluate a mental health intervention for trauma-exposed Latina immigrants with depression and/or PTSD for primary care clinics that serve the uninsured. The intervention was designed to be simultaneously responsive to patients’ preferences for individual psychotherapy, to the needs of safety-net primary care clinics for efficient services, and to address the social isolation that is common to the Latina immigrant experience. Developed based on findings from the research team’s formative research, the resulting intervention incorporated individual and group sessions and combined evidence-based interventions to reduce depression and PTSD symptoms, increase group readiness, and improve perceived social support. Twenty-eight trauma-exposed low-income Latina immigrant women who screened positive for depression and/or PTSD participated in an open pilot trial of the intervention at a community primary care clinic. Results indicated that the intervention was feasible, acceptable, and safe. A randomized controlled trial of the intervention is warranted. PMID:26913774

Open trial of exposure therapy for PTSD among patients with severe and persistent mental illness.

PubMed

Grubaugh, Anouk L; Clapp, Joshua D; Frueh, B Christopher; Tuerk, Peter W; Knapp, Rebecca G; Egede, Leonard E

2016-03-01

There are few empirical data regarding effective treatment of trauma-related symptoms among individuals with severe mental illness (SMI; e.g., bipolar disorder, schizophrenia). This under-examined clinical issue is significant because rates of trauma and PTSD are higher among individuals with SMI relative to the general population, and there are sufficient data to suggest that PTSD symptoms exacerbate the overall course and prognosis of SMI. 34 veterans with SMI received prolonged exposure (PE) for PTSD using an open trial study design. Data suggest that PE is feasible to implement, well-tolerated, and results in clinically significant decreases in PTSD severity in patients with SMI. Mean CAPS scores improved 27.2 points from baseline to immediate post [95% CI for mean change: -44.3, - 10.1; p = 0.002, paired t-test, and treatment gains were maintained at 6 months [mean change from baseline to 6-months, -16.1; 95% CI: -31.0, -1.2; p = 0.034, paired t-test]. The current data support the use of exposure-based interventions for PTSD among individuals with SMI and highlight the need for rigorous randomized efficacy trials investigating frontline PTSD interventions in this patient population. Copyright © 2015. Published by Elsevier Ltd.

The Role of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in Medicine: Addressing the Psychological and Physical Symptoms Stemming from Adverse Life Experiences

PubMed Central

Shapiro, Francine

2014-01-01

Background: A substantial body of research shows that adverse life experiences contribute to both psychological and biomedical pathology. Eye movement desensitization and reprocessing (EMDR) therapy is an empirically validated treatment for trauma, including such negative life experiences as commonly present in medical practice. The positive therapeutic outcomes rapidly achieved without homework or detailed description of the disturbing event offer the medical community an efficient treatment approach with a wide range of applications. Methods: All randomized studies and significant clinical reports related to EMDR therapy for treating the experiential basis of both psychological and somatic disorders are reviewed. Also reviewed are the recent studies evaluating the eye movement component of the therapy, which has been posited to contribute to the rapid improvement attributable to EMDR treatment. Results: Twenty-four randomized controlled trials support the positive effects of EMDR therapy in the treatment of emotional trauma and other adverse life experiences relevant to clinical practice. Seven of 10 studies reported EMDR therapy to be more rapid and/or more effective than trauma-focused cognitive behavioral therapy. Twelve randomized studies of the eye movement component noted rapid decreases in negative emotions and/or vividness of disturbing images, with an additional 8 reporting a variety of other memory effects. Numerous other evaluations document that EMDR therapy provides relief from a variety of somatic complaints. Conclusion: EMDR therapy provides physicians and other clinicians with an efficient approach to address psychological and physiologic symptoms stemming from adverse life experiences. Clinicians should therefore evaluate patients for experiential contributors to clinical manifestations. PMID:24626074

The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!') has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies, developing a trauma narrative, improving parent-child interaction and psycho-education. The main study aim is to evaluate the effectiveness of the specific therapeutic factors in the program. A secondary objective is to study mediating and moderating factors. Methods/design This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140) are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health) care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the child. Mediators tested are the ability to differentiate and express emotions, emotional security, coping strategies, feelings of guilt and parent-child interaction. Mental health of the parent, parenting stress, disturbances in parent-child attachment, duration and severity of the domestic violence and demographics are examined for their moderating effect. Data are collected one week before the program starts (T1), and one week (T2) and six months (T3) after finishing the program. Both intention-to-treat and completer analyses will be done. Discussion Adverse outcomes after witnessing interparental violence are highly diverse and may be explained by multiple risk factors. An important question for prevention programs is therefore to what extent a specific focus on potential psychotrauma is useful. This trial may point to several directions for optimizing public health response to children's exposure to interparental violence. Trial registration Netherlands Trial Register (NTR): NTR3064 PMID:22309641

What is the evidence for rest, ice, compression, and elevation therapy in the treatment of ankle sprains in adults?

PubMed

van den Bekerom, Michel P J; Struijs, Peter A A; Blankevoort, Leendert; Welling, Lieke; van Dijk, C Niek; Kerkhoffs, Gino M M J

2012-01-01

Ankle sprains are common problems in acute medical care. The variation in treatment observed for the acutely injured lateral ankle ligament complex in the first week after the injury suggests a lack of evidence-based management strategies for this problem. To analyze the effectiveness of applying rest, ice, compression, and elevation (RICE) therapy begun within 72 hours after trauma for patients in the initial period after ankle sprain. Eligible studies were published original randomized or quasi-randomized controlled trials concerning at least 1 of the 4 subtreatments of RICE therapy in the treatment of acute ankle sprains in adults. MEDLINE, Cochrane Clinical Trial Register, CINAHL, and EMBASE. The lists of references of retrieved publications also were checked manually. We extracted relevant data on treatment outcome (pain, swelling, ankle mobility or range of motion, return to sports, return to work, complications, and patient satisfaction) and assessed the quality of included studies. If feasible, the results of comparable studies were pooled using fixed- or random-effects models. After deduction of the overlaps among the different databases, evaluation of the abstracts, and contact with some authors, 24 potentially eligible trials remained. The full texts of these articles were retrieved and thoroughly assessed as described. This resulted in the inclusion of 11 trials involving 868 patients. The main reason for exclusion was that the authors did not describe a well-defined control group without the intervention of interest. Insufficient evidence is available from randomized controlled trials to determine the relative effectiveness of RICE therapy for acute ankle sprains in adults. Treatment decisions must be made on an individual basis, carefully weighing the relative benefits and risks of each option, and must be based on expert opinions and national guidelines.

Stem cell therapy for reconstruction of alveolar cleft and trauma defects in adults: A randomized controlled, clinical trial.

PubMed

Bajestan, Mona N; Rajan, Archana; Edwards, Sean P; Aronovich, Sharon; Cevidanes, Lucia H S; Polymeri, Angeliki; Travan, Suncica; Kaigler, Darnell

2017-10-01

Stem cell therapy with bone marrow-derived mesenchymal stem cells is a promising tissue engineering strategy to promote regeneration of craniofacial bone. To determine whether cell therapy with ex vivo expanded stem cell populations would be safe and efficacious in the regeneration of large alveolar defects in patients with a history of cleft palate or craniofacial trauma. Eighteen patients (10 patients with traumatic injury and 8 patients with cleft palate) presenting with missing teeth associated with horizontal alveolar bone deficiencies were included in this randomized controlled clinical trial. Patients were randomized to receive either conventional autogenous block grafts or stem cell therapy. After a healing period of 4 months the treated sites were re-entered and the bone width re-assessed prior to implant placement. Implant stability was evaluated through torque testing of the implant upon insertion and at 6 months postloading. The mean gain in bone width was 1.5 ± 1.5 mm in the stem cell therapy group and 3.3 ± 1.4 mm in the control group. Overall, bone gain was higher in trauma patients as compared to patients with cleft palate, for both the control and the stem cell therapy groups. Most postoperative complications were wound dehiscences and incision line openings. Implants were placed successfully in 5 out of 10 patients in the stem cell therapy group and in all 8 patients in the control group. One implant from the control/cleft palate group failed before loading, while the rest of the implants were loaded successfully and remained stable at 6 months. The patients who did not receive implants were re-treated with autogenous block bone graft. The ability of stem cells to treat large alveolar defects is safe, yet, their ability to completely reconstitute large alveolar defects is limited. This approach requires further optimization to meet the outcomes seen using current methods to treat large defects, particularly those resultant of cleft palate. © 2017 Wiley Periodicals, Inc.

Utilizing Social Media for Community Consultation and Public Disclosure in Exception from Informed Consent Trials

PubMed Central

Stephens, Shannon W.; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D.; Wang, Henry E.; Bosarge, Patrick L.

2016-01-01

Background The U.S. Food and Drug Administration and Department of Health and Human Services outline regulations allowing an Exception From Informed Consent (EFIC) for research conducted in an emergency settings. Acute care clinical trials utilizing EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. Methods We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC TXA). As part of the CC/PD process, we developed research study advertisements using the social media website Facebook. The Facebook advertisements directed users to a regional study website that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. Results During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times, (12 displays per target population) with 374 individuals selected the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15-24 (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement, spent > 3 minutes on the study website [3min – 49 min]. Commonly accessed webpages were “Contact Us” (PROPPR 5.5%, TXA 7.7%), “Study-specific FAQs” (PROPPR 2.4%), ROC-TXA 6.7%) and “Opt-Out of Research” (PROPPR 2.5%, ROC-TXA 3.8%). Of 51 total individuals viewing the opt-out of research information (PROPPR 19, ROC-TXA 32), Time spent on that specific page was modest (PROPPR 62 seconds, ROC-TXA 55 seconds), with no individuals requesting to opt-out of either study participation. Conclusion In clinical trauma trials, using EFIC, social media may provide a viable option for facilitating the CC/PD process. Level Of Evidence Descriptive Study, Level IV. PMID:26998781

Using social media for community consultation and public disclosure in exception from informed consent trials.

PubMed

Stephens, Shannon W; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D; Wang, Henry E; Bosarge, Patrick L

2016-06-01

The US Food and Drug Administration and the Department of Health and Human Services outline regulations allowing an exception from informed consent (EFIC) for research conducted in an emergency setting. Acute care clinical trials using EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC-TXA). As part of the CC/PD process, we developed research study advertisements using the social media Web site Facebook. The Facebook advertisements directed users to a regional study Web site that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times (12 displays per target population) with 374 individuals selecting the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15 years and 24 years (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement spent more than 3 minutes on the study Web site (3-49 minutes). Commonly accessed Web pages were "contact us" (PROPPR, 5.5%; ROC-TXA, 7.7%), "study-specific FAQs" (PROPPR, 2.4%; ROC-TXA, 6.7%), and "opt out of research" (PROPPR, 2.5%; ROC-TXA, 3.8%). Of 51 total individuals viewing the opt out of research information (PROPPR, 19; ROC-TXA, 32), time spent on that specific page was modest (PROPPR, 62 seconds; ROC-TXA, 55 seconds), with no individuals requesting to opt out of either study participation. In clinical trauma trials using EFIC, social media may provide a viable option for facilitating the CC/PD process.

Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD

PubMed Central

Markowitz, John C.; Petkova, Eva; Neria, Yuval; Van Meter, Page E.; Zhao, Yihong; Hembree, Elizabeth; Lovell, Karina; Biyanova, Tatyana; Marshall, Randall D.

2015-01-01

Background Exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder (PTSD). No treatment benefits all patients, however. We tested Interpersonal Psychotherapy, which has demonstrated antidepressant efficacy and showed promise in pilot PTSD research, as a non-exposure-based, non-cognitive behavioral PTSD treatment. Methods A randomized, fourteen-week trial compared Interpersonal Psychotherapy; Prolonged Exposure, an exposure-based exemplar; and Relaxation Therapy, an active control psychotherapy. Subjects were 110 unmedicated patients having DSM-IV chronic PTSD and Clinician-Administered PTSD Scale (CAPS) score >50. Randomization stratified for comorbid major depression. We hypothesized Interpersonal Psychotherapy would be no more than minimally inferior (CAPS difference <12.5 points) to Prolonged Exposure. Results All therapies had large within-group pre/post effect sizes (d=1.32–1.88). Response rates (>30% CAPS improvement) were: Interpersonal Psychotherapy 63%, Prolonged Exposure 47%, Relaxation Therapy 38% (n.s.). Interpersonal psychotherapy and Prolonged Exposure CAPS outcome differed by 5.5 points (n.s.); the null hypothesis of more than minimal Interpersonal Psychotherapy inferiority was rejected (p=0.035). Patients with comorbid major depression dropped out from Prolonged Exposure nine times more than non-depressed Prolonged Exposure patients. Interpersonal Psychotherapy and Prolonged Exposure improved quality of life and social functioning more than Relaxation Therapy. Conclusions This first controlled study of individual Interpersonal Psychotherapy for PTSD demonstrated non-inferiority to the “gold standard” PTSD treatment. Interpersonal Psychotherapy had (non-significantly) lower attrition and higher response rates than Prolonged Exposure. Contradicting a widespread clinical belief, PTSD treatment may not require cognitive behavioral exposure to trauma reminders. Moreover, as differential therapeutics, patients with comorbid major depression may fare better in Interpersonal Psychotherapy than Prolonged Exposure. PMID:25677355

Trauma-focused cognitive behavioral therapy or eye movement desensitization and reprocessing: what works in children with posttraumatic stress symptoms? A randomized controlled trial.

PubMed

Diehle, Julia; Opmeer, Brent C; Boer, Frits; Mannarino, Anthony P; Lindauer, Ramón J L

2015-02-01

To prevent adverse long-term effects, children who suffer from posttraumatic stress symptoms (PTSS) need treatment. Trauma-focused cognitive behavioral therapy (TF-CBT) is an established treatment for children with PTSS. However, alternatives are important for non-responders or if TF-CBT trained therapists are unavailable. Eye movement desensitization and reprocessing (EMDR) is a promising treatment for which sound comparative evidence is lacking. The current randomized controlled trial investigates the effectiveness and efficiency of both treatments. Forty-eight children (8-18 years) were randomly assigned to eight sessions of TF-CBT or EMDR. The primary outcome was PTSS as measured with the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA). Secondary outcomes included parental report of child PTSD diagnosis status and questionnaires on comorbid problems. The Children's Revised Impact of Event Scale was administered during the course of treatment. TF-CBT and EMDR showed large reductions from pre- to post-treatment on the CAPS-CA (-20.2; 95% CI -12.2 to -28.1 and -20.9; 95% CI -32.7 to -9.1). The difference in reduction was small and not statistically significant (mean difference of 0.69, 95% CI -13.4 to 14.8). Treatment duration was not significantly shorter for EMDR (p = 0.09). Mixed model analysis of monitored PTSS during treatment showed a significant effect for time (p < 0.001) but not for treatment (p = 0.44) or the interaction of time by treatment (p = 0.74). Parents of children treated with TF-CBT reported a significant reduction of comorbid depressive and hyperactive symptoms. TF-CBT and EMDR are effective and efficient in reducing PTSS in children.

Cost-effectiveness of motivational intervention with significant others for patients with alcohol misuse.

PubMed

Shepard, Donald S; Lwin, Aung K; Barnett, Nancy P; Mastroleo, Nadine; Colby, Suzanne M; Gwaltney, Chad; Monti, Peter M

2016-05-01

To estimate the incremental cost, cost-effectiveness and benefit-cost ratio of incorporating a significant other (SO) into motivational intervention for alcohol misuse. We obtained economic data from the one year with the intervention in full operation for patients in a recent randomized trial. The underlying trial took place at a major urban hospital in the United States. The trial randomized 406 (68.7% male) eligible hazardous drinkers (196 during the economic study) admitted to the emergency department or trauma unit. The motivational interview condition consisted of one in-person session featuring personalized normative feedback. The significant other motivational interview condition comprised one joint session with the participant and SO in which the SO's perspective and support were elicited. We ascertained activities across 445 representative time segments through work sampling (including staff idle time), calculated the incremental cost in per patient of incorporating an SO, expressed the results in 2014 US$, incorporated quality and mortality effects from a closely related trial and derived the cost per quality-adjusted life-year (QALY) gained. From a health system perspective, the incremental cost per patient of adding an SO was $341.09 [95% confidence interval (CI) = $244.44-437.74]. The incremental cost per year per hazardous drinker averted was $3623 (CI = $1777-22,709), the cost per QALY gained $32,200 (CI = $15,800-201,700), and the benefit-cost ratio was 4.73 (95% CI = 0.7-9.66). If adding an SO into the intervention strategy were concentrated during the hours with highest risk or in a trauma unit, it would become even more cost-beneficial. Using criteria established by the World Health Organization (cost-effectiveness below the country's gross domestic product per capita), incorporating a significant other into a patient's motivational intervention for alcohol misuse is highly cost-effective. © 2015 Society for the Study of Addiction.

Effects of Timing and Intensity of Neurorehabilitation on Functional Outcome After Traumatic Brain Injury: A Systematic Review and Meta-Analysis.

PubMed

Königs, Marsh; Beurskens, Eva A; Snoep, Lian; Scherder, Erik J; Oosterlaan, Jaap

2018-06-01

To systematically review evidence on the effects of timing and intensity of neurorehabilitation on the functional recovery of patients with moderate to severe traumatic brain injury (TBI) and aggregate the available evidence using meta-analytic methods. PubMed, Embase, PsycINFO, and Cochrane Database. Electronic databases were searched for prospective controlled clinical trials assessing the effect of timing or intensity of multidisciplinary neurorehabilitation programs on functional outcome of patients with moderate or severe TBI. A total of 5961 unique records were screened for relevance, of which 58 full-text articles were assessed for eligibility by 2 independent authors. Eleven articles were included for systematic review and meta-analysis. Two independent authors performed data extraction and risk of bias analysis using the Cochrane Collaboration tool. Discrepancies between authors were resolved by consensus. Systematic review of a total of 6 randomized controlled trials, 1 quasi-randomized trial, and 4 controlled trials revealed consistent evidence for a beneficial effect of early onset neurorehabilitation in the trauma center and intensive neurorehabilitation in the rehabilitation facility on functional outcome compared with usual care. Meta-analytic quantification revealed a large-sized positive effect for early onset rehabilitation programs (d=1.02; P<.001; 95% confidence interval [CI], 0.56-1.47) and a medium-sized positive effect for intensive neurorehabilitation programs (d=.67; P<.001; 95% CI, .38-.97) compared with usual care. These effects were replicated based solely on studies with a low overall risk of bias. The available evidence indicates that early onset neurorehabilitation in the trauma center and more intensive neurorehabilitation in the rehabilitation facility promote functional recovery of patients with moderate to severe TBI compared with usual care. These findings support the integration of early onset and more intensive neurorehabilitation in the chain of care for patients with TBI. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias.

PubMed

del Junco, Deborah J; Fox, Erin E; Camp, Elizabeth A; Rahbar, Mohammad H; Holcomb, John B

2013-07-01

Because randomized clinical trials in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multisystem responses to injury that necessitate highly dynamic treatment regimens such as blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Drawing on recent experience in the design, data collection, monitoring, and analysis of the 10-site observational PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, 7 common and sometimes overlapping biases are described through examples and resolution strategies. Sources of bias in trauma research include ignoring (1) variation in patients' indications for treatment (indication bias), (2) the dependency of intervention delivery on patient survival (survival bias), (3) time-varying treatment, (4) time-dependent confounding, (5) nonuniform intervention effects over time, (6) nonrandom missing data mechanisms, and (7) imperfectly defined variables. This list is not exhaustive. The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients.

Prognostic significance of blood lactate and lactate clearance in trauma patients.

PubMed

Régnier, Marie-Alix; Raux, Mathieu; Le Manach, Yannick; Asencio, Yves; Gaillard, Johann; Devilliers, Catherine; Langeron, Olivier; Riou, Bruno

2012-12-01

Lactate has been shown to be a prognostic biomarker in trauma. Although lactate clearance has already been proposed as an intermediate endpoint in randomized trials, its precise role in trauma patients remains to be determined. Blood lactate levels and lactate clearance (LC) were calculated at admission and 2 and 4 h later in trauma patients. The association of initial blood lactate level and lactate clearance with mortality was tested using receiver-operating characteristics curve, logistic regression using triage scores, Trauma Related Injury Severity Score as a reference standard, and reclassification method. The authors evaluated 586 trauma patients (mean age 38±16 yr, 84% blunt and 16% penetrating, mortality 13%). Blood lactate levels at admission were elevated in 327 (56%) patients. The lactate clearance should be calculated within the first 2 h after admission as LC0-2 h was correlated with LC0-4 h (R=0.55, P<0.001) but not with LC2-4 h (R=0.04, not significant). The lactate clearance provides additional predictive information to initial blood lactate levels and triage scores and the reference score. This additional information may be summarized using a categorical approach (i.e., less than or equal to -20 %/h) in contrast to initial blood lactate. The results were comparable in patients with high (5 mM/l or more) initial blood lactate. Early (0-2 h) lactate clearance is an important and independent prognostic variable that should probably be incorporated in future decision schemes for the resuscitation of trauma patients.

Do Children and Adolescents Have Different Types of Trauma Narratives and Does It Matter? Reliability and Face Validation for a Narrative Taxonomy.

PubMed

Scheeringa, Michael S; Lilly, Megan E; Staiger, Allison B; Heller, Maren L; Jones, Edward G; Weems, Carl F

2017-06-01

The construction of trauma narratives is a major component of several psychotherapy approaches for trauma-related problems, but questions remain as to whether fully expressive narratives are necessary and whether it is detrimental to ask avoidant youths to tell their narratives repeatedly. Characteristics of trauma narratives during psychotherapy have not been examined in youths and this represents a salient gap in knowledge. This study aimed to begin filling this gap by identifying categories of trauma narratives and empirically validating them. Youths (N = 47) aged 7 to 18 years, who were involved in a randomized controlled trial, received cognitive behavioral therapy. Transcripts of all narrative exposure therapy sessions for each youth were rated. Four categories were identified and were named expressive, avoidant, fabricated, and undemonstrative. Interrater reliability for identifying these categories was good, and face validation of the categories was supported by statistically significant differences between categories on the number of data elements of the trauma events, negative emotion words, and positive emotion words. These promising findings indicate that different types of narrative styles can be reliably identified. There was strong evidence for reduction of posttraumatic stress symptoms in each of the categories (Cohen's d = 0.9 to 2.5). Favorable treatment outcomes for all categories suggest that more remembering is not always better and clients appeared to effectively deal with memories in different ways. Copyright © 2017 International Society for Traumatic Stress Studies.

Debriefing interventions for the prevention of psychological trauma in women following childbirth.

PubMed

Bastos, Maria Helena; Furuta, Marie; Small, Rhonda; McKenzie-McHarg, Kirstie; Bick, Debra

2015-04-10

Childbirth is a complex life event that can be associated with both positive and negative psychological responses. When giving birth is experienced as particularly traumatic this can have a negative impact on a woman's postnatal emotional well-being. There has been an increasing focus on women's psychological trauma symptoms following childbirth, including the relatively rare phenomenon of post-traumatic stress disorder (PTSD), and the benefit of debriefing interventions to prevent this. In this review we examined the evidence for debriefing as a preventative intervention for psychological trauma following childbirth. To assess the effects of debriefing interventions compared with standard postnatal care for the prevention of psychological trauma in women following childbirth. The trials registers of the Cochrane Depression, Anxiety and Neurosis Group (CCDANCTR-References and CCDANCTR-Studies) and the Cochrane Pregnancy and Childbirth Group were searched up to 4 March 2015. These registers include relevant randomised controlled trials from the following bibliographic databases: the Cochrane Library (all years to date), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). Additional searches were conducted in CENTRAL, MEDLINE, EMBASE, PsycINFO, and Maternity and Infant Care. The reference lists of all included studies were checked for additional published reports and citations of unpublished research. Experts in the field were contacted. We included randomised controlled trials (RCTs) and quasi-randomised trials comparing postnatal debriefing interventions with standard postnatal care for the prevention of psychological trauma of women following childbirth. The intervention consisted of at least one debriefing intervention session, which had the purpose of allowing women to describe their experience and to normalise their emotional reaction to that experience. Three authors independently assessed trial quality and extracted data. Meta-analysis was conducted where there were more than two trials examining the same outcomes. We included seven trials (eight articles) from three countries (UK, Australia and Sweden) that fulfilled the inclusion criteria. The number of women contributing data to each outcome varied from 102 to 1745. Methodological quality was variable and most of the studies were of low quality. The quality of evidence for the prevalence of psychological trauma (primary outcome) and the prevalence of depression symptoms was rated low or very low, based on few studies (ranging from a single study to three studies) with high risk of bias in main domains such as performance bias, random sequence generation, allocation concealment and incomplete outcome data. The quality of evidence for the remaining outcomes (that is prevalence of anxiety, prevalence of fear of childbirth, prevalence of general psychological morbidity, health service utilization and attrition from treatment) was not assessed as data were not available.Among women who had a high level of obstetric intervention during labour and birth, we found no difference between standard postnatal care with debriefing and standard postnatal care without debriefing on psychological trauma symptoms within three months postpartum (RR 0.61; 95% CI 0.28 to 1.31; n = 425) or at three to six months postpartum (RR 0.62; 95% CI 0.27 to 1.42; n = 246). The results were based on two trials, respectively. Among women who experienced a distressing or traumatic birth, there was no evidence of an effect of psychological debriefing on the prevention of PTSD (measured by the MINI-PTSD) at four to six weeks postpartum (RR 1.15; 95% CI 0.66 to 2.01; n = 102) or at six months (RR 0.35; 95% CI 0.10 to 1.23; n = 103). The results were based on one small trial. One trial involving low-risk women who delivered healthy infants at or near term reported no significant difference between the intervention group and the control group in the proportion of women who met the diagnostic criteria for psychological trauma during the year following childbirth (RR 1.06; 95% CI 0.88 to 1.28; n = 1745). We did not find any information about attrition rates. We did not find any high quality evidence to inform practice, with substantial heterogeneity being found between the studies conducted to date. There is little or no evidence to support either a positive or adverse effect of psychological debriefing for the prevention of psychological trauma in women following childbirth. There is no evidence to support routine debriefing for women who perceive giving birth as psychologically traumatic.Future research should provide greater detail of the outcome measures used, and with scales for measuring psychological trauma validated against clinical diagnostic interviews. High rates of obstetric intervention in some birth settings may mean that women require improved emotional care from health professionals to reduce the risk of childbirth being experienced as traumatic. As all included trials excluded women unable to communicate in the native language of the study setting, there is no information on the response of these women to psychological debriefing. No included studies were conducted in low or middle-income countries.

The associations of earlier trauma exposures and history of mental disorders with PTSD after subsequent traumas.

PubMed

Kessler, R C; Aguilar-Gaxiola, S; Alonso, J; Bromet, E J; Gureje, O; Karam, E G; Koenen, K C; Lee, S; Liu, H; Pennell, B-E; Petukhova, M V; Sampson, N A; Shahly, V; Stein, D J; Atwoli, L; Borges, G; Bunting, B; de Girolamo, G; Gluzman, S F; Haro, J M; Hinkov, H; Kawakami, N; Kovess-Masfety, V; Navarro-Mateu, F; Posada-Villa, J; Scott, K M; Shalev, A Y; Ten Have, M; Torres, Y; Viana, M C; Zaslavsky, A M

2017-09-19

Although earlier trauma exposure is known to predict posttraumatic stress disorder (PTSD) after subsequent traumas, it is unclear whether this association is limited to cases where the earlier trauma led to PTSD. Resolution of this uncertainty has important implications for research on pretrauma vulnerability to PTSD. We examined this issue in the World Health Organization (WHO) World Mental Health (WMH) Surveys with 34 676 respondents who reported lifetime trauma exposure. One lifetime trauma was selected randomly for each respondent. DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) PTSD due to that trauma was assessed. We reported in a previous paper that four earlier traumas involving interpersonal violence significantly predicted PTSD after subsequent random traumas (odds ratio (OR)=1.3-2.5). We also assessed 14 lifetime DSM-IV mood, anxiety, disruptive behavior and substance disorders before random traumas. We show in the current report that only prior anxiety disorders significantly predicted PTSD in a multivariate model (OR=1.5-4.3) and that these disorders interacted significantly with three of the earlier traumas (witnessing atrocities, physical violence victimization and rape). History of witnessing atrocities significantly predicted PTSD after subsequent random traumas only among respondents with prior PTSD (OR=5.6). Histories of physical violence victimization (OR=1.5) and rape after age 17 years (OR=17.6) significantly predicted only among respondents with no history of prior anxiety disorders. Although only preliminary due to reliance on retrospective reports, these results suggest that history of anxiety disorders and history of a limited number of earlier traumas might usefully be targeted in future prospective studies as distinct foci of research on individual differences in vulnerability to PTSD after subsequent traumas.Molecular Psychiatry advance online publication, 19 September 2017; doi:10.1038/mp.2017.194.

Intravenous zoledronic acid for the treatment of osteoporosis: The evidence of its therapeutic effect

PubMed Central

Lewiecki, E Michael

2010-01-01

Introduction: Osteoporosis is a disease characterized by low bone mineral density and poor bone quality resulting in reduced bone strength and increased risk of fracture. Oral bisphosphonates, first-line therapy for most patients with osteoporosis, are associated with suboptimal adherence to therapy due to factors that include a complex dosing regimen and gastrointestinal intolerance in some patients. Intravenous bisphosphonates address these limitations through infrequent injectable dosing that assures 100% bioavailability. Intravenous zoledronic acid is the newest bisphosphonate to be approved for the treatment of osteoporosis. Aims: This review assesses the evidence for the therapeutic effects of intravenous zoledronic acid for the treatment of osteoporosis. Evidence review: Zoledronic acid 5 mg administered as an annual 15-min intravenous infusion has been shown to reduce the risk of vertebral fractures, hip fractures, and other fractures in a three-year randomized, double-blind, placebo-controlled trial in women with postmenopausal osteoporosis. In a randomized, double-blind, placebo-controlled trial in women and men with a recent surgical repair of low-trauma hip fracture, it reduced the risk of new clinical fractures and improved survival. In both studies, zoledronic acid was associated with a good safety profile and was generally well tolerated. Zoledronic acid has the potential to improve clinical outcomes by reducing the risk of fracture in patients with osteoporosis. Clinical value: Intravenous zoledronic acid 5 mg every 12 months reduces fracture risk in women with postmenopausal osteoporosis and in women and men with recent low-trauma hip fracture. PMID:20694061

Psychosocial rehabilitation after war trauma with adaptive disclosure: Design and rationale of a comparative efficacy trial.

PubMed

Yeterian, Julie D; Berke, Danielle S; Litz, Brett T

2017-10-01

Posttraumatic stress disorder (PTSD) from warzone exposure is associated with chronic and disabling social and occupational problems. However, functional impairment is rarely assessed or targeted directly in PTSD treatments, which instead focus on symptom reduction. Trauma-related contributors to diminished functioning, including guilt, shame, and anger resulting from morally compromising or loss-based war experiences, are also underemphasized. The goal of this clinical trial is to fill a substantial gap in the treatment of military-related PTSD by testing a modified Adaptive Disclosure (AD) therapy for war-related PTSD stemming from moral injury and traumatic loss focused on improving psychosocial functioning AD. This paper describes the rationale and design of a multi-site randomized controlled trial comparing AD to Present-Centered Therapy (PCT). We will recruit 186 veterans with PTSD, who will be assessed at baseline, post-treatment, and 3- and 6-months post-treatment. Primary outcomes are functional changes (i.e., functioning/disability and quality of life). Secondary outcomes are mental health variables (i.e., PTSD, depression, guilt, shame). We hypothesize that veterans treated with AD will experience greater improvements in all outcomes compared to those treated with PCT. This trial will advance knowledge in rehabilitation research by testing the first therapy specifically designed to address psychosocial functioning among veterans with war-related PTSD. The results may improve the quality of mental health care for veterans by offering an ecologically sound treatment for experiences that are uniquely impactful for war veterans. Published by Elsevier Inc.

Randomized clinical trial of ligasure™ versus conventional splenectomy for injured spleen in blunt abdominal trauma.

PubMed

Amirkazem, Vejdan Seyyed; Malihe, Khosravi

2017-02-01

Spleen is the most common organ damaged in cases of blunt abdominal trauma and splenectomy and splenorrhaphy are the main surgical procedures that are used in surgical treatment of such cases. In routine open splenectomy cases, after laparotomy, application of sutures in splenic vasculature is the most widely used procedure to cease the bleeding. This clinical trial evaluates the role and benefits of the Ligasure™ system in traumatic splenectomy without using any suture materials and compares the result with conventional method of splenectomy. After making decision for splenectomy secondary to a blunt abdominal trauma, patients in control group (39) underwent splenectomy using conventional method with silk suture ligation of splenic vasculature. In the interventional group (41) a Ligasure™ vascular sealing system was used for ligating of the splenic vein and artery. The results of operation time, volume of intra-operation bleeding and post-operative complications were compared in both groups. The mean operation times in control and interventional group were 21 and 12 min respectively (p < 0.05). The average volume of bleeding in control group during open splenectomy was 280 cc, but in the interventional group decreased significantly to 80 ml (p < 0.05) using the Ligasure system. Post-operative complications such as bleeding were non-existent in both groups. The application of Ligasure™ in blunt abdominal trauma for splenectomy not only can decrease the operation time but also can decrease the volume of bleeding during operation without any additional increase in post-operative complications. This method is recommendable in traumatic splenic injuries that require splenectomy in order to control the bleeding as opposed to use of traditional silk sutures. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Exploratory and Confirmatory Analysis of the Trauma Practices Questionnaire

ERIC Educational Resources Information Center

Craig, Carlton D.; Sprang, Ginny

2009-01-01

Objective: The present study provides psychometric data for the Trauma Practices Questionnaire (TPQ). Method: A nationally randomized sample of 2,400 surveys was sent to self-identified trauma treatment specialists, and 711 (29.6%) were returned. Results: An exploratory factor analysis (N = 319) conducted on a randomly split sample (RSS) revealed…

Rib fractures in trauma patients: does operative fixation improve outcome?

PubMed

Majak, Peter; Næss, Pål A

2016-12-01

Renewed interest in surgical fixation of rib fractures has emerged. However, conservative treatment is still preferred at most surgical departments. We wanted to evaluate whether operative treatment of rib fractures may benefit severely injured patients. Several studies report a reduction in mechanical ventilation time, ICU length of stay (LOS), hospital LOS, pneumonia, need for tracheostomy, pain and costs in operatively treated patients with multiple rib fractures compared with patients treated nonoperatively. Although patient selection and timing of the operation seem crucial for successful outcome, no consensus exists. Mortality reduction has only been shown in a few studies. Most studies are retrospective cohort and case-control studies. Only four randomized control trials exist. Conservative treatment, consisting of respiratory assistance and pain control, is still the treatment of choice in the vast majority of patients with multiple rib fractures. In selected patients, operative fixation of fractured ribs within 72 h postinjury may lead to better outcome. More randomized control trials are needed to further determine who benefits from surgical fixation of rib fractures.

Changes in Negative Cognitions Mediate PTSD Symptom Reductions During Client-Centered Therapy and Prolonged Exposure for Adolescents

PubMed Central

McLean, Carmen P.; Yeh, Rebecca; Rosenfield, David; Foa, Edna B.

2015-01-01

Objective To assess whether changes in negative trauma-related cognitions play an important role in reducing symptoms of posttraumatic stress disorder (PTSD) and depression during prolonged exposure therapy for adolescents (PE-A). Method Secondary analysis of data from a randomized controlled trial comparing PE-A with client-centered therapy (CCT) for PTSD. Participants were 61 adolescent female sexual assault survivors ages 13–18 who received 8–14 weekly sessions of PE-A or CCT at a community rape crisis center. PTSD severity was assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment. Participants also completed self-report measures of negative posttraumatic cognitions and depressive symptoms at the same assessment points. Results Cross lag panel mediation analyses showed that change in negative trauma-related cognitions mediated change in PTSD symptoms and depressive symptoms whereas change in PTSD and depressive symptoms did not mediate change in negative cognitions. Conclusion Our findings support EPT and suggest that change in negative trauma-related cognitions is a mechanism of both PE-A and CCT. PMID:25812826

Update on child abuse prevention.

PubMed

Krugman, Scott D; Lane, Wendy G; Walsh, Christina M

2007-12-01

Child abuse remains a significant problem in the United States with 2.9 million reports and 825 000 indicated cases in 2005. This report will highlight recent efforts toward child abuse prevention, focusing on home visiting programs, abusive head trauma primary prevention, parent training programs, sexual abuse prevention, and the effectiveness of laws banning corporal punishment. Most home visitation programs have demonstrated a lack of effectiveness in recent randomized trials. One exception is the Nurse Family Partnership, which remains the most effective and longest enduring intervention for high-risk families. Child sexual abuse prevention programs and parent training programs need further evaluation with more rigorous methodology and outcome measures. Providing universal parent education about coping with crying infants appears to be effective in lowering the incidence of abusive head trauma. Although advocated for, further study will determine the effectiveness of laws banning corporal punishment or mandating abusive head trauma education to parents of newborns. Pediatricians play an important role in the prevention of child maltreatment. Their knowledge of the effectiveness of different programs can help guide parents toward appropriate services.

The Effect of Whole Body Massage on the Process and Physiological Outcome of Trauma ICU Patients: A Double-Blind Randomized Clinical Trial

PubMed Central

Hatefi, Masoud; Jaafarpour, Molouk; Khajavikhan, Javaher; Kokhazade, Taleb

2015-01-01

Background and Aim Hospitalization of traumatic patients in the Intensive Care Unit (ICU) and their critical condition can cause haemodynamic instabilities and deterioration in the level of consciousness. The study aimed to investigate the effect of whole body massage on the vital signs, Glasgow Coma Scale (GCS) scores and arterial blood gases (ABG) in trauma ICU patients. Materials and Methods In a randomized, double-blind trial, 108 trauma ICU patients received whole body massage {experimental group (n=54)}, or routine care {control group (n=54)}. The patients vital signs; systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR), Temperature (T), GCS score and ABG parameters were measured by a nurse at the same time in both groups before the intervention and 1 hour and 3 hours after the intervention with a checklist. The patient in experimental group received full body massage in 45 minute by a family member. Results According to the findings, significant differences were observed between experimental and control groups in SBP 1 hour and 3 hours after intervention (p< 0.001), DBP, RR and PR 1 hour after intervention (p<0.001) and GCS 1 hour and 3 hours after intervention (p<0.05). Of ABG parameters, significant differences were observed between experimental and control groups in O2 saturation (p<0.001), PH (p<0.001) and pO2 (p<0.05). No significant differences between experimental and control groups in Temperature, pCO2 and HCO3 (p>0.05). Conclusion With respect to this study, massage therapy is a safe and effective treatment in intensive care units to reduce patient’s physical and psychological problems. Therefore the use of massage therapy is recommended to clinical practice as a routine method. PMID:26266191

Secondary Prevention of Chronic PTSD by Early and Short-Term Administration of Escitalopram: A Prospective Randomized, Placebo-Controlled, Double-Blind Trial.

PubMed

Zohar, Joseph; Fostick, Leah; Juven-Wetzler, Alzabeta; Kaplan, Zeev; Shalev, Hadar; Schreiber, Gavriel; Miroshnik, Natalie; Shalev, Arieh Y; Stein, Dan J; Seedat, Soraya; Suliman, Sharain; Klein, Ehud

Prospective studies have not identified a viable pharmacologic strategy for secondary prevention of posttraumatic stress disorder (PTSD). The authors examined whether preventive intervention via early and short-term administration of a selective serotonin reuptake inhibitor (SSRI), within 1 month of exposure to a traumatic event (before diagnosis of PTSD could be made), may reduce the severity of PTSD symptoms according to DSM-IV at 13 months' follow-up. Over 25,000 screening calls to patients referred to an emergency department for a traumatic event performed between June 2006 and December 2008 yielded 353 participants who were recruited within the month following a traumatic event . Participants were randomly assigned in a double-blind design to escitalopram (n = 176) or placebo (n = 177). The per-protocol analysis comprised 198 participants (escitalopram, n = 102; placebo, n = 96) who received treatment for 12 to 24 weeks and were available for follow-up at week 56. The primary outcome measure, the Clinician Administered PTSD Scale (CAPS), revealed no prevention effect. However, a secondary outcome, the Pittsburgh Sleep Quality Inventory (PSQI), showed better results for the SSRI group than for the placebo group. For a subset of participants who experienced intentional trauma (missile attacks, rape, or physical assault; n = 50), the prevention effect was found on both primary and secondary measures (CAPS, PSQI and measures of depression and global illness severity). Early and short-term administration of escitalopram was not shown to prevent PTSD, although it did improve sleep quality. In a subgroup of participants who experienced intentional trauma, however, this early-treatment approach may be effective as secondary prevention. This large study is the first to investigate the preventive effect of early administration of escitalopram on PTSD. It highlights the relevance of the type of trauma (intentional vs unintentional) to the outcome. ClinicalTrials.gov identifier: NCT00300313​​. © Copyright 2018 Physicians Postgraduate Press, Inc.

Trauma-associated lung injury differs clinically and biologically from acute lung injury due to other clinical disorders*

PubMed Central

Calfee, Carolyn S.; Eisner, Mark D.; Ware, Lorraine B.; Thompson, B. Taylor; Parsons, Polly E.; Wheeler, Arthur P.; Korpak, Anna; Matthay, Michael A.

2009-01-01

Objective Patients with trauma-associated acute lung injury have better outcomes than patients with other clinical risks for lung injury, but the mechanisms behind these improved outcomes are unclear. We sought to compare the clinical and biological features of patients with trauma-associated lung injury with those of patients with other risks for lung injury and to determine whether the improved outcomes of trauma patients reflect their baseline health status or less severe lung injury, or both. Design, Setting, and Patients Analysis of clinical and biological data from 1,451 patients enrolled in two large randomized, controlled trials of ventilator management in acute lung injury. Measurements and Main Results Compared with patients with other clinical risks for lung injury, trauma patients were younger and generally less acutely and chronically ill. Even after adjusting for these baseline differences, trauma patients had significantly lower plasma levels of intercellular adhesion molecule-1, von Willebrand factor antigen, surfactant protein-D, and soluble tumor necrosis factor receptor-1, which are biomarkers of lung epithelial and endothelial injury previously found to be prognostic in acute lung injury. In contrast, markers of acute inflammation, except for interleukin-6, and disordered coagulation were similar in trauma and nontrauma patients. Trauma-associated lung injury patients had a significantly lower odds of death at 90 days, even after adjusting for baseline clinical factors including age, gender, ethnicity, comorbidities, and severity of illness (odds ratio, 0.44; 95% confidence interval, 0.24 – 0.82; p = .01). Conclusions Patients with trauma-associated lung injury are less acutely and chronically ill than other lung injury patients; however, these baseline clinical differences do not adequately explain their improved outcomes. Instead, the better outcomes of the trauma population may be explained, in part, by less severe lung epithelial and endothelial injury. PMID:17944012

Issues in the design of multisite clinical trials of psychotherapy: VA Cooperative Study No. 494 as an example.

PubMed

Schnurr, Paula P; Friedman, Matthew J; Engel, Charles C; Foa, Edna B; Shea, M Tracie; Resick, Patricia M; James, Kenneth E; Chow, Bruce K

2005-12-01

This article describes issues in the design of an ongoing multisite randomized clinical trial of psychotherapy for treating posttraumatic stress disorder (PTSD) in female veterans and active duty personnel. Research aimed at testing treatments for PTSD in women who have served in the military is especially important due to the high prevalence of PTSD in this population. VA Cooperative Study 494 was designed to enroll 384 participants across 12 sites. Participants are randomly assigned to receive 10 weekly sessions of individual psychotherapy: Prolonged Exposure, a specific cognitive-behavioral therapy protocol for PTSD, or present-centered therapy, a comparison treatment that addresses current interpersonal problems but avoids a trauma focus. PTSD is the primary outcome. Additional outcomes are comorbid problems such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and service utilization. Follow-up assessments are conducted at the end of treatment and then 3 and 6 months after treatment. Both treatments are delivered according to a manual. Videotapes of therapy sessions are viewed by experts who provide feedback to therapists throughout the trial to ensure adherence to the treatment manual. Discussion includes issues encountered in multisite psychotherapy trials along with the rationale for our decisions about how we addressed these issues in CSP #494.

Imagery rescripting and eye movement desensitisation and reprocessing for treatment of adults with childhood trauma-related post-traumatic stress disorder: IREM study design.

PubMed

Boterhoven de Haan, Katrina L; Lee, Christopher W; Fassbinder, Eva; Voncken, Marisol J; Meewisse, Mariel; Van Es, Saskia M; Menninga, Simone; Kousemaker, Margriet; Arntz, Arnoud

2017-05-04

Post-traumatic stress disorder (PTSD) that originates from childhood trauma experiences can develop into a chronic condition that has lasting effects on an individual's functioning and quality of life. While there are evidence-based guidelines for treating adult onset PTSD, treatments for adults with childhood trauma-related PTSD (Ch-PTSD) are varied and subject to ongoing debate. This study will test the effectiveness of two trauma-focused treatments, imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR) in participants with Ch-PTSD. Both have been found effective in treatment of adult PTSD or mixed onset PTSD and previous research indicates they are well-tolerated treatments. However, we know less about their effectiveness for treating Ch-PTSD or their underlying working mechanisms. IREM is an international multicentre randomised controlled trial involving seven sites across Australia, Germany and the Netherlands. We aim to recruit 142 participants (minimum of n = 20 per site), who will be randomly assigned to treatment condition. Assessments will be conducted before treatment until 1-year follow-up. Assessments before and after the waitlist will assess change in time only. The primary outcome measure is change in PTSD symptom severity from pre-treatment to 8-weeks post-treatment. Secondary outcome measures include change in severity of depression, anger, trauma-related cognitions, guilt, shame, dissociation and quality of life. Underlying mechanisms of treatment will be assessed on changes in vividness, valence and encapsulated belief of a worst trauma memory. Additional sub-studies will include qualitative investigation of treatment experiences from the participant and therapists' perspective, changes in memory and the impact of treatment fidelity on outcome measures. The primary aims of this study are to compare the effectiveness of EMDR and ImRs in treating Ch-PTSD and to investigate the underlying working mechanisms of the two treatments. The large-scale international design will make a significant contribution to our understanding of how these treatments address the needs of individuals with Ch-PTSD and therefore, potentially improve their effectiveness. Australian New Zealand Clinical Trials Registry ACTRN12614000750684 . Registered 16 July 2014.

Effectiveness of cognitive-behavioral trauma treatment for incarcerated women with mental illnesses and substance abuse disorders.

PubMed

Wolff, Nancy; Frueh, B Christopher; Shi, Jing; Schumann, Brooke E

2012-10-01

An open trial design was used to examine the implementation and effectiveness of a cognitive-behavioral intervention (Seeking Safety) for comorbid post-traumatic stress disorder (PTSD) and substance use disorder (SUD) for incarcerated women with Axis I mental disorders who self-referred for specialty trauma treatment. The study sample was female inmates aged 18 and old who were primarily minority, had experienced childhood-based trauma, committed violent crimes, had a serious mental illness, and resided in maximum, medium, and minimum compounds of a women's prison. A total of 74 women completed the group intervention, with the average attending 23 of the 28 sessions (82%). Implementation feasibility was demonstrated by the ability to recruit, screen, assign, and retain participation. Effectiveness was supported by changes pre-post intervention on the PTSD Checklist (ES=0.56) and Global Severity Index (ES=0.47). Of the 19 completers with PCL scores of 50 or higher pre-intervention, 16 (84%) had scores below 50, the "cut score" consistent with or supportive of a PTSD diagnosis. Three-quarters or more of participants reported that Seeking Safety was helpful in each of the following areas: overall, for traumatic stress symptoms, for substance use, to focus on safety, and to learn safe coping skills. Future directions include the need for larger scale randomized controlled trials in medium or maximum security prisons and fidelity evaluations of non-research dissemination efforts. Published by Elsevier Ltd.

Management of trauma pain in the emergency setting: low-dose methoxyflurane or nitrous oxide? A systematic review and indirect treatment comparison.

PubMed

Porter, Keith M; Siddiqui, Mohd Kashif; Sharma, Ikksheta; Dickerson, Sara; Eberhardt, Alice

2018-01-01

Low-dose methoxyflurane and nitrous oxide (N 2 O; 50:50 with oxygen) are both self-administered, self-titrated, rapid-acting, nonnarcotic, and noninvasive inhalational agents with similar onset times of pain relief. The aim of this review was to compare the clinical efficacy, safety, and tolerability of these analgesics in emergency care. A systematic literature search and review according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were performed using Embase, Medline, the Cochrane Library, several clinical trial registers, and emergency-medicine conference material. Although both compounds have been used for many years in emergency care, the search found only a few controlled studies and no head-to-head trials performed in this setting. Two double-blind, randomized studies comparing their respective study medication (low-dose methoxyflurane or N 2 O) to placebo were identified that could be compared in an indirect approach by using placebo as a bridging comparator. Both agents provided rapid pain relief to trauma patients, with no significant differences between them; both treatments were generally well tolerated. Both low-dose methoxyflurane and N 2 O are suitable options for the pain treatment of trauma patients in the emergency setting. Due to the ease of administration and portability, inhaled low-dose methoxyflurane, however, may not only offer advantages in emergency situations in remote or difficult-to-reach locations and mass-casualty situations but also be of significant value in urban and rural environments.

Evaluation of a Trauma-Focused CBT Training Programme for IAPT services.

PubMed

Murray, Hannah

2017-09-01

Therapists in Improving Access to Psychological Therapies (IAPT) services are often expected to treat complex presentations of post-traumatic stress disorder (PTSD), such as individuals with multiple, prolonged or early life trauma histories and significant co-morbidity, for which they have received minimal training. Although high recovery rates for PTSD have been demonstrated in randomized controlled trials, these are not always replicated in routine practice, suggesting that training interventions are required to fill the research-practice gap. This study investigated the outcomes of a therapist training programme on treating PTSD with trauma-focused cognitive behavioural therapy (TF-CBT). Twenty therapists from ten IAPT services participated in the training, which consisted of workshops, webinars and consultation sessions over a 6-month period. Feedback indicated that participants found the training highly acceptable. PTSD knowledge and self- and supervisor-rated competence on TF-CBT measures improved following the training and improvements were maintained a year later. Client outcomes on a PTSD measure improved following the training. Participants reported attempts to disseminate learning from the course back to their teams. The findings indicate that the training programme was successful in improving TF-CBT knowledge, skills and outcomes for IAPT therapists. Tentative support for training 'trauma experts' within IAPT services was found, although institutional constraints and staff turnover may limit the sustainability of the model.

A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD

DTIC Science & Technology

2012-06-01

controlled trial to evaluate the efficacy and tolerability of the alpha-1 adrenergic antagonist, prazosin, for reducing trauma nightmares and sleep...efficacy and tolerability of the alpha-1 adrenergic antagonist prazosin compared to placebo for combat stress- related nightmares, sleep disturbance

Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial.

PubMed

Connelly, Christopher R; Van, Philbert Y; Hart, Kyle D; Louis, Scott G; Fair, Kelly A; Erickson, Anfin S; Rick, Elizabeth A; Simeon, Erika C; Bulger, Eileen M; Arbabi, Saman; Holcomb, John B; Moore, Laura J; Schreiber, Martin A

2016-10-19

Prophylactic enoxaparin is used to prevent venous thromboembolism (VTE) in surgical and trauma patients. However, VTE remains an important source of morbidity and mortality, potentially exacerbated by antithrombin III or anti-Factor Xa deficiencies and missed enoxaparin doses. Recent data suggest that a difference in reaction time (time to initial fibrin formation) greater than 1 minute between heparinase and standard thrombelastogram (TEG) is associated with a decreased risk of VTE. To evaluate the effectiveness of TEG-adjusted prophylactic enoxaparin dosing among trauma and surgical patients. This randomized clinical trial, conducted from October 2012 to May 2015, compared standard dosing (30 mg twice daily) with TEG-adjusted enoxaparin dosing (35 mg twice daily) for 185 surgical and trauma patients screened for VTE at 3 level I trauma centers in the United States. The incidence of VTE, bleeding complications, anti-Factor Xa deficiency, and antithrombin III deficiency. Of the 185 trial participants, 89 were randomized to the control group (median age, 44.0 years; 55.1% male) and 96 to the intervention group (median age, 48.5 years; 74.0% male). Patients in the intervention group received a higher median enoxaparin dose than control patients (35 mg vs 30 mg twice daily; P < .001). Anti-Factor Xa levels in intervention patients were not higher than levels in control patients until day 6 (0.4 U/mL vs 0.21 U/mL; P < .001). Only 22 patients (11.9%) achieved a difference in reaction time greater than 1 minute, which was similar between the control and intervention groups (10.4% vs 13.5%; P = .68). The time to enoxaparin initiation was similar between the control and intervention groups (median [range] days, 1.0 [0.0-2.0] vs 1.0 [1.0-2.0]; P = .39), and the number of patients who missed at least 1 dose was also similar (43 [48.3%] vs 54 [56.3%]; P = .30). Rates of VTE (6 [6.7%] vs 6 [6.3%]; P > .99) were similar, but the difference in bleeding complications (5 [5.6%] vs 13 [13.5%]; P = .08) was not statistically significant. Antithrombin III and anti-Factor Xa deficiencies and hypercoagulable TEG parameters, including elevated coagulation index (>3), maximum amplitude (>74 mm), and G value (>12.4 dynes/cm2), were prevalent in both groups. Identified risk factors for VTE included older age (61.0 years vs 46.0 years; P = .04), higher body mass index (calculated as weight in kilograms divided by height in meters squared; 30.6 vs 27.1; P = .03), increased Acute Physiology and Chronic Health Evaluation II score (8.5 vs 7.0; P = .03), and increased percentage of missed doses per patient (14.8% vs 2.5%; P = .05). The incidence of VTE was low and similar between groups; however, few patients achieved a difference in reaction time greater than 1 minute. Antithrombin III deficiencies and hypercoagulable TEG parameters were prevalent among patients with VTE. Low VTE incidence may be due to an early time to enoxaparin initiation and an overall healthier and less severely injured study population than previously reported. clinicaltrials.gov Identifier: NCT00990236.

Using Virtual Reality and Videogames for Traumatic Brain Injury Rehabilitation: A Structured Literature Review.

PubMed

Pietrzak, Eva; Pullman, Stephen; McGuire, Annabel

2014-08-01

This article reviews the available literature about the use of novel methods of rehabilitation using virtual reality interventions for people living with posttraumatic brain injuries. The MEDLINE, EMBASE, SCOPUS, and Cochrane Library databases were searched using the terms "virtual reality" OR "video games" AND "traumatic brain injury." Included studies investigated therapeutic use of virtual reality in adults with a brain trauma resulting from acquired closed head injury, reported outcomes that included measures of motor or cognitive functionality, and were published in a peer-reviewed journal written in English. Eighteen articles fulfilled inclusion criteria. Eight were case studies, five studies had a quasi-experimental design with a pre-post comparison, and five were pilot randomized control trials or comparative studies. The virtual reality systems used were commercial or custom designed for the study and ranged from expensive, fully immersive systems to cheap online games or videogames. In before-after comparisons, improvements in balance were seen in four case studies and two small randomized control trials. Between-group comparisons in these randomized control trials showed no difference between virtual reality and traditional therapy. Post-training improvements were also seen for upper extremity functions (five small studies) and for various cognitive function measures (four case studies and one pilot randomized control trial). Attitudes of participants toward virtual reality interventions was more positive than for traditional therapy (three studies). The evidence that the use of virtual reality in rehabilitation of traumatic brain injury improves motor and cognitive functionality is currently very limited. However, this approach has the potential to provide alternative, possibly more affordable and available rehabilitation therapy for traumatic brain injury in settings where access to therapy is limited by geographical or financial constraints.

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

PubMed

Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

2014-11-20

Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection. The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery

PubMed Central

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-01-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. PMID:12562974

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery.

PubMed

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-02-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.

Strategies for Small Volume Resuscitation: Hyperosmotic-Hyperoncotic Solutions, Hemoglobin Based Oxygen Carriers and Closed-Loop Resuscitation

NASA Technical Reports Server (NTRS)

Kramer, George C.; Wade, Charles E.; Dubick, Michael A.; Atkins, James L.

2004-01-01

Introduction: Logistic constraints on combat casualty care preclude traditional resuscitation strategies which can require volumes and weights 3 fold or greater than hemorrhaged volume. We present a review of quantitative analyses of clinical and animal data on small volume strategies using 1) hypertonic-hyperosmotic solutions (HHS); 2) hemoglobin based oxygen carriers (HBOCs) and 3) closed-loop infusion regimens.Methods and Results: Literature searches and recent queries to industry and academic researchers have allowed us to evaluate the record of 81 human HHS studies (12 trauma trials), 19 human HBOCs studies (3trauma trials) and two clinical studies of closed-loop resuscitation.There are several hundreds animal studies and at least 82 clinical trials and reports evaluating small volume7.2%-7.5% hypertonic saline (HS) most often combined with colloids, e.g., dextran (HSD) or hetastarch(HSS). HSD and HSS data has been published for 1,108 and 392 patients, respectively. Human studies have documented volume sparing and hemodynamic improvements. Meta-analyses suggest improved survival for hypotensive trauma patients treated with HSD with significant reductions in mortality found for patients with blood pressure < 70 mmHg, head trauma, and penetrating injury requiring surgery. HSD and HSS have received regulatory approval in 14 and 3 countries, respectively, with 81,000+ units sold. The primary reported use was head injury and trauma resuscitation. Complications and reported adverse events are surprisingly rare and not significantly different from other solutions.HBOCs are potent volume expanders in addition to oxygen carriers with volume expansion greater than standard colloids. Several investigators have evaluated small volume hyperoncotic HBOCs or HS-HBOC formulations for hypotensive and normotensive resuscitation in animals. A consistent finding in resuscitation with HBOCs is depressed cardiac output. There is some evidence that HBOCs more efficiently unload oxygen from plasma hemoglobin as well as facilitate RBC unloading. We analyzed one volunteer study, 15 intraoperative trials, and 3 trauma studies using HBOCs. Perioperative studies generally suggest ability to deliver oxygen, but one trauma trial using HBOCs (HemAssist) for treatment of trauma resulted in a dramatic increase in mortality, while an intraoperative trauma study using Polyheme demonstrated reductions in blood use and lower mortality compared to historic controls of patients refusing blood. Transfusion reductions with HBOC use have been modest. Two HBOCs (Hemopure and Polyheme) are now in new or planned large-scale multicenter prehospital trials of trauma treatment. A new implementation of small volume resuscitation is closed-loop resuscitation (CLR), which employs microprocessors to titrate just enough fluid to reach a physiologic target . Animal studies suggest less risk of rebleeding in uncontrolled hemorrhage and a reduction in fluid needs with CLR. The first clinical application of CLR was treatment of burn shock and the US Army. Conclusions: Independently sponsored civilian trauma trials and clinical evaluations in operational combat conditions of different small volume strategies are warranted.

Lost but not forgotten: patients lost to follow-up in a trauma database

PubMed Central

Murnaghan, M. Lucas; Buckley, Richard E.

2002-01-01

Objectives To determine the characteristics of patients lost to follow-up and to identify if they are significantly different from those who are followed up in the context of a prospective randomized controlled trial. Design A retrospective review of a prospectively acquired trauma database. Setting A level 1 university-affiliated trauma hospital. Patients Two hundred and thirty-six patients treated for displaced intra-articular calcaneal fractures between April 1991 and December 1996. Of these, 198 were categorized as “attenders” and the remaining 38 were deemed “nonattenders.” Demographics, severity of injury, intervention and post-treatment status of the 2 groups were compared. Demographic information, including age, gender, occupation workload, Workers’ Compensation Board involvement and other standard trauma information were compared and the differences analyzed. Results The nonattenders were younger than the attenders, and there was a significantly increased proportion of Aboriginal Canadians in the nonattenders group. Attenders were more likely to be “skilled or semi-skilled clerical, sales, service or trades crafts” workers, and nonattenders were more likely to be “unskilled clerical, sales, service or labour” workers. Attenders were more likely to have a preoperative Bohler’s angle of < 0°, compared with a preoperative Bohler’s angle of 0° to 15° for nonattenders. Conclusions This trauma population is at higher risk of being marginalized by society and may not have the same accessibility to a study nurse or a hospital contact person. Patients lost to follow-up are a demographically and clinically different patient population from those who remain involved in a long-term prospective trauma study. PMID:12067171

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

PubMed Central

2013-01-01

Background Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. Methods/Design A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. Discussion The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. Trial registration Trial registration: ISRCTN79584912 PMID:23702050

Comparison of the Effects of Lanolin, Peppermint, and Dexpanthenol Creams on Treatment of Traumatic Nipples in Breastfeeding Mothers.

PubMed

Shanazi, Mahnaz; Farshbaf Khalili, Azizeh; Kamalifard, Mahin; Asghari Jafarabadi, Mohammad; Masoudin, Kazhal; Esmaeli, Fariba

2015-12-01

Traumatic nipple is among the most common problems of the breastfeeding period which leads to early cessation of breastfeeding. The study aimed to compare the effects of the lanolin, peppermint, and dexpanthenol creams on the treatment of traumatic nipples. This double-blind randomized controlled trial was carried out on 126 breastfeeding mothers. The mothers had visited at the health centers and children's hospitals in Sanandaj City. The selected participants were randomly divided into the following three groups of lanolin, peppermint, and dexpanthenol cream groups. Nipple pain was measured using the Store scale while trauma was measured with the Champion scale. Analyses were carried out through the Kruskal-Wallis test, Chi-square, ANOVA, and repeated measures ANOVA by using SPSS software ver. 13. The result showed that the mean score of nipple pain and nipple trauma at the prior to intervention stage, third, seventh, and fourteenth days of intervention was not significantly different between three groups. But, repeated measures ANOVA showed a significant difference in comparison of the four time periods of intervention in each group. RESULTS of this study revealed that the lanolin, peppermint, and dexpanthenol medicines had similar therapeutic effects on traumatic nipple.

A Transdiagnostic Community-Based Mental Health Treatment for Comorbid Disorders: Development and Outcomes of a Randomized Controlled Trial among Burmese Refugees in Thailand

PubMed Central

Bolton, Paul; Lee, Catherine; Haroz, Emily E.; Murray, Laura; Dorsey, Shannon; Robinson, Courtland; Ugueto, Ana M.; Bass, Judith

2014-01-01

Background Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting. Methods and Findings We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was −0.49 (95% CI: −0.59, −0.40) for depression, −0.43 (95% CI: −0.51, −0.35) for PTS, −0.42 (95% CI: −0.58, −0.27) for functional impairment, −0.48 (95% CI: −0.61, −0.34) for anxiety, −0.24 (95% CI: −0.34, −0.15) for aggression, and −0.03 (95% CI: −0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention. Conclusions CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs. Trial registration ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary PMID:25386945

The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial.

PubMed

Overbeek, Mathilde M; de Schipper, J Clasien; Lamers-Winkelman, Francien; Schuengel, Carlo

2012-02-06

Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!') has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies, developing a trauma narrative, improving parent-child interaction and psycho-education. The main study aim is to evaluate the effectiveness of the specific therapeutic factors in the program. A secondary objective is to study mediating and moderating factors. This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140) are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health) care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the child. Mediators tested are the ability to differentiate and express emotions, emotional security, coping strategies, feelings of guilt and parent-child interaction. Mental health of the parent, parenting stress, disturbances in parent-child attachment, duration and severity of the domestic violence and demographics are examined for their moderating effect. Data are collected one week before the program starts (T1), and one week (T2) and six months (T3) after finishing the program. Both intention-to-treat and completer analyses will be done. Adverse outcomes after witnessing interparental violence are highly diverse and may be explained by multiple risk factors. An important question for prevention programs is therefore to what extent a specific focus on potential psychotrauma is useful. This trial may point to several directions for optimizing public health response to children's exposure to interparental violence.

Prehospital Use of Plasma for Traumatic Hemorrhage

DTIC Science & Technology

2013-06-01

Treatment Trials Network which h as trialed pre-hospital use of midazolam autoinjection for status epilepticus and is tria ling the use of in travenous...history and current status . J Trauma 2011; 70:811-12. 48. Ogilvie MP, Ryan ML, Proctor KG. Hetastarch during initial resuscitation from trauma. J

An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial.

PubMed

Krupnick, Janice L; Green, Bonnie L; Amdur, Richard; Alaoui, Adil; Belouali, Anas; Roberge, Erika; Cueva, David; Roberts, Miguel; Melnikoff, Elizabeth; Dutton, Mary Ann

2017-07-01

[Correction Notice: An Erratum for this article was reported in Vol 9(4) of Psychological Trauma: Theory, Research, Practice, and Policy (see record 2016-54154-001). In the article, the names of authors Adil Alaoui and Anas Belouali were misspelled as Adil Aloui and Anas Beloui respectively. All versions of this article have been corrected.] Objective: Veterans suffering from posttraumatic stress disorder (PTSD) may avoid or fail to follow through with a full course of face-to-face mental health treatment for a variety of reasons. We conducted a pilot effectiveness trial of an online intervention for veterans with current PTSD to determine the feasibility, safety, and preliminary effectiveness of an online writing intervention (i.e., Warriors Internet Recovery & EDucation [WIRED]) as an adjunct to face-to-face psychotherapy. Method: Veterans ( N = 34) who had served in Iraq or Afghanistan with current PTSD subsequent to deployment-related trauma were randomized to Veterans Affairs (VA) mental health treatment as usual (TAU) or to treatment as usual plus the online intervention (TAU + WIRED). All research participants were recruited from the Trauma Services Program, VA Medical Center, Washington, DC. They completed baseline assessments as well as assessments 12 weeks and 24 weeks after the baseline assessment. The online intervention consisted of therapist-guided writing, using principles of prolonged exposure and cognitive therapy. The intervention was adapted from an evidence-based treatment used in The Netherlands and Germany for individuals who had been exposed to nonmilitary traumas. Results: In addition to showing that the online intervention was both feasible to develop and implement, as well as being safe, the results showed preliminary evidence of the effectiveness of the TAU + WIRED intervention in this patient population, with particular evidence in reducing PTSD symptoms of hyperarousal. Conclusion: With minor modifications to enhance the therapeutic alliance, this intervention should be tested in a larger clinical trial to determine whether this method of online intervention might provide another alternative to face-to-face treatment for veterans with PTSD. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Patient-Reported Outcome Measures for Hand and Wrist Trauma

PubMed Central

Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

2016-01-01

Background: Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. Methods: A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. Results: The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. Conclusions: The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology. PMID:27418884

Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network.

PubMed

Hien, Denise A; Jiang, Huiping; Campbell, Aimee N C; Hu, Mei-Chen; Miele, Gloria M; Cohen, Lisa R; Brigham, Gregory S; Capstick, Carrie; Kulaga, Agatha; Robinson, James; Suarez-Morales, Lourdes; Nunes, Edward V

2010-01-01

The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.

An open-label pilot study of aripiprazole for male and female veterans with chronic post-traumatic stress disorder who respond suboptimally to antidepressants.

PubMed

Youssef, Nagy A; Marx, Christine E; Bradford, Daniel W; Zinn, Sandra; Hertzberg, Michael A; Kilts, Jason D; Naylor, Jennifer C; Butterfield, Marian I; Strauss, Jennifer L

2012-07-01

Emerging data suggest that second-generation antipsychotics such as aripiprazole may be effective in the treatment of post-traumatic stress disorder (PTSD). However, few clinical trials have used aripiprazole in PTSD, and data are limited on its use in Veterans with PTSD. The objective of this pilot trial was to investigate the safety and efficacy of aripiprazole in Veterans with PTSD. Ten individuals (five men and five women) meeting the Diagnostic and statistical manual of mental disorders, 4th ed., PTSD criteria participated in this 12-week, open-label, flexibly dosed monotherapy trial. The dose range of aripiprazole was 5-30 mg/day, titrated to tolerability and clinical response. The primary outcome measure was the Clinician-Administered PTSD Scale. Additional outcomes included the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale (Top-8), the Davidson Trauma Scale, the Positive and Negative Syndrome Scale, the Beck Depression Inventory-Fast Screen, and Clinical Global Impressions-Improvement. Eight participants completed the study, and aripiprazole was generally well tolerated and associated with a significant improvement in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (primary outcome measure) and by the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale, and the Davidson Trauma Scale. An improvement was also observed on all three Positive and Negative Syndrome Scale subscales and the Beck Depression Inventory-Fast Screen, and the average Clinical Global Impressions-Improvement ratings indicated that patients were 'much improved'. These promising initial results merit further investigation in a larger, randomized-controlled trial.

No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial

PubMed Central

2011-01-01

Background The WHO advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position in which she feels most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery; however RCTs of interventions to encourage upright positions are scarce. The aim of this study was to test, by means of a randomized controlled trial, the hypothesis that the use of a birthing seat during the second stage of labor, for healthy nulliparous women, decreases the number of instrumentally assisted births and may thus counterbalance any increase in perineal trauma and blood loss. Methods A randomized controlled trial in Sweden where 1002 women were randomized to birth on a birth seat (experimental group) or birth in any other position (control group). Data were collected between November 2006 and July 2009. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included perineal lacerations, perineal edema, maternal blood loss and hemoglobin. Analysis was by intention to treat. Results The main findings of this study were that birth on the birth seat did not reduce the number of instrumental vaginal births, there was an increase in blood loss between 500 ml and 1000 ml in women who gave birth on the seat but no increase in bleeding over 1000 ml and no increase in perineal lacerations or perineal edema. Conclusions The birth seat did not reduce the number of instrumental vaginal births. The study confirmed an increased blood loss 500 ml - 1000 ml but not over 1000 ml for women giving birth on the seat. Giving birth on a birth seat caused no adverse consequences for perineal outcomes and may even be protective against episiotomies. Trial registration number ClinicalTrials.gov.ID: NCT01182038 PMID:21435238

What Is the Evidence for Rest, Ice, Compression, and Elevation Therapy in the Treatment of Ankle Sprains in Adults?

PubMed Central

van den Bekerom, Michel P.J; Struijs, Peter A.A; Blankevoort, Leendert; Welling, Lieke; van Dijk, C. Niek; Kerkhoffs, Gino M.M.J

2012-01-01

Context: Ankle sprains are common problems in acute medical care. The variation in treatment observed for the acutely injured lateral ankle ligament complex in the first week after the injury suggests a lack of evidence-based management strategies for this problem. Objective: To analyze the effectiveness of applying rest, ice, compression, and elevation (RICE) therapy begun within 72 hours after trauma for patients in the initial period after ankle sprain. Study Selection: Eligible studies were published original randomized or quasi-randomized controlled trials concerning at least 1 of the 4 subtreatments of RICE therapy in the treatment of acute ankle sprains in adults. Data Sources: MEDLINE, Cochrane Clinical Trial Register, CINAHL, and EMBASE. The lists of references of retrieved publications also were checked manually. Data Extraction: We extracted relevant data on treatment outcome (pain, swelling, ankle mobility or range of motion, return to sports, return to work, complications, and patient satisfaction) and assessed the quality of included studies. If feasible, the results of comparable studies were pooled using fixed- or random-effects models. Data Synthesis: After deduction of the overlaps among the different databases, evaluation of the abstracts, and contact with some authors, 24 potentially eligible trials remained. The full texts of these articles were retrieved and thoroughly assessed as described. This resulted in the inclusion of 11 trials involving 868 patients. The main reason for exclusion was that the authors did not describe a well-defined control group without the intervention of interest. Conclusions: Insufficient evidence is available from randomized controlled trials to determine the relative effectiveness of RICE therapy for acute ankle sprains in adults. Treatment decisions must be made on an individual basis, carefully weighing the relative benefits and risks of each option, and must be based on expert opinions and national guidelines. PMID:22889660

The Efficacy of a Group Cognitive Behavioral Therapy for War-Affected Young Migrants Living in Australia: A Cluster Randomized Controlled Trial

PubMed Central

Ooi, Chew S.; Rooney, Rosanna M.; Roberts, Clare; Kane, Robert T.; Wright, Bernadette; Chatzisarantis, Nikos

2016-01-01

Background: Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia. Methods and Findings: A cluster randomized controlled trial with pre-test, post-test, and 3-month follow-up design was employed. A total of 82 participants (aged 10–17 years) were randomized by school into the 8-week intervention (n = 45) or the waiting list (WL) control condition (n = 37). Study outcomes included symptoms of post-traumatic stress disorder, depression, internalizing and externalizing problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1, 155) = 5.20, p = 0.024, partial η2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2, 122) = 7.24, p = 0.001, partial η2 = 0.20. Conclusions: These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000 948998. PMID:27843435

When Is It Appropriate to Use Glutamine in Critical Illness?

PubMed

Mundi, Manpreet S; Shah, Meera; Hurt, Ryan T

2016-08-01

Glutamine is a nonessential amino acid, which under trauma or critical illness can become essential. A number of historic small single-center randomized controlled trials (RCTs) have demonstrated positive treatment effects on clinical outcomes with glutamine supplementation. Meta-analyses based on these trials demonstrated a significant reduction in hospital mortality, intensive care unit (ICU) length of stay (LOS), and hospital LOS with intravenous (IV) glutamine. Similar results were not noted in 2 large multicenter RCTs (REDOXS and MetaPlus) assessing the efficacy of glutamine supplementation in ventilated ICU patients. The REDOXS trial of 40 ICUs randomized 1223 ventilated ICU patients to glutamine (IV and enteral), antioxidants, both glutamine and antioxidants, or placebo. The main conclusions were a trend toward increased 28-day mortality and significant increased hospital and 6-month mortality in those who received glutamine. The MetaPlus trial of 14 ICUs, which randomized 301 ventilated ICU patients to glutamine-enriched enteral vs an isocaloric diet, noted increased 6-month mortality in the glutamine-supplemented group. Newer RCTs have focused on specific populations and have demonstrated benefits in burn and elective surgery patients with glutamine supplementation. Whether larger studies will confirm these findings is yet to be determined. Recent American Society for Parenteral and Enteral Nutrition guidelines recommend that IV and enteral glutamine should not be used in the critical care setting based on the moderate quality of evidence available. We agree with these recommendations and would encourage larger multicenter studies to evaluate the risks and benefits of glutamine in burn and elective surgery patients. © 2016 American Society for Parenteral and Enteral Nutrition.

Thromboelastogram-guided enoxaparin dosing does not confer protection from deep venous thrombosis: a randomized controlled pilot trial.

PubMed

Louis, Scott G; Van, Philbert Y; Riha, Gordon M; Barton, Jeffrey S; Kunio, Nicholas R; Underwood, Samantha J; Differding, Jerome A; Rick, Elizabeth; Ginzburg, Enrique; Schreiber, Martin A

2014-04-01

The incidence of deep venous thrombosis (DVT) remains high in general surgery and trauma patients despite widespread prophylaxis with enoxaparin. A recent study demonstrated decreased incidence of DVT if patients on enoxaparin had a change in R time (ΔR) of greater than 1 minute when heparinase-activated thromboelastography (TEG) was compared with normal TEG. We hypothesized that using ΔR-guided dosing would result in decreased DVT rates. A prospective, randomized controlled trial was performed at a Level 1 trauma center. Both trauma and general surgery patients were included. Upon enrollment, demographic data including age, sex, body mass index, and Acute Physiology and Chronic Health Evaluation II score were obtained. Enrolled patients were randomized to standard (30 mg twice a day) or TEG-guided dosing. Dose-adjusted patients underwent daily enoxaparin titration to achieve an ΔR of 1 minute to 2 minutes. Venous thromboembolism screening was performed per institutional protocol. Antithrombin III (AT-III) and anti-Xa levels were drawn at peak enoxaparin concentrations. A total of 87 patients were enrolled. There was no difference in demographic data between the groups. No pulmonary emboli were identified. The control group had a DVT rate of 16%, while the experimental group had a rate of 14% (p = nonsignificant). The experimental group's median enoxaparin dosage, 50 mg twice a day, was significantly higher than that of the control (p < 0.01). TEG ΔR was not different between the control and experimental groups. Beginning at Day 3, anti-Xa levels were higher in the experimental group (p < 0.05). There was no difference in AT-III activity between the two groups; 67% of the patients demonstrated AT-III deficiency. TEG adjusted enoxaparin dosing led to significant increases in anti-Xa activity, which did not correlate with a decreased DVT rate. Failure to reduce the DVT rate and increase ΔR despite increased dosing and increased anti-Xa activity is consistent with the high rate of AT-III deficiency detected in this study cohort. These data suggest that the future of DVT prevention may not lie in the optimization of low molecular weight heparin therapy but rather in compounds that increase antithrombin directly or operate independently of the AT-III pathway. Therapeutic study, level III.

Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

PubMed

Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

2015-09-01

Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal consideration and care to the primary outcome analysis. Copyright © 2015 Elsevier Inc. All rights reserved.

Childhood traumas as a risk factor for HIV-risk behaviours amongst young women and men living in urban informal settlements in South Africa: A cross-sectional study.

PubMed

Gibbs, Andrew; Dunkle, Kristin; Washington, Laura; Willan, Samantha; Shai, Nwabisa; Jewkes, Rachel

2018-01-01

Childhood traumas, in the form of physical, sexual, and emotional abuse and neglect, are globally widespread and highly prevalent, and associated with a range of subsequent poor health outcomes. This study sought to understand the relationship between physical, sexual and emotional childhood abuse and subsequent HIV-risk behaviours amongst young people (18-30) living in urban informal settlements in Durban, South Africa. Data came from self-completed questionnaires amongst 680 women and 677 men comprising the baseline of the Stepping Stones and Creating Futures intervention trial. Men and women were analysed separately. Logistic regression models assessed the relationship between six HIV-risk behaviours and four measures of trauma: the form of trauma, the severity of each trauma, the range of traumas, and overall severity of childhood trauma. Childhood traumas were incredibly prevalent in this population. All childhood traumas were associated with a range of HIV-risk behaviours. This was for the ever/never trauma, as well as the severity of each type of trauma, the range of trauma, and overall severity of childhood trauma. Despite the wider harsh contexts of urban informal settlements, childhood traumas still play a significant role in shaping subsequent HIV-risk behaviours amongst young people. Interventions to reduce childhood traumas for populations in informal settlements need to be developed. In addition, trauma focused therapies need to be considered as part of wider HIV-prevention interventions for young adults. ClinicalTrials.gov NCT03022370.

Antenatal perineal massage for reducing perineal trauma.

PubMed

Beckmann, Michael M; Stock, Owen M

2013-04-30

Perineal trauma following vaginal birth can be associated with significant short-term and long-term morbidity. Antenatal perineal massage has been proposed as one method of decreasing the incidence of perineal trauma. To assess the effect of antenatal digital perineal massage on the incidence of perineal trauma at birth and subsequent morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (22 October 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2012, Issue 10), PubMed (1966 to October 2012), EMBASE (1980 to October 2012) and reference lists of relevant articles. Randomised and quasi-randomised controlled trials evaluating any described method of antenatal digital perineal massage undertaken for at least the last four weeks of pregnancy. Both review authors independently applied the selection criteria, extracted data from the included studies and assessed study quality. We contacted study authors for additional information. We included four trials (2497 women) comparing digital perineal massage with control. All were of good quality. Antenatal digital perineal massage was associated with an overall reduction in the incidence of trauma requiring suturing (four trials, 2480 women, risk ratio (RR) 0.91 (95% confidence interval (CI) 0.86 to 0.96), number needed to treat to benefit (NNTB) 15 (10 to 36)) and women practicing perineal massage were less likely to have an episiotomy (four trials, 2480 women, RR 0.84 (95% CI 0.74 to 0.95), NNTB 21 (12 to 75)). These findings were significant for women without previous vaginal birth only. No differences were seen in the incidence of first- or second-degree perineal tears or third-/fourth-degree perineal trauma. Only women who have previously birthed vaginally reported a statistically significant reduction in the incidence of pain at three months postpartum (one trial, 376 women, RR 0.45 (95% CI 0.24 to 0.87) NNTB 13 (7 to 60)). No significant differences were observed in the incidence of instrumental deliveries, sexual satisfaction, or incontinence of urine, faeces or flatus for any women who practised perineal massage compared with those who did not massage. Antenatal digital perineal massage reduces the likelihood of perineal trauma (mainly episiotomies) and the reporting of ongoing perineal pain, and is generally well accepted by women. As such, women should be made aware of the likely benefit of perineal massage and provided with information on how to massage.

Trauma and recent life events in individuals at ultra high risk for psychosis: review and meta-analysis.

PubMed

Kraan, Tamar; Velthorst, Eva; Smit, Filip; de Haan, Lieuwe; van der Gaag, Mark

2015-02-01

Childhood trauma and recent life-events have been related to psychotic disorders. The aim of the present study was to examine whether childhood trauma and recent life-events are significantly more prevalent in patients at Ultra High Risk (UHR) of developing a psychotic disorder compared to healthy controls. A search of PsychInfo and Embase was conducted, relevant papers were reviewed, and three random-effects meta-analyses were performed. One meta-analysis assessed the prevalence rate of childhood trauma in UHR subjects and two meta-analyses were conducted to compare UHR subjects and healthy control subjects on the experience of childhood trauma and recent life-events. We found 12 studies on the prevalence of (childhood) trauma in UHR populations and 4 studies on recent life-events in UHR populations. We performed a meta-analysis on 6 studies (of which trauma prevalence rates were available) on childhood trauma in UHR populations, yielding a mean prevalence rate of 86.8% (95% CI 77%-93%). Childhood trauma was significantly more prevalent in UHR subjects compared to healthy control groups (Random effects Hedges' g=1.09; Z=4.60, p<.001). In contrast to our hypothesis, life-event rates were significantly lower in UHR subjects compared to healthy controls (Random effects Hedges' g=-0.53; Z=-2.36, p<.02). Our meta-analytic results illustrate that childhood trauma is highly prevalent among UHR subjects and that childhood trauma is related to UHR status. These results are in line with studies on childhood trauma in psychotic populations. In contrast to studies on recent life-events in psychotic populations, our results show that recent life-events are not associated with UHR status. Copyright © 2014 Elsevier B.V. All rights reserved.

Hydrocortisone prevents immunosuppression by interleukin-10+ natural killer cells after trauma-hemorrhage.

PubMed

Roquilly, Antoine; Broquet, Alexis; Jacqueline, Cédric; Masson, Damien; Segain, Jean Pierre; Braudeau, Cecile; Vourc'h, Mickael; Caillon, Jocelyne; Altare, Frédéric; Josien, Regis; Retière, Christelle; Villadangos, Jose; Asehnoune, Karim

2014-12-01

Trauma induces a state of immunosuppression, which is responsible for the development of nosocomial infections. Hydrocortisone reduces the rate of pneumonia in patients with trauma. Because alterations of dendritic cells and natural killer cells play a central role in trauma-induced immunosuppression, we investigated whether hydrocortisone modulates the dendritic cell/natural killer cell cross talk in the context of posttraumatic pneumonia. Experimental study. Research laboratory from an university hospital. Bagg Albino/cJ mice (weight, 20-24 g). First, in an a priori substudy of a multicenter, randomized, double-blind, placebo-controlled trial of hydrocortisone (200 mg/d for 7 d) in patients with severe trauma, we have measured the blood levels of five cytokines (tumor necrosis factor-α, interleukin-6, interleukin-10, interleukin-12, interleukin-17) at day 1 and day 8. In a second step, the effects of hydrocortisone on dendritic cell/natural killer cell cross talk were studied in a mouse model of posttraumatic pneumonia. Hydrocortisone (0.6 mg/mice i.p.) was administered immediately after hemorrhage. Twenty-four hours later, the mice were challenged with Staphylococcus aureus (7 × 10 colony-forming units). Using sera collected during a multicenter study in patients with trauma, we found that hydrocortisone decreased the blood level of interleukin-10, a cytokine centrally involved in the regulation of dendritic cell/natural killer cell cluster. In a mouse model of trauma-hemorrhage-induced immunosuppression, splenic natural killer cells induced an interleukin-10-dependent elimination of splenic dendritic cell. Hydrocortisone treatment reduced this suppressive function of natural killer cells and increased survival of mice with posthemorrhage pneumonia. The reduction of the interleukin-10 level in natural killer cells by hydrocortisone was partially dependent on the up-regulation of glucocorticoid-induced tumor necrosis factor receptor-ligand (TNFsf18) on dendritic cell. These data demonstrate that trauma-induced immunosuppression is characterized by an interleukin-10-dependent elimination of dendritic cell by natural killer cells and that hydrocortisone improves outcome by limiting this immunosuppressive feedback loop.

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial.

PubMed

Kok, Tim; de Haan, Hein A; van der Meer, Margreet; Najavits, Lisa M; DeJong, Cor A J

2013-06-04

Traumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population. A randomized controlled trial (RCT) will be used to test the efficacy of Seeking Safety compared to Cognitive Behavioral Therapy (CBT) in a population of SUD outpatients. Each treatment will consist of 12 group sessions. The primary outcome measure will be substance use severity. Secondary outcome measures are PTSD and trauma symptoms, coping skills, functioning, and cognitions. Questionnaires will be administered at the start of treatment, at the end of treatment (three months after the start of treatment) and at follow-up (six months after the start of treatment). This study protocol presents a RCT in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to CBT. It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up. Furthermore, a lower drop-out rate is expected for the intervention group. If the intervention proves to be effective, it can be implemented. A cost-effectiveness analysis will be conducted to evaluate the two treatments. The protocol for this study is registered with the Netherlands Trial Register with number NTR3084 and approved by the local medical ethical committee (METC\\11270.haa).

The alpha1-adrenergic antagonist prazosin ameliorates combat trauma nightmares in veterans with posttraumatic stress disorder: a report of 4 cases.

PubMed

Raskind, M A; Dobie, D J; Kanter, E D; Petrie, E C; Thompson, C E; Peskind, E R

2000-02-01

Central nervous system (CNS) adrenergic hyperresponsiveness may be involved in the pathophysiology of posttraumatic stress disorder (PTSD). Two Vietnam combat veterans with PTSD prescribed the centrally active alpha1-adrenergic antagonist prazosin for symptoms of benign prostatic hypertrophy unexpectedly reported elimination of combat trauma nightmares. This observation prompted an open-label feasibility trial of prazosin for combat trauma nightmares in chronic combat-induced PTSD. Four consecutively identified combat veterans with chronic DSM-IV PTSD and severe intractable combat trauma nightmares participated in an 8-week open trial of escalating-dose prazosin. Nightmare severity response was rated using the nightmare item of the Clinician Administered PTSD Scale and the Clinical Global Impressions-Change scale. The 2 patients who achieved a daily prazosin dose of at least 5 mg were markedly improved, with complete elimination of trauma nightmares and resumption of normal dreaming. The 2 subjects limited to 2 mg of prazosin to avoid excessive blood pressure reduction were moderately improved with at least 50% reduction in nightmare severity. These clinical observations, together with neurobiological evidence for alpha1-adrenergic regulation of CNS neurobiological systems relevant to PTSD, provide rationale for placebo-controlled trials of prazosin for PTSD combat trauma nightmares.

Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit.

PubMed

Johnson, Kari; Fleury, Julie; McClain, Darya

2018-08-01

Evaluate music listening for delirium prevention among patients admitted to a Trauma Intensive Care and Trauma Orthopaedic Unit. The Roy Adaptation Model provided the theoretical framework focusing on modifying contextual stimuli. Randomised controlled trial, 40 patients aged 55 and older. Participants randomly assigned to receive music listening or usual care for 60 minutes, twice a day, over three days. Pre-recorded self-selected music using an iPod and headsets, with slow tempo, low pitch and simple repetitive rhythms to alter physiologic responses. Heart rate, respiratory rate, systolic and diastolic blood pressure, confusion assessment method. Repeated measures ANOVA, F(4, 134) = 4.75, p = .001, suggested statistically significant differences in heart rate pre/post music listening, and F(1, 37) = 10.44, p = .003 in systolic blood pressure pre/post music listening. Post-hoc analysis reported changes at three time periods of statistical significance; (p = .010), (p = .005) and (p = .039) and a change in systolic blood pressure pre/post music listening; (p = .001) of statistical significance. All participants screened negative for delirium. Music addresses pathophysiologic mechanisms that contribute to delirium; neurotransmitter imbalance, inflammation and acute physiologic stressors. Music to prevent delirium is one of few that provide support in a critical care setting. Copyright © 2018 Elsevier Ltd. All rights reserved.

Posttraumatic Stress Disorder, Health Problems, and Depression Among African American Women in Residential Substance Use Treatment.

PubMed

Meshberg-Cohen, Sarah; Presseau, Candice; Thacker, Leroy R; Hefner, Kathryn; Svikis, Dace

2016-07-01

Rates of posttraumatic stress disorder (PTSD) are high among women seeking treatment for substance use disorders (SUDs). Minority women, in particular, experience high rates of trauma and may be less likely to disclose trauma history. This article identifies items from pre-existing screening measures that can be used across settings to sensitively but noninvasively identify women with likely PTSD. For a sample of 104 African American women in residential SUD treatment who provided informed consent as a part of a larger randomized clinical trial, the prevalence of trauma and PTSD, as well as the relationships between trauma, health, depression, and distress, was examined. Measures included Posttraumatic Stress Diagnostic Scale (PDS), Center for Epidemiologic Studies-Depression Scale (CES-D), Pennebaker Inventory of Limbic Languidness (PILL), and Brief Symptom Inventory (BSI). Additional analyses were undertaken to determine if a subset of noninvasive items could serve to identify the presence of a probable PTSD diagnosis. Most women (94.2%) reported at least one lifetime trauma, with over half (51.0%) meeting DSM-IV criteria for PTSD. Women with greater trauma symptom severity reported more health problems and higher levels of depression and distress. Five BSI items and one CES-D item were significantly associated with a probable PTSD diagnosis with a sensitivity of 88.7%, a specificity of 66.7%, a positive predictive value of 73.4%, a negative predictive value of 85.0%, and an accuracy of 77.9%. Findings affirm that African American women with SUDs present for residential treatment with comorbid psychiatric and emotional conditions that warrant assessment and treatment. Results highlight potential benefits of brief screening with routine measures and coordinated access to ancillary psychiatric and medical services, in conjunction with substance treatment, such as in residential or primary care.

Is non-operative management safe and effective for all splenic blunt trauma? A systematic review

PubMed Central

2013-01-01

Introduction The goal of non-operative management (NOM) for blunt splenic trauma (BST) is to preserve the spleen. The advantages of NOM for minor splenic trauma have been extensively reported, whereas its value for the more severe splenic injuries is still debated. The aim of this systematic review was to evaluate the available published evidence on NOM in patients with splenic trauma and to compare it with the operative management (OM) in terms of mortality, morbidity and duration of hospital stay. Methods For this systematic review we followed the "Preferred Reporting Items for Systematic Reviews and Meta-analyses" statement. A systematic search was performed on PubMed for studies published from January 2000 to December 2011, without language restrictions, which compared NOM vs. OM for splenic trauma injuries and which at least 10 patients with BST. Results We identified 21 non randomized studies: 1 Clinical Controlled Trial and 20 retrospective cohort studies analyzing a total of 16,940 patients with BST. NOM represents the gold standard treatment for minor splenic trauma and is associated with decreased mortality in severe splenic trauma (4.78% vs. 13.5% in NOM and OM, respectively), according to the literature. Of note, in BST treated operatively, concurrent injuries accounted for the higher mortality. In addition, it was not possible to determine post-treatment morbidity in major splenic trauma. The definition of hemodynamic stability varied greatly in the literature depending on the surgeon and the trauma team, representing a further bias. Moreover, data on the remaining analyzed outcomes (hospital stay, number of blood transfusions, abdominal abscesses, overwhelming post-splenectomy infection) were not reported in all included studies or were not comparable, precluding the possibility to perform a meaningful cumulative analysis and comparison. Conclusions NOM of BST, preserving the spleen, is the treatment of choice for the American Association for the Surgery of Trauma grades I and II. Conclusions are more difficult to outline for higher grades of splenic injury, because of the substantial heterogeneity of expertise among different hospitals, and potentially inappropriate comparison groups. PMID:24004931

Is non-operative management safe and effective for all splenic blunt trauma? A systematic review.

PubMed

Cirocchi, Roberto; Boselli, Carlo; Corsi, Alessia; Farinella, Eriberto; Listorti, Chiara; Trastulli, Stefano; Renzi, Claudio; Desiderio, Jacopo; Santoro, Alberto; Cagini, Lucio; Parisi, Amilcare; Redler, Adriano; Noya, Giuseppe; Fingerhut, Abe

2013-09-03

The goal of non-operative management (NOM) for blunt splenic trauma (BST) is to preserve the spleen. The advantages of NOM for minor splenic trauma have been extensively reported, whereas its value for the more severe splenic injuries is still debated. The aim of this systematic review was to evaluate the available published evidence on NOM in patients with splenic trauma and to compare it with the operative management (OM) in terms of mortality, morbidity and duration of hospital stay. For this systematic review we followed the "Preferred Reporting Items for Systematic Reviews and Meta-analyses" statement. A systematic search was performed on PubMed for studies published from January 2000 to December 2011, without language restrictions, which compared NOM vs. OM for splenic trauma injuries and which at least 10 patients with BST. We identified 21 non randomized studies: 1 Clinical Controlled Trial and 20 retrospective cohort studies analyzing a total of 16,940 patients with BST. NOM represents the gold standard treatment for minor splenic trauma and is associated with decreased mortality in severe splenic trauma (4.78% vs. 13.5% in NOM and OM, respectively), according to the literature. Of note, in BST treated operatively, concurrent injuries accounted for the higher mortality. In addition, it was not possible to determine post-treatment morbidity in major splenic trauma. The definition of hemodynamic stability varied greatly in the literature depending on the surgeon and the trauma team, representing a further bias. Moreover, data on the remaining analyzed outcomes (hospital stay, number of blood transfusions, abdominal abscesses, overwhelming post-splenectomy infection) were not reported in all included studies or were not comparable, precluding the possibility to perform a meaningful cumulative analysis and comparison. NOM of BST, preserving the spleen, is the treatment of choice for the American Association for the Surgery of Trauma grades I and II. Conclusions are more difficult to outline for higher grades of splenic injury, because of the substantial heterogeneity of expertise among different hospitals, and potentially inappropriate comparison groups.

Provocative discography screening improves surgical outcome.

PubMed

Margetic, Petra; Pavic, Roman; Stancic, Marin F

2013-10-01

The objective of this study was to compare the surgical outcomes of patients operated on, with or without discography prior to operation. The study was designed as a randomized controlled trial, using power analysis with McNemar's test on two correlated proportions. The study comprised of 310 patients divided into trial (207) and control (103) groups. Inclusion criteria were low back pain resistant to nonsurgical treatment for more than 6 months and conventional radiological findings showing degenerative changes without a clear generator of pain. Exclusion criteria were red flags (tumor, trauma, and infection). After standard radiological diagnostic imaging (X-ray, CT, and MR), patients filled in the Oswestry Disability Index (ODI), SF-36, Zung, and MSP questionnaires. Depending on their radiological findings, patients were included and randomly placed in the trial or control group. At the 1-year follow-up examination, patients filled in the ODI, SF-36, and Likert scale questionnaires. The difference between preoperative and postoperative ODI in the control group degenerative disc disease (DDD) subgroup was 22.07 %. The difference between preoperative and postoperative ODI in the trial group DDD subgroup was 35.04 %. Differences between preoperative and postoperative ODI in the control group other indications subgroup was 26.13 %. Differences between preoperative and postoperative ODI in the trial group other indications subgroup was 28.42 %. DDD treated surgically without discography did not reach the clinically significant improvement of 15 ODI points for the patients treated with fusion. Provocative discography screening with psychological testing in the trial group made improvement following fusion clinically significant.

Prognostic value of major extracranial injury in traumatic brain injury: an individual patient data meta-analysis in 39,274 patients.

PubMed

van Leeuwen, Nikki; Lingsma, Hester F; Perel, Pablo; Lecky, Fiona; Roozenbeek, Bob; Lu, Juan; Shakur, Haleema; Weir, James; Steyerberg, Ewout W; Maas, Andrew I R

2012-04-01

Major extracranial injury (MEI) is common in traumatic brain injury (TBI) patients, but the effect on outcome is controversial. To assess the prognostic value of MEI on mortality after TBI in an individual patient data meta-analysis of 3 observational TBI studies (International Mission on Prognosis and Clinical Trial Design in TBI [IMPACT]), a randomized controlled trial (Corticosteroid Randomization After Significant Head Injury [CRASH]), and a trauma registry (Trauma Audit and Research Network [TARN]). MEI (extracranial injury with an Abbreviated Injury Scale ≥ 3 or requiring hospital admission) was related to mortality with logistic regression analysis, adjusted for age, Glasgow Coma Scale motor score, and pupil reactivity and stratified by TBI severity. We pooled odds ratios (ORs) with random-effects meta-analysis. We included 39,274 patients. Mortality was 25%, and 32% had MEI. MEI was a strong predictor for mortality in TARN, with adjusted odds ratios of 2.81 (95% confidence interval [CI], 2.44-3.23) in mild, 2.18 (95% CI, 1.80-2.65) in moderate, and 2.14 (95% CI, 1.95-2.35) in severe TBI patients. The prognostic effect was smaller in IMPACT and CRASH, with pooled adjusted odds ratios of 2.14 (95% CI, 0.93-4.91) in mild, 1.46 (95% CI, 1.14-1.85) in moderate, and 1.18 (95% CI, 1.03-1.55) in severe TBI. When patients who died within 6 hours after injury were excluded from TARN, the effect of MEI was comparable with IMPACT and CRASH. MEI is an important prognostic factor for mortality in TBI patients. However, the effect varies by population, which explains the controversy in the literature. The strength of the effect is smaller in patients with more severe brain injury and depends on time of inclusion in a study.

Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial.

PubMed

Garland, Eric L; Roberts-Lewis, Amelia; Tronnier, Christine D; Graves, Rebecca; Kelley, Karen

2016-02-01

In many clinical settings, there is a high comorbidity between substance use disorders, psychiatric disorders, and traumatic stress. Novel therapies are needed to address these co-occurring issues efficiently. The aim of the present study was to conduct a pragmatic randomized controlled trial comparing Mindfulness-Oriented Recovery Enhancement (MORE) to group Cognitive-Behavioral Therapy (CBT) and treatment-as-usual (TAU) for previously homeless men residing in a therapeutic community. Men with co-occurring substance use and psychiatric disorders, as well as extensive trauma histories, were randomly assigned to 10 weeks of group treatment with MORE (n = 64), CBT (n = 64), or TAU (n = 52). Study findings indicated that from pre-to post-treatment MORE was associated with modest yet significantly greater improvements in substance craving, post-traumatic stress, and negative affect than CBT, and greater improvements in post-traumatic stress and positive affect than TAU. A significant indirect effect of MORE on decreasing craving and post-traumatic stress by increasing dispositional mindfulness was observed, suggesting that MORE may target these issues via enhancing mindful awareness in everyday life. This pragmatic trial represents the first head-to-head comparison of MORE against an empirically-supported treatment for co-occurring disorders. Results suggest that MORE, as an integrative therapy designed to bolster self-regulatory capacity, may hold promise as a treatment for intersecting clinical conditions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Antenatal perineal massage for reducing perineal trauma.

PubMed

Beckmann, M M; Garrett, A J

2006-01-25

Perineal trauma following vaginal birth can be associated with significant short- and long-term morbidity. Antenatal perineal massage has been proposed as one method of decreasing the incidence of perineal trauma. To assess the effect of antenatal perineal massage on the incidence of perineal trauma at birth and subsequent morbidity. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), PubMed (1966 to January 2005), EMBASE (1980 to January 2005) and reference lists of relevant articles. Randomised and quasi-randomised controlled trials evaluating any described method of antenatal perineal massage undertaken for at least the last four weeks of pregnancy. Both review authors independently applied the selection criteria, extracted data from the included studies and assessed study quality. We contacted study authors for additional information. Three trials (2434 women) comparing digital perineal massage with control were included. All were of good quality. Antenatal perineal massage was associated with an overall reduction in the incidence of trauma requiring suturing (three trials, 2417 women, relative risk (RR) 0.91 (95% confidence interval (CI) 0.86 to 0.96), number needed to treat (NNT) 16 (10 to 39)). This reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.90 (95% CI 0.84 to 0.96), NNT 14 (9 to 35)). Women who practised perineal massage were less likely to have an episiotomy (three trials, 2417 women, RR 0.85 (95% CI 0.75 to 0.97), NNT 23 (13 to 111)). Again this reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.85 (95% CI 0.74 to 0.97), NNT 20 (11 to 110)). No differences were seen in the incidence of 1st or 2nd degree perineal tears or 3rd/4th degree perineal trauma. Only women who have previously birthed vaginally reported a statistically significant reduction in the incidence of pain at three months postpartum (one trial, 376 women, RR 0.68 (95% CI 0.50 to 0.91) NNT 13 (7 to 60)). No significant differences were observed in the incidence of instrumental deliveries, sexual satisfaction, or incontinence of urine, faeces or flatus for any women who practised perineal massage compared with those who did not massage. Antenatal perineal massage reduces the likelihood of perineal trauma (mainly episiotomies) and the reporting of ongoing perineal pain and is generally well accepted by women. As such, women should be made aware of the likely benefit of perineal massage and provided with information on how to massage.

Tube thorocostomy: management and outcome in patients with penetrating chest trauma.

PubMed

Muslim, Muhammad; Bilal, Amer; Salim, Muhammad; Khan, Muhammad Abid; Baseer, Abdul; Ahmed, Manzoor

2008-01-01

Penetrating chest trauma is common in this part of the world due to present situation in tribal areas. The first line of management after resuscitation in these patients is tube thoracostomy combined with analgesia and incentive spirometry. After tube thoracostomy following surgery or trauma there are two schools of thought one favours application of continuous low pressure suction to the chest tubes beyond the water seal while other are against it. We studied the application of continuous low pressure suction in patients with penetrating chest trauma. This Randomized clinical controlled trial was conducted in the department of thoracic surgery Post Graduate Medical Institute Lady Reading Hospital Peshawar from July 2007 to March 2008. The objectives of study were to evaluate the effectiveness of continuous low pressure suction in patients with penetrating chest trauma for evacuation of blood, expansion of lung and prevention of clotted Haemothorax. One hundred patients who underwent tube thoracostomy after penetrating chest trauma from fire arm injury or stab wounds were included in the study. Patients with multiple trauma, blunt chest trauma and those intubated for any pulmonary or pleural disease were excluded from the study. After resuscitation, detailed examination and necessary investigations patients were randomized to two groups. Group I included patients who had continuous low pressure suction applied to their chest drains. Group II included those patients whose chest drains were placed on water seal only. Lung expansion development of pneumothorax or clotted Haemothorax, time to removal of chest drain and hospital stay was noted in each group. There were fifty patients in each group. The two groups were not significantly different from each other regarding age, sex, pre-intubation haemoglobin and pre intubation nutritional status. Full lung expansion was achieved in forty six (92%) patients in group I and thirty seven (74%) in group II. Partial lung expansion or pneumothorax was present in three (60%) in group I and 10 (20%) in group II. One patient in group I and three (6%) patients in group II had no response. The mean time to removal of chest drains were 8.2 +/- 3.14 days in group I and 12.6 +/- 4.20 days in group II. The length of hospital stay was 7.2 +/- 2.07 days and 12.4 +/- 3.63 days in group I and II respectively. Clotted Haemothorax requiring surgery developed in three (6%) patients in group I and 8 (16%) patients in group II. Placing chest tubes on continuous low pressure suction after penetrating chest trauma helps evacuation of blood, expansion of lung and prevents the development of clotted Haemothorax. It also reduces the time to removal of chest drains, the hospital stay and the chances of surgery for clotted Haemothorax or Empyema.

Improving practice in community-based settings: a randomized trial of supervision – study protocol

PubMed Central

2013-01-01

Background Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes ‘gold standard’ supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. Methods/Design The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. Discussion This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. Trial registration ClinicalTrials.gov NCT01800266 PMID:23937766

Intimate partner violence outcomes in women with PTSD and substance use: a secondary analysis of NIDA Clinical Trials Network "Women and Trauma" Multi-site Study.

PubMed

Cohen, Lisa R; Field, Craig; Campbell, Aimee N C; Hien, Denise A

2013-07-01

Studies have shown strong associations between intimate partner violence (IPV) and both posttraumatic stress disorder (PTSD) and substance use disorders (SUD). Despite these linkages, research on the dual diagnosis of PTSD-SUD and its relationship to IPV is in an early stage, and little is known about how PTSD-SUD treatment might influence IPV outcomes. The current study is a secondary analysis of a larger NIDA Clinical Trials Network study exploring the effectiveness of two behavioral interventions for women with comorbid PTSD-SUD. Participants (n=288) were randomly assigned to Seeking Safety (SS), a cognitive-behavioral treatment that focuses on trauma and substance abuse symptoms, or to Women's Health Education, a psychoeducational group. Logistic regressions were used to examine how treatment condition, identified risk factors and their interactions were related to IPV. Results showed that participants who were abstinent at baseline were significantly less likely to experience IPV over the 12-month follow-up period, whereas participants living with someone with an alcohol problem were significantly more likely to experience IPV over follow-up. Findings also showed that at a trend level participants with recent interpersonal trauma at baseline and higher total of lifetime trauma exposures were more likely to report IPV during follow-up. Although there was no main effect for treatment condition, a significant interaction between treatment condition and baseline abstinence was found. Participants who were abstinent at baseline and in the SS condition were significantly less likely to report IPV over follow-up. These findings indicate that an integrated treatment for PTSD and SUD was associated with significantly better IPV outcomes for a subset of individuals. The possibility that women with PTSD-SUD may differentially benefit from SS has important clinical implications. Further research examining the intersection of PTSD, SUD and IPV, and the impact of treatment on a range of outcomes is needed. Copyright © 2013 Elsevier Ltd. All rights reserved.

The effect of active warming in prehospital trauma care during road and air ambulance transportation - a clinical randomized trial.

PubMed

Lundgren, Peter; Henriksson, Otto; Naredi, Peter; Björnstig, Ulf

2011-10-21

Prevention and treatment of hypothermia by active warming in prehospital trauma care is recommended but scientific evidence of its effectiveness in a clinical setting is scarce. The objective of this study was to evaluate the effect of additional active warming during road or air ambulance transportation of trauma patients. Patients were assigned to either passive warming with blankets or passive warming with blankets with the addition of an active warming intervention using a large chemical heat pad applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort and vital signs were monitored. Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5°C) to 36.0°C (95% CI; 35.7-36.3°C) (p < 0.05) in patients assigned to passive warming only (n = 22) and from 35.6°C (95% CI; 35.2-36.0°C) to 36.4°C (95% CI; 36.1-36.7°C) (p < 0.05) in patients assigned to additional active warming (n = 26) with no significant differences between the groups. Cold discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients assigned to additional active warming, the difference in cold discomfort change being statistically significant (p < 0.05). Patients assigned to additional active warming also presented a statistically significant decrease in heart rate and respiratory frequency (p < 0.05). In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive warming is an effective treatment to establish a slow rewarming rate and to reduce cold discomfort during prehospital transportation. However, the addition of active warming using a chemical heat pad applied to the torso will significantly improve thermal comfort even further and might also reduce the cold induced stress response. ClinicalTrials.gov: NCT01400152.

Effect of ARDS Severity and Etiology on Short-Term Outcomes.

PubMed

El-Haddad, Haitham; Jang, Hyejeong; Chen, Wei; Soubani, Ayman O

2017-09-01

We evaluated the outcome of subjects with ARDS in relation to etiology and severity in a retrospective cohort study of the ARDS Network randomized controlled trials. The primary outcome was 28-d mortality. The secondary outcomes were 60-d mortality and ventilator- and ICU-free days. For severity of ARDS, subjects were stratified according to P aO2 /F IO2 . The etiology of ARDS was classified into sepsis, pneumonia, aspiration, trauma, and others. A total of 2,914 subjects were included in these trials. Outcomes were modeled with multivariable regressions adjusted for baseline covariates, age, sex, race, Acute Physiology and Chronic Health Evaluation III (APACHE III), vasopressor use, modified lung injury score, diabetes mellitus, cancer status, body mass index, pre-ICU location, ICU location, and study. There was no statistically significant difference in 28-d mortality in relation to ARDS severity. Subjects with trauma, compared with other etiologies of ARDS, had significantly lower mortality at 28 d (odds ratio [OR] = 0.47, 95% CI 0.26-0.83, P = .01). Sixty-day mortality was significantly lower for trauma subjects and those with severe ARDS group (OR = 0.5, 95% CI 0.3-0.85, P = .01 and OR = 0.71, 95% CI 0.52-0.98, P = .034, respectively). There were statistically significantly more ICU-free days and ventilator-free days for the aspiration group (OR = 1.09, 95% CI 1.02-1.17, P = .01 and OR = 1.09, 95% CI 1.02-1.16, P = .01, respectively). There was no statistically significant difference in ICU-free days or ventilator-free days in relation to severity of ARDS. Severity of ARDS based on P aO2 /F IO2 did not impact 28-d mortality, ventilator-free days, or ICU-free days. Among the etiologies of ARDS, trauma subjects had the lowest 28- and 60-d mortality, whereas subjects with aspiration had more ICU-free days and ventilator-free days. Copyright © 2017 by Daedalus Enterprises.

Implementing the Bounce Back Trauma Intervention in Urban Elementary Schools: A Real-World Replication Trial

ERIC Educational Resources Information Center

Santiago, Catherine DeCarlo; Raviv, Tali; Ros, Anna Maria; Brewer, Stephanie K.; Distel, Laura M. L.; Torres, Stephanie A.; Fuller, Anne K.; Lewis, Krystal M.; Coyne, Claire A.; Cicchetti, Colleen; Langley, Audra K.

2018-01-01

The current study provides the first replication trial of Bounce Back, a school-based intervention for elementary students exposed to trauma, in a different school district and geographical area. Participants in this study were 52 1st through 4th graders (M[subscript age] = 7.76 years; 65% male) who were predominately Latino (82%). Schools were…

Analysis of Remote Trauma Transfers in South Central Texas with Comparison with Current US Combat Operations: Results of the RemTORN-I Study

DTIC Science & Technology

2013-01-01

product and procoagulant use by paramedical personnel, and clinical trials of freeze-dried plasma, tranexamic acid , and other intravascular...of administering tranexamic acid to bleeding trauma patients using evidence from the CRASH-2 trial. PLoS One. 2011;6(5):e18987. 3. Gonzalez RP

Patient-Reported Outcome Measures for Hand and Wrist Trauma: Is There Sufficient Evidence of Reliability, Validity, and Responsiveness?

PubMed

Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

2016-03-01

Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology.

The effect of uterine fundal pressure on the duration of the second stage of labor: a randomized controlled trial.

PubMed

Api, Olus; Balcin, Muge Emeksiz; Ugurel, Vedat; Api, Murat; Turan, Cem; Unal, Orhan

2009-01-01

To determine the effect of uterine fundal pressure on shortening the second stage of labor and on the fetal outcome. Randomized controlled trial. Teaching and research hospital. One hundred ninety-seven women between 37 and 42 gestational weeks with singleton cephalic presentation admitted to the delivery unit. Random allocation into groups with or without manual fundal pressure during the second stage of labor. The primary outcome measure was the duration of the second stage of labor. Secondary outcome measures were umbilical artery pH, HCO3-, base excess, pO2, pCO2 values and the rate of instrumental delivery, severe maternal morbidity/mortality, neonatal trauma, admission to neonatal intensive care unit, and neonatal death. There were no significant differences in the mean duration of the second stage of labor and secondary outcome measures except for mean pO2 which was lower and mean pCO2 which was higher in the fundal pressure group. Nevertheless, the values still remained within normal ranges and there were no neonates with an Apgar score <7 in either of the groups. Application of fundal pressure on a delivering woman was ineffective in shortening the second stage of labor.

Psychological therapies for children and adolescents exposed to trauma.

PubMed

Gillies, Donna; Maiocchi, Licia; Bhandari, Abhishta P; Taylor, Fiona; Gray, Carl; O'Brien, Louise

2016-10-11

Children and adolescents who have experienced trauma are at high risk of developing post-traumatic stress disorder (PTSD) and other negative emotional, behavioural and mental health outcomes, all of which are associated with high personal and health costs. A wide range of psychological treatments are used to prevent negative outcomes associated with trauma in children and adolescents. To assess the effects of psychological therapies in preventing PTSD and associated negative emotional, behavioural and mental health outcomes in children and adolescents who have undergone a traumatic event. We searched the Cochrane Common Mental Disorders Group's Specialised Register to 29 May 2015. This register contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We also checked reference lists of relevant studies and reviews. We did not restrict the searches by date, language or publication status. All randomised controlled trials of psychological therapies compared with a control such as treatment as usual, waiting list or no treatment, pharmacological therapy or other treatments in children or adolescents who had undergone a traumatic event. Two members of the review group independently extracted data. We calculated odds ratios for binary outcomes and standardised mean differences for continuous outcomes using a random-effects model. We analysed data as short-term (up to and including one month after therapy), medium-term (one month to one year after therapy) and long-term (one year or longer). Investigators included 6201 participants in the 51 included trials. Twenty studies included only children, two included only preschool children and ten only adolescents; all others included both children and adolescents. Participants were exposed to sexual abuse in 12 trials, to war or community violence in ten, to physical trauma and natural disaster in six each and to interpersonal violence in three; participants had suffered a life-threatening illness and had been physically abused or maltreated in one trial each. Participants in remaining trials were exposed to a range of traumas.Most trials compared a psychological therapy with a control such as treatment as usual, wait list or no treatment. Seventeen trials used cognitive-behavioural therapy (CBT); four used family therapy; three required debriefing; two trials each used eye movement desensitisation and reprocessing (EMDR), narrative therapy, psychoeducation and supportive therapy; and one trial each provided exposure and CBT plus narrative therapy. Eight trials compared CBT with supportive therapy, two compared CBT with EMDR and one trial each compared CBT with psychodynamic therapy, exposure plus supportive therapy with supportive therapy alone and narrative therapy plus CBT versus CBT alone. Four trials compared individual delivery of psychological therapy to a group model of the same therapy, and one compared CBT for children versus CBT for both mothers and children.The likelihood of being diagnosed with PTSD in children and adolescents who received a psychological therapy was significantly reduced compared to those who received no treatment, treatment as usual or were on a waiting list for up to a month following treatment (odds ratio (OR) 0.51, 95% confidence interval (CI) 0.34 to 0.77; number needed to treat for an additional beneficial outcome (NNTB) 6.25, 95% CI 3.70 to 16.67; five studies; 874 participants). However the overall quality of evidence for the diagnosis of PTSD was rated as very low. PTSD symptoms were also significantly reduced for a month after therapy (standardised mean difference (SMD) -0.42, 95% CI -0.61 to -0.24; 15 studies; 2051 participants) and the quality of evidence was rated as low. These effects of psychological therapies were not apparent over the longer term.CBT was found to be no more or less effective than EMDR and supportive therapy in reducing diagnosis of PTSD in the short term (OR 0.74, 95% CI 0.29 to 1.91; 2 studies; 160 participants), however this was considered very low quality evidence. For reduction of PTSD symptoms in the short term, there was a small effect favouring CBT over EMDR, play therapy and supportive therapies (SMD -0.24, 95% CI -0.42 to -0.05; 7 studies; 466 participants). The quality of evidence for this outcome was rated as moderate.We did not identify any studies that compared pharmacological therapies with psychological therapies. The meta-analyses in this review provide some evidence for the effectiveness of psychological therapies in prevention of PTSD and reduction of symptoms in children and adolescents exposed to trauma for up to a month. However, our confidence in these findings is limited by the quality of the included studies and by substantial heterogeneity between studies. Much more evidence is needed to demonstrate the relative effectiveness of different psychological therapies for children exposed to trauma, particularly over the longer term. High-quality studies should be conducted to compare these therapies.

Comparison of the Effects of Lanolin, Peppermint, and Dexpanthenol Creams on Treatment of Traumatic Nipples in Breastfeeding Mothers

PubMed Central

Shanazi, Mahnaz; Farshbaf Khalili, Azizeh; Kamalifard, Mahin; Asghari Jafarabadi, Mohammad; Masoudin, Kazhal; Esmaeli, Fariba

2015-01-01

Introduction: Traumatic nipple is among the most common problems of the breastfeeding period which leads to early cessation of breastfeeding. The study aimed to compare the effects of the lanolin, peppermint, and dexpanthenol creams on the treatment of traumatic nipples. Methods: This double-blind randomized controlled trial was carried out on 126 breastfeeding mothers. The mothers had visited at the health centers and children’s hospitals in Sanandaj City. The selected participants were randomly divided into the following three groups of lanolin, peppermint, and dexpanthenol cream groups. Nipple pain was measured using the Store scale while trauma was measured with the Champion scale. Analyses were carried out through the Kruskal–Wallis test, Chi-square, ANOVA, and repeated measures ANOVA by using SPSS software ver. 13. Results: The result showed that the mean score of nipple pain and nipple trauma at the prior to intervention stage, third, seventh, and fourteenth days of intervention was not significantly different between three groups. But, repeated measures ANOVA showed a significant difference in comparison of the four time periods of intervention in each group. Conclusion: Results of this study revealed that the lanolin, peppermint, and dexpanthenol medicines had similar therapeutic effects on traumatic nipple. PMID:26744729

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).

PubMed

OʼToole, Robert V; Joshi, Manjari; Carlini, Anthony R; Sikorski, Robert A; Dagal, Armagan; Murray, Clinton K; Weaver, Michael J; Paryavi, Ebrahim; Stall, Alec C; Scharfstein, Daniel O; Agel, Julie; Zadnik, Mary; Bosse, Michael J; Castillo, Renan C

2017-04-01

Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.

Pilot trial of an expressive writing intervention with HIV-positive methamphetamine-using men who have sex with men.

PubMed

Carrico, Adam W; Nation, Austin; Gómez, Walter; Sundberg, Jeffrey; Dilworth, Samantha E; Johnson, Mallory O; Moskowitz, Judith T; Rose, Carol Dawson

2015-06-01

Among men who have sex with men (MSM), the co-occurrence of trauma and stimulant use has negative implications for HIV/AIDS prevention. HIV-positive, methamphetamine-using MSM were recruited to pilot test a 7-session, multicomponent resilient affective processing (RAP) intervention that included expressive writing exercises targeting HIV-related traumatic stress. An open-phase pilot with 10 participants provided support for feasibility of intervention delivery such that 99% of the RAP sessions were completed in a 1-month period. Subsequently, 23 additional participants were enrolled in a pilot randomized controlled trial of the RAP intervention (n = 12) versus an attention-control condition that included writing exercises about neutral topics (n = 11). Acceptability was evidenced by participants randomized to RAP expressing significantly more negative emotions in their writing and reporting greater likelihood of recommending expressive writing exercises to a friend living with HIV. Over the 3-month follow-up period, attention-control participants reported significant decreases in HIV-related traumatic stress while RAP intervention participants reported no significant changes. Compared to attention-control participants, those in the RAP intervention reported significant reductions in the frequency of methamphetamine use immediately following the 1-month RAP intervention period. Thematic analyses of RAP expressive writing exercises revealed that multiple negative life events characterized by social stigma or loss contribute to the complex nature of HIV-related traumatic stress. Findings support the feasibility and acceptability of an exposure-based intervention targeting HIV-related traumatic stress. However, more intensive intervention approaches that simultaneously target trauma and stimulant use will likely be needed to optimize HIV/AIDS prevention efforts with this population. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Cost-Effectiveness Analysis of Trauma-Focused Cognitive Behavioral Therapy: A Randomized Control Trial among Norwegian Youth.

PubMed

Aas, Eline; Iversen, Tor; Holt, Tonje; Ormhaug, Silje M; Jensen, Tine K

2018-06-07

Traumatic events by young people can adversely affect their psychological and social well-being when left untreated. This can result in high costs for society. In this study, we aimed to evaluate whether trauma-focused cognitive behavioral therapy (TF-CBT) is a cost-effective alternative to therapy as usual (TAU). Individual-level data were collected from 2008 to 2013, as part of a randomized control trial in Norwegian youth, 10-18 years of age, presenting with symptoms of posttraumatic stress (N = 156). Health outcomes, costs, and patient and family characteristics were recorded. Health-related quality of life (HRQoL) was measured with the 16D instrument, and quality-adjusted life-years (QALYs) were derived; total costs included the costs of therapy, and last we calculated the incremental cost-effectiveness ratio (ratio of differences in costs and QALYs gained). We performed nonparametric bootstrapping and used the results to draw a cost-effectiveness acceptability curve depicting the probability that TF-CBT is cost-effective. HRQoL increased in both treatment groups, whereas no significant differences in QALYs were observed. Resource use measured in minutes per session was significantly higher in the TF-CBT group; however, total minutes of therapy and costs were not significantly different between the two groups. In addition, use of resources, such as psychological counseling services, welfare services, and medication, was lower in the TF-CBT group posttreatment. The likelihood of TF-CBT being cost-effective varied from 91% to 96%. TF-CBT is likely to be a cost-effective alternative to standard treatment and should be recommended as the guideline treatment for youth with posttraumatic stress disorder.

Cognitive restructuring and imagery modification for posttraumatic stress disorder (CRIM-PTSD): A pilot study.

PubMed

Müller-Engelmann, Meike; Steil, Regina

2017-03-01

Cognitive restructuring and imagery modification for PTSD (CRIM-PTSD) is a new short intervention. It consists of the cognitive restructuring of core trauma-related dysfunctional beliefs about the self and the use of imagery to encourage more functional beliefs. A randomized controlled trial showed that CRIM was effective for reducing posttraumatic stress disorder (PTSD) in survivors of childhood sexual abuse (CSA) when it focused on the feeling of being contaminated. For this study, CRIM was adapted to treat PTSD symptoms more generally and after various types of trauma by addressing the patients' negative self-concept. Ten patients with PTSD received two assessment sessions, two treatment sessions, and a booster session. The Clinician-Administered PTSD Scale (CAPS) was administered prior to and four weeks after treatment. Self-ratings, e.g., the Posttraumatic Diagnostic Scale (PDS) and the Posttraumatic Cognitions Inventory (PTCI), were administered at baseline, immediately posttreatment, and four weeks after treatment. The participants showed significant improvements in both clinician-rated (d = 2.55; p < 0.01) and self-reported PTSD symptoms (d = 1.47; p < 0.01). One month after treatment, 9 patients no longer fully met the diagnostic criteria for PTSD. The results are limited by the small sample size and the lack of a control group. This pilot study suggests that addressing the negative self-concept of PTSD patients using a combination of cognitive techniques and imagery modification can effectively reduce PTSD symptoms. Further research is needed to assess the treatment's effects and stability in a randomized controlled trial. Copyright © 2016 Elsevier Ltd. All rights reserved.

Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3-4: A Multi-Center, Randomized Controlled Trial.

PubMed

Hifumi, Toru; Kuroda, Yasuhiro; Kawakita, Kenya; Yamashita, Susumu; Oda, Yasutaka; Dohi, Kenji; Maekawa, Tsuyoshi

2016-06-01

In our prospective, multi-center, randomized controlled trial (RCT)-the Brain Hypothermia (B-HYPO) study-we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3-4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3-4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3-4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3-4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3-4).

Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3–4: A Multi-Center, Randomized Controlled Trial

PubMed Central

Kuroda, Yasuhiro; Kawakita, Kenya; Yamashita, Susumu; Oda, Yasutaka; Dohi, Kenji; Maekawa, Tsuyoshi

2016-01-01

Abstract In our prospective, multi-center, randomized controlled trial (RCT)—the Brain Hypothermia (B-HYPO) study—we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3–4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3–4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3–4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3–4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3–4). PMID:26413933

Impact of Interactive e-Learning Modules on Appropriateness of Imaging Referrals: A Multicenter, Randomized, Crossover Study.

PubMed

Velan, Gary M; Goergen, Stacy K; Grimm, Jane; Shulruf, Boaz

2015-11-01

Health care expenditure on diagnostic imaging investigations is increasing, and many tests are ordered inappropriately. Validated clinical decision rules (CDRs) for certain conditions are available to aid in assessing the need for imaging. However, awareness and utilization of CDRs are lacking. This study compared the efficacy and perceived impact of interactive e-learning modules versus static versions of CDRs, for learning about appropriate imaging referrals. A multicenter, randomized, crossover trial was performed; participants were volunteer medical students and recent graduates. In week 1, group 1 received an e-learning module on appropriate imaging referrals for pulmonary embolism; group 2 received PDF versions of relevant CDRs, and an online quiz with feedback. In week 2, the groups crossed over, focusing on imaging referrals for cervical spine trauma in adults. Online assessments were administered to both groups at the end of each week, and participants completed an online questionnaire at the end of the trial. Group 1 (e-learning module) performed significantly better on the pulmonary embolism knowledge assessment. After the crossover, participants in group 2 (e-learning module) were significantly more likely to improve their scores in the assessment of cervical spine trauma knowledge. Both groups gave positive evaluations of the e-learning modules. Interactive e-learning was significantly more effective for learning in this cohort, compared with static CDRs. We believe that the authentic clinical scenarios, feedback, and integration provided by the e-learning modules contributed to their impact. This study has implications for implementation of e-learning tools to facilitate appropriate referrals for imaging investigations in clinical practice. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

Betrayal trauma: relationship to physical health, psychological distress, and a written disclosure intervention.

PubMed

Freyd, Jennifer J; Klest, Bridget; Allard, Carolyn B

2005-01-01

In the current study we sought, first, to distinguish associations with health arising from types of trauma as indicated by betrayal trauma theory (Freyd, 1996, 2001), and, second, to investigate the impact of disclosing a trauma history in survey form and/or writing essays about betrayal traumas. We recruited 99 community adults reporting at least 12 months of chronic medical illness or pain, 80 of whom completed all four sessions of this six-month longitudinal intervention study. Participants were randomly assigned to write about betrayal traumas or neutral events, and they were randomly assigned to complete an extensive trauma survey or a long personality inventory, producing four groups of participants. All 99 participants were assessed at their initial visit for trauma history using the Brief Betrayal Trauma Survey (BBTS) and physical and mental symptoms. The BBTS assesses exposure to both traumas high in betrayal (such as abuse by a close other) and traumas low in betrayal but high in life-threat (such as an automobile accident). Exposure to traumas with high betrayal was significantly correlated with number of physical illness, anxiety, dissociation, and depression symptoms. Amount of exposure to other types of traumas (low betrayal traumas) did not predict symptoms over and above exposure to betrayal trauma. While neither the survey manipulation nor the writing intervention led to main effects on change in symptoms over time, there were interactions between betrayal trauma history and condition such that participants with many betrayal traumas fared better in the control conditions while participants with fewer betrayal traumas had better outcomes if they were placed in the trauma writing and/or survey conditions. We discuss ongoing and future research aimed at evaluating the role of increased structure in writing assignments as beneficial for those with severe histories of betrayal trauma.

Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial.

PubMed

Wald, I; Fruchter, E; Ginat, K; Stolin, E; Dagan, D; Bliese, P D; Quartana, P J; Sipos, M L; Pine, D S; Bar-Haim, Y

2016-09-01

Efficacy of pre-trauma prevention for post-traumatic stress disorder (PTSD) has not yet been established in a randomized controlled trial. Attention bias modification training (ABMT), a computerized intervention, is thought to mitigate stress-related symptoms by targeting disruptions in threat monitoring. We examined the efficacy of ABMT delivered before combat in mitigating risk for PTSD following combat. We conducted a double-blind, four-arm randomized controlled trial of 719 infantry soldiers to compare the efficacy of eight sessions of ABMT (n = 179), four sessions of ABMT (n = 184), four sessions of attention control training (ACT; n = 180), or no-training control (n = 176). Outcome symptoms were measured at baseline, 6-month follow-up, 10 days following combat exposure, and 4 months following combat. Primary outcome was PTSD prevalence 4 months post-combat determined in a clinical interview using the Clinician-Administered PTSD Scale. Secondary outcomes were self-reported PTSD and depression symptoms, collected at all four assessments. PTSD prevalence 4 months post-combat was 7.8% in the no-training control group, 6.7% with eight-session ABMT, 2.6% with four-session ABMT, and 5% with ACT. Four sessions of ABMT reduced risk for PTSD relative to the no-training condition (odds ratio 3.13, 95% confidence interval 1.01-9.22, p < 0.05, number needed to treat = 19.2). No other between-group differences were found. The results were consistent across a variety of analytic techniques and data imputation approaches. Four sessions of ABMT, delivered prior to combat deployment, mitigated PTSD risk following combat exposure. Given its low cost and high scalability potential, and observed number needed to treat, research into larger-scale applications is warranted. The ClinicalTrials.gov identifier is NCT01723215.

Stress as a seizure precipitant: Identification, associated factors, and treatment options.

PubMed

McKee, Heather R; Privitera, Michael D

2017-01-01

Stress is a common and important seizure precipitant reported by epilepsy patients. Studies to date have used different methodologies to identify relationships between epilepsy and stress. Several studies have identified anxiety, depression, and childhood trauma as being more common in patients with epilepsy who report stress as a seizure precipitant compared to patients with epilepsy who did not identify stress as a seizure precipitant. In one survey study it was found that a majority of patients with stress-triggered seizures had used some type of stress reduction method on their own and, of those who tried this, an even larger majority felt that these methods improved their seizures. Additionally, small to moderate sized prospective trials, including randomized clinical trials, using general stress reduction methods have shown promise in improving outcomes in patients with epilepsy, but results on seizure frequency have been inconsistent. Based on these studies, we recommend that when clinicians encounter patients who report stress as a seizure precipitant, these patients should be screened for a treatable mood disorder. Furthermore, although seizure reduction with stress reduction methods has not been proven in a randomized controlled trial, other important endpoints like quality of life were improved. Therefore, recommending stress reduction methods to patients with epilepsy appears to be a reasonable low risk adjunctive to standard treatments. The current review highlights the need for future research to help further clarify biological mechanisms of the stress-seizure relationship and emphasizes the need for larger randomized controlled trials to help develop evidence based treatment recommendations for our epilepsy patients. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Cumulative trauma disorders: A review.

PubMed

Iqbal, Zaheen A; Alghadir, Ahmad H

2017-08-03

Cumulative trauma disorder (CTD) is a term for various injuries of the musculoskeletal and nervous systems that are caused by repetitive tasks, forceful exertions, vibrations, mechanical compression or sustained postures. Although there are many studies citing incidence of CTDs, there are fewer articles about its etiology, pathology and management. The aim of our study was to discuss the etiology, pathogenesis, prevention and management of CTDs. A literature search was performed using various electronic databases. The search was limited to articles in English language pertaining to randomized clinical trials, cohort studies and systematic reviews of CTDs. A total of 180 papers were identified to be relevant published since 1959. Out of these, 125 papers reported about its incidence and 50 about its conservative treatment. Workplace environment, same task repeatability and little variability, decreased time for rest, increase in expectations are major factors for developing CTDs. Prevention of its etiology and early diagnosis can be the best to decrease its incidence and severity. For effective management of CTDs, its treatment should be divided into Primordial, Primary, Secondary and Tertiary prevention.

Formative Evaluation: A Case Study of the Illinois Birth-to-Three IV-E Waiver.

PubMed

Rolock, Nancy; Snyder, Susan M; Tate, Cynthia

2015-01-01

Few interventions addressing early childhood trauma have adequate evidence. The Illinois Birth-to-Three Waiver is a 5-year federal project to reduce trauma and increase permanency for young children. In this article the authors describe the explorative and formative phases, including: (a) developing a well-built research question; (b) working with purveyors of evidence-supported interventions (ESIs); (c) adapting ESIs to a large public child welfare system; (d) developing fidelity measures, assessment data and outcomes; and (e) managing the challenges of implementing a randomized controlled trial. Public and private agency staff work in conjunction with university partners to merge implementation science, program evaluation, and intervention research. The project's theory of change stipulates that working with the triad of birth parent(s), foster parent(s), and focal child is critical to achieving project outcomes. The authors articulate the importance of working closely with an interdisciplinary team to achieve these outcomes, and the challenges associated with the early stages of implementation.

Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem. Methods/Design This is a single centre study conducted at Queen’s Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr−1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score). Discussion Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration. Trial registration The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011). ISRCTN: ISRCTN92946117. Registered 26 October 2012. PMID:24885267

Cognitive processing therapy versus supportive counseling for acute stress disorder following assault: a randomized pilot trial.

PubMed

Nixon, Reginald D V

2012-12-01

The study tested the efficacy and tolerability of cognitive processing therapy (CPT) for survivors of assault with acute stress disorder. Participants (N=30) were randomly allocated to CPT or supportive counseling. Therapy comprised six individual weekly sessions of 90-min duration. Independent diagnostic assessment for PTSD was conducted at posttreatment. Participants completed self-report measures of posttraumatic stress, depression, and negative trauma-related beliefs at pre-, posttreatment, and 6-month follow-up. Results indicated that both interventions were successful in reducing symptoms at posttreatment with no statistical difference between the two; within and between-group effect sizes and the proportion of participants not meeting PTSD criteria was greater in CPT. Treatment gains were maintained for both groups at 6-month follow-up. Copyright © 2012. Published by Elsevier Ltd.

Physiological Predictors of Response to Exposure, Relaxation, and Rescripting Therapy for Chronic Nightmares in a Randomized Clinical Trial

PubMed Central

Davis, Joanne L.; Rhudy, Jamie L.; Pruiksma, Kristi E.; Byrd, Patricia; Williams, Amy E.; McCabe, Klanci M.; Bartley, Emily J.

2011-01-01

Study Objectives: Evidence supports the use of cognitive behavioral therapies for nightmares in trauma-exposed individuals. This randomized clinical trial replicated a study of exposure, relaxation, and rescripting therapy(ERRT) and extended prior research by including broad measures of mental health difficulties, self-reported physical health problems, and quality of life. Additionally, physiological correlates of treatment-related change assessed from a script-driven imagery paradigm were examined. Methods: Forty-seven individuals were randomized to treatment or waitlist control. Results: The treatment group demonstrated improvements relative to the control group at the one-week post-treatment assessment. At the 6-month follow-up assessment, significant improvements were found for frequency and severity of nightmares, posttraumatic stress disorder symptoms, depression, sleep quality and quantity, physical health symptoms, anger, dissociation, and tension reduction behaviors. Participants also reported improved quality of life. Treatment-related decreases in heart rate to nightmare imagery were correlated with improvements in sleep quality and quantity; treatment-related decreases in skin conductance to nightmare imagery were correlated with improvements in nightmare severity, posttraumatic stress disorder symptom severity, sleep quality, and fear of sleep; and treatment-related decreases in corrugator activity to nightmare imagery were correlated with improved physical health. Conclusions: Findings provide additional support for the use of ERRT in treating nightmares and related difficulties and improving sleep. Citation: Davis JL; Rhudy JL; Pruiksma KE; Byrd P; Williams AE; McCabe KM; Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med 2011;7(6):622-631. PMID:22171201

Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

PubMed

Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

2014-06-01

Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and depressive symptoms, occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention. Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization. Future investigation should replicate this preliminary observation. If the finding is replicated, orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers. clinicaltrials.gov identifier: NCT00619255.

Compelled attention: the effects of viewing trauma-related stimuli on concurrent task performance in posttraumatic stress disorder.

PubMed

Chemtob, C M; Roitblat, H L; Hamada, R S; Muraoka, M Y; Carlson, J G; Bauer, G B

1999-04-01

We examined the ability of Vietnam veterans with PTSD to focus attention on a primary digit detection task while concurrently viewing neutral or Vietnam-related picture and word distractors. Controlling for combat exposure, military service, and psychopathology, veterans with PTSD took longer to detect the target when Vietnam-related pictures were distractors. There were no reaction time differences when word stimuli were distractors. The latency effect was specific to trials with trauma-related pictures and did not spread to neutral trials interleaved within a mixed block of trauma and neutral pictures. Individuals with PTSD recalled proportionally more Vietnam-related words than other groups, implying differential attention to Vietnam-related words. Attending to trauma-related pictures interferes with performance of a concurrent task by individuals with PTSD.

Medical interventions for traumatic hyphema

PubMed Central

Gharaibeh, Almutez; Savage, Howard I; Scherer, Roberta W; Goldberg, Morton F; Lindsley, Kristina

2012-01-01

Background Traumatic hyphema is the entry of blood into the anterior chamber (the space between the cornea and iris) subsequent to a blow or a projectile striking the eye. Hyphema uncommonly causes permanent loss of vision. Associated trauma (e.g., corneal staining, traumatic cataract, angle recession glaucoma, optic atrophy, etc.) may seriously affect vision. Such complications may lead to permanent impairment of vision. Patients with sickle cell trait/disease may be particularly susceptible to increases of elevated intraocular pressure. If rebleeding occurs, the rates and severity of complications increase. Objectives The objective of this review was to assess the effectiveness of various medical interventions in the management of traumatic hyphema. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 6), MEDLINE (January 1950 to June 2010), EMBASE (January 1980 to June 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (http://clinicaltrials.gov). We searched the reference lists of identified trial reports to find additional trials. We also searched the ISI Web of Science Social Sciences Citation Index (SSCI) to find studies that cited the identified trials. There were no language or date restrictions in the search for trials. The electronic databases were last searched on 25 June 2010. Selection criteria Two authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. In this review, we included randomized and quasi-randomized trials that compared various medical interventions to other medical interventions or control groups for the treatment of traumatic hyphema following closed globe trauma. There were no restrictions regarding age, gender, severity of the closed globe trauma or level of visual acuity at the time of enrollment. Data collection and analysis Two authors independently extracted the data for the primary and secondary outcomes. We entered and analyzed data using Review Manager (RevMan) 5. We performed meta-analyses using a fixed-effect model and reported dichotomous outcomes as odds ratios and continuous outcomes as mean differences. Main results Nineteen randomized and seven quasi-randomized studies with 2,560 participants were included in this review. Interventions included antifibrinolytic agents (oral and systemic aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, monocular versus bilateral patching, elevation of the head, and bed rest. No intervention had a significant effect on visual acuity whether measured at two weeks or less after the trauma or at longer time periods. The number of days for the primary hyphema to resolve appeared to be longer with the use of aminocaproic acid compared to no use, but was not altered by any other intervention. Systemic aminocaproic acid reduced the rate of recurrent hemorrhage (odds ratio (OR) 0.25, 95% confidence interval (CI) 0.11 to 0.5), but a sensitivity analysis omitting studies not using an intention-to-treat (ITT) analysis reduced the strength of the evidence (OR 0.41, 95% CI 0.16 to 1.09). We obtained similar results for topical aminocaproic acid (OR 0.42, 95% CI 0.16 to 1.10). We found tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (OR 0.25, 95% CI 0.13 to 0.49), as did aminomethylbenzoic acid as reported in a single study (OR 0.07, 95% CI 0.01 to 0.32). The evidence to support an associated reduction in the risk of complications from secondary hemorrhage (i.e., corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compares with placebo. We found no difference in the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose. The available evidence on usage of corticosteroids, cycloplegics or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials. We found no difference in effect between a single versus binocular patch nor ambulation versus complete bed rest on the risk of secondary hemorrhage or time to rebleed. Authors’ conclusions Traumatic hyphema in the absence of other intraocular injuries, uncommonly leads to permanent loss of vision. Complications resulting from secondary hemorrhage could lead to permanent impairment of vision, especially in patients with sickle cell trait/disease. We found no evidence to show an effect on visual acuity by any of the interventions evaluated in this review. Although evidence is limited, it appears that patients with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhaging. However, hyphema in patients on aminocaproic acid take longer to clear. Other than the possible benefits of antifibrinolytic usage to reduce the rate of secondary hemorrhage, the decision to use corticosteroids, cycloplegics, or non-drug interventions (such as binocular patching, bed rest, or head elevation) should remain individualized because no solid scientific evidence supports a benefit. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value. PMID:21249670

Subjective safety and self-confidence in prehospital trauma care and learning progress after trauma-courses: part of the prospective longitudinal mixed-methods EPPTC-trial.

PubMed

Häske, David; Beckers, Stefan K; Hofmann, Marzellus; Lefering, Rolf; Grützner, Paul A; Stöckle, Ulrich; Papathanassiou, Vassilios; Münzberg, Matthias

2017-08-14

Prehospital trauma care is stressful and requires multi-professional teamwork. A decrease in the number of accident victims ultimately affects the routine and skills and underlines the importance of effective training. Standardized courses, like PHTLS, are established for health care professionals to improve the prehospital care of trauma patients. The aim of the study was to investigate the subjective safety in prehospital trauma care and learning progress by paramedics in a longitudinal analysis. This was a prospective intervention trial and part of the mixed-method longitudinal EPPTC-trial, evaluating subjective and objective changes among participants and real patient care as a result of PHTLS courses. Participants were evaluated with pre/post questionnaires as well as one year after the course. We included 236 datasets. In the pre/post comparison, an increased performance could be observed in nearly all cases. The result shows that the expectations of the participants of the course were fully met even after one year (p = 0.002). The subjective safety in trauma care is significantly better even one year after the course (p < 0.001). Regression analysis showed that (ABCDE)-structure is decisive (p = 0.036) as well as safety in rare and common skills (both p < 0.001). Most skills are also rated better after one year. Knowledge and specific safety are assessed as worse after one year. The courses meet the expectations of the participants and increase the subjective safety in the prehospital care of trauma patients. ABCDE-structure and safety in skills are crucial. In the short term, both safety in skills and knowledge can be increased, but the courses do not have the power to maintain knowledge and specific subjective safety issues over a year. German Clinical Trials Register, ID DRKS00004713 , registered 14. February 2014.

Vicarious Trauma: Predictors of Clinicians' Disrupted Cognitions about Self-Esteem and Self-Intimacy

ERIC Educational Resources Information Center

Way, Ineke; VanDeusen, Karen; Cottrell, Tom

2007-01-01

This study examined vicarious trauma in clinicians who provide sexual abuse treatment (N = 383). A random sample of clinical members from the Association for the Treatment of Sexual Abusers and American Professional Society on the Abuse of Children were surveyed. Vicarious trauma was measured using the Trauma Stress Institute Belief Scale…

Universal Screening for Intimate Partner and Sexual Violence in Trauma Patients - What About the Men? An EAST Multicenter Trial.

PubMed

Zakrison, Tanya L; Rattan, Rishi; Milian Valdés, Davel; Ruiz, Xiomara; Gelbard, Rondi; Cline, John; Turay, David; Luo-Owen, Xian; Namias, Nicholas; George, Jessica; Yeh, Dante; Pust, Daniel; Williams, Brian H

2018-02-14

A recent EAST-supported, multicenter trial demonstrated a similar rate of intimate partner and sexual violence (IPSV) between male and female trauma patients, regardless of mechanism. Our objective was to perform a subgroup analysis of our affected male cohort as this remains an understudied group in the trauma literature. We conducted a recent EAST-supported, cross-sectional, multicenter trial over one year (03/15-04/16) involving four Level I trauma centers throughout the United States. We performed universal screening of adult trauma patients using the validated HITS (Hurt, Insult, Threaten, Scream) and SAVE (sexual violence) screening surveys. Risk factors for male patients were identified. Chi-squared test compared categorical variables with significance at p<0.05. Parametric data is presented as mean +/-standard deviation. A total of 2,034 trauma patients were screened, of which 1,281 (63%) were men. Of this cohort, 119 men (9.3%) screened positive for intimate partner violence, 14.1% for IPSV and 6.5% for sexual violence. On categorical analysis of the HITS screen, the proportion of men that were physically hurt was 4.8% compared to 4.3% for women (p = 0.896). A total of 4.8% of men screened positive for both intimate partner and sexual violence. The total proportion of men who presented with any history of intimate partner violence, sexual violence or both (IPSV) was 15.8%. More men affected by penetrating trauma screened positive for IPSV (p < 0.00001). IPSV positivity in men was associated with mental illness, substance abuse, and trauma recidivism. One out of every twenty men that present to trauma centers is a survivor of both intimate partner and sexual violence, with one out of every six men experiencing some form of violence. Men are at similar risk for physical abuse as women when this intimate partner violence occurs. IPSV is associated with penetrating trauma in men. Support programs for this population may potentially impact associated mental illness, substance abuse, trauma recidivism and even societal-level violence. III STUDY TYPE: Diagnostic.

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

PubMed

de Bont, Paul A J M; van den Berg, David P G; van der Vleugel, Berber M; de Roos, Carlijn; Mulder, Cornelis L; Becker, Eni S; de Jongh, Ad; van der Gaag, Mark; van Minnen, Agnes

2013-05-23

Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. Trial registration: ISRCTN79584912.

Bending without breaking: A narrative review of trauma-sensitive yoga for women with PTSD.

PubMed

Nolan, Caitlin R

2016-08-01

The purpose of this review is to evaluate the peer-reviewed empirical evidence on the use of Trauma-Sensitive Yoga (TSY) for the treatment of women with post-traumatic stress disorder (PTSD): specifically interpersonal trauma such as intimate partner violence. To date, no such review has been conducted. Articles meeting study inclusionary criteria were identified through electronic database searches. A total of five studies (N = 5) were selected and reviewed. These studies included two randomized controlled trials (RCT), one follow-up of an RCT, one quasi-experimental study, and one qualitative study. There is tentative evidence to support the efficacy of TSY in reducing PTSD, depression, and anxiety symptomatology for women with PTSD; there is also tentative evidence confirming the feasibility of implementing TSY as an adjunctive mental health intervention, particularly for individuals who are non-responsive to cognitive-based psychotherapies. The qualitative findings speak to a number of benefits of yoga practice stimulated by TSY participation centering on the phenomenon of peaceful embodiment. Replication of these results using larger and more diverse samples and rigorous study designs by independent researchers would add credibility to these findings and contribute to the growing body of knowledge on TSY. Additionally, there is a dearth of studies on this nascent form of therapeutic yoga. Therefore, further research is needed to explore the potential efficacy of TSY with other types of trauma, populations, and settings. Copyright © 2016 Elsevier Ltd. All rights reserved.

A pilot study of modified cognitive-behavioral therapy for childhood traumatic grief (CBT-CTG).

PubMed

Cohen, Judith A; Mannarino, Anthony P; Staron, Virginia R

2006-12-01

This pilot study evaluated outcomes for a modified 12-session protocol of cognitive-behavioral therapy for childhood traumatic grief (CBT-CTG) conducted between March 2004 and October 2005. CTG is an emerging condition characterized by a combination of posttraumatic stress and unresolved grief symptoms. This two-module treatment model consisting of sequential trauma- and grief-focused components was shortened from a previously presented 16-session protocol. Thirty-nine children ages 6 to 17 years old with CTG and their parents received the modified 12-session protocol of CBT-CTG. CTG and posttraumatic stress disorder (PTSD) symptoms were assessed at pretreatment, after the trauma-focused module, and after the grief-focused module (at posttreatment). Child depression, anxiety, and behavioral symptoms, as well as parental depression and PTSD symptoms, were assessed at pre- and posttreatment. Children reported significant improvement in CTG, PTSD, depression, and anxiety, and parents reported significant improvement in children's PTSD, internalizing and total behavior problems, and their personal PTSD symptoms. Although PTSD significantly improved only during the trauma-focused module of treatment, CTG improved significantly during both trauma- and grief-focused modules of treatment. Child satisfaction and parent satisfaction for this treatment protocol were also high. These findings suggest that the shortened CBT-CTG protocol, which is similar in the number of sessions to what many community child bereavement programs offer, may be acceptable and efficacious for this population. The CBT-CTG model requires further evaluation in randomized, controlled treatment trials.

Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial

PubMed Central

Carver, David A; Bressan, Alexsander K; Schieman, Colin; Grondin, Sean C; Kirkpatrick, Andrew W; Lall, Rohan; McBeth, Paul B; Dunham, Michael B; Ball, Chad G

2018-01-01

Introduction Haemothorax following blunt thoracic trauma is a common source of morbidity and mortality. The optimal management of moderate to large haemothoraces has yet to be defined. Observational data have suggested that expectant management may be an appropriate strategy in stable patients. This study aims to compare the outcomes of patients with haemothoraces following blunt thoracic trauma treated with either chest drainage or expectant management. Methods and analysis This is a single-centre, dual-arm randomised controlled trial. Patients presenting with a moderate to large sized haemothorax following blunt thoracic trauma will be assessed for eligibility. Eligible patients will then undergo an informed consent process followed by randomisation to either (1) chest drainage (tube thoracostomy) or (2) expectant management. These groups will be compared for the rate of additional thoracic interventions, major thoracic complications, length of stay and mortality. Ethics and dissemination This study has been approved by the institution’s research ethics board and registered with ClinicalTrials.gov. All eligible participants will provide informed consent prior to randomisation. The results of this study may provide guidance in an area where there remains significant variation between clinicians. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number NCT03050502. PMID:29502092

Study participant reported outcomes of mental health interventions: results from a randomized controlled trial among survivors of systematic violence in southern Iraq.

PubMed

Mahmooth, Z; Weiss, W M; Zangana, G A S; Bolton, P

2018-01-01

Common mental health problems experienced by survivors of systematic violence include trauma, depression, and anxiety. A trial of mental health interventions by community mental health workers for survivors of systematic violence in southern Iraq showed benefits from two psychotherapies on trauma, depression, anxiety, and function: Common Elements Treatment Approach (CETA) and cognitive processing therapy (CPT). This study assessed whether other non-predetermined changes reported by intervention participants were more common than in the control group. The trial involved 342 participants (CETA: 99 intervention, 50 control; CPT: 129 intervention, 64 control). Sixteen intervention-related changes since enrollment were identified from free-listing interviews of 15 early therapy completers. The changes were then added as a new quantitative module to the follow-up questionnaire. The changes were organized into eight groupings by thematic analysis - family, social standing, anger management, interest in regular activities, optimism, feeling close to God, avoiding smoking and drugs, and physical health. All participants were interviewed with this module and responses were compared between intervention and control participants. Multi-level, multi-variate regression models showed CETA intervention subjects with significant, positive changes relative to CETA controls on most themes. CPT intervention subjects showed little to no change compared with CPT controls in most themes. Participants receiving CETA reported more positive changes from therapy compared with controls than did participants receiving CPT. This study suggests differential effects of psychotherapy beyond the predetermined clinical outcome measures and that identification of these effects should be part of intervention evaluations.

Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures

ClinicalTrials.gov

2017-10-06

Drug Effect; Rib Fractures; Rib Trauma; Surgical Procedure, Unspecified; Pain; Catheter (Other); Nerve Pain; Local Infiltration; Anesthesia, Local; Intercostal Rib; Opioid Dependence; Chest Injury Trauma; Pneumonia

Improving practice in community-based settings: a randomized trial of supervision - study protocol.

PubMed

Dorsey, Shannon; Pullmann, Michael D; Deblinger, Esther; Berliner, Lucy; Kerns, Suzanne E; Thompson, Kelly; Unützer, Jürgen; Weisz, John R; Garland, Ann F

2013-08-10

Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes 'gold standard' supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. ClinicalTrials.gov NCT01800266.

The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda.

PubMed

Nakimuli-Mpungu, Etheldreda; Okello, James; Kinyanda, Eugene; Alderman, Stephen; Nakku, Juliet; Alderman, Jeffrey S; Pavia, Alison; Adaku, Alex; Allden, Kathleen; Musisi, Seggane

2013-10-01

The effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa. To assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda. 631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants. In comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=-1.84, 95%CI (-3.38 to -0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=-2.14, 95%CI (-4.21 to -0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61-6.40), p=0.018] than participants who attended only one session. Selection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences. The group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial. © 2013 Elsevier B.V. All rights reserved.

The influence of parenteral glutamine supplementation on glucose homeostasis in critically ill polytrauma patients--A randomized-controlled clinical study.

PubMed

Grintescu, Ioana Marina; Luca Vasiliu, Irina; Cucereanu Badica, Ioana; Mirea, Liliana; Pavelescu, Daniela; Balanescu, Andreea; Grintescu, Ioana Cristina

2015-06-01

Rapid onset of resistance to insulin is a prominent component of stress metabolism in multiple trauma patients. Recent studies have clarified the role of amino acids (especially glutamine) in glucose transportation and the benefits of parenteral alanyl-glutamine supplementation (0.3-0.6 g/kg/day) in glucose homeostasis. The aims of this study are to evaluate the incidence of hyperglycemic episodes and the need for exogenous insulin to maintain stable glucose levels in critically ill polytrauma patients supplemented with parenteral glutamine dipeptide (Dipeptiven(®)) versus standard nutritional support. This was an open-label randomized-controlled trial of 82 polytrauma patients aged 20-60 years old, randomly assigned into two equal groups independent of sex, age and Injury Severity Score. We excluded patients with diabetes mellitus, or renal or hepatic failure. One group received parenteral Dipeptiven(®) supplementation of 0.5 g/kg/day and the other received standard isocaloric isoproteinic nutritional support. We found that 63% of patients in the glutamine-supplemented group had no hyperglycemic episodes; only 37% required exogenous insulin (mean daily requirement of 44 units/day). In the control group, 51% of patients required insulin (mean daily requirement 63 unit/day; p = 0.0407). The effect of glutamine supplementation on glucose homeostasis is associated with a lower incidence of hyperglycemia among critically ill polytrauma patients, and leads to a lower mean daily dose of insulin. Controlled-trials.com Identifier: ISRCTN71592366 (http://www.controlled-trials.com/ISRCTN71592366/ISRCTN71592366). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Adapting Cognitive-Behavioral Therapy for Depressed Adolescents Exposed to Interpersonal Trauma: A Case Study with Two Teens

ERIC Educational Resources Information Center

DePrince, Anne P.; Shirk, Stephen R.

2013-01-01

A substantial body of evidence indicates that interpersonal trauma increases risk for adolescent and adult depression. Findings from 4 clinical trials for adolescent depression show poorer response to standard cognitive-behavioral therapy (CBT) among depressed adolescents with a trauma history than youth without such a history. This paper reports…

Efficacy of a new device to optimize positive pressure ventilation via face mask in edentulous patients: a randomized trial.

PubMed

Niño, Maria C; Pauwels, Andres; Raffan, Fernando; Arango, Enrique; Romero, David J; Benitez, Daniel

2017-04-01

Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients. This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only). The primary outcomes were peak inspiratory pressure and tidal volume values of the first 14 breaths. The secondary outcome was the incidence of complications. Data from 37 patients were collected during a one-year period (twenty in the NIPARA device group and 17 in the control group). The difference in mean PIP was not statistically significant. The tidal volume was 1.5 times greater in the NIPARA group than in the control group. One patient from the intervention group had minimal oral trauma. In the administration of face mask ventilation, NIPARA is an effective device that significantly improves the tidal volume administered in edentulous patients.

Clinical Application of Mesenchymal Stem Cells and Novel Supportive Therapies for Oral Bone Regeneration

PubMed Central

O'Valle, Francisco; Lanis, Alejandro; Dohan Ehrenfest, David M.; Wang, Hom-Lay; Galindo-Moreno, Pablo

2015-01-01

Bone regeneration is often needed prior to dental implant treatment due to the lack of adequate quantity and quality of the bone after infectious diseases, trauma, tumor, or congenital conditions. In these situations, cell transplantation technologies may help to overcome the limitations of autografts, xenografts, allografts, and alloplastic materials. A database search was conducted to include human clinical trials (randomized or controlled) and case reports/series describing the clinical use of mesenchymal stem cells (MSCs) in the oral cavity for bone regeneration only specifically excluding periodontal regeneration. Additionally, novel advances in related technologies are also described. 190 records were identified. 51 articles were selected for full-text assessment, and only 28 met the inclusion criteria: 9 case series, 10 case reports, and 9 randomized controlled clinical trials. Collectively, they evaluate the use of MSCs in a total of 290 patients in 342 interventions. The current published literature is very diverse in methodology and measurement of outcomes. Moreover, the clinical significance is limited. Therefore, the use of these techniques should be further studied in more challenging clinical scenarios with well-designed and standardized RCTs, potentially in combination with new scaffolding techniques and bioactive molecules to improve the final outcomes. PMID:26064899

Intermittent catheterization with hydrophilic catheters as a treatment of chronic neurogenic urinary retention.

PubMed

Chartier-Kastler, Emmanuel; Denys, Pierre

2011-01-01

Neurogenic bladder can be effectively managed with intermittent catheterization (IC) to improve or restore continence, but there is no consensus on which type of catheter is preferred. Hydrophilic catheters were developed to reduce urethral friction, thereby minimizing trauma and sticking, and making them more acceptable to the patient, and easier and safer to use. The objective of this article was to review the literature on the benefits of hydrophilic catheters in patients with neurogenic bladder. A large body of experimental and observational evidence, including randomized controlled trials, was identified using PubMed. Compared with plastic catheters that have been manually lubricated with gel, hydrophilic catheters reduce urinary tract infection and microhematuria. Hydrophilic catheters are also associated with high levels of patient satisfaction because they are comfortable to use. There is a wealth of evidence, including randomized controlled trials, to support the benefits of hydrophilic catheters in terms of safety and quality of life, especially in men with spinal cord injury. More data are required for spina bifida, multiple sclerosis, and in women. Further research is warranted, especially large-scale and long-term robust comparisons of different types of catheter, and in well-defined and stratified populations. Copyright © 2010 Wiley-Liss, Inc.

Nonoperative management of blunt hepatic trauma: A systematic review.

PubMed

Boese, Christoph Kolja; Hackl, Michael; Müller, Lars Peter; Ruchholtz, Steffen; Frink, Michael; Lechler, Philipp

2015-10-01

Nonoperative management (NOM) has become the standard treatment in hemodynamically stable patients with blunt hepatic injuries. While the reported overall success rates of NOM are excellent, there is a lack of consensus regarding the risk factors predicting the failure of NOM. The aim of this systematic review was to identify the incidence and prognostic factors for failure of NOM in adult patients with blunt hepatic trauma. Prospective studies reporting prognostic factors for the failure of nonoperative treatment of blunt liver injuries were identified by searching MEDLINE and the Cochrane Central Register of Controlled Trials. We screened 798 titles and abstracts, of which 8 single-center prospective observational studies, reporting 410 patients, were included in the qualitative and quantitative synthesis. No randomized controlled trials were found. The pooled failure rate of NOM was 9.5% (0-24%). Twenty-six prognostic factors predicting the failure of NOM were reported, of which six reached statistical significance in one or more studies: blood pressure (p < 0.05), fluid resuscitation (p = 0.02), blood transfusion (p = 0.003), peritoneal signs (p < 0.0001), Injury Severity Score (ISS) (p = 0.03), and associated intra-abdominal injuries (p < 0.01). There is evidence that patients presenting with clinical signs of shock, a high ISS, associated intra-abdominal injuries, and peritoneal signs are at an increased risk of failure of NOM for the treatment of blunt hepatic injuries. Systematic review, level III.

Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review.

PubMed

Hoagwood, Kimberly Eaton; Acri, Mary; Morrissey, Meghan; Peth-Pierce, Robin

2017-01-01

To systematically review experimental evidence about animal-assisted therapies (AAT) for children or adolescents with or at risk for mental health conditions, we reviewed all experimental AAT studies published between 2000-2015, and compared studies by animal type, intervention, and outcomes. Studies were included if used therapeutically for children and adolescents (≤21 years) with or at risk for a mental health problem; used random assignment or a waitlist comparison/control group; and included child-specific outcome data. Of 1,535 studies, 24 met inclusion criteria. Of 24 studies identified, almost half were randomized controlled trials, with 9 of 11 published in the past two years. The largest group addresses equine therapies for autism. Findings are generally promising for positive effects associated with equine therapies for autism and canine therapies for childhood trauma. The AAT research base is slim; a more focused research agenda is outlined.

Efficacy of physical exercise in preventing falls in older adults with cognitive impairment: a systematic review and meta-analysis.

PubMed

Chan, Wai Chi; Yeung, Jerry Wing Fai; Wong, Corine Sau Man; Lam, Linda Chiu Wa; Chung, Ka Fai; Luk, James Ka Hay; Lee, Jenny Shun Wah; Law, Andrew Chi Kin

2015-02-01

Numerous studies have reported the prevention of falls through exercise among cognitively healthy older people. This study aimed to determine whether the current evidence supports that physical exercise is also efficacious in preventing falls in older adults with cognitive impairment. Two independent reviewers searched MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing & Allied Health Literature; the Cochrane Central Register of Controlled Trials; the Cochrane Bone, Joint, and Muscle Trauma Group Specialized Register; ClinicalTrials.gov; and the UK Clinical Research Network Study Portfolio up to July 2013 without language restriction. We included randomized controlled trials that examined the efficacy of physical exercise in older adults with cognitive impairment. The methodological qualities of the included trials were appraised according to the criteria developed for the Cochrane review of fall prevention trials. The primary outcome measure was the rate ratio of falls. A meta-analysis was performed to estimate the pooled rate ratio and summarize the results of the trials on fall prevention through physical exercise. Seven randomized controlled trials involving 781 participants were included, 4 of which examined solely older people with cognitive impairment. Subgroup data on persons with cognitive impairment were obtained from the other 3 trials that targeted older populations in general. The meta-analysis showed that physical exercise had a significant effect in preventing falls in older adults with cognitive impairment, with a pooled estimate of rate ratio of 0.68 (95% confidence interval 0.51-0.91). The present analysis suggests that physical exercise has a positive effect on preventing falls in older adults with cognitive impairment. Further studies will be required to determine the modality and frequency of exercise that are optimal for the prevention of falls in this population. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

PubMed Central

Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

2015-01-01

Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

The safety and efficacy of the administration of recombinant activated factor VII in major surgery and trauma patients.

PubMed

Wilson, Stephen J; Bellamy, Mark C; Giannoudis, Peter V

2005-05-01

Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular injury makes it an attractive potential treatment for massive, uncontrolled bleeding associated with surgery and trauma. This article describes the evidence relating to surgery and trauma. The lack of large, controlled trials of rFVIIa means that a definitive recommendation regarding its use cannot be made at present. However, in the context of clearly defined protocols and balanced treatment strategies, rFVIIa may have a role in traumatic bleeding. Large scale, randomised controlled trials in trauma are required, as is further work on the safety profile of rFVIIa with an independent international safety monitoring committee.

Preventing PTSD with oxytocin: effects of oxytocin administration on fear neurocircuitry and PTSD symptom development in recently trauma-exposed individuals

PubMed Central

Frijling, Jessie L.

2017-01-01

ABSTRACT Background: Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which develops in approximately 10% of trauma-exposed individuals. Currently, there are few early preventive interventions available for PTSD. Intranasal oxytocin administration early posttrauma may prevent PTSD symptom development, as oxytocin administration was previously found to beneficially impact neurobiological (e.g. amygdala reactivity) and socio-emotional PTSD vulnerability factors. Objective: The overall aim of this dissertation was to investigate the potential of intranasal oxytocin administration as early preventive intervention for PTSD. Methods: We performed a functional magnetic resonance imaging (fMRI) study to assess the acute effects of a single administration of oxytocin on the functional fear neurocircuitry – consisting of the amygdala and (pre)frontal brain regions – in recently trauma-exposed emergency department patients (range n = 37–41). In addition, we performed a multicentre randomized double-blind placebo-controlled clinical trial (RCT) to assess the efficacy of repeated intranasal oxytocin administration early after trauma for preventing PTSD symptom development up to six months posttrauma (n = 107). Results: In our fMRI experiments we observed acutely increased amygdala reactivity to fearful faces and attenuated amygdala-ventromedial and ventrolateral prefrontal cortex functional connectivity after a single oxytocin administration in recently trauma-exposed individuals. However, in our RCT we found that repeated intranasal oxytocin administration early posttrauma reduced subsequent PTSD symptom development in recently trauma-exposed emergency department patients with high acute PTSD symptoms. Conclusions: These findings indicate that repeated intranasal oxytocin is a promising early preventive intervention for PTSD for individuals at increased risk for PTSD due to high acute symptom severity. Administration frequency dependent effects of oxytocin or the effects of oxytocin administration on salience processing may serve as explanatory frameworks for the contrasting oxytocin effects on anxiety-related measures in our clinical and neuroimaging studies. PMID:28451068

The extent of adhesion induction through electrocoagulation and suturing in an experimental rat study.

PubMed

Wallwiener, Christian W; Kraemer, Bernhard; Wallwiener, Markus; Brochhausen, Christoph; Isaacson, Keith B; Rajab, Taufiek K

2010-03-01

To investigate the effect of three types of peritoneal trauma occurring during surgery (high-frequency bipolar current, suturing, and mechanical damage) on postoperative adhesion formation in a rodent animal model. Randomized, controlled experimental trial in an in vitro animal model. Laboratory facilities of a university department of obstetrics and gynecology. Thirty-five female Wistar rats. Bilateral experimental lesions were created on the abdominal wall in every animal. The effect of minimal electrocoagulation was examined by creating lesions (n = 14) through sweeps of a bipolar forceps with a duration of 1 second and standardized pressure. For extensive electrocoagulation standardized lesions (n = 14) were created using sweeps of a duration of 3 seconds and three times more pressure. For mechanical trauma, standardized lesions (n = 14) were created by denuding the peritoneum mechanically. To study the additive effect of suturing, experimental lesions were created by suturing plus minimal electrocoagulation (n = 14) or mechanical denuding (n = 14). Adhesion incidence, quantity, and quality of the resulting adhesions were scored 14 days postoperatively. Adhesions were studied histopathologically. Mechanical denuding of the peritoneum did not result in adhesion formation. After minimal electrocoagulation, mean adhesion quantity of the traumatized area averaged 0%. This contrasted with extensive electrocoagulation, where there was 50% adhesion. Additional suturing increased mean adhesion quantity to 73% and 64% for superficial electrocoagulation and mechanical denuding, respectively. We conclude that superficial trauma limited mostly to the parietal peritoneum may be a negligible factor in adhesion formation in this model. This appears to be irrespective of the mode of trauma. However, additional trauma to the underlying tissues, either by deeper electrocoagulation or suturing, leads to significantly increased adhesion formation. These data also show that there is a spectrum of electrocoagulation trauma at the lower end of which there is little adhesion formation. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Examining the Impact of Trauma-Informed Cognitive Behavioral Therapy on Perinatal Mental Health Outcomes Among Survivors of Intimate Partner Violence (The PATH Study): Protocol for a Feasibility Study

PubMed Central

Parkinson, Sarah; Jackson, Brianna

2018-01-01

Background Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, and posttraumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) interventions as a gold standard for those with symptomatology consistent with anxiety disorders, mood disorders, and PTSD. However, efficacy has not been evaluated among a population of pregnant survivors of IPV. Objective We present the protocol that will be used to explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomatology resulting from IPV. A secondary aim will be to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial. Methods The Promoting Attachment Through Healing (PATH) study will use a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through the hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). A feasibility sample of 20 pregnant women (cohort 1) will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program’s perinatal clinical nurse specialist, with evaluation at baseline, at two months postpartum (intervention and online questionnaire), and at six and twelve months postpartum (online questionnaire only). Concurrently, we will conduct a retrospective audit of 100 medical charts (cohort 2; 50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental illness symptomatology, improved maternal-infant attachment, maternal coping, and maternal quality of life. Additionally, the feasibility of the protocol and acceptability of the intervention from the women’s perspective will be examined. Inductive content analysis of all qualitative data will be used to determine common themes. Additionally, descriptive statistics, including measures of central tendency and dispersion, will be computed for all continuous variables. Alternatively, frequency tables will be constructed for all categorical variables. Results The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Participant recruitment for cohort 1 has started and we have finished data collection for cohort 2. It is anticipated that the results will be available by the end of 2018. Conclusions Findings will assess the acceptability of the study methodology and protocol for a full-scale randomized controlled trial. Furthermore, if CBT is proven effective for pregnant survivors of IPV, this intervention could be readily adopted by health care and social support services, thereby contributing to an improved standard of care for this unique population. Trial Registration ClinicalTrials.gov NCT03536442; https://www.clinicaltrials.gov/ct2/show/NCT03536442 (Archived by WebCite at http://www.webcitation.org/6zeurv1ay) Registered Report Identifier RR1-10.2196/9820 PMID:29802091

A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of the Acute Coagulopathy of Trauma

DTIC Science & Technology

2013-08-01

Investigation of "Plasma First Resuscitation" for Traumatic Hemorrhage and Attenuation of the Acute Coagulopathy of Trauma PRINCIPAL INVESTIGATOR...34Plasma First Resuscitation" for Traumatic Hemorrhage and Attenuation of the Acute Coagulopathy of Trauma 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH...is the most preventable cause of death in trauma patients. Coagulopathy has been documented in up to one third of trauma patients upon arrival to the

Effectiveness of Educational Poster on Knowledge of Emergency Management of Dental Trauma–Part 1. Cluster Randomised Controlled Trial for Primary and Secondary School Teachers

PubMed Central

Young, Cecilia; Wong, Kin Yau; Cheung, Lim K.

2013-01-01

Objective To investigate the effectiveness of educational posters in improving the knowledge level of primary and secondary school teachers regarding emergency management of dental trauma. Methods A cluster randomised controlled trial was conducted. 32 schools with a total of 515 teachers were randomised into intervention (poster) and control groups at the school level. Teachers’ baseline levels of knowledge about dental trauma were obtained by using a questionnaire. Posters containing information on dental trauma management were displayed in the school medical room, the common room used by staff, and on a notice board for 2 weeks in each school of the intervention group; in the control group, no posters were displayed. Teachers in both groups completed the questionnaire after 2 weeks. Results The teachers in the intervention schools (where posters were displayed for 2 weeks) showed statistically significant improvement in scores in cases where they had not previously learned about dental emergencies from sources other than first aid training, with an average score increase of 2.6656 (score range of questionnaire, −13 to 9; p-value <0.0001). Conclusion Educational posters on the management of dental trauma can significantly improve the level of knowledge of primary and secondary school teachers in Hong Kong. KClinicalTrials.com HKCTR-1307 ClinicalTrials.gov: NCT01707355 PMID:24147154

Perineal techniques during the second stage of labour for reducing perineal trauma.

PubMed

Aasheim, Vigdis; Nilsen, Anne Britt Vika; Lukasse, Mirjam; Reinar, Liv Merete

2011-12-07

Most vaginal births are associated with some form of trauma to the genital tract. The morbidity associated with perineal trauma is significant, especially when it comes to third- and fourth-degree tears. Different perineal techniques and interventions are being used to prevent perineal trauma. These interventions include perineal massage, warm compresses and perineal management techniques. The objective of this review was to assess the effect of perineal techniques during the second stage of labour on the incidence of perineal trauma. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 May 2011), the Cochrane Central Register of ControlledTrials (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (January 1966 to 20 May 2011) and CINAHL (January 1983 to 20 May 2011). Published and unpublished randomised and quasi-randomised controlled trials evaluating any described perineal techniques during the second stage. Three review authors independently assessed trails for inclusion, extracted data and evaluated methodological quality. Data were checked for accuracy. We included eight trials involving 11,651 randomised women. There was a significant effect of warm compresses on reduction of third- and fourth-degree tears (risk ratio (RR) 0.48, 95% confidence interval (CI) 0.28 to 0.84 (two studies, 1525 women)). There was also a significant effect towards favouring massage versus hands off to reduce third- and fourth-degree tears (RR 0.52, 95% CI 0.29 to 0.94 (two studies, 2147 women)). Hands off (or poised) versus hand on showed no effect on third- and fourth-degree tears, but we observed a significant effect of hands off on reduced rate of episiotomy (RR 0.69, 95% CI 0.50 to 0.96 (two studies, 6547 women)). The use of warm compresses on the perineum is associated with a decreased occurrence of perineal trauma. The procedure has shown to be acceptable to women and midwives. This procedure may therefore be offered to women.

Predicted Unfavorable Neurologic Outcome Is Overestimated by the Marshall Computed Tomography Score, Corticosteroid Randomization After Significant Head Injury (CRASH), and International Mission for Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) Models in Patients with Severe Traumatic Brain Injury Managed with Early Decompressive Craniectomy.

PubMed

Charry, Jose D; Tejada, Jorman H; Pinzon, Miguel A; Tejada, Wilson A; Ochoa, Juan D; Falla, Manuel; Tovar, Jesus H; Cuellar-Bahamón, Ana M; Solano, Juan P

2017-05-01

Traumatic brain injury (TBI) is of public health interest and produces significant mortality and disability in Colombia. Calculators and prognostic models have been developed to establish neurologic outcomes. We tested prognostic models (the Marshall computed tomography [CT] score, International Mission for Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT), and Corticosteroid Randomization After Significant Head Injury) for 14-day mortality, 6-month mortality, and 6-month outcome in patients with TBI at a university hospital in Colombia. A 127-patient cohort with TBI was treated in a regional trauma center in Colombia over 2 years and bivariate and multivariate analyses were used. Discriminatory power of the models, their accuracy, and precision was assessed by both logistic regression and area under the receiver operating characteristic curve (AUC). Shapiro-Wilk, χ 2 , and Wilcoxon test were used to compare real outcomes in the cohort against predicted outcomes. The group's median age was 33 years, and 84.25% were male. The injury severity score median was 25, and median Glasgow Coma Scale motor score was 3. Six-month mortality was 29.13%. Six-month unfavorable outcome was 37%. Mortality prediction by Marshall CT score was 52.8%, P = 0.104 (AUC 0.585; 95% confidence interval [CI] 0 0.489-0.681), the mortality prediction by CRASH prognosis calculator was 59.9%, P < 0.001 (AUC 0.706; 95% CI 0.590-0.821), and the unfavorable outcome prediction by IMPACT was 77%, P < 0.048 (AUC 0.670; 95% CI 0.575-0.763). In a university hospital in Colombia, the Marshall CT score, IMPACT, and Corticosteroid Randomization After Significant Head Injury models overestimated the adverse neurologic outcome in patients with severe head trauma. Copyright © 2017 Elsevier Inc. All rights reserved.

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Tetanus: A Potential Public Health Threat in Times of Disaster.

PubMed

Finkelstein, Paige; Teisch, Laura; Allen, Casey J; Ruiz, Gabriel

2017-06-01

Tetanus is a potentially fatal condition that is rare in urban environments but is seen in developing countries and post-natural-disaster. Therefore, the purpose of this report was to review the epidemiology, pathogenesis, and management of tetanus in the trauma patient. A thorough literature review was conducted to look for the most current and thorough guidelines on the prophylaxis and treatment of tetanus. PUBMED (National Center for Biotechnology Information, National Institutes of Health; Bethesda, Maryland USA), MEDLINE (US National Library of Medicine, National Institutes of Health; Bethesda, Maryland USA), and Cochrane Library (The Cochrane Collaboration; Oxford, United Kingdom) databases were searched for articles in English, published from 2005 to 2015, using the keywords "Tetanus," "Trauma/Surgery," and "Disaster." Controlled trials, randomized controlled trials, trials of adult patients, published guidelines, expert opinions, and review articles were selected and extracted. Current vaccination schedules in developed countries provide prophylaxis for tetanus. However, when severe natural disasters occur, many patients may not be able to provide a reliable vaccination history. In these situations, tetanus immune globulin (TIG) is indicated; if resources are not limited, both tetanus toxoid and TIG should be given to those with high-risk wounds. If resources are limited, TIG should be reserved for those that would benefit most or those least likely to have the protective antibodies. Although tetanus is a disease that has a low incidence in the developed world due to high rates of immunization, during large-scale natural disasters, compounding factors like the types of injuries, lack of medical services and supplies, and the delay in treatment associated with an already low immunization rate result in an increased incidence and outbreaks of the disease that has higher mortality in an underdeveloped society. It is important for the urban physician that cares for trauma and critical patients to become familiar with the protocols for treatment and immunization of patients that have tetanus-prone wounds, as well as recognize the potential for outbreaks in the settings of major natural disasters. Finkelstein P , Teisch L , Allen CJ , Ruiz G . Tetanus: a potential public health threat in times of disaster. Prehosp Disaster Med. 2017;32(3):339-342.

An Investigation of Depression, Trauma History, and Symptom Severity in Individuals Enrolled in a Treatment Trial for Chronic PTSD

PubMed Central

Bedard-Gilligan, Michele; Duax Jakob, Jeanne M.; Doane, Lisa Stines; Jaeger, Jeff; Eftekhari, Afsoon; Feeny, Norah; Zoellner, Lori A.

2015-01-01

Objectives To explore how factors such as major depressive disorder (MDD) and trauma history, including the presence of childhood abuse, influence diverse clinical outcomes such as severity and functioning in a sample with posttraumatic stress disorder (PTSD). Method In this study, 200 men and women seeking treatment for chronic PTSD in a clinical trial were assessed for trauma history and major depressive disorder and compared on symptom severity, psychosocial functioning, dissociation, treatment history, and extent of diagnostic co-occurrence. Results Overall, childhood abuse did not consistently predict clinical severity. However, co-occurring MDD, and to a lesser extent a high level of trauma exposure, did predict greater severity, worse functioning, greater dissociation, more extensive treatment history, and additional co-occurring disorders. Conclusions These findings suggest that presence of co-occurring depression may be a more critical marker of severity and impairment than history of childhood abuse or repeated trauma exposure. Furthermore, they emphasize the importance of assessing MDD and its impact on treatment seeking and treatment response for those with PTSD. PMID:25900026

Plasma transfusion for patients with severe hemorrhage: what is the evidence?

PubMed

Callum, Jeannie L; Rizoli, Sandro

2012-05-01

The following review will detail the current knowledge in massive hemorrhage with regard to the pathophysiology of the coagulation disturbance, the role of plasma, the role of alternatives to plasma, and the clinical value of having a massive transfusion protocol. The coagulation disturbance in trauma patients is more than just the result of consumption of clotting factors at sites of injury and dilution from the infusion of intravenous fluids and red blood cells (RBCs). Even before substantial amounts of fluid resuscitation and RBC transfusion, one-quarter of trauma patients already have abnormal coagulation variables. There is an apparent role for the activation of protein C, hypofibrinogenemia, and fibrin(gen)olysis in the coagulation disturbance after trauma and massive hemorrhage. None of these three disturbances would be completely mitigated by the use of plasma alone, suggesting that there may be an opportunity to improve care of these patients with alternative strategies, such as fibrinogen concentrates and antifibrinolytics. Despite numerous retrospective cohort studies evaluating 1:1 plasma to RBC formula-driven resuscitation, the overall clinical value of this approach is unclear. Studies have even raised concerns regarding a potential increase in morbidity associated with this approach, particularly for patients overtriaged to 1:1 where a massive transfusion is unlikely. We also do not have sufficient evidence to recommend either goal-directed therapy with thromboelastography or early use of fibrinogen replacement, with either cryoprecipitate or fibrinogen concentrates. We have high-quality data that argue against the role for recombinant Factor VIIa that should prompt removal of this strategy from existing protocols. In contrast, we have high-level evidence that all bleeding trauma patients should receive tranexamic acid as soon as possible after injury. This therapy must be included in hemorrhage protocols. If we are to improve the care of massively bleeding patients on a firm scientific ground, we will need large-scale randomized trials to delineate the role of coagulation replacement and the utility of laboratory monitoring. But even until these trials are completed, it is clear that a massive transfusion protocol is needed in all hospitals that manage bleeding patients, to ensure a prompt and coordinated response to hemorrhage. © 2012 American Association of Blood Banks.

Psychodynamic psychotherapy for posttraumatic stress disorder related to childhood abuse--Principles for a treatment manual.

PubMed

Wöller, Wolfgang; Leichsenring, Falk; Leweke, Frank; Kruse, Johannes

2012-01-01

In this article, the authors present a psychodynamically oriented psychotherapy approach for posttraumatic stress disorder (PTSD) related to childhood abuse. This neurobiologically informed, phase-oriented treatment approach, which has been developed in Germany during the past 20 years, takes into account the broad comorbidity and the large degree of ego-function impairment typically found in these patients. Based on a psychodynamic relationship orientation, this treatment integrates a variety of trauma-specific imaginative and resource-oriented techniques. The approach places major emphasis on the prevention of vicarious traumatization. The authors are presently planning to test the approach in a randomized controlled trial aimed at strengthening the evidence base for psychodynamic psychotherapy in PTSD.

Improving AIDS Care After Trauma (ImpACT): Pilot Outcomes of a Coping intervention Among HIV-Infected Women with Sexual Trauma in South Africa.

PubMed

Sikkema, Kathleen J; Mulawa, Marta I; Robertson, Corne; Watt, Melissa H; Ciya, Nonceba; Stein, Dan J; Cherenack, Emily M; Choi, Karmel W; Kombora, Matapelo; Joska, John A

2018-03-01

Improving AIDS Care after Trauma (ImpACT), a coping intervention for HIV-infected women with sexual abuse histories, was evaluated for feasibility and potential efficacy in a public clinic in Cape Town, South Africa. Sixty-four participants were enrolled prior to starting antiretroviral therapy (ART). After completing baseline assessments, participants were randomly assigned to standard of care (SoC: three adherence counseling sessions) or ImpACT (SoC plus four individual and three group sessions). Participants completed assessments at 3 months (after individual sessions) and 6 months post-baseline. In exploratory analysis of primary outcomes, ImpACT participants, compared to SoC, reported greater reductions in avoidance and arousal symptoms of PTSD and greater increases in ART adherence motivation at 3 months. Clinically significant decreases in overall PTSD symptoms were also demonstrated at 3 months. These effects continued as trends at the 6-month assessment, in addition to increases in social/spiritual coping. In analysis of secondary outcomes, high levels of non-adherence to ART and poor care engagement were evident at 6 months, with no differences between study arms. A trauma-focused, culturally-adapted individual intervention delivered by a non-specialist in the HIV care setting is feasible and acceptable. Preliminary findings suggest ImpACT has potential to reduce PTSD symptoms and increase ART adherence motivation, but a more intensive intervention may be needed to improve and maintain care engagement among this population. ClinicalTrials.gov NCT02223390.

Incidence of urinary extravasation and rate of ureteral stenting after high-grade renal trauma in adults: a meta-analysis

PubMed Central

Anderson, Ross E.; Fiander, Michelle; McFarland, Mary M.; Stoddard, Gregory J.; Hotaling, James M.; Myers, Jeremy B.

2018-01-01

Background Collecting system injury and urinary extravasation is an important yet understudied aspect of renal trauma. We aimed to examine the incidence of urinary extravasation and also the rates of ureteral stenting after high-grade renal trauma (HGRT) in adults. Methods A search strategy was developed to search Ovid Medline, Embase, CINAHL, and Cochrane Library. Two reviewers screened titles and abstracts, followed by full-text review of the relevant publications. Studies were included if they indicated the number of patients with HGRT [the American Association for the Surgery of Trauma (AAST) grades III–IV or equivalents] and number of patients with urinary extravasation. A descriptive meta-analysis of binary proportions was performed with random-effects model to calculate the incidence of urinary extravasation and rates of ureteral stenting. Results After screening, 24 and 20 studies were included for calculating urinary extravasation and stenting rates, respectively. Most studies involved blunt injury and were retrospective single-center case series. Incidence of urinary extravasation was 29% (95% CI: 17–42%) after HGRT (grade III–V), and 51% (95% CI: 38–64%) when only grade IV–V injuries were combined. Overall, 29% (95% CI: 22–36%) of patients with urinary extravasation underwent ureteral stenting. Conclusions Approximately 30% of patients with HGRT are diagnosed with urinary extravasation and 29% of those with urinary extravasation undergo ureteral stenting. Understanding the rate of urinary extravasation and interventions is the first step in creating a prospective trial designed to demonstrate when ureteral stenting and aggressive management of urinary extravasation is needed. PMID:29928614

Incidence of urinary extravasation and rate of ureteral stenting after high-grade renal trauma in adults: a meta-analysis.

PubMed

Keihani, Sorena; Anderson, Ross E; Fiander, Michelle; McFarland, Mary M; Stoddard, Gregory J; Hotaling, James M; Myers, Jeremy B

2018-05-01

Collecting system injury and urinary extravasation is an important yet understudied aspect of renal trauma. We aimed to examine the incidence of urinary extravasation and also the rates of ureteral stenting after high-grade renal trauma (HGRT) in adults. A search strategy was developed to search Ovid Medline, Embase, CINAHL, and Cochrane Library. Two reviewers screened titles and abstracts, followed by full-text review of the relevant publications. Studies were included if they indicated the number of patients with HGRT [the American Association for the Surgery of Trauma (AAST) grades III-IV or equivalents] and number of patients with urinary extravasation. A descriptive meta-analysis of binary proportions was performed with random-effects model to calculate the incidence of urinary extravasation and rates of ureteral stenting. After screening, 24 and 20 studies were included for calculating urinary extravasation and stenting rates, respectively. Most studies involved blunt injury and were retrospective single-center case series. Incidence of urinary extravasation was 29% (95% CI: 17-42%) after HGRT (grade III-V), and 51% (95% CI: 38-64%) when only grade IV-V injuries were combined. Overall, 29% (95% CI: 22-36%) of patients with urinary extravasation underwent ureteral stenting. Approximately 30% of patients with HGRT are diagnosed with urinary extravasation and 29% of those with urinary extravasation undergo ureteral stenting. Understanding the rate of urinary extravasation and interventions is the first step in creating a prospective trial designed to demonstrate when ureteral stenting and aggressive management of urinary extravasation is needed.

[Treatment of vaginismus with EMDR: a report of two cases].

PubMed

Torun, Fuat

2010-01-01

Vaginismus is a type of sexual dysfunction in which spasm of the vaginal musculature prevents penetrative intercourse. The main diagnostic criterion is the presence of recurrent or persistent involuntary spasm of the musculature of the outer third of the vagina that interferes with sexual intercourse. In many cases associated pain or the fear of pain may contribute to its persistence. Herein we report 2 patients that presented with vaginismus that developed secondary to childhood sexual trauma, which was treated with the Eye Movement Desensitization and Reprocessing (EMDR) technique. EMDR is a non-pharmacologic treatment for psychological trauma. Randomized controlled trials with posttraumatic stress disorder patients and with victims of sexual abuse have shown that EMDR is effective. The standard 8-phase EMDR protocol was used in both of the presented cases. Following 3 sessions of EMDR, the patients exhibited a substantial reduction in self-reported and clinician-rated anxiety, and a reduction in the credibility of dysfunctional beliefs concerning sexual intercourse. These findings support the notion that EMDR could be an effective treatment alternative for patients with vaginismus of traumatic etiology.

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial.

PubMed

Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Lauridsen, Jørgen T; Sjøgaard, Gisela; Toft, Palle

2015-07-23

Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative impact on the degree of independence and quality of life. In the NONSEDA trial we randomize critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit. It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit. Investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 700 patients in total, with a substudy concerning 200 of these patients. Inclusion criteria will be intubated, mechanically ventilated patients with expected duration of mechanical ventilation >24 h. Exclusion criteria will be patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or placing the patient in a prone position. The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up trial. The co-primary outcome will be quality of life regarding physical function (SF-36, physical component) and degree of independence in activities of daily living (Barthel Index), and this will be assessed for all 700 patients participating in the NONSEDA trial. The secondary outcomes, which will be assessed for the subpopulation of 200 NONSEDA patients in the trial site, Kolding, will be 6-min walking distance, handgrip strength, muscle size (ultrasonographic measurement of the rectus femoris muscle cross-sectional area) and biomechanical data on lower extremity function (maximal voluntary contraction, rate of force development and endurance). This study is the first to investigate the effect of no sedation during critical illness on physical function. If an effect is found, it will add important information on how to prevent muscle weakness following critical illness. The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02034942, 9 January 2014).

Randomized controlled trial of SecondStory, an intervention targeting posttraumatic growth, with bereaved adults.

PubMed

Roepke, Ann Marie; Tsukayama, Eli; Forgeard, Marie; Blackie, Laura; Jayawickreme, Eranda

2018-06-01

People often report positive psychological changes after adversity, a phenomenon known as posttraumatic growth (PTG). Few PTG-focused interventions have been rigorously tested, and measurement strategies have had significant limitations. This study evaluated the effects of a new group-format psychosocial intervention, SecondStory, aimed at facilitating PTG by helping participants make meaning of the past and plan a purposeful future. In a randomized controlled trial, adults (N = 112, 64% women) bereaved within 5 years were randomly assigned to SecondStory or an active control, expressive writing. The primary outcome, PTG, was measured using two contrasting methods: the Posttraumatic Growth Inventory, which asks participants retrospectively how much they believe they have changed due to struggling with adversity, and the Current-Standing Posttraumatic Growth Inventory, which tracks quantifiable change in participants' standing in PTG domains over time. Secondary outcomes included depression symptoms, posttraumatic stress symptoms, and life satisfaction. Outcomes were measured at 2-week intervals: pretest, posttest, and three follow-up occasions. Hierarchical linear modeling was used to assess whether SecondStory participants experienced greater gains in primary and/or secondary outcomes over the 8-week trial. Results indicated that SecondStory participants did not show significantly greater improvements than control participants on measures of PTG, posttraumatic stress, or life satisfaction, but they did show greater decreases in depression symptoms by the first follow-up. These findings suggest that SecondStory may not facilitate PTG more effectively than existing interventions but may be promising for addressing depression. Positive interventions may productively be refined to support people experiencing trauma and loss. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa.

PubMed

Pallitto, Christina; García-Moreno, Claudia; Stöeckl, Heidi; Hatcher, Abigail; MacPhail, Catherine; Mokoatle, Keneoue; Woollett, Nataly

2016-11-05

Intimate partner violence (IPV) during or before pregnancy is associated with many adverse health outcomes. Pregnancy-related complications or poor infant health outcomes can arise from direct trauma as well as physiological effects of stress, both of which impact maternal health and fetal growth and development. Antenatal care can be a key entry point within the health system for many women, particularly in low-resource settings. Interventions to identify violence during pregnancy and offer women support and counselling may reduce the occurrence of violence and mitigate its consequences. Following a formative research phase, a randomized controlled trial will be conducted to test a nurse-led empowerment counselling intervention, originally developed for high-income settings and adapted for urban South Africa. The primary outcome is reduction of partner violence, and secondary outcomes include improvement in women's mental health, safety and self-efficacy. The study aims to recruit 504 pregnant women from three antenatal clinics in Johannesburg who will be randomized to the nurse-led empowerment arm (two 30-min counselling sessions) or enhanced control condition (a referral list) to determine whether participants in the intervention arm have better outcomes as compared to the those in the control arm. This research will provide much needed evidence on whether a short counselling intervention delivered by nurses is efficacious and feasible in low resource settings that have high prevalence of IPV and HIV. The study was registered in the South African Clinical Trials Registry (DOH-27-0414-4720) on 11 August 2014 and in the ISRCTN Registry ( ISRCTN35969343 ) on 23 May 2016).

Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study

PubMed Central

Nidich, Sanford; Seng, Angela; Compton, Blaze; O’Connor, Tom; Salerno, John W; Nidich, Randi

2017-01-01

Context: Compared with the general population, trauma experiences are higher among incarcerated women. Objective: To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Design: Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Main Outcome Measures: Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Results: Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. Conclusion: The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted. PMID:28333611

Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study.

PubMed

Nidich, Sanford; Seng, Angela; Compton, Blaze; O'connor, Tom; Salerno, John W; Nidich, Randi

2017-01-01

Compared with the general population, trauma experiences are higher among incarcerated women. To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted.

Post-traumatic stress disorder in older adults: a systematic review of the psychotherapy treatment literature.

PubMed

Dinnen, Stephanie; Simiola, Vanessa; Cook, Joan M

2015-01-01

Older adults represent the fastest growing segment of the US and industrialized populations. However, older adults have generally not been included in randomized clinical trials of psychotherapy for post-traumatic stress disorder (PTSD). This review examined reports of psychological treatment for trauma-related problems, primarily PTSD, in studies with samples of at least 50% adults aged 55 and older using standardized measures. A systematic review of the literature was conducted on psychotherapy for PTSD with older adults using PubMed, Medline, PsychInfo, CINAHL, PILOTS, and Google Scholar. A total of 42 studies were retrieved for full review; 22 were excluded because they did not provide at least one outcome measure or results were not reported by age in the case of mixed-age samples. Of the 20 studies that met review criteria, there were: 13 case studies or series, three uncontrolled pilot studies, two randomized clinical trials, one non-randomized concurrent control study and one post hoc effectiveness study. Significant methodological limitations in the current older adult PTSD treatment outcome literature were found reducing its internal validity and generalizability, including non-randomized research designs, lack of comparison conditions and small sample sizes. Select evidence-based interventions validated in younger and middle-aged populations appear acceptable and efficacious with older adults. There are few treatment studies on subsets of the older adult population including cultural and ethnic minorities, women, the oldest old (over 85), and those who are cognitively impaired. Implications for clinical practice and future research directions are discussed.

[Summary: Scientific evaluation of EMDR psychotherapy].

PubMed

Haour, F; de Beaurepaire, C

2016-06-01

The evaluation of psychotherapy methods is made difficult by their practical and theoretical diversities as well as the increasing number of available therapies. Evaluation based on scientific criteria in randomized control trials is providing the highest level of proof and recognition by Health Agencies. A recently described integrative psychotherapy, eye movement desensitization and reprocessing (EMDR), developed by F. Shapiro since 1989, has been confronted with the validation procedure used in pharmacological treatment. It was of interest to review the scientific validation steps carried out for this EMDR psychotherapy and for its mechanisms of action. The practical and methodological protocol of the EMDR psychotherapy for trauma integration is reviewed as well as clinical results and mechanisms. This EMDR therapy, focused on the resolutions of traumas, was started by treating patients with post-traumatic stress disorders (PTSD). The integrative EMDR protocol obtained the highest level of efficiency, for PTSD treatment, twenty years after its first publication. The efficiency of the protocol is now under study and scientific evaluation for troubles in which the trauma experiences are triggers or factors of maintenance of the troubles: anxiety, depression, phobia, sexual troubles, schizophrenia, etc. This new integrative psychotherapy follows the pathways and the timing observed for the evaluation and the validation of other therapies. Copyright © 2016 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Avoidance as an obstacle to preventing depression among urban women at high risk for violent trauma.

PubMed

Silverstein, Michael; Kistin, Caroline; Bair-Merritt, Megan; Wiltsey-Stirman, Shannon; Feinberg, Emily; Diaz-Linhart, Yaminette; Sandler, Jenna; Chen, Ning; Cabral, Howard

2016-02-01

The impact of depression interventions is often attenuated in women who have experienced trauma. We explored whether psychological avoidance could explain this phenomenon. We synthesized two pilot randomized trials of problem-solving education (PSE) among a total of 93 urban mothers. Outcomes included depressive symptoms and perceived stress. Mothers with avoidant coping styles experienced an average 1.25 episodes of moderately severe depressive symptoms over 3 months of follow-up, compared to 0.40 episodes among those with non-avoidant coping (adjusted incident rate ratio [aIRR] 2.18; 95 % CI 1.06, 4.48). PSE tended to perform better among mothers with non-avoidant coping. Among mothers with non-avoidant coping, PSE mothers experienced an average 0.24 episodes, compared to 0.58 episodes among non-avoidant controls (aIRR 0.27; 95 % CI 0.05, 1.34). Among mothers with avoidant coping, PSE mothers experienced an average 1.26 episodes, compared to 1.20 episodes among avoidant controls (aIRR 0.76; 95 % CI 0.44, 1.33). This trend toward differential impact persisted when avoidance was measured as a problem-solving style and among traumatized mothers with and without avoidant PTSD symptoms. Further research is warranted to explore the hypothesis that psychological avoidance could explain why certain depression treatment and prevention strategies break down in the presence of trauma.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents.

PubMed

Batista, Klaus Bsl; Thiruvenkatachari, Badri; Harrison, Jayne E; O'Brien, Kevin D

2018-03-13

Prominent upper front teeth are a common problem affecting about a quarter of 12-year-old children in the UK. The condition develops when permanent teeth erupt. These teeth are more likely to be injured and their appearance can cause significant distress. Children are often referred to an orthodontist for treatment with dental braces to reduce the prominence of their teeth. If a child is referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait and provide treatment in adolescence. To assess the effects of orthodontic treatment for prominent upper front teeth initiated when children are seven to 11 years old ('early treatment' in two phases) compared to in adolescence at around 12 to 16 years old ('late treatment' in one phase); to assess the effects of late treatment compared to no treatment; and to assess the effects of different types of orthodontic braces. Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 27 September 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 8), MEDLINE Ovid (1946 to 27 September 2017), and Embase Ovid (1980 to 27 September 2017). The US National Institutes of Health Ongoing Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. Randomised controlled trials of orthodontic treatments to correct prominent upper front teeth (Class II malocclusion) in children and adolescents. We included trials that compared early treatment in children (two-phase) with any type of orthodontic braces (removable, fixed, functional) or head-braces versus late treatment in adolescents (one-phase) with any type of orthodontic braces or head-braces, and trials that compared any type of orthodontic braces or head-braces versus no treatment or another type of orthodontic brace or appliance (where treatment started at a similar age in the intervention groups).We excluded trials involving participants with a cleft lip or palate, or other craniofacial deformity/syndrome, and trials that recruited patients who had previously received surgical treatment for their Class II malocclusion. Review authors screened the search results, extracted data and assessed risk of bias independently. We used odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used the fixed-effect model for meta-analyses including two or three studies and the random-effects model for more than three studies. We included 27 RCTs based on data from 1251 participants.Three trials compared early treatment with a functional appliance versus late treatment for overjet, ANB and incisal trauma. After phase one of early treatment (i.e. before the other group had received any intervention), there was a reduction in overjet and ANB reduction favouring treatment with a functional appliance; however, when both groups had completed treatment, there was no difference between groups in final overjet (MD 0.21, 95% CI -0.10 to 0.51, P = 0.18; 343 participants) (low-quality evidence) or ANB (MD -0.02, 95% CI -0.47 to 0.43; 347 participants) (moderate-quality evidence). Early treatment with functional appliances reduced the incidence of incisal trauma compared to late treatment (OR 0.56, 95% CI 0.33 to 0.95; 332 participants) (moderate-quality evidence). The difference in the incidence of incisal trauma was clinically important with 30% (51/171) of participants reporting new trauma in the late treatment group compared to only 19% (31/161) of participants who had received early treatment.Two trials compared early treatment using headgear versus late treatment. After phase one of early treatment, headgear had reduced overjet and ANB; however, when both groups had completed treatment, there was no evidence of a difference between groups in overjet (MD -0.22, 95% CI -0.56 to 0.12; 238 participants) (low-quality evidence) or ANB (MD -0.27, 95% CI -0.80 to 0.26; 231 participants) (low-quality evidence). Early (two-phase) treatment with headgear reduced the incidence of incisal trauma (OR 0.45, 95% CI 0.25 to 0.80; 237 participants) (low-quality evidence), with almost half the incidence of new incisal trauma (24/117) compared to the late treatment group (44/120).Seven trials compared late treatment with functional appliances versus no treatment. There was a reduction in final overjet with both fixed functional appliances (MD -5.46 mm, 95% CI -6.63 to -4.28; 2 trials, 61 participants) and removable functional appliances (MD -4.62, 95% CI -5.33 to -3.92; 3 trials, 122 participants) (low-quality evidence). There was no evidence of a difference in final ANB between fixed functional appliances and no treatment (MD -0.53°, 95% CI -1.27 to -0.22; 3 trials, 89 participants) (low-quality evidence), but removable functional appliances seemed to reduce ANB compared to no treatment (MD -2.37°, 95% CI -3.01 to -1.74; 2 trials, 99 participants) (low-quality evidence).Six trials compared orthodontic treatment for adolescents with Twin Block versus other appliances and found no difference in overjet (0.08 mm, 95% CI -0.60 to 0.76; 4 trials, 259 participants) (low-quality evidence). The reduction in ANB favoured treatment with a Twin Block (-0.56°, 95% CI -0.96 to -0.16; 6 trials, 320 participants) (low-quality evidence).Three trials compared orthodontic treatment for adolescents with removable functional appliances versus fixed functional appliances and found a reduction in overjet in favour of fixed appliances (0.74, 95% CI 0.15 to 1.33; two trials, 154 participants) (low-quality evidence), and a reduction in ANB in favour of removable appliances (-1.04°, 95% CI -1.60 to -0.49; 3 trials, 185 participants) (low-quality evidence). Evidence of low to moderate quality suggests that providing early orthodontic treatment for children with prominent upper front teeth is more effective for reducing the incidence of incisal trauma than providing one course of orthodontic treatment in adolescence. There appear to be no other advantages of providing early treatment when compared to late treatment. Low-quality evidence suggests that, compared to no treatment, late treatment in adolescence with functional appliances, is effective for reducing the prominence of upper front teeth.

Development and validation of a prognostic model to predict death in patients with traumatic bleeding, and evaluation of the effect of tranexamic acid on mortality according to baseline risk: a secondary analysis of a randomised controlled trial.

PubMed

Perel, P; Prieto-Merino, D; Shakur, H; Roberts, I

2013-06-01

Severe bleeding accounts for about one-third of in-hospital trauma deaths. Patients with a high baseline risk of death have the most to gain from the use of life-saving treatments. An accurate and user-friendly prognostic model to predict mortality in bleeding trauma patients could assist doctors and paramedics in pre-hospital triage and could shorten the time to diagnostic and life-saving procedures such as surgery and tranexamic acid (TXA). The aim of the study was to develop and validate a prognostic model for early mortality in patients with traumatic bleeding and to examine whether or not the effect of TXA on the risk of death and thrombotic events in bleeding adult trauma patients varies according to baseline risk. Multivariable logistic regression and risk-stratified analysis of a large international cohort of trauma patients. Two hundred and seventy-four hospitals in 40 high-, medium- and low-income countries. We derived prognostic models in a large placebo-controlled trial of the effects of early administration of a short course of TXA [Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial]. The trial included 20,127 trauma patients with, or at risk of, significant bleeding, within 8 hours of injury. We externally validated the model on 14,220 selected trauma patients from the Trauma Audit and Research Network (TARN), which included mainly patients from the UK. We examined the effect of TXA on all-cause mortality, death due to bleeding and thrombotic events (fatal and non-fatal myocardial infarction, stroke, deep-vein thrombosis and pulmonary embolism) within risk strata in the CRASH-2 trial data set and we estimated the proportion of premature deaths averted by applying the odds ratio (OR) from the CRASH-2 trial to each of the risk strata in TARN. For the stratified analysis according baseline risk we considered the intervention TXA (1 g over 10 minutes followed by 1 g over 8 hours) or matching placebo. For the prognostic models we included predictors for death in hospital within 4 weeks of injury. For the stratified analysis we reported ORs for all causes of death, death due to bleeding, and fatal and non-fatal thrombotic events associated with the use of TXA according to baseline risk. A total of 3076 (15%) patients died in the CRASH-2 trial and 1705 (12%) in the TARN data set. Glasgow Coma Scale score, age and systolic blood pressure were the strongest predictors of mortality. Discrimination and calibration were satisfactory, with C-statistics > 0.80 in both CRASH-2 trial and TARN data sets. A simple chart was constructed to readily provide the probability of death at the point of care, while a web-based calculator is available for a more detailed risk assessment. TXA reduced all-cause mortality and death due to bleeding in each stratum of baseline risk. There was no evidence of heterogeneity in the effect of TXA on all-cause mortality (p-value for interaction = 0.96) or death due to bleeding (p= 0.98). There was a significant reduction in the odds of fatal and non-fatal thrombotic events with TXA (OR = 0.69, 95% confidence interval 0.53 to 0.89; p= 0.005). There was no evidence of heterogeneity in the effect of TXA on the risk of thrombotic events (p= 0.74). This prognostic model can be used to obtain valid predictions of mortality in patients with traumatic bleeding. TXA can be administered safely to a wide spectrum of bleeding trauma patients and should not be restricted to the most severely injured. Future research should evaluate whether or not the use of this prognostic model in clinical practice has an impact on the management and outcomes of trauma patients.

Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial.

PubMed

Holcomb, John B; Tilley, Barbara C; Baraniuk, Sarah; Fox, Erin E; Wade, Charles E; Podbielski, Jeanette M; del Junco, Deborah J; Brasel, Karen J; Bulger, Eileen M; Callcut, Rachael A; Cohen, Mitchell Jay; Cotton, Bryan A; Fabian, Timothy C; Inaba, Kenji; Kerby, Jeffrey D; Muskat, Peter; O'Keeffe, Terence; Rizoli, Sandro; Robinson, Bryce R H; Scalea, Thomas M; Schreiber, Martin A; Stein, Deborah M; Weinberg, Jordan A; Callum, Jeannie L; Hess, John R; Matijevic, Nena; Miller, Christopher N; Pittet, Jean-Francois; Hoyt, David B; Pearson, Gail D; Leroux, Brian; van Belle, Gerald

2015-02-03

Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, -4.2% [95% CI, -9.6% to 1.1%]; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, -3.7% [95% CI, -10.2% to 2.7%]; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, -5.4% [95% CI, -10.4% to -0.5%]; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. clinicaltrials.gov Identifier: NCT01545232.

Evolution de la reanimation transfusionnelle du blesse hemorragique grave au sein des forces militaires americaines (Evolution of US Military Transfusion Support for Resuscitation of Trauma and Hemorrhagic Shock)

DTIC Science & Technology

2013-04-15

Trauma Registry; Fresh whole blood; 1:1:1 component therapy; Platelet:RBC; FFP:RBC; Freeze-dried plasma; Tranexamic acid ∗ Auteur correspondant. Adresse e...Effects of tranexamic acid on death, vascular occlu- sive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a...randomised, placebo-controlled trial. Lancet 2010;376:23–32. [74] Morrison JJ, et al. Military application of tranexamic acid in trauma emer- gency

Scientific publications in critical care medicine journals from Chinese authors: a 10-year survey of the literature.

PubMed

Li, Zhi; Liao, Zhuan; Wu, Fei-Xiang; Yang, Li-Qun; Sun, Yu-Ming; Yu, Wei-Feng

2010-10-01

People of Chinese ethnicity are the largest population in the world. Critical care medicine in China is developing rapidly and has achieved great advances in recent 20 years. The research contribution in critical care medicine among Chinese individuals in the three major regions of China--Mainland (ML), Hong Kong (HK), and Taiwan (TW)--is unknown. Articles published in 18 journals on critical care medicine originating from ML, TW, and HK from 1999 to 2008 were retrieved from the PubMed database and Science Citation Index Expanded. Quantity and quality analyses were conducted for the total numbers of articles, clinical trials, randomized controlled trials, impact factors (IF), citations, and articles published in high-impact journals. There were 932 articles from ML (268), TW (506), and HK (158) from 1999 to 2008. The annual total numbers of articles of the three regions increased gradually from 1999 to 2008 (from 57 to 157). From 2002 onward, the number of articles published from ML exceeded that from HK, but TW still has the dominance in both annual and total number of articles published compared with ML and HK. The accumulated IF of articles from TW (1676.67) was higher than that from ML (708.25) and HK (449.51). TW had the highest average IF of 3.31 followed by HK of 2.85 and ML of 2.64. HK had the highest average citations of each article of 10.73, followed by TW of 6.74 and ML of 5.34. The Journal of Trauma was the most popular journal in the three regions. The total numbers of articles in China increased markedly from 1999 to 2008. TW published the most number of articles, clinical trials, and randomised controlled trials among the three regions. The Journal of Trauma was the most popular journal in the three regions.

Out-of-hospital tracheal intubation with single-use versus reusable metal laryngoscope blades: a multicenter randomized controlled trial.

PubMed

Jabre, Patricia; Galinski, Michel; Ricard-Hibon, Agnes; Devaud, Marie Laure; Ruscev, Mirko; Kulstad, Erik; Vicaut, Eric; Adnet, Fréderic; Margenet, Alain; Marty, Jean; Combes, Xavier

2011-03-01

Emergency tracheal intubation is reported to be more difficult with single-use plastic than with reusable metal laryngoscope blades in both inhospital and out-of-hospital settings. Single-use metal blades have been developed but have not been compared with conventional metal blades. This controlled trial compares the efficacy and safety of single-use metal blades with reusable metal blades in out-of-hospital emergency tracheal intubation. This randomized controlled trial was carried out in France with out-of-hospital emergency medical units (Services de Médecine d'Urgence et de Réanimation). This was a multicenter prospective noninferiority randomized controlled trial in adult out-of-hospital patients requiring emergency tracheal intubation. Patients were randomly assigned to either single-use or reusable metal laryngoscope blades and intubated by a senior physician or a nurse anesthetist. The primary outcome was first-pass intubation success. Secondary outcomes were incidence of difficult intubation, need for alternate airway devices, and early intubation-related complications (esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest). The study included 817 patients, including 409 intubated with single-use blades and 408 with a reusable blade. First-pass intubation success was similar in both groups: 292 (71.4%) for single-use blades, 290 (71.1%) for reusable blades. The 95% confidence interval (CI) for the difference in treatments (0.3%; 95% CI -5.9% to 6.5%) did not include the prespecified inferiority margin of -7%. There was no difference in rate of difficult intubation (difference 3%; 95% CI -7% to 2%), need for alternate airway (difference 4%; 95% CI -8% to 1%), or early complication rate (difference 3%; 95% CI -3% to 8%). First-pass out-of-hospital tracheal intubation success with single-use metal laryngoscopy blades was noninferior to first-pass success with reusable metal laryngoscope blades. Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

The Building Wealth and Health Network: methods and baseline characteristics from a randomized controlled trial for families with young children participating in temporary assistance for needy families (TANF).

PubMed

Sun, Jing; Patel, Falguni; Kirzner, Rachel; Newton-Famous, Nijah; Owens, Constance; Welles, Seth L; Chilton, Mariana

2016-07-16

Families with children under age six participating in the Temporary Assistance for Needy Families Program (TANF) must participate in work-related activities for 20 h per week. However, due to financial hardship, poor health, and exposure to violence and adversity, families may experience great difficulty in reaching self-sufficiency. The purpose of this report is to describe study design and baseline findings of a trauma-informed financial empowerment and peer support intervention meant to mitigate these hardships. We conducted a randomized controlled trial of a 28-week intervention called Building Wealth and Health Network to improve financial security and maternal and child health among caregivers participating in TANF. Participants, recruited from County Assistance offices in Philadelphia, PA, were randomized into two intervention groups (partial and full) and one control group. Participants completed questionnaires at baseline to assess career readiness, economic hardship, health and wellbeing, exposure to adversity and violence, and interaction with criminal justice systems. Baseline characteristics demonstrate that among 103 participants, there were no significant differences by group. Mean age of participants was 25 years, and youngest child was 30 months. The majority of participants were women (94.2 %), never married (83.5 %), unemployed (94.2 %), and without a bank account (66.0 %). Many reported economic hardship (32.0 % very low household food secure, 65.0 % housing insecure, and 31.1 % severe energy insecure), and depression (57.3 %). Exposure to adversity was prevalent, where 38.8 % reported four or more Adverse Childhood Experiences including abuse, neglect and household dysfunction. In terms of community violence, 64.7 % saw a seriously wounded person after an incident of violence, and 27.2 % had seen someone killed. Finally, 14.6 % spent time in an adult correctional institution, and 48.5 % of the fathers of the youngest child spent time in prison. Baseline findings demonstrate that caregivers participating in TANF have suffered significant childhood adversity, adult violence exposure, and poverty-related stressors that can limit workforce success. High prevalence of housing and food insecurity, exposure to adversity, violence and criminal justice systems demands comprehensive programming to support families. Trauma-informed approaches to career readiness such as the Building Wealth and Health Network offer opportunities for potential success in the workforce. This study is retrospectively registered with ClinicalTrials.gov. The Identifier is: NCT02577705 The Registration date is October 13, 2015.

A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study.

PubMed

Assaf-Balut, Carla; García de la Torre, Nuria; Durán, Alejandra; Fuentes, Manuel; Bordiú, Elena; Del Valle, Laura; Familiar, Cristina; Ortolá, Ana; Jiménez, Inés; Herraiz, Miguel A; Izquierdo, Nuria; Perez, Noelia; Torrejon, María J; Ortega, María I; Illana, Francisco J; Runkle, Isabelle; de Miguel, Maria P; Montañez, Carmen; Barabash, Ana; Cuesta, Martín; Rubio, Miguel A; Calle-Pascual, Alfonso L

2017-01-01

Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied. We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8-12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24-28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat. A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56-0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57-0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24-28 and 36-38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05). An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes.

Cognitive therapy and eye movement desensitization and reprocessing for reducing psychopathology among disaster-bereaved individuals: study protocol for a randomized controlled trial.

PubMed

Lenferink, Lonneke I M; Piersma, Eline; de Keijser, Jos; Smid, Geert E; Boelen, Paul A

2017-01-01

Background : Confrontation with a traumatic (e.g. disaster-related) loss is a risk factor for the development of psychopathology, including symptoms of prolonged grief (PG), posttraumatic stress (PTS), and depression. Although interventions have been developed for reducing post-loss psychopathology, more research into the effectiveness of treatment is needed to improve care for bereaved persons. Cognitive therapy (CT) and eye movement desensitization and reprocessing (EMDR) have been shown to be effective in trauma-exposed populations. We hypothesize that CT and EMDR are also effective in reducing symptoms among people exposed to traumatic loss. Objective : In this article we describe the rationale of a randomized controlled trial (RCT) to examine (1) treatment effects of CT and EMDR for reducing PG, PTS, and depression among traumatically bereaved people, and (2) the associations between improvements in PG, PTS, and depression symptoms on the one hand and tentative mechanisms of change, including a sense of unrealness, negative cognitions, avoidance behaviour, and intrusive memories, on the other hand. Method : A two-armed (intervention versus waiting list controls) RCT will be conducted. Participants will be asked to fill in questionnaires prior to treatment, during treatment, and one, 12, and 24 weeks post-treatment. Potential participants are people who have lost one or multiple significant other(s) in the Ukrainian plane disaster in 2014 with clinically significant levels of self-rated PG, PTS, and/or depression. Multiple regression, including analysis of covariance, and multilevel regression analyses will be used. Discussion : There is a need for treatment for psychopathology following traumatic loss. Strengths of this study are the development of a treatment that targets grief and trauma-related complaints and the examination of potential mechanisms of change in CT and EMDR. Bereaved people, clinicians, and researchers could benefit from the results of this study.

A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study

PubMed Central

Assaf-Balut, Carla; García de la Torre, Nuria; Durán, Alejandra; Fuentes, Manuel; Bordiú, Elena; del Valle, Laura; Familiar, Cristina; Ortolá, Ana; Jiménez, Inés; Herraiz, Miguel A.; Izquierdo, Nuria; Perez, Noelia; Torrejon, María J.; Ortega, María I.; Illana, Francisco J.; Runkle, Isabelle; de Miguel, Maria P.; Montañez, Carmen; Barabash, Ana; Cuesta, Martín; Rubio, Miguel A.

2017-01-01

Background Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied. Methods We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8–12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24–28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat. Results A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56–0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57–0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24–28 and 36–38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05). Conclusions An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes. PMID:29049303

Mental health impact of social capital interventions: a systematic review.

PubMed

Flores, Elaine C; Fuhr, Daniela C; Bayer, Angela M; Lescano, Andres G; Thorogood, Nicki; Simms, Victoria

2018-02-01

Mental disorders are a major contributor to the global burden of disease and disability, and can be extremely costly at both individual and community level. Social capital, (SC) defined as an individual's social relationships and participation in community networks, may lower the risk of mental disorders while increasing resilience capacity, adaptation and recovery. SC interventions may be a cost-effective way of preventing and ameliorating these conditions. However, the impact of these SC interventions on mental health still needs research. We conducted a systematic review of SC-based interventions to investigate their effect on mental health outcomes from controlled, quasi-experimental studies or pilot trials. We searched twelve academic databases, three clinical trials registries, hand-searched references and contacted field experts. Studies' quality was assessed with the Cochrane Risk of Bias tools for randomized and non-randomized studies. Seven studies were included in the review, published between 2006 and 2016. There was substantial heterogeneity in the definitions of both SC and mental disorders among the studies, preventing us from calculating pooled effect sizes. The interventions included community engagement and educative programs, cognitive processing therapy and sociotherapy for trauma survivors, and neighbourhood projects. There are paucity of SC interventions investigating the effect on mental health outcomes. This study showed that both SC scores and mental health outcomes improved over time but there was little evidence of benefit compared to control groups in the long term. Further high-quality trials are needed, especially among adverse populations to assess sustainability of effect.

The Efficacy of Acupressure for Symptom Management: A Systematic Review

PubMed Central

Lee, Eun Jin; Frazier, Susan

2011-01-01

Context Acupressure is a non-invasive strategy used to manage various symptoms. Objectives The purpose of this paper was to review randomized controlled trials (RCTs) that investigated the efficacy of acupressure for the management of symptoms. Methods A literature search was conducted in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, and PubMed, using the key words acupressure, clinical trial, human, and/or randomized. RCTs published between January 1, 2000 and January 31, 2010, which used acupressure as an intervention for one group, were included when they were written in English and when there were four or more studies of the efficacy of acupressure for that particular symptom. Results Forty-three studies were included in this review. Investigators in 16 of 23 studies concluded acupressure was effective, primarily for the management of nausea and vomiting in patients during pregnancy and during chemotherapy. Investigators in nine of ten studies concluded that acupressure was effective for pain in patients with dysmenorrhea, during labor, and after trauma. Investigators of four studies concluded that acupressure was effective in the management of dyspnea and investigators in six studies concluded that acupressure was effective in improving fatigue and reducing insomnia in a variety of populations. However, evaluation of the RCT reports indicated a significant likelihood of bias. Conclusion Acupressure may be a useful strategy for the management of multiple symptoms in a variety of patient populations, but rigorous trials are needed. Inclusion of acupressure as an intervention may improve patient outcomes. PMID:21531533

Stepped care versus standard trauma-focused cognitive behavioral therapy for young children

PubMed Central

Salloum, Alison; Wang, Wei; Robst, John; Murphy, Tanya K.; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

2015-01-01

Background Compare the effectiveness and cost of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT), a new service delivery method designed to address treatment barriers, to standard TF-CBT among young children who were experiencing posttraumatic stress symptoms (PTSS). Methods A total of 53 children (ages 3-7 years) who were experiencing PTSS were randomly assigned (2:1) to receive SC-TF-CBT or TF-CBT. Assessments by a blinded evaluator occurred at screening/baseline, after Step One for SC-TF-CBT, post-treatment, and 3-month follow-up. Trial registration: ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01603563 Results There were comparable improvements over time in PTSS and secondary outcomes in both conditions. Non-inferiority of SC-TF-CBT compared to TF-CBT was supported for the primary outcome of PTSS, and the secondary outcomes of severity and internalizing symptoms, but not for externalizing symptoms. There were no statistical differences in comparisons of changes over time from pre- to post-treatment and pre- to 3 month follow-up for PTSD diagnostic status, treatment response or remission. Parent satisfaction was high for both conditions. Costs were 51.3% lower for children in SC-TF-CBT compared to TF-CBT. Conclusions Although future research is needed, preliminary evidence suggests that SC-TF-CBT is comparable to TF-CBT, and delivery costs are significantly less than standard care. SC-TF-CBT may be a viable service delivery system to address treatment barriers. PMID:26443493

Medical interventions for traumatic hyphema

PubMed Central

Gharaibeh, Almutez; Savage, Howard I; Scherer, Roberta W; Goldberg, Morton F; Lindsley, Kristina

2014-01-01

Background Traumatic hyphema is the entry of blood into the anterior chamber (the space between the cornea and iris) subsequent to a blow or a projectile striking the eye. Hyphema uncommonly causes permanent loss of vision. Associated trauma (e.g. corneal staining, traumatic cataract, angle recession glaucoma, optic atrophy, etc.) may seriously affect vision. Such complications may lead to permanent impairment of vision. Patients with sickle cell trait/disease may be particularly susceptible to increases of elevated intraocular pressure. If rebleeding occurs, the rates and severity of complications increase. Objectives To assess the effectiveness of various medical interventions in the management of traumatic hyphema. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMED-LINE (January 1946 to August 2013), EMBASE (January 1980 to August 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 30 August 2013. Selection criteria Two authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. In this review, we included randomized and quasi-randomized trials that compared various medical interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed globe trauma. We applied no restrictions regarding age, gender, severity of the closed globe trauma, or level of visual acuity at the time of enrolment. Data collection and analysis Two authors independently extracted the data for the primary and secondary outcomes. We entered and analyzed data using Review Manager 5. We performed meta-analyses using a fixed-effect model and reported dichotomous outcomes as odds ratios and continuous outcomes as mean differences. Main results We included 20 randomized and seven quasi-randomized studies with 2643 participants in this review. Interventions included antifibrinolytic agents (oral and systemic aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest. No intervention had a significant effect on visual acuity whether measured at two weeks or less after the trauma or at longer time periods. The number of days for the primary hyphema to resolve appeared to be longer with the use of aminocaproic acid compared with no use, but was not altered by any other intervention. Systemic aminocaproic acid reduced the rate of recurrent hemorrhage (odds ratio (OR) 0.25, 95% confidence interval (CI) 0.11 to 0.57), but a sensitivity analysis omitting studies not using an intention-to-treat (ITT) analysis reduced the strength of the evidence (OR 0.41, 95% CI 0.16 to 1.09). We obtained similar results for topical aminocaproic acid (OR 0.42, 95% CI 0.16 to 1.10). We found tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (OR 0.25, 95% CI 0.13 to 0.49), as did aminomethylbenzoic acid as reported in one study (OR 0.07, 95% CI 0.01 to 0.32). The evidence to support an associated reduction in the risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no difference in the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose. The available evidence on usage of corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials. We found no difference in effect between a single versus binocular patch or ambulation versus complete bed rest on the risk of secondary hemorrhage or time to rebleed. Authors’ conclusions Traumatic hyphema in the absence of other intraocular injuries uncommonly leads to permanent loss of vision. Complications resulting from secondary hemorrhage could lead to permanent impairment of vision, especially in patients with sickle cell trait/disease. We found no evidence to show an effect on visual acuity by any of the interventions evaluated in this review. Although evidence was limited, it appears that patients with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhaging. However, hyphema in patients treated with aminocaproic acid take longer to clear. Other than the possible benefits of antifibrinolytic usage to reduce the rate of secondary hemorrhage, the decision to use corticosteroids, cycloplegics, or nondrug interventions (such as binocular patching, bed rest, or head elevation) should remain individualized because no solid scientific evidence supports a benefit. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value. PMID:24302299

Collider bias in trauma comparative effectiveness research: the stratification blues for systematic reviews.

PubMed

Del Junco, Deborah J; Bulger, Eileen M; Fox, Erin E; Holcomb, John B; Brasel, Karen J; Hoyt, David B; Grady, James J; Duran, Sarah; Klotz, Patricia; Dubick, Michael A; Wade, Charles E

2015-05-01

Collider bias, or stratifying data by a covariate consequence rather than cause (confounder) of treatment and outcome, plagues randomised and observational trauma research. Of the seven trials of prehospital hypertonic saline in dextran (HSD) that have been evaluated in systematic reviews, none found an overall between-group difference in survival, but four reported significant subgroup effects. We hypothesised that an avoidable type of collider bias often introduced inadvertently into trauma comparative effectiveness research could explain the incongruous findings. The two most recent HSD trials, a single-site pilot and a multi-site pivotal study, provided data for a secondary analysis to more closely examine the potential for collider bias. The two trials had followed the a priori statistical analysis plan to subgroup patients by a post-randomisation covariate and well-established surrogate for bleeding severity, massive transfusion (MT), ≥ 10 unit of red blood cells within 24h of admission. Despite favourable HSD effects in the MT subgroup, opposite effects in the non-transfused subgroup halted the pivotal trial early. In addition to analyzing the data from the two trials, we constructed causal diagrams and performed a meta-analysis of the results from all seven trials to assess the extent to which collider bias could explain null overall effects with subgroup heterogeneity. As in previous trials, HSD induced significantly greater increases in systolic blood pressure (SBP) from prehospital to admission than control crystalloid (p=0.003). Proportionately more HSD than control decedents accrued in the non-transfused subgroup, but with paradoxically longer survival. Despite different study populations and a span of over 20 years across the seven trials, the reported mortality effects were consistently null, summary RR=0.99 (p=0.864, homogeneity p=0.709). HSD delayed blood transfusion by modifying standard triggers like SBP with no detectable effect on survival. The reported heterogeneous HSD effects in subgroups can be explained by collider bias that trauma researchers can avoid by improved covariate selection and data capture strategies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Earlier Endpoints Are Required for Hemorrhagic Shock Trials among Severely Injured Patients

PubMed Central

Fox, Erin E.; Holcomb, John B.; Wade, Charles E.; Bulger, Eileen M.; Tilley, Barbara C.

2016-01-01

Background Choosing the appropriate endpoint for a trauma hemorrhage control trial can determine the likelihood of its success. Recent Phase 3 trials and observational studies have used 24-hour and/or 30-day all-cause mortality as the primary endpoint and some have not used exception from informed consent (EFIC), resulting in multiple failed trials. Five recent high-quality prospective studies among 4,064 hemorrhaging trauma patients provide new evidence to support earlier primary endpoints. Methods The goal of this project was to determine the optimal endpoint for hemorrhage control trials using existing literature and new analyses of previously published data. Results Recent studies among bleeding trauma patients show that hemorrhagic deaths occur rapidly, at a high rate, and in a consistent pattern. Early preventable deaths among trauma patients are largely due to hemorrhage and the median time to hemorrhagic death from admission is 2.0-2.6 hours. Approximately 85% of hemorrhagic deaths occur within 6 hours. The hourly mortality rate due to traumatic injury decreases rapidly after enrollment from 4.6% per hour at 1 hour post-enrollment to 1% per hour at 6 hours to <0.1% per hour by 9 hours and thereafter. Early primary endpoints (within 6 hours) have critically important benefits for hemorrhage control trials, including being congruent with the median time to hemorrhagic death, biologic plausibility, and enabling the use of all-cause mortality, which is definitive and objective. Conclusions Primary endpoints should be congruent with the timing of the disease process. Therefore, if a resuscitation/hemorrhage control intervention is under study, a primary endpoint of all-cause mortality evaluated within the first 6 hours is appropriate. Before choosing the timing of the primary endpoint for a large multicenter trial, we recommend performing a Phase 2 trial under EFIC to better understand the effects of the hemorrhage control intervention and distribution of time to death. When early primary endpoints are used, patients should be monitored for multiple subsequent secondary safety endpoints, including 24 hour and 30 day all-cause mortality as well as the customary safety endpoints. PMID:28207628

Empirical support for the definition of a complex trauma event in children and adolescents.

PubMed

Wamser-Nanney, Rachel; Vandenberg, Brian R

2013-12-01

Complex trauma events have been defined as chronic, interpersonal traumas that begin early in life (Cook, Blaustein, Spinazzola, & van der Kolk, 2003). The complex trauma definition has been examined in adults, as indicated by the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) field trial; however, this research was lacking in child populations. The symptom presentations of complexly traumatized children were contrasted with those exposed to other, less severe trauma ecologies that met 1 or 2 features of the complex trauma definition. Included in this study were 346 treatment-seeking children and adolescents (ages 3–18 years) who had experienced atraumatic event. Results indicated that child survivors of complex trauma presented with higher levels of generalized behavior problems and trauma-related symptoms than those who experienced (a) acute noninterpersonal trauma, (b) chronic interpersonal trauma that begins later in life, and (c) acute interpersonal trauma. Greater levels of behavioral problems were observed in children exposed to complex trauma as compared to those who experienced a traumatic event that begins early in life. These results provide support for the complex trauma event definition and suggest the need for a complex trauma diagnostic construct for children and adolescents.

RANDOMIZED CONTROLLED TRIALS IN ORTHOPEDICS AND TRAUMATOLOGY: SYSTEMATIC ANALYSIS ON THE NATIONAL EVIDENCE

PubMed Central

de Moraes, Vinícius Ynoe; Moreira, Cesar Domingues; Tamaoki, Marcel Jun Sugawara; Faloppa, Flávio; Belloti, Joao Carlos

2015-01-01

Objective: To assess whether there has been any improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through the application of standardized and validated scores. Methods: We electronically selected all RCTs published in the two indexed Brazilian journals that focus on orthopedics, over the period 2000-2009: Acta Ortopédica Brasileira (AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers in accordance with the Jadad scale and the Cochrane Bone, Joint and Muscle Trauma Group score. The studies selected were grouped as follows: 1) publication period (2000-2004 or 2004-2009); 2) journal of publication (AOB or RBO). Results: Twenty-two papers were selected: 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportions (nRCT/nTotal of published papers) of RCTs published in the two journals (p = 0.458), or in the Jadad score (p = 0.722) and Cochrane score (p = 0.630). Conclusion: The relative quality and quantity of RCTs in the journals analyzed were similar. There was a trend towards improvement of quality, but there was no increase in the number of RCTs between the two periods analyzed. PMID:27026971

Augmenting cognitive processing therapy to improve sleep impairment in PTSD: A randomized controlled trial.

PubMed

Galovski, Tara E; Harik, Juliette M; Blain, Leah M; Elwood, Lisa; Gloth, Chelsea; Fletcher, Thomas D

2016-02-01

Despite the success of empirically supported treatments for posttraumatic stress disorder (PTSD), sleep impairment frequently remains refractory after treatment. This single-site, randomized controlled trial examined the effectiveness of sleep-directed hypnosis as a complement to an empirically supported psychotherapy for PTSD (cognitive processing therapy [CPT]). Participants completed either 3 weeks of hypnosis (n = 52) or a symptom monitoring control condition (n = 56) before beginning standard CPT. Multilevel modeling was used to investigate differential patterns of change to determine whether hypnosis resulted in improvements in sleep, PTSD, and depression. An intervening variable approach was then used to determine whether improvements in sleep achieved during hypnosis augmented change in PTSD and depression during CPT. After the initial phase of treatment (hypnosis or symptom monitoring), the hypnosis condition showed significantly greater improvement than the control condition in sleep and depression, but not PTSD. After CPT, both conditions demonstrated significant improvement in sleep and PTSD; however, the hypnosis condition demonstrated greater improvement in depressive symptoms. As sleep improved, there were corresponding improvements in PTSD and depression, with a stronger relationship between sleep and PTSD. Hypnosis was effective in improving sleep impairment, but those improvements did not augment gains in PTSD recovery during the trauma-focused intervention. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The effect of paramedic training on pre-hospital trauma care (EPPTC-study): a study protocol for a prospective semi-qualitative observational trial

PubMed Central

2014-01-01

Background Accidents are the leading cause of death in adults prior to middle age. The care of severely injured patients is an interdisciplinary challenge. Limited evidence is available concerning pre-hospital trauma care training programs and the advantage of such programs for trauma patients. The effect on trauma care procedures or on the safety of emergency crews on the scene is limited; however, there is a high level of experience and expert opinion. Methods I – Video-recorded case studies are the basis of an assessment tool and checklist being developed to verify the results of programs to train participants in the care of seriously injured patients, also known as “objective structured clinical examination” (OSCE). The timing, completeness and quality of the individual measures are assessed using appropriate scales. The evaluation of team communication and interaction will be analyzed with qualitative methods and quantified and verified by existing instruments (e.g. the Clinical Team Scale). The developed assessment tool is validated by several experts in the fields of trauma care, trauma research and medical education. II a) In a German emergency medical service, the subjective assessment of paramedics of their pre-hospital care of trauma patients is evaluated at three time points, namely before, immediately after and one year after training. b) The effect of a standardized course concept on the quality of documentation in actual field operations is determined based on three items relevant to patient safety before and after the course. c) The assessment tool will be used to assess the effect of a standardized course concept on procedures and team communication in pre-hospital trauma care using scenario-based case studies. Discussion This study explores the effect of training on paramedics. After successful study completion, further multicenter studies are conceivable, which would evaluate emergency-physician staffed teams. The influence on the patients and prehospital measures should be assessed based on a retrospective analysis of the emergency room data. Trials registration German Clinical Trials Register, ID DRKS00004713. PMID:24528532

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755.

Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial.

PubMed

Viveen, Jetske; Doornberg, Job N; Kodde, Izaak F; Goossens, Pjotr; Koenraadt, Koen L M; The, Bertram; Eygendaal, Denise

2017-11-22

The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program. If conservative treatment fails, an operative release of the posttraumatic stiff elbow is often performed. The best Evidence-Based rehabilitation protocol for patients after an operative release is unknown to date and differs per surgeon, hospital and country. Options include early- or delayed motion supervised by a physical therapist, immediate continuous passive motion (CPM), (night) splinting and a static progressive or dynamic splinting program. The SET-Study (Stiff Elbow Trial) is a single-centre, prospective, randomized controlled trial. The primary objective of this study is to compare the active Range of Motion (ROM) (flexion arc and rotational arc) twelve months after surgery between three groups. The first group will receive in-hospital CPM in combination with early motion Physical Therapy (PT) supervised by a physical therapist, the second group will receive only in-hospital early motion PT supervised by a physical therapist and the third group will receive outpatient supervised PT from postoperative day seven till ten. Secondary outcome measures will be Patient Reported Outcome Measures (PROMs) including the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), the quick Disabilities of Arm, Shoulder and Hand (qDASH) score, Visual Analogue pain Scale in rest and activity (VAS), Pain Catastrophizing Scale (PCS), the Short Form (SF)-36, the Centre for Epidemiological Studies Depression Scale Revised (CESD-R) and the Work Rehabilitation Questionnaire (WORQ) for the upper limb. A successful completion of this trial will provide evidence on the best rehabilitation protocol in order to (re)gain optimal motion after surgical release of the stiff elbow. The trial is registered at the Dutch Trial Register: NTR6067 , 31-8-2016.

Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change.

PubMed

Kangaslampi, Samuli; Garoff, Ferdinand; Peltonen, Kirsi

2015-06-17

Millions of children worldwide suffer from posttraumatic stress disorder (PTSD) symptoms and other mental health problems due to repeated exposure to war or organized violence. Forms of cognitive-behavioral therapy (CBT) are the most commonly used treatment for PTSD and appear to be effective for children as well, but little is known about the mechanisms of change through which they achieve their effectiveness. Here we present the study protocol of a randomized controlled trial (RCT) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy (NET), a CBT-based, manualized, short-term intervention for PTSD symptoms resulting from repeated traumatization, in immigrant children traumatized by war. We are conducting a multicentre, pragmatic RCT in a usual care setting. Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention (NET) and control (treatment as usual, TAU) groups of equal sizes. The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group, on the primary outcomes of PTSD and depressive symptoms, psychological distress, resilience, and level of cognitive performance. The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness. The possible moderating effects of peritraumatic dissociation, level of cognitive performance, and gender on treatment effectiveness will also be considered. We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience, and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions. The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war. The trial will also generate insights into the complex relationships between PTSD, memory functions, posttraumatic cognitions and cognitive performance in children, and help guide the future development and implementation of therapeutic interventions for PTSD in children. ClinicalTrials.gov NCT02425280 . Registered 15 April 2015.

Clinical Decision Support for a Multicenter Trial of Pediatric Head Trauma

PubMed Central

Swietlik, Marguerite; Deakyne, Sara; Hoffman, Jeffrey M.; Grundmeier, Robert W.; Paterno, Marilyn D.; Rocha, Beatriz H.; Schaeffer, Molly H; Pabbathi, Deepika; Alessandrini, Evaline; Ballard, Dustin; Goldberg, Howard S.; Kuppermann, Nathan; Dayan, Peter S.

2016-01-01

Summary Introduction For children who present to emergency departments (EDs) due to blunt head trauma, ED clinicians must decide who requires computed tomography (CT) scanning to evaluate for traumatic brain injury (TBI). The Pediatric Emergency Care Applied Research Network (PECARN) derived and validated two age-based prediction rules to identify children at very low risk of clinically-important traumatic brain injuries (ciTBIs) who do not typically require CT scans. In this case report, we describe the strategy used to implement the PECARN TBI prediction rules via electronic health record (EHR) clinical decision support (CDS) as the intervention in a multicenter clinical trial. Methods Thirteen EDs participated in this trial. The 10 sites receiving the CDS intervention used the Epic® EHR. All sites implementing EHR-based CDS built the rules by using the vendor’s CDS engine. Based on a sociotechnical analysis, we designed the CDS so that recommendations could be displayed immediately after any provider entered prediction rule data. One central site developed and tested the intervention package to be exported to other sites. The intervention package included a clinical trial alert, an electronic data collection form, the CDS rules and the format for recommendations. Results The original PECARN head trauma prediction rules were derived from physician documentation while this pragmatic trial led each site to customize their workflows and allow multiple different providers to complete the head trauma assessments. These differences in workflows led to varying completion rates across sites as well as differences in the types of providers completing the electronic data form. Site variation in internal change management processes made it challenging to maintain the same rigor across all sites. This led to downstream effects when data reports were developed. Conclusions The process of a centralized build and export of a CDS system in one commercial EHR system successfully supported a multicenter clinical trial. PMID:27437059

Predictors of attrition from an expressive writing intervention for sexual abuse survivors.

PubMed

Harte, Christopher B; Hamilton, Lisa D; Meston, Cindy M

2013-01-01

This study examined predictors of attrition from a clinical trial examining the effects of an expressive writing intervention for sexual problems among female survivors of child sexual abuse. Participants were 124 women all reporting sexual difficulties, who were randomized to a trauma-focused condition (n = 45), an experimental sexual schema-focused condition (n = 37), or a control condition (n = 42). Thirty-five women (28%) dropped out before completing posttreatment assessments. Younger age, less education, and increased use of positive coping strategies were each independently associated with dropout. Results have implications for both researchers and clinicians working with this population, and it is hoped that these data can help bolster retention of those who are more likely to discontinue treatment.

Platelet Activation after Presyncope by Lower Body Negative Pressure in Humans

DTIC Science & Technology

2014-12-29

present study may exacerbate bleeding after trauma and explain the beneficial effect of early treatment with antifibrinolytics, e.g. tranexamic acid [31... tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 377: 1096–101, 1101. Central

The effect of perineal control with hands-on and hand-poised methods on perineal trauma and delivery outcome

PubMed Central

Foroughipour, Azam; Firuzeh, Farah; Ghahiri, Ataolah; Norbakhsh, Vajihe; Heidari, Tayebeh

2011-01-01

BACKGROUND: The objective of the present study was to evaluate the effect of the two methods of delivery, “hands-on” vs. “hands poised”, on perineal trauma and delivery outcome in primiparous women referred to Shariati Hospital of Isfahan during 2007-2008. METHODS: In a clinical trial study, 100 low risk primiparous pregnant women were randomly assigned to two hands-on and hand-poised (hands-off) groups. In the hands-on group, this method was used to control fetal head in the second stage of labor. It means that the fingers of one hand supported fetal occiput and the other hand applied slight pressure on the head to control the delivery of the head during the crowning process. In the hands-poised group, midwife observed the parturient woman and do not touch perineum during the second labor stage while fetal head was delivering. Then, the two groups were compared in terms of perineal trauma, as well as neonatal and delivery outcome. RESULTS: Demographic characteristics of all studied women were similar in two groups. The rate of episiotomy was higher in hands-on group (84% vs. 40%, p = 0.001). The rate of postpartum hemorrhage (4th stage) was higher in hands-on group (12% vs. 4%, p = 0.04). The rate of mild and moderate postpartum pain in hands-on group was higher than hands-off group (70% vs. 58% and 29% vs. 10%, p < 0.001) but sever pain was not different in two groups. CONCLUSIONS: It seems that hands-poised method is associated with less perineal trauma, particularly regarding the lower need for episiotomy and postpartum hemorrhage. PMID:22279480

Time to wound closure in trauma patients with disorders in wound healing is shortened by supplements containing antioxidant micronutrients and glutamine: a PRCT.

PubMed

Blass, Sandra C; Goost, Hans; Tolba, René H; Stoffel-Wagner, Birgit; Kabir, Koroush; Burger, Christof; Stehle, Peter; Ellinger, Sabine

2012-08-01

: We hypothesize that wound closure in trauma patients with disorders in wound healing is accelerated by supplementation of antioxidant micronutrients and glutamine. In a randomized, double-blind, placebo-controlled trial, 20 trauma patients with disorders in wound healing were orally supplemented with antioxidant micronutrients (ascorbic acid, α-tocopherol, β-carotene, zinc, selenium) and glutamine (verum) or they received isoenergetic amounts of maltodextrine (placebo) for 14 days. Plasma/serum levels of micronutrients, glutamine, and vascular endothelial growth factor-A (VEGF-A) were determined before and after supplementation. In the wound, several parameters of microcirculation were measured. Time from study entry to wound closure was recorded. Micronutrients in plasma/serum did not change except for selenium which increased in the verum group (1.1 ± 0.2 vs. 1.4 ± 0.2 μmol/l; P = 0.009). Glutamine decreased only in the placebo group (562 ± 68 vs. 526 ± 55 μmol/l; P = 0.047). The prevalence of hypovitaminoses and the concentration of VEGF-A did not change. Considering microcirculation, only O(2)-saturation decreased in the placebo group (56.7 ± 23.4 vs. 44.0 ± 24.0 [arbitrary units]; P = 0.043). Wound closure occurred more rapidly in the verum than in the placebo group (35 ± 22 vs. 70 ± 35 d; P = 0.01). Time to wound closure can be shortened by oral antioxidant and glutamine containing supplements in trauma patients with disorders in wound healing. Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Onset of Coagulation Function Recovery Is Delayed in Severely Injured Trauma Patients with Venous Thromboembolism.

PubMed

McCully, Belinda H; Connelly, Christopher R; Fair, Kelly A; Holcomb, John B; Fox, Erin E; Wade, Charles E; Bulger, Eileen M; Schreiber, Martin A

2017-07-01

Altered coagulation function after trauma can contribute to development of venous thromboembolism (VTE). Severe trauma impairs coagulation function, but the trajectory for recovery is not known. We hypothesized that enhanced, early recovery of coagulation function increases VTE risk in severely injured trauma patients. Secondary analysis was performed on data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, excluding patients who died within 24 hours or were on pre-injury anticoagulants. Patient characteristics, adverse outcomes, and parameters of platelet function and coagulation (thromboelastography) were compared from admission to 72 hours between VTE (n = 83) and non-VTE (n = 475) patients. A p value < 0.05 indicates significance. Despite similar patient demographics, VTE patients exhibited hypercoagulable thromboelastography parameters and enhanced platelet function at admission (p < 0.05). Both groups exhibited hypocoagulable thromboelastography parameters, platelet dysfunction, and suppressed clot lysis (low clot lysis at 30 minutes) 2 hours after admission (p < 0.05). The VTE patients exhibited delayed coagulation recovery (a significant change compared with 2 hours) of K-value (48 vs 24 hours), α-angle (no recovery), maximum amplitude (24 vs 12 hours), and clot lysis at 30 minutes (48 vs 12 hours). Platelet function recovery mediated by arachidonic acid (72 vs 4 hours), ADP (72 vs 12 hours), and collagen (48 vs 12 hours) was delayed in VTE patients. The VTE patients had lower mortality (4% vs 13%; p < 0.05), but fewer hospital-free days (0 days [interquartile range 0 to 8 days] vs 10 days [interquartile range 0 to 20 days]; p < 0.05) and higher complication rates (p < 0.05). Recovery from platelet dysfunction and coagulopathy after severe trauma were delayed in VTE patients. Suppressed clot lysis and compensatory mechanisms associated with altered coagulation that can potentiate VTE formation require additional investigation. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Process analysis of trauma-focused cognitive behavioural therapy for individuals with schizophrenia.

PubMed

O'Driscoll, Ciarán; Mason, Oliver; Brady, Francesca; Smith, Ben; Steel, Craig

2016-06-01

Therapeutic alliance, modality, and ability to engage with the process of therapy have been the main focus of research into what makes psychotherapy successful. Individuals with complex trauma histories or schizophrenia are suggested to be more difficult to engage and may be less likely to benefit from therapy. This study aimed to track the in-session 'process' of working alliance and emotional processing of trauma memories for individuals with schizophrenia. The study utilized session recordings from the treatment arm of an open randomized clinical trial investigating trauma-focused cognitive behavioural therapy (TF-CBT) for individuals with schizophrenia (N = 26). Observer measures of working alliance, emotional processing, and affect arousal were rated at early and late phases of therapy. Correlation analysis was undertaken for process measures. Temporal analysis of expressed emotions was also reported. Working alliance was established and maintained throughout the therapy; however, agreement on goals reduced at the late phase. The participants appeared to be able to engage in emotional processing, but not to the required level for successful cognitive restructuring. This study undertook novel exploration of process variables not usually explored in CBT. It is also the first study of process for TF-CBT with individuals with schizophrenia. This complex clinical sample showed no difficulty in engagement; however, they may not be able to fully undertake the cognitive-emotional demands of this type of therapy. Clinical and research implications and potential limitations of these methods are considered. This sample showed no difficulties engaging with TF-CBT and forming a working alliance. However, the participants may not have achieved a level of active involvement required for successful cognitive restructuring of trauma memories. This discrepancy may relate to the mediating role of both working alliance and cognitive-emotional processing. The results underscore the importance of therapists understanding the relationship between alliance and other process factors which may be implicit in facilitating change. © 2015 The British Psychological Society.

Deep venous thrombosis prophylaxis in trauma: improved compliance with a novel miniaturized pneumatic compression device.

PubMed

Murakami, Maki; McDill, Tandace L; Cindrick-Pounds, Lori; Loran, David B; Woodside, Kenneth J; Mileski, William J; Hunter, Glenn C; Killewich, Lois A

2003-11-01

Intermittent pneumatic compression (IPC) devices prevent lower-extremity deep venous thrombosis (LEDVT) when used properly, but compliance remains an issue. Devices are frequently discontinued when patients are out of bed, and they are rarely used in emergency departments. Trauma patients are at high risk for LEDVT; however, IPCs are underused in this population because of compliance limitations. The hypothesis of this study was that a new miniaturized, portable, battery-powered pneumatic compression device improves compliance in trauma patients over that provided by a standard device. This was a prospective trial in which trauma patients (mean age, 46 years; revised trauma score, 11.7) were randomized to DVT prophylaxis with a standard calf-length sequential IPC device (SCD group) or a miniaturized sequential device (continuous enhanced-circulation therapy [CECT] group). The CECT device can be battery-operated for up to 6 hours and worn during ambulation. Timers attached to the devices, which recorded the time each device was applied to the legs and functioning, were used to quantify compliance. For each subject in each location during hospitalization, compliance rates were determined by dividing the number of minutes the device was functioning by the total minutes in that location. Compliance rates for all subjects were averaged in each location: emergency department, operating room, intensive care unit, and nursing ward. Total compliance rate in the CECT group was significantly higher than in the SCD group (77.7% vs. 58.9%, P =.004). Compliance in the emergency department and nursing ward were also significantly greater with the CECT device (P =.002 and P =.008 respectively). Previous studies have demonstrated that reduced compliance with IPC devices results in a higher incidence of LEDVT. Given its ability to improve compliance, the CECT may provide superior DVT prevention compared with that provided by standard devices.

A randomized trial of teen online problem solving for improving executive function deficits following pediatric traumatic brain injury.

PubMed

Wade, Shari L; Walz, Nicolay C; Carey, JoAnne; Williams, Kendra M; Cass, Jennifer; Herren, Luke; Mark, Erin; Yeates, Keith Owen

2010-01-01

To examine the efficacy of teen online problem solving (TOPS) in improving executive function (EF) deficits following traumatic brain injury (TBI) in adolescence. Families of adolescents (aged 11-18 years) with moderate to severe TBI were recruited from the trauma registry of 2 tertiary-care children's hospitals and then randomly assigned to receive TOPS (n = 20), a cognitive-behavioral, skill-building intervention, or access to online resources regarding TBI (Internet resource comparison; n = 21). Parent and teen reports of EF were assessed at baseline and a posttreatment follow-up (mean = 7.88 months later). Improvements in self-reported EF skills were moderated by TBI severity, with teens with severe TBI in the TOPS treatment reporting significantly greater improvements than did those with severe TBI in the Internet resource comparison. The treatment groups did not differ on parent ratings of EF at the follow up. Findings suggest that TOPS may be effective in improving EF skills among teens with severe TBI.

Enhancing Risk Detection Among Homeless Youth: A Randomized Clinical Trial of a Promising Pilot Intervention.

PubMed

Bender, Kimberly A; DePrince, Anne; Begun, Stephanie; Hathaway, Jessica; Haffejee, Badiah; Schau, Nicholas

2016-03-02

Homeless youth frequently experience victimization, and youth with histories of trauma often fail to detect danger risks, making them vulnerable to subsequent victimization. The current study describes a pilot test of a skills-based intervention designed to improve risk detection among homeless youth through focusing attention to internal, interpersonal, and environmental cues. Youth aged 18 to 21 years (N = 74) were recruited from a shelter and randomly assigned to receive usual case management services or usual services plus a 3-day manualized risk detection intervention. Pretest and posttest interviews assessed youths' risk detection abilities through vignettes describing risky situations and asking youth to identify risk cues present. Separate 2 (intervention vs. control) × 2 (pretest vs. posttest) mixed ANOVAs found significant interaction effects, as intervention youth significantly improved in overall risk detection compared with control youth. Post hoc subgroup analyses found the intervention had a greater effect for youth without previous experiences of indirect victimization than those with previous indirect victimization experiences. © The Author(s) 2016.

The Effect of Warm Compress Bistage Intervention on the Rate of Episiotomy, Perineal Trauma, and Postpartum Pain Intensity in Primiparous Women with Delayed Valsalva Maneuver Referring to the Selected Hospitals of Shiraz University of Medical Sciences in 2012-2013.

PubMed

Akbarzadeh, Marzieh; Vaziri, Faride; Farahmand, Mahnaz; Masoudi, Zahra; Amooee, Sedigheh; Zare, Najaf

2016-02-01

Genital trauma during vaginal delivery may result from episiotomy, spontaneous perineal tears (perineum, vagina), or both. In 2012, this study aimed to investigate the effect of warm compress bistage intervention on the rate of episiotomy, perineal trauma, and postpartum pain intensity in the primiparous woman with delayed Valsalva maneuver. In this randomized clinical trial, which was performed in hospitals in Shiraz, Iran, in 2012-2013, 150 women were randomly divided into 2 groups: 1 intervention and 1 control. The intervention group received warm compress bistage intervention at 7-cm and 10-cm dilatation and zero position during the first and second stages of labor for 15 to 20 minutes, whereas the control group received the hospitals' routine care. After delivery, the prevalence of episiotomy; intact perineum; location, degree, and length of rupture; and postpartum pain intensity were assessed in the 2 groups. Following that, the data were analyzed with SPSS statistical software (version 16) using χ test, t test, and odds ratio. The results revealed a significant difference between the intervention and control groups regarding the frequency of intact perinea (27% vs 6.7%) and the frequency of episiotomy (45% vs 90.70%). In addition, the frequency of the location of rupture (P = .019), mean length of episiotomy incision (P = .02), and mean intensity of pain the day after delivery (P < .001) were significantly lower in the intervention group compared with the control group. However, the rate of ruptures was higher in the intervention group. Warm compress bistage intervention was effective in reducing episiotomies and the mean length of episiotomy incision, reducing pain after delivery, and increasing the rate of intact perinea. However, the rate of ruptures slightly increased in the intervention group compared with the control group.

Physical properties of root cementum: part 24. Root resorption of the first premolars after 4 weeks of occlusal trauma.

PubMed

Cakmak, Fethiye; Turk, Tamer; Karadeniz, Ersan Ilsay; Elekdag-Turk, Selma; Darendeliler, M Ali

2014-05-01

In orthodontics, adding restorative materials on occlusal or lingual surfaces is a common method to create a mini-biteplane to increase patients' vertical dimension temporarily to facilitate several treatment procedures. However, this method transmits excessive occlusal forces through the periodontal ligament and causes trauma. In this prospective randomized clinical trial, we measured and compared quantitatively the volumes of root resorption after 4 weeks of occlusal trauma. Forty-eight maxillary and mandibular first premolars of 12 patients (6 girls, 6 boys) comprised the sample for this study. One side of each patient was randomly selected as the control. On the contralateral side, a light-cured glass ionomer cement (Transbond Plus Light Cure Band Adhesive; 3M Unitek, Monrovia, Calif) was bonded onto the occlusal surface of the mandibular first premolar so that the cement was in contact with the maxillary first premolar. After 4 weeks, both first premolars were extracted. Each sample was imaged using a microcomputed tomography system (1172; SkyScan, Aartselaar, Belgium) and analyzed with specially designed software for volumetric measurements of resorption craters. Furthermore, pain was evaluated with a visual analog scale for 7 days. There were significant differences in the amounts of root resorption between the control and the experimentally traumatized teeth. No significant difference among the buccal, lingual, mesial, and distal surfaces was found in either jaw. Furthermore, no significant difference existed in the amount of root resorption among the cervical, middle, and apical thirds of both jaws. There was no correlation between age, sex, volume of the root resorption craters, and pain. Restorative buildups, used to increase the vertical dimension by 2 mm for 4 weeks, caused root resorption along the sides of the teeth during the active bite-increase period. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Prophylactic antibiotics for penetrating abdominal trauma.

PubMed

Brand, Martin; Grieve, Andrew

2013-11-18

Penetrating abdominal trauma occurs when the peritoneal cavity is breached. Routine laparotomy for penetrating abdominal injuries began in the 1800s, with antibiotics first being used in World War II to combat septic complications associated with these injuries. This practice was marked with a reduction in sepsis-related mortality and morbidity. Whether prophylactic antibiotics are required in the prevention of infective complications following penetrating abdominal trauma is controversial, however, as no randomised placebo controlled trials have been published to date. There has also been debate about the timing of antibiotic prophylaxis. In 1972 Fullen noted a 7% to 11% post-surgical infection rate with pre-operative antibiotics, a 33% to 57% infection rate with intra-operative antibiotic administration and 30% to 70% infection rate with only post-operative antibiotic administration. Current guidelines state there is sufficient class I evidence to support the use of a single pre-operative broad spectrum antibiotic dose, with aerobic and anaerobic cover, and continuation (up to 24 hours) only in the event of a hollow viscus perforation found at exploratory laparotomy. To assess the benefits and harms of prophylactic antibiotics administered for penetrating abdominal injuries for the reduction of the incidence of septic complications, such as septicaemia, intra-abdominal abscesses and wound infections. Searches were not restricted by date, language or publication status. We searched the following electronic databases: the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2013, issue 12 of 12), MEDLINE (OvidSP), Embase (OvidSP), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), ISI Web of Science: Conference Proceedings Citation Index- Science (CPCI-S) and PubMed. Searches were last conducted in January 2013. All randomised controlled trials of antibiotic prophylaxis in patients with penetrating abdominal trauma versus no antibiotics or placebo. Two authors screened the literature search results independently. We identified no trials meeting the inclusion criteria. There is currently no information from randomised controlled trials to support or refute the use of antibiotics for patients with penetrating abdominal trauma.

Development, Evaluation and Implementation of Chief Complaint Groupings to Activate Data Collection: A Multi-Center Study of Clinical Decision Support for Children with Head Trauma.

PubMed

Deakyne, S J; Bajaj, L; Hoffman, J; Alessandrini, E; Ballard, D W; Norris, R; Tzimenatos, L; Swietlik, M; Tham, E; Grundmeier, R W; Kuppermann, N; Dayan, P S

2015-01-01

Overuse of cranial computed tomography scans in children with blunt head trauma unnecessarily exposes them to radiation. The Pediatric Emergency Care Applied Research Network (PECARN) blunt head trauma prediction rules identify children who do not require a computed tomography scan. Electronic health record (EHR) based clinical decision support (CDS) may effectively implement these rules but must only be provided for appropriate patients in order to minimize excessive alerts. To develop, implement and evaluate site-specific groupings of chief complaints (CC) that accurately identify children with head trauma, in order to activate data collection in an EHR. As part of a 13 site clinical trial comparing cranial computed tomography use before and after implementation of CDS, four PECARN sites centrally developed and locally implemented CC groupings to trigger a clinical trial alert (CTA) to facilitate the completion of an emergency department head trauma data collection template. We tested and chose CC groupings to attain high sensitivity while maintaining at least moderate specificity. Due to variability in CCs available, identical groupings across sites were not possible. We noted substantial variability in the sensitivity and specificity of seemingly similar CC groupings between sites. The implemented CC groupings had sensitivities greater than 90% with specificities between 75-89%. During the trial, formal testing and provider feedback led to tailoring of the CC groupings at some sites. CC groupings can be successfully developed and implemented across multiple sites to accurately identify patients who should have a CTA triggered to facilitate EHR data collection. However, CC groupings will necessarily vary in order to attain high sensitivity and moderate-to-high specificity. In future trials, the balance between sensitivity and specificity should be considered based on the nature of the clinical condition, including prevalence and morbidity, in addition to the goals of the intervention being considered.

Mental practice: a simple tool to enhance team-based trauma resuscitation.

PubMed

Lorello, Gianni R; Hicks, Christopher M; Ahmed, Sana-Ara; Unger, Zoe; Chandra, Deven; Hayter, Megan A

2016-03-01

Effective trauma resuscitation requires the coordinated efforts of an interdisciplinary team. Mental practice (MP) is defined as the mental rehearsal of activity in the absence of gross muscular movements and has been demonstrated to enhance acquiring technical and procedural skills. The role of MP to promote nontechnical, team-based skills for trauma has yet to be investigated. We randomized anaesthesiology, emergency medicine, and surgery residents to two-member teams randomly assigned to either an MP or control group. The MP group engaged in 20 minutes of MP, and the control group received 20 minutes of Advanced Trauma Life Support (ATLS) training. All teams then participated in a high-fidelity simulated adult trauma resuscitation and received debriefing on communication, leadership, and teamwork. Two blinded raters independently scored video recordings of the simulated resuscitations using the Mayo High Performance Teamwork Scale (MHPTS), a validated team-based behavioural rating scale. The Mann-Whitney U-test was used to assess for between-group differences. Seventy-eight residents provided informed written consent and were recruited. The MP group outperformed the control group with significant effect on teamwork behaviour as assessed using the MHPTS: r=0.67, p<0.01. MP leads to improvement in team-based skills compared to traditional simulation-based trauma instruction. We feel that MP may be a useful and inexpensive tool for improving nontechnical skills instruction effectiveness for team-based trauma care.

The incidence of thromboembolism formation following the use of recombinant factor VIIa in patients suffering from blunt force trauma compared with penetrating trauma: a systematic review.

PubMed

Devlin, Raymond; Bonanno, Laura; Badeaux, Jennifer

2016-03-01

Rapid replacement of blood loss is critical in patients suffering from traumatic hemorrhage. When the availability of blood products is limited, certain interventions have shown promise in conserving blood supplies. Recombinant factor (rF) VIIa has been administered, as an off-label use, to assist in controlling hemorrhage in trauma patients. Although rFVIIa has a tendency to remain localized to areas of vascular insult, there may be an increase in thromboembolism formation when patients suffer multiple sites of injury as seen in blunt force trauma. This review aimed to synthesize the best available evidence regarding the incidence of thromboembolism formation after receiving rFVIIa as an adjunct to hemorrhage control measures (standard resuscitation efforts consisting of varying amounts of packed red blood cells [PRBCs], fresh frozen plasma [FFP], platelets and crystalloid solutions) in patients suffering from traumatic injuries (blunt force and penetrating trauma). Civilian and combat trauma patients who were 15 years and older suffering from blunt force and penetrating traumatic injuries. Use of rFVIIa as an adjunct to hemorrhage control measures (standard resuscitation efforts consisting of varying amounts of PRBCs, FFP, platelets and crystalloid solutions). This review considered both experimental and epidemiological study designs. Confirmed formation of thromboembolism (confirmation based on specific diagnostic tests such as ultrasound, ventilation-perfusion scan or angiography). The databases searched included CINAHL, Ovid MEDLINE, Web of Science, EMBASE and the Cochrane Control Register of Clinical Trials. Studies published after June 1986 were considered for inclusion in this review. Search for unpublished studies was performed. Studies selected for inclusion were critically appraised by two independent reviewers using standardized critical appraisal instruments from the Joanna Briggs Institute (JBI). Data was extracted from articles using standardized data extraction instruments from the JBI. Quantitative results were pooled in statistical meta-analysis using the Joanna Briggs software for meta-analysis. Two studies with a total of 831 participants were included. Both the studies were randomized, placebo-controlled, double-blind trials. No studies of combat trauma patients met the inclusion criteria for this review. A meta-analysis was performed. In blunt force trauma patients, the incidence of thromboembolism formation on administering rFVIIa revealed an overall relative risk of 1.17 with a 95% confidence interval (CI) from 0.77 to 1.79; results not statistically significant (P = 0.4594); large CI and imprecise estimate. In penetrating trauma patients, the incidence of thromboembolism formation on administering rFVIIa revealed an overall relative risk of 0.77 with a 95% CI from 0.27 to 2.20; results not statistically significant (P = 0.6242); very large CI and imprecise estimate. The estimates of the effects are imprecise, results are compatible with effects in opposite directions, increase or decrease of thromboembolism formation, and an increase of thromboembolism formation cannot be excluded. When rFVIIa is administered to trauma patients, there does not appear to be an increased risk of thromboembolism formation favoring one type of injury over the other (blunt force versus penetrating trauma). Owing to large CIs and imprecise estimates, the overall risk of thromboembolism cannot be excluded. The use of rFVIIa does appear to decrease the overall need for blood products in trauma patients with no statistically significant improvement in survival rates. With the high cost of rFVIIa, its use is limited to those facilities that can afford it. In situations wherein blood supply is limited, rFVIIa could conserve limited supplies of blood products with no difference in thromboembolism risk between blunt force versus penetrating trauma, but the high cost will ultimately limit its use to facilities that can afford it. The use of rFVIIa in blunt force and penetrating trauma patients has a JBI Grade B Recommendation (Appendix I). This review excluded patients receiving pharmacologic anticoagulation such as warfarin sodium or heparin. The actions of these drugs will most likely counteract the desired coagulation effect of rFVIIa. Many studies do not account for the effects of rFVIIa in trauma patients receiving pharmacologic anticoagulation and this could be a future area of research.

Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial.

PubMed

Laaninen, Matias; Sand, Juhani; Nordback, Isto; Vasama, Kaija; Laukkarinen, Johanna

2016-11-01

The aim of this study was to study whether post-pancreaticoduodenectomy complications (PPDC) in high-risk patients can be reduced with hydrocortisone. Soft pancreas is a well-known risk factor for PPDC. Previously, we have shown that patients with >40% acini in the pancreatic transection line are most prone to PPDC. Recent studies have demonstrated that surgical trauma leads to inflammation of the pancreatic remnant, which precedes PPDC. On the basis of power analysis, randomized controlled trial (RCT) (Clinicaltrials.gov NCT01460615), 155 patients (February 2011-May 2015) scheduled for pancreaticoduodenectomy were randomized to intravenous (i.v.) treatment with hydrocortisone 100 mg or placebo. All patients received the first dose at the induction of anesthesia. During the operation, the percentage of acini was calculated from pancreatic transection line frozen samples by a pathologist. As planned, only the high-risk patients with >40% acini (n = 62) continued in the study to receive in total 8 doses of randomization-based hydrocortisone/placebo every 8 hours. Primary endpoints were urine trypsinogen positive days and overall complications (Clavien-Dindo III-IV). Postoperative pancreatic fistulas (POPFs), postpancreatectomy hemorrhage (PPH), and delayed gastric emptying (DGE) were also graded. Hydrocortisone treatment did not alter trypsinogen release (2 or more positive days 46% vs 50%), but it significantly reduced overall complications compared with placebo in the high-risk patients (18% vs 41%; P < 0.05; Clavien-Dindo III-IV). Also, clinically significant POPF (11% vs 27%), PPH (14% vs 24%), and DGE (29% vs 44%) tended to be lower in the hydrocortisone group. Ninety-day mortality was zero. This RCT shows that in high-risk patients, overall PPDC can be significantly reduced with hydrocortisone treatment. Inflammation may be an important mediator of PPDC.

Predicting and Preventing Loss to Follow-up of Adult Trauma Patients in Randomized Controlled Trials: An Example from the FLOW Trial.

PubMed

Madden, Kim; Scott, Taryn; McKay, Paula; Petrisor, Brad A; Jeray, Kyle J; Tanner, Stephanie L; Bhandari, Mohit; Sprague, Sheila

2017-07-05

High loss-to-follow-up rates are a risk in even the most rigorously designed randomized controlled trials (RCTs). Consequently, predicting and preventing loss to follow-up are important methodological considerations. We hypothesized that certain baseline characteristics are associated with a greater likelihood of patients being lost to follow-up. Our primary objective was to determine which baseline characteristics are associated with loss to follow-up within 12 months after an open fracture in adult patients participating in the Fluid Lavage of Open Wounds (FLOW) trial. We also present strategies to reduce loss to follow-up in trauma trials. Data for this study were derived from the FLOW trial, a funded trial in which payments to clinical sites were tied to participant retention. We conducted a binary logistic regression analysis with loss to follow-up as the dependent variable to determine participant characteristics associated with a higher risk of loss to follow-up. Complete data were available for 2,381 of 2,447 participants. One hundred and sixty-three participants (6.7%) were lost to follow-up. Participants who received treatment in the U.S. were more likely to be lost to follow-up than those who received treatment in other countries (odds ratio [OR] = 3.56, 95% confidence interval [CI]: 2.46 to 5.17, p < 0.001). Male sex (OR = 1.75, 95% CI: 1.15 to 2.67, p = 0.009), current smoking (OR = 1.82, 95% CI: 1.28 to 2.58, p = 0.001), high-risk alcohol consumption (OR = 1.88, 95% CI: 1.16 to 3.05, p = 0.010), and an age of <30 years (OR = 2.16, 95% CI: 1.19 to 3.95, p = 0.012) all significantly increased the odds of a patient being lost to follow-up. Conversely, participants who had sustained polytrauma (OR = 0.52, 95% CI: 0.37 to 0.73, p < 0.001) or had a Gustilo-Anderson type-IIIA, B, or C fracture (OR = 0.60, 95% CI: 0.38 to 0.94, p = 0.024) had lower odds of being lost to follow-up. Using a number of strategies, we were able to reduce the loss-to-follow-up rate to <7%. Males, current smokers, young participants, participants who consumed a high-risk amount of alcohol, and participants in the U.S. were more likely to be lost to follow-up even after these strategies had been employed; therefore, additional strategies should be developed to target these high-risk participants. This study highlights an important need to develop additional strategies to minimize loss to follow-up, including targeted participant-retention strategies. Male sex, an age of <30 years, current smoking, high-risk alcohol consumption, and treatment in a developed country with a predominantly privately funded health-care system increased the likelihood of participants being lost to follow-up. Therefore, strategies should be targeted to these participants. Use of the planning and prevention strategies outlined in the current study can minimize loss to follow-up in orthopaedic trials.

Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial.

PubMed

Carver, David A; Bressan, Alexsander K; Schieman, Colin; Grondin, Sean C; Kirkpatrick, Andrew W; Lall, Rohan; McBeth, Paul B; Dunham, Michael B; Ball, Chad G

2018-03-03

Haemothorax following blunt thoracic trauma is a common source of morbidity and mortality. The optimal management of moderate to large haemothoraces has yet to be defined. Observational data have suggested that expectant management may be an appropriate strategy in stable patients. This study aims to compare the outcomes of patients with haemothoraces following blunt thoracic trauma treated with either chest drainage or expectant management. This is a single-centre, dual-arm randomised controlled trial. Patients presenting with a moderate to large sized haemothorax following blunt thoracic trauma will be assessed for eligibility. Eligible patients will then undergo an informed consent process followed by randomisation to either (1) chest drainage (tube thoracostomy) or (2) expectant management. These groups will be compared for the rate of additional thoracic interventions, major thoracic complications, length of stay and mortality. This study has been approved by the institution's research ethics board and registered with ClinicalTrials.gov. All eligible participants will provide informed consent prior to randomisation. The results of this study may provide guidance in an area where there remains significant variation between clinicians. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. NCT03050502. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Frequent intravenous pulses of growth hormone together with alanylglutamine supplementation in prolonged critical illness after multiple trauma: effects on glucose control, plasma IGF-I and glutamine.

PubMed

Duska, Frantisek; Fric, Michal; Pazout, Jaroslav; Waldauf, Petr; Tůma, Petr; Pachl, Jan

2008-02-01

We aim to demonstrate that low dose growth hormone (GH) administered in i.v. pulses every 3h is able to normalize IGF-I levels in subjects with prolonged critical illness, after multiple trauma. We also ask whether it is possible to control glycaemia during such a treatment and how alanylglutamine (AG) supplementation influences plasma glutamine concentration. We used a prospective double-blind (group 1 vs. 2), randomized trial with an open-label control arm (group 3). Thirty multiple trauma patients (median age: 36, 42, 46 years) were randomized on day 4 after trauma to receive (group 1, n=10) i.v. AG supplementation (0.3 g/kg day from day 4 till 17) and i.v. GH (0.05 mg/kg day divided into 8 boluses, maximum dose at 3 AM, administered on days 7-17) or AG and placebo (group 2, n=10). Group 3 (n=10) received isocaloric isonitrogenous (proteins 1.5 g/kg day) nutrition without AG. Glycaemia was controlled by i.v. insulin infusion according to a routine protocol. GH treatment caused an increase of IGF-I (from median 169 on day 4 to 493 ng/ml on day 17), IGFBP-3 (from 2.4 to 3.2 microg/ml) and a fall in IGFBP-1 (from 11.5 to 3.1 microg/ml), whilst in both groups 2 and 3 these indices remained unchanged. At the end of the study (day 17) IGF-I and IGFBP-1 differed significantly among groups (p=0.008 resp. p=0.010, Kruskal-Wallis). Plasma glutamine remained below the normal range through the study in all groups (median: 0.18-0.30 mM), but had a tendency to rise in group 2 in contrast with a fall in groups 1 and 3 (NS). Group 1 required more insulin (p<0.01) than did the control group but median glycaemia was only 0.4-0.5 mM higher in group 1 (6.5 mM) than in groups 2 and 3 (6.1 resp. 6.0 mM). GH (0.05 g/kg day) administered in i.v. pulses is able to normalize IGF-I levels in subjects with prolonged critical illness after trauma. During this treatment, the standard dose of AG prevents worsening of plasma glutamine deficiency and glucose control is possible using routine algorithms, but it requires higher insulin doses.

Geographic Distribution of Trauma Centers and Injury Related Mortality in the United States

PubMed Central

Brown, Joshua B.; Rosengart, Matthew R.; Billiar, Timothy R.; Peitzman, Andrew B.; Sperry, Jason L.

2015-01-01

Background Regionalized trauma care improves outcomes; however access to care is not uniform across the US. The objective was to evaluate whether geographic distribution of trauma centers correlates with injury mortality across state trauma systems. Methods Level I/II trauma centers in the contiguous US were mapped. State-level age-adjusted injury fatality rates/100,000people were obtained and evaluated for spatial autocorrelation. Nearest neighbor ratios (NNR) were generated for each state. A NNR<1 indicates clustering, while NNR>1 indicates dispersion. NNR were tested for difference from random geographic distribution. Fatality rates and NNR were examined for correlation. Fatality rates were compared between states with trauma center clustering versus dispersion. Trauma center distribution and population density were evaluated. Spatial-lag regression determined the association between fatality rate and NNR, controlling for state-level demographics, population density, injury severity, trauma system resources, and socioeconomic factors. Results Fatality rates were spatially autocorrelated (Moran's I=0.35, p<0.01). Nine states had a clustered pattern (median NNR 0.55, IQR 0.48–0.60), 22 had a dispersed pattern (median NNR 2.00, IQR 1.68–3.99), and 10 had a random pattern (median NNR 0.90, IQR 0.85–1.00) of trauma center distribution. Fatality rate and NNR were correlated (ρ=0.34, p=0.03). Clustered states had a lower median injury fatality rate compared to dispersed states (56.9 [IQR 46.5–58.9] versus 64.9 [IQR 52.5–77.1], p=0.04). Dispersed compared to clustered states had more counties without a trauma center that had higher population density than counties with a trauma center (5.7% versus 1.2%, p<0.01). Spatial-lag regression demonstrated fatality rates increased 0.02/100,000persons for each unit increase in NNR (p<0.01). Conclusions Geographic distribution of trauma centers correlates with injury mortality, with more clustered state trauma centers associated with lower fatality rates. This may be a result of access relative to population density. These results may have implications for trauma system planning and requires further study to investigate underlying mechanisms PMID:26517780

Collider Bias in Trauma Comparative Effectiveness Research: The Stratification Blues for Systematic Reviews

DTIC Science & Technology

2015-05-01

of treatment and outcome, plagues randomised and observational trauma research. Of the seven trials of prehospital hypertonic saline in dextran (HSD...hypertonic saline in dextran (HSD) for hypovolaemic trauma patients [11–17] evaluated in systematic reviews [18–26], none found an overall between-group...containing either HSD (7.5% NaCl with 6% dextran -70) or the standard-of-care, i.e., lactated Ringer’s in the pilot [11]; normal saline (0.9%) in the pivotal

Interventions to support recovery after domestic and sexual violence in primary care.

PubMed

Hegarty, Kelsey; Tarzia, Laura; Hooker, Leesa; Taft, Angela

2016-10-01

Experiences of domestic and sexual violence are common in patients attending primary care. Most often they are not identified due to barriers to asking by health practitioners and disclosure by patients. Women are more likely than men to experience such violence and present with mental and physical health symptoms to health practitioners. If identified through screening or case finding as experiencing violence they need to be supported to recover from these traumas. This paper draws on systematic reviews published in 2013-2015 and a further literature search undertaken to identify recent intervention studies relevant to recovery from domestic and sexual violence in primary care. There is limited evidence as to what interventions in primary care assist with recovery from domestic violence; however, they can be categorized into the following areas: first line response and referral, psychological treatments, safety planning and advocacy, including through home visitation and peer support programmes, and parenting and mother-child interventions. Sexual violence interventions usually include trauma informed care and models to support recovery. The most promising results have been from nurse home visiting advocacy programmes, mother-child psychotherapeutic interventions, and specific psychological treatments (Cognitive Behaviour Therapy, Trauma informed Cognitive Behaviour Therapy and, for sexual assault, Exposure and Eye Movement Desensitization and Reprocessing Interventions). Holistic healing models have not been formally tested by randomized controlled trials, but show some promise. Further research into what supports women and their children on their trajectory of recovery from domestic and sexual violence is urgently needed.

How can second-stage management prevent perineal trauma? Critical review.

PubMed Central

Flynn, P.; Franiek, J.; Janssen, P.; Hannah, W. J.; Klein, M. C.

1997-01-01

OBJECTIVE: To learn which factors influencing perineal integrity were modifiable by physicians and pregnant women. DATA SOURCES: Medical, nursing, and midwifery literature was searched mainly for randomized controlled trials. STUDY SELECTION: We chose articles on perineal trauma pattern, sexual dysfunction or satisfaction, urinary incontinence, and pelvic floor function. We identified 80 papers and studied 16 in detail. SYNTHESIS: Five factors affected perineal integrity: episiotomy, third-trimester perineal massage, mother's position in second-stage labour, method of pushing, and administration of epidural analgesia. Episiotomy does not improve perineal outcomes when used routinely. Third-trimester perineal massage was discussed only in inadequate studies. Studies comparing position in birth chairs and recumbent versus upright positions were inadequate for making firm recommendations. Studies of methods of pushing and use of epidural analgesia were limited and uncontrolled; no recommendations were possible. CONCLUSION: Only limiting episiotomy can be strongly recommended. In the absence of strong data to the contrary, women should be encouraged to engage in perineal massage if they wish and to adopt the birth positions of their choice. Caretakers should be aware of the possibility of interfering with placental function when women hold their breath for a long time when pushing. PMID:9626426

How can second-stage management prevent perineal trauma? Critical review.

PubMed

Flynn, P; Franiek, J; Janssen, P; Hannah, W J; Klein, M C

1997-01-01

To learn which factors influencing perineal integrity were modifiable by physicians and pregnant women. Medical, nursing, and midwifery literature was searched mainly for randomized controlled trials. We chose articles on perineal trauma pattern, sexual dysfunction or satisfaction, urinary incontinence, and pelvic floor function. We identified 80 papers and studied 16 in detail. Five factors affected perineal integrity: episiotomy, third-trimester perineal massage, mother's position in second-stage labour, method of pushing, and administration of epidural analgesia. Episiotomy does not improve perineal outcomes when used routinely. Third-trimester perineal massage was discussed only in inadequate studies. Studies comparing position in birth chairs and recumbent versus upright positions were inadequate for making firm recommendations. Studies of methods of pushing and use of epidural analgesia were limited and uncontrolled; no recommendations were possible. Only limiting episiotomy can be strongly recommended. In the absence of strong data to the contrary, women should be encouraged to engage in perineal massage if they wish and to adopt the birth positions of their choice. Caretakers should be aware of the possibility of interfering with placental function when women hold their breath for a long time when pushing.

The Cellie Coping Kit for Children with Injury: Initial feasibility, acceptability, and outcomes.

PubMed

Marsac, M L; Weiss, D; Kohser, K L; Van Allen, J; Seegan, P; Ostrowski-Delahanty, S; McGar, A; Winston, F K; Kassam-Adams, N

2018-04-15

Physical and psychological challenges can arise from paediatric injury, which can impact child health outcomes. Evidence-based resources to promote recovery are limited. The low cost, portable Cellie Coping Kit for Children with Injury provides evidence-based strategies to help children manage injury-related challenges. This study aimed to describe intervention feasibility and explore initial outcomes (learning, quality of life [QOL], and trauma symptoms). Three independent pilot studies were conducted. Child-parent dyads (n = 61) participated in the intervention; ~36% completed a 4-week follow-up assessment. Results suggested that the intervention was feasible (e.g., 95% of parents would recommend the intervention; >85% reported that it was easy to use). Over 70% of participants reported learning new skills. No statistically significant differences were detected for children's QOL or trauma symptoms preintervention to postintervention. Preliminary research suggests that the Cellie Coping Kit for Children with Injuries is a feasible, low-cost, preventive intervention, which may provide families with strategies to promote recovery from paediatric injury. Future research, including a randomized controlled trial, ought to further examine targeted long-term intervention outcomes. © 2018 John Wiley & Sons Ltd.

Literature Review: Herbal Medicine Treatment after Large-Scale Disasters.

PubMed

Takayama, Shin; Kaneko, Soichiro; Numata, Takehiro; Kamiya, Tetsuharu; Arita, Ryutaro; Saito, Natsumi; Kikuchi, Akiko; Ohsawa, Minoru; Kohayagawa, Yoshitaka; Ishii, Tadashi

2017-01-01

Large-scale natural disasters, such as earthquakes, tsunamis, volcanic eruptions, and typhoons, occur worldwide. After the Great East Japan earthquake and tsunami, our medical support operation's experiences suggested that traditional medicine might be useful for treating the various symptoms of the survivors. However, little information is available regarding herbal medicine treatment in such situations. Considering that further disasters will occur, we performed a literature review and summarized the traditional medicine approaches for treatment after large-scale disasters. We searched PubMed and Cochrane Library for articles written in English, and Ichushi for those written in Japanese. Articles published before 31 March 2016 were included. Keywords "disaster" and "herbal medicine" were used in our search. Among studies involving herbal medicine after a disaster, we found two randomized controlled trials investigating post-traumatic stress disorder (PTSD), three retrospective investigations of trauma or common diseases, and seven case series or case reports of dizziness, pain, and psychosomatic symptoms. In conclusion, herbal medicine has been used to treat trauma, PTSD, and other symptoms after disasters. However, few articles have been published, likely due to the difficulty in designing high quality studies in such situations. Further study will be needed to clarify the usefulness of herbal medicine after disasters.

A Clinician’s Guide to PTSD Treatments for Returning Veterans

PubMed Central

Sharpless, Brian A.; Barber, Jacques P.

2011-01-01

What options are available to mental health providers helping clients with posttraumatic stress disorder (PTSD)? In this paper we review many of the current pharmacological and psychological interventions available to help prevent and treat PTSD with an emphasis on combat-related traumas and Veteran populations. There is strong evidence supporting the use of several therapies including prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR), and cognitive processing therapies (CPT), with PE possessing the most empirical evidence in favor of its efficacy. There have been relatively fewer studies of non-exposure based modalities (e.g., psychodynamic, interpersonal, and dialectical behavior therapy perspectives), but there is no evidence that these treatments are less effective. Pharmacotherapy is promising (especially paroxetine, sertraline, and venlafaxine), but more research comparing the relative merits of medication vs. psychotherapy and the efficacy of combined treatments is needed. Given the recent influx of combat-related traumas due to ongoing conflicts in Iraq and Afghanistan, there is clearly an urgent need to conduct more randomized clinical trials research and effectiveness studies in military and Department of Veterans Affairs PTSD samples. Finally, we provide references to a number of PTSD treatment manuals and propose several recommendations to help guide clinicians’ treatment selections. PMID:21475611

EMDR beyond PTSD: A Systematic Literature Review

PubMed Central

Valiente-Gómez, Alicia; Moreno-Alcázar, Ana; Treen, Devi; Cedrón, Carlos; Colom, Francesc; Pérez, Víctor; Amann, Benedikt L.

2017-01-01

Background: Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapeutic approach that has demonstrated efficacy in the treatment of Post-traumatic Stress Disorder (PTSD) through several randomized controlled trials (RCT). Solid evidence shows that traumatic events can contribute to the onset of severe mental disorders and can worsen their prognosis. The aim of this systematic review is to summarize the most important findings from RCT conducted in the treatment of comorbid traumatic events in psychosis, bipolar disorder, unipolar depression, anxiety disorders, substance use disorders, and chronic back pain. Methods: Using PubMed, ScienceDirect, and Scopus, we conducted a systematic literature search of RCT studies published up to December 2016 that used EMDR therapy in the mentioned psychiatric conditions. Results: RCT are still scarce in these comorbid conditions but the available evidence suggests that EMDR therapy improves trauma-associated symptoms and has a minor effect on the primary disorders by reaching partial symptomatic improvement. Conclusions: EMDR therapy could be a useful psychotherapy to treat trauma-associated symptoms in patients with comorbid psychiatric disorders. Preliminary evidence also suggests that EMDR therapy might be useful to improve psychotic or affective symptoms and could be an add-on treatment in chronic pain conditions. PMID:29018388

Hemoglobin-Based Oxygen Carrier (HBOC) Development in Trauma: Previous Regulatory Challenges, Lessons Learned, and a Path Forward.

PubMed

Keipert, Peter E

2017-01-01

Historically, hemoglobin-based oxygen carriers (HBOCs) were being developed as "blood substitutes," despite their transient circulatory half-life (~ 24 h) vs. transfused red blood cells (RBCs). More recently, HBOC commercial development focused on "oxygen therapeutic" indications to provide a temporary oxygenation bridge until medical or surgical interventions (including RBC transfusion, if required) can be initiated. This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. These trials all failed due to safety concerns (e.g., cardiac events, mortality) and certain protocol design limitations. In 2008 the Food and Drug Administration (FDA) put all HBOC trials in the US on clinical hold due to the unfavorable benefit:risk profile demonstrated by various HBOCs in different clinical studies in a meta-analysis published by Natanson et al. (2008). During standard resuscitation in trauma, organ dysfunction and failure can occur due to ischemia in critical tissues, which can be detected by the degree of lactic acidosis. SANGART'S Phase 2 trauma program with MP4OX therefore added lactate >5 mmol/L as an inclusion criterion to enroll patients who had lost sufficient blood to cause a tissue oxygen debt. This was key to the successful conduct of their Phase 2 program (ex-US, from 2009 to 2012) to evaluate MP4OX as an adjunct to standard fluid resuscitation and transfusion of RBCs. In 2013, SANGART shared their Phase 2b results with the FDA, and succeeded in getting the FDA to agree that a planned Phase 2c higher dose comparison study of MP4OX in trauma could include clinical sites in the US. Unfortunately, SANGART failed to secure new funding and was forced to terminate development and operations in Dec 2013, even though a regulatory path forward with FDA approval to proceed in trauma had been achieved.

Examining the Impact of Trauma-Informed Cognitive Behavioral Therapy on Perinatal Mental Health Outcomes Among Survivors of Intimate Partner Violence (The PATH Study): Protocol for a Feasibility Study.

PubMed

Jackson, Kimberley T; Parkinson, Sarah; Jackson, Brianna; Mantler, Tara

2018-05-25

Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, and posttraumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) interventions as a gold standard for those with symptomatology consistent with anxiety disorders, mood disorders, and PTSD. However, efficacy has not been evaluated among a population of pregnant survivors of IPV. We present the protocol that will be used to explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomatology resulting from IPV. A secondary aim will be to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial. The Promoting Attachment Through Healing (PATH) study will use a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through the hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). A feasibility sample of 20 pregnant women (cohort 1) will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program's perinatal clinical nurse specialist, with evaluation at baseline, at two months postpartum (intervention and online questionnaire), and at six and twelve months postpartum (online questionnaire only). Concurrently, we will conduct a retrospective audit of 100 medical charts (cohort 2; 50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental illness symptomatology, improved maternal-infant attachment, maternal coping, and maternal quality of life. Additionally, the feasibility of the protocol and acceptability of the intervention from the women's perspective will be examined. Inductive content analysis of all qualitative data will be used to determine common themes. Additionally, descriptive statistics, including measures of central tendency and dispersion, will be computed for all continuous variables. Alternatively, frequency tables will be constructed for all categorical variables. The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Participant recruitment for cohort 1 has started and we have finished data collection for cohort 2. It is anticipated that the results will be available by the end of 2018. Findings will assess the acceptability of the study methodology and protocol for a full-scale randomized controlled trial. Furthermore, if CBT is proven effective for pregnant survivors of IPV, this intervention could be readily adopted by health care and social support services, thereby contributing to an improved standard of care for this unique population. ClinicalTrials.gov NCT03536442; https://www.clinicaltrials.gov/ct2/show/NCT03536442 (Archived by WebCite at http://www.webcitation.org/6zeurv1ay). RR1-10.2196/9820. ©Kimberley T Jackson, Sarah Parkinson, Brianna Jackson, Tara Mantler. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2018.

Standard versus Rotation Technique for Insertion of Supraglottic Airway Devices: Systematic Review and Meta-Analysis

PubMed Central

Park, Jin Ha; Lee, Jong Seok; Nam, Sang Beom; Ju, Jin Wu

2016-01-01

Purpose Supraglottic airway devices have been widely utilized as an alternative to tracheal intubation in various clinical situations. The rotation technique has been proposed to improve the insertion success rate of supraglottic airways. However, the clinical efficacy of this technique remains uncertain as previous results have been inconsistent, depending on the variable evaluated. Materials and Methods We systematically searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials in April 2015 for randomized controlled trials that compared the rotation and standard techniques for inserting supraglottic airways. Results Thirteen randomized controlled trials (1505 patients, 753 with the rotation technique) were included. The success rate at the first attempt was significantly higher with the rotation technique than with the standard technique [relative risk (RR): 1.13; 95% confidence interval (CI): 1.05 to 1.23; p=0.002]. The rotation technique provided significantly higher overall success rates (RR: 1.06; 95% CI: 1.04 to 1.09; p<0.001). Device insertion was completed faster with the rotation technique (mean difference: -4.6 seconds; 95% CI: -7.37 to -1.74; p=0.002). The incidence of blood staining on the removed device (RR: 0.36; 95% CI: 0.27 to 0.47; p<0.001) was significantly lower with the rotation technique. Conclusion The rotation technique provided higher first-attempt and overall success rates, faster insertion, and a lower incidence of blood on the removed device, reflecting less mucosal trauma. Thus, it may be considered as an alternative to the standard technique when predicting or encountering difficulty in inserting supraglottic airways. PMID:27189296

Measuring the effectiveness of in-hospital and on-base Prevent Alcohol and Risk-related Trauma in Youth (P.A.R.T.Y.) programs on reducing alcohol related harms in naval trainees: P.A.R.T.Y. Defence study protocol.

PubMed

Watterson, Jason; Gabbe, Belinda; Dietze, Paul; Thompson, Jennifer; Oborn, Michael; Rosenfeld, Jeffrey V

2017-05-02

Reducing alcohol related harms in Australian Defence Force (ADF) trainees has been identified as a priority, but there are few evidence-based prevention programs available for the military setting. The study aims to test whether the P.A.R.T.Y. program delivered in-hospital or on-base, can reduce harmful alcohol consumption among ADF trainees. The study is a 3-arm randomized controlled trial, involving 953 Royal Australian Navy trainees from a single base. Trainees, aged 18 to 30 years, will be randomly assigned to the study arms: i. in-hospital P.A.R.T.Y.; ii. On-base P.A.R.T.Y.; and iii. All groups will receive the routine ADF annual alcohol awareness training. The primary outcome is the proportion of participants reporting an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above at 12 months' post-intervention. The secondary outcome is the number of alcohol related incidents reported to the Royal Australian Navy (RAN) in the 12 months' post-intervention. This is the first trial of the use of the P.A.R.T.Y. program in the military. If the proposed intervention proves efficacious, it may be a useful program in the early education of RAN trainees. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001332617 , date of registration: 18/12/2014 'retrospectively registered'.

Piloting a psycho-social intervention for incarcerated women with trauma histories: lessons learned and future recommendations.

PubMed

Liebman, Rachel E; Burnette, Mandi L; Raimondi, Christina; Nichols-Hadeed, Corey; Merle, Patricia; Cerulli, Catherine

2014-08-01

Trauma and related mental health disorders are common among incarcerated women, but empirically sound mental health interventions are lacking in prisons. Implementing such interventions is fraught with legal and logistical barriers. These barriers can be particularly detrimental for trauma-specific interventions given the unique needs of trauma survivors, yet there is little documentation of these issues or how to address them. This study describes a pilot study of an 8-week, strengths-based, trauma-focused intervention for 26 incarcerated women. Women reported considerable mental health problems and trauma. The study highlights the importance of adapting stringent research methodologies for prison-based trauma interventions. For instance, women with trauma were reluctant to participate in an intervention advertised as trauma-based. Moreover, a randomized wait list control design was unfeasible because women wanted the support of their friends when discussing trauma and could not control their schedules 9 weeks in advance. Ultimately, this work may inform future efforts to implement effective trauma-based interventions behind prison walls. © The Author(s) 2013.

Retention in the National Institute on Drug Abuse Clinical Trials Network Women and Trauma Study: implications for posttrial implementation.

PubMed

Pinto, Rogério M; Campbell, Aimee N C; Hien, Denise A; Yu, Gary; Gorroochurn, Prakash

2011-04-01

This study aimed to identify factors that influenced retention in the National Institute on Drug Abuse-funded Women and Trauma Study, conducted within the Clinical Trials Network (CTN). Women (N=346) were recruited from and received treatment in 6 CTN-affiliated sites. Log-linear and logistic models were used to explore factors associated with retention. The mean number of treatment sessions attended was 6.8 (SD=3.9). Women with more education, higher attendance at 12-step meetings, and strong therapeutic alliance between facilitator and participant had better retention rates. Significant site differences were found; the site with the highest retention rate provided child care and had the lowest average monthly intake. To retain women with histories of trauma and substance abuse in "real world" psychiatric settings, emphasis on regulating individual-level and site-related modifiable variables are crucial. © 2011 American Orthopsychiatric Association.

Implementation of a Family Planning Clinic-Based Partner Violence and Reproductive Coercion Intervention: Provider and Patient Perspectives.

PubMed

Miller, Elizabeth; McCauley, Heather L; Decker, Michele R; Levenson, Rebecca; Zelazny, Sarah; Jones, Kelley A; Anderson, Heather; Silverman, Jay G

2017-06-01

Despite multiple calls for clinic-based services to identify and support women victimized by partner violence, screening remains uncommon in family planning clinics. Furthermore, traditional screening, based on disclosure of violence, may miss women who fear reporting their experiences. Strategies that are sensitive to the signs, symptoms and impact of trauma require exploration. In 2011, as part of a cluster randomized controlled trial, staff at 11 Pennsylvania family planning clinics were trained to offer a trauma-informed intervention addressing intimate partner violence and reproductive coercion to all women seeking care, regardless of exposure to violence. The intervention sought to educate women about available resources and harm reduction strategies. In 2013, at the conclusion of the trial, 18 providers, five administrators and 49 patients completed semistructured interviews exploring acceptability of the intervention and barriers to implementation. Consensus and open coding strategies were used to analyze the data. Providers reported that the intervention increased their confidence in discussing intimate partner violence and reproductive coercion. They noted that asking patients to share the educational information with other women facilitated the conversation. Barriers to implementation included lack of time and not having routine reminders to offer the intervention. Patients described how receiving the intervention gave them important information, made them feel supported and less isolated, and empowered them to help others. A universal intervention may be acceptable to providers and patients. However, successful implementation in family planning settings may require attention to system-level factors that providers view as barriers. Copyright © 2017 by the Guttmacher Institute.

Rectal analgesia for the relief of perineal pain after childbirth: a randomised controlled trial of diclofenac suppositories.

PubMed

Dodd, Jodie M; Hedayati, Hedyeh; Pearce, Elizabeth; Hotham, Neil; Crowther, Caroline A

2004-10-01

To evaluate rectal diclofenac in the relief of perineal pain after trauma during childbirth. A randomised, double-blind trial. Delivery Suite, Women's and Children's Hospital, South Australia. Women with a second-degree (or greater) perineal tear or episiotomy. Women were randomly allocated to either diclofenac or placebo suppositories (Anusol), using a computer-generated randomisation schedule with stratification for parity and mode of birth. Treatment packs contained two x 100 mg diclofenac or two placebo suppositories, the first being inserted when suturing was complete, and the second 12-24 hours after birth. Women were asked to complete questionnaires at 24 and 48 hours after birth relating to their degree of perineal pain using the validated Short Form McGill Pain Questionnaire. Pain scores at 24 and 48 hours after birth. A total of 133 women were recruited, with 67 randomised to diclofenac suppositories and 66 to placebo. Women in the diclofenac group were significantly less likely to experience pain at 24 hours while walking (RR 0.8; 95% CI 0.6 to 1.0), sitting (RR 0.8; 95% CI 0.6 to 1.0), passing urine (RR 0.6; 95% CI 0.4 to 1.0) and on opening their bowels (RR 0.6; 95% CI 0.2 to 0.9) compared with those women who received placebo. These differences were not sustained 48 hours after birth. The use of rectal non-steroidal anti-inflammatory drug suppositories is a simple, effective and safe method of reducing the pain experienced by women following perineal trauma within the first 24 hours after childbirth.

VATS versus intrapleural streptokinase: A prospective, randomized, controlled clinical trial for optimum treatment of post-traumatic Residual Hemothorax.

PubMed

Kumar, S; Rathi, V; Rattan, A; Chaudhary, S; Agarwal, N

2015-09-01

Post-traumatic residual haemothorax (RH) is common and carries significant morbidity. However, its optimal treatment is not clear. The aim of this study was to find the extent of this problem and the choice of treatment between VATS and intra-pleural streptokinase instillation (IPSI). This RCT, conducted over 18 months period, included all patients of chest trauma between 18 and 70 years of age, admitted with haemothorax or haemopneumothorax requiring inter-costal drain (ICD) insertion. 154 events of haemothorax/haemopneumothorax requiring ICD insertion were enrolled. RH was seen in 48 (31%) patients: 13 patients were excluded from RCT after refusal for treatment. Seventeen (49%) patients of remaining 35 RH cases were randomized to IPSI group and 18 (51%) patients were randomized to VATS group. The outcome parameters were resolution of RH and treatment related complications. RH resolved equally well in VATS and IPSI group [13 patients (72%) versus 12 patients (71%), respectively; continuity-adjusted p=1]. Morbidity wise no difference (p-value 0.529) was seen in the two groups. Post-traumatic RH is seen in 1/3rd patients and is equally well treated by VATS and IPSI. Copyright © 2015 Elsevier Ltd. All rights reserved.

A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan.

PubMed

Lo, Jessica W; Bunce, Catey; Charteris, David; Banerjee, Philip; Phillips, Rachel; Cornelius, Victoria R

2016-08-02

Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. ASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity). ISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.

Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial.

PubMed

Goodkind, Jessica R; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L; Baca, Brandon; Ndayisenga, Martin; Greene, R Neil; Shantzek, Cece

2017-02-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their feasibility and acceptability. In the current mixed-methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African, and Iraqi refugee adults and to engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013 and 2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, and postintervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs.

CHALLENGES AND INNOVATIONS IN A COMMUNITY-BASED PARTICIPATORY RANDOMIZED CONTROLLED TRIAL

PubMed Central

Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian; Baca, Brandon; Ndaysenga, Martin; Greene, R. Neil; Shantzek, Cece

2016-01-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African and Iraqi refugee adults and engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013-2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, post-intervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs. PMID:27179291

A new low-cost negative-pressure wound therapy versus a commercially available therapy device widely used to treat complex traumatic injuries: a prospective, randomized, non-inferiority trial.

PubMed

Kamamoto, Fabio; Lima, Ana Lucia Munhoz; Rezende, Marcelo Rosa de; Mattar-Junior, Rames; Leonhardt, Marcos de Camargo; Kojima, Kodi Edson; Santos, Carla Chineze Dos

2017-12-01

Negative-pressure wound therapy has been widely adopted to reduce the complexity of treating a broad range of acute and chronic wounds. However, its cost is high. The objective of this study was to evaluate the following two different methods of negative-pressure wound therapy in terms of healing time: a low-cost method of negative-pressure wound therapy (a pressure stabilizer device connected to a hospital wall-vacuum system with a gauze-sealed dressing, USP) and the standard of care (vacuum-assisted closure, VAC). This is a randomized, controlled, non-inferiority, unblinded trial. Patients admitted with complex injuries to a trauma center in a public referral hospital who were indicated for orthopedic surgery were randomized to a USP or VAC group. The primary outcome was the time required to achieve a "ready for surgery condition", which was defined as a wound bed with healthy granulation tissue and without necrosis or purulent secretion. Wound bed area contraction, granulation tissue growth and the direct costs of the dressings were secondary outcomes. Variation in area and granulation tissue growth were essentially the same between the systems, and healing time was equal between the groups (p=0.379). In both systems, serial debridement increased wound area (p=0.934), and granulation tissue was also increased (p=0.408). The mean treatment cost was US$ 15.15 in the USP group and US$ 872.59 in the VAC group. For treating complex traumatic injuries, USP was non-inferior to and less expensive than VAC.

Barriers and Facilitators to Deaf Trauma Survivors' Help-Seeking Behavior: Lessons for Behavioral Clinical Trials Research

ERIC Educational Resources Information Center

Anderson, Melissa L.; Wolf Craig, Kelly S.; Ziedonis, Douglas M.

2017-01-01

Deaf individuals experience significant obstacles to participating in behavioral health research when careful consideration is not given to accessibility during the design of study methodology. To inform such considerations, we conducted an exploratory secondary analysis of a mixed-methods study that originally explored 16 Deaf trauma survivors'…

Selective versus routine use of episiotomy for vaginal birth

PubMed Central

Jiang, Hong; Qian, Xu; Carroli, Guillermo; Garner, Paul

2017-01-01

Background Some clinicians believe that routine episiotomy, a surgical cut of the vagina and perineum, will prevent serious tears during childbirth. On the other hand, an episiotomy guarantees perineal trauma and sutures. Objectives To assess the effects on mother and baby of a policy of selective episiotomy ('only if needed') compared with a policy of routine episiotomy ('part of routine management') for vaginal births. Search methods We searched Cochrane Pregnancy and Childbirth's Trials Register (14 September 2016) and reference lists of retrieved studies. Selection criteria Randomised controlled trials (RCTs) comparing selective versus routine use of episiotomy, irrespective of parity, setting or surgical type of episiotomy. We included trials where either unassisted or assisted vaginal births were intended. Quasi-RCTs, trials using a cross-over design or those published in abstract form only were not eligible for inclusion in this review. Data collection and analysis Two authors independently screened studies, extracted data, and assessed risk of bias. A third author mediated where there was no clear consensus. We observed good practice for data analysis and interpretation where trialists were review authors. We used fixed-effect models unless heterogeneity precluded this, expressed results as risk ratios (RR) and 95% confidence intervals (CI), and assessed the certainty of the evidence using GRADE. Main results This updated review includes 12 studies (6177 women), 11 in women in labour for whom a vaginal birth was intended, and one in women where an assisted birth was anticipated. Two were trials each with more than 1000 women (Argentina and the UK), and the rest were smaller (from Canada, Germany, Spain, Ireland, Malaysia, Pakistan, Columbia and Saudi Arabia). Eight trials included primiparous women only, and four trials were in both primiparous and multiparous women. For risk of bias, allocation was adequately concealed and reported in nine trials; sequence generation random and adequately reported in three trials; blinding of outcomes adequate and reported in one trial, blinding of participants and personnel reported in one trial. For women where an unassisted vaginal birth was anticipated, a policy of selective episiotomy may result in 30% fewer women experiencing severe perineal/vaginal trauma (RR 0.70, 95% CI 0.52 to 0.94; 5375 women; eight RCTs; low-certainty evidence). We do not know if there is a difference for blood loss at delivery (an average of 27 mL less with selective episiotomy, 95% CI from 75 mL less to 20 mL more; two trials, 336 women, very low-certainty evidence). Both selective and routine episiotomy have little or no effect on infants with Apgar score less than seven at five minutes (four trials, no events; 3908 women, moderate-certainty evidence); and there may be little or no difference in perineal infection (RR 0.90, 95% CI 0.45 to 1.82, three trials, 1467 participants, low-certainty evidence). For pain, we do not know if selective episiotomy compared with routine results in fewer women with moderate or severe perineal pain (measured on a visual analogue scale) at three days postpartum (RR 0.71, 95% CI 0.48 to 1.05, one trial, 165 participants, very low-certainty evidence). There is probably little or no difference for long-term (six months or more) dyspareunia (RR1.14, 95% CI 0.84 to 1.53, three trials, 1107 participants, moderate-certainty evidence); and there may be little or no difference for long-term (six months or more) urinary incontinence (average RR 0.98, 95% CI 0.67 to 1.44, three trials, 1107 participants, low-certainty evidence). One trial reported genital prolapse at three years postpartum. There was no clear difference between the two groups (RR 0.30, 95% CI 0.06 to 1.41; 365 women; one trial, low certainty evidence). Other outcomes relating to long-term effects were not reported (urinary fistula, rectal fistula, and faecal incontinence). Subgroup analyses by parity (primiparae versus multiparae) and by surgical method (midline versus mediolateral episiotomy) did not identify any modifying effects. Pain was not well assessed, and women's preferences were not reported. One trial examined selective episiotomy compared with routine episiotomy in women where an operative vaginal delivery was intended in 175 women, and did not show clear difference on severe perineal trauma between the restrictive and routine use of episiotomy, but the analysis was underpowered. Authors' conclusions In women where no instrumental delivery is intended, selective episiotomy policies result in fewer women with severe perineal/vaginal trauma. Other findings, both in the short or long term, provide no clear evidence that selective episiotomy policies results in harm to mother or baby. The review thus demonstrates that believing that routine episiotomy reduces perineal/vaginal trauma is not justified by current evidence. Further research in women where instrumental delivery is intended may help clarify if routine episiotomy is useful in this particular group. These trials should use better, standardised outcome assessment methods. Selective versus routine use of episiotomy for vaginal birth What is the issue? Normal birth can cause tears to the vagina and the surrounding tissue, usually as the baby's head is born, and sometimes these tears extend to the rectum. These are repaired surgically, but take time to heal. To avoid these severe tears, doctors have recommended making a surgical cut to the perineum with scissors or scalpel to prevent severe tearing and facilitate the birth. This intervention, known as an episiotomy, is used as a routine care policy during births in some countries. Both a tear and an episiotomy need sutures, and can result in severe pain, bleeding, infection, pain with sex, and can contribute to long term urinary incontinence. Why is this important? An episiotomy requires suturing and benefits and harms as part of routine management of normal births remains unclear. In particular, we need to know if it does indeed prevent large tears, because women otherwise may be subjected to an unnecessary operation, pain and in some cases long-term problems. The question of whether to apply a policy of routine episiotomy is important for clinical practice and for the health and well-being of women and babies. What evidence did we find? We prepared this edition of this review by updating the methods and searching for evidence from the medical literature on 14 September 2016. The review now includes 11 randomised controlled trials (with 5977 women) that compared episiotomy as needed (selective episiotomy) with routine episiotomy in terms of benefits and harms for mother and baby in women at low risk of instrumental delivery. The trials were from ten different countries. In women where health staff were only conducting selective episiotomy, there may be 30% fewer with severe perineal trauma at birth compared with women where a policy of routine episiotomy was applied (eight trials, 5375 women, low-certainty evidence). We do not know if there is a difference in average blood loss between the groups (two trials, very low-certainty evidence). There is probably no difference in Apgar less than seven at five minutes, with no events in either groups (moderate-certainty evidence). We do not know if there is a difference in the number of women with moderate or severe perineal pain three days after giving birth (one trial, 165 women, very low-certainty evidence) but careful assessment of women's pain was not well carried out in the included trials. There may be little or no difference in the number of women developing perineal infection (two trials, low-certainty evidence); and there is probably little or no difference in women reporting painful sexual intercourse six months or more after delivery (three trials, 1107 women, moderate-certainty evidence); for urinary incontinence six months or more after delivery, there may be little or no difference between the groups. One study reported genital prolapse three years after the birth and there was no clear difference between groups (low-certainty evidence). Other important outcomes relating to long-term effects were not reported in these trials (urinary fistula, rectal fistula, and faecal incontinence). One trial examined selective episiotomy compared with routine episiotomy in women for whom an operative vaginal birth was intended. The results showed no clear difference in severe perineal trauma between the restrictive and routine use of episiotomy. Women's views on the different policies were not reported. What does this mean? Overall, the findings show that selective use of episiotomy in women (where a normal delivery without forceps is anticipated) means that fewer women have severe perineal trauma. Thus the rationale for conducting routine episiotomies to prevent severe perineal trauma is not justified by current evidence, and we could not identify any benefits of routine episiotomy for the baby or the mother. More research is needed in order to inform policy in women where an instrumental birth is planned and episiotomy is often advocated. Outcomes could be better standardised and measured. PMID:28176333

Are plain radiographs sufficient to exclude cervical spine injuries in low-risk adults?

PubMed

Hunter, Benton R; Keim, Samuel M; Seupaul, Rawle A; Hern, Gene

2014-02-01

The routine use of clinical decision rules and three-view plain radiography to clear the cervical spine in blunt trauma patients has been recently called into question. In low-risk adult blunt trauma patients, can plain radiographs adequately exclude cervical spine injury when clinical prediction rules cannot? Four observational studies investigating the performance of plain radiographs in detecting cervical spine injury in low-risk adult blunt trauma patients were reviewed. The consistently poor performance of plain radiographs to rule out cervical spine injury in adult blunt trauma victims is concerning. Large, rigorously performed prospective trials focusing on low- or low/moderate-risk patients will be needed to truly define the utility of plain radiographs of the cervical spine in blunt trauma. Copyright © 2014 Elsevier Inc. All rights reserved.

Strengthening family coping resources: the feasibility of a multifamily group intervention for families exposed to trauma.

PubMed

Kiser, Laurel J; Donohue, April; Hodgkinson, Stacy; Medoff, Deborah; Black, Maureen M

2010-12-01

Families exposed to urban poverty face a disproportionate risk of exposure to repeated trauma. Repeated exposures can lead to severe and chronic reactions in multiple family members with effects that ripple throughout the family system. Interventions for distressed families residing in traumatic contexts, such as low-income, urban settings are desperately needed. This report presents preliminary data in support of Strengthening Family Coping Resources, a trauma-focused, multifamily, skill-building intervention. Strengthening Family Coping Resources is designed for families living in traumatic contexts with the goal of reducing symptoms of posttraumatic stress disorder and other trauma-related disorders in children and caregivers. Results from open trials suggest Strengthening Family Coping Resources is a feasible intervention with positive effects on children's symptoms of trauma-related distress.

How the changes in the system affect trauma care provision: The assessment of and implications for Lithuanian trauma service performance in 2007-2012.

PubMed

Dambrauskas, Žilvinas; Aukštakalnis, Vytautas; Karbonskienė, Aurika; Kačiurinas, Dmitrijus; Vokietienė, Jolanta; Lapka, Robertas; Pamerneckas, Algimantas; Porvaneckas, Narūnas; Stašaitis, Kęstutis; Jasinskas, Nedas; Dobožinskas, Paulius; Vaitkaitis, Dinas; Lunevičius, Raimundas

2017-01-01

The aim of this study was to identify and assess the effects of changes in the Lithuanian trauma service from 2007 to 2012. We postulate that the implications derived from this study will be of importance to trauma policy planners and makers in Lithuania and throughout other countries of Eastern and Central Europe. Out of 10,390 trauma admissions to four trauma centers in 2007, 294 patients (2.8%) were randomly selected for the first arm of a representative study sample. Similarly, of 9918 trauma admissions in 2012, 250 (2.5%) were randomly chosen for comparison in the study arm. Only cases with a diagnosis falling into the ICD-10 "S" and "T" codes were included. A survey of whom regarding changes in quality of trauma care from 2007 to 2012 was carried out by emergency medical service (EMS) providers. The Revised Trauma Score (RTS) mean value was 7.45±1.04 for the 2007 year arm; it was 7.53±0.93 for the 2012 year arm (P=0.33). Mean time from the moment of a call from the site of the traumatic event to the patient's arrival at the trauma center did not differ between the arms of the sample: 49.95min in 2007 vs. 51.6min in 2012 (P=0.81). An application of the operational procedures such as a cervical spine protection using a hard collar, oxygen therapy, infusion of intravenous fluids, and pain relief on the trauma scene was more frequent in 2012 than in 2007. Management of trauma patients in the emergency department improved regarding the availability of 24/7 computed tomography scanner facilities and an on-site radiographer. Time to CT-scanning was reduced by 38.8%, and time to decision-making was reduced by 16.5% in 2012. Changes in operational procedures in the Lithuanian pre-hospital care provision and management of trauma patients in emergency departments of trauma centers improved the efficiency of trauma care delivery over the 2007-2012 period. Copyright © 2017 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Sp. z o.o. All rights reserved.

Sensitivity of bedside ultrasound and supine anteroposterior chest radiographs for the identification of pneumothorax after blunt trauma.

PubMed

Wilkerson, R Gentry; Stone, Michael B

2010-01-01

Supine anteroposterior (AP) chest radiographs in patients with blunt trauma have poor sensitivity for the identification of pneumothorax. Ultrasound (US) has been proposed as an alternative screening test for pneumothorax in this population. The authors conducted an evidence-based review of the medical literature to compare sensitivity of bedside US and AP chest radiographs in identifying pneumothorax after blunt trauma. MEDLINE and EMBASE databases were searched for trials from 1965 through June 2009 using a search strategy derived from the following PICO formulation of our clinical question: patients included adult (18 + years) emergency department (ED) patients in whom pneumothorax was suspected after blunt trauma. The intervention was thoracic ultrasonography for the detection of pneumothorax. The comparator was the supine AP chest radiograph during the initial evaluation of the patient. The outcome was the diagnostic performance of US in identifying the presence of pneumothorax in the study population. The criterion standard for the presence or absence of pneumothorax was computed tomography (CT) of the chest or a rush of air during thoracostomy tube placement (in unstable patients). Prospective, observational trials of emergency physician (EP)-performed thoracic US were included. Trials in which the exams were performed by radiologists or surgeons, or trials that investigated patients suffering penetrating trauma or with spontaneous or iatrogenic pneumothoraces, were excluded. The methodologic quality of the studies was assessed. Qualitative methods were used to summarize the study results. Data analysis consisted of test performance (sensitivity and specificity, with 95% confidence intervals [CIs]) of thoracic US and supine AP chest radiography. Four prospective observational studies were identified, with a total of 606 subjects who met the inclusion and exclusion criteria. The sensitivity and specificity of US for the detection of pneumothorax ranged from 86% to 98% and 97% to 100%, respectively. The sensitivity of supine AP chest radiographs for the detection of pneumothorax ranged from 28% to 75%. The specificity of supine AP chest radiographs was 100% in all included studies. This evidence-based review suggests that bedside thoracic US is a more sensitive screening test than supine AP chest radiography for the detection of pneumothorax in adult patients with blunt chest trauma. (c) 2010 by the Society for Academic Emergency Medicine.

Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial.

PubMed

Amaral, M B F; de Ávila, J M S; Abreu, M H G; Mesquita, R A

2015-11-01

Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Operative versus nonoperative treatment of unstable lateral malleolar fractures: a randomized multicenter trial.

PubMed

Sanders, David W; Tieszer, Christina; Corbett, Bradley

2012-03-01

To compare clinical and functional outcomes after operative and nonoperative treatment of undisplaced, unstable, isolated fibula fractures. Randomized multicenter clinical trial. Six level 1 trauma centers. Eighty-one patients with undisplaced, unstable, isolated fibula fractures as confirmed by an external rotation stress examination demonstrating an increase in medial clear space to 5 mm or greater were followed for 12 months after treatment. Forty-one patients were treated operatively by open reduction and internal fixation of the fibula. Forty patients underwent nonoperative treatment, which included the use of a short leg cast or brace and protected weight bearing for 6 weeks. Functional outcomes determined using the Olerud-Molander Ankle Score and the Short Form 36. Radiographic outcomes included measurement of union and displacement at each visit. There were no statistically significant differences in functional outcome scores or pace of recovery between the operative and nonoperative groups at any time interval (β = -0.28, 3.49; P = 0.936). Complications in the nonoperative group included 8 patients with a medial clear space ≥5 mm and 8 patients with delayed union or nonunion. In the operative group, 5 patients had a surgical site infection and 5 patients required hardware removal. Patients managed operatively had equivalent functional outcomes compared with nonoperative treatment; however, the risk of displacement and problems with union was substantially lower in patients managed with surgery.

An aerobic walking programme versus muscle strengthening programme for chronic low back pain: a randomized controlled trial.

PubMed

Shnayderman, Ilana; Katz-Leurer, Michal

2013-03-01

To assess the effect of aerobic walking training as compared to active training, which includes muscle strengthening, on functional abilities among patients with chronic low back pain. Randomized controlled clinical trial with blind assessors. Outpatient clinic. Fifty-two sedentary patients, aged 18-65 years with chronic low back pain. Patients who were post surgery, post trauma, with cardiovascular problems, and with oncological disease were excluded. Experimental 'walking' group: moderate intense treadmill walking; control 'exercise' group: specific low back exercise; both, twice a week for six weeks. Six-minute walking test, Fear-Avoidance Belief Questionnaire, back and abdomen muscle endurance tests, Oswestry Disability Questionnaire, Low Back Pain Functional Scale (LBPFS). Significant improvements were noted in all outcome measures in both groups with non-significant difference between groups. The mean distance in metres covered during 6 minutes increased by 70.7 (95% confidence interval (CI) 12.3-127.7) in the 'walking' group and by 43.8 (95% CI 19.6-68.0) in the 'exercise' group. The trunk flexor endurance test showed significant improvement in both groups, increasing by 0.6 (95% CI 0.0-1.1) in the 'walking' group and by 1.1 (95% CI 0.3-1.8) in the 'exercise' group. A six-week walk training programme was as effective as six weeks of specific strengthening exercises programme for the low back.

Is fibrin sealant effective and safe in total knee arthroplasty? A meta-analysis of randomized trials

PubMed Central

2014-01-01

The objective of this study was to evaluate the efficacy and safety of fibrin sealant in patients following total knee arthroplasty (TKA). A comprehensive literature search of the electronic databases PubMed, MEDLINE, Web of Science, and Cochrane Library for published randomized controlled trials (RCTs) was undertaken. The evidence base was critically appraised using a tool from the Cochrane Bone, Joint and Muscle Trauma Group. Eight RCTs involving 641 patients were included. The use of fibrin sealant significantly reduced postoperative drainage (weighted mean difference (WMD) −346, 95% confidence interval (CI) −496.29 to −197.54, P < 0.00001) and blood transfusions (risk ratio (RR) 0.47, 95% CI 0.35 to 0.63, P < 0.00001) and led to a significant improvement in the range of motion (WMD 16.59, 95% CI 6.92 to 26.25, P = 0.0008). However, using fibrin sealant did not significantly reduced total blood loss (WMD −305.25, 95% CI −679.44 to 68.95, P = 0.11). Regarding complications, there were no significant differences in any adverse events, fever, infection, or hematoma among the study groups. In conclusion, the present meta-analysis indicates that the use of fibrin sealant was effective and safe as a hemostatic therapy for patients with TKA. PMID:24884626

Unemployment in Iraqi Refugees: The Interaction of Pre and Post-Displacement Trauma

PubMed Central

Wright, A. Michelle; Dhalimi, Abir; Lumley, Mark A.; Jamil, Hikmet; Pole, Nnamdi; Arnetz, Judith E.; Arnetz, Bengt B.

2016-01-01

Previous refugee research has been unable to link pre-displacement trauma with unemployment in the host country. The current study assessed the role of pre-displacement trauma, post-displacement trauma, and the interaction of both trauma types to prospectively examine unemployment in a random sample of newly-arrived Iraqi refugees. Participants (N=286) were interviewed three times over the first two years post-arrival. Refugees were assessed for pre-displacement trauma exposure, post-displacement trauma exposure, a history of unemployment in the country of origin and host country, and symptoms of posttraumatic stress disorder (PTSD) and depression. Analyses found that neither pre-displacement nor post-displacement trauma independently predicted unemployment 2 years post-arrival; however, the interaction of pre and post-displacement trauma predicted 2-year unemployment. Refugees with high levels of both pre and post-displacement trauma had a 91% predicted probability of unemployment, whereas those with low levels of both traumas had a 20% predicted probability. This interaction remained significant after controlling for sociodemographic variables and mental health upon arrival to the U.S. Resettlement agencies and community organizations should consider the interactive effect of encountering additional trauma after escaping the hardships of the refugee's country of origin. PMID:27535348

Randomized control trial to evaluate the effects of acute testosterone administration in men on muscle mass, strength, and physical function following ACL reconstructive surgery: rationale, design, methods.

PubMed

Wu, Brian W; Berger, Max; Sum, Jonathan C; Hatch, George F; Schroeder, E Todd

2014-12-06

The anterior cruciate ligament (ACL) is one of four major ligaments in the knee that provide stability during physical activity. A tear in the ACL is characterized by joint instability that leads to decreased activity, knee dysfunction, reduced quality of life and a loss of muscle mass and strength. While rehabilitation is the standard-of-care for return to daily function, additional surgical reconstruction can provide individuals with an opportunity to return to sports and strenuous physical activity. Over 200,000 ACL reconstructions are performed in the United States each year, and rehabilitation following surgery is slow and expensive. One possible method to improve the recovery process is the use of intramuscular testosterone, which has been shown to increase muscle mass and strength independent of exercise. With short-term use of supraphysiologic doses of testosterone, we hope to reduce loss of muscle mass and strength and minimize loss of physical function following ACL reconstruction compared to standard-of-care alone. This study is a double-blinded randomized control trial. Men 18-50 years of age, scheduled for ACL reconstruction are randomized into two groups. Participants randomized to the testosterone group receive intramuscular testosterone administration once per week for 8 weeks starting 2 weeks prior to surgery. Participants randomized to the control group receive a saline placebo intramuscularly instead of testosterone. Lean mass, muscle strength and physical function are measured at 5 time points: 2 weeks pre-surgery, 1 day pre-surgery, and 6, 12, 24 weeks post-surgery. Both groups follow standard-of-care rehabilitation protocol. We believe that testosterone therapy will help reduce the loss of muscle mass and strength experienced after ACL injury and reconstruction. Hopefully this will provide a way to shorten the rehabilitation necessary following ACL reconstruction. If successful, testosterone therapy may also be used for other injuries involving trauma and muscle atrophy. NCT01595581, REGISTRATION: May 8, 2012.

A Randomized Implementation Study of Trauma-Focused Cognitive Behavioral Therapy for Adjudicated Teens in Residential Treatment Facilities.

PubMed

Cohen, Judith A; Mannarino, Anthony P; Jankowski, Kay; Rosenberg, Stanley; Kodya, Suzanne; Wolford, George L

2016-05-01

Adjudicated youth in residential treatment facilities (RTFs) have high rates of trauma exposure and post-traumatic stress disorder (PTSD). This study evaluated strategies for implementing trauma-focused cognitive behavioral therapy (TF-CBT) in RTF. Therapists (N = 129) treating adjudicated youth were randomized by RTF program (N = 18) to receive one of the two TF-CBT implementation strategies: (1) web-based TF-CBT training + consultation (W) or (2) W + 2 day live TF-CBT workshop + twice monthly phone consultation (W + L). Youth trauma screening and PTSD symptoms were assessed via online dashboard data entry using the University of California at Los Angeles PTSD Reaction Index. Youth depressive symptoms were assessed with the Mood and Feelings Questionnaire-Short Version. Outcomes were therapist screening; TF-CBT engagement, completion, and fidelity; and youth improvement in PTSD and depressive symptoms. The W + L condition resulted in significantly more therapists conducting trauma screening (p = .0005), completing treatment (p = .03), and completing TF-CBT with fidelity (p = .001) than the W condition. Therapist licensure significantly impacted several outcomes. Adjudicated RTF youth receiving TF-CBT across conditions experienced statistically and clinically significant improvement in PTSD (p = .001) and depressive (p = .018) symptoms. W + L is generally superior to W for implementing TF-CBT in RTF. TF-CBT is effective for improving trauma-related symptoms in adjudicated RTF youth. Implementation barriers are discussed. © The Author(s) 2016.

Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study.

PubMed

Novo, Patricia; Landin-Romero, Ramon; Radua, Joaquim; Vicens, Victor; Fernandez, Isabel; Garcia, Francisca; Pomarol-Clotet, Edith; McKenna, Peter J; Shapiro, Francine; Amann, Benedikt L

2014-09-30

Traumatic events are frequent in bipolar patients and can worsen the course of the disease. Psychotherapeutic interventions for these events have not been studied so far. Twenty DSM-IV bipolar I and II patients with subsyndromal mood symptoms and a history of traumatic events were randomly assigned to Eye Movement Desensitization and Reprocessing therapy (n=10) or treatment as usual (n=10). The treatment group received between 14 and 18 Eye Movement Desensitization and Reprocessing sessions during 12 weeks. Evaluations of affective symptoms, symptoms of trauma and trauma impact were carried out by a blind rater at baseline, 2 weeks, 5 weeks, 8 weeks, 12 weeks and at 24 weeks follow-up. Patients in the treatment group showed a statistically significant improvement in depressive and hypomanic symptoms, symptoms of trauma and trauma impact compared to the treatment as usual group after intervention. This effect was only partly maintained in trauma impact at the 24 weeks follow-up visit. One patient dropped from Eye Movement Desensitization and Reprocessing group whereas four from the treatment as usual group. This pilot study suggests that Eye Movement Desensitization and Reprocessing therapy may be an effective and safe intervention to treat subsyndromal mood and trauma symptoms in traumatized bipolar patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A Randomized Implementation Study of Trauma-Focused Cognitive Behavioral Therapy for Adjudicated Teens in Residential Treatment Facilities

PubMed Central

Cohen, Judith A.; Mannarino, Anthony P.; Jankowski, Kay; Rosenberg, Stanley; Kodya, Suzanne; Wolford, George L.

2016-01-01

Adjudicated youth in residential treatment facilities (RTFs) have high rates of trauma exposure and post-traumatic stress disorder (PTSD). This study evaluated strategies for implementing trauma-focused cognitive behavioral therapy (TF-CBT) in RTF. Therapists (N = 129) treating adjudicated youth were randomized by RTF program (N = 18) to receive one of the two TF-CBT implementation strategies: (1) web-based TF-CBT training + consultation (W) or (2) W + 2 day live TF-CBT workshop + twice monthly phone consultation (W + L). Youth trauma screening and PTSD symptoms were assessed via online dashboard data entry using the University of California at Los Angeles PTSD Reaction Index. Youth depressive symptoms were assessed with the Mood and Feelings Questionnaire–Short Version. Outcomes were therapist screening; TF-CBT engagement, completion, and fidelity; and youth improvement in PTSD and depressive symptoms. The W + L condition resulted in significantly more therapists conducting trauma screening (p = .0005), completing treatment (p = .03), and completing TF-CBT with fidelity (p = .001) than the W condition. Therapist licensure significantly impacted several outcomes. Adjudicated RTF youth receiving TF-CBT across conditions experienced statistically and clinically significant improvement in PTSD (p = .001) and depressive (p = .018) symptoms. W + L is generally superior to W for implementing TF-CBT in RTF. TF-CBT is effective for improving trauma-related symptoms in adjudicated RTF youth. Implementation barriers are discussed. PMID:26747845

Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial.

PubMed

Homayouni, Kaynoosh; Foruzi, Shima; Kalhori, Fereshte

2016-09-01

Pes anserinus tendino-bursitis is a condition caused by repetitive friction over the bursa or direct trauma to knee joint and it presents with proximal medial tibial pain and swelling. The aim of this study is to determine the effects of kinesiotaping in comparison with naproxen and physical therapy in treatment of pes anserinus tendino-bursitis. In a randomized comparative clinical trial 56 patients with clinical diagnosis of pes anserinus tendino-bursitis were randomly assigned to kinesiotaping and naproxen/physical therapy (28 patients in each group). Kinesiotaping on the tender area in the form of space-correction (lifting) technique was used and repeated for three times with a one-week interval. Another group received naproxen (250mg TID for 10 days) and ten sessions of daily physical therapy. The visual analog scale (VAS) was used for evaluation of pain. The depth of swelling of the area was measured with sonography before and after treatment. Wilcoxon signed ranks test has been used for determining the influence of interventions on pain (VAS) and swelling scores in each group. The ANCOVA (Analysis of covariance) test was applied for comparing the influence of interventions on VAS and swelling scores after adjustment for co-variables. At end of the study, 27 patients remained in the kinesiotaping group and 19 patients in naproxen/physical therapy group. Treatment with kinesiotaping significantly decreased the pain (P=0.0001) and swelling scores (P=0.0001) in comparison with naproxen/physical therapy after adjustment for baseline characteristics. Kinesiotaping was safe without any complications except for a mild local skin irritation in one patient. Kinesiotaping is more effective than naproxen plus physical therapy in reduction of pain and swelling in patients with pes anserinus tendino-bursitis. www.ClinicalTrials.gov identifier is NCT01680263.

Geographic distribution of trauma centers and injury-related mortality in the United States.

PubMed

Brown, Joshua B; Rosengart, Matthew R; Billiar, Timothy R; Peitzman, Andrew B; Sperry, Jason L

2016-01-01

Regionalized trauma care improves outcomes; however, access to care is not uniform across the United States. The objective was to evaluate whether geographic distribution of trauma centers correlates with injury mortality across state trauma systems. Level I or II trauma centers in the contiguous United States were mapped. State-level age-adjusted injury fatality rates per 100,000 people were obtained and evaluated for spatial autocorrelation. Nearest neighbor ratios (NNRs) were generated for each state. A NNR less than 1 indicates clustering, while a NNR greater than 1 indicates dispersion. NNRs were tested for difference from random geographic distribution. Fatality rates and NNRs were examined for correlation. Fatality rates were compared between states with trauma center clustering versus dispersion. Trauma center distribution and population density were evaluated. Spatial-lag regression determined the association between fatality rate and NNR, controlling for state-level demographics, population density, injury severity, trauma system resources, and socioeconomic factors. Fatality rates were spatially autocorrelated (Moran's I = 0.35, p < 0.01). Nine states had a clustered pattern (median NNR, 0.55; interquartile range [IQR], 0.48-0.60), 22 had a dispersed pattern (median NNR, 2.00; IQR, 1.68-3.99), and 10 had a random pattern (median NNR, 0.90; IQR, 0.85-1.00) of trauma center distribution. Fatality rate and NNR were correlated (ρ = 0.34, p = 0.03). Clustered states had a lower median injury fatality rate compared with dispersed states (56.9 [IQR, 46.5-58.9] vs. 64.9 [IQR, 52.5-77.1]; p = 0.04). Dispersed compared with clustered states had more counties without a trauma center that had higher population density than counties with a trauma center (5.7% vs. 1.2%, p < 0.01). Spatial-lag regression demonstrated that fatality rates increased by 0.02 per 100,000 persons for each unit increase in NNR (p < 0.01). Geographic distribution of trauma centers correlates with injury mortality, with more clustered state trauma centers associated with lower fatality rates. This may be a result of access relative to population density. These results may have implications for trauma system planning and require further study to investigate underlying mechanisms. Therapeutic/care management study, level IV.

Building Capacity for Trauma-Informed Care in the Child Welfare System: Initial Results of a Statewide Implementation.

PubMed

Lang, Jason M; Campbell, Kimberly; Shanley, Paul; Crusto, Cindy A; Connell, Christian M

2016-05-01

Exposure to childhood trauma is a major public health concern and is especially prevalent among children in the child welfare system (CWS). State and tribal CWSs are increasingly focusing efforts on identifying and serving children exposed to trauma through the creation of trauma-informed systems. This evaluation of a statewide initiative in Connecticut describes the strategies used to create a trauma-informed CWS, including workforce development, trauma screening, policy change, and improved access to evidence-based trauma-focused treatments during the initial 2-year implementation period. Changes in system readiness and capacity to deliver trauma-informed care were evaluated using stratified random samples of child welfare staff who completed a comprehensive assessment prior to (N = 223) and 2 years following implementation (N = 231). Results indicated significant improvements in trauma-informed knowledge, practice, and collaboration across nearly all child welfare domains assessed, suggesting system-wide improvements in readiness and capacity to provide trauma-informed care. Variability across domains was observed, and frontline staff reported greater improvements than supervisors/managers in some domains. Lessons learned and recommendations for implementation and evaluation of trauma-informed care in child welfare and other child-serving systems are discussed. © The Author(s) 2016.

Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol

PubMed Central

Marjanovic, Nicolas; Frasca, Denis; Asehnoune, Karim; Paugam, Catherine; Lasocki, Sigismond; Ichai, Carole; Lefrant, Jean-Yves; Leone, Marc; Dahyot-Fizelier, Claire; Pottecher, Julien; Falcon, Dominique; Veber, Benoit; Constantin, Jean-Michel; Seguin, Sabrina; Guénézan, Jérémy; Mimoz, Olivier

2017-01-01

Introduction Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients. Methods and analysis This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay. Ethics and dissemination This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. Trial registration Clinical Trials NCT02534974 PMID:28790042

Strengthening Family Coping Resources: The Feasibility of a Multifamily Group Intervention for Families Exposed to Trauma*

PubMed Central

Kiser, Laurel J.; Donohue, April; Hodgkinson, Stacy; Medoff, Deborah; Black, Maureen M.

2010-01-01

Families exposed to urban poverty face a disproportionate risk of exposure to repeated trauma. Repeated exposures can lead to severe and chronic reactions in multiple family members with effects that ripple throughout the family system. Interventions for distressed families residing in traumatic contexts, such as low-income, urban settings are desperately needed. This report presents preliminary data in support of Strengthening Family Coping Resources, a trauma-focused, multifamily, skill-building intervention. Strengthening Family Coping Resources is designed for families living in traumatic contexts with the goal of reducing symptoms of posttraumatic stress disorder and other trauma-related disorders in children and caregivers. Results from open trials suggest Strengthening Family Coping Resources is a feasible intervention with positive effects on children’s symptoms of trauma-related distress. PMID:21105068

Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax.

PubMed

Kulvatunyou, N; Erickson, L; Vijayasekaran, A; Gries, L; Joseph, B; Friese, R F; O'Keeffe, T; Tang, A L; Wynne, J L; Rhee, P

2014-01-01

Small pigtail catheters appear to work as well as the traditional large-bore chest tubes in patients with traumatic pneumothorax, but it is not known whether the smaller pigtail catheters are associated with less tube-site pain. This study was conducted to compare tube-site pain following pigtail catheter or chest tube insertion in patients with uncomplicated traumatic pneumothorax. This prospective randomized trial compared 14-Fr pigtail catheters and 28-Fr chest tubes in patients with traumatic pneumothorax presenting to a level I trauma centre from July 2010 to February 2012. Patients who required emergency tube placement, those who refused and those who could not respond to pain assessment were excluded. Primary outcomes were tube-site pain, as assessed by a numerical rating scale, and total pain medication use. Secondary outcomes included the success rate of pneumothorax resolution and insertion-related complications. Forty patients were enrolled. Baseline characteristics of 20 patients in the pigtail catheter group were similar to those of 20 patients in the chest tube group. No patient had a flail chest or haemothorax. Pain scores related to chest wall trauma were similar in the two groups. Patients with a pigtail catheter had significantly lower mean(s.d.) tube-site pain scores than those with a chest tube, at baseline after tube insertion (3.2(0.6) versus 7.7(0.6); P < 0.001), on day 1 (1.9(0.5) versus 6.2(0.7); P < 0.001) and day 2 (2.1(1.1) versus 5.5(1.0); P = 0.040). The decreased use of pain medication associated with pigtail catheter was not significantly different. The duration of tube insertion, success rate and insertion-related complications were all similar in the two groups. For patients with a simple, uncomplicated traumatic pneumothorax, use of a 14-Fr pigtail catheter is associated with reduced pain at the site of insertion, with no other clinically important differences noted compared with chest tubes. NCT01537289 (http://clinicaltrials.gov). © 2013 BJS Society Ltd. Published by John Wiley & Sons Ltd.

Definition of infection after fracture fixation: A systematic review of randomized controlled trials to evaluate current practice.

PubMed

Metsemakers, W J; Kortram, K; Morgenstern, M; Moriarty, T F; Meex, I; Kuehl, R; Nijs, S; Richards, R G; Raschke, M; Borens, O; Kates, S L; Zalavras, C; Giannoudis, P V; Verhofstad, M H J

2018-03-01

One of the most challenging musculoskeletal complications in modern trauma surgery is infection after fracture fixation (IAFF). Although infections are clinically obvious in many cases, a clear definition of the term IAFF is crucial, not only for the evaluation of published research data but also for the establishment of uniform treatment concepts. The aim of this systematic review was to identify the definitions used in the scientific literature to describe infectious complications after internal fixation of fractures. The hypothesis of this study was that the majority of fracture-related literature do not define IAFF. A comprehensive search was performed in Embase, Cochrane, Google Scholar, Medline (OvidSP), PubMed publisher and Web-of-Science for randomized controlled trials (RCTs) on fracture fixation. Data were collected on the definition of infectious complications after fracture fixation used in each study. Study selection was accomplished through two phases. During the first phase, titles and abstracts were reviewed for relevance, and the full texts of relevant articles were obtained. During the second phase, full-text articles were reviewed. All definitions were literally extracted and collected in a database. Then, a classification was designed to rate the quality of the description of IAFF. A total of 100 RCT's were identified in the search. Of 100 studies, only two (2%) cited a validated definition to describe IAFF. In 28 (28%) RCTs, the authors used a self-designed definition. In the other 70 RCTs, (70%) there was no description of a definition in the Methods section, although all of the articles described infections as an outcome parameter in the Results section. This systematic review shows that IAFF is not defined in a large majority of the fracture-related literature. To our knowledge, this is the first study conducted with the objective to explore this important issue. The lack of a consensus definition remains a problem in current orthopedic trauma research and treatment and this void should be addressed in the near future. Copyright © 2017 Elsevier Ltd. All rights reserved.

Phase III, randomized, double-blind, placebo-controlled trial of topical 2 % lidocaine for the prevention and treatment of oral mucosal pain in children.

PubMed

Coudert, Amélie E; Ostertag, Agnès; Baaroun, Vanessa; Artaud, Catherine; Ifi-Naulin, Chantal; Druo, Jean-Patick; Princ, Guy; Descroix, Vianney

2014-05-01

The aim of this study was to assess the efficacy in pain reduction of topical 2 % lidocaine compared to a placebo cream in children with oral mucosal lesions due to trauma or aphthous ulcers or in the prevention of clamp placement pain. The design was a double-blind, randomized, placebo-controlled, four-center trial on 64 patients. Pain intensity and relief were measured using a 100-mm visual analog scale (VAS). One-tailed Student's t test and ANOVA were used for statistical analyses. Independent of the pain origin, application of 2 % lidocaine cream led to a mean reduction in VAS pain intensity of 19.7 mm ± 18.3, which was significantly greater than that obtained with the placebo cream (p = .025). Analyses showed a statistically significant efficacy of the 2 % lidocaine cream (p < .0001). Its efficacy was not associated to any local or systemic adverse drug reaction, as reported by the patients. As the most important population represented in our patients was children whom a rubber dam clamp was placed, we also specifically analysed this population, and we were able to demonstrate a significantly greater efficacy of the 2 % lidocaine cream on the pain caused by the rubber dam clamp placement in comparison to the placebo cream (p < .005). A significant reduction in pain intensity occurred after application of 2 % lidocaine cream, and the effect was significantly greater than that obtained with the placebo cream. Considering the study's limitations, this product appears safe for use in children. For painful benign lesions of the oral mucosa (trauma or aphthous ulcers) or for preventing painful iatrogenic procedures such as rubber dam clamp placement, it is essential to treat or prevent pain onset, especially in the pediatric population for whom a painful experience could end in refusal of dental care. Application of a topical anesthetic in this specific situation is of particular interest, as is defining its efficacy and safety.

The effectiveness of transdermal opioid in the management multiple rib fractures: randomized clinical trial.

PubMed

Solak, Okan; Oz, Gürhan; Kokulu, Serdar; Solak, Ozlem; Doğan, Gökçen; Esme, Hıdır; Ocalan, Kubilay; Baki, Elif Doğan

2013-09-01

The most commonly observed pathology in chest traumas is rib fracture, and the most important clinical symptom is severe pain. To investigate the effectiveness of intramuscular opioid (IMO), intravenous patient-controlled analgesia (IVPCA) and the Fentanyl transdermal therapeutic system (TTS) in the management of rib fracture pain. Prospective randomized clinical trial. In our prospective and randomised study, we included 45 patients with a diagnosis of multiple rib fractures. There were three groups and intercostal nerve blockage (ICB) in the first day and oral paracetamol for five days was administered to each group as standard. In Group IMO (n=15), 4×40 mg pethidine HCl was administered to the patients, while in Group IVPCA (n=15) this was 5 μg/mL continuous intravenous fentanyl and was 50 μg fentanyl TTS in Group TTS (n=15). The demographics, injury data and vital signs of the patients were recorded. Pain was scored using Visual Analogue Scale (VAS). The pain during lying down (VASl) and mobilisation (VASm) was detected. There were no differences between the three groups regarding age, sex, the trauma pattern, the number and distribution of costal fracture localisations, the presence of additional pathology, complications, thoracal catheter and the duration of thoracal catheter. No significant difference between the groups regarding systolic and diastolic arterial tension, number of breaths and beats in a minute was observed (p>0.05). We observed an improvement in the mean VAS score after treatment in all three groups. The mean VASl score significantly decreased after treatment in each group (p<0.05). The mean VASl and VASm scores measured on the 1(st), 2(nd), 3(rd), 4(th) and 5(th) days were found to be higher in Group IMO than in Groups IVPCA and TTS; however, these differences were not statistically significant (p>0.05). In the analgesia of patients with multiple rib fractures, TTS administration with ICB showed similar effectiveness with IVPCA administration with ICB. In the management of pain due to multiple rib fractures, TTS administration is a safe, non-invasive and effective procedure.

Effect of clinical decision rules, patient cost and malpractice information on clinician brain CT image ordering: a randomized controlled trial.

PubMed

Gimbel, Ronald W; Pirrallo, Ronald G; Lowe, Steven C; Wright, David W; Zhang, Lu; Woo, Min-Jae; Fontelo, Paul; Liu, Fang; Connor, Zachary

2018-03-12

The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns. Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians. Using simulation, we explored whether the presentation of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems. Multi-center, double-blinded simulation-based randomized controlled trial. Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient. This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order. The malpractice and cost information differed by assigned group to test the any temporal relationship. The simulation closed with a second vignette and an imaging decision. One hundred sixteen of the 167 participants (66.9%) initially ordered a brain CT scan. After CCHR presentation, the number of clinicians ordering a CT dropped to 76 (45.8%), representing a 21.1% reduction in CT ordering (P = 0.002). This reduction in CT ordering was maintained, in comparison to initial imaging orders, when presented with malpractice review information (p = 0.002) and patient cost information (p = 0.002). About 57% of clinicians changed their order during study, while 43% never modified their imaging order. This study suggests that ED clinician brain CT imaging decisions may be influenced by clinical decision support rules, patient out-of-pocket cost information and findings from malpractice case review. NCT03449862 , February 27, 2018, Retrospectively registered.

COMBAT: A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

DTIC Science & Technology

2015-08-01

energy depletion. The latter is accompanied by an increased metabolic rate (including in- creased energy expenditure and oxygen consumption ) (14, 18... consumption in response to maximal oxygen availability predicts postinjury multiple organ failure. J Trauma 33: 58–65; discussion 65–67, 1992. 36... oxygen consumption in response to maximal oxygen availability predicts post- injury multiple organ failure. J Trauma. 1992;33(1):58Y65. 16. Minei JP

COMBAT - A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

DTIC Science & Technology

2015-08-01

energy depletion. The latter is accompanied by an increased metabolic rate (including in- creased energy expenditure and oxygen consumption ) (14, 18... consumption in response to maximal oxygen availability predicts postinjury multiple organ failure. J Trauma 33: 58–65; discussion 65–67, 1992. 36... oxygen consumption in response to maximal oxygen availability predicts post- injury multiple organ failure. J Trauma. 1992;33(1):58Y65. 16. Minei JP

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

The effects of perineal management techniques on labor complications

PubMed Central

Fahami, Fariba; Shokoohi, Zohreh; Kianpour, Mariam

2012-01-01

Background: Many women suffer from perineal trauma during the normal vaginal delivery. Perineal trauma is mainly associated with pain and complications after the childbirth. Perineal management techniques can play a significant role in perineal trauma reduction. This study aimed to compare the effects of perineal management techniques (hands-off technique, Ritgen maneuver and perineal massage using a lubricant during delivery) on the labor complications. Materials and Methods: This quasi-experimental clinical trial was conducted on 99 primiparous women who referred to Daran Hospital, Isfahan, Iran for normal vaginal delivery in 2009. The subjects were selected using a convenient method and randomly assigned to three groups of Ritgen maneuver, hands-off technique and perineal massage with lubricant. A questionnaire was used to determine the demographic characteristics of the participants and complications after birth. The short form of McGill Pain Questionnaire and the visual analogue scale for pain were also employed. The incidence and degree of perineal tears were evaluated immediately after delivery. Moreover, the incidence and severity of perineal pain were assessed 24 hours and also 6 weeks after delivery. Findings: In the Ritgen maneuver group, the frequency of tears, the relative frequency of tear degrees, the severity of perineal pain 24 hours after delivery and the frequency of pain and perineal pain severity 6 weeks after delivery were significantly different from the other two methods. Conclusions: Hands-off technique during parturition of the neonate's head was associated with fewer complications after delivery. It was even better than perineal massage during the parturition. PMID:23493441

Effects of topical phenytoin on nasal wound healing after mechanical trauma: An experimental study.

PubMed

Şimşek, Gökçe; Ciftci, Osman; Karadag, Neşe; Karatas, Erkan; Kizilay, Ahmet

2014-12-01

Impaired postoperative wound healing is the second most common morbidity after synechia formation in endoscopic sinus surgery. The aim of this experimental study was to investigate the potential effects of topical phenytoin on wound healing after nasal mucosal trauma in rats. An experimental study at the Inonu University Faculty of Medicine. Twenty-four rats were randomized into three groups: 1) phenytoin group (n = 8), 2) control group (n = 8), and 3) vehicle group (n = 8). After damaging the right nasal cavity, in the phenytoin group, 1% topical phenytoin cream was applied for 7 days. The rats in the control group did not receive any treatment. The vehicle group was treated with daily topical cold cream for 1 week. The rats were sacrificed at the end, and the nasal cavities were excised. Tissue edema and inflammatory cell infiltration were compared among the groups. Additionally, proliferating cell nuclear antigen (PCNA) and cluster of differentiation 31 (CD31) immunoexpression levels were evaluated. Furthermore, in biochemical analysis, the tissue levels of vascular endothelial growth factor and (EGF) of the groups were investigated. In the phenytoin group, tissue edema and inflammatory cell infiltration were significantly decreased, and PCNA and CD31 immunoexpression levels were more prominent (P < .001) and the tissue EGF levels were significantly higher (P < .01). Topical phenytoin treatment may alter the nasal wound healing after mechanical trauma. The potential beneficial effects of topical phenytoin on nasal mucosa should be investigated by further experimental and human trials. NA. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

“Do You Expect Me to Receive PTSD Care in a Setting Where Most of the Other Patients Remind Me of the Perpetrator?”: Home-Based Telemedicine to Address Barriers to Care Unique to Military Sexual Trauma and Veterans Affairs Hospitals

PubMed Central

Gilmore, Amanda K.; Davis, Margaret T.; Grubaugh, Anouk; Resnick, Heidi; Birks, Anna; Denier, Carol; Muzzy, Wendy; Tuerk, Peter; Acierno, Ron

2016-01-01

Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barriers to care that are inherent to the treatment environment, such as with female veterans who have experienced military sexual trauma (MST) and who must present to VA Medical Centers where the majority of patients share features with perpetrator (e.g. gender, clothing) and may function as reminders of the trauma. Delivering evidence-based therapies to female veterans with MST-related PTSD via HBT can provide needed treatment to this population. This manuscript describes an ongoing federally funded randomized controlled trial comparing Prolonged Exposure (PE) delivered in-person to PE delivered via HBT. Outcomes include session attendance, satisfaction with services, and clinical and quality of life indices. It is hypothesized that based on intent-to-treat analyses, HBT delivery of PE will be more effective than SD at improving both clinical and quality of life outcomes at post, 3-, and 6-month follow-up. This is because ‘dose received’, that is fewer sessions missed, and lower attrition, will be observed in the HBT group. Although the current manuscript focuses on female veterans with MST-related PTSD, implications for other populations facing systemic barriers are discussed. PMID:26992740

"Do you expect me to receive PTSD care in a setting where most of the other patients remind me of the perpetrator?": Home-based telemedicine to address barriers to care unique to military sexual trauma and veterans affairs hospitals.

PubMed

Gilmore, Amanda K; Davis, Margaret T; Grubaugh, Anouk; Resnick, Heidi; Birks, Anna; Denier, Carol; Muzzy, Wendy; Tuerk, Peter; Acierno, Ron

2016-05-01

Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barriers to care that are inherent to the treatment environment, such as with female veterans who have experienced military sexual trauma (MST) and who must present to VA Medical Centers where the majority of patients share features with perpetrator (e.g. gender, clothing) and may function as reminders of the trauma. Delivering evidence-based therapies to female veterans with MST-related PTSD via HBT can provide needed treatment to this population. This manuscript describes an ongoing federally funded randomized controlled trial comparing Prolonged Exposure (PE) delivered in-person to PE delivered via HBT. Outcomes include session attendance, satisfaction with services, and clinical and quality of life indices. It is hypothesized that based on intent-to-treat analyses, HBT delivery of PE will be more effective than SD at improving both clinical and quality of life outcomes at post, 3-, and 6-month follow-up. This is because 'dose received', that is fewer sessions missed, and lower attrition, will be observed in the HBT group. Although the current manuscript focuses on female veterans with MST-related PTSD, implications for other populations facing systemic barriers are discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

Trauma history characteristics associated with mental states at clinical high risk for psychosis.

PubMed

Russo, Debra A; Stochl, Jan; Painter, Michelle; Dobler, Veronika; Jackson, Erica; Jones, Peter B; Perez, Jesus

2014-12-15

Traumatic experiences have been positively associated with both severity of attenuated psychotic symptoms in individuals at high risk (HR) for psychosis and transitions into psychotic disorders. Our aim was to determine what characteristics of the trauma history are more likely to be associated with individuals at HR. The Trauma History Screen (THS) was used to enable emphasis on number and perceived intensity of adverse life events and age at trauma exposure. Sixty help-seeking individuals who met HR criteria were compared to a random sample of 60 healthy volunteers. Both groups were aged 16-35 and resided in the same geographical location. HR participants experienced their first trauma at an earlier age, continued to experience trauma at younger developmental stages, especially during early/mid adolescence and were exposed to a high number of traumas. They were more depressed and anxious, but did not experience more distress in relation to trauma. Both incidences of trauma and age at which trauma occurred were the most likely predictors of becoming HR. This work emphasises the importance of assessing trauma characteristics in HR individuals to enable differentiation between psychotic-like experiences that may reflect dissociative responses to trauma and genuine prodromal psychotic presentations. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Dental Fear in Children with Repeated Tooth Injuries.

PubMed

Negovetić Vranić, Dubravka; Ivančić Jokić, Nataša; Bakarčić, Danko; Carek, Andreja; Rotim, Željko; Verzak, Željko

2016-06-01

Tooth injuries are serious clinical conditions. Some children experience dental trauma only once, while others are more prone to repeated tooth injuries. Repeated dental trauma occurs in 19.4% to 30% of patients. Pain and dental trauma are the most common reasons for fear and anxiety. The main objective of this study was to investigate how dental trauma, as well as repeated dental trauma affects the occurrence and development of dental fear in children. The study was conducted on a random sample of 147 subjects (88 boys and 59 girls) aged 5-8 and 9-12 years. Subjects in both age groups were divided into subroups without dental trauma, with one dental trauma and with repeated dental trauma. The validated Children’s Fear Survey Schedule – Dental Subscale was used on fear assessment. Results showed that only 12.2% of children without trauma, 33.3% with one trauma and 51.7% with repeated trauma were not afraid of injection. Older children had a significantly lower fear of injections, touch of an unknown person, choking, going to the hospital and people in white uniforms. Dentist was not the cause of fear in 65.5% of patients with repeated trauma. With each repeated injury of teeth, the degree of their fear of dental treatment was lower.

Unemployment in Iraqi refugees: The interaction of pre and post-displacement trauma.

PubMed

Wright, A Michelle; Dhalimi, Abir; Lumley, Mark A; Jamil, Hikmet; Pole, Nnamdi; Arnetz, Judith E; Arnetz, Bengt B

2016-12-01

Previous refugee research has been unable to link pre-displacement trauma with unemployment in the host country. The current study assessed the role of pre-displacement trauma, post-displacement trauma, and the interaction of both trauma types to prospectively examine unemployment in a random sample of newly-arrived Iraqi refugees. Participants (N = 286) were interviewed three times over the first two years post-arrival. Refugees were assessed for pre-displacement trauma exposure, post-displacement trauma exposure, a history of unemployment in the country of origin and host country, and symptoms of posttraumatic stress disorder (PTSD) and depression. Analyses found that neither pre-displacement nor post-displacement trauma independently predicted unemployment 2 years post-arrival; however, the interaction of pre and post-displacement trauma predicted 2-year unemployment. Refugees with high levels of both pre and post-displacement trauma had a 91% predicted probability of unemployment, whereas those with low levels of both traumas had a 20% predicted probability. This interaction remained significant after controlling for sociodemographic variables and mental health upon arrival to the US. Resettlement agencies and community organizations should consider the interactive effect of encountering additional trauma after escaping the hardships of the refugee's country of origin. © 2016 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

Comparing the Efficiency of Two Different Extraction Techniques in Removal of Maxillary Third Molars: A Randomized Controlled Trial.

PubMed

Edward, Joseph; Aziz, Mubarak A; Madhu Usha, Arjun; Narayanan, Jyothi K

2017-12-01

Extractions are routine procedures in dental surgery. Traditional extraction techniques use a combination of severing the periodontal attachment, luxation with an elevator, and removal with forceps. A new technique of extraction of maxillary third molar is introduced in this study-Joedds technique, which is compared with the conventional technique. One hundred people were included in the study, the people were divided into two groups by means of simple random sampling. In one group conventional technique of maxillary third molar extraction was used and on second Joedds technique was used. Statistical analysis was carried out with student's t test. Analysis of 100 patients based on parameters showed that the novel joedds technique had minimal trauma to surrounding tissues, less tuberosity and root fractures and the time taken for extraction was <2 min while compared to other group of patients. This novel technique has proved to be better than conventional third molar extraction technique, with minimal complications. If Proper selection of cases and right technique are used.

A Randomized, Controlled Trial of Wholistic Hybrid Derived From Eye Movement Desensitization and Reprocessing and Emotional Freedom Technique (WHEE) for Self-Treatment of Pain, Depression, and Anxiety in Chronic Pain Patients

PubMed Central

Benor, Daniel; Rossiter-Thornton, John; Toussaint, Loren

2016-01-01

In this pilot study, a convenience sample of 24 chronic pain patients (17 with chronic fatigue syndrome/fibromyalgia) were randomized into WHEE treatment and wait-list control groups for 6 weeks. Assessments of depression, anxiety, and pain were completed before, during, and at 1 and 3 months after treatment. Wait-listed patients then received an identical course of WHEE and assessments. WHEE decreased anxiety (P < .5) and depression (P < .05) compared with the control group. The wait-list-turned-WHEE assessments demonstrated decreased pain severity (P < .05) and depression (P < .04) but not pain interference or anxiety. WHEE appears a promising method for pain, anxiety, and depression in patients with chronic pain, compared to standard medical care alone. Though a small pilot study, the present results suggest that further research appears warranted. An incidental finding was that a majority of patients with chronic pain had suffered psychological trauma in childhood and/or adulthood. PMID:27432773

2013 SYR Accepted Poster Abstracts.

PubMed

2013-01-01

SYR 2013 Accepted Poster abstracts: 1. Benefits of Yoga as a Wellness Practice in a Veterans Affairs (VA) Health Care Setting: If You Build It, Will They Come? 2. Yoga-based Psychotherapy Group With Urban Youth Exposed to Trauma. 3. Embodied Health: The Effects of a Mind�Body Course for Medical Students. 4. Interoceptive Awareness and Vegetable Intake After a Yoga and Stress Management Intervention. 5. Yoga Reduces Performance Anxiety in Adolescent Musicians. 6. Designing and Implementing a Therapeutic Yoga Program for Older Women With Knee Osteoarthritis. 7. Yoga and Life Skills Eating Disorder Prevention Among 5th Grade Females: A Controlled Trial. 8. A Randomized, Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioral Functioning of Middle School Children. 9. Feasibility of a Multisite, Community based Randomized Study of Yoga and Wellness Education for Women With Breast Cancer Undergoing Chemotherapy. 10. A Delphi Study for the Development of Protocol Guidelines for Yoga Interventions in Mental Health. 11. Impact Investigation of Breathwalk Daily Practice: Canada�India Collaborative Study. 12. Yoga Improves Distress, Fatigue, and Insomnia in Older Veteran Cancer Survivors: Results of a Pilot Study. 13. Assessment of Kundalini Mantra and Meditation as an Adjunctive Treatment With Mental Health Consumers. 14. Kundalini Yoga Therapy Versus Cognitive Behavior Therapy for Generalized Anxiety Disorder and Co-Occurring Mood Disorder. 15. Baseline Differences in Women Versus Men Initiating Yoga Programs to Aid Smoking Cessation: Quitting in Balance Versus QuitStrong. 16. Pranayam Practice: Impact on Focus and Everyday Life of Work and Relationships. 17. Participation in a Tailored Yoga Program is Associated With Improved Physical Health in Persons With Arthritis. 18. Effects of Yoga on Blood Pressure: Systematic Review and Meta-analysis. 19. A Quasi-experimental Trial of a Yoga based Intervention to Reduce Stress and Promote Health and Well-being Among Middle School Educators. 20. A Systematic Review of Yoga-based Interventions for Objective and Subjective Balance Measures. 21. Disparities in Yoga Use: A Multivariate Analysis of 2007 National Health Interview Survey Data. 22. Implementing Yoga Therapy Adapted for Older Veterans Who Are Cancer Survivors. 23. Randomized, Controlled Trial of Yoga for Women With Major Depressive Disorder: Decreased Ruminations as Potential Mechanism for Effects on Depression? 24. Yoga Beyond the Metropolis: A Yoga Telehealth Program for Veterans. 25. Yoga Practice Frequency, Relationship Maintenance Behaviors, and the Potential Mediating Role of Relationally Interdependent Cognition. 26. Effects of Medical Yoga in Quality of Life, Blood Pressure, and Heart Rate in Patients With Paroxysmal Atrial Fibrillation. 27. Yoga During School May Promote Emotion Regulation Capacity in Adolescents: A Group Randomized, Controlled Study. 28. Integrated Yoga Therapy in a Single Session as a Stress Management Technique in Comparison With Other Techniques. 29. Effects of a Classroom-based Yoga Intervention on Stress and Attention in Second and Third Grade Students. 30. Improving Memory, Attention, and Executive Function in Older Adults with Yoga Therapy. 31. Reasons for Starting and Continuing Yoga. 32. Yoga and Stress Management May Buffer Against Sexual Risk-Taking Behavior Increases in College Freshmen. 33. Whole-systems Ayurveda and Yoga Therapy for Obesity: Outcomes of a Pilot Study. 34. Women�s Phenomenological Experiences of Exercise, Breathing, and the Body During Yoga for Smoking Cessation Treatment. 35. Mindfulness as a Tool for Trauma Recovery: Examination of a Gender-responsive Trauma-informed Integrative Mindfulness Program for Female Inmates. 36. Yoga After Stroke Leads to Multiple Physical Improvements. 37. Tele-Yoga in Patients With Chronic Obstructive Pulmonary Disease and Heart Failure: A Mixed-methods Study of Feasibility, Acceptability, and Safety. 38. Effects of an Ashtanga Yoga-based Health and Wellness Curriculum on Physical and Emotional Well-being, Engagement Toward School, and Academic Performance of K-6 Students. 39. Yoga as a Facilitator for Participation Following an 8-week Yoga for Individuals With Chronic Stroke. 40. Standardization of Design and Reporting of Yoga Interventions for Musculoskeletal Conditions: A Delphi Approach. 41. Creating S.P.A.C.E. Through Yoga: Africa Yoga Project Teachers Promote Personal Transformation, Peaceful Communities, and Purpose-filled Service.

Impact of trauma system structure on injury outcomes: a systematic review protocol.

PubMed

Moore, Lynne; Champion, Howard; O'Reilly, Gerard; Leppaniemi, Ari; Cameron, Peter; Palmer, Cameron; Abu-Zidan, Fikri M; Gabbe, Belinda; Gaarder, Christine; Yanchar, Natalie; Stelfox, Henry Thomas; Coimbra, Raul; Kortbeek, John; Noonan, Vanessa; Gunning, Amy; Leenan, Luke; Gordon, Malcolm; Khajanchi, Monty; Shemilt, Michèle; Porgo, Valérie; Turgeon, Alexis F

2017-01-21

Injury represents one of the greatest public health challenges of our time with over 5 million deaths and 100 million people temporarily or permanently disabled every year worldwide. The effectiveness of trauma systems in decreasing injury mortality and morbidity has been well demonstrated. However, the organisation of trauma care varies significantly across trauma systems and we know little about which components of trauma systems contribute to their effectiveness. The objective of the study described in this protocol is to systematically review evidence of the impact of trauma system components on clinically significant outcomes including mortality, function and disability, quality of life, and resource utilization. We will perform a systematic review of studies evaluating the association between at least one trauma system component (e.g. accreditation by a central agency, interfacility transfer agreements) and at least one injury outcome (e.g. mortality, disability, resource use). We will search MEDLINE, EMBASE, COCHRANE central, and BIOSIS/Web of Knowledge databases, thesis holdings, key injury organisation websites and conference proceedings for eligible studies. Pairs of independent reviewers will evaluate studies for eligibility and extract data from included articles. Methodological quality will be evaluated using elements of the ROBINS-I tool and the Cochrane risk of bias tool for non-randomized and randomized studies, respectively. Strength of evidence will be evaluated using the GRADE tool. We expect to advance knowledge on the components of trauma systems that contribute to their effectiveness. This may lead to recommendations on trauma system structure that will help policy-makers make informed decisions as to where resources should be focused. The review may also lead to specific recommendations for future research efforts. This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 28-06-2016. PROSPERO 2016:CRD42016041336 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041336 .

A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD

DTIC Science & Technology

2013-08-01

sleep disturbance, and other hyperarousal symptoms typical of PTSD (11). Specific stimulation of CNS alpha-1 adreno- receptors disrupts REM sleep (36...result from excessive brain responsiveness to released norepinephrine disrupting rapid eye movement ( REM ) and other sleep stages (Mellman, Kumar, Kulick...in 2006, sought help for distressing combat trauma night- mares, sleep disruption, and daytime intrusive ruminations about previous combat events. He

An evaluation of the efficacy of a topical gel with Triester Glycerol Oxide (TGO) in the treatment of minor recurrent aphthous stomatitis in a Turkish cohort: A randomized, double-blind, placebo-controlled clinical trial.

PubMed

Ofluoglu, D; Ergun, S; Warnakulasuriya, S; Namdar-Pekiner, F; Tanyeri, H

2017-03-01

Triester glycerol oxide gel (Protefix® Queisser Pharma, Germany) is a new topical agent that has the property of adherence to the oral mucosa by forming a lipid film which protects against mechanical trauma and may help to reduce oral tissue moisture loss and inflammation. The aim of this clinical trial was to determine the efficacy of a topical TGO gel and to also compare it with triamcinolone acetonide pomade in the treatment of minor recurrent aphthous stomatitis. This study was a randomized, double-blind, placebo-controlled clinical trial and 180 patients with the complaint of minor aphthous ulcers were enrolled in this study. The sociodemographic data and clinical characteristics of the ulcer were collected by questionnaire. Ulcer size and pain level measurements were performed and the efficacy indices for ulcer pain and size were calculated at day 0,2,4,6 by the same investigator. Significant differences were not detected among the demographics and ulcer histories including age, gender, onset of ulcer, mean healing time, family RAS history and ulcer localization between three groups. The pain score in TGO group was found statistically lower at day 2,4, and 6. Efficacy index and improvement rate of TGO group, regarding pain score, was higher than the other two groups at day 2 and 4. The reduction in ulcer size was statistically higher in TGO group than the other two groups at day 4 and 6. Topical application of TGO gel could decrease pain intensity, accelerate ulcer healing without any side effects, utilizing an easy appliable and accessible procedure. Therefore TGO gel could be a well-tolerated, safe, topical therapeutic agent in the clinical practice of RAS treatment.

Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

PubMed

Langella, Luciana G; Silva, Paula F C; Costa-Santos, Larissa; Gonçalves, Marcela L L; Motta, Lara J; Deana, Alessandro M; Fernandes, Kristianne P S; Mesquita-Ferrari, Raquel A; Bussadori, Sandra Kalil

2018-01-26

Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears, and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction, and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits, and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to compare the effects of two sources of photobiomodulation in individuals with TMD. A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals aged 18-65 years allocated to either a laser group or light-emitting diode (LED) group submitted to 12 sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale and maximum vertical mandibular movement will be determined with the aid of digital calipers. This study compares the effects of two modalities of laser therapy on the pain and orofacial function of patients with TMD dysfunction. Photobiomodulation and LED therapy are treatment options for reducing the inflammatory process and pain as well as inducing the regeneration of the target tissue. ClinicalTrials.gov, NCT03257748 . Registered on 8 August 2017.

Effect of Preventive Supplementation with Zinc and Other Micronutrients on Non-Malarial Morbidity in Tanzanian Pre-School Children: A Randomized Trial

PubMed Central

Veenemans, Jacobien; Schouten, Laura R. A.; Ottenhof, Maarten J.; Mank, Theo G.; Uges, Donald R. A.; Mbugi, Erasto V.; Demir, Ayşe Y.; Kraaijenhagen, Rob J.; Savelkoul, Huub F. J.; Verhoef, Hans

2012-01-01

Background The efficacy of preventive zinc supplementation against diarrhea and respiratory illness may depend on simultaneous supplementation with other micronutrients. We aimed to assess the effect of supplementation with zinc and multiple micronutrients on diarrhea and other causes of non-malarial morbidity. Methods and Findings Rural Tanzanian children (n = 612) aged 6–60 months and with height-for-age z-score < –1.5 SD were randomized to daily supplementation with zinc (10 mg) alone, multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Children were followed for an average of 45 weeks. During follow-up, we recorded morbidity episodes. We found no evidence that concurrent supplementation with multi-nutrients influenced the magnitude of the effect of zinc on rates of diarrhea, respiratory illness, fever without localizing signs, or other illness (guardian-reported illness with symptoms involving skin, ears, eyes and abscesses, but excluding trauma or burns). Zinc supplementation reduced the hazard rate of diarrhea by 24% (4%–40%). By contrast, multi-nutrients seemed to increase this rate (HR; 95% CI: 1.19; 0.94–1.50), particularly in children with asymptomatic Giardia infection at baseline (2.03; 1.24–3.32). Zinc also protected against episodes of fever without localizing signs (0.75; 0.57–0.96), but we found no evidence that it reduced the overall number of clinic visits. Conclusions We found no evidence that the efficacy of zinc supplements in reducing diarrhea rates is enhanced by concurrent supplementation with other micronutrients. By reducing rates of fever without localizing signs, supplementation with zinc may reduce inappropriate drug use with anti-malarial medications and antibiotics. Trial Registration ClinicalTrials.gov NCT00623857 PMID:22870238

Helping Alliance, Retention, and Treatment Outcomes: A Secondary Analysis From the NIDA Clinical Trials Network Women and Trauma Study

PubMed Central

Ruglass, Lesia M.; Miele, Gloria M.; Hien, Denise A.; Campbell, Aimee N. C.; Hu, Mei-Chen; Caldeira, Nathilee; Jiang, Huiping; Litt, Lisa; Killeen, Therese; Hatch-Maillette, Mary; Najavits, Lisa; Brown, Chanda; Robinson, James A.; Brigham, Gregory S.; Nunes, Edward V.

2013-01-01

We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions. Alliance was not related to substance use outcomes. Implications and limitations of the findings are discussed. PMID:22475068

Remote just-in-time telementored trauma ultrasound: a double-factorial randomized controlled trial examining fluid detection and remote knobology control through an ultrasound graphic user interface display.

PubMed

Kirkpatrick, Andrew W; McKee, Ian; McKee, Jessica L; Ma, Irene; McBeth, Paul B; Roberts, Derek J; Wurster, Charles L; Parfitt, Robbie; Ball, Chad G; Oberg, Scott; Sevcik, William; Hamilton, Douglas R

2016-05-01

Remote-telementored ultrasound involves novice examiners being remotely guided by experts using informatic-technologies. However, requiring a novice to perform ultrasound is a cognitively demanding task exacerbated by unfamiliarity with ultrasound-machine controls. We incorporated a randomized evaluation of using remote control of the ultrasound functionality (knobology) within a study in which the images generated by distant naive examiners were viewed on an ultrasound graphic user interface (GUI) display viewed on laptop computers by mentors in different cities. Fire-fighters in Edmonton (101) were remotely mentored from Calgary (n = 65), Nanaimo (n = 19), and Memphis (n = 17) to examine an ultrasound phantom randomized to contain free fluid or not. Remote mentors (2 surgeons, 1 internist, and 1 ED physician) were randomly assigned to use GUI knobology control during mentoring (GUIK+/GUIK-). Remote-telementored ultrasound was feasible in all cases. Overall accuracy for fluid detection was 97% (confidence interval = 91 to 99%) with 3 false negatives (FNs). Positive/negative likelihood ratios were infinity/0.0625. One FN occurred with the GUIK+ and 2 without (GUIK-). There were no statistical test performance differences in either group (GUIK+ and GUIK-). Ultrasound-naive 1st responders can be remotely mentored with high accuracy, although providing basic remote control of the knobology did not affect outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

[Psychological intervention after trauma--does it work?].

PubMed

Smedsrud, Marit Kristine; Hem, Erlend; Ekeberg, Øivind

2005-06-30

A Cochrane review from 1998 concluded that single-session intervention does not prevent the onset of post-traumatic stress disorder. This led to a debate about what is the best, if any, psychological treatment after traumas. In consequence, some clinicians have become doubtful about as how to deal with traumatized patients. We present three examples in order to illustrate situations in which psychological intervention is useful. The conclusions in the Cochrane review are well documented. However, insufficient correspondence between the traumas and the intervention offered gave us cause to question the clinical importance of existing studies. Future studies of psychological intervention after traumas should use an individualized design in which the intervention is in proportion to the trauma. Based on knowledge not given by randomized controlled studies, we recommend clinicians to offer psychological help to those exposed to traumatic incidents. Most people need adequate information after traumas. For those who develop health problems, intervention until recovery is recommended.

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

2017-03-01

To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. Multicentre, open, cluster randomised controlled trial. Obstetric units in the Netherlands. Women with a singleton pregnancy beyond 24 weeks of gestation. Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training. Intention-to-treat analyses were performed at the cluster level, including a measurement 1 year prior to the intervention. Primary outcome was a composite outcome of obstetric complications during the first year post-intervention, including low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischaemic encephalopathy. Maternal and perinatal mortality were also registered. Each study group included 12 units with a median unit size of 1224 women, combining for a total of 28 657 women. In total, 471 medical professionals received the training course. The composite outcome of obstetric complications did not differ between study groups [odds ratio (OR) 1.0, 95% confidence interval (CI) 0.80-1.3]. Team training reduced trauma due to shoulder dystocia (OR 0.50, 95% CI 0.25-0.99) and increased invasive treatment for severe postpartum haemorrhage (OR 2.2, 95% CI 1.2-3.9) compared with no intervention. Other outcomes did not differ between study groups. A 1-day, off-site, simulation-based team training, focusing on teamwork skills, did not reduce a composite of obstetric complications. 1-day, off-site, simulation-based team training did not reduce a composite of obstetric complications. © 2016 Royal College of Obstetricians and Gynaecologists.

Expressive writing as a therapeutic process for drug-dependent women.

PubMed

Meshberg-Cohen, Sarah; Svikis, Dace; McMahon, Thomas J

2014-01-01

Although women with substance use disorders (SUDs) have high rates of trauma and posttraumatic stress, many addiction programs do not offer trauma-specific treatments. One promising intervention is Pennebaker's expressive writing, which involves daily, 20-minute writing sessions to facilitate disclosure of stressful experiences. Women (N = 149) in residential treatment completed a randomized clinical trial comparing expressive writing with control writing. Repeated-measures analysis of variance was used to document change in psychological and physical distress from baseline to 2-week and 1-month follow-ups. Analyses also examined immediate levels of negative affect following expressive writing. Expressive writing participants showed greater reductions in posttraumatic symptom severity, depression, and anxiety scores, when compared with control writing participants at the 2-week follow-up. No group differences were found at the 1-month follow-up. Safety data were encouraging: although expressive writing participants showed increased negative affect immediately after each writing session, there were no differences in pre-writing negative affect scores between conditions the following day. By the final writing session, participants were able to write about traumatic/stressful events without having a spike in negative affect. Results suggest that expressive writing may be a brief, safe, low-cost, adjunct to SUD treatment that warrants further study as a strategy for addressing posttraumatic distress in substance-abusing women.

Listen protect connect for traumatized schoolchildren: a pilot study of psychological first aid.

PubMed

Ramirez, Marizen; Harland, Karisa; Frederick, Maisha; Shepherd, Rhoda; Wong, Marleen; Cavanaugh, Joseph E

2013-01-01

Listen Protect Connect (LPC), a school-based program of Psychological First Aid delivered by non-mental health professionals, is intended to support trauma-exposed children. Our objective was to implement LPC in a school setting and assess the effectiveness of LPC on improving psychosocial outcomes associated with trauma. A pilot quasi-experiment was conducted with middle school children self-identified or referred to the school nurse as potentially exposed to stressful life experiences. LPC was provided to students by the school nurse, and questionnaires were administered at baseline, 2-, 4- and 8-weeks to assess life stressors, symptoms of post-traumatic stress disorder and depression, social support, and school connectedness. A total of 71 measurements were collected from 20 children in all. Although a small sample size, multiple measurements allowed for multivariable mixed effects models to analyze changes in the repeated outcomes over time. Students who received the intervention had reduced depressive and posttraumatic stress symptoms from baseline throughout follow-up period. Total social support also increased significantly from baseline through 8-weeks, and school connectedness increased up to 4-weeks post-intervention. This study demonstrates the potential of LPC as a school-based intervention of Psychological First Aid. Future randomized trials of LPC are needed, however.

Interventions for Posttraumatic Stress With Children Exposed to Violence: Factors Associated With Treatment Success.

PubMed

Miller-Graff, Laura E; Campion, Karen

2016-03-01

In the past 15 years, there have been a substantial number of rigorous studies examining the effectiveness of various treatments for child trauma and posttraumatic stress disorder (PTSD). Although a number of review articles exist, many have focused on randomized controlled trials or specific treatment methodologies, both of which limit the ability to draw conclusions across studies and the statistical power to test the effect of particular treatment characteristics on treatment outcomes. The current study is a review and meta-analysis of 74 studies examining treatments for children exposed to violence. After reviewing the literature, we examined the relationship of a variety of treatment characteristics (e.g., group or individual treatments) and sample characteristics (e.g., average age) on treatment effect sizes. Results indicated that individual therapies and those with exposure paradigms within a cognitive-behavioral therapy or skills-building framework show the most promise, but treatment is somewhat less effective for those with more severe symptomology and for younger children. Future treatments should consider the developmental and social contexts that may impede treatment progress for young children and consider how best to develop the effectiveness of group interventions that can be readily delivered in settings of mass trauma. © 2015 Wiley Periodicals, Inc.

A summary of trauma and trauma-related papers published in BJOMS during 2008-2009.

PubMed

Kusanale, Atul; Mackenzie, Neil; Arakeri, Gururaj; McLeod, Niall; Brennan, Peter A

2010-09-01

This paper provides a summary of the 49 trauma and related papers published in British Journal of Oral and Maxillofacial Surgery during the period January 2008 to December 2009. 16/49 (32%) of these publications were full length articles, which covered areas such as epidemiology, service provision, materials and operative surgery. In addition there were other articles including short communications, technical notes, letters to the editor and interesting cases. Whilst fewer full length articles were published compared to the other sub-specialties, it was reassuring to see that the studies represent all aspects of trauma. More basic science and randomized control studies relating to trauma need to be encouraged. Copyright 2010 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Techniques for assisting difficult delivery at caesarean section.

PubMed

Waterfall, Heather; Grivell, Rosalie M; Dodd, Jodie M

2016-01-31

Caesarean section involves making an incision in the woman's abdomen and cutting through the uterine muscle. The baby is then delivered through that incision. Difficult caesarean birth may result in injury for the infant or complications for the mother. Methods to assist with delivery include vacuum or forceps extraction or manual delivery utilising fundal pressure. Medication that relaxes the uterus (tocolytic medication) may facilitate the birth of the baby at caesarean section. Delivery of the impacted head after prolonged obstructed labour can be associated with significant maternal and neonatal complication; to facilitate delivery of the head the surgeon may utilise either reverse breech extraction or head pushing. To compare the use of tocolysis (routine or selective use) with no use of tocolysis or placebo and to compare different extraction methods at the time of caesarean section for outcomes of infant birth trauma, maternal complications (particularly postpartum haemorrhage requiring blood transfusion), and long-term measures of infant and childhood morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2015) and reference lists of retrieved studies. All published, unpublished, and ongoing randomised controlled trials comparing the use of tocolytic agents (routine or selective) at caesarean section versus no use of tocolytic or placebo at caesarean section to facilitate the birth of the baby. Use of instrument versus manual delivery to facilitate birth of the baby. Reverse breech extraction versus head pushing to facilitate delivery of the deeply impacted fetal head. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Seven randomised controlled trials, involving 582 women undergoing caesarean section were included in this review. The risk of bias of included trials was variable, with some trials not adequately describing allocation or randomisation.Three comparisons were included. 1. Tocolysis versus no tocolysisA single randomised trial involving 97 women was identified and included in the review. Birth trauma was not reported. There were no cases of any maternal side-effect reported in either the nitroglycerin or the placebo group. No other maternal and infant health outcomes were reported. 2. Reverse breech extraction versus head push for the deeply impacted head at full dilation at caesarean section Four randomised trials involving 357 women were identified and included in the review. The primary outcome of birth trauma was reported by three trials and there was no difference between reverse breech extraction and head push for this rare outcome (three studies, 239 women, risk ratio (RR) 1.55, 95% confidence interval (CI) 0.42 to 5.73). Secondary outcomes including endometritis rate (three studies, 285 women, average RR 0.52, 95% CI 0.26 to 1.05, Tau I² = 0.22, I² = 56%), extension of uterine incision (four studies, 357 women, average RR 0.23, 95% CI 0.13 to 0.40), mean blood loss (three studies, 298 women, mean difference (MD) -294.92, 95% CI -493.25 to -96.59; I² = 98%) and neonatal intensive care unit (NICU)/special care nursery (SCN) admission (two studies, 226 babies, average RR 0.53, 95% CI 0.23 to 1.22, Tau I² = 0.27, I² = 74%) were decreased with reverse breech extraction. No differences were observed between groups for many of the other secondary outcomes reported (blood loss > 500 mL; blood transfusion; wound infection; mean hospital stay; average Apgar score).There was significant heterogeneity between the trials for the outcomes mean blood loss, operative time and mean hospital stay, making comparison difficult. However the operation duration was significantly shorter for reverse breech extraction, which may correspond with ease of delivery and therefore, the amount of tissue trauma and therefore, significantly less blood loss. Given the heterogeneity, we cannot define the amount of difference in blood loss, operative time or hospital stay however. 3. Instrument (vacuum or forceps) versus manual extraction at elective caesarean section Two randomised trials involving 128 women were identified and included in the review. Only one trial reported maternal and infant health outcomes as prespecified in this review. This trial reported birth trauma as an outcome but there were no instances of birth trauma in either comparison group. There were no differences found in mean fall in haemoglobin (Hb) between groups (one study, 44 women, MD 0.03, 95% CI -0.53 to 0.59), or in uterine incision extension (one study, 44 women, RR 0.70, 95% CI 0.13 to 3.73). There is currently insufficient information available from randomised trials to support or refute the routine or selective use of tocolytic agents or instrument to facilitate infant birth at the time of difficult caesarean section. There is limited evidence that reverse breech extraction may improve maternal and fetal outcomes, though there was no difference in primary outcome of infant birth trauma. Further randomised controlled trials are needed to answer these questions.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial.

PubMed

Battle, Ceri; Abbott, Zoe; Hutchings, Hayley A; O'Neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona E; Jones, Sally; Gagg, James; Body, Richard; Evans, Philip A

2017-07-10

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal , presentation at appropriate conferences and to stakeholders at professional meetings. ISRCTN95571506; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

12 A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients: stumbl trial.

PubMed

Battle, Ceri; Hutchings, Hayley; Abbott, Zoe; O'neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona; Jones, Sally; Gagg, James; Body, Rick; Evans, Phillip

2017-12-01

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multi-centre, cluster-randomised (stepped wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a five month period; in the initial period acting as the controls (normal care) and the second period, acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a six week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory).Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Health Care Research Wales Research Permissions and the HRA have granted approval for the study. Patient recruitment commenced in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at Professional Meetings. © 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Arrhythmogenic epilepsy and pacing need: A matter of controversy

PubMed Central

Kepez, Alper; Erdogan, Okan

2015-01-01

There is increasing awareness among the cardiology community regarding ictal bradyarrhythmias as a cause of loss of consciousness. A high degree of suspicion is necessary when diagnosing ictal bradyarrhythmias, and delay in diagnosing this condition may lead to morbidity associated with falls and trauma. Ictal bradyarrhythmias have also been suggested to be associated with sudden unexplained death in epilepsy, although evidence related to this association is limited. There is no guideline-directed therapy for symptomatic ictal bradyarrhythmias due to a lack of randomized, controlled trials. Cardiac pacemaker therapy is commonly used for these patients; however, currently, there is no universal agreement on the pacing indications for these patients. In this review, we focus on the pathophysiology and clinical presentation of ictal bradyarrhythmias and then discuss the pacing need based on the available literature data. PMID:26488022

Weight-based enoxaparin dosing and deep vein thrombosis in hospitalized trauma patients: A double-blind, randomized, pilot study.

PubMed

Kay, Annika Bickford; Majercik, Sarah; Sorensen, Jeffrey; Woller, Scott C; Stevens, Scott M; White, Thomas W; Morris, David S; Baldwin, Margaret; Bledsoe, Joseph R

2018-04-23

Venous thromboembolism is a cause of morbidity and mortality in trauma patients. Chemoprophylaxis with low-molecular-weight heparin at a standardized dose is recommended. Conventional chemoprophylaxis may be inadequate. We hypothesized that a weight-adjusted enoxaparin prophylaxis regimen would reduce the frequency of venous thromboembolism in hospitalized trauma patients and at 90-day follow-up. This prospective, randomized pilot study enrolled adult patients admitted to a level 1 trauma center between July 2013 and January 2015. Subjects were randomized to receive either standard (30 mg subcutaneously every 12 hours) or weight-based (0.5mg/kg subcutaneously every 12 hours) enoxaparin. Surveillance duplex ultrasound for lower extremity deep vein thrombosis was performed on hospital days 1, 3, and 7, and weekly thereafter. The primary outcome was deep vein thrombosis during hospitalization. Secondary outcomes included venous thromboembolism at 90 days and significant bleeding events. Two hundred thirty-four (124 standard, 110 weight-based) subjects were enrolled. There was no difference between standard and weight-based regarding age, body mass index, percentage female gender, injury severity score, or percentage that had surgery. There was a trend toward less in-hospital deep vein thrombosis in weight-based (12 [9.7%] standard vs 4 [3.6%] weight-based, P = .075). At 90 days, there was no difference in venous thromboembolism (12 [9.7%] standard vs 6 [5.5%] weight-based, P =.34). There was 1 bleeding event, which occurred in a standard subject. Weight-based enoxaparin dosing for venous thromboembolism chemoprophylaxis in trauma patients may provide better protection against venous thromboembolism than standard. A definitive study is necessary to determine whether weight-based dosing is superior to standard. Copyright © 2018 Elsevier Inc. All rights reserved.

[Reconstructive surgery of cranio-orbital injuries].

PubMed

Eolchiian, S A; Potapov, A A; Serova, N K; Kataev, M G; Sergeeva, L A; Zakharova, N E; Van Damm, P

2011-01-01

The aim of study was to optimize evaluation and surgery of cranioorbital injuries in different periods after trauma. Material and methods. We analyzed 374 patients with cranioorbital injuries treated in Burdenko Neurosurgery Institute in different periods after trauma from January 1998 till April 2010. 288 (77%) underwent skull and facial skeleton reconstructive surgery within 24 hours - 7 years after trauma. Clinical and CT examination data were used for preoperative planning and assessment of surgery results. Stereolithographic models (STLM) were applied for preoperative planning in 89 cases. The follow-up period ranged from 4 months up to 10 years. Results. In 254 (88%) of 288 patients reconstruction of anterior skull base, upper and/or midface with restoration of different parts of orbit was performed. Anterior skull base CSF leaks repair, calvarial vault reconstruction, maxillar and mandibular osteosynthesis were done in 34 (12%) cases. 242 (84%) of 288 patients underwent one reconstructive operation, while 46 (16%)--two and more (totally 105 operations). The patients with extended frontoorbital and midface fractures commonly needed more than one operation--in 27 (62.8%) cases. Different plastic materials were used for reconstruction in 233 (80.9%) patients, of those in 147 (51%) cases split calvarial bone grafts were preferred. Good functional and cosmetic results were achieved in 261 (90.6%) of 288 patients while acceptable were observed in 27 (9.4%). Conclusion. Active single-stage surgical management for repair of combined cranioorbital injury in acute period with primary reconstruction optimizes functional and cosmetic outcomes and prevents the problems of delayed or secondary reconstruction. Severe extended anterior skull base, upper and midface injuries when intracranial surgery is needed produced the most challenging difficulties for adequate reconstruction. Randomized trial is required to define the extent and optimal timing of reconstructive surgery in patients with severe traumatic brain injury and craniofacial injury in acute period of trauma.

A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation.

PubMed

Tamames, Ilmar; King, Curtis; Bas, Esperanza; Dietrich, W Dalton; Telischi, Fred; Rajguru, Suhrud M

2016-09-01

The trauma caused during cochlear implant insertion can lead to cell death and a loss of residual hair cells in the cochlea. Various therapeutic approaches have been studied to prevent cochlear implant-induced residual hearing loss with limited success. In the present study, we show the efficacy of mild to moderate therapeutic hypothermia of 4 to 6 °C applied to the cochlea in reducing residual hearing loss associated with the electrode insertion trauma. Rats were randomly distributed in three groups: control contralateral cochleae, normothermic implanted cochleae and hypothermic implanted cochleae. Localized hypothermia was delivered to the middle turn of the cochlea for 20 min before and after implantation using a custom-designed probe perfused with cooled fluorocarbon. Auditory brainstem responses (ABRs) were recorded to assess the hearing function prior to and post-cochlear implantation at various time points up to 30 days. At the conclusion of the trials, inner ears were harvested for histology and cell count. The approach was extended to cadaver temporal bones to study the potential surgical approach and efficacy of our device. In this case, the hypothermia probe was placed next to the round window niche via the facial recess or a myringotomy. A significant loss of residual hearing was observed in the normothermic implant group. Comparatively, the residual hearing in the cochleae receiving therapeutic hypothermia was significantly conserved. Histology confirmed a significant loss of outer hair cells in normothermic cochleae receiving the surgical trauma when compared to the hypothermia treated group. In human temporal bones, a controlled and effective cooling of the cochlea was achieved using our approach. Collectively, these results suggest that therapeutic hypothermia during cochlear implantation may reduce traumatic effects of electrode insertion and improve conservation of residual hearing. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Post-traumatic stress disorder--a diagnostic and therapeutic challenge.

PubMed

Frommberger, Ulrich; Angenendt, Jörg; Berger, Mathias

2014-01-31

In Germany, the one-month prevalence of post-traumatic stress disorder (PTSD) is in the range of 1% to 3%. Soldiers, persons injured in accidents, and victims of domestic violence increasingly seek medical help for symptoms of emotional stress. Days lost from work and monetary compensation for emotional disturbances are markedly on the rise. The term "PTSD" is commonly used uncritically and imprecisely, with too little regard for the existing diagnostic criteria. It is at risk of turning into a nonspecific collective term for emotional stress of any kind. We selectively reviewed the literature in the PubMed database and pertinent journals, with additional consideration of the recommendations and guidelines of medical societies from Germany and abroad. The characteristic types of reactions seen in PTSD are nightmares and an intense, repetitive, intrusive "reliving" of the traumatic event(s). Emotional traumatization manifests itself not only as PTSD but also through major effects on other mental and somatic diseases. An early, trauma-focused behavioral therapeutic intervention involving several sessions, generally on an outpatient basis, can prevent the development of PTSD. The most important components of effective treatment are a focus on the particular trauma experienced and confrontation with the patient's memories of the trauma. The best existing evidence is for cognitive therapy, behavioral therapy according to the exposure paradigm of Foa, and eye movement desensitization and reprocessing therapy. The most recent meta-analysis reveals effect strengths of g = 1.14 for all types of psychotherapy and g = 0.42 for all types of pharmacotherapy taken together (with considerable differences among psychotherapeutic methods and among drugs). The efficacy of psychodynamic therapy, systemic therapy, body-oriented therapy, and hypnotherapy has not been adequately documented in randomized controlled trials. PTSD can be precisely diagnosed and effectively treated when the diagnostic criteria and guideline recommendations are taken into account. Referral for trauma-focused psychotherapy should be considered if the acute symptoms persist for several weeks.

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial

PubMed Central

Tavakoli, Nader; Agah, Shahram; Azizi, Ali; Masoodi, Mohsen; Amiri, Hassan; Sheikhvatan, Mehrdad; Syedsalehi, Bahare; Behnam, Behdad; Arabahmadi, Mehran; Mehrazi, Maryam

2017-01-01

Background Tranexamic acid (TXA), a synthetic antifibrinolytic drug, is effective as a treatment for serious hemorrhage, including bleeding arising from major trauma and post-operative interventions. Significant acute gastrointestinal bleeding may have a poor outcome despite routine medical and endoscopic treatments. The aim of this study was to assess whether early intravenous and/or intravenous plus topical administration of TXA reduces the need for urgent endoscopy for acute gastrointestinal bleeding. Method This double-blind randomized clinical trial included 410 patients with proven acute gastrointestinal bleeding. All patients received conventional therapy. The subjects were randomized to three groups: (A) 138 patients received intravenous TXA (1 g q6h); (B) 133 patients received topical TXA (1 g single dose by nasogastric tube) plus systemic TXA; and (C) 139 patients received a placebo (sodium chloride 0.9%) for 24 hours. Subgroup statistical analyses were conducted for urgent endoscopy, mortality, re-bleeding, blood transfusion, endoscopic and/or surgical intervention rates, and health status. Results The time to endoscopy was significantly shorter in group C (15.58 ± 7.994, p < 0.001). A need for urgent endoscopy was seen in 14.49%, 10.52%, and 30.21% of patients in groups A, B, and C, respectively (p < 0.001). No significant statistical differences were seen between treatment groups regarding mortality, re-bleeding, blood transfusion, and endoscopic and/or surgical intervention rates. No thromboembolic event was documented during the 1-week follow up. Conclusions Our results showed that the antifibrinolytic properties of TXA can aid in changing an urgent endoscopy to an elective procedure, with better outcomes for both physicians and patients. PMID:29435313

Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial.

PubMed

Dehghan, Niloofar; McKee, Michael D; Jenkinson, Richard J; Schemitsch, Emil H; Stas, Venessa; Nauth, Aaron; Hall, Jeremy A; Stephen, David J; Kreder, Hans J

2016-07-01

The aim of this study was to compare early weightbearing and range of motion (ROM) to nonweightbearing and immobilization in a cast after surgical fixation of unstable ankle fractures. Multicentre randomized controlled trial. Two-level one trauma centers. One hundred ten patients who underwent open reduction and internal fixation of an unstable ankle fracture were recruited and randomized. One of 2 rehabilitation protocols: (1) Early weightbearing (weightbearing and ROM at 2 weeks, Early WB) or (2) Late weightbearing (nonweightbearing and cast immobilization for 6 weeks, Late WB). The primary outcome measure was time to return to work (RTW). Secondary outcome measures included: ankle ROM, SF-36 heath outcome scores, Olerud/Molander ankle function score, and rates of complications. There was no difference in RTW. At 6 weeks postoperatively, patients in the Early WB group had significantly improved ankle ROM (41 vs. 29, P < 0.0001); Olerud/Molander ankle function scores (45 vs. 32, P = 0.0007), and SF-36 scores on both the physical (51 vs. 42, P = 0.008) and mental (66 vs. 54, P = 0.0008) components. There were no differences with regard to wound complications or infections and no cases of fixation failure or loss of reduction. Patients in the Late WB group had higher rates of planned/performed hardware removal due to plate irritation (19% vs. 2%, P = 0.005). Given the convenience for the patient, early improved functional outcome, and the lack of an increased complication rate, we recommend early postoperative weightbearing and ROM in patients with surgically treated ankle fractures. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military.

PubMed

Cigrang, Jeffrey A; Rauch, Sheila A; Mintz, Jim; Brundige, Antoinette R; Mitchell, Jennifer A; Najera, Elizabeth; Litz, Brett T; Young-McCaughan, Stacey; Roache, John D; Hembree, Elizabeth A; Goodie, Jeffrey L; Sonnek, Scott M; Peterson, Alan L

2017-12-01

Many military service members with PTSD do not receive evidence-based specialty behavioral health treatment because of perceived barriers and stigma. Behavioral health providers in primary care can deliver brief, effective treatments expanding access and reducing barriers and stigma. The purpose of this randomized clinical trial was to determine if a brief cognitive-behavior therapy delivered in primary care using the Primary Care Behavioral Health model would be effective at reducing PTSD and co-occurring symptoms. A total of 67 service members (50 men, 17 women) were randomized to receive a brief, trauma-focused intervention developed for the primary care setting called Prolonged Exposure for Primary Care (PE-PC) or a delayed treatment minimal contact control condition. Inclusion criteria were significant PTSD symptoms following military deployment, medication stability, and interest in receiving treatment for PTSD symptoms in primary care. Exclusion criteria were moderate or greater risk of suicide, severe brain injury, or alcohol/substance use at a level that required immediate treatment. Assessments were completed at baseline, posttreatment/postminimal contact control, and at 8-week and 6-month posttreatment follow-up points. Primary measures were the PTSD Symptom Scale-Interview and the PTSD Checklist-Stressor-Specific. PE-PC resulted in larger reduction in PTSD severity and general distress than the minimal contact control. Delayed treatment evidenced medium to large effects comparable to the immediate intervention group. Treatment benefits persisted through the 6-month follow-up of the study. PE-PC delivered in integrated primary care is effective for the treatment of PTSD and co-occurring symptoms and may help reduce barriers and stigma found in specialty care settings. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Effect of low-level laser therapy on pain and perineal healing after episiotomy: A triple-blind randomized controlled trial.

PubMed

Alvarenga, Marina B; de Oliveira, Sonia Maria Junqueira Vasconcellos; Francisco, Adriana A; da Silva, Flora Maria B; Sousa, Marcelo; Nobre, Moacyr Roberto

2017-02-01

Episiotomy is associated with perineal pain and healing complications. The low-level laser therapy (LLLT) reduces pain and inflammation and stimulates the healing process. This study aimed to assess the effect of LLLT on pain and perineal healing after an episiotomy. A randomized, triple-blind, parallel clinical trial with 54 postpartum women who had a spontaneous birth with a right mediolateral episiotomy. The women were randomized into two groups: the experimental group (applications of LLLT n = 29) or the placebo group (simulated LLLT applications n = 25). Three sessions of real or sham irradiation were performed at 6-10 hours after normal birth, and the 2nd and 3rd applications were performed at 20-24 hours and 40-48 hours after the first session, respectively. Perineal pain was recorded using a Numeric Scale ranging from 0 to 10 (0 = absence and 10 = worst pain). Perineal healing was assessed using the redness, oedema, ecchymosis, discharge, and approximation (REEDA) scale. Both groups were assessed four times: in each of the three LLLT sessions and at 7-10 days after normal birth. The groups were compared using the Student's t, Mann-Whitney, and Chi-square tests. There was no significant difference between the groups regarding perineal healing after LLLT. The perineal pain scores were statistically higher in the experimental group in the first assessment and after the third LLLT. There was no significant difference between the groups related to the perineal pain scores 7-10 days after normal birth. The use of LLLT does not provide any benefit for treating postpartum perineal trauma using these specific protocol and parameters. Lasers Surg. Med. 49:181-188, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Effects of atorvastatin on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injury; a randomized double-blind placebo-controlled clinical trial.

PubMed

Farzanegan, Gholam Reza; Derakhshan, Nima; Khalili, Hosseinali; Ghaffarpasand, Fariborz; Paydar, Shahram

2017-10-01

The aim of the current study was to investigate the effects of atorvastatin on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injury (TBI). The study was conducted as a randomized clinical trial during a 16-month period from May 2015 and August 2016 in a level I trauma center in Shiraz, Southern Iran. We included 65 patients with moderate (GCS: 9-13) to severe (GCS: 5-8) TBI who had brain contusions of less than 30cc volume. We excluded those who required surgical intervention. Patients were randomly assigned to receive daily 20mg atorvastatin for 10days (n=21) or placebo in the same dosage (n=23). The brain contusion volumetry was performed on days 0, 3 and 7 utilizing spiral thin-cut brain CT-Scan (1-mm thickness). The outcome measured included modified Rankin scale (MRS), Glasgow Outcome Scale (GOS) and Disability rating Scale (DRS) which were all evaluated 3months post-injury. There was no significant difference between two study group regarding the baseline, 3rd day and 7th day of the contusion volume and the rate of contusion expansion. However, functional outcome scales of GOS, MRS and DRS at 3-months post-injury were significantly better in atorvastatin arm of the study compared to placebo (p values of 0.043, 0.039 and 0.030 respectively). Even though atorvastatin was not found to be more effective than placebo in reducing contusion expansion rate, it was associated with improved functional outcomes at 3-months following moderate to severe TBI. Copyright © 2017 Elsevier Ltd. All rights reserved.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

PubMed

Backes, Manouk; Dingemans, Siem A; Schep, Niels W L; Bloemers, Frank W; Van Dijkman, Bart; Garssen, Frank P; Haverlag, Robert; Hoogendoorn, Jochem M; Joosse, Pieter; Mirck, Boj; Postma, Victor; Ritchie, Ewan; Roerdink, W Herbert; Sintenie, Jan Bernard; Soesman, Nicolaj M R; Sosef, Nico L; Twigt, Bas A; Van Veen, Ruben N; Van der Veen, Alexander H; Van Velde, Romuald; Vos, Dagmar I; De Vries, Mark R; Winkelhagen, Jasper; Goslings, J Carel; Schepers, Tim

2015-02-06

In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Trauma-Informed Medical Care: Patient Response to a Primary Care Provider Communication Training

PubMed Central

Green, Bonnie L.; Saunders, Pamela A.; Power, Elizabeth; Dass-Brailsford, Priscilla; Schelbert, Kavitha Bhat; Giller, Esther; Wissow, Larry; Hurtado de Mendoza, Alejandra; Mete, Mihriye

2016-01-01

Trauma exposure predicts mental disorders and health outcomes; yet there is little training of primary care providers about trauma’s effects, and how to better interact with trauma survivors. This study adapted a theory-based approach to working with trauma survivors, Risking Connection, into a 6-hour CME course, Trauma-Informed Medical Care (TI-Med), to evaluate its feasibility and preliminary efficacy. We randomized four primary care sites to training or wait-list conditions; PCPs at wait-list sites were trained after reassessment. Primary care providers (PCPs) were Family Medicine residents (n = 17; 2 sites) or community physicians (n = 13; 2 sites). Outcomes reported here comprised a survey of 400 actual patients seen by the PCPs in the study. Patients, mostly minority, completed surveys before or after their provider received training. Patients rated PCPs significantly higher after training on a scale encompassing partnership issues. Breakdowns showed lower partnership scores for those with trauma or posttraumatic stress symptoms. Future studies will need to include more specific trauma-related outcomes. Nevertheless, this training is a promising initial approach to teaching trauma-informed communication skills to PCPs. PMID:27721673

Traumatized refugees: morbidity, treatment and predictors of outcome.

PubMed

Buhmann, Caecilie Böck

2014-08-01

Despite large numbers of traumatized refugees, little is known about effective treatment of war trauma in refugees and immigrants. Few studies evaluating treatment have been published and most studies are follow-up studies with methodological limitations and little comparability across studies. The purpose of the PhD is to characterize transcultural trauma patients in Denmark needing psychiatric treatment with regards to psychopathology and predictors of mental health and to evaluate the effects of the treatment. Two studies reported in 4 papers form the basis of the thesis. FORLOB (Paper 1-3) was a follow-up study that included all patients receiving treatment at the Competence Center for Transcultural Psychiatry in Copenhagen from April 2008 to February 2010. Patients completed self-ratings of symptoms of PTSD, depression and anxiety as well as level of functioning and quality of life (HTQ, HSCL-25, SDS & WHO-5) before treatment and after treatment. Associations of co-morbid diagnoses and predictors of the patients' health condition were examined with linear and logistic regression and Pearson's correlation coefficients. Treatment in FORLOB consisted of a combination of Sertraline, Mianserin, psycho-education and Trauma-Focused Cognitive Behavioral Therapy (TFCBT). The treatment administered to each patient was monitored in detail and changes in outcome and predictors of change were analyzed. PTF1 (Paper 4) was a randomized controlled clinical trial with 2x2 factorial design (antidepressants, TFCBT, antidepressants & TFCBT, waiting list). Potential participants were screened amongst adult patients referred to the Competence Center for Transcultural Psychiatry in the period June 2009-2011. Patients with PTSD, war trauma and without a psychotic disorder were included. The manualized treatment consisted of weekly sessions with a physician and/or psychologist over a period of 6 months. The treatment effect was evaluated with a combination of self-ratings and blinded and non-blinded observer ratings. Outcome measures included symptoms of PTSD, depression, anxiety, pain and somatization, quality of life and level of functioning (HTQ, HSCL-25, SCL-90, WHO-5, SDS, VAS, Hamilton, GAF). Treatment was offered with translation and screening instruments were translated to the six most common languages in the patient group covering the needs of 92% of patients. In FORLOB, patients had several co-morbidities and not just PTSD. Almost all patients had depression, pain and untreated somatic complaints in addition to PTSD. Furthermore, 36-58% had physical problems they were in treatment for, 9-16% of patients had psychotic symptoms mainly related to their trauma, 27% had enduring personality change due to catastrophic events according to ICD-10 and 46% reported traumatic brain injury. Patients reporting chronic pain had higher symptom scores on HSCL-25 and HTQ and patients with psychotic symptoms scored higher on all symptom clusters on HTQ. At pre-treatment assessment, the patients' level of functioning and quality of life were very low, the majority of patients lived on public subsidies, education levels were low and most patients had a limited social network. In FORLOB, we found a moderate significant change (Cohen's d 0.44-0.67) on all self-report outcome measures (HTQ, HSCL-25, SDS and WHO-5) after combination treatment. We found less improvement in PTSD when patients were receiving public subsidies and less improvement of depression when patients reported pain in the upper extremities. We found a positive association between systematic use of CBT methods and improvement in patient condition. In PTF1, the randomized clinical trial, we found a small, but significant effect of treatment with medicine on blinded observer-ratings of depression and anxiety (Ham-D and Ham-A) and a large effect on non-blinded ratings of level of functioning (GAF-F and GAF-S), in addition to a small effect on self-reported level of functioning and headache (SDS and VAS). Cohen's d calculated as the differences between randomization groups receiving medicine and not receiving medicine ranged from 0.91-1.01 on GAF-F and GAF-S, whereas on the other ratings showing significant change Cohen's d was 0.31-0.41. We did not find any effect of psychotherapy on any outcomes nor any effect of psycho-therapy or medicine on the primary outcome measure, PTSD. Traditionally, treatment of traumatized refugees have focused on PTSD, but this study demonstrates that patients suffer from numerous psychiatric and somatic co-morbidities and the comprehensiveness of PTSD in explaining symptoms of traumatized refugees is questionable. This has implications for the type and implementation of treatment. PTF1 is the largest randomized clinical trial published on the treatment of traumatized refugees. It is a strength of PTF1 that it includes a waiting list control group thereby accounting for any effects due to spontaneous recovery and that treatment modalities are examined separately and in combination. In both FORLOB and PTF1, treatment adherence and patient compliance with treatment was thoroughly documented. Effect sizes were moderate in FORLOB and small in PTF1. There were discrepancies between the results in FORLOB and PTF1 with regards to the effect measured on self-ratings that can only partially be explained by methodological limitations of the follow-up study. Both studies are undertaken under pragmatic and realistic circumstances and the results are therefore relevant to other contexts. Patients are representative of patients in other North-European studies of traumatized refugees but differ from patients in trials published on culturally adapted CBT and Narrative Exposure Therapy.

Effectiveness of Implementing Evidence-based Interventions to Reduce C-spine Image Ordering in the Emergency Department: A Systematic Review.

PubMed

Desai, Shashwat; Liu, Chaocheng; Kirkland, Scott W; Krebs, Lynette D; Keto-Lambert, Diana; Rowe, Brian H

2018-06-01

Appropriate use of imaging for adult patients with cervical spine (C-spine) injuries in the emergency department (ED) is a longstanding issue. Guidance for C-spine ordering exists; however, the effectiveness of the decision support implementation in the ED is not well studied. This systematic review examines the implementation and effectiveness of evidence-based interventions aimed at reducing C-spine imaging in adults presenting to the ED with neck trauma. Six electronic databases and the gray literature were searched. Comparative intervention studies were eligible for inclusion. Two independent reviewers screened for study eligibility, study quality, and extracted data. The change in imaging was reported using individual odds ratios (ORs) with 95% confidence intervals (CIs) using random effects. A total of 990 unique citations were screened for relevance of which six before-after studies and one randomized controlled trial were included. None of the studies were assessed as high quality. Interventions consisted primarily of locally developed guidelines or established clinical decision rules such as the NEXUS or the Canadian C-spine rule. Overall, implementation of interventions aimed at reducing C-spine image ordering resulted in a statistically significant reduction in imaging (OR = 0.69, 95% CI = 0.51-0.93); however, heterogeneity was high (I 2  = 82%). Subgroup analysis revealed no differences between studies that specified enrolling alert and stable patients compared to unspecified trauma (p = 0.81) or between studies employing multifaceted versus nonmultifaceted interventions (p = 0.66). While studies generally provided details on implementation strategies (e.g., teaching sessions, pocket cards, posters, computerized decision support) the effectiveness of these implementation strategies were frequently not reported. There is moderate evidence regarding the effectiveness of interventions to reduce C-spine image ordering in adult patients seen in the ED with neck trauma. Given the national and international focus on improving appropriateness and reducing unnecessary C-spine imaging through campaigns such as Choosing Wisely, additional interventional research in this field is warranted. © 2017 by the Society for Academic Emergency Medicine.

Exploring the Influence of Ethnicity, Age, and Trauma on Prisoners' World Assumptions

ERIC Educational Resources Information Center

Gibson, Sandy

2011-01-01

In this study, the author explores world assumptions of prisoners, how these assumptions vary by ethnicity and age, and whether trauma history affects world assumptions. A random sample of young and old prisoners, matched for prison location, was drawn from the New Jersey Department of Corrections prison population. Age and ethnicity had…

Unraveling Probation Officers' Practices with Youths with Histories of Trauma and Stressful Life Events

ERIC Educational Resources Information Center

Maschi, Tina; Schwalbe, Craig S.

2012-01-01

This study examines how probation officers' (POs) knowledge of juveniles' trauma influences probation practices. The study was conducted with POs who responded to a Web-based survey ("n" = 308). The POs were directed to randomly select one juvenile from their caseload and to complete the Probation Practices Assessment Survey to assess their…

Vicarious Trauma: An Exploratory Study of the Impact of Providing Sexual Abuse Treatment on Clinicians' Trust and Intimacy

ERIC Educational Resources Information Center

VanDeusen, Karen M.; Way, Ineke

2006-01-01

This study examined vicarious trauma effects in male and female clinicians who treat sexual abuse survivors (n = 111) and sexual offenders (n = 272). The national survey was conducted using a random sample of clinical members of two professional organizations. Analyses tested the relationships between demographic variables, maltreatment history,…

Risk Factors for Vascular Occlusive Events and Death Due to Bleeding in Trauma Patients; an Analysis of the CRASH-2 Cohort

PubMed Central

Pealing, Louise; Perel, Pablo; Prieto-Merino, David; Roberts, Ian

2012-01-01

Background Vascular occlusive events can complicate recovery following trauma. We examined risk factors for venous and arterial vascular occlusive events in trauma patients and the extent to which the risk of vascular occlusive events varies with the severity of bleeding. Methods and Findings We conducted a cohort analysis using data from a large international, double-blind, randomised, placebo-controlled trial (The CRASH-2 trial) [1]. We studied the association between patient demographic and physiological parameters at hospital admission and the risk of vascular occlusive events. To assess the extent to which risk of vascular occlusive events varies with severity of bleeding, we constructed a prognostic model for the risk of death due to bleeding and assessed the relationship between risk of death due to bleeding and risk of vascular occlusive events. There were 20,127 trauma patients with outcome data including 204 (1.01%) patients with a venous event (pulmonary embolism or deep vein thrombosis) and 200 (0.99%) with an arterial event (myocardial infarction or stroke). There were 81 deaths due to vascular occlusive events. Increasing age, decreasing systolic blood pressure, increased respiratory rates, longer central capillary refill times, higher heart rates and lower Glasgow Coma Scores (all p<0.02) were strong risk factors for venous and arterial vascular occlusive events. Patients with more severe bleeding as assessed by predicted risk of haemorrhage death had a greatly increased risk for all types of vascular occlusive event (all p<0.001). Conclusions Patients with severe traumatic bleeding are at greatly increased risk of venous and arterial vascular occlusive events. Older age and blunt trauma are also risk factors for vascular occlusive events. Effective treatment of bleeding may reduce venous and arterial vascular occlusive complications in trauma patients. PMID:23251374

Treatment of co-occurring PTSD-AUD: Effects of exposure-based and non-trauma focused psychotherapy on alcohol and trauma cue-reactivity

PubMed Central

Nosen, Elizabeth; Littlefield, Andrew K.; Schumacher, Julie A.; Stasiewicz, Paul R.; Coffey, Scott F.

2014-01-01

Laboratory studies have shown that exposure to trauma memories increases both craving and salivation responses to alcohol cues among individual with co-occurring posttraumatic stress disorder (PTSD) and alcohol dependence (AD). The purpose of the present study was to examine 1) whether this cue reactivity is dampened following exposure-based treatment for PTSD and 2) how changes in reactivity to trauma cues correspond to changes in alcohol cue-reactivity. Adults with current PTSD and AD (N=120) were randomly assigned to 9–12 sessions of either Trauma-focused Exposure Therapy (EXP) for PTSD or Health & Lifestyles (HLS, a non-trauma focused comparison treatment), concurrent with 6-week residential AD treatment-asusual. Participants completed trauma and alcohol cue-reactivity laboratory sessions before and after treatment. Compared to HLS, individuals receiving EXP showed significantly greater reductions in negative affect elicited by trauma cues following treatment. Both treatments demonstrated similar, moderate to large reductions in craving and salivary reactivity over time. Interestingly, latent change in trauma cue-elicited distress over the course of treatment predicted latent change in both trauma cue-elicited alcohol craving and salivation. Overall, findings highlight the utility of integrating trauma-focused therapies like EXP into substance use treatment in the interests of reducing PTSD symptoms and distress associated with trauma cues. PMID:25127178

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias.

PubMed

Goldberg, Henrique; Mibielli, Marco Antonio; Nunes, Carlos Pereira; Goldberg, Stephanie Wrobel; Buchman, Luiz; Mezitis, Spyros Ge; Rzetelna, Helio; Oliveira, Lisa; Geller, Mauro; Wajnsztajn, Fernanda

2017-01-01

This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B 12 . To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B 12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B 12 . A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B 12, and Group B (n=200) receiving vitamin B 12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events. The results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B 12 , with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups. The combination of uridine, cytidine, and vitamin B 12 was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

Multicomponent behavioral treatment for chronic combat-related posttraumatic stress disorder: A randomized controlled trial

PubMed Central

Beidel, Deborah C.; Frueh, B. Christopher; Uhde, Thomas W.; Wong, Nina; Mentrikoski, Janelle M.

2010-01-01

This study examined the efficacy of a multicomponent cognitive-behavioral therapy, Trauma Management Therapy, which combines exposure therapy and social emotional rehabilitation, to exposure therapy only in a group of male combat veterans with chronic posttraumatic stress disorder (PTSD). Thirty-five male Vietnam veterans with PTSD were randomly assigned to receive either Trauma Management Therapy (TMT) or Exposure Therapy Only (EXP). Participants were assessed at pre-treatment, mid-treatment, and post-treatment. Primary clinical outcomes were reduction of PTSD symptoms and improved social emotional functioning. Results indicated that veterans in both conditions showed statistically significant and clinically meaningful reductions in PTSD symptoms from pre- to post-treatment, though consistent with a priori hypotheses there were no group differences on PTSD variables. However, compared to the EXP group, participants in the TMT group showed increased frequency in social activities and greater time spent in social activities. These changes occurred from mid-treatment (after completion of exposure therapy) to post-treatment (after completion of the social emotional rehabilitation component); supporting the hypothesis that TMT alone would result in improved social functioning. Although the TMT group also had a significant decrease in episodes of physical rage, that change occurred prior to introduction of the social emotional component of TMT. This study demonstrates efficacy of exposure therapy for treating the core symptoms of PTSD among combat veterans with a severe and chronic form of this disorder. Moreover, multi-component CBT shows promise for improving social functioning beyond that provided by exposure therapy alone, particularly by increasing social engagement/interpersonal functioning in a cohort of veterans with severe and chronic PTSD. PMID:20951543

Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy

PubMed Central

Gonzalez, Eduardo; Moore, Ernest E.; Moore, Hunter B.; Chapman, Michael P.; Chin, Theresa L.; Ghasabyan, Arsen; Wohlauer, Max V.; Barnett, Carlton C.; Bensard, Denis D.; Biffl, Walter L.; Burlew, Clay C.; Johnson, Jeffrey L.; Pieracci, Fredric M.; Jurkovich, Gregory J.; Banerjee, Anirban; Silliman, Christopher C.; Sauaia, Angela

2017-01-01

Background Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely. We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA). Methods This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival. Results One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2–11), TEG: 4.5 (2–8)] (P = 0.317), but more plasma units [CCA: 2.0 (0–4), TEG: 0.0 (0–3)] (P = 0.022), and more platelets units [CCA: 0.0 (0–1), TEG: 0.0 (0–0)] (P = 0.041) in the first 2 hours of resuscitation. Conclusions Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation. PMID:26720428

The effect of trauma-focused therapy on the altered T cell distribution in individuals with PTSD: evidence from a randomized controlled trial.

PubMed

Morath, Julia; Gola, Hannah; Sommershof, Annette; Hamuni, Gilava; Kolassa, Stephan; Catani, Claudia; Adenauer, Hannah; Ruf-Leuschner, Martina; Schauer, Maggie; Elbert, Thomas; Groettrup, Marcus; Kolassa, Iris-Tatjana

2014-07-01

Posttraumatic stress disorder (PTSD) is associated with a reduced ratio of naïve cytotoxic T lymphocytes, an increased ratio of memory cytotoxic T lymphocytes, and a reduced proportion of FoxP3(+) regulatory T lymphocytes. This study investigated whether these immunological alterations are reversible through an evidence-based psychotherapeutic treatment. Therefore, 34 individuals with PTSD were randomly assigned to either a treatment condition of 12 sessions narrative exposure therapy (NET) or a waitlist control (WLC) group. PTSD symptoms were significantly reduced in the NET group, but not in the WLC group, four months post-therapy (effect size: Hedges' g = -1.61). One year after therapy, PTSD symptoms were improved even further in the NET group compared to baseline (Hedges' g = -1.96). This symptom improvement was mirrored in an increase in the originally reduced proportion of regulatory T cells (Tregs) in the NET group at the one-year follow-up, when comparing subgroups matched for baseline Treg numbers. However, no changes were found for the initially reduced proportion of CD45RA(+)CCR7(+) naïve T lymphocytes. In conclusion, NET was effective in reducing trauma-related PTSD symptoms and had a positive effect on the proportion of Tregs cells, thus demonstrating an effect of psychotherapy on an immunological level. Yet, the shift in the proportion of naïve and memory T lymphocytes in individuals with PTSD, discussed in the literature as a correlate of premature immunosenescence, was not reversible and thus might render these patients permanently more susceptible to infectious diseases. Copyright © 2014 Elsevier Ltd. All rights reserved.

Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial.

PubMed

Gordon, James S; Staples, Julie K; Blyta, Afrim; Bytyqi, Murat; Wilson, Amy T

2008-09-01

To determine whether participation in a mind-body skills group program based on psychological self-care, mind-body techniques, and self-expression decreases symptoms of posttraumatic stress disorder (PTSD). Eighty-two adolescents meeting criteria for PTSD according to the Harvard Trauma Questionnaire (which corresponds with 16 of the 17 diagnostic criteria for PTSD in DSM-IV) were randomly assigned to a 12-session mind-body group program or a wait-list control group. The program was conducted by high school teachers in consultation with psychiatrists and psychologists and included meditation, guided imagery, and breathing techniques; self-expression through words, drawings, and movement; autogenic training and biofeedback; and genograms. Changes in PTSD symptoms were measured using the Harvard Trauma Questionnaire. The study was conducted from September 2004 to May 2005 by The Center for Mind-Body Medicine at a high school in the Suhareka region of Kosovo. Students in the immediate intervention group had significantly lower PTSD symptom scores following the intervention than those in the wait-list control group (F = 29.8, df = 1,76; p < .001). Preintervention and postintervention scores (mean [SD]) for the intervention group were 2.5 (0.3) and 2.0 (0.3), respectively, and for the control group, 2.5 (0.3) and 2.4 (0.4), respectively. The decreased PTSD symptom scores were maintained in the initial intervention group at 3-month follow-up. After the wait-list control group received the intervention, there was a significant decrease (p < .001) in PTSD symptom scores compared to the preintervention scores. Mind-body skills groups can reduce PTSD symptoms in war-traumatized high school students and can be effectively led by trained and supervised schoolteachers. Copyright 2008 Physicians Postgraduate Press, Inc.

A Follow-Up Study from a Multisite, Randomized Controlled Trial for Traumatized Children Receiving TF-CBT.

PubMed

Jensen, Tine K; Holt, Tonje; Ormhaug, Silje M

2017-11-01

Trauma-focused cognitive behavioral therapy (TF-CBT) is the treatment of choice for traumatized youth, however, follow-up studies are scarce, and treatment effects for co-occurring depression show mixed findings. The aims of this study were to examine whether treatment effects of TF-CBT are maintained at 18 month follow-up and whether degree of co-occurring depression influences treatment effects. As rapid improvement in psychological functioning is warranted for youth, we also investigated whether the symptom trajectory was different for TF-CBT compared to therapy as usual (TAU). The sample consisted of 156 youth (M age = 15.05, 79.50% girls) randomly assigned to TF-CBT or TAU. The youth were assessed for posttraumatic stress symptoms (PTSS), depression, anxiety and general mental health symptoms. Mixed effects analyses followed the symptom courses over 5 time points. Youth receiving TF-CBT maintained their symptom improvement at 18 months follow-up with scores below clinical cut-of on all symptom measures. The most depressed youth had also a significant decline in symptoms that were maintained at follow-up. Symptom trajectories differed as the TF-CBT group reported a more rapid symptom reduction compared to the TAU condition. In the TAU condition, participants received 1.5 times the number of treatment sessions compared to the TF-CBT participants. After 18 months the groups were significantly different on general mental health symptoms only. In conclusion, youth receiving TF-CBT experienced more efficient improvement in trauma related symptoms than youth receiving TAU and these improvements were maintained after 18 months. Also youth experiencing serious co-occurring depression benefitted from TF-CBT.

Investigating the Extent Realistic Moulage Impacts on Immersion and Performance Among Undergraduate Paramedicine Students in a Simulation-based Trauma Scenario: A Pilot Study.

PubMed

Mills, Brennen W; Miles, Alecka K; Phan, Tina; Dykstra, Peggy M C; Hansen, Sara S; Walsh, Andrew S; Reid, David N; Langdon, Claire

2018-04-18

Many healthcare education commentators suggest that moulage can be used in simulation to enhance scenario realism. However, few studies investigate to what extent using moulage in simulation impacts learners. We undertook a mixed-methods pilot study investigating how moulage influences student immersion and performance in simulation. Fifty undergraduate paramedicine students were randomized into two groups completing a trauma-based scenario with or without patient moulage. Task immersion was determined via a self-report questionnaire (National Aeronautics and Space Administration Task Load Index), eye-tracking, and postsimulation interviews. Performance was measured via independent observation of video by two paramedic clinical educators and time-to-action-when students first applied pressure to the primary wound. Eye-tracking suggested that students attended to the thigh wound more often with the inclusion of moulage than without. National Aeronautics and Space Administration Task Load Index data suggested that the inclusion of moulage heightened students' feeling of being rushed throughout the scenario. This elicited an expedited performance of tasks with moulage present compared with not. Students experienced greater immersion with the inclusion of moulage. However, including moulage enhanced scenario difficulty to the extent that overall clinical performance was negatively affected. However, no differences were found when more heavily weighting items felt to contribute most to the survivability of the patient. Including moulage engendered immersion and a greater sense of urgency and did not sacrifice performance of key life-saving interventions. As a result of undertaking this pilot project, we suggest that a large-scale randomized controlled trial is feasible and should be undertaken before implementing change to curricula.

Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.

PubMed

Flanagan, Julianne C; Sippel, Lauren M; Wahlquist, Amy; Moran-Santa Maria, Megan M; Back, Sudie E

2018-03-01

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition for which Prolonged Exposure (PE) therapy is highly efficacious. However, for some individuals, premature dropout and residual PTSD symptoms remain obstacles. The neuropeptide oxytocin is a promising candidate to enhance PE due to its ability to enhance 1) prosocial cognition and behavior, which are theorized to promote positive working alliance, and 2) extinction learning, which is the central mechanism of action underlying successful PE treatment. Despite a robust theoretical rationale, no studies to date have combined evidence-based psychotherapy for PTSD with oxytocin. This randomized, placebo-controlled, double-blind pilot trial examined the feasibility, safety, and preliminary efficacy of augmenting PE with oxytocin. Participants were 17 individuals with diverse index traumas. Participants self-administered intranasal oxytocin (40 IU) or matching placebo 45 min prior to each weekly PE therapy session. One adverse event occurred in the placebo group and three individuals dropped out (17.6%; 2 oxytocin group and 1 placebo group). The oxytocin group demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores, although these differences did not reach statistical significance. Although preliminary, the findings support the feasibility of oxytocin combined with PE. Adequately powered studies are necessary to determine whether oxytocin enhances PE treatment outcomes and to examine potential mechanisms, such as accelerating extinction learning, enhancing early response, and preventing premature dropout. NCT03238924. Copyright © 2017. Published by Elsevier Ltd.

A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury.

PubMed

Wade, Shari L; Walz, Nicolay C; Carey, JoAnne; McMullen, Kendra M; Cass, Jennifer; Mark, Erin; Yeates, Keith Owen

2012-11-01

To examine the results of a randomized clinical trial (RCT) of Teen Online Problem Solving (TOPS), an online problem solving therapy model, in increasing problem-solving skills and decreasing depressive symptoms and global distress for caregivers of adolescents with traumatic brain injury (TBI). Families of adolescents aged 11-18 who sustained a moderate to severe TBI between 3 and 19 months earlier were recruited from hospital trauma registries. Participants were assigned to receive a web-based, problem-solving intervention (TOPS, n = 20), or access to online resources pertaining to TBI (Internet Resource Comparison; IRC; n = 21). Parent report of problem solving skills, depressive symptoms, global distress, utilization, and satisfaction were assessed pre- and posttreatment. Groups were compared on follow-up scores after controlling for pretreatment levels. Family income was examined as a potential moderator of treatment efficacy. Improvement in problem solving was examined as a mediator of reductions in depression and distress. Forty-one participants provided consent and completed baseline assessments, with follow-up assessments completed on 35 participants (16 TOPS and 19 IRC). Parents in both groups reported a high level of satisfaction with both interventions. Improvements in problem solving skills and depression were moderated by family income, with caregivers of lower income in TOPS reporting greater improvements. Increases in problem solving partially mediated reductions in global distress. Findings suggest that TOPS may be effective in improving problem solving skills and reducing depressive symptoms for certain subsets of caregivers in families of adolescents with TBI.

Preference for gel over suppository as delivery vehicle for a rectal microbicide: Results of a randomized, crossover acceptability trial among men who have sex with men

PubMed Central

Carballo-Diéguez, A.; Dolezal, C.; Bauermeister, J.A.; O’Brien, B.; Ventuneac, A.; Mayer, K.

2009-01-01

Objective To assess whether men who have sex with men (MSM) prefer a gel or a suppository as a delivery vehicle for a rectal microbicide. Methods 77 HIV-negative MSM with recent history of inconsistent condom use during receptive anal intercourse (RAI) who acknowledged being at risk of contracting HIV were enrolled in a randomized, crossover acceptability trial. They compared 35 ml of placebo gel with 8 g placebo rectal suppositories used in up to three RAI occasions each. Results Participants preferred the gel over the suppository (75% vs. 25%, p <.001), and so did their partners (71% vs. 29%, p <.001). The gel received more favorable ratings overall and on attributes such as color, smell, consistency, feeling in rectum immediately after insertion and/or 30 minutes after insertion, and application process. The gel resulted in less negative ratings in terms of participants being bothered by leakage, soiling, bloating, gassiness, stomach cramps, urge to have bowel movement, diarrhea, pain or trauma. Participants liked the gel more in terms of feelings during anal sex, sexual satisfaction, partners’ sexual satisfaction, and liking the product when condoms were used and when condoms were not used. Conclusions In this sample taken from one of the populations most likely to benefit from rectal microbicide availability, gel had higher acceptability than suppository as a potential microbicide vehicle. PMID:19028952

Augmenting CPT to Improve Sleep Impairment in PTSD: A Randomized Clinical Trial

PubMed Central

Galovski, Tara E.; Mott, Juliette; Blain, Leah M.; Elwood, Lisa; Gloth, Chelsea; Fletcher, Thomas

2015-01-01

Objective Despite the success of empirically supported treatments for posttraumatic stress disorder (PTSD), sleep impairment frequently remains refractory following treatment for PTSD. This single-site, randomized controlled trial examined the effectiveness of sleep-directed hypnosis as a complement to an empirically supported psychotherapy for PTSD (cognitive processing therapy; CPT). Method Participants completed either 3 weeks of hypnosis (n = 52) or a symptom monitoring control condition (n = 56) before beginning standard CPT. Multilevel modeling was used to investigate differential patterns of change to determine whether hypnosis resulted in improvements in sleep, PTSD, and depression. An intervening variable approach was then used to determine whether improvements in sleep achieved during hypnosis augmented change in PTSD and depression during CPT. Results After the initial phase of treatment (hypnosis or symptom monitoring), the hypnosis condition showed significantly greater improvement than the control condition in sleep and depression, but not PTSD. After CPT, both conditions demonstrated significant improvement in sleep and PTSD; however, the hypnosis condition demonstrated greater improvement in depressive symptoms. As sleep improved, there were corresponding improvements in PTSD and depression, with a stronger relationship between sleep and PTSD. Conclusion Hypnosis was effective in improving sleep impairment, but those improvements did not augment gains in PTSD recovery during the trauma-focused intervention. Public Health Significance: This study suggests that hypnosis may be a viable treatment option in a stepped-care approach for treating sleep impairment in individuals suffering from PTSD. PMID:26689303

Influence of needle bevel design on injection pain and needle deformation in dental local infiltration anaesthesia - randomized clinical trial.

PubMed

Dau, M; Buttchereit, I; Ganz, C; Frerich, B; Anisimova, E N; Daubländer, M; Kämmerer, P W

2017-11-01

The aims of this in vivo study were to evaluate the impact of needle bevel design on patients' pain perception and the mechanical deformation of the needle tip after the injection. In a prospective single-blinded trial, 150 patients received conventional infiltration anaesthesia for dental treatment by one examiner. Patients were randomized for one out of three different needle bevel types (scalpel-designed bevel needle (SB), n=50; triple bevel needle (TB), n=50; regular bevel needle (RB), n=50). Subjects' self-reported injection pain perception was evaluated using a numeric rating scale (NRS). For each needle tip, deformations after single use were measured using SEM. A significant lower injection pain level was found in SB (mean 2.1±1.2) than in TB (mean 3.5±1.6;) and RB (mean 3.4±1.0; all P<0.001). A needle deformation was detected in about 97.3% of all needles (SB 50/50, TB 50/50, and RB: 46/50). A higher number of barbs were found in SB (29/50) versus TB (17/50) and RB (19/50). For dental local infiltration anaesthesia, injection needles with a scalpel-designed bevel demonstrated significantly less injection pain. Needle tip deflections after anaesthetic agent infiltration, especially barbed hooks on the non-cutting edge may result in greater soft tissue trauma. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Trauma Collaborative Care Intervention: Effect on Surgeon Confidence in Managing Psychosocial Complications After Orthopaedic Trauma.

PubMed

Wegener, Stephen T; Carroll, Eben A; Gary, Joshua L; McKinley, Todd O; OʼToole, Robert V; Sietsema, Debra L; Castillo, Renan C; Frey, Katherine P; Scharfstein, Daniel O; Huang, Yanjie; Collins, Susan C J; MacKenzie, Ellen J

2017-08-01

The impact of the Trauma Collaborative Care (TCC) program on surgeon confidence in managing the psychosocial sequelae of orthopaedic trauma was evaluated as part of a larger prospective, multisite, cluster clinical trial. We compared confidence and perceived resource availability among surgeons practicing in trauma centers that implemented the TCC program with orthopaedic trauma surgeons in similar trauma centers that did not implement the TCC. Prospective cohort design. Level-I trauma centers. Attending surgeons and fellows (N = 95 Pre and N = 82 Post). Self-report 10-item measure of surgeon confidence in managing psychosocial issues associated with trauma and perceived availability of support resources. Analyses, performed on the entire sample and repeated on the subset of 52 surgeons who responded to the survey at both times points, found surgeons at intervention sites experienced a significantly greater positive improvement (P < 0.05) in their (1) belief that they have strategies to help orthopaedic trauma patients change their psychosocial situation; (2) confidence in making appropriate referrals for orthopaedic trauma patients with psychosocial problems; and (3) belief that they have access to information to guide the management of psychosocial issues related to recovery. Initial data suggest that the establishment of the TCC program can improve surgeons' perceived availability of resources and their confidence in managing the psychosocial sequelae after injury. Further studies will be required to determine if this translates into beneficial patient effects. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Chronic PTSD Treated with Metacognitive Therapy: An Open Trial

ERIC Educational Resources Information Center

Wells, Adrian; Welford, Mary; Fraser, Janelle; King, Paul; Mendel, Elizabeth; Wisely, Julie; Knight, Alice; Rees, David

2008-01-01

This paper reports on an open trial of metacognitive therapy (MCT) for chronic PTSD. MCT does not require imaginal reliving, prolonged exposure, or challenging of thoughts about trauma. It is based on an information-processing model of factors that impede normal and in-built recovery processes. It is targeted at modifying maladaptive styles of…

Trauma and PTSD in the WHO World Mental Health Surveys.

PubMed

Kessler, Ronald C; Aguilar-Gaxiola, Sergio; Alonso, Jordi; Benjet, Corina; Bromet, Evelyn J; Cardoso, Graça; Degenhardt, Louisa; de Girolamo, Giovanni; Dinolova, Rumyana V; Ferry, Finola; Florescu, Silvia; Gureje, Oye; Haro, Josep Maria; Huang, Yueqin; Karam, Elie G; Kawakami, Norito; Lee, Sing; Lepine, Jean-Pierre; Levinson, Daphna; Navarro-Mateu, Fernando; Pennell, Beth-Ellen; Piazza, Marina; Posada-Villa, José; Scott, Kate M; Stein, Dan J; Ten Have, Margreet; Torres, Yolanda; Viana, Maria Carmen; Petukhova, Maria V; Sampson, Nancy A; Zaslavsky, Alan M; Koenen, Karestan C

2017-01-01

Background : Although post-traumatic stress disorder (PTSD) onset-persistence is thought to vary significantly by trauma type, most epidemiological surveys are incapable of assessing this because they evaluate lifetime PTSD only for traumas nominated by respondents as their 'worst.' Objective : To review research on associations of trauma type with PTSD in the WHO World Mental Health (WMH) surveys, a series of epidemiological surveys that obtained representative data on trauma-specific PTSD. Method : WMH Surveys in 24 countries (n = 68,894) assessed 29 lifetime traumas and evaluated PTSD twice for each respondent: once for the 'worst' lifetime trauma and separately for a randomly-selected trauma with weighting to adjust for individual differences in trauma exposures. PTSD onset-persistence was evaluated with the WHO Composite International Diagnostic Interview. Results : In total, 70.4% of respondents experienced lifetime traumas, with exposure averaging 3.2 traumas per capita. Substantial between-trauma differences were found in PTSD onset but less in persistence. Traumas involving interpersonal violence had highest risk. Burden of PTSD, determined by multiplying trauma prevalence by trauma-specific PTSD risk and persistence, was 77.7 person-years/100 respondents. The trauma types with highest proportions of this burden were rape (13.1%), other sexual assault (15.1%), being stalked (9.8%), and unexpected death of a loved one (11.6%). The first three of these four represent relatively uncommon traumas with high PTSD risk and the last a very common trauma with low PTSD risk. The broad category of intimate partner sexual violence accounted for nearly 42.7% of all person-years with PTSD. Prior trauma history predicted both future trauma exposure and future PTSD risk. Conclusions : Trauma exposure is common throughout the world, unequally distributed, and differential across trauma types with respect to PTSD risk. Although a substantial minority of PTSD cases remits within months after onset, mean symptom duration is considerably longer than previously recognized.

Trauma and PTSD in the WHO World Mental Health Surveys

PubMed Central

Kessler, Ronald C.; Aguilar-Gaxiola, Sergio; Alonso, Jordi; Benjet, Corina; Bromet, Evelyn J.; Cardoso, Graça; Degenhardt, Louisa; de Girolamo, Giovanni; Dinolova, Rumyana V.; Ferry, Finola; Florescu, Silvia; Gureje, Oye; Haro, Josep Maria; Huang, Yueqin; Karam, Elie G.; Kawakami, Norito; Lee, Sing; Lepine, Jean-Pierre; Levinson, Daphna; Navarro-Mateu, Fernando; Pennell, Beth-Ellen; Piazza, Marina; Posada-Villa, José; Scott, Kate M.; Stein, Dan J.; Ten Have, Margreet; Torres, Yolanda; Viana, Maria Carmen; Petukhova, Maria V.; Sampson, Nancy A.; Zaslavsky, Alan M.; Koenen, Karestan C.

2017-01-01

ABSTRACT Background: Although post-traumatic stress disorder (PTSD) onset-persistence is thought to vary significantly by trauma type, most epidemiological surveys are incapable of assessing this because they evaluate lifetime PTSD only for traumas nominated by respondents as their ‘worst.’ Objective: To review research on associations of trauma type with PTSD in the WHO World Mental Health (WMH) surveys, a series of epidemiological surveys that obtained representative data on trauma-specific PTSD. Method: WMH Surveys in 24 countries (n = 68,894) assessed 29 lifetime traumas and evaluated PTSD twice for each respondent: once for the ‘worst’ lifetime trauma and separately for a randomly-selected trauma with weighting to adjust for individual differences in trauma exposures. PTSD onset-persistence was evaluated with the WHO Composite International Diagnostic Interview. Results: In total, 70.4% of respondents experienced lifetime traumas, with exposure averaging 3.2 traumas per capita. Substantial between-trauma differences were found in PTSD onset but less in persistence. Traumas involving interpersonal violence had highest risk. Burden of PTSD, determined by multiplying trauma prevalence by trauma-specific PTSD risk and persistence, was 77.7 person-years/100 respondents. The trauma types with highest proportions of this burden were rape (13.1%), other sexual assault (15.1%), being stalked (9.8%), and unexpected death of a loved one (11.6%). The first three of these four represent relatively uncommon traumas with high PTSD risk and the last a very common trauma with low PTSD risk. The broad category of intimate partner sexual violence accounted for nearly 42.7% of all person-years with PTSD. Prior trauma history predicted both future trauma exposure and future PTSD risk. Conclusions: Trauma exposure is common throughout the world, unequally distributed, and differential across trauma types with respect to PTSD risk. Although a substantial minority of PTSD cases remits within months after onset, mean symptom duration is considerably longer than previously recognized. PMID:29075426

Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial

PubMed Central

Clifton, Guy L; Valadka, Alex; Zygun, David; Coffey, Christopher S; Drever, Pamala; Fourwinds, Sierra; Janis, L Scott; Wilde, Elizabeth; Taylor, Pauline; Harshman, Kathy; Conley, Adam; Puccio, Ava; Levin, Harvey S; McCauley, Stephen R; Bucholz, Richard D; Smith, Kenneth R; Schmidt, John H; Scott, James N; Yonas, Howard; Okonkwo, David O

2013-01-01

Summary Background The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury. We aimed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury. Methods The National Acute Brain Injury Study: Hypothermia II (NABIS: H II) was a randomised, multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada. Patients with non-penetrating brain injury who were 16–45 years old and were not responsive to instructions were randomly assigned (1:1) by a random number generator to hypothermia or normothermia. Patients randomly assigned to hypothermia were cooled to 35°C until their trauma assessment was completed. Patients who had none of a second set of exclusion criteria were either cooled to 33°C for 48 h and then gradually rewarmed or treated at normothermia, depending upon their initial treatment assignment. Investigators who assessed the outcome measures were masked to treatment allocation. The primary outcome was the Glasgow outcome scale score at 6 months. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, NCT00178711. Findings Enrolment occurred from December, 2005, to June, 2009, when the trial was terminated for futility. Follow-up was from June, 2006, to December, 2009. 232 patients were initially randomised a mean of 1·6 h (SD 0·5) after injury: 119 to hypothermia and 113 to normothermia. 97 patients (52 in the hypothermia group and 45 in the normothermia group) did not meet any of the second set of exclusion criteria. The mean time to 35°C for the 52 patients in the hypothermia group was 2·6 h (SD 1·2) and to 33°C was 4·4 h (1·5). Outcome was poor (severe disability, vegetative state, or death) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group (relative risk [RR] 1·08, 95% CI 0·76–1·53; p=0·67). 12 patients in the hypothermia group died compared with eight in the normothermia group (RR 1·30, 95% CI 0·58–2·52; p=0·52). Interpretation This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury. Funding National Institute of Neurological Disorders and Stroke. PMID:21169065

Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial

PubMed Central

2014-01-01

Background Distal radius fractures are among the most common fractures seen in the hospital emergency department. Of these, over 40% are considered unstable and require some form of fixation. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery. Few studies have compared different types of plates, which may have various features, different plate and screw designs or may be manufactured from different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures: one made from stainless steel (Trimed™ Volar Plate, Trimed™, California, USA) and the other made from titanium (Medartis® Aptus Volar Plate, Medartis®, Basel, Switzerland). The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture. Methods/Design This study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates: one plate manufactured from stainless steel (Trimed™ Volar Plate) and one plate manufactured from titanium (Medartis® Aptus Volar Plate). The surgery will be performed at a major trauma hospital in Brisbane, Australia. Outcome measures including function, adverse events, range of movement, strength, disability, radiological findings and health-related quality of life will be collected at 6 weeks, 3, 6, 12 and 24 months following surgery. A parallel economic analysis will also be performed. This randomized clinical trial is due to deliver results in December 2016. Discussion Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type. Trial registration ACTRN12612000969864 PMID:24612524

Primary prevention of pediatric abusive head trauma: a cost audit and cost-utility analysis.

PubMed

Friedman, Joshua; Reed, Peter; Sharplin, Peter; Kelly, Patrick

2012-01-01

To obtain comprehensive, reliable data on the direct cost of pediatric abusive head trauma in New Zealand, and to use this data to evaluate the possible cost-benefit of a national primary prevention program. A 5 year cohort of infants with abusive head trauma admitted to hospital in Auckland, New Zealand was reviewed. We determined the direct costs of hospital care (from hospital and Ministry of Health financial records), community rehabilitation (from the Accident Compensation Corporation), special education (from the Ministry of Education), investigation and child protection (from the Police and Child Protective Services), criminal trials (from the Police, prosecution and defence), punishment of offenders (from the Department of Corrections) and life-time care for moderate or severe disability (from the Accident Compensation Corporation). Analysis of the possible cost-utility of a national primary prevention program was undertaken, using the costs established in our cohort, recent New Zealand national data on the incidence of pediatric abusive head trauma, international data on quality of life after head trauma, and published international literature on prevention programs. There were 52 cases of abusive head trauma in the sample. Hospital costs totaled $NZ2,433,340, child protection $NZ1,560,123, police investigation $NZ1,842,237, criminal trials $NZ3,214,020, punishment of offenders $NZ4,411,852 and community rehabilitation $NZ2,895,848. Projected education costs for disabled survivors were $NZ2,452,148, and the cost of projected lifetime care was $NZ33,624,297. Total costs were $NZ52,433,864, averaging $NZ1,008,344 per child. Cost-utility analysis resulted in a strongly positive economic argument for primary prevention, with expected case scenarios showing lowered net costs with improved health outcomes. Pediatric abusive head trauma is very expensive, and on a conservative estimate the costs of acute hospitalization represent no more than 4% of lifetime direct costs. If shaken baby prevention programs are effective, there is likely to be a strong economic argument for their implementation. This study also provides robust data for future cost-benefit analysis in the field of abusive head trauma prevention. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial.

PubMed

Driver, Brian E; Prekker, Matthew E; Klein, Lauren R; Reardon, Robert F; Miner, James R; Fagerstrom, Erik T; Cleghorn, Mitchell R; McGill, John W; Cole, Jon B

2018-05-16

The tracheal tube introducer, known as the bougie, is typically used to aid tracheal intubation in poor laryngoscopic views or after intubation attempts fail. The effect of routine bougie use on first-attempt intubation success is unclear. To compare first attempt intubation success facilitated by the bougie vs the endotracheal tube + stylet. The Bougie Use in Emergency Airway Management (BEAM) trial was a randomized clinical trial conducted from September 2016 through August 2017 in the emergency department at Hennepin County Medical Center, an urban, academic department in Minneapolis, Minnesota, where emergency physicians perform all endotracheal intubations. Included patients were 18 years and older who were consecutively admitted to the emergency department and underwent emergency orotracheal intubation with a Macintosh laryngoscope blade for respiratory arrest, difficulty breathing, or airway protection. Patients were randomly assigned to undergo the initial intubation attempt facilitated by bougie (n = 381) or endotracheal tube + stylet (n = 376). The primary outcome was first-attempt intubation success in patients with at least 1 difficult airway characteristic (body fluids obscuring the laryngeal view, airway obstruction or edema, obesity, short neck, small mandible, large tongue, facial trauma, or the need for cervical spine immobilization). Secondary outcomes were first-attempt success in all patients, first-attempt intubation success without hypoxemia, first-attempt duration, esophageal intubation, and hypoxemia. Among 757 patients who were randomized (mean age, 46 years; women, 230 [30%]), 757 patients (100%) completed the trial. Among the 380 patients with at least 1 difficult airway characteristic, first-attempt intubation success was higher in the bougie group (96%) than in the endotracheal tube + stylet group (82%) (absolute between-group difference, 14% [95% CI, 8% to 20%]). Among all patients, first-attempt intubation success in the bougie group (98%) was higher than the endotracheal tube + stylet group (87%) (absolute difference, 11% [95% CI, 7% to 14%]). The median duration of the first intubation attempt (38 seconds vs 36 seconds) and the incidence of hypoxemia (13% vs 14%) did not differ significantly between the bougie and endotracheal tube + stylet groups. In this emergency department, use of a bougie compared with an endotracheal tube + stylet resulted in significantly higher first-attempt intubation success among patients undergoing emergency endotracheal intubation. However, these findings should be considered provisional until the generalizability is assessed in other institutions and settings. clinicaltrials.gov Identifier: NCT02902146.

Methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association, 1999-2013.

PubMed

Landorf, Karl B; Menz, Hylton B; Armstrong, David G; Herbert, Robert D

2015-07-01

Randomized trials must be of high methodological quality to yield credible, actionable findings. The main aim of this project was to evaluate whether there has been an improvement in the methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association (JAPMA). Randomized trials published in JAPMA during a 15-year period (January 1999 to December 2013) were evaluated. The methodological quality of randomized trials was evaluated using the PEDro scale (scores range from 0 to 10, with 0 being lowest quality). Linear regression was used to assess changes in methodological quality over time. A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6. Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal. Researchers seeking to publish reports of randomized trials should seek to meet current best-practice standards in the conduct and reporting of their trials.

Machine learning and new vital signs monitoring in civilian en route care: A systematic review of the literature and future implications for the military.

PubMed

Liu, Nehemiah T; Salinas, Jose

2016-11-01

Although air transport medical services are today an integral part of trauma systems in most developed countries, to date, there are no reviews on recent innovations in civilian en route care. The purpose of this systematic review was to identify potential machine learning and new vital signs monitoring technologies in civilian en route care that could help close civilian and military capability gaps in monitoring and the early detection and treatment of various trauma injuries. MEDLINE, the Cochrane Database of Systematic Reviews, and citation review of relevant primary and review articles were searched for studies involving civilian en route care, air medical transport, and technologies from January 2005 to November 2015. Data were abstracted on study design, population, year, sponsors, innovation category, details of technologies, and outcomes. Thirteen observational studies involving civilian medical transport met inclusion criteria. Studies either focused on machine learning and software algorithms (n = 5), new vital signs monitoring (n = 6), or both (n = 2). Innovations involved continuous digital acquisition of physiologic data and parameter extraction. Importantly, all studies (n = 13) demonstrated improved outcomes where applicable and potential use during civilian and military en route care. However, almost all studies required further validation in prospective and/or randomized controlled trials. Potential machine learning technologies and monitoring of novel vital signs such as heart rate variability and complexity in civilian en route care could help enhance en route care for our nation's war fighters. In a complex global environment, they could potentially fill capability gaps such as monitoring and the early detection and treatment of various trauma injuries. However, the impact of these innovations and technologies will require further validation before widespread acceptance and prehospital use. Systematic review, level V.

Using the trauma film paradigm to explore interpersonal processes after trauma exposure.

PubMed

Woodward, Matthew J; Beck, J Gayle

2017-07-01

The present study sought to examine ways in which social support might influence trauma symptoms using a variation of the trauma film paradigm. Sixty-seven undergraduate female students in romantic relationships were randomized to watch a stressful film clip depicting a sexual assault, either in the presence (PP) or absence (PA) of their romantic partner. Analyses showed that the PP condition experienced more intrusive memories of the film than the PA condition. In addition, participants in the PP condition whose romantic partner reported low relationship trust had higher film-related distress than participants in the PP condition whose romantic partner reported high relationship trust. Observational coding of partner behaviors after viewing the film clip found that greater expression of negative emotion from partners predicted participants' negative affect and intrusive memories over time. Positive emotional support did not have any effect upon participants' distress. Findings identify possible ways in which interpersonal processes influence trauma adjustment and suggest that the trauma film paradigm can be adapted to examine the role of interpersonal processes in post-trauma adjustment. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study

PubMed Central

2014-01-01

Background Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Methods/Design Prospective observational study with two consecutive cohorts of patients. Setting: A high-volume, academic, supra-regional trauma centre in Germany. Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call. Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. Discussion Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. Trial registration Current Controlled Trials ISRCTN74557102. PMID:24589310

The focus of Langenbeck's Archives of Surgery in the 21st century.

PubMed

Schneider, Martin; Weitz, Jürgen; Büchler, Markus W

2010-04-01

The Langenbeck's Archives of Surgery has been serving as a publication platform for clinical and scientific progress in the field of surgery for 150 years. In order to maintain this long-standing tradition throughout the coming decades, it will be mandatory to face the challenges posed by increasing specialization of surgical subdisciplines, modern technologies, and interdisciplinary treatment options. Continued efforts need to be directed at minimizing surgical trauma, not at least with respect to current demographic development. Adoption of progressive technologies from the fields of biophysics, mechatronics, and biomedical imaging solutions will likely gain a major impact on the further development of surgical operation techniques. Expanding insight from genomic and molecular medicine will facilitate personalized, interdisciplinary treatment concepts for malignant disease, in which surgical resection techniques will need to be integrated. The introduction of novel diagnostic and treatment concepts will mandate solid evaluation of their clinical effectiveness and safety, which can only be achieved by randomized, controlled trials in the field of surgery. Extracting study ideas from the contributions by clinicians and basic scientists, and promoting the conduction of clinical trials will therefore range among the most important tasks for the Langenbeck's Archives of Surgery in the 21st century.

Introduction to a Special Issue Dialectical Behavior Therapy: Evolution and Adaptations in the 21(st) Century.

PubMed

Miller, Alec L

2015-01-01

Born from the randomized controlled trial by Linehan and colleagues in 1991, dialectical behavior therapy (DBT) has become the gold standard for treatment of individuals who are suicidal and have borderline personality disorder. In this special issue, we begin with a historical review of DBT provided by the treatment developer herself. We then introduce readers to new, 21(st) century adaptations developed of this treatment modality. In this issue we explore the use of DBT for suicidal adolescents with one paper focusing on Latina teens and their parents, and one focused on the more recently developed walking the middle path skills module. Other papers in this issue include unique adaptations of DBT for eating disorders, and disorders of over-control, as well as trauma in incarcerated male adolescents. We also look at transdiagnostic applications of DBT and finally a comparison of DBT with mentalization-based treatment.

History of carotid surgery: from ancient greeks to the modern era.

PubMed

Tallarita, Tiziano; Gerbino, Maurizio; Gurrieri, Carmelina; Lanzino, Giuseppe

2013-12-01

A relationship between decreased carotid arterial flow and apoplectic manifestations was already suspected by the ancient Greeks. Early attempts at carotid surgery, however, were limited to emergency arterial ligation in patients with neck trauma. Attempts to suture arterial stumps together to restore blood flow paved the way for Carrel's revolutionary idea of reconstructing the resected or injured arterial segment with an interposition vein graft. DeBakey and Eastcott were the first to perform carotid endarterectomy in North America and the United Kingdom, respectively. In 1959, DeBakey proposed a cooperative study to assess the effectiveness of carotid endarterectomy in the treatment and prevention of ischemic cerebrovascular disease. The study was officially designated the Joint Study of Extracranial Arterial Occlusion and represented the first trial in the United States in which large numbers of patients were randomly allocated to surgical or nonsurgical therapy.