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Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of font size and paper thickness on the response to, and completion of, a self-completion postal questionnaire among older people with joint pain.Study Design and Setting: Randomized trial. People aged 50 years and older with joint pain who consulted a general practitioner at one of five general practices in Central Cheshire were sent a postal questionnaire. Questionnaire format (large or small font size, thick or thin paper) was randomly allocated using a 2 x 2 factorial design.Results: Questionnaires were received from 502 out of 650 participants (crude response 77%). Response was significantly higher for participants receiving questionnaires with a larger font size (79.3% vs. 75.2%; hazard ratio 1.26, 95% confidence interval: 1.02, 1.56). Paper thickness had no significant effect on response. Completion (measure by assessing double-page turnover error) was increased in participants receiving questionnaires printed on thicker paper (3.2% vs. 7.1%; P=0.049) but was not affected by font size.Conclusion: This study demonstrates that questionnaires in larger font and on thicker paper may produce higher and more complete responses than surveys using standard size font and standard thickness paper, and should therefore be considered in studies among older people. [ABSTRACT FROM AUTHOR]

Emergency contraception (EC) with 10 mg mifepristone can prevent pregnancy up to 5 days after a single act of unprotected intercourse. No methods have been shown to be effective when treatment is administered more than 5 days after a single unprotected act or after several unprotected acts. Therefore, we tested, among 699 Chinese women requesting EC and exposed to the risk of pregnancy described, the potential of 100 mg mifepristone followed 2 days later by 0.4 mg misoprostol orally, when administered in the luteal phase of the cycle. At the time of treatment urinary pregnancy test had to be negative. Despite treatment, 25 women (2.7%) became pregnant. Among women with treatment delayed more than 5 days, the pregnancy rate was related to the number of acts of intercourse before treatment, being 1.4% with one episode and increasing to 6.5% when the number of episodes was two or more (relative risk = 4.62, 95% CI: 1.06–20.18). Side effects within a week after treatment were mild, and most women (57.2%) had menstruation within 3 days as expected. An occasional treatment with mifepristone in combination with misoprostol could provide an option for preventing unwanted pregnancies in women who are late for EC. [Copyright &y& Elsevier]

Background: Misophonia is a condition marked by dysregulated emotions and behaviors in response to trigger sounds, often chewing, breathing, or coughing. Evidence suggests that misophonia develops in adolescence and the emotions and behaviors are a conditioned response to distress, resulting in social avoidance, stress, and family conflict. In addition, co-occurrence with other psychiatric illnesses such as anxiety, OCD, and Tourette syndrome is common. A transdiagnostic cognitive behavioral therapeutic (CBT) approach appears appropriate. There are currently no controlled studies of youth with misophonia. The current paper describes the approach to a pilot randomized, blinded family-based treatment study for youth ages 8-16 years. Preliminary results from a pilot open trial also are described.Methods: A 2-phase dual site telehealth treatment study using a transdiagnostic CBT approach, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A; Ehrenreich-May et al., 2018), is proposed. Phase 1 consisted of a 4-case pilot of UP-C/A. Phase 2 includes a randomized trial comparing the UP-C/A to a standard relaxation and education protocol.Results: Preliminary results from the pilot show modest improvements in evaluator-rated misophonia symptoms on the Clinical Global Impression Severity and Improvement scales.Limitations: There is little research to inform evidence-based practice for youth with misophonia. Study limitations include lack of standardized misophonia assessment instruments and an absence of formal diagnostic criteria.Conclusions: The current paper describes proposed methods for the first randomized controlled trial for youth with misophonia and their families along with results from a 4-case pilot. [ABSTRACT FROM AUTHOR]

Although randomized interventional studies are the gold standard of clinical study designs, they are not always feasible or necessary. In such cases, observational studies can bring insights into critical questions while minimizing harm and cost. There are numerous observational study designs, each with strengths and demerits. Unfortunately, it is not uncommon for observational study designs to be poorly designed or reported. In this article, the authors discuss similarities and differences between observational study designs, their application, and tenets of good use and proper reporting focusing on neurosurgery. The authors illustrated neurosurgical case scenarios to describe case reports, case series, and cohort, cross-sectional, and case-control studies. The study design definitions and applications are taken from seminal research methodology readings and updated observational study reporting guidelines. The authors have given a succinct account of the structure, functioning, and uses of common observational study designs in Neurosurgery. Specifically, they discussed the concepts of study direction, temporal sequence, advantages, and disadvantages. Also, they highlighted the differences between case reports and case series; case series and descriptive cohort studies; and cohort and case-control studies. Also, they discussed their impacts on internal validity, external validity, and relevance. This paper disambiguates widely held misconceptions on the different observational study designs. In addition, it uses case-based scenarios to facilitate comprehension and relevance to the academic neurosurgery audience. [ABSTRACT FROM AUTHOR]

Background: The long-term effect of early intervention in infants at risk for developmental disorders is unclear. The VIP project (n=46, originally) evaluated by means of a randomised controlled trial the effect of the family centred early intervention programme COPCA (Coping with and Caring for infants with special needs) in comparison to that of traditional infant physiotherapy (TIP).Aims: To evaluate the effect of early intervention on functional outcome at school age.Methods and Procedures: Parents of 40 children (median age 8.3years) participated in this follow-up study. Outcome was assessed with a standardised parental interview (Vineland Adaptive Behaviour Scale) and questionnaires (Developmental Coordination Disorder Questionnaire, Child Behaviour Checklist, Utrechtse Coping List, and questions on educational approach). Quantified video information on physiotherapeutic actions during infancy was available.Outcomes and Results: Child functional outcome in the two randomised groups was similar. Process evaluation revealed that some physiotherapeutic actions were associated with child mobility and parental educational approach at follow-up: e.g., training and instructing were associated with worse mobility.Conclusions and Implications: Functional outcome at school age after early intervention with COPCA is similar to that after TIP. However, some specific physiotherapeutic actions, in particular the physiotherapist's approach, are associated with outcome.What This Paper Adds: Early intervention is generally applied in infants at risk for developing disorders, with the aim of improving overall functional outcome. However, little is known on the long-term effect. The VIP project evaluated by means of a randomised controlled trial the effect of the family centred early intervention programme COPCA (Coping with and Caring for infants with special needs) in comparison to that of traditional infant physical therapy (TIP). Outcome at 18months corrected age was virtually similar. Process evaluation of the physiotherapy actions revealed that some characteristics of COPCA were associated with improved developmental outcome at 18months. This paper presents data on functional outcome at school age (median 8.3years) in 87% of the original participants. Outcome of infants who received three months of COPCA and that of infants who received three months of TIP was similar. Yet, parents of families who had received the COPCA intervention still more often used a trial and error approach when the child learned a new skill than parents of children who had received TIP. Process evaluation showed that more time spent on caregiver training and strict instructions during early intervention was associated with worse mobility. Four other physiotherapeutic actions were associated with parental educational approach. None of the neuromotor actions were associated with child outcome at school age. We conclude that long-term outcome after three months of COPCA or TIP is similar. However, our study does suggest that the professional approach of the physiotherapist can make a difference. [ABSTRACT FROM AUTHOR]

Background: Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration.Methods: The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial was a Phase III multi-site, randomized trial to compare the effectiveness and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with a 1:1:2 ratio. In this trial, these three types of blood products were to be transfused in a pre-defined order that differed by treatment arm. In this paper, we present approaches from the PROPPR trial that we used to define and calculate the occurrence of out of order blood transfusion errors. We applied the proposed method to calculate protocol adherence to the specified order of transfusion in each treatment arm.Results: Using our proposed method, protocol adherence was greater in the 1:1:1 group than in the 1:1:2 group (96% vs 93%) (p<0.0001), although out of order transfusion errors in both groups were low. Final transfusion ratios of plasma to platelets to red blood cells for the 1:1:1 ratio group was 0.93:1.32:1, while the transfusion ratio for the 1:1:2 ratio group was 0.48:0.48:1.Conclusions: Overall, PROPPR adherence to blood transfusion order pre-specified in the protocol was high, and the required order of transfusions for the 1:1:2 group was more difficult to achieve. The approaches proposed in this manuscript were useful in evaluating the PROPPR adherence and are potentially useful for other trials where a specific treatment orders with varying durations must be maintained. [ABSTRACT FROM AUTHOR]

Purpose: Radiation therapy (RT) after breast-conserving surgery reduces locoregional recurrences and improves survival but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomized clinical trial initiated in 1991 and to report dose-volume data based on individual 3-dimensional treatment plans for organs at risk.Methods and Materials: The trial included 1187 patients with T1-2 N0 breast cancer randomized to postoperative tangential whole breast RT or no further treatment. The prescription dose to the clinical target volume was 48 to 54 Gy. We present 20-year follow-up on survival, cause of death, morbidity, and later malignancies. For a cohort of patients (n = 157) with accessible computed tomography-based 3-dimensional treatment plans in Dicom-RT format, dose-volume descriptors for organs at risk were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques.Results: The cumulative incidence of cardiac mortality was 12.4% in the control group and 13.0% in the RT group (P = .8). There was an increase in stroke mortality: 3.4% in the control group versus 6.7% in the RT group (P = .018). Incidences of contralateral breast cancer and lung cancer were similar between groups. The median Dmean (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1), and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0).Conclusions: In this trial, serious late side effects of whole breast RT were limited and less than previously reported in large meta-analyses. We observed no increase in cardiac mortality in irradiated patients. Doses to the heart were a median Dmean of 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation. [ABSTRACT FROM AUTHOR]

Aims: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.Methods: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.Discussion: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation. [ABSTRACT FROM AUTHOR]

Background: Experimental and observational research suggests hyperoxia following resuscitation from cardiac arrest is associated with neurological injury and worse clinical outcomes. This paper describes the rationale and design of the EXACT trial. EXACT aims to determine whether reducing oxygen in the acute phase of post-resuscitation care for out-of-hospital cardiac arrest (OHCA) improves survival.Methods: EXACT is a multi-centre, randomised (1:1), single-blind, parallel trial. Presumed cardiac OHCA cases who achieve a return of spontaneous circulation will be eligible if they are comatose, with an advanced airway and have an oxygen saturation (SpO2) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO2 of 90-94% (intervention) or 98-100% (control). Study treatment will continue until admission to an intensive care unit or hospital ward. The primary outcome is survival to hospital discharge. Secondary outcomes include 12-month survival and quality of life.Results: The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control). Further sites are due to commence in 2019, recruitment is expected to take three years.Conclusion: This study will determine if early reduction of oxygen leads to improved outcomes in OHCA. Such a finding may potentially change clinical practice with implications on future OHCA survival outcomes.Trial Registration Number: NCT03138005. [ABSTRACT FROM AUTHOR]

Dissonance-based eating disorder prevention leads to decreases in risk factors for these disorders. Although controlled trials have demonstrated that targeted, manualized programs reduce eating disorder risk, concerns regarding implementation and dissemination remain. A primary concern is the difficulty in adapting programs for a high school setting for populations at highest risk: adolescents. This paper describes the REbeL Peer Education model and assesses the initial pilot trials of the intervention. The program is novel in that it utilizes a voluntary, self-selection model that is sustainable in a high school setting, and focuses on empowerment and effective cognitive dissonance based prevention activities. High school peer-educators self-selected into the semi-manualized dissonance based intervention. Group activities were peer led, designed to critique the thin ideal, and designed to empower macro (school and larger community wide) changes in the pilot trial (N=47) assess the effectiveness and feasibility of the intervention. Results of the initial pilot study revealed preliminary support for the feasibility of the program, increases in feelings of empowerment, and decreases in eating disorder cognitions and behaviors with moderate to large effect sizes. Feedback from participants indicated that the intervention was enjoyable, educational, and empowering. This study is the first to adapt dissonance-based prevention models to a semi-manualized, peer-led, prevention program integrated into high school settings. [ABSTRACT FROM AUTHOR]

Background: We conducted a meta-analysis to evaluate and compare the advantages of laparoscopy-assisted distal gastrectomy (LADG) over open distal gastrectomy (ODG) for treating early gastric cancer (EGC).Methods: We searched MEDLINE, EMBASE, Science Citation Index, and Cochrane Controlled Trial Register for relevant papers published between January 1990 and January 2010 by using the following search terms: laparoscopy-assisted gastrectomy, laparoscopic gastrectomy, and early gastric cancer. The following data were analyzed: operative time, estimated blood loss, number of harvested lymph nodes, time required for resumption of oral intake, duration of hospital stay, frequency of analgesic administration, complications, tumor recurrence, and mortality.Results: We selected four papers reporting randomized control studies (RCTs) that compared LADG with ODG for EGC. Our meta-analysis included 267 patients with EGC; of these, 134 and 133 had undergone LADG and ODG, respectively. The volume of intraoperative blood loss, frequency of analgesic administration, and rate of complications were significantly lesser for LADG than for ODG. However, the time required for resumption of oral intake and duration of hospital stay did not significantly differ between LADG and ODG. The operative time for LADG was significantly longer than that for ODG; further, the number of harvested lymph nodes was significantly lesser in the LADG group than in the ODG group.Conclusion: LADG is advantageous over ODG because it results in lesser blood loss, is less painful, and is associated with a low risk of complications. Additional RCTs that compare LADG and ODG and investigate the long-term oncological outcomes of LADG are required to determine the advantages of LADG over ODG. [ABSTRACT FROM AUTHOR]

Objective: Efficacy and safety of long-term use of antidepressants (AD) in bipolar disorder (BD) patients remains highly controversial. Here we performed a meta-analysis of randomized controlled trials (RCTs) exploring the efficacy and safety of long-term AD use in BD patients.Methods: English-written literature published in peer-reviewed journal was systematically searched from Pubmed, EMBASE, CENTRAL, PsycINFO and Clinicaltrials.gov. Each database was searched from its first available time to August 31, 2016. Additional papers were searched from recent guidelines, expert consensus and systematic reviews by hand. RCTs exploring the efficacy and safety of long-term (≥4m) antidepressant treatment for patients with bipolar disorder were eligible. Two authors (HF, JL) independently extracted the data. Risk ratio (RR), number needed to treat (NNT) and/or number needed to harm (NNH) for new depressive episodes and new manic/hypomanic episodes were calculated. Subgroup analyses were performed based on treatment regimen (AD monotherapy or combined with MS), types of antidepressants, funding source, bipolar subtypes and treatment duration.Results: Eleven trials with 692 bipolar disorder patients were included in the meta-analysis. The risk of bias assessment demonstrated moderate bias risk. Antidepressants were superior to placebo in reducing new depressive episodes in bipolar disorders without increasing risk of new manic/hypomanic episodes either used as monotherapy or in combination with MS. Subgroup analyses revealed that greater benefit and lower risk may be achieved in BD II than in BD I. However, compared with MS monotherapy, AD monotherapy significantly increased the risk of affective switch with no improvement in prophylaxis of new depressive episodes.Conclusions: Reduced new depressive episodes may be achieved by long-term AD treatment with no significantly increased risk of new manic/hypomanic episodes in BD, particularly in BD II. The elevated risk of affective switch of AD monotherapy compared with MS monotherapy may be contributed to the protective effect of MS in diminishing manic/hypomanic episodes. Further studies are needed to verify our findings. [ABSTRACT FROM AUTHOR]

Objective: The Learning Health System (LHS) requires integration of research into routine practice. 'eSource' or embedding clinical trial functionalities into routine electronic health record (EHR) systems has long been put forward as a solution to the rising costs of research. We aimed to create and validate an eSource solution that would be readily extensible as part of a LHS.Materials and Methods: The EU FP7 TRANSFoRm project's approach is based on dual modelling, using the Clinical Research Information Model (CRIM) and the Clinical Data Integration Model of meaning (CDIM) to bridge the gap between clinical and research data structures, using the CDISC Operational Data Model (ODM) standard. Validation against GCP requirements was conducted in a clinical site, and a cluster randomised evaluation by site nested into a live clinical trial.Results: Using the form definition element of ODM, we linked precisely modelled data queries to data elements, constrained against CDIM concepts, to enable automated patient identification for specific protocols and pre-population of electronic case report forms (e-CRF). Both control and eSource sites recruited better than expected with no significant difference. Completeness of clinical forms was significantly improved by eSource, but Patient Related Outcome Measures (PROMs) were less well completed on smartphones than paper in this population.Discussion: The TRANSFoRm approach provides an ontologically-based approach to eSource in a low-resource, heterogeneous, highly distributed environment, that allows precise prospective mapping of data elements in the EHR.Conclusion: Further studies using this approach to CDISC should optimise the delivery of PROMS, whilst building a sustainable infrastructure for eSource with research networks, trials units and EHR vendors. [ABSTRACT FROM AUTHOR]

Background and Objective: Different review articles support the usefulness and effectiveness of mindfulness techniques in health and wellbeing. In this paper we present a first prototype of a mobile application to help with the training and practice of mindfulness, taking into account the lacks detected in a previous literature review. Our aim was to measure acceptance and perceived quality, as well as gather data about app usage. Their dependence on demographic variables and the change in mindful level was also measured.Materials and Methods: Two versions of a new application were developed, "Mindfulness" and "Mindfulness Sci". The application has been tested in two pilot studies: in traditional face-to-face mindfulness groups and in individual and independent use.Results: 3977 users were involved in this study: 26 in the first trial during an 8-week usage period and 3951 in the second trial during 17 months. In the first study, participants assessed the app with high scores. They considered it as a helping tool for mindfulness practice, user-friendly and with high quality of use. The positive perception was maintained after 8-weeks meditation workshops, and participants considered that its use could contribute to obtain benefits for mental and physical health. In the second study, we found rather weak associations between usage time and age, nationality and educational level. The mindful level showed a weak positive correlation with the session accomplished but slightly above the boundary of statistical significance (p-value=0.051). Videos and information stood out as the most accessed resources.Conclusions: Up to our knowledge, this is the first app developed with the help of health professionals in Spanish that could be used with a general aim, in health and wellbeing. The results are promising with a positive evaluation in face-to-face and independent use situations. Therefore, the number of potential users is enormous in a global worldwide context. [ABSTRACT FROM AUTHOR]

Dissonance-based eating disorder prevention leads to decreases in risk factors for these disorders. Although controlled trials have demonstrated that targeted, manualized programs reduce eating disorder risk, concerns regarding implementation and dissemination remain. A primary concern is the difficulty in adapting programs for a high school setting for populations at highest risk: adolescents. This paper describes the REbeL Peer Education model and assesses the initial pilot trials of the intervention. The program is novel in that it utilizes a voluntary, self-selection model that is sustainable in a high school setting, and focuses on empowerment and effective cognitive dissonance based prevention activities. High school peer-educators self-selected into the semi-manualized dissonance based intervention. Group activities were peer led, designed to critique the thin ideal, and designed to empower macro (school and larger community wide) changes in The pilot trial (N=47) assess the effectiveness and feasibility of the intervention. Results of the initial pilot study revealed preliminary support for the feasibility of the program, increases in feelings of empowerment, and decreases in eating disorder cognitions and behaviors with moderate to large effect sizes. Feedback from participants indicated that the intervention was enjoyable, educational, and empowering. This study is the first to adapt dissonance-based prevention models to a semi-manualized, peer-led, prevention program integrated into high school settings. [ABSTRACT FROM AUTHOR]

Introduction: Excisional surgical debridement (SD) is still the gold standard in the treatment of deeply burned hands, though the intricate anatomy is easily damaged. Previous studies demonstrated that enzymatic debridement with the bromelain debriding agent NexoBrid® (EDNX) is more selective and thus can preserve viable tissue with excellent outcome results. So far no method paper has been published presenting different treatment algorithms in this new field. Therefore our aim was to close this gap by presenting our detailed learning curve in EDNX of deeply burned hands.Methods: We conducted a single-center prospective observational clinical trial treating 20 patients with deeply burned hands with EDNX. Different anaesthetic procedures, debridement and wound treatment algorithms were compared and main pitfalls described.Results: EDNX was efficient in 90% of the treatments though correct wound bed evaluation was challenging and found unusual compared to SD. Post EDNX surprisingly the majority of the burn surface area was found overestimated (18 wounds). Finally we simplified our process and reduced treatment costs by following a modified treatment algorithm and treating under plexus anaesthesia bedside through a single nurse and one burn surgeon solely. Suprathel® could be shown to be an appropriate dressing for wound treatment after EDNX. Complete healing (less 5% rest defect) was achieved at an average of day 28.Conclusion: EDNX in deep burned hands is promising regarding handling and duration of the treatment, efficiency and selectivity of debridement, healing potential and early rehabilitation. Following our treatment algorithm EDNX can be performed easily and even without special knowledge in burn wound depth evaluation. [ABSTRACT FROM AUTHOR]

Background: This paper includes the voices of people who are members of a peer-led drug user group (SNAP) in Canada who are receiving heroin-assisted treatment (HAT) outside of a clinical trial. Drawing from critical drug studies, we problematize the criteria for severe opioid use disorder (OUD) from the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, by exploring SNAP members' experiences in relation to heroin-assisted treatment, and examining how SNAP participants' narratives challenge conventional notions of what constitutes severe opioid use disorder.Method: Drawing on critical analysis and research guidelines developed by drug user unions and organizations, and critical methodological frameworks on ethical community-based-and-responsive research for social justice, in this paper we focus on semi-structured interviews conducted with 36 SNAP members at the Vancouver Area Network of Drug Users site in the Downtown Eastside of Vancouver, Canada. We included opened ended questions about experiences prior to receiving HAT, experiences while receiving HAT, experiences of drug use and cessation, and future hopes.Results: Although SNAP participants were diagnosed as suffering from OUD, the DSM-5 criteria for OUD fails to encompass their diverse experiences of opioid use. Nor does the DSM diagnosis capture the complexities of their lived experience. The DSM OUD constructs an idea of addiction and the addicted person based on a list of symptoms thought to be associated with extended use of opioids. The problem with this is that many of these "symptoms" of drug use are, in the case of SNAP participants, tied to contextual issues of living in the DTES, experiencing structural vulnerability, and being the target of punitive drug policies and laws.Conclusion: To label someone as having a severe disorder shifts the focus from political and social issues, including the lived experiences of people who use heroin. The DSM-5 de-contextualizes drug use. How addiction and heroin are constituted has political implications that will determine what types of services and programs will be set up. Treating a disorder, or a person with a disorder, requires a much different approach than understanding heroin use as a habit. SNAP, and their allies, are rupturing conventional ideas about heroin and taken for granted assumptions about people who use heroin. [ABSTRACT FROM AUTHOR]

Objective: The main aim of this paper is to investigate the prediction that greater subjective identification with relevant groups and social categories (i.e. 'family' and 'transplantees') can be an outcome of post-traumatic growth (PTG). To date there are no studies that have explored these relationships.Methods: A longitudinal study was conducted with a group of 100 liver transplant patients from the outpatient populations of the participating centre. Data were collected by means of a self-report questionnaire, which was completed at two different time points (T1 and T2) that were 24months apart. PTG was assessed using the Post-Traumatic Growth Inventory, while both transplantee and family identification were assessed using group identification scales. A path model was tested, using a structural equation model (SEM) approach, to examine the reciprocal effects among family identification, transplantee identification, and PTG over time.Results: As predicted, we found that greater PTG T1 predicted both greater family identification T2 and marginally greater transplantee identification T2. However, the two identification variables did not predict PTG over time.Conclusions: The results show that family identification and transplantee identification may be outcomes of the PTG process, confirming the importance of adopting a thriving multidimensional model of adjustment to medical illness, whereby people facing adverse life events, such as transplantation, may flourish rather than deteriorate psychologically. [ABSTRACT FROM AUTHOR]

Introduction: Acetabular fracture surgery is amongst the most challenging tasks in the field of trauma surgery and careful preoperative planning is crucial for success. The aim of this paper is to describe the preliminary outcome of the utilization of an innovative computerized virtual planning system for acetabular fractures.Methods: 3D models of acetabular fractures and surrounding soft tissues from six patients were constructed from preoperative CT scans. A novel highly-automatic segmentation technique was performed on the 3D model to separate each fracture fragment, then 3D virtual reduction was performed. Additionally, the models were used to assess potential surgical approaches with reference to both the fracture and the surrounding soft tissues. The time required for virtual planning was recorded. After surgery, the virtual plan was compared to the real surgery with respect to surgical approach and reduction sequence. A Likert scale questionnaire was completed by the surgeons to evaluate their satisfaction with the system.Results: Virtual planning was successfully completed in all cases. The planned surgical approach was followed in all cases with the planned reduction sequence followed completely in five cases and partially in one. The mean time required for virtual planning was 38.7min (range 21-57, SD=15.5). The mean time required for planning of B-type fractures was 25.0min (range 21-30, SD=4.6), of C-type fracture 52.3min (range 49-57, SD=4.2). The results of the questionnaire demonstrated a high level of satisfaction with the planning system.Conclusion: This study demonstrates that the virtual planning system is feasible in clinical settings with high satisfaction and acceptability from the surgeons. It provides a viable option for the planning of acetabular fracture surgery. [ABSTRACT FROM AUTHOR]

Background: In epidemiological studies, statins appear to benefit mood, and there are now some randomized controlled trials examining the efficacy of statins. However, the role of statins in depression remains uncertain. Thus the aim of this paper was to assess the effect of statins on depressive symptoms by performing a meta-analysis of all double-blind, randomized, placebo controlled clinical trials (RCT) conducted in subjects with depression.Methods: A systematic search was executed using PubMed and ClinicalTrials.gov in November 30th, 2015 for all double-blind, RCT of statins versus placebo in persons with depressive symptoms. Sixty-seven potential articles were identified through search of electronic databases, of those three met inclusion criteria and were included in the meta-analysis. The outcome measure was change in Hamilton Depression Rating Scale (HDRS) scores associated with statin use. A meta-analysis was conducted and standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated. GRADE was used to assess study quality.Results: The three articles included provided data on 165 participants with moderate to severe depression. Of these, 82 were randomized to statins as an adjuvant therapy to antidepressant treatment (i.e., citalopram or fluoxetine) and 83 to the placebo arm. All studies were double-blind RCTs, with a follow-up of 6-12 weeks. The statin agents evaluated were lovastatin, atorvastatin, and simvastatin. When compared to placebo, statins, as add-on to treatment as usual, largely improved depressive symptoms as assessed by the HDRS (SMD=-0.73, 95% IC -1.04 to -0.42, p<0.001, 3 between-group comparisons, n=165). No serious adverse effects were reported.Conclusions: Our results suggest that adjunctive treatment with statins could be useful for the treatment of depressive symptoms. Additional double-blind, randomised, placebo-controlled trials are necessary to settle the matter. [ABSTRACT FROM AUTHOR]

Background: Theory-of-mind (ToM) refers to knowledge and awareness of mental states in oneself and others. Various training programs have been developed to improve ToM in children.Objectives: In the present study, we conducted a quantitative review of ToM training programs that have been tested in controlled studies.Data Sources: A literature search was conducted using PubMed, PsycInfo, the Cochrane Library, and manual searches.Review Methods: We identified 32 papers with 45 studies or experiments that included 1529 children with an average age of 63 months (SD=28.7).Results: ToM training procedures were more effective than control procedures and their aggregate effect size was moderately strong (Hedges' g=0.75, CI=0.60-0.89, p<.001). Moderator analyses revealed that although ToM training programs were generally effective, ToM skill-related outcomes increased with length of training sessions and were significantly higher in active control studies.Conclusion: ToM training procedures can effectively enhance ToM in children. [ABSTRACT FROM AUTHOR]

Purpose: Kilovoltage intrafraction monitoring (KIM) is a new real-time 3-dimensional image guidance method. Unlike previous real-time image guidance methods, KIM uses a standard linear accelerator without any additional equipment needed. The first prospective clinical trial of KIM is underway for prostate cancer radiation therapy. In this paper we report on the measured motion accuracy and precision using real-time KIM-guided gating.Methods and Materials: Imaging and motion information from the first 200 fractions from 6 patient prostate cancer radiation therapy volumetric modulated arc therapy treatments were analyzed. A 3-mm/5-second action threshold was used to trigger a gating event where the beam is paused and the couch position adjusted to realign the prostate to the treatment isocenter. To quantify the in vivo accuracy and precision, KIM was compared with simultaneously acquired kV/MV triangulation for 187 fractions.Results: KIM was successfully used in 197 of 200 fractions. Gating events occurred in 29 fractions (14.5%). In these 29 fractions, the percentage of beam-on time, the prostate displacement was >3 mm from the isocenter position, reduced from 73% without KIM to 24% with KIM-guided gating. Displacements >5 mm were reduced from 16% without KIM to 0% with KIM. The KIM accuracy was measured at <0.3 mm in all 3 dimensions. The KIM precision was <0.6 mm in all 3 dimensions.Conclusions: Clinical implementation of real-time KIM image guidance combined with gating for prostate cancer eliminates large prostate displacements during treatment delivery. Both in vivo KIM accuracy and precision are well below 1 mm. [ABSTRACT FROM AUTHOR]

Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.Methods and Materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.Conclusions: Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT. [ABSTRACT FROM AUTHOR]

Background: Side effects of medications for opioid use disorder (MOUD) such as weight gain contribute to their stigma. Substantial evidence suggests that women have a more severe side effect profile to MOUD than men, and concerns about weight gain during treatment are prevalent. However, the few studies reporting sex differences in weight gain during treatment show conflicting results and are restricted to methadone. In addition, little is known about possible sex differences in weight gain to buprenorphine, which is the most commonly prescribed MOUD in the United States.Methods: To address these issues, we performed a systematic review and meta-analysis on the few studies reporting longitudinal data on sex differences in body mass index (BMI) gain during methadone treatment (Study 1). In a separate study, we also re-analyzed data from trial CTN-0030 of the National Institute on Drug Abuse Clinical Trial Network (NIDA CTN), which involved a 12-week buprenorphine treatment regimen (Study 2; n = 360; 209 Male, 151 Female).Results: For Study 1, across all papers reporting longitudinal data (k = 4, n = 362 OUD patients), there were BMI increases that ranged from 2.2 to 5.4 BMI after at least one year of methadone treatment, but there were no significant sex differences in BMI increases (Standardized Mean Difference, Female > Male = 0.352, SE =0.270; 95 % CI = [-0.18 0.88]; p = .193). Study 2 showed no significant differences in weight before and after 12 weeks of buprenorphine treatment nor did it show sex differences in weight change with treatment (β = 2.34, p = .511).Conclusion: These analyses corroborate evidence of weight gain with methadone treatment but did not observe a sex-based disparity in weight gain with methadone or buprenorphine treatment for OUD. [ABSTRACT FROM AUTHOR]

Since wrist-joint position affects finger muscle length and grip strength, we studied its biomechanical relevance in prolonged handwriting. We recruited participants from young adults, aged 18-24, and separated them into control (n=22) and in-pain (n=18) groups, based whether or not they experience pain while handwriting. The participants then performed a writing task for 30 min on a computerized system which measured their wrist-joint angle and documented their handwriting kinematics. The in-pain group perceived more soreness and had a less-extended wrist joint, longer on-paper time, and slower stroke velocity compared to control group. There was no significant difference in handwriting speed and quality between the two groups. The wrist extension angle significantly correlated with perceived soreness. Ergonomic and biomechanical analyses provide important information about the handwriting process. Knowledge of pen tip movement kinematics and wrist-joint position can help occupational therapists plan treatment for individuals with handwriting induced pain. [ABSTRACT FROM AUTHOR]

Abstract: Valid criteria to identify young people who are believed to be at ultra high risk (UHR) of developing a psychotic episode were developed over the last decade. The first randomized controlled trial of treatment in a UHR cohort indicated that specific pharmacotherapy and psychotherapy delayed onset of disorder, and possibly reduced incidence. This paper reports results of follow-up of that trial. 41 of the 59 (69.5%) participants in the original study agreed to follow-up. No differences were found in transition rate, level of symptomatology or functioning between participants who received a combination of psychological treatment and anti-psychotic medication compared to those who received supportive therapy alone. A significant proportion of both treatment groups reported moderate levels of psychiatric morbidity and a continuing need and desire for care at this follow-up. Low levels of hospitalisation were noted for those who did progress to psychosis. Conclusions that can be drawn from this exploratory study are limited by the relatively small number of participants in the original study and the failure to follow-up the entire cohort. Although participants may have been treated too briefly to result in enduring positive effects, there appear to have been some cost savings in inpatient mental health treatment required after the end of the trial for individuals in both treatment groups who developed psychosis. [Copyright &y& Elsevier]

Head and neck cancer is the fifth most common cancer in the United States, with an overall survival rate of approximately 40-50%. In an effort to improve patient outcomes, research efforts designed to maximize benefit and reduce toxicities of therapy are in progress. Basic research in cancer biology has accelerated this endeavor and provided preclinical data and technology to support clinically relevant advances in early detection, prognostic and predictive biomarkers. Recent completion of the Human Genome Project has promoted the rapid development of novel "omics" technologies that allow more broad based study from a systems biology perspective. However, clinically relevant application of resultant gene signatures to clinical trials within cooperative groups has advanced slowly. In light of the large numbers of variables intrinsic to biomarker studies, validation of preliminary data for clinical implementation presents a significant challenge and may only be realized with large trials that involve significant patient numbers. The Radiation Therapy Oncology Group (RTOG) Head and Neck Cancer Translational Research Program recognizes this problem and brings together three unique features to facilitate this research: (1) availability of large numbers of clinical specimens from homogeneously treated patients through multi-institutional clinical trials; (2) a team of physicians, scientists, and staff focused on patient-oriented head-and-neck cancer research with the common goal of improving cancer care; and (3) a funding mechanism through the RTOG Seed Grant Program. In this position paper we outline strategic plans to further promote translational research within the framework of the RTOG. [ABSTRACT FROM AUTHOR]

Abstract: Approximately 50% of African American (AA) smokers are light smokers (smoke ≤10 cigarettes a day), yet this group is understudied despite being at-risk of smoking-related death and disease. This study is a secondary analysis of data from a clinical trial that assessed the efficacy of nicotine gum and counseling for smoking cessation among African American light smokers. The purpose of the current paper was to assess nicotine dependence among participants enrolled in the clinical trial using three measures of nicotine dependence. The Cigarette Dependence Scale (CDS), the Fagerstrom Test for Nicotine Dependence Scale (FTND), and the Nicotine Dependence Syndrome Scale (NDSS) were administered to 700 participants (67% female; mean age=45 years). Exhaled carbon monoxide (CO) and serum cotinine were assessed. The CDS showed the strongest association with biochemical markers (r =0.28 for cotinine and 0.25 for CO). Factor analysis of the NDSS revealed five factors: drive, priority, tolerance, continuity, and stereotypy. Compared to those who smoked 1–5 CPD, smokers who averaged 6–10 CPD scored higher on all three dependence (p <0.001) and two biochemical measures (p <0.001), and on three of the five NDSS subscales (Drive, p <0.001; Stereotypy, p <0.01; and Tolerance, p <0.01). Given the different domains tapped by each instrument, the use of multiple measures might yield the most comprehensive assessment of nicotine dependence. Results suggest the validity of these scales for African American light smokers and point to the need for sensitivity to differential levels of nicotine dependence among subgroups of light smokers. [Copyright &y& Elsevier]

Rationale and Objectives: Automatic lung segmentation in volumetric computed tomography (CT) images has been extensively investigated, and several methods have been proposed. Most methods distinguish the lung parenchyma from the surrounding anatomy based on the difference in CT attenuation values. This leads to an irregular and inconsistent lung boundary for the regions near the mediastinum, which can cause inconsistent boundaries both across subjects and within subjects scanned at different intervals of time. Processes like lung image registration and lung atlas construction can be affected by such inconsistencies. Therefore there is a need for a more consistent lung surface near the mediastinum.Materials and Methods: This paper presents a fully automatic method for the three-dimensional smoothing of the lung boundary using information from the segmented human airway tree. First, using the segmented airway tree, we define a bounding box around the mediastinum for each lung, within which all operations are performed. We then define all generations of the airway tree distal to the right and left main stem bronchi to be part of the respective lungs and exclude all other segments. Finally, we perform a fast morphological closing with an ellipsoidal kernel to smooth the surface of the lung.Results: This method has been tested by processing the segmented lungs from eight normal datasets. The mean value of the magnitude of curvedness of the lung contours, averaged over all the datasets, is 0.13 postsmoothing, compared with 4.91 before smoothing. The accuracy of the lung contours after smoothing is assessed by comparing the automatic results to manually traced smooth lung borders by a human analyst. Averaged over all volumes, the root mean square difference between human and computer borders is 0.8691 mm after smoothing, compared with 1.3012 mm before smoothing. The mean similarity index, which is an area overlap measure based on the kappa statistic, is 0.9958 (SD 0.0032), after smoothing.Conclusions: We have described a novel scheme for smoothing the lung contour around the mediastinum. The method is based on using anatomic information from the segmented airway tree. The validation results show that there is good agreement between manual and computer results. Because there are no accepted criteria for defining the lung boundary near the mediastinum, we believe our method of defining the boundary based on the structure of the airway tree provides a good basis for three-dimensional smoothing. [ABSTRACT FROM AUTHOR]

Aim: This paper evaluates the effect of the adjunct of the hydrosoluble fiber glucomannan to a Step-One-Diet in 40 plasma hypercholesterolemic children, during a randomized controlled trial, to reduce plasma cholesterol.Methods: All the subjects recruited underwent an 8-week run in diet period; a Step-One-Diet was prescribed. After that, they were randomly allocated to one of two groups: Step-One-Diet only (control), and Step-One-Diet plus glucomannan in gelatine capsules. After another 8 weeks of treatment, the results were compared within and between the two groups.Results: Glucomannan treated group showed decreased values in plasma total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) vs. control group after 8 weeks of treatment. The percentage decrease showed a statistically significant difference between sex groups. Decreases were observed in favor of female vs. male children in TC (24% vs. 9%) and LDL-C (30% vs. 9%).Conclusions: These results suggest that glucomannan may represent a rationale adjunct to diet therapy in primary prevention in high risk hypercholesterolemic children. [ABSTRACT FROM AUTHOR]

Objectives. Recently, new products have been introduced to repair composite restorations that may be used as ‘one-step’ primers or monomers and silane compounds which are used separately as ‘multi-step’ primers. The aim of this study was to compare the shear bond strength of the new composite resin to aged composite, by using different adhesion primers.Methods. The substrates were particulate filler composite (Z250, 3M-ESPE), which was aged by boiling for 8 h and storing at 37 °C in water for 3 weeks. The aged substrate surfaces were wet-ground flat with 320-grit silicon carbide paper and subjected randomly (n=8) to either one-step adhesion primer: Compoconnect (CC) (Heraus Kulzer), or multi-step: Clearfil Repair (CF) (Kuraray) or an intermediate resin: Scothchbond Multi-purpose adhesive resin (3M-ESPE) according to the manufacturers'' recommendations. Specimens with no surface treatment were used as control (C). New composite resin (Z250) was added to the substrate using 2 mm layer increments and light cured. The specimens were either water stored for 48 h or water stored for 24 h and then thermocycled for 6000 cycles. The shear bond strengths were measured with a crosshead speed of 1.0 mm/min using a universal testing machine. Data were analysed by two-way ANOVA and Tukey''s post-hoc tests (p=0.05).Results. All surface treatment methods showed significant difference compared to control (p<0.05). CF showed higher bond strength than CC and MP (p<0.05). Storage condition did not show a significant difference (p>0.05) in bond strength values.Conclusion. It was concluded that multi-step adhesion primer yielded higher bond strength compared to one-step primer or intermediate resin. [Copyright &y& Elsevier]

Clinical trials for the treatment of schizophrenia now often include cognitive assessments in addition to clinical ratings of symptoms. Recently, these trials have included cross-national assessments. It is not clear if translated psychological tests produce consistent results across different languages. This paper presents the results of a study of the comparability of the results of cognitive assessments in different English-speaking countries and a number of countries where tests were translated into other languages. Performance on tests of executive functioning, verbal and visuo-spatial learning and memory, language skills, psychomotor speed, and vigilance was compared across the first episode patients with schizophrenia (n=301) assessed in six different languages (English, French, Finnish, German, Hebrew, and Afrikaans), including two different countries where patients were assessed in English and other languages: Canada (French) and South Africa (Afrikaans). The variance in performance across the sites tested in English was as large as the variance between English and non-English speakers when all tests were considered. Performance differences across English and other languages were found only for executive functions, vigilance, and psychomotor speed, with executive functioning differences nonsignificant when education was considered. No differences were found between English and non-English speakers in Canada. These results suggest that the translation of tests of memory and verbal skills can lead to consistent results across translated versions of the tests. Differences between countries were greater than differences between languages, suggesting the need to consider representativeness of patient samples in terms of local educational attainment. In general, these data support the validity of cross-national neuropsychological assessments. [Copyright &y& Elsevier]

Vulnerability–stress models suggest that training in specific stress management techniques should yield benefits to those suffering from schizophrenia and related disorders. In this paper, we describe an evaluation of the impact of adding a stress management program to other medical and psychosocial interventions for such patients. Outcomes were compared for 121 patients randomly assigned to receive either a 12-week stress management program with follow-up sessions or participation in a social activities group. The two treatment conditions did not differ in levels of symptoms, perceived stress or life skills immediately after completion of treatment or at 1-year follow-up. Patients who received the stress management program did have fewer hospital admissions in the year following treatment. This effect of stress management was most apparent for those who showed high levels of attendance for treatment sessions. It was concluded that training in stress management may provide patients with skills for coping with acute stressors and reduce the likelihood of subsequent acute exacerbation of symptoms with need for hospitalization. [Copyright &y& Elsevier]

Los Angeles County established its first drug court program in 1994 in response to escalating criminal activity associated with substance abuse and overcrowded jails. This paper describes results of an evaluation of 803 drug court participants admitted to the program between 1994 and 1997. Of all drug court participants, 76% remained free of any new arrests throughout the one-year followup period, compared to 63% of participants in a drug diversion education program and 49% of the felony defendants not exposed to either program. Of offenders completing the drug court program 80% had no arrests, compared to 67% for non-completers. Drug related re-arrests were significantly lower among drug court graduates (13%) than offenders with no program participation (30%). The study results suggest that drug court participation and graduation decrease the likelihood of repeated arrests, including drug-related arrests. Drug courts represent a promising collaboration between criminal justice and public health agencies. [ABSTRACT FROM AUTHOR]

Drivers' non-compliance with rules is a prominent factor in collisions with trains at railway level crossings. Road user impatience and frustration has been identified as an underlying factor in non-compliance and can be characterised as a specific risk factor. However, research on non-compliance related to waiting times and driver inconvenience lacks in the literature. This paper, therefore, seeks to enhance the currently limited understanding of the relationship between waiting times and risky driver behaviour. An Advanced Driving Simulator was used to obtain objective measures of level crossing non-compliance. Subjective measures on driver frustration and decision-making processes were also collected. Sixty participants completed six driving tasks each, with the tasks varying in terms of traffic conditions, number of trains and associated waiting times. This study shows that increased waiting times result in higher levels of frustration and an increased likelihood of risky driving behaviour, particularly for waiting times longer than 3 min. Non-compliance included entering the activated crossing before boom gates are down, entering the crossing after the train passage but before signals are deactivated, stopping/reversing on the crossing. Subjective data revealed that participants did not comply with level crossing rules due to factors including time pressure, impatience/frustration and low perceived risk. The results suggest that, where possible, waiting times should be standardised at values lower than 3 min to reduce the likelihood of risky road user behaviour. [ABSTRACT FROM AUTHOR]

The Shandong Intervention Trial was a factorial, double-blind, placebo-controlled trial to determine whether any of 3 interventions, alone or in combination, could reduce the prevalence of precancerous gastric lesions in Linqu County, Shandong Province, China, a region with high gastric cancer mortality rates and a prevalence in adults of Helicobacter pylori of approximately 67%. The 3 interventions were one-time treatment with amoxicillin and omeprazole for Helicobacter pylori infection, and long-term administration of a garlic supplement (aged garlic extract and steam-distilled garlic oil) and a vitamin supplement (vitamins E and C and selenium). This paper describes the design and initial findings on treatment compliance, completeness of follow-up data, and eradication of Helicobacter pylori. [ABSTRACT FROM AUTHOR]

Aims: Both retroperitoneal pelvic packing and primary angioembolization are widely used to control haemorrhage related to pelvic fractures. It is still unknown which protocol is the safest. The primary aim of this study is to compare survival and complications of pelvic packing and angioembolization in massive haemorrhage related to pelvic fractures.Methods: Patients with haemodynamically unstable pelvic fractures were quasi-randomized to either pelvic packing (PACK) or angiography (ANGIO) using the time of admission as separator. Physiological markers of haemorrhage, time to intervention, procedure/surgical time, transfusion requirements, complications and early mortality were recorded and analyzed.Results: 29 patients were randomized to PACK and 27 patients to ANGIO. The Injury Severity Score (ISS) in the ANGIO group was lower than in the PACK group (43 ± 7 vs 48 ± 6) (p<0.01). The median time from admission to angiography for the ANGIO group was 102 min (range 76-214), and longer than 77 min (range 43-125) from admission to surgery for the PACK group (p<0.01). The procedure time for the ANGIO group was 84 min (range 62-105); while the surgical time was 60 min (range 41-92) for the PACK group (p<0.001). The ANGIO group received 6.4 units packed red blood cells (range 4-10) in the first 24h after angiography. The PACK group required 5.2 units (range 3-10) in the first 24h after leaving the operating theatre (p=0.124). 9 patients in the ANGIO group underwent pelvic packing for persistent bleeding. 6 patients in the PACK group required pelvic angiography after pelvic packing for ongoing hypotension following packing (p=0.353). 5 patients in the ANGIO group died (2 from exsanguination), while 4 in the PACK group died (none from exsanguination) (p=0.449). Complications occurred without differences in both groups.Conclusions: Compared with angioembolization, pelvic packing has shorter time to intervention and surgical time. Thus pelvic packing is the more rapid treatment of severe pelvic trauma than pelvic angioembolization. It is suitable for patients with haemodynamic instability at centers where the interventional radiology staff is not in-house at all times.Registration: ClinicalTrials.gov (NCT02535624) and ISRCTN registry (ISRCTN91713422). [ABSTRACT FROM AUTHOR]