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Background: Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults.Methods: This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12.Discussion: The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults.Trial Registration: The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016. [ABSTRACT FROM AUTHOR]

Background: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.Methods: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.Results: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.Conclusion: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. [ABSTRACT FROM AUTHOR]

Objectives: A prospective parallel cohort trial was conducted to compare outcomes of patients treated with maxillary protraction vs LeFort 1 maxillary advancement surgery.Setting and Sample Population: The primary site for the clinical trial is Children's Hospital Los Angeles; the satellite test site is Seattle Children's Hospital. All patients have isolated cleft lip and palate and a skeletal Class III malocclusion.Material and Methods: A total of 50 patients, ages 11-14, will be recruited for the maxillary protraction cohort. The maxillary surgery cohort consists of 50 patients, ages 16-21, who will undergo LeFort 1 maxillary advancement surgery. Patients with additional medical or cognitive handicaps were excluded from the study.Results: Current recruitment of patients is on track to complete the study within the proposed recruitment period.Conclusion: This observational trial is collecting information that will examine dental, skeletal, financial and quality-of-life issues from both research cohorts. [ABSTRACT FROM AUTHOR]

Introduction:  The use of interventional radiology (IR) in the treatment of pediatric solid tumors has markedly increased over the last three decades. However, data on effectiveness of IR-techniques, such as embolization/ablation, are scarce. In this systematic review and meta-analysis, we examined the outcomes of IR-procedures in the treatment of solid tumors in children.Materials and Methods:  Using a defined search strategy, we searched for studies reporting the use of IR-techniques for pediatric solid tumors from 1980 to 2017. Reports with less than three patients, review, and opinion articles were excluded. The study was conducted under preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. We analyzed dichotomous and continuous variables by appropriate statistical methods.Results:  Of 567 articles screened, 21 papers met the inclusion criteria (12 retrospective, 7 prospective, and 2 randomized-control trials). Many of the analyzed papers described relatively small cohorts of patients. IR-guided procedures were mainly rescue procedures to treat primarily unresectable tumors, local recurrences, or metastases. Inclusion/exclusion criteria and success definition were not specified in most reports. Major side effects were documented in 17/286 (6%) infants, while minor side effects were self-limiting in most patients. Six studies had a comparison between tumor embolization (127 infants) to surgery or chemotherapy without IR-procedures (113 controls). The meta-analysis showed lower mortality (16 vs. 47%) and surgical time for resection (206 vs. 250 m), higher 2-year tumor-free survival (82 vs. 36%), and favorable histology in IR group (p < 0.001 for all).Conclusion:  IR-guided techniques are promising in the treatment of pediatric solid tumors. Further prospective (randomized) trials are needed to clarify efficacy. [ABSTRACT FROM AUTHOR]

Objective: To determine possible changes in outcome from acute respiratory distress syndrome (ARDS) and to compare severity of lung injury and methods of treatment from 1967 to 1994.Data Sources: Computerized (Medline, Current Contents) and manual (Cumulated Index Medicus) literature search using the key word and/or title ARDS.Study Selection: Only clinical studies published as full papers reporting data on both patient mortality (survival) and oxygenation index (PaO2/FIO2) were included. Single case reports, abstracts, reviews and editorials were excluded from evaluation.Data Extraction: Relevant data were extracted in duplicate, followed by quality checks on approximately 80% of data extracted.Data Synthesis: 101 papers reporting on 3264 patients were included: 48 studies (2207 patients) were performed in the USA, 43 studies (742 patients) in Europe and 10 studies (315 patients) elsewhere. Mortality reported in these studies was 53 +/- 22% (mean +/- SD), with no apparent trend towards a higher survival (1994: 22 studies, mortality 51 +/- 19%). The mean PaO2/FIO2 ratio remained unchanged throughout the observation period (118 +/- 47 mmHg). No correlation could be established between outcome and PaO2/FIO2 or lung injury score. Patients who underwent pressure-limited ventilation had a significantly lower mortality (35 +/- 20%) than patients on volume-cycled ventilation (54 +/- 22%) or patients for whom there was no precise information on ventilatory support (59 +/- 19%). Significantly lower PaO2/FIO2 ratios (61 +/- 17 mmHg) were observed in patients prior to extracorporeal lung assist, together with mortality rates in the range of those for conventionally treated patients (55 +/- 22%).Conclusions: The mortality of ARDS patients remained constant throughout the period studied. Therefore, the standard for outcome in ARDS should be a mortality in the 50% range. Neither PaO2/FIO2 ratio nor lung injury score was a reliable predictor for outcome in ARDS. Patients might benefit from pressure-limited ventilatory support, as well as extracorporeal lung assist. Since crucial data were missing in most clinical studies, thus preventing direct comparison, we emphasize the importance of using standardized definitions and study entry criteria. [ABSTRACT FROM AUTHOR]

Purpose: Postmicturition dribbling (PMD) is a stressful symptom in middle-aged men characterized by urinary leakage after the completion of normal voiding. Appropriate treatments have not yet been introduced. This study assessed the efficacy of treatment of PMD with 75 mg udenafil daily.Materials and Methods: The study included 138 men with regular sexual lifestyles. The Hallym PMD questionnaire (HPMDQ) was used to assess PMD symptoms. After all basic examinations, patients were randomly assigned to either udenafil or placebo. Patients completed the surveys, uroflowmetry (UFM), a bladder scan, and the paper test during the follow-up visit.Results: The mean age of the patients was 57.6 years. PMD with one of every three urinations was experienced by 59 patients (42.8%), whereas 45 patients (32.6%) experienced PMD with two of every three urinations. PMD with every urination was experienced by 34 patients (24.6%). More than half of the patients (89 patients, 65.4%) indicated that persistent PMD symptoms would likely result in moderate to severe discomfort in their daily activities. As time passed, the udenafil group showed significant improvement in PMD symptoms (p = 0.001).Conclusion: Udenafil 75 mg once daily can be an effective treatment for patients with PMD symptoms. [ABSTRACT FROM AUTHOR]

Objective: To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.Methods: A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer.Results: Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001).Conclusions: Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. [ABSTRACT FROM AUTHOR]

Propensity score methods are commonly used in statistical analyses of observational data to reduce the impact of confounding bias in estimations of average treatment effect. While the propensity score is defined as the conditional probability of a subject being in the treatment group given that subject's covariates, the most precise estimation of average treatment effect results from specifying the propensity score as a function of true confounders and predictors only. This property has been demonstrated via simulation in multiple prior research articles. However, we have seen no theoretical explanation as to why this should be so. This paper provides that theoretical proof. Furthermore, this paper presents a method for performing the necessary variable selection by means of elastic net regression, and then estimating the propensity scores so as to obtain optimal estimates of average treatment effect. The proposed method is compared against two other recently introduced methods, outcome-adaptive lasso and covariate balancing propensity score. Extensive simulation analyses are employed to determine the circumstances under which each method appears most effective. We applied the proposed methods to examine the effect of pre-cardiac surgery coagulation indicator on mortality based on a linked dataset from a retrospective review of 1390 patient medical records at Jewish Hospital (Louisville, KY) with the Society of Thoracic Surgeons database. [ABSTRACT FROM AUTHOR]

Background: Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial.Methods: This paper reports on process evaluation. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved.Results: Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up.Conclusion: Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool.Trial Registration: Clinical Trials.gov , NCT03328247 . Registered on 1 November 2017. [ABSTRACT FROM AUTHOR]

Purpose: Age, sex, and type of fracture have traditionally been described as prognostic factors for proximal humeral fractures (PHFs). Some non-medical patient-related factors may play a role in the outcome. This paper evaluates the association of comorbidities and socioeconomic factors with clinical outcomes for PHF.Methods: A total of 217 patients with PHF were evaluated according to Neer's classification with X-ray. Comorbidities were assessed through the Charlson comorbidity index and, non-medical patient-related factors were determined with a 52-item questionnaire concerning personal behaviors such as social activities, family support, economic solvency, and leisure-time activities. The clinical outcome was assessed with the Constant-Murley Score (CMS), with a minimum 1-year follow-up. The minimal clinically relevant difference for the CMS was set at 10 points. A multivariable analysis was performed to adjust for comorbidities and non-medical patient-related factors, such as age, sex, fracture classification, and treatment.Results: One hundred and eighty-three patients completed the initial research protocol, while 126 of them completed the 1-year follow-up. The mean age was 71.6 years (SD ± 13.3), and 79.3% of the patients were women. In the bivariable analysis, age and comorbidities were correlated with the CMS (correlation coefficient: - 0.34 [- 0.49, 0.17] and 0.35 [0.18, 0.50], respectively), as well as non-medical patient-related factors and the fracture pattern (p value ANOVA < 0.001). In the multivariable regression model, the effects of considering oneself socially active, without economic problems, and self-sufficient were associated with a higher CMS than the effect of the fracture pattern (beta coefficient: 11.69 [6.09-17.30], 15.54 [8.32-22.75], and 10.61 [3.34-17.88], respectively).Conclusion: Socioeconomic status had a higher impact on functional outcomes than fracture pattern in patients with PHF. [ABSTRACT FROM AUTHOR]

Background: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia.Methods: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age.Results: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control.Conclusion: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation.Trial Registration: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009. [ABSTRACT FROM AUTHOR]

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]

Background: Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required.Results: Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified.Conclusions: Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article. [ABSTRACT FROM AUTHOR]

Background: Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown.Methods/design: The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36-mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan.Discussion: We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.Trial Registration: ClinicalTrials.gov NCT03677037 . Registered on 19 September 2018. [ABSTRACT FROM AUTHOR]

Aim: To evaluate an innovative paediatric neurorehabilitation model in relation to improving quality of neurorehabilitation and reducing length of stay (LOS) for children with acquired brain injury.Method: A process evaluation approach was conducted in line with Medical Research Council evaluation of complex interventions guidance. Analysis was conducted on routinely collected patient data from 2017 to 2018, including LOS and family feedback. Descriptive and inferential statistics were used for quantitative analysis and qualitative data was analysed thematically.Results: Outcomes for 70 children (0-16y, median age 5y, IQR 1-11y, 46 males, 24 females) referred to the service indicated improved function and reduced complexity of need. The mean LOS was 10.6 days compared to baseline mean LOS of 41 days (2011-2012). High satisfaction from the families was recorded; however, ongoing needs and service gaps regarding long-term support were identified.Interpretation: This service model is effective in delivering quality paediatric neurorehabilitation, demonstrating a sustained impact on LOS, and positive patient outcome data and family feedback for this group of patients. What this paper adds Investment in early intensive neurorehabilitation and supported discharge impacts length of stay (LOS) for children with acquired brain injury. Early intensive neurorehabilitation and supported discharge is effective. This is demonstrated by a sustained reduction in LOS, positive patient outcomes, and family feedback. [ABSTRACT FROM AUTHOR]

Purpose - Cognitive self-rehabilitation lacks updated means and tools. The purpose of this paper is to evaluate the effect of cognitively simulating mobile games on the cognitive skills and recreation of older people with memory impairment. Design/methodology/approach - Mobile games that require cognitive skills were developed. The games were tested by memory-impaired older adults, average age of 90. Gaming interventions took place for three months on a daily basis. Game outcomes were automatically recorded and user feedback was collected by interviews. The progress of the testees was also evaluated by means of Trial Making Test A. Findings - Improvement in game scores was found. Other significant effects of game play were enhanced recreation and self-managed activity level. Game play did not have any effect on the traditional Trail Making Test results but the results of the Trail Making game showed improvement. The Trail Making game also showed a large variance in daily scores, which implies that performing just a single Trail Making Test might lead to misreading a person's condition. Research limitations/implications - The results are an encouragement for conducting further testing (on a larger test group, over a longer time) and continuing with game development for cognitively impaired older adults. A similar game trial will also be arranged for a younger population with better overall health condition. Practical implications - New business opportunities are also possible in game development and gaming services. Social implications - Games have the potential for self-rehabilitation and to support extending independent living at home. Originality/value - The paper provides a synopsis of novel cognitive recreation tools, an analysis of their effect and user feedback from professional staff as well as potential new ideas for game developers. [ABSTRACT FROM AUTHOR]

Conventionally, pediatric patients with major burns need frozen cadaveric allografts to save their lives. However, these allografts are insufficient in many burn units because of cultural and local governmental laws in China. This paper reported 22 pediatric patients with major burns who received fresh scalp allografts from their parents, siblings, or relatives from January 2011 to December 2017. These 22 pediatric patients sustained deep partial-thickness to full-thickness burns involving 40% total body surface area (TBSA) on average. Wounds were covered with fresh scalp allografts alone or with postage stamp autografts and fresh scalp allografts post excision. Data were collected from medical files of the treated patients, including sex, age, etiology of burn injury, abbreviated burn severity index (ABSI), and TBSA. Postoperative variables included early survival rate of skin grafts, mean time to rejection, length of hospital stay (LHS), healing time of donor sites, and follow-up complications of donors. The 1-year survival rate of the 22 pediatric patients included into the study was 100%. The early survival rate of the scalp allografts was similar to the autografts. The mean time to rejection was 15.5 ± 3.60 days. The average LHS was 58 days. All donor sites healed within 7.6 days on average, without scar formation, alopecia areata, or folliculitis. Following up data of the donors revealed a full psychological sense of accomplishment and no regrets of donating the scalp to save the burned children. Therefore, the use of fresh scalp allografts is a feasible alternative to save pediatric patients with major burns when frozen allografts are unavailable. [ABSTRACT FROM AUTHOR]

There is a dearth of robust methods to estimate the causal effects of multiple treatments when the outcome is binary. This paper uses two unique sets of simulations to propose and evaluate the use of Bayesian additive regression trees in such settings. First, we compare Bayesian additive regression trees to several approaches that have been proposed for continuous outcomes, including inverse probability of treatment weighting, targeted maximum likelihood estimator, vector matching, and regression adjustment. Results suggest that under conditions of non-linearity and non-additivity of both the treatment assignment and outcome generating mechanisms, Bayesian additive regression trees, targeted maximum likelihood estimator, and inverse probability of treatment weighting using generalized boosted models provide better bias reduction and smaller root mean squared error. Bayesian additive regression trees and targeted maximum likelihood estimator provide more consistent 95% confidence interval coverage and better large-sample convergence property. Second, we supply Bayesian additive regression trees with a strategy to identify a common support region for retaining inferential units and for avoiding extrapolating over areas of the covariate space where common support does not exist. Bayesian additive regression trees retain more inferential units than the generalized propensity score-based strategy, and shows lower bias, compared to targeted maximum likelihood estimator or generalized boosted model, in a variety of scenarios differing by the degree of covariate overlap. A case study examining the effects of three surgical approaches for non-small cell lung cancer demonstrates the methods. [ABSTRACT FROM AUTHOR]

Constructing causal inference methods to handle longitudinal data in observational studies is of high interest. In an observational setting, treatment assignment at each clinical visit follows a decision strategy where the treating clinician selects treatment based on current and past clinical measurements as well as treatment histories. These time-dependent structures, coupled with inherent correlations between and within each visit, add on to the data complexity. Despite recent interest in Bayesian causal methods, only a limited literature has explored approaches to handle longitudinal data and no method handles repeatedly measured outcomes. In this paper, we extended two Bayesian approaches: Bayesian estimation of marginal structural models and two-stage Bayesian propensity score analysis to handle a repeatedly measured outcome. Our proposed methods permit causal estimation of treatment effects at each visit. Time-dependent inverse probability of treatment weights are obtained from the Markov chain Monte Carlo samples of the posterior treatment assignment model for each follow-up visit. We use a simulation study to validate and compare the proposed methods and illustrate our approaches through a study of intravenous immunoglobulin therapy in treating newly diagnosed juvenile dermatomyositis. [ABSTRACT FROM AUTHOR]

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When establishing an effective treatment with binary data in a two-stage design, one-sided tests for a proportion p are employed. Researchers use the parameter configuration at the boundary of the null hypothesis space to determine a rejection region and an optimal design. However, it is unclear whether the (maximum) Type I error rate is achieved at the boundary especially when the sample size in stage 2 varies. In this paper, we first prove that this is true for a large family of tests in adaptive two-stage designs by showing that any test in the family has a nondecreasing power in p and then derive optimal designs. Second, similar results are established for m-stage designs with m > 2. Supplementary materials for this article are available online. [ABSTRACT FROM AUTHOR]

Background: Though home-based human immunodeficiency virus (HIV) counseling and testing (HBHCT) is implemented in many sub-Saharan African countries as part of their HIV programs, linkage to HIV care remains a challenge. The purpose of this study is to test an intervention to enhance linkage to HIV care and improve HIV viral suppression among individuals testing HIV positive during HBHCT in rural Uganda.Methods: The PATH (Providing Access To HIV Care)/Ekkubo Study is a cluster-randomized controlled trial which compares the efficacy of an enhanced linkage to HIV care intervention vs. standard-of-care (paper-based referrals) at achieving individual and population-level HIV viral suppression, and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and antiretroviral therapy initiation following HBHCT. Approximately 600 men and women aged 18-59 who test HIV positive during district-wide HBHCT in rural Uganda will be enrolled in this study. Villages (clusters) are pair matched by population size and then randomly assigned to the intervention or standard-of-care arm. Study teams visit households and participants complete a baseline questionnaire, receive HIV counseling and testing, and have blood drawn for HIV viral load and CD4 testing. At baseline, standard-of-care arm participants receive referrals to HIV care including a paper-based referral and then receive their CD4 results via home visit 2 weeks later. Intervention arm participants receive an intervention counseling session at baseline, up to three follow-up counseling sessions at home, and a booster session at the HIV clinic if they present for care. These sessions each last approximately 30 min and consist of counseling to help clients: identify and reduce barriers to HIV care engagement, disclose their HIV status, identify a treatment supporter, and overcome HIV-related stigma through links to social support resources in the community. Participants in both arms complete interviewer-administered questionnaires at six and 12 months follow-up, HIV viral load and CD4 testing at 12 months follow-up, and allow access to their medical records.Discussion: The findings of this study can inform the integration of a potentially cost-effective approach to improving rates of linkage to care and HIV viral suppression in HBHCT. If effective, this intervention can improve treatment outcomes, reduce mortality, and through its effect on individual and population-level HIV viral load, and decrease HIV incidence.Trial Registration: NCT02545673. [ABSTRACT FROM AUTHOR]

Background: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.Methods and Design: This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.Discussion: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.Trial Registration: ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016. [ABSTRACT FROM AUTHOR]

Background: Despite strong evidence giving guidance for effective fall prevention interventions in community-residing older people, there is currently no clear model for engaging general medical practitioners in fall prevention and routine use of allied health professionals in fall prevention has been slow, limiting widespread dissemination. This protocol paper outlines an implementation-effectiveness study of the Integrated Solutions for Sustainable Fall Prevention (iSOLVE) intervention which has developed integrated processes and pathways to identify older people at risk of falls and engage a whole of primary care approach to fall prevention.Methods/design: This protocol paper presents the iSOLVE implementation processes and change strategies and outlines the study design of a blended type 2 hybrid design. The study consists of a two-arm cluster randomized controlled trial in 28 general practices and recruiting 560 patients in Sydney, Australia, to evaluate effectiveness of the iSOLVE intervention in changing general practitioner fall management practices and reducing patient falls and the cost effectiveness from a healthcare funder perspective. Secondary outcomes include change in medications known to increase fall risk. We will simultaneously conduct a multi-methodology evaluation to investigate the workability and utility of the implementation intervention. The implementation evaluation includes in-depth interviews and surveys with general practitioners and allied health professionals to explore acceptability and uptake of the intervention, the coherence of the proposed changes for those in the work setting, and how to facilitate the collective action needed to implement changes in practice; social network mapping will explore professional relationships and influences on referral patterns; and, a survey of GPs in the geographical intervention zone will test diffusion of evidence-based fall prevention practices. The project works in partnership with a primary care health network, state fall prevention leaders, and a community of practice of fall prevention advocates.Discussion: The design is aimed at providing clear direction for sustainability and informing decisions about generalization of the iSOLVE intervention processes and change strategies. While challenges exist in hybrid designs, there is a potential for significant outcomes as the iSOLVE pathways project brings together practice and research to collectively solve a major national problem with implications for policy service delivery.Trial Registration: Australian New Zealand Clinial Trials Registry ACTRN12615000401550. [ABSTRACT FROM AUTHOR]

Background: The efficacy of many cognitive behavioral component interventions has not been examined, with worry outcome monitoring among them.Methods: To address this issue, 51 participants with clinical levels of generalized anxiety disorder were randomly assigned to a treatment or control condition for 10 days. The treatment condition consisted of a brief ecological momentary intervention termed the Worry Outcome Journal (WOJ). WOJ participants recorded worries and tracked their outcomes, rating worry distress, interference, and expected outcome probabilities. Thought log (TL) control participants completed a record of their everyday thoughts and rated associated distress. All participants made four entries on paper each day when randomly prompted by text message. They then entered their paper contents online each night. After 30 days they reviewed their contents electronically and completed follow-up measures.Results: Primary results revealed significant reductions in worry for WOJ users compared to TL users at postintervention. A marginally significant difference was found at 20-day follow-up and treatment gains were maintained. Secondary analyses showed no harmful increases in worry beliefs for WOJ users, as well as preliminary evidence for decreases in beliefs about the uncontrollability of thoughts in both groups.Conclusion: The WOJ may be a viable therapist-independent treatment for reducing worry, even after only 10 days of use. [ABSTRACT FROM AUTHOR]

It has long been recognized that sample size calculations for cluster randomized trials require consideration of the correlation between multiple observations within the same cluster. When measurements are taken at anything other than a single point in time, these correlations depend not only on the cluster but also on the time separation between measurements and additionally, on whether different participants (cross-sectional designs) or the same participants (cohort designs) are repeatedly measured. This is particularly relevant in trials with multiple periods of measurement, such as the cluster cross-over and stepped-wedge designs, but also to some degree in parallel designs. Several papers describing sample size methodology for these designs have been published, but this methodology might not be accessible to all researchers. In this article we provide a tutorial on sample size calculation for cluster randomized designs with particular emphasis on designs with multiple periods of measurement and provide a web-based tool, the Shiny CRT Calculator, to allow researchers to easily conduct these sample size calculations. We consider both cross-sectional and cohort designs and allow for a variety of assumed within-cluster correlation structures. We consider cluster heterogeneity in treatment effects (for designs where treatment is crossed with cluster), as well as individually randomized group-treatment trials with differential clustering between arms, for example designs where clustering arises from interventions being delivered in groups. The calculator will compute power or precision, as a function of cluster size or number of clusters, for a wide variety of designs and correlation structures. We illustrate the methodology and the flexibility of the Shiny CRT Calculator using a range of examples. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the comparative outcome and cost of vascular plugs versus coils for internal iliac artery embolization prior to endovascular aortic aneurysm repair.Method: A search was performed for internal iliac artery embolization studies in adult patients from January 2005 to July 2018. Inclusion criteria included embolization of unilateral or bilateral IIAs with either coils or plug(s) prior to endovascular aortic repair. Meta-analysis was performed using a fixed effects model with the inverse variance-weighted average method to determine pooled differences in surgical time, fluoroscopy time, radiation exposure, number of devices used, cost of devices, and post-embolization buttock claudication. Heterogeneity was assessed using the Chi-square statistic. Pooled outcomes were compared, and quality assessments were evaluated using the Newcastle-Ottawa scale.Result: Six studies met inclusion criteria. One hundred and eighty-one patients were included in the study, of which 87 were in the plug group and 94 in the coil group. Vascular plug use led to 35.32 min shorter surgery time (p < 0.001), 15.64 min less fluoroscopy time (p < 0.001), 157,599 mGy/cm2 less radiation (p < 0.001), and 5.88 fewer occlusive devices (p < 0.001) than the use of coils alone. The estimated total cost of occlusion devices was $575.45 USD lower in the plug cohort (p < 0.001). The development of buttock claudication 12 months after EVAR was 11% less likely in the plug cohort but was not statistically significant (p = 0.71).Conclusion: The vascular plug appears to be superior to coils in embolization of the internal iliac artery due to shorter surgical time, fluoroscopy time, radiation exposure, and total cost of occlusive devices. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Child birth order (CBO) in the family has received little attention in the field of prevention science. CBO is relevant to early interventionists from a public health perspective, as the most widely disseminated home-visiting program has traditionally targeted mothers and their first-born children. The current paper revisits a previous publication by Shaw et al. (2009) on the effectiveness of the Family Check-Up (FCU) to evaluate CBO (firstborn vs. middle vs. youngest) as a moderator of treatment effects of the FCU in relation to improvements in parenting, maternal depressive symptoms, and child outcomes from ages 2 to 4 in a sample of low-income, ethnically diverse families (N = 709) with multiple children. Results suggest that the FCU elicited improvements in observed parenting from ages 2 to 3 primarily for target children who were the youngest or middle children, but not for firstborns. Findings are discussed in the context of implications for prevention science research, dissemination, and public policy. [ABSTRACT FROM AUTHOR]

Surrogate endpoints play an important role in drug development when they can be used to measure treatment effect early compared to the final clinical outcome and to predict clinical benefit or harm. Such endpoints are assessed for their predictive value of clinical benefit by investigating the surrogate relationship between treatment effects on the surrogate and final outcomes using meta-analytic methods. When surrogate relationships vary across treatment classes, such validation may fail due to limited data within each treatment class. In this paper, two alternative Bayesian meta-analytic methods are introduced which allow for borrowing of information from other treatment classes when exploring the surrogacy in a particular class. The first approach extends a standard model for the evaluation of surrogate endpoints to a hierarchical meta-analysis model assuming full exchangeability of surrogate relationships across all the treatment classes, thus facilitating borrowing of information across the classes. The second method is able to relax this assumption by allowing for partial exchangeability of surrogate relationships across treatment classes to avoid excessive borrowing of information from distinctly different classes. We carried out a simulation study to assess the proposed methods in nine data scenarios and compared them with subgroup analysis using the standard model within each treatment class. We also applied the methods to an illustrative example in colorectal cancer which led to obtaining the parameters describing the surrogate relationships with higher precision. [ABSTRACT FROM AUTHOR]

Background: Physiologic data that is automatically collected during anesthesia is widely used for medical record keeping and clinical research. These data contain artifacts, which are not relevant in clinical care, but may influence research results. The aim of this study was to explore the effect of different methods of filtering and processing artifacts in anesthesiology data on study findings in order to demonstrate the importance of proper artifact filtering.Methods: The authors performed a systematic literature search to identify artifact filtering methods. Subsequently, these methods were applied to the data of anesthesia procedures with invasive blood pressure monitoring. Different hypotension measures were calculated (i.e., presence, duration, maximum deviation below threshold, and area under threshold) across different definitions (i.e., thresholds for mean arterial pressure of 50, 60, 65, 70 mmHg). These were then used to estimate the association with postoperative myocardial injury.Results: After screening 3,585 papers, the authors included 38 papers that reported artifact filtering methods. The authors applied eight of these methods to the data of 2,988 anesthesia procedures. The occurrence of hypotension (defined with a threshold of 50 mmHg) varied from 24% with a median filter of seven measurements to 55% without an artifact filtering method, and between 76 and 90% with a threshold of 65 mmHg. Standardized odds ratios for presence of hypotension ranged from 1.16 (95% CI, 1.07 to 1.26) to 1.24 (1.14 to 1.34) when hypotension was defined with a threshold of 50 mmHg. Similar variations in standardized odds ratios were found when applying methods to other hypotension measures and definitions.Conclusions: The method of artifact filtering can have substantial effects on estimates of hypotension prevalence. The effect on the association between intraoperative hypotension and postoperative myocardial injury was relatively small. Nevertheless, the authors recommend that researchers carefully consider artifacts handling and report the methodology used. [ABSTRACT FROM AUTHOR]

Aim: To assess the responsiveness, concurrent validity, and feasibility of the Dyskinesia Impairment Scale (DIS) in non-ambulatory patients with dyskinetic cerebral palsy (CP).Method: The study is a secondary analysis of data collected in the IDYS trial, a randomized controlled trial on the effects of intrathecal baclofen (ITB). The DIS and Barry-Albright Dystonia Scale (BADS) were conducted at baseline and after 3 months of ITB or placebo treatment. Responsiveness was assessed by comparing the effect sizes and correlation of change after treatment between the DIS and BADS. Concurrent validity was evaluated by assessing the correlations between scales. Feasibility was evaluated for each DIS item by the number of participants who successfully accomplished the item.Results: Thirty-three non-ambulatory patients (9 females, 24 males) with dyskinetic CP (ITB-treated: n=17, mean [SD] age: 14y 1mo [4y 1mo]; placebo-treated: n=16, mean [SD] age: 14y 7mo [4y]) were included in the study. The effect sizes for BADS and DIS were similar in The ITB-treated group (-0.29 and -0.22 respectively). Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001). The DIS dystonia subscale and BADS correlated at baseline and follow-up (r=0.78; p<0.001 and r=0.79; p<0.001). Not all DIS activity items could be performed in this sample of patients.Interpretation: For non-ambulatory patients with dyskinetic CP, the responsiveness of the DIS equalled the responsiveness of BADS. Concurrent validity was adequate. Feasibility for activity items was restricted in patients with severe dyskinetic CP.What This Paper Adds: The Dyskinesia Impairment Scale (DIS) and Barry-Albright Dystonia Scale showed similar responsiveness in non-ambulatory patients with dyskinetic cerebral palsy (CP). No floor or ceiling effect was observed for DIS in non-ambulatory participants. The concurrent validity of DIS was adequate in non-ambulatory participants. Patients with dyskinetic CP in Gross Motor Function Classification System levels IV and V could not perform all DIS activity items. [ABSTRACT FROM AUTHOR]

Background: Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- and middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan.Methods: We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant's child.Discussion: The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12619001386123. Registered prospectively on 10/10/2019. [ABSTRACT FROM AUTHOR]

The problem of how to best select variables for confounding adjustment forms one of the key challenges in the evaluation of exposure or treatment effects in observational studies. Routine practice is often based on stepwise selection procedures that use hypothesis testing, change-in-estimate assessments or the lasso, which have all been criticised for - amongst other things - not giving sufficient priority to the selection of confounders. This has prompted vigorous recent activity in developing procedures that prioritise the selection of confounders, while preventing the selection of so-called instrumental variables that are associated with exposure, but not outcome (after adjustment for the exposure). A major drawback of all these procedures is that there is no finite sample size at which they are guaranteed to deliver treatment effect estimators and associated confidence intervals with adequate performance. This is the result of the estimator jumping back and forth between different selected models, and standard confidence intervals ignoring the resulting model selection uncertainty. In this paper, we will develop insight into this by evaluating the finite-sample distribution of the exposure effect estimator in linear regression, under a number of the aforementioned confounder selection procedures. We will show that by making clever use of propensity scores, a simple and generic solution is obtained in the context of generalized linear models, which overcomes this concern (under weaker conditions than competing proposals). Specifically, we propose to use separate regularized regressions for the outcome and propensity score models in order to construct a doubly robust 'g-estimator'; when these models are sufficiently sparse and correctly specified, standard confidence intervals for the g-estimator implicitly incorporate the uncertainty induced by the variable selection procedure. [ABSTRACT FROM AUTHOR]

Non-adherence to assigned treatment is a common issue in cluster randomised trials. In these settings, the efficacy estimand may also be of interest. Many methodological contributions in recent years have advocated using instrumental variables to identify and estimate the local average treatment effect. However, the clustered nature of randomisation in cluster randomised trials adds to the complexity of such analyses. In this paper, we show that the local average treatment effect can be estimated via two-stage least squares regression using cluster-level summaries of the outcome and treatment received under certain assumptions. We propose the use of baseline variables to adjust the cluster-level summaries before performing two-stage least squares in order to improve efficiency. Implementation needs to account for the reduced sample size, as well as the possible heteroscedasticity, to obtain valid inferences. Simulations are used to assess the performance of two-stage least squares of cluster-level summaries under cluster-level or individual-level non-adherence, with and without weighting and robust standard errors. The impact of adjusting for baseline covariates and of appropriate degrees of freedom correction for inference is also explored. The methods are then illustrated by re-analysing a cluster randomised trial carried out in a specific UK primary care setting. Two-stage least squares estimation using cluster-level summaries provides estimates with small to negligible bias and coverage close to nominal level, provided the appropriate small sample degrees of freedom correction and robust standard errors are used for inference. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate tolerability of and response to rituximab in children with myelin oligodendrocyte glycoprotein (MOG) antibody-positive relapsing neuroinflammatory disease. This was an observational study of prospectively collected data on 12 consecutive children (eight females, four males; median age at onset 10y 6mo [interquartile range {IQR} 7y 2mo-12y 5mo], median follow-up 2y 1mo [IQR 1y 7mo-2y 6mo]) with central nervous system inflammation and persistent serum MOG immunoglobulin G positivity more than 12 weeks after clinical presentation. Patients received a standardized rituximab treatment protocol. MOG antibody testing was performed following standardized cell-based methods. Median clinical follow-up after rituximab induction was 2 years (IQR 1y 7mo-2y 10mo). The relapse rate in the first 12 months posttreatment was 0 (IQR 0-0). After rituximab, two patients relapsed during B-cell suppression and four showed clinical or radiological disease recurrences at B-cell reconstitution. Mild-to-moderate infusion related adverse events occurred in two patients. Leukopenia developed in seven patients and serum immunoglobulin suppression in five patients with no significant age effect on the risk of their development. None developed severe life-threatening events. Rituximab-induced B-cell suppression was associated with absence of relapses in 10 patients who were MOG-positive with recurrent disease. Rituximab was well tolerated. The most frequent adverse effects were hypogammaglobulinemia and leukopenia. We recommend monitoring of complete blood counts and immunoglobulins in this population. WHAT THIS PAPER ADDS: Rituximab appears to control disease in most anti-myelin oligodendrocyte glycoprotein-positive patients with relapsing neuroinflammatory disease. Rituximab was associated with transitory, mild-to-moderate infusion-related effects. Half of patients treated with rituximab developed leukopenia or hypogammaglobulinemia. No opportunistic infections were observed. [ABSTRACT FROM AUTHOR]

Ordinal responses are common in clinical studies. Although the proportional odds model is a popular option for analyzing ordered-categorical data, it cannot control the type I error rate when the proportional odds assumption fails to hold. The latent Weibull model was recently shown to be a superior candidate for modeling ordinal data, with remarkably better performance than the latent normal model when the data are highly skewed. In clinical trials with ordinal responses, a balanced design is common, with equal sample allocation for each treatment. However, a more ethical approach is to adopt a response-adaptive allocation scheme in which more patients receive the better treatment. In this paper, we propose the use of the doubly adaptive biased coin design to generate treatment allocations that benefit the trial participants. The proposed treatment allocation scheme not only allows more patients to receive the better treatment, it also maintains compatible test power for the comparison of treatment efficiencies. A clinical example is used to illustrate the proposed procedure. [ABSTRACT FROM AUTHOR]

Background: Although robotic surgery is popular around the world, its safety and efficacy over classical open surgery is still controversial. The purpose of this article is to compare the safety and efficacy of robotic pancreaticoduodenectomy (RPD) and open pancreaticoduodenectomy (OPD).Methods: A literature search of PubMed, Web of Science, and the Cochrane Library database up to July 29, 2018 was performed and the meta-analysis was performed using RevMan 5.2 software with Fixed and random effects models applied. The IRB approval and written consent were not needed for this paper.Results: Twelve non-randomized retrospective studies and 1 non-randomized prospective study consisting of 2403 patients were included in this meta-analysis. There were 788 (33%) patients in the RPD group and 1615 (67%) patients in the OPD group. Although RPD was associated with a longer operative time (weighted mean difference [WMD]: 71.74 min; 95% CI 23.37-120.12; p = 0.004), patient might benefit from less blood loss (WMD: - 374.03 ml; 95% CI - 506.84 to - 241.21; p < 0.00001), shorter length of stay (WMD: - 5.19 day; 95% CI - 8.42 to - 1.97; p = 0.002), and lower wound infection rate (odds ratio: 0.17; 95% CI 0.04-0.80; p = 0.02). No statistically significant difference was observed in positive margin rate, lymph nodes harvested, postoperative complications, reoperation or readmission rate, and mortality rate.Conclusions: Robotic pancreaticoduodenectomy is a safe and feasible alternative to open pancreaticoduodenectomy with regard to short-term outcomes. Further studies on the long-term outcomes of these surgical techniques are needed. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Young people account for more than a quarter of new HIV infections in the US, with the majority of cases among young men who have sex with men; young transgender women are also vulnerable to infection. Substance use, particularly alcohol misuse, is a driver of sexual transmission and a potential barrier to engagement in the HIV prevention and care continuum, however vulnerable youth are difficult to reach for substance use services due, in part, to complex social and structural factors and limited access to health care. The Community Prevention Services Task Force recommends electronic screening and brief intervention as an evidence-based intervention for the prevention of excessive alcohol consumption; however, no prior studies have extended this model to community-based populations of youth that are susceptible to HIV infection. This paper describes the study protocol for an electronic screening and brief intervention to reduce alcohol misuse among adolescents and young adults vulnerable to HIV infection in community-based settings.Methods: This study, Step Up, Test Up, is a randomized controlled trial of an electronic alcohol screening and brief intervention among youth, ages 16-25, who are vulnerable to HIV infection. Individuals who present for HIV testing at one of three community-based locations are recruited for study participation. Eligibility includes those aged 16-25 years, HIV-negative or unknown HIV status, male or trans female with a history of sex with men, and English-speaking. Participants who screen at moderate to high risk for alcohol misuse on the Alcohol Use Disorders Identification Test (AUDIT) are randomized (1:1) to either an electronic brief intervention to reduce alcohol misuse or a time-and attention-matched control. The primary outcome is change in the frequency/quantity of recent alcohol use at 1, 3, 6 and 12-month follow-up.Discussion: Testing of evidence-based interventions to reduce alcohol misuse among youth vulnerable to HIV infection are needed. This study will provide evidence to determine feasibility and efficacy of a brief electronically-delivered intervention to reduce alcohol misuse for this population.Trial Registration: ClinicalTrials.gov number, NCT02703116, registered March 9, 2016. [ABSTRACT FROM AUTHOR]

Background: Prolonged grief disorder (PGD) is a new diagnosis in the 11th edition of the International Classification of Diseases, estimated to affect 1 in 10 bereaved people and causing significant distress and impairment. Maladaptive thoughts play an important role in PGD. We have previously validated the typical beliefs questionnaire (TBQ), which contains five kinds of thinking commonly seen in PGD: protesting the death, negative thoughts about the world, needing the person, less grief is wrong, and grieving too much. The current paper examines the role of maladaptive cognition as measured by the TBQ in PGD and its change with treatment.Methods: Among participants in a multisite clinical trial including 394 adults, we examined (a) the relationship between maladaptive thoughts at baseline and treatment outcomes, (b) the relationship between maladaptive thoughts and suicidality at baseline and posttreatment, and (c) the effect of treatment with and without complicated grief therapy (CGT) on maladaptive thinking.Results: TBQ scores were associated with treatment outcomes and were strongly related to suicidal thinking before and after treatment. TBQ scores showed significantly greater reduction in participants who received CGT with citalopram versus citalopram alone (adjusted mean standard error [SE] difference, -2.45 [0.85]; p = .004) and those who received CGT with placebo versus placebo alone (adjusted mean [SE] difference, -3.44 [0.90]; p < .001).Conclusions: Maladaptive thoughts, as measured by the TBQ, have clinical and research significance for PGD and its treatment. [ABSTRACT FROM AUTHOR]

Objective: The use of relative and absolute effect estimates has important implications for the interpretation of study findings. Likewise, examining additive and multiplicative interaction can lead to differing conclusions about the joint effects of two exposure variables. The aim of this paper is to examine the relationship between BMI and mortality on the relative and absolute scales and investigate interaction between BMI and age.Methods: Data from 68,132 participants in the Women's Health Initiative (WHI) study were used. The risk ratio and risk difference of BMI on mortality were estimated. A product term was also included to examine interaction between BMI and age on the multiplicative scale, and the relative excess risk of interaction was calculated to measure additive interaction.Results: Results demonstrated that the mortality risk ratio decreased as women aged, but the mortality risk difference increased as women aged. Evidence of additive and multiplicative interaction between age and BMI was found.Conclusions: In postmenopausal women, the relative mortality risk associated with high BMI decreased with increasing age, but the absolute risk of high BMI increased with increasing age. This indicates the importance of considering the interaction between age and BMI to understand mortality risk in older women. [ABSTRACT FROM AUTHOR]

The relative risk, risk difference, and odds ratio are three major indices of differences in risks of diseases between different groups. Although widely used in research and practice in biomedical and epidemiologic research, misconceptions are not uncommon about their relationships. Many publications offer contradicting advices in how to use them in studies. Some biomedical researchers believe that these indices are related in a monotone fashion, and, thus, changes in one direction in one of the indices can be interpreted as same directional changes in the other two. Misconceptions about these three indices such as the monotone relationship are so prevalent in the biomedical and epidemiologic research that clarifications of such popular beliefs are warranted. In this paper, we take a systematic approach to characterize the relationships among the indices. We develop key results to elucidate the intricate relationships between the indices. Our findings speak to the need for investigators to carefully consider the different indices before using them in their studies, since they are not interchangeable and results based on one index are generally not translatable into any of the others. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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Background: The incidence of a peri-implant soft tissue dehiscence/deficiency (PSTD) is not a rare finding. Despite multiple previous attempts aimed at correcting the PSTDs, a classification of these conditions has not yet been proposed. This lack in the literature may also lead to discrepancies in the reported treatment outcomes and thus misinform the clinician or the readers. The aim of the present article was therefore to present a classification of peri-implant PSTD at a single implant site.Methods: Four classes of PSTDs were discussed based on the position of the gingival margin of the implant-supported crown in relation to the homologous natural tooth. In addition, the bucco-lingual position of the implant head was also taken into consideration. Each class was further subdivided based on the height of the anatomical papillae.Results: Subsequently, for each respective category a surgical approach (including bilaminar techniques, the combined prosthetic-surgical approach or soft tissue augmentation with a submerged healing) was also suggested.Conclusion: This paper provides a new classification system for describing PSTDs at single implant sites, with the appropriate recommended treatment protocol. [ABSTRACT FROM AUTHOR]

The aim of this paper is to present our results and experience in the treatment of snoring using the non-ablative Erbium: Yttrium Aluminum Garnet (Er:YAG) laser. Twenty-four patients (18 male and 6 female) with snoring problems due to soft palate hypertrophy were treated with 3 treatment procedures with Er:YAG 2940-nm laser (long pulse mode, 10 Hz, fluence 1.8-2.0 J/cm2) performed at 2-week intervals. The treatment procedures were performed in outpatient settings. One treatment session lasts 15-20 min. Subjective (questionnaires) and objective (polygraph) outcome measures were assessed at baseline and 3 months after the final laser treatment. Wilcoxon Signed Rank was used to compare before and after scores. All polygraph variables showed some improvement 3 months after the end of treatment; however, only the reduction of the number of hypopnea episodes per hour was statistically significant (p = 0.034). In 13/24 patients, snoring time accounted for less than 5% of the sleep time after the treatment compared to 6/24 patients at baseline. The questionnaire survey showed statistically significant improvement in the quality of sleep and life of the patients as well as their partners after Er:YAG treatment (p < 0.001). The assessment of daytime sleepiness using the Epworth scale also improved 3 months after the end of treatment (p = 0.010). Based on our observations, the treatment of snoring with the Er:YAG laser is an effective and non-invasive therapeutic method. Further studies with long-term follow-up and a control group are warranted to confirm the promising results obtained in case series. [ABSTRACT FROM AUTHOR]

Background: We sought to determine whether subjective outcomes one or more years after antireflux surgery are affected by the operating surgeon.Methods: We reviewed records of patients who had antireflux surgery from June 2000 to June 2002 and mailed the patients a 19-item survey that focused on current medication use, postoperative symptom improvement, and satisfaction with surgery. We tested the significance of predictor variables using chi-squared and Fisher exact tests for categorical variables and analysis of variance for continuous variables.Results: We mailed the survey to 74 patients. Ninety-one percent of the operations were initially laparoscopic, with 5 (7%) subsequently converting to open. Ninety-five percent of patients were taking protein pump inhibitors (PPIs) preoperatively. Surgeons (n = 7) were divided into four groups, with the four surgeons who did two or fewer procedures in one group. Fifty-two of 74 patients (70%) responded to the survey (mean age, [SD] 44 [21] years, 37% male). The mean duration of followup was 2.1 [0.46] years. Thirty-eight percent of patients were taking medications for gastroesophageal reflux disease at the time of survey completion. It was found that the surgeon had an influence on patients' perceptions of the success of the surgery and whether having surgery was a good idea. We did not identify a statistically significant effect of the surgeon on preoperative symptom severity, postoperative ability to belch, dysphagia, medication use, and lifestyle.Conclusion: A patient's surgeon has an effect on satisfaction with antireflux surgery. Further research should clarify specific practices of the surgeon (patient selection, operative technique, followup) associated with best outcome. [ABSTRACT FROM AUTHOR]

Unlabelled: A strong link exists between gastroesophageal reflux disease (GERD) and airway diseases. Surgical therapy has been recommended as it is more effective than medical therapy in the short-term, but there is little data on the effectiveness of surgery long-term. We analyzed the long-term response of GERD-related airway disease after laparoscopic anti-reflux surgery (LARS).Methods: In 2004, we contacted 128 patients with airway symptoms and GERD who underwent laparoscopic antireflux surgery (LARS) between 12/1993 and 12/ 2002. At median follow-up of 53 months (19-110 mo) we studied the effects on symptoms, esophageal acid exposure, and medication use and we analyzed the data to determine predictors of successful resolution of airway symptoms.Results: Cough, hoarseness, wheezing, sore throat, and dyspnea improved in 65-75% of patients. Heartburn improved in 91% (105/116) of patients and regurgitation in 92% (90/98). The response rate for airway symptoms was the same in patients with and without heartburn. Almost every patient took proton pump inhibitors (PPIs) preoperatively (99%, 127/128) and 61% (n = 78) were taking double or triple dose. Postoperatively, 33% (n = 45) of patients were using daily antiacid therapy but no one was on double dose. The only factor that predicted a successful surgical outcome was the presence of abnormal reflux in the pharynx as determined by 24-hour pharyngeal pH monitoring. One hundred eleven (87%) patients rated their results as excellent (n = 78, 57%) or good (n = 33, 24%).Conclusion: LARS provides an effective and durable barrier to reflux, and in so doing improves GERD-related airway symptoms in approximately 70% of patients and improves typical GERD symptoms in approximately 90% of patients. Pharyngeal pH monitoring identifies those patients more likely to benefit from LARS, but better diagnostic tools are needed to improve the response of airway symptoms to that of typical esophageal symptoms. [ABSTRACT FROM AUTHOR]