Search

Objectives: To investigate whether intensified cooperation between general practitioner (GP), care manager and rehabilitation coordinator (RC) for patients sick-listed for stress-related mental disorder, combined with a person-centred dialogue meeting with employer, could reduce sick-leave days compared with usual care manager contact. Design: Pragmatic cluster-randomised controlled trial, randomisation at primary care centre (PCC) level. Setting: PCCs in Region Västra Götaland, Sweden, with care manager organisation. Participants: Of 30 invited PCCs, 28 (93%) accepted the invitation and recruited 258 patients newly sick-listed due to stress-related mental disorder (n = 142 intervention, n = 116 control PCCs). Intervention: Cooperation between GP, care manager and rehabilitation coordinator from start of illness notification plus a person-centred dialogue meeting between patient and employer within 3 months. Regular contact with care manager was continued at the control PCCs. Main outcome measures: 12-months net and gross number of sick-leave days. Secondary outcomes: Symptoms of stress, depression, anxiety; work ability and health related quality of life (EQ-5D) over 12 months. Results: There were no significant differences between intervention and control groups after 12 months: days on sick-leave (12-months net sick-leave days, intervention, mean = 110.7 days (95% confidence interval (CI) 82.6 − 138.8); control, mean = 99.1 days (95% CI 73.9 − 124.3)), stress, depression, or anxiety symptoms, work ability or EQ-5D. There were no significant differences between intervention and control groups concerning proportion on sick-leave after 3, 6, 12 months. At 3 months 64.8% were on sick-leave in intervention group vs 54.3% in control group; 6 months 38% vs 32.8%, and12 months 16.9% vs 15.5%. Conclusion: Increased cooperation at the PCC between GP, care manager and RC for stress-related mental disorder coupled with an early workplace contact in the form of a person-centred dialogue meeting does not reduce days of sick-leave or speed up rehabilitation. Trial registration: ClinicalTrials.gov Identifier: NCT03250026 CO-WORK-CARE First Posted: August 15, 2017. Recruitment of PCCs: September 2017. Inclusion of patients from December 2017 [ABSTRACT FROM AUTHOR]

Background and Aims: Anxiety is one of the most important issues in the dental environment for children. The aim of this study was to investigate the effect of music on the level of anxiety and cooperation of children during dental treatment. Materials and Methods: In this study 58 children aged 6 to 8 years were randomly divided into two groups: the intervention group (music played) and the control group (no music played). Children's anxiety was assessed using the Venham Picture Test and Frankel Behavior Rating Scale, and their heart rate was also measured. Results: The results showed that in the intervention group, the level of anxiety based on the Venham Picture Test and Frankel Behavior Rating Scale was significantly lower. Additionally, the heart rate of children in this group was lower during the treatment (P<0.05). Conclusion: Based on the findings of this study, the use of music as a non-pharmacological method can be beneficial in reducing anxiety and improving the cooperation of children in the dental environment. [ABSTRACT FROM AUTHOR]

The present study aimed to examine the effectiveness of a multi-component intervention on cooperative behaviors in children with autism spectrum disorder (ASD). In this study, three dyads comprising six boys aged between 4.5 and 7 years with ASD participated, following a randomized multiple baseline design. The participants were asked to construct models together using toy sets. The visual analysis and randomization test (p <.01) showed that the intervention increased cooperative behaviors for all six participants, and improvements were maintained after the intervention components were terminated. Four participants in two dyads demonstrated generalization to three new toy sets. For the remaining two participants, the interdependent group contingency was reintroduced in order for them to demonstrate cooperative behaviors. [ABSTRACT FROM AUTHOR]

Nutrition‐sensitive agriculture (NSA) interventions offer a means to improve the dietary quality of rural, undernourished populations. Their effectiveness could be further increased by understanding how household dynamics enable or inhibit the uptake of NSA behaviours. We used a convergent parallel mixed‐methods design to describe the links between household dynamics—specifically intrahousehold power inequalities and intrahousehold cooperation—and dietary quality and to explore whether household dynamics mediated or modified the effects of NSA interventions tested in a cluster‐randomized trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN). We use quantitative data from cross‐sectional surveys in 148 village clusters at UPAVAN's baseline and 32 months afterwards (endline), and qualitative data from family case studies and focus group discussions with intervention participants and facilitators. We found that households cooperated to grow and buy nutritious foods, and gendered power inequalities were associated with women's dietary quality, but cooperation and women's use of power was inhibited by several interlinked factors. UPAVAN interventions were more successful in more supportive, cooperative households, and in some cases, the interventions increased women's decision‐making power. However, women's decisions to enter into negotiations with family members depended on whether women deemed the practices promoted by UPAVAN interventions to be feasible, as well as women's confidence and previous cultivation success. We conclude that interventions may be more effective if they can elicit cooperation from the whole household. This will require a move towards more family‐centric intervention models that empower women while involving other family members and accounting for the varied ways that families cooperate and negotiate. Key messages: Household cooperation and intrahousehold power inequalities may influence children's and mothers' dietary diversity in rural OdishaThese factors partly determine the effects of nutrition‐sensitive agriculture (NSA) interventions tested in Upscaling Participatory Action and Videos for Agriculture and Nutrition, indicating that NSA interventions may be more effective if they include multiple family members.There is wide heterogeneity in household dynamics and the constraints that families face. Further research is needed to identify how interventions can respond to this heterogeneity so that NSA interventions are effective in an inclusive and empowering way. [ABSTRACT FROM AUTHOR]

Copyright of Kinesiologia Slovenica is the property of Faculty of Sport 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.)

A team's cognitions of interpersonally coordinated actions are a crucial component for successful team performance. Here, we present an approach to practice team action by way of imagery and examine its impact on team cognitions in long-term memory. We investigated the impact of a 4-week team action imagery intervention on futsal players' mental representations of team-level tactics. Skilled futsal players were assigned to either an imagery training group or a no imagery training control group. Participants in the imagery training group practiced four team-level tactics by imagining team actions in specific game situations for three times a week. Results revealed that the imagery training group's representations were more similar to that of an expert representation after the intervention compared with the control group. This study indicates that team action imagery training can have a significant impact on players' tactical skill representations and thus order formation in long-term memory. [ABSTRACT FROM AUTHOR]

Statement of the Problem: Pharmacologic management of uncooperative behavior is a growing trend in dentistry. Determining the most appropriate drug, route of administration, and proper candidate for sedation have been the goal of several investigations. Purpose: The aim of this study was to compare the sedative effect of intranasal (IN) sedation of midazolam (MDZ) in compare to dexmedetomidine (DEX) while taking into consideration the effect of dental fear, and psychological status on sedation success. Materials and Method: This double-blind randomized clinical trial included 92 uncooperative dental patients aged 4-6. Study participants were randomly assigned to receive either 0.2mg/kg IN MDZ or 1μg/kg DEX. Sedation was evaluated using the Houpt sedation rating scale. Vital signs were recorded before and during sedation. Prior to sedation, the level of dental fear was determined through children's fear survey schedule-dental subscale (CFSSDS). Psychological characteristics were screened using the strengths and difficulties questionnaire (SDQ). Data were analyzed using T-test, Mann-Whitney, Chi-square, and repeated- measures analysis of variance (ANOVA). Results: Overall ratings of sedation and subscales of sleep, crying, and movement were comparable between groups (p> 0.05); however, more acceptable behavior (overall scores (4+5+6) was observed in MDZ group compared to DEX group (64% vs. 47.7%) (p= 0.007). All participants were found to have abnormal levels of dental fear (CFSS-DS≥38). However, according to SDQ, the study participants have mainly shown normal behavioral status. A significant association was found between dental fear and sedation success (MDZ, p= 0.001, DEX, p= 0.03), while similar findings were not observed for psychological characteristics (MDZ, p= 0.09 and p= 0.41; DEX, p= 0.71 and p= 0.53). Physiological parameters remained within normal limits in both groups. Conclusion: Sedation with IN MDZ resulted in overall behaviors, which were more satisfactory in highly fearful pediatric dental patients. Despite baseline uncooperative behaviors, the psychological status of study participants were close to average and were not associated with sedation failure. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) 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.)

Simulation has become increasingly important in teaching clinical nursing skills. Cooperative simulation practices based on social interdependence theory support skill acquisition by reducing student anxiety through practice. The aim of this experimental study, conducted with 60 junior nursing students, was to compare the effects of cooperative versus individual practice on psychomotor skill performance and student anxiety during simulation with a standardized patient. The results demonstrated that students who performed practice cooperatively had higher psychomotor skills scores and lower anxiety scores. [ABSTRACT FROM AUTHOR]

Background: The African Surgical OutcomeS-2 (ASOS-2) trial tested an enhanced postoperative surveillance intervention to reduce postoperative mortality in Africa. We undertook a concurrent evaluation to understand the process of intervention delivery.Methods: Mixed-methods process evaluation, including field notes, interviews, and post-trial questionnaire responses. Qualitative analysis used the framework method with subsequent creation of comparative case studies, grouping hospitals by intervention fidelity. A post-trial questionnaire was developed using initial qualitative analyses. Categorical variables were summarised as count (%) and continuous variables as median (inter-quartile range [IQR]). Odds ratios (OR) were used to rank influences by impact on fidelity.Results: The dataset included eight in-depth case studies, and 96 questionnaire responses (response rate 67%) plus intervention fidelity data for each trial site. Overall, 57% (n=55/96) of hospitals achieved intervention delivery using an inclusive definition of fidelity. Delivery of the ASOS-2 interventions and data collection presented a significant burden to the investigators, outstripping limited resources. The influences most associated with fidelity were: surgical staff enthusiasm for the trial (OR=3.0; 95% confidence interval [CI], 1.3-7.0); nursing management support of the trial (OR=2.6; 95% CI, 1.1-6.5); performance of a dummy run (OR=2.6; 95% CI, 1.1-6.1); nursing colleagues seeing the value of the intervention(s) (OR=2.1; 95% CI, 0.9-5.7); and site investigators' belief in the effectiveness of the intervention (OR=3.2; 95% CI, 1.2-9.4).Conclusions: ASOS-2 has proved that coordinated interventional research across Africa is possible, but delivering the ASOS-2 interventions was a major challenge for many investigators. Future improvement science efforts must include better planning for intervention delivery, additional support to investigators, and promotion of strong inter-professional teamwork.Clinical Trial Registration: ClinicalTrials gov NCT03853824. [ABSTRACT FROM AUTHOR]

Affective response to exercise may mediate the effects of self-paced exercise on exercise adherence. Fiftynine low-active (exercise <60 min/week), overweight (body mass index: 25.0-39.9) adults (ages 18-65) were randomly assigned to self-paced (but not to exceed 76% maximum heart rate) or prescribed moderate intensity exercise (64-76% maximum heart rate) in the context of otherwise identical 6-month print-based exercise promotion programs. Frequency and duration of exercise sessions and affective responses (good/bad) to exercise were assessed via ecological momentary assessment throughout the 6-month program. A regression-based mediation model was used to estimate (a) effects of experimental condition on affective response to exercise (path a = 0.20, SE = 0.28, f2 = 0.02); (b) effects of affective response on duration/latency of the next exercise session (path b = 0.47, SE = 0.25, f2 = 0.04); and (c) indirect effects of experimental condition on exercise outcomes via affective response (path ab = 0.11, SE = 0.06, f2 = 0.10). Results provide modest preliminary support for a mediational pathway linking self-paced exercise, affective response, and exercise adherence. [ABSTRACT FROM AUTHOR]

Background: Assessing the fidelity of an implementation strategy is important to understand why and how the strategy influences the uptake of evidence-based interventions. The present study aims to assess the fidelity of the two procedures for engaging primary care (PC) professionals and for the deployment of an implementation strategy for optimizing type 2 diabetes prevention in routine PC within the PREDIAPS randomized cluster implementation trial. Method: We conducted a mixed-method fidelity evaluation study of the PVS-PREDIAPS implementation strategy. Nine PC centers from the Basque Health Service (Osakidetza) were allocated to two different procedures to engage physicians and nurses and deploy a implementation strategy to model and adapt the clinical intervention and its implementation to their specific contexts: a Global procedure, promoting the cooperation of all healthcare professionals from the beginning; or a Sequential procedure, centered first on nurses who then pursued the pragmatic cooperation of physicians. Process indicators of the delivery and receipt of implementation strategy actions, documented modifications to the planned implementation strategy, and a structured group interview with centers' leaders were all used to assess the following components of fidelity: adherence, dose, quality of delivery, professionals' responsiveness and program differentiation. Results: Generally, the procedures compared for professionals engagement and deployment of the implementation strategy were carried out with the planned differentiation. Nonetheless, some unexpected between-group differences were observed, the initial rate of collaboration of nurses being higher in the Sequential (93%) than in the Global (67%) groups. Exposure rate to the programed implementation actions (% of hours received out of those delivered) were similar in both groups by professional category, with nurses (86%) having a higher rate of exposure than physicians (75%). Professionals identified half of the planned discrete strategies and their rating of strategies' perceived usefulness was overwhelmingly positive, with few differences between Sequential and Global centers. Conclusions: The PVS-PREDIAPS implementation strategy has been implemented with high fidelity and minor unplanned reactive modifications. Professionals' exposure to the implementation strategy was high in both groups. The centers' organizational context (i.e., work overload) led to small mismatches between groups in participation and exposure of professionals to implementation actions. Trial registration: Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017. [ABSTRACT FROM AUTHOR]

Background: Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence.Methods: In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients' care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18-30 months of follow-up.Discussion: TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions.Trial Registration: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824. [ABSTRACT FROM AUTHOR]

Introduction: The gap between depression treatment needs and the available mental health workforce is particularly large in rural areas. Collaborative care (CoCM) is an evidence-based approach that leverages limited mental health specialists for maximum population effect. This study evaluates depression treatment outcomes, clinical processes of care, and primary care provider experiences for CoCM implementation in 8 rural clinics treating low-income patients.Method: We used CoCM registry data to analyze depression response and remission then used logistic regression to model variance in depression outcomes. Primary care providers reported their experiences with this practice change 18 months following program launch.Results: Participating clinics enrolled 5,187 adult patients, approximately 15% of the adult patient population. Mean PHQ-9 depression score was 16.1 at baseline and 10.9 at last individual measurement, a statistically and clinically significant improvement (SD6.7; 95% CI [4.9, 5.3]). Suicidal ideation also reduced significantly. Multivariate logistic regression predicted the probability of depression response and remission after controlling for several demographic attributes and processes of care, showing a significant amount of variance in outcomes could be explained by clinic, length of time in treatment, and age. Primary care providers reported positive experiences overall.Discussion: Three quarters of participating primary care clinics, adapting CoCM for limited resource settings, exceeded depression response outcomes reported in a controlled research trial and mirrored results of large-scale quality improvement implementations. Future research should examine quality improvement strategies to address clinic-level variation and sustain improvements in clinical outcomes achieved. (PsycInfo Database Record (c) 2020 APA, all rights reserved). [ABSTRACT FROM AUTHOR]

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.Design, Setting, and Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.Interventions: Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.Main Outcomes and Measures: The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.Results: Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).Conclusions and Relevance: Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.Trial Registration: ClinicalTrials.gov Identifier: NCT02022111. [ABSTRACT FROM AUTHOR]

Background Pulmonary hypertension is a rare, chronic and life-threatening group of diseases. Recent advances in pulmonary hypertension management prolong survival and improve quality-of-life. However, highly complex drug therapy enhances the risk of drug-related problems. Objective To assess the impact of involving clinical pharmacists in the collaborative care of pulmonary hypertension patients. Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension. Methods This prospective multicenter randomized controlled trial included incident pulmonary hypertension patients who were followed-up for 18 months. Randomization using an adapted Zelen method allocated patients to collaborative care (n = 41) or usual care groups (n = 51). A collaborative care program involving clinical pharmacists was developed through a close partnership between with physicians, nurses and pharmacists. Besides usual care, the program includes regular one-to-one interviews between the pharmacist and the patient. These interviews had following objectives: to perform an exhaustive medication history review; to identify the patient' needs, knowledge and skills; to define educational objectives and to provide patients with relevant information when needed. Following each interview, a standardized report form containing the pharmacist's recommendations was provided to physicians and nurses and discussed collaboratively. An ancillary economic analysis was performed. Main outcome measure Number of drug-related problems and their outcomes. Results The number of drug-related problems was not significantly different between groups (1.6 ± 1.5 vs. 1.9 ± 2.4; p = 0.41). More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01). Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life were not statistically different between groups. Collaborative care decreased costs of drug-related hospitalizations. Conclusion Including clinical pharmacists in the multidisciplinary care of hospitalized patients with pulmonary hypertension improved the outcome of drug-related problems and reduced the costs of related hospitalization. However, we observed no efficacy on medication errors, clinical outcomes or medication adherence. Clinical Trial Registration ClinicalTrials.gov Identifier NCT01038284. [ABSTRACT FROM AUTHOR]

Parent-mediated intervention is widely used for pre-schoolers with autism spectrum disorder (ASD). Previous studies indicate small-to-moderate effects on social communication skills, but with a wide heterogeneity that requires further research. In this randomized controlled trial (RCT), cooperative parent-mediated therapy (CPMT) an individual parent coaching program for young children with ASD was administered to preschool children with ASD. All children received the same low-intensity psychosocial intervention (LPI) delivered in community settings, to evaluate the potential additional benefit of CPMT. Thirty-four participants with ASD (7 females; 27 males; aged 2, 6, 11 years) and their parents were included in the trial. The primary blinded outcome was social communication skills, assessed using the ADOS-G social communication algorithm score (ADOS-G SC). Secondary outcomes included ASD symptom severity, parent-rated language abilities and emotional/behavioral problems, and self-reported caregiver stress. Evaluations were made at baseline and post-treatment (at 6 months) by an independent multidisciplinary team. Results documented that CPMT showed an additional benefit on LPI with significant improvements of the primary blinded outcome, socio-communication skills, and of some secondary outcomes such as ASD symptom severity, emotional problems and parental stress related to parent–child dysfunctional interaction. No additional benefit was found for language abilities. Findings of our RCT show that CPMT provide an additional significant short-term treatment benefit on ASD core symptoms, when compared with active control group receiving only LPI. [ABSTRACT FROM AUTHOR]

Interpersonal coordination is an important skill for promoting collective behavior in team sports. This study tested the impact of two types of tools in facilitating triadic coordination. 16 males aged under 12 years were divided into four groups with similar skill levels and average ages. Each group performed a three-versus- one ball passing task under three conditions: a one-elasticband tool linking the three players, a three-elastic-bands tool linking the three players, and without a tool linking the three players. The dependent variables were ball passing frequency, frequency and amplitude of inner angles of the triangle formed by the players, and duration of the synchronized patterns of the inner angles. The results show that neither tool increased ball-passing frequency or the duration of synchronized patterns. However, both tools increased the frequency of inner angles, and the three-elastic- bands tool decreased the amplitude of inner angles. From these results, we conclude that elastic-band tools affect spatial and temporal triadic formation by means of haptic and visual information. Specifically, compared with the one-elastic-band tool, the three-elastic-bands tool stabilizes the triadic spatial formation. We also explore the implications for how these tools can be used in practice. [ABSTRACT FROM AUTHOR]

Prosociality is a central topic in positive psychology. An important but under-studied distinction can be made between active and reactive expressions. We suggest that the novel construct of social mindfulness represents active rather than reactive prosociality. Across four studies (N = 2,594), including a multi-wave representative sample spanning six years, social mindfulness is found to correlate with personality traits associated with prosocial and/or antisocial behavior. We find positive associations with empathy, social value orientation, and general prosocial behavior, and negative associations with moral disengagement and narcissism. Importantly, social mindfulness emerges as an active rather than a reactive characteristic that is more strongly related to HEXACO honesty-humility (active cooperation) than to HEXACO agreeableness (reactive cooperation). The association between social mindfulness and honesty-humility was found across measures six years apart. Given the well-established link between prosociality and well-being, emphasizing social mindfulness may be a good start to promote the latter. [ABSTRACT FROM AUTHOR]

This article reports on a cluster randomized trial of cooperative learning (CL) as a way to prevent escalation in alcohol use during middle school (N = 1,460 seventh-grade students, age 12-13, seven intervention and eight control schools). We hypothesized that CL, by bringing students together in group-based learning activities using positive interdependence, would interrupt the process of deviant peer clustering, provide at-risk youth with prosocial influences, and in turn, reduce escalations in alcohol use. Results indicated that CL significantly reduced growth in deviant peer affiliation and actual alcohol use, and effects for willingness to use alcohol were at the threshold of significance (p = .05). CL also attenuated the link between willingness to use alcohol and later alcohol use. [ABSTRACT FROM AUTHOR]

Background: The benefit of early integration of palliative care into oncological care is suggested to be due to increased psychosocial support. In Belgium, psychosocial care is part of standard oncological care. The aim of this randomised controlled trial is to examine whether early and systematic integration of palliative care alongside standard psychosocial oncological care provides added benefit compared with usual care.Methods: In this randomised controlled trial, eligible patients were 18 years or older, and had advanced cancer due to a solid tumour, an European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months, and were within the first 12 weeks of a new primary tumour or had a diagnosis of progression. Patients were randomly assigned (1:1), by block design using a computer-generated sequence, either to early and systematic integration of palliative care into oncological care, or standard oncological care alone in a setting where all patients are offered multidisciplinary oncology care by medical specialists, psychologists, social workers, dieticians, and specialist nurses. The primary endpoint was change in global health status/quality of life scale assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ C30) at 12 weeks. The McGill Quality of Life Questionnaire (MQOL), which includes the additional existential wellbeing dimension, was also used. Analysis was by intention to treat. This trial is ongoing, but closed for accrual, and is registered with ClinicalTrials.gov, number NCT01865396.Findings: From April 29, 2013, to Feb 29, 2016, we screened 468 patients for eligibility, of whom 186 were enrolled and randomly assigned to the early and systematic palliative care group (92 patients) or the standard oncological care group (94). Compliance at 12 weeks was 71% (65 patients) in the intervention group versus 72% (68) in the control group. The overall quality of life score at 12 weeks, by the EORTC QLQ C30, was 54·39 (95% CI 49·23-59·56) in the standard oncological care group versus 61·98 (57·02-66·95) in the early and systematic palliative care group (difference 7·60 [95% CI 0·59-14·60]; p=0·03); and by the MQOL Single Item Scale, 5·94 (95% CI 5·50-6·39) in the standard oncological care group versus 7·05 (6·59-7·50) in the early and systematic palliative care group (difference 1·11 [95% CI 0·49-1·73]; p=0.0006).Interpretation: The findings of this study show that a model of early and systematic integration of palliative care in oncological care increases the quality of life of patients with advanced cancer. Our findings also show that early and systematic integration of palliative care is more beneficial for patients with advanced cancer than palliative care consultations offered on demand, even when psychosocial support has already been offered. Through integration of care, oncologists and specialised palliative care teams should work together to enhance the quality of life of patients with advanced cancer.Funding: Research Foundation Flanders, Flemish Cancer Society (Kom Op Tegen Kanker). [ABSTRACT FROM AUTHOR]

The purpose of this study was to investigate the effects of structured physical activity program on social interaction and communication of children with autism spectrum disorder (ASD). Fifty children with ASD from a special school were randomly divided into experimental and control groups. 25 children with ASD were placed in the experimental group, and the other 25 children as the control group participated in regular physical activity. A total of forty-one participants completed the study. A 12-week structured physical activity program was implemented with a total of 24 exercise sessions targeting social interaction and communication of children with ASD, and a quasi-experimental design was used for this study. Data were collected using quantitative and qualitative instruments. SSIS and ABLLS-R results showed that an overall improvement in social skills and social interaction for the experimental group across interim and posttests, F=8.425, p=0.001 (p<0.005), and significant improvements appeared in communication, cooperation, social interaction, and self-control subdomains (p<0.005). Conversely, no statistically significant differences were found in the control group (p>0.005). The study concluded that the special structured physical activity program positively influenced social interaction and communication skills of children with ASD, especially in social skills, communication, prompt response, and frequency of expression. [ABSTRACT FROM AUTHOR]

Background: A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces.Methods/design: This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed.Discussion: The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided.Trial Registration: ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment.Methods: Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors. Primary outcome measures to assess teams NTS were the validated Global Assessment of Obstetric Team Performance (GAOTP) and Clinical Teamwork Scale (CTS). Secondary outcome measures were the 'friends and family test', technical skills, and the System Usability Scale (SUS). Sample size estimation was calculated by using 80% power 5% significance two tailed test (p1=85% p2=40%) n=34.Results: 38 teams from August 2014-February 2016, were recruited, technical issues with failure of recording equipment meant 4 teams were excluded from teamwork analysis (1 intervention 3 control). Teamwork improved across all domains with the intervention (using a decision support mobile digital platform) p <0.01. CTS improved between 6.7-16.8% (average 14.2%) and GAOTP between 8.6-17.1% (average 13.5%) for all domains. Using the control group as baseline, the intervention improved teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (p<0.01). There was no statistical difference in the time technical skills were achieved. Assessors were more likely to recommend intervention teams 87.5% (77/88) than control teams 63.6% (56/88) p<0.01 to their friends or family. The SUS was 'Good' (69) becoming excellently 'Usable' (81.6) over the study period.Conclusion: We report a decision support system, which improved NTS when managing PPH. Lack of teamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during an emergency. [ABSTRACT FROM AUTHOR]

The Newborn Behavioral Observations (NBO) system is a neurobehavioral observation tool designed to sensitize parents to infants' capacities and individuality and to enhance the parent--infant relationship by strengthening parents' confidence and practical skills in caring for their children. The NBO's focus on relationship building is intended for infant mental health professionals who strive for a relational, family-centered model of care versus a pathology-based model. This study assessed the impact of the NBO on the sensitivity of mother--infant interaction in the first 4 months of life. Primiparous mothers and their full-term infants were randomized into experimental and control groups. The intervention group participated in the NBO in the hospital within 2 days of birth and again at home at 1 month postpartum. At 4 months, dyads (n = 35) were videotaped during semistructured play episodes, which were coded to assess parent--child sensitivity in interactions with one another. Intervention infants were 2.8 times more likely to be classified as "cooperative" (sensitive) than control group infants. Intervention mothers were 2.5 times more likely to be classified as sensitive than control mothers. These findings highlight the potential of the NBO to promote positive maternal--infant relations by influencing newborn behavior and suggest that the NBO is an effective, time-limited intervention for strengthening relationships between parents and infants. [ABSTRACT FROM AUTHOR]

Background: Care provided in the emergency department (ED) can cost up to five times as much as care received for comparable diagnoses in alternative settings. Small groups of patients, many of whom suffer from an opioid use disorder, often account for a large proportion of total ED visits. We recently conducted, and demonstrated the effectiveness of, the first randomized controlled trial of a citywide ED care-coordination program intending to reduce prescription-opioid-related ED visits. All EDs in the metropolitan study area were connected to a Web-based information exchange system.Objective: The objective of this article was to perform an economic evaluation of the 12-month trial from a third-party-payer perspective.Methods: We modeled the person-period monthly for the 12-month observation period, and estimated total treatment costs and return on investment (ROI) with regard to cost offsets, over time, for all visits where the patient was admitted to and discharged from the ED.Results: By the end of month 4, the mean cumulative cost differential was significantly lower for intervention relative to treatment-as-usual participants (-$1370; p = 0.03); this figure climbed to -$3200 (p = 0.02) by the end of month 12. The ROI trended upward throughout the observation period, but failed to reach statistical significance by the end of month 12 (ROI = 3.39, p = 0.07).Conclusion: The intervention produced significant cost offsets by the end of month 4, which continued to accumulate throughout the trial; however, ROI was not significant. Because the per-patient administrative costs of the program are incurred at the time of enrollment, our results highlight the importance of future studies that are able to follow participants for a period beyond 12 months to more accurately estimate the program's ROI. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.Trial Registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016. [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Background Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. Design A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Methods Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. Discussion The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people.Methods: This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality.Discussion: Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.Trial Registration: ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015. [ABSTRACT FROM AUTHOR]

Objective: Growing interest in collaborative goal-setting has raised questions. First, are patients making the 'right choices' from a biomedical perspective? Second, are patients and providers setting goals of appropriate difficulty? Finally, what types of support will patients need to accomplish their goals? We analyzed goals and action plans from a trial of collaborative goal-setting among 302 residents of a high-poverty urban region who had multiple chronic conditions.Methods: Patients used a low-literacy aid to prioritize one of their chronic conditions and then set a goal for that condition with their primary care provider. Patients created patient-driven action plans for reaching these goals.Results: Patients chose to focus on conditions that were in poor control and set ambitious chronic disease management goals. The mean goal weight loss -16.8lbs (SD 19.5), goal HbA1C reduction was -1.3% (SD 1.7%) and goal blood pressure reduction was -9.8mmHg (SD 19.2mmHg). Patient-driven action plans spanned domains including health behavior (58.9%) and psychosocial (23.5%).Conclusions: High-risk, low-SES patients identified high priority conditions, set ambitious goals and generate individualized action plans for chronic disease management.Practice Implications: Practices may require flexible personnel who can support patients using a blend of coaching, social support and navigation. [ABSTRACT FROM AUTHOR]

Background: Older inpatients are at risk of hospital-associated geriatric syndromes including delirium, functional decline, incontinence, falls and pressure injuries. These contribute to longer hospital stays, loss of independence, and death. Effective interventions to reduce geriatric syndromes remain poorly implemented due to their complexity, and require an organised approach to change care practices and systems. Eat Walk Engage is a complex multi-component intervention with structured implementation, which has shown reduced geriatric syndromes and length of stay in pilot studies at one hospital. This study will test effectiveness of implementing Eat Walk Engage using a multi-site cluster randomised trial to inform transferability of this intervention.Methods: A hybrid study design will evaluate the effectiveness and implementation strategy of Eat Walk Engage in a real-world setting. A multisite cluster randomised study will be conducted in 8 medical and surgical wards in 4 hospitals, with one ward in each site randomised to implement Eat Walk Engage (intervention) and one to continue usual care (control). Intervention wards will be supported to develop and implement locally tailored strategies to enhance early mobility, nutrition, and meaningful activities. Resources will include a trained, mentored facilitator, audit support, a trained healthcare assistant, and support by an expert facilitator team using the i-PARIHS implementation framework. Patient outcomes and process measures before and after intervention will be compared between intervention and control wards. Primary outcomes are any hospital-associated geriatric syndrome (delirium, functional decline, falls, pressure injuries, new incontinence) and length of stay. Secondary outcomes include discharge destination; 30-day mortality, function and quality of life; 6 month readmissions; and cost-effectiveness. Process measures including patient interviews, activity mapping and mealtime audits will inform interventions in each site and measure improvement progress. Factors influencing the trajectory of implementation success will be monitored on implementation wards.Discussion: Using a hybrid design and guided by an explicit implementation framework, the CHERISH study will establish the effectiveness, cost-effectiveness and transferability of a successful pilot program for improving care of older inpatients, and identify features that support successful implementation.Trial Registration: ACTRN12615000879561 registered prospectively 21/8/2015. [ABSTRACT FROM AUTHOR]

Background: Comparative assessment of treatment results in paediatric hepatoblastoma trials has been hampered by small patient numbers and the use of multiple disparate staging systems by the four major trial groups. To address this challenge, we formed a global coalition, the Children's Hepatic tumors International Collaboration (CHIC), with the aim of creating a common approach to staging and risk stratification in this rare cancer.Methods: The CHIC steering committee-consisting of leadership from the four major cooperative trial groups (the International Childhood Liver Tumours Strategy Group, Children's Oncology Group, the German Society for Paediatric Oncology and Haematology, and the Japanese Study Group for Paediatric Liver Tumours)-created a shared international database that includes comprehensive data from 1605 children treated in eight multicentre hepatoblastoma trials over 25 years. Diagnostic factors found to be most prognostic on initial analysis were PRETreatment EXTent of disease (PRETEXT) group; age younger than 3 years, 3-7 years, and 8 years or older; α fetoprotein (AFP) concentration of 100 ng/mL or lower and 101-1000 ng/mL; and the PRETEXT annotation factors metastatic disease (M), macrovascular involvement of all hepatic veins (V) or portal bifurcation (P), contiguous extrahepatic tumour (E), multifocal tumour (F), and spontaneous rupture (R). We defined five clinically relevant backbone groups on the basis of established prognostic factors: PRETEXT I/II, PRETEXT III, PRETEXT IV, metastatic disease, and AFP concentration of 100 ng/mL or lower at diagnosis. We then carried the additional factors into a hierarchical backwards elimination multivariable analysis and used the results to create a new international staging system.Results: Within each backbone group, we identified constellations of factors that were most predictive of outcome in that group. The robustness of candidate models was then interrogated using the bootstrapping procedure. Using the clinically established PRETEXT groups I, II, III, and IV as our stems, we created risk stratification trees based on 5 year event-free survival and clinical applicability. We defined and adopted four risk groups: very low, low, intermediate, and high.Interpretation: We have created a unified global approach to risk stratification in children with hepatoblastoma on the basis of rigorous statistical interrogation of what is, to the best of our knowledge, the largest dataset ever assembled for this rare paediatric tumour. This achievement provides the structural framework for further collaboration and prospective international cooperative study, such as the Paediatric Hepatic International Tumour Trial (PHITT).Funding: European Network for Cancer Research in Children and Adolescents, funded through the Framework Program 7 of the European Commission (grant number 261474); Children's Oncology Group CureSearch grant contributed by the Hepatoblastoma Foundation; Practical Research for Innovative Cancer Control and Project Promoting Clinical Trials for Development of New Drugs and Medical Devices, Japan Agency for Medical Research; and Swiss Cancer Research grant. [ABSTRACT FROM AUTHOR]

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149). [ABSTRACT FROM AUTHOR]

Background: Collaborative group intervention (CGI) in patients with functional somatic syndromes (FSS) has been shown to improve mental quality of life.Objective: To analyse incremental cost-utility of CGI compared to enhanced medical care in patients with FSS.Methods: An economic evaluation alongside a cluster-randomised controlled trial was performed. 35 general practitioners (GPs) recruited 300 FSS patients. Patients in the CGI arm were offered 10 group sessions within 3months and 2 booster sessions 6 and 12months after baseline. Costs were assessed via questionnaire. Quality adjusted life years (QALYs) were calculated using the SF-6D index, derived from the 36-item short-form health survey (SF-36). We calculated patients' net-monetary-benefit (NMB), estimated the treatment effect via regression, and generated cost-effectiveness acceptability curves.Results: Using intention-to-treat analysis, total costs during the 12-month study period were 5777EUR in the intervention, and 6858EUR in the control group. Controlling for possible confounders, we found a small, but significant positive intervention effect on QALYs (+0.017; p=0.019) and an insignificant cost saving resulting from a cost-increase in the control group (-10.5%; p=0.278). NMB regression showed that the probability of CGI to be cost-effective was 69% for a willingness to pay (WTP) of 0EUR/QALY, increased to 92% for a WTP of 50,000EUR/QALY and reached the level of 95% at a WTP of 70,375EUR/QALY. Subgroup analyses yielded that CGI was only cost-effective in severe somatic symptom severity (PHQ-15≥15).Conclusion: CGI has a high probability to be a cost-effective treatment for FSS, in particular for patients with severe somatic symptom severity. [ABSTRACT FROM AUTHOR]

Background: Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users.Objectives: We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients.Methods: We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual.Results: The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively.Conclusion: This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. [ABSTRACT FROM AUTHOR]

Anxiety disorders are characterized by hyperactivity in both the amygdala and the anterior insula. Interventions that normalize activity in these areas may therefore be effective in treating anxiety disorders. Recently, there has been significant interest in the potential use of oxytocin (OT), as well as vasopressin (AVP) antagonists, as treatments for anxiety disorders. In this double-blind, placebo-controlled, pharmaco- fMRI study, 153 men and 151 women were randomized to treatment with either 24 IU intranasal OT, 20 IU intranasal AVP, or placebo and imaged with fMRI as they played the iterated Prisoner's Dilemma game with same-sex human and computer partners. In men, OT attenuated the fMRI response to unreciprocated cooperation (CD), a negative social interaction, within the amygdala and anterior insula. This effect was specific to interactions with human partners. In contrast, among women, OT unexpectedly attenuated the amygdala and anterior insula response to unreciprocated cooperation from computer but not human partners. Among women, AVP did not significantly modulate the response to unreciprocated cooperation in either the amygdala or the anterior insula. However, among men, AVP attenuated the BOLD response to CD outcomes with human partners across a relatively large cluster including the amygdala and the anterior insula, which was contrary to expectations. Our results suggest that OT may decrease the stress of negative social interactions among men, whereas these effects were not found in women interacting with human partners. These findings support continued investigation into the possible efficacy of OT as a treatment for anxiety disorders. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of collaborative care of mental health problems is clear for depression and growing but mixed for anxiety disorders, including posttraumatic stress disorder (PTSD). We know little about whether collaborative care can be effective in settings that serve low-income patients such as Federally Qualified Health Centers (FQHCs).Objective: We compared the effectiveness of minimally enhanced usual care (MEU) versus collaborative care for PTSD with a care manager (PCM).Design: This was a multi-site patient randomized controlled trial of PTSD care improvement over 1 year.Participants: We recruited and enrolled 404 patients in six FQHCs from June 2010 to October 2012. Patients were eligible if they had a primary care appointment, no obvious physical or cognitive obstacles to participation, were age 18-65 years, planned to continue care at the study location for 1 year, and met criteria for a past month diagnosis of PTSD.Main Measures: The main outcomes were PTSD diagnosis and symptom severity (range, 0-136) based on the Clinician-Administered PTSD Scale (CAPS). Secondary outcomes were medication and counseling for mental health problems, and health-related quality of life assessed at baseline, 6 months, and 12 months.Key Results: Patients in both conditions improved similarly over the 1-year evaluation period. At 12 months, PTSD diagnoses had an absolute decrease of 56.7% for PCM patients and 60.6% for MEU patients. PTSD symptoms decreased by 26.8 and 24.2 points, respectively. MEU and PCM patients also did not differ in process of care outcomes or health-related quality of life. Patients who actually engaged in care management had mental health care visits that were 14% higher (p < 0.01) and mental health medication prescription rates that were 15.2% higher (p < 0.01) than patients with no engagement.Conclusions: A minimally enhanced usual care intervention was similarly effective as collaborative care for patients in FQHCs. [ABSTRACT FROM AUTHOR]

Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.Trial Registration: ClinicalTrials.gov NCT02655354 . Registered 27 July 2015. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to examine the efficacy of a collaborative care intervention in reducing depression, pain, and fatigue and improve quality of life.Methods: A total of 261 patients with advanced cancer and 179 family caregivers were randomized to a web-based collaborative care intervention or enhanced usual care. The intervention included the following: 1) a web site with written and audiovisual self-management strategies, a bulletin board, and other resources; 2) visits with a care coordinator during a physician's appointment every 2 months; and 3) telephone follow-up every 2 weeks. Primary patient outcomes included measures of depression, pain, fatigue, and health-related quality of life. Secondary outcomes included Interleukin (IL)-1α, IL-1β, IL-6, and IL-8 levels, Natural Killer (NK) cell numbers, and caregiver stress and depression.Results: At the baseline, 51% of the patients reported 1 or more symptoms in the clinical range. For patients who presented with clinical levels of symptoms and were randomized to the intervention, reductions in depression (Cohen's d = 0.71), pain (Cohen's d = 0.62), and fatigue (Cohen's d = 0.26) and improvements in quality of life (Cohen's d = 0.99) were observed when compared to those in the enhanced usual car arm at 6 months. Reductions in IL-6 (φ = 0.18), IL-1β (φ = 0.35), IL-1α (φ = 0.19), and IL-8 (φ = 0.15) and increases in NK cell numbers (φ = 0.23) were observed in comparison with enhanced usual care arm at 6 months. Reductions in caregiver stress (Cohen's d = 0.75) and depression (Cohen's d = 0.37) were observed at 6 months for caregivers whose loved ones were randomized to the intervention arm.Conclusions: The integration of screening and symptom management into cancer care is recommended. [ABSTRACT FROM AUTHOR]

OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data. [ABSTRACT FROM AUTHOR]

Background: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.Methods/design: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.Discussion: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Trial Registration: Current Controlled Trials ISRCTN66138978. [ABSTRACT FROM AUTHOR]

Objective: To use data from a randomized trial to determine the cost-effectiveness of a collaborative care (CC) depression and anxiety treatment program and to assess effects of the CC program on health care utilization.Methods: The CC intervention's impact on health-related quality of life, depression-free days (DFDs), and anxiety-free days (AFDs) over the 24-week postdischarge period was calculated and compared with the enhanced usual care (EUC) condition using independent samples t tests and random-effects regression models. Costs for both the CC and EUC conditions were calculated on the basis of staff time, overhead expenses, and treatment materials. Using this information, incremental cost-effectiveness ratios were calculated. A cost-effectiveness acceptability plot was created using nonparametric bootstrapping with 10,000 replications, and the likelihood of the CC intervention's cost-effectiveness was assessed using standard cutoffs. As a secondary analysis, we determined whether the CC intervention led to reductions in postdischarge health care utilization and costs.Results: The CC intervention was more costly than the EUC intervention ($209.86 vs. $34.59; z = -11.71; P < 0.001), but was associated with significantly greater increases in quality-adjusted life-years (t = -2.49; P = 0.01) and DFDs (t = -2.13; P = 0.03), but not AFDs (t = -1.92; P = 0.057). This translated into an incremental cost-effectiveness ratio of $3337.06 per quality-adjusted life-year saved, $13.36 per DFD, and $13.74 per AFD. Compared with the EUC intervention, the CC intervention was also associated with fewer emergency department visits but no differences in overall costs.Conclusions: This CC intervention was associated with clinically relevant improvements, was cost-effective, and was associated with fewer emergency department visits in the 24 weeks after discharge. [ABSTRACT FROM AUTHOR]

The study was a randomized controlled trial evaluating the efficacy of a brief and preventatively-focused parenting discussion group for dealing with disobedient behavior in preschool-aged children. Eighty-five parents with children aged between 3 and 5 years who were concerned about the noncompliant behavior of their child were recruited from Auckland, New Zealand and Brisbane, Australia. Compared to the waitlist control group (n = 40), parents in the intervention group (n = 45) reported greater improvements in disruptive child behavior, ineffective parenting practices and parenting confidence, as well as clinically significant improvements in child behavior and parenting. All of these effects were maintained at 6-month follow up. No group differences were found for parental wellbeing, inter-parental conflict and general relationship quality, although intervention parents reported improvements in parental wellbeing and inter-parental conflict at 6-month follow-up. The findings are discussed in terms of the implications for making brief and effective parenting support available to parents. [ABSTRACT FROM AUTHOR]

Background: Few evidence-based, on-line resources exist to support home-based care of childhood long-term conditions.Methods: In a feasibility study, children with stages 3, 4, or 5 chronic kidney disease, parents and professionals collaboratively developed a novel Online Parent Information and Support (OPIS) application. Parents were randomized to an intervention arm with access to OPIS or a control arm without access. OPIS usage was assessed using Google Analytics. Parents in the intervention arm completed the Suitability Assessment of Materials (SAM) and User Interface Satisfaction (USE) questionnaires and participated in qualitative interviews.Results: Twenty parents accessed OPIS with a mean of 23.3 (SD 20.8, range 2-64) visits per user. Responses from the SAM and USE questionnaires were positive, most respondents rating OPIS highly and finding it easy to use. Qualitative suggestions include refinement of OPIS components, enabling personalization of OPIS functionalities and proactive endorsements of OPIS by professionals.Conclusions: Implementation of OPIS into standard practice is feasible in the centre where it was developed. Suggested developments will augment reported strengths to inform ongoing testing in the wider UK network of units. Our design and methods are transferrable to developing and evaluating web-applications to support home-based clinical care-giving for other long-term conditions. [ABSTRACT FROM AUTHOR]

Background: Institutional Health Partnerships are long-term, institution to institution partnerships between high income and low and middle income countries which seek to build capacity and strengthen health institutions in order to improve health service delivery and outcomes. Funding for Institutional Health Partnerships has increased in recent years. This paper outlines a rapid evidence review on the effectiveness of this modality.Methods: A rapid evidence review of published and grey literature was conducted. Content relating to the effectiveness of working in partnership and methods and frameworks used were extracted and analysed. The results of this analysis were used to structure a discussion regarding the next steps to strengthen the evidence base for the effectiveness of institutional health partnerships.Results: The evidence review, including citation mapping, returned 27 published papers and 17 grey literature documents that met all of the inclusion criteria. Most of the literature did not meet the high standards of formal academic rigour and there was no original research amongst this literature that specifically addressed the effectiveness of institutional health partnerships. This was not surprising given institutional health partnerships do not lend themselves easily to case control studies and randomised control trials due to their high level of diversity and operation in complex social systems. There was, however, a body of practice based knowledge and experience.Conclusions: Evidence for the effectiveness of Institutional Health Partnerships is thin both in terms of quantity and academic rigour. There is a need to better define and differentiate Institutional Health Partnerships in order to measure and compare effectiveness across such a diverse group. Effectiveness needs to be measured at the level of individual partnerships, the bodies that facilitate partnership programmes and the level of health service delivery. There is a need to develop indicators and frameworks that specifically address the benefits and values of partnership working and how these relate to effectiveness. These indicators need to be content neutral of specific interventions which are already measured through routine project monitoring and evaluation. This will allow the development of methodological pathways to assess the effectiveness of institutional health partnerships. Until more primary research is conducted or published there is little benefit in further systematic reviews. [ABSTRACT FROM AUTHOR]

In 2007, the first trainee-led surgical research network was founded in the United Kingdom (UK). The West Midlands Research Collaborative was started by a group of enthusiastic adult surgical trainees who saw the benefits of altruistic collaboration to generate high quality, multicenter research. Seeing the success of their research projects, including randomized controlled trials, trainees in other regions and specialties were spurred on to founding their own research collaboratives. The Pediatric Surgical Trainee Research Network was started in 2011 by a group of UK trainees with the aim to promote, facilitate, and encourage trainee-led research in pediatric surgery. This article summarizes the history and evolution of the trainee collaborative surgical research. It examines the challenges which multicenter research entails and the steps the collaboratives have taken to overcome them. We describe some of the projects which have been successfully completed and the benefits that the trainee networks have for patients and surgeons alike. [ABSTRACT FROM AUTHOR]

Recent research has examined the effects of oxytocin (OT) and vasopressin (AVP) on human social behavior and brain function. However, most participants have been male, while previous research in our lab demonstrated sexually differentiated effects of OT and AVP on the neural response to reciprocated cooperation. Here we extend our previous work by significantly increasing the number of participants to enable the use of more stringent statistical thresholds that permit more precise localization of OT and AVP effects in the brain. In a double-blind, placebo-controlled study, 153 men and 151 women were randomized to receive 24 IU intranasal OT, 20 IU intranasal AVP or placebo. Afterwards, they were imaged with fMRI while playing an iterated Prisoner's Dilemma Game with same-sex partners. Sex differences were observed for effects of OT on the neural response to reciprocated cooperation, such that OT increased the caduate/putamen response among males, whereas it decreased this response among females. Thus, 24 IU OT may increase the reward or salience of positive social interactions among men, while decreasing their reward or salience among women. Similar sex differences were also observed for AVP effects within bilateral insula and right supramarginal gyrus when a more liberal statistical threshold was employed. While our findings support previous suggestions that exogenous nonapeptides may be effective treatments for disorders such as depression and autism spectrum disorder, they caution against uniformly extending such treatments to men and women alike. [ABSTRACT FROM AUTHOR]

Background: Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.Discussion: Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada. [ABSTRACT FROM AUTHOR]

Background: Both antenatal and postpartum depression have adverse, lasting effects on maternal and child well-being. Socioeconomically disadvantaged women are at increased risk for perinatal depression and have experienced difficulty accessing evidence-based depression care. The authors evaluated whether "MOMCare,"a culturally relevant, collaborative care intervention, providing a choice of brief interpersonal psychotherapy and/or antidepressants, is associated with improved quality of care and depressive outcomes compared to intensive public health Maternity Support Services (MSS-Plus).Methods: A randomized multisite controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System. From January 2010 to July 2012, pregnant women were recruited who met criteria for probable major depression and/or dysthymia, English-speaking, had telephone access, and ≥18 years old. The primary outcome was depression severity at 3-, 6-, 12-, 18-month postbaseline assessments; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care.Results: All participants were on Medicaid and 27 years old on average; 58% were non-White; 71% were unmarried; and 65% had probable PTSD. From before birth to 18 months postbaseline, MOMCare (n = 83) compared to MSS-Plus participants (n = 85) attained significantly lower levels of depression severity (Wald's χ(2) = 6.09, df = 1, P = .01) and PTSD severity (Wald's χ(2) = 4.61, df = 1, P = .04), higher rates of depression remission (Wald's χ(2) = 3.67, df = 1, P = .05), and had a greater likelihood of receiving ≥4 mental health visits (Wald's χ(2) = 58.23, df = 1, P < .0001) and of adhering to antidepressants in the prior month (Wald's χ(2) = 10.00, df = 1, P < .01).Conclusion: Compared to MSS-Plus, MOMCare showed significant improvement in quality of care, depression severity, and remission rates from before birth to 18 months postbaseline for socioeconomically disadvantaged women. Findings suggest that evidence-based perinatal depression care can be integrated into the services of a county public health system in the United States.Clinical Trial Registration: ClinicalTrials.govNCT01045655. [ABSTRACT FROM AUTHOR]