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Trial design: This is a randomized, controlled, superiority, double-blinded, parallel-group, two-arms trial with an allocation ratio of 1:1. This study aimed to assess whether the cavity design could affect the clinical performance of the CAD/CAM generated indirect resin composite restoration in endodontically treated teeth (ETT) evaluated using the Modified USPHS criteria after a two-year follow up. Methods: A total of 30 participants who underwent endodontic treatment for MOD cavities in permanent molars were divided randomly into two parallel groups (n = 30 restorations) according to the performed cavity design to group 1 in which there was no cuspal reduction (inlay) and group 2 in which cuspal reduction was performed (overlay). All pulp chambers were filled with bulk fill flowable composite, and the cavities were prepared following the criteria of the cavities for indirect restorations and restored using nano-hybrid composite resin blocks (Brilliant, Coltene, Switzerland). The restorations were evaluated using the modified USPHS criteria at baseline, six months, one-year and two years follow-up visits. For qualitative data, frequencies (n) and percentages (%) were used to display the data, while mean and standard deviation (SD) were used for quantitative data. The normality of the data was evaluated using the Shapiro-Wilk and Kolmogorov-Smirnov tests. For every test, P ≤ 0.05 was used as the significance threshold. Results: Twenty-six individuals completed the follow-up period after receiving the assigned intervention.The inter-group comparison showed that, at the 6- months and 12- months observation points, the overlay design had significantly better marginal adaptation, less incidence of discoloration or tooth/restoration fracture, and similar marginal integrity and caries incidence to the inlay design. After 24- months, the overlay design still had better marginal adaptation, less incidence of discoloration or tooth/restoration fracture and less caries incidence in comparison to the inlay design, while there was no difference in the marginal integrity between either design. Conclusions and clinical relevance: Cuspal reduction in endodontically treated teeth showed better clinical performance than the cusp preservation thus, the former is more reliable. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) are considered to produce the highest level of evidence in the original studies that informs the practice of evidence-based medicine (EBM). By manipulating an independent variable to study its impact on the outcome, RCTs establish causal relationships and provide valuable insights into clinical treatment. To improve patient outcomes and optimize the use of clinical resources, the practice of EBM plays a crucial role in designing and conducting RCTs to evaluate the effectiveness of clinical interventions. This review aims to explore the essential steps involved in conducting a rigorous and reliable RCT, ensuring the generation of highquality evidence. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Collaborations with traditional healers have been proposed to improve HIV testing uptake. We hypothesized that healer-delivered HIV testing would improve HIV testing uptake, compared with referral to clinic-based HIV testing. We conducted a cluster randomized trial to determine the effectiveness of traditional healers delivering counseling and HIV testing in Mwanza, Tanzania (ClinicalTrials.gov NCT#04071873). Intervention arm healers provided counseling and offered point-of-care HIV tests to adult clients of unknown HIV serostatus. Control arm healers provided referral for clinic-based testing. Primary outcome was receipt of an HIV test within 90 days of enrollment. Secondary outcomes were new HIV diagnosis and linkage to care. In the intervention, 100 clients (100%) received an HIV test, compared with 73 (73%) of control participants (p < 0.001). Two intervention arm participants (2%) had a new diagnosis compared with zero in the control arm (p = 0.50). Engaging traditional healers might provide a culturally concordant opportunity to improve HIV testing uptake. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to examine the effects of a psychoeducational program on the cognitive emotion regulation levels of individuals with multiple sclerosis (MS). Design and Method: This study followed a randomized, controlled quasi‐experimental design. A questionnaire including descriptive characteristics and disease‐related characteristics and the Cognitive Emotion Regulation Questionnaire were used in the data collection. Findings: The difference between the pretest–posttest and follow‐up test mean scores of the patients in the experimental group was significant (p < 0.05). Conclusion: The psychoeducation program based on the rational emotional behavioral approach increased the use of cognitive emotion regulation strategies in individuals with MS. [ABSTRACT FROM AUTHOR]

Objective: Many individuals with an eating disorder do not receive appropriate care. Low‐threshold interventions could help bridge this treatment gap. The study aim was to evaluate the effectiveness of Featback, a fully automated online self‐help intervention, online expert‐patient support and their combination. Method: A randomized controlled trial with a 12‐month follow‐up period was conducted. Participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, a fully automated online self‐help intervention, (2) chat or email support from a recovered expert patient, (3) Featback with expert‐patient support and (4) a waiting list control condition. The intervention period was 8 weeks and there was a total of six online assessments. The main outcome constituted reduction of eating disorder symptoms over time. Results: Three hundred fifty five participants, of whom 43% had never received eating disorder treatment, were randomized. The three active interventions were superior to a waitlist in reducing eating disorder symptoms (d = −0.38), with no significant difference in effectiveness between the three interventions. Participants in conditions with expert‐patient support were more satisfied with the intervention. Discussion: Internet‐based self‐help, expert‐patient support and their combination were effective in reducing eating disorder symptoms compared to a waiting list control condition. Guidance improved satisfaction with the internet intervention but not its effectiveness. Low‐threshold interventions such as Featback and expert‐patient support can reduce eating disorder symptoms and reach the large group of underserved individuals, complementing existing forms of eating disorder treatment. Public significance statement: Individuals with eating‐related problems who received (1) a fully automated internet‐based intervention, (2) chat and e‐mail support by a recovered individual or (3) their combination, experienced stronger reductions in eating disorder symptoms than those who received (4) usual care. Such brief and easy‐access interventions play an important role in reaching individuals who are currently not reached by other forms of treatment. [ABSTRACT FROM AUTHOR]

Background: OSA is associated with metabolic syndrome (MS), but it is unclear whether OSA treatment with CPAP can revert MS.Research Question: Does OSA treatment with CPAP per se have effects on the MS reversibility and the associated metabolic, adiposity and vascular parameters?Study Design and Methods: The TREATOSA-MS trial is a randomized placebo-controlled trial that enrolled adult patients with a recent diagnosis of MS and moderate or severe OSA (apnea-hypopnea index [AHI], ≥ 15 events/h) to undergo therapeutic CPAP or nasal dilator strips (placebo group) for 6 months. Before and after each intervention, we measured anthropometric variables, BP, glucose, and lipid profile. To control potential-related mechanisms and consequences, we also measured adiposity biomarkers (leptin and adiponectin), body composition, food intake, physical activity, subcutaneous and abdominal fat (visceral and hepatic fat), and endothelial function.Results: One hundred patients (79% men; mean age, 48 ± 9 years; BMI, 33 ± 4 kg/m2; AHI, 58 ± 29 events/h) completed the study (n = 50 per group). The mean CPAP adherence was 5.5 ± 1.5 h/night. After 6 months, most patients with OSA randomized to CPAP retained the MS diagnosis, but the rate of MS reversibility was higher than observed in the placebo group (18% vs 4%; OR, 5.27; 95% CI, 1.27-35.86; P = .04). In the secondary analysis, CPAP did not promote significant reductions in the individual components of MS, weight, hepatic steatosis, lipid profile, adiponectin, and leptin, but did promote a very modest reduction in visceral fat and improved endothelial function (all analyses were adjusted for baseline values).Interpretation: Despite the higher rate of MS reversibility after CPAP therapy as compared with placebo, most patients retained this diagnosis. The lack of significant or relevant effects on adiposity biomarkers and depots supports the modest role of OSA in modulating MS.Trial Registration: ClinicalTrials.gov; No.: NCT02295202; URL: www.Clinicaltrials: gov. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE.Research Question: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?Study Design and Methods: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months.Results: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97).Interpretation: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.Trial Registry: ClinicalTrials.gov; No.: NCT02746185; URL: www.Clinicaltrials: gov. [ABSTRACT FROM AUTHOR]

Objectives: Use of Motivational Interviewing (MI) in education may improve medication-overuse headache (MOH) patients' ability to cope with pain. In a randomised controlled trial, we evaluated the effect of education focusing on behavioural change among MOH patients.Methods: Ninety-eight MOH patients were randomized (1:1) to standard treatment and 12-weeks of MI-based education versus standard treatment alone after detoxification. Outcome of interest was changes in coping strategies measured by the Coping Strategy Questionnaire at four- and nine months.Results: The educational program improved patients' perceived efficacy in the use of their coping strategies to control pain, both at four-and nine months follow-up (mean±SE): ∆:0.84 ± 0.35, 95% CI:0.16;1.52, p = 0.02 and: ∆: 0.90 ± 0.39, 95% CI:0.14;1.66, p = 0.02, respectively. No between-group differences were detected in the other coping subscales. Within the intervention group, the coping strategy subscales Catastrophizing, and Reinterpretation of pain sensation were significantly improved at nine months follow-up (p = 0.003 vs. p = 0.012, respectively). No changes were found in the control group.Conclusion: MI-based education focused on behavioural changes improved MOH patients' perceived efficacy in the use of their coping strategies to control pain.Practice Implications: Education based on MI could be valuable for MOH patients with respect to behavioural changes and perceived headache control. [ABSTRACT FROM AUTHOR]

Rationale: Laryngeal edema is a known complication of endotracheal intubation that may cause airway obstruction upon extubation. The only test available to predict this complication is the cuff leak test (CLT). Objectives: Given the uncertainty of the CLT's clinical utility, we conducted the COMIC (Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients) pilot study to examine the feasibility of undertaking a larger trial. Methods: COMIC is a multicentered, parallel-group randomized trial performed in Canada, Saudi Arabia, and Poland. We enrolled mechanically ventilated adults admitted to the intensive care unit who were deemed ready for extubation. Those allocated to the intervention arm had the results of their CLT communicated to the healthcare team, who then decided to proceed with extubation or not. In those randomized to the control arm, the CLT results were not communicated to the healthcare team and patients were extubated, regardless of the CLT result. The primary outcomes focused on feasibility. Results: One hundred patients (56 in the intervention and 44 in the control arm) were enrolled. All feasibility criteria were met, including 1) recruitment rate of 7.6 patients/month, 2) consent rate of 88.3% (95% confidence interval [CI], 82.1-94.5%), and 3) protocol adherence of 98% (95% CI, 95-100%). There were two episodes of clinically significant stridor in the intervention group and four patients who required reintubation in each group. Conclusions: The results of the COMIC pilot trial support the feasibility of a larger trial to determine the effect of the CLT on reintubation and clinically important stridor.Clinical trial registered with www.clinicaltrials.gov (NCT03372707). [ABSTRACT FROM AUTHOR]

Background: Evaluation of a complex intervention are often described as being diminished by difficulties regarding acceptability, compliance, delivery of the intervention, recruitment and retention. Research of peer learning for nursing students have found several positive benefits while studies of peer learning for newly graduated nurses are lacking. This study aimed (1) to investigate the study process in terms of (a) first-line managers' perspectives on the intervention study, the difficulties they face and how they handle these and (b) new graduates' fidelity to the intervention and (2) to examine the effect of the peer learning intervention in workplace introduction for newly graduated nurses. Methods: A mixed-methods approach using semi-structured interviews with eight managers, repeated checklist for fidelity and questionnaires conducted with 35 new graduates from June 2015 and January 2018, whereof 21 in the intervention group. The peer learning intervention's central elements included pairs of new graduates starting their workplace introduction at the same time, working the same shift and sharing responsibility for a group of patients for 3 weeks. The intervention also included 3 months of regular peer reflection. Results: Managers offered mostly positive descriptions of using peer learning during workplace introduction. The intervention fidelity was generally good. Because of recruitment problems and thereby small sample size, it was difficult to draw conclusions about peer learning effects and, thus, the study hypothesis could either be accepted or rejected. Thereby, the study should be regarded as a pilot. Conclusions: The present study found positive experiences of, from managers, and fidelity to the peer learning intervention; regarding the experimental design, there were lessons learned. Trial registration: Before starting data collection, a trial registration was registered at (Trial ID ISRCTN14737280). [ABSTRACT FROM AUTHOR]

Purpose: A diagnosis of cancer often derails an individual's goals. The purpose of this mixed-methods analysis was to describe the evolution of adolescent and young adult (AYA)-reported goals in the year after a diagnosis of new or advanced cancer. Methods: As part of the Promoting Resilience in Stress Management (PRISM) phase 2 randomized controlled trial, AYAs with cancer (ages 12–25 years) were asked at baseline, 6 months, and 12 months: "Please give an example of a goal you hope to accomplish over the next month/year." We used content analysis to categorize goals as follows: life milestones, physical health, mental/emotional health, cancer specific, and hobbies/interests. We summarized goal categories at each time point: for the entire cohort, by baseline diagnosis status (new vs. advanced cancer), treatment status (on-therapy vs. off-therapy), and baseline health-related quality of life (high vs. low). Results: Eighty-six participants completed the study and were included in the analysis (control: n = 41, PRISM: n = 45); 69 reported their goals at 6 months, and 54 at 12 months. Participants submitted a total of 169 goals at baseline, 148 at 6 months, and 126 at 12 months. At baseline, cancer-specific goals were most common for the short-term (35%), whereas milestone goals were most common for the long-term (46%). At 6 months, milestone goals were most common in both short- (38%) and long-term (51%) categories. A similar pattern was seen at 12 months. Conclusion: AYAs' goals change over the first year of their cancer experience, with a shift in short-term goals from cancer-specific goals at baseline to milestone goals at later time points. ClinicalTrials.gov (NCT02340884). [ABSTRACT FROM AUTHOR]

Hypertension is one of the serious health issues worldwide and requires medications and lifestyle modifications to prevent its serious complications. Lifestyle modification requires health literacy which is an important factor for people with hypertension to manage themselves to control blood pressure. Health literacy is the cognitive and social skills of individuals to acquire, access to, understand, and use information to stay healthy. This randomized controlled trial aimed to examine the effectiveness of Health Education and Health Empowerment Program to improve health literacy in Thai adults with uncontrolled hypertension. Two sub-district health promoting hospitals in a province in the east of Thailand were randomly selected and assigned to an intervention hospital and a control hospital. Twenty participants in each hospital were randomly selected. Participants in the experimental group received a 4-week Program, whereas participants in the control group received only usual care. The Health Literacy for Hypertension Questionnaire was administered at baseline (week 0), immediate post-in- tervention (week 4) and at follow-up after 4 weeks of intervention completion (week 8). Two-way mixed ANOVA and repeated measures were used to analyze the data. The results indicated that participants in intervention group had a significantly higher health literacy mean scores than those in the control group at immediately post-intervention and follow-up period. The mean scores of health literacy in hypertension in the intervention group had significantly increased over time. These findings indicate the benefit of the program in improving health literacy among people with uncontrolled hypertension. Further testing of the program with participants in other provinces is needed to validate the results before implementation in practice. [ABSTRACT FROM AUTHOR]

Objective: Youth with sickle cell disease (SCD) are at risk for neurocognitive deficits including problems with working memory (WM), but few interventions to improve functioning exist. This study sought to determine the feasibility and efficacy of home-based, digital WM training on short-term memory and WM, behavioral outcomes, and academic fluency using a parallel group randomized controlled trial design.Methods: 47 children (7-16 years) with SCD and short-term memory or WM difficulties were randomized to Cogmed Working Memory Training at home on a tablet device (N = 24) or to a standard care Waitlist group (N = 23) that used Cogmed after the waiting period. Primary outcomes assessed in clinic included performance on verbal and nonverbal short-term memory and WM tasks. Secondary outcomes included parent-rated executive functioning and tests of math and reading fluency.Results: In the evaluable sample, the Cogmed group (N = 21) showed greater improvement in visual WM compared with the Waitlist group (N = 22; p = .03, d = 0.70 [CI95 = 0.08, 1.31]). When examining a combined sample of participants, those who completed ≥10 training sessions exhibited significant improvements in verbal short-term memory, visual WM, and math fluency. Adherence to Cogmed was lower than expected (M = 9.07 sessions, SD = 7.77), with 19 participants (41%) completing at least 10 sessions. Conclusions: Visual WM, an ability commonly affected by SCD, is modifiable with cognitive training. Benefits extended to verbal short-term memory and math fluency when patients completed a sufficient training dose. Additional research is needed to identify ideal candidates for training and determine whether training gains are sustainable and generalize to real-world outcomes. [ABSTRACT FROM AUTHOR]

Objective: Unintentional injuries are the leading cause of death for children under 19 years of age. For preschoolers, many injuries occur in the home. Addressing this issue, this study assessed if a storybook about home safety could be effective to increase preschoolers' safety knowledge and reduce their injury-risk behaviors.Methods: Applying a randomized controlled trial design, normally developing English speaking preschool children (3.5-5.5 years) in Southwestern Ontario Canada were randomly assigned to the control condition (a storybook about healthy eating, N = 30) or the intervention condition (a storybook about home hazards, N = 29). They read the assigned storybook with their mother for 4 weeks; time spent reading was tracked, and fidelity checks based on home visits were implemented.Results: Comparing postintervention knowledge, understanding score, and risk behaviors across groups revealed that children who received the intervention were able to identify more hazards, provide more comprehensive safety explanations, and demonstrate fewer risky behaviors compared with children in the control group (ηp2 = 0.13, 0.19, and 0.51, respectively), who showed no significant changes over time in safety knowledge, understanding, or risk behaviors. Compliance with reading the safety book and fidelity in how they did so were very good.Conclusions: A storybook can be an effective resource for educating young children about home safety and reducing their hazard-directed risk behaviors. [ABSTRACT FROM AUTHOR]

Background: Advance care planning (ACP) is intended to help patients and their spokespersons prepare for end-of-life decision making, yet little is known about what factors influence the extent to which spokespersons feel prepared for that role. Objective: To examine spokespersons' perceived preparedness for surrogate decision making after engaging in ACP. Design: Mixed methods experimental design with qualitative thematic analysis and data transformation (creating categorical data from rich qualitative data) of interviews collected during a randomized controlled trial (2012–2017). Setting/Participants: Two tertiary care medical centers (Hershey, PA and Boston, MA). Of 285 dyads (patients with advanced illness and their spokespersons) enrolled in the trial, 200 spokesperson interviews were purposively sampled and 198 included in the analyses. Main Outcomes and Measures: Interviews with spokespersons (four weeks post-intervention) explored spokespersons' perceived preparedness for surrogate decision making, occurrence of ACP conversations, and spokespersons' intentions regarding future surrogate decisions. Data transformation was used to categorize participants' responses into three categories: Very Prepared, Very Unprepared, or In Between Prepared and Unprepared. Themes and categories were compared across arms. Results: About 72.72% of spokespersons (144/198) reported being Very Prepared and 27.28% (54/198) reported being Very Unprepared or In Between with no differences in preparedness across study arms. Occurrence of post-intervention ACP conversations did not influence perceived preparedness; however, spokespersons who used an ACP decision aid reported more conversations. Four themes emerged to explain spokespersons' perceived preparedness: (1) perceptions about ACP; (2) level of comfort with uncertainty; (3) relational issues; and (4) personal characteristics. Regarding future intentions, it emerged that spokespersons believed their knowledge of patient wishes, as well as other personal, relational, situational, and emotional factors would influence their surrogate decisions. Conclusions: Factors extrinsic to specific ACP interventions influence how prepared spokespersons feel to act as spokespersons. Understanding these factors is important for understanding how to improve concordance between patients' stated end-of-life wishes and surrogate decisions. Trial Registration: NCT02429479 [ABSTRACT FROM AUTHOR]

Clinical practice guidelines support cognitive rehabilitation for people with a history of mild traumatic brain injury (mTBI) and cognitive impairment, but no class I randomized clinical trials have evaluated the efficacy of self-administered computerized cognitive training. The goal of this study was to evaluate the efficacy of a self-administered computerized plasticity-based cognitive training programmes in primarily military/veteran participants with a history of mTBI and cognitive impairment. A multisite randomized double-blind clinical trial of a behavioural intervention with an active control was conducted from September 2013 to February 2017 including assessments at baseline, post-training, and after a 3-month follow-up period. Participants self-administered cognitive training (experimental and active control) programmes at home, remotely supervised by a healthcare coach, with an intended training schedule of 5 days per week, 1 h per day, for 13 weeks. Participants (149 contacted, 83 intent-to-treat) were confirmed to have a history of mTBI (mean of 7.2 years post-injury) through medical history/clinician interview and persistent cognitive impairment through neuropsychological testing and/or quantitative participant reported measure. The experimental intervention was a brain plasticity-based computerized cognitive training programme targeting speed/accuracy of information processing, and the active control was composed of computer games. The primary cognitive function measure was a composite of nine standardized neuropsychological assessments, and the primary directly observed functional measure a timed instrumental activities of daily living assessment. Secondary outcome measures included participant-reported assessments of cognitive and mental health. The treatment group showed an improvement in the composite cognitive measure significantly larger than that of the active control group at both the post-training [+6.9 points, confidence interval (CI) +1.0 to +12.7, P = 0.025, d = 0.555] and the follow-up visit (+7.4 points, CI +0.6 to +14.3, P = 0.039, d = 0.591). Both large and small cognitive function improvements were seen twice as frequently in the treatment group than in the active control group. No significant between-group effects were seen on other measures, including the directly-observed functional and symptom measures. Statistically equivalent improvements in both groups were seen in depressive and cognitive symptoms. [ABSTRACT FROM AUTHOR]

Background: Target lesion failure remains an issue with contemporary drug-eluting stents. Thus, the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was designed to further improve early healing. This study aimed to investigate whether the DTS is noninferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population.Methods: The SORT OUT X (Combo Stent Versus Orsiro Stent) trial, was a large-scale, randomized, multicenter, single-blind, 2-arm, noninferiority trial with registry-based follow-up. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction, or target lesion revascularization within 12 months, analyzed using intention-to-treat. The trial was powered for assessing target lesion failure noninferiority of the DTS compared with the SES with a predetermined noninferiority margin of 0.021.Results: A total of 3146 patients were randomized to treatment with the DTS (1578 patients; 2008 lesions) or SES (1568 patients; 1982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%) assigned the DTS and 58 patients (3.7%) assigned the SES met the primary end point (absolute risk difference, 2.6% [upper limit of 1-sided 95% CI, 4.1%]; P (noninferiority)=0.76). The SES was superior to the DTS (incidence rate ratios for target lesion failure, 1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was explained mainly by a higher incidence of target lesion revascularization in the DTS group compared with the SES group (53 [3.4%] vs. 24 [1.5%]; incidence rate ratio, 2.22 [95% CI, 1.37-3.61]; P=0.0012).Conclusions: The DTS did not confirm noninferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the 2 stent groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03216733. [ABSTRACT FROM AUTHOR]

Background: This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral recession type 1 multiple gingival recessions after 6 months postoperatively.Methods: A total of 21 patients were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelialized (DE) SCTG. Periodontal clinical parameters and esthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and esthetics were assessed with visual analogue scale after 7 days and 6 months, respectively.Results: All clinical parameters, with the exception of probing depth, demonstrated differences in intragroup evaluation, comparing baseline to 6-month evaluation (P <0.05). Both groups presented reduction of recession depth and recession width and gain of keratinized tissue thickness, keratinized tissue width, and clinical attachment level (P <0.05). Intergroup comparison (DBS × DE) demonstrated no significant differences considering clinical parameters and periods. Both techniques improved esthetics evaluated by patients, without a difference between groups in patients and professional analysis. However, DBS group presented inferior pain/discomfort compared with DE (P <0.05).Conclusion: DBS and DE associated with CAF presented satisfactory clinical outcomes. However, DBS presented inferior morbidity, an important fact for decision-making process. [ABSTRACT FROM AUTHOR]

Aims: Medical procedures and hospitalizations can be experienced as traumatic and can lead to post-traumatic stress reactions. Eye movement desensitization and reprocessing (EMDR) shows promising results but very few long-term studies have been published. Therefore, our aim was to test the long-term (8 months post-treatment) effectiveness of EMDR in children and adolescents with medically related subthreshold post-traumatic stress disorder (PTSD). Methods and results: Seventy-four children (including 39 with congenital or acquired heart disease) aged 4–15 (M = 9.6 years) with subthreshold PTSD after previous hospitalization were included into a parallel group randomized controlled trial. Participants were randomized to EMDR (n = 37) or care-as-usual (CAU) (n = 37; medical care only). The primary outcome was PTSD symptoms of the child. Secondary outcomes were symptoms of depression and blood–injection–injury (BII) phobia, sleep problems, and health-related quality of life (HrQoL) of the child. Assessments of all outcomes were planned at baseline and 8 weeks and 8 months after the start of EMDR/CAU. We hypothesized that the EMDR group would show significantly more improvements on all outcomes over time. Both groups showed improvements over time on child's symptoms of PTSD (only parent report), depression, BII phobia, sleep problems, and most HrQoL subscales. GEE analyses showed no significant differences between the EMDR group (nT2 = 33, nT3 = 30) and the CAU group (nT2 = 35, nT3 = 32) on the primary outcome. One superior effect of EMDR over time was found for reducing parent-reported BII phobia of the child. Conclusion: EMDR did not perform better than CAU in reducing subthreshold PTSD up to 8 months post-treatment in previously hospitalized children. Possible explanations and clinical implications are discussed. [ABSTRACT FROM AUTHOR]

Background: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time.Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the International Classification of Sleep Disorders (second edition) were included. The study comprised a ≥17-day observation period and a 3-week treatment period during which modafinil (200 mg) or placebo was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety.Results: In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 min; p < 0.001). AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively. Frequent AEs in the modafinil group were headache (n = 6), dry mouth (n = 3), and nausea (n = 3); no clinically significant AEs occurred.Conclusion: Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time.Clinical Trial Registration: JapicCTI; 142539. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to investigate the effectiveness of a Computer-based Cognitive Behavioral Therapy (CCBT) and identify the characteristics of depressed adolescents that participated in the CCBT program.Methods: Screening tests for depression and help-seeking variables were conducted in school-aged Korean adolescents (n= 376, mean age=15.71 years, 53.7% female). The number of adolescents that scored above the threshold for mild depression (PHQ-9, CES-D) was 139. Fifty adolescents agreed to participate in the randomized controlled trial (RCT) of CCBT program. Twenty-five adolescents were randomly assigned to the treatment group, and the other 25 to the waitlist control group. The treatment group engaged in CCBT with therapeutic support. To identify variables affecting the outcomes, the quality of their homework compliance also was assessed.Results: Participants (n=50) who agreed to participate in the CCBT program demonstrated different help-seeking attitudes - a greater recognition of the need for help and lower interpersonal openness - compared to the adolescents (n=87) who did not participate (t = -2.93, p < .01; t = 3.50, p < .001). The treatment group showed significant improvements in depression, self-esteem, and quality of life compared to the waitlist group. Adolescents with high homework compliance showed a significant decrease in the depression scores compared to adolescents with low homework compliance.Limitations: Small sample size, no follow-up assessments.Conclusion: CCBT could be an effective alternative for depressed adolescents, especially those who tend to have low interpersonal openness. To improve the effects of CCBT, therapeutic support needs to be provided. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of studying creatine in juvenile dermatomyositis (JDM). Secondary objectives were to determine the effect of creatine on muscle function and metabolism, aerobic capacity, fatigue, physical activity, and quality of life (QOL), as well as its safety.Methods: We conducted a 6-month, double-blind, randomized, multiple-baseline design; patients were assigned to creatine or placebo. Feasibility was assessed using attended study visits, completed study procedures, and adherence. Muscle function, aerobic capacity, and muscle strength were assessed with standardized exercise tests. Muscle metabolism was assessed using a 31-Phosphorus Magnetic Resonance Spectroscopy protocol. Fatigue, physical activity, and QOL were assessed by questionnaires. Statistical significance was estimated using a randomization (permutation) test. Changes in outcome measures taken at baseline and end-of-study were calculated using paired t-tests.Results: Median (range) adherence to the study drug was 88.5% (20.5-95.5%) and the proportion of subjects with 80% adherence or higher was 76.9%. There were no missed study visits. There were no statistically significant changes in muscle function, strength, aerobic capacity, disease activity, fatigue, physical activity, or QOL while subjects were receiving creatine compared to placebo. There were statistically significant adaptations in muscle metabolism (e.g., decrease in change in muscle pH following exercise, and decrease in phosphate/phosphocreatine ratio) at the end-of-study compared to baseline. There were no significant adverse effects.Conclusion: Creatine supplementation in children with JDM is feasible to study, and is safe and well-tolerated; it may lead to improvements in muscle metabolism. [ABSTRACT FROM AUTHOR]

Few comprehensive primary prevention approaches for youth have been evaluated for effects on multiple types of violence. Dating Matters®: Strategies to Promote Healthy Teen Relationships (Dating Matters) is a comprehensive teen dating violence (TDV) prevention model designed by the Centers for Disease Control and Prevention and evaluated using a longitudinal stratified cluster-randomized controlled trial to determine effectiveness for preventing TDV and promoting healthy relationship behaviors among middle school students. In this study, we examine the prevention effects on secondary outcomes, including victimization and perpetration of physical violence, bullying, and cyberbullying. This study examined the effectiveness of Dating Matters compared to a standard-of-care TDV prevention program in 46 middle schools in four high-risk urban communities across the USA. The analytic sample (N = 3301; 53% female; 50% Black, non-Hispanic; and 31% Hispanic) consisted of 6th-8th grade students who had an opportunity for exposure to Dating Matters in all three grades or the standard-of-care in 8th grade only. Results demonstrated that both male and female students attending schools implementing Dating Matters reported 11% less bullying perpetration and 11% less physical violence perpetration than students in comparison schools. Female Dating Matters students reported 9% less cyberbullying victimization and 10% less cyberbullying perpetration relative to the standard-of-care. When compared to an existing evidence-based intervention for TDV, Dating Matters demonstrated protective effects on physical violence, bullying, and cyberbullying for most groups of students. The Dating Matters comprehensive prevention model holds promise for reducing multiple forms of violence among middle school-aged youth. ClinicalTrials.gov Identifier: NCT01672541. [ABSTRACT FROM AUTHOR]

Background: Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions.Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open-label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis.Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except the mean age of the intervention group, which was higher compared to the control group (63.96 ± 7.86 versus 59.52 ± 5.93, p-value = 0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35% ± 2.15% versus 91.17% ± 9.76%, p < 0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (Z=-2.65, p < 0.01). The control group showed a non-significant increase (Z=-1.79, p = 0.07).Conclusion: The MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention.Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296 . [ABSTRACT FROM AUTHOR]

Background: Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical antibiotics in prevention of SSI.Methods: This was a double-blind randomized trial on patients with acute appendicitis who underwent open appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction.Results: 205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p = 0.005) and SSO (24.6% Vs 13.4% Vs 43.5%; p = 0.0003) as compared to group III. Groups I and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.Conclusions: Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve the outcome and did not decrease rates of SSI or other complications. [ABSTRACT FROM AUTHOR]

Background: A current recommendation for the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) is conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF). This randomized NPC-0501 trial evaluated the therapeutic effect of changing to an induction-concurrent sequence or accelerated-fractionation sequence, and/or replacing 5-fluorouracil with capecitabine (X).Methods: Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially were randomly allocated to 1 of 6 treatment arms (6-arm full-randomization cohort). The protocol was amended in 2009 to permit centers to opt out of randomization regarding fractionation (3-arm chemotherapy cohort).Results: A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012. Based on the overall comparisons, neither changing the chemotherapy sequence nor accelerated fractionation improved treatment outcome. However, secondary analyses demonstrated that when adjusted for RT parameters and other significant factors, the induction-concurrent sequence, especially the induction-PX regimen, achieved significant improvements in progression-free survival (PFS) and overall survival. Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons. Comparison of the induction-PX versus the adjuvant-PF regimen demonstrated better PFS (78% vs 62%; P = .027) without an increase in overall late toxicity.Conclusions: For patients irradiated using conventional fractionation, changing the chemotherapy sequence from a concurrent-adjuvant to an induction-concurrent sequence, particularly using induction cisplatin and capecitabine, potentially could improve efficacy without an adverse impact on late toxicity. However, further validation is needed for confirmation of these findings. [ABSTRACT FROM AUTHOR]

The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group (n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group (n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes (PROs) refer to any report of the status of a patient's health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patient's response by a clinician or any other external party. While many PROs, such as the Pediatric Quality of Life Inventory (PedsQL), were originally administered in paper-and-pencil format, these are now available as electronic versions (ePROs). Although ePROs might well have used the same structure as their paper versions, we developed an alternate ePedsQL incorporating three software functions: 1) a non-forcing non-response alert, 2) a conditional question branch of the School Functioning Scale that only displays for (pre) school children, and 3) a vertical item-by-item display for small-screen devices. This report evaluated the effect of these functions on item non-response rate, survey completion time, and user experience. Methods: All surveys were conducted via the online/computer mode. We compared the dynamic format containing the three functions with the basic format in a randomized comparative study in 2803 children and 6289 caregivers in Japan. Results: We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = − 4.411, p < 0.001 by generalized linear mixed model analysis). The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit (CFI 0.933, RMSEA 0.060, SRMR 0.038) but the errors of observed variables were larger for the dynamic format than the basic format. Conclusions: We confirmed the robustness of the ePedsQL in different formats. The non-response rate of ePedsQL was very low even in the absence of an alert. The branch and item-by-item display were effective but unnecessary for all populations. Our findings further understanding of how humans respond to special software functions and different digital survey formats and provide new insight on how the three tested functions might be most successfully implemented. [ABSTRACT FROM AUTHOR]

Study Question: Does an artificially induced FSH surge at the time of hCG trigger improve IVF/ICSI outcomes?Summary Answer: An additional FSH bolus administered at the time of hCG trigger has no effect on clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate in women undergoing the long GnRH agonist (GnRHa) protocol for IVF/ICSI.What Is Known Already: Normal ovulation is preceded by a surge in both LH and FSH. Few randomized clinical trials have specifically investigated the role of the FSH surge. Some studies indicated that FSH given at hCG ovulation trigger boosts fertilization rate and even prevents ovarian hyperstimulation syndrome (OHSS).Study Design, Size, Duration: This was a randomized, double-blinded, placebo-controlled trial conducted at a single IVF center, from June 2012 to November 2013. A sample size calculation indicated that 347 women per group would be adequate. A total of 732 women undergoing IVF/ICSI were randomized, using electronically randomized tables, to the intervention or placebo groups. Participants and clinical doctors were blinded to the treatment allocation.Participants/materials, Setting, Methods: Patients aged ≤42 years who were treated with IVF/ICSI owing to tubal factor, male factor, unexplained, endometriosis and multiple factors were enrolled in this trial. Subjects all received a standard long GnRHa protocol for IVF/ICSI and hCG 6000-10 000 IU to trigger oocyte maturation. A total of 364 and 368 patients were randomized to receive a urinary FSH (uFSH) bolus (6 ampules, 450 IU) and placebo, respectively, at the time of the hCG trigger. The primary outcome measure was clinical pregnancy rate. The secondary outcome measures were FSH level on the day of oocyte retrieval, number of oocytes retrieved, good-quality embryo rate, live birth rate and rate of OHSS.Main Results and the Role Of Chance: There were no significant differences in the baseline demographic characteristics between the two study groups. There were also no significant differences between groups in cycle characteristics, such as the mean number of stimulation days, total gonadotrophin dose and peak estradiol. The clinical pregnancy rate was 51.6% in the placebo group and 52.7% in the FSH co-trigger group, with an absolute rate difference of 1.1% (95% CI -6.1% to 8.3%). The number of oocytes retrieved was 10.47 ± 4.52 and 10.74 ± 5.01 (P = 0.44), the rate of good-quality embryos was 37% and 33.9% (P = 0.093) and the implantation rate was 35% and 36% (P = 0.7) in the placebo group and the FSH co-trigger group, respectively.Limitations, Reasons For Caution: This was a single-center study, which may limit its effectiveness. The use of uFSH is a limitation, as this is not the same as the natural FSH. We did not collect follicular fluid for further study of molecular changes after the use of uFSH as a co-trigger.Wider Implications Of the Findings: Based on previous data and our results, an additional FSH bolus administered at the time of hCG trigger has no benefit on clinical pregnancy rates in women undergoing the long GnRHa protocol in IVF/ICSI: a single hCG trigger is sufficient.Study Funding/competing Interest(s): This study was supported by the National Key Research and Development Program of China (2016YFC1000205); Sun Yat-Sen University Clinical Research 5010 Program (2016004); the Science and Technology Project of Guangdong Province (2016A020216011 and 2017A020213028); and Science Technology Research Project of Guangdong Province (S2011010004662). There are no conflicts of interest to declare.Trial Registration Number: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-12002246).Trial Registration Date: 20 May 2012.Date Of First Patient’s Enrolment: 10 June 2012. [ABSTRACT FROM AUTHOR]

Background: Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.Methods: The messages were designed by a panel of experts, and SMS Quality Evaluation Questionnaire was used to evaluate their quality. A two-arm randomized controlled trial was conducted to evaluate the effectiveness of this management model. Participants were randomly divided into an intervention group (IG) who received evaluated messages and a control group (CG) who received regular education. The primary outcomes were changes in plasma glucose and control rates, and the secondary outcomes were improvements in diet control, physical activities, weight control, etc. RESULTS: A total of 42 messages covering five main domains: health awareness, diet control, physical activities, living habits and weight control were designed, and the average scores of the messages were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. In the SMS intervention, 171 patients with an average age of 55.1 years were involved, including 86 in the CG and 85 in the IG. At 12 months, compared with the control group (CG), the decrease of fasting plasma glucose (FPG) (1.5 vs. 0.4, P = 0.011) and control rate (49.4% vs. 33.3%, P = 0.034), the postprandial glucose (PPG) (5.8 vs. 4.2, P = 0.009) and control rate (57.8% vs. 33.7%, P = 0.002) were better in the intervention group (IG). In terms of self-management, improvements in weight control (49.3% vs. 28.2%, P = 0.031), vegetables consumption (87.3% vs. 29.0%, P < 0.001), fruits consumption (27.5% vs. 7.4%, P = 0.022), and physical activities (84.7% vs. 70.0%, P = 0.036) were better in the IG than in the CG.Conclusions: The overall quality of the messages was high. It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.Trial Registration: Clinicaltrials.gov, ChiCTR1900023445. Registered May 28, 2019--Retrospectively registered. [ABSTRACT FROM AUTHOR]

Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians' trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea. [ABSTRACT FROM AUTHOR]

Background: Effects of very low carbohydrate (VLC) diets on appetite response in individuals with type 2 diabetes remain unclear.Objective: A secondary analysis was conducted to determine appetite responses to an energy-restricted [30% of energy (%E) deficit] very low carbohydrate (VLC) diet compared with a higher carbohydrate (HC) diet in adults who were overweight or obese with type 2 diabetes.Methods: Forty-four men and 40 women (mean ± SD, age: 58.7 ± 6.6 y; weight: 100.4 ± 15.5 kg; BMI: 34.5 ± 4.1 kg/m2; glycated hemoglobin: 7.3 ± 1.0%; duration of diabetes: 6.7 ± 5.6 y) were randomly assigned to diets categorized as VLC [14%E carbohydrate (<50 g/d), 28%E protein, 58%E fat (<10%E saturated fat)], or energy-matched HC [53%E carbohydrate, 17%E protein, 30%E fat (<10%E saturated fat)] combined with progressive multicomponent exercise (60 min; 3 d/wk). Body weight, average weekly "daily fasting" and "daily overall" appetite perceptions (hunger, fullness, prospective consumption, and desire to eat-visual analog scales) were assessed at baseline and after 4 and 16 wk. Changes between diets over time were assessed using repeated measures ANOVA.Results: Significant decreases in body weight did not differ between groups (VLC: -11.0 ± 5.4 kg/16 wk compared with HC: -10.1 ± 4.3 kg/16 wk, P = 0.40). Compared with HC, VLC had greater decreases in "daily overall" ratings of fullness (P time × diet < 0.01), such that scores were higher in HC at Week 4 (VLC:48 ± 3 vs HC:56 ± 3 mm, P = 0.001) and 16 (VLC:51 ± 2 vs HC:57 ± 3 mm, P = 0.019). Compared with HC, VLC had greater increases in prospective consumption ratings (P time × diet = 0.03), such that scores were lower in HC at Week 4 (VLC:33 ± 2 vs HC:28 ± 2 mm, P = 0.008), but not at Week 16 (VLC:33 ± 2 vs HC 31 ± 2 mm, P = 0.289).Conclusions: In the context of energy restriction, both HC and VLC energy-matched diets promoted comparable effects on fasting perceptions of appetite, but the HC diet resulted in greater "daily overall" fullness and reduced prospective consumption. Further research is required to evaluate the effects of ad libitum diets differing in amounts of carbohydrate on appetite response in populations with type 2 diabetes. This trial was registered at www.anzctr.org.au as ACTRN12612000369820. [ABSTRACT FROM AUTHOR]

Background: Internet-based intervention could help drug users recover from drug dependence. This study evaluated the effectiveness of a newly developed web-based relapse prevention program (e-SMARPP) for people with a drug problem, including the use of methamphetamine, in Japan.Methods: The study was a pilot randomized controlled trial comprised of 48 psychiatric outpatients diagnosed with drug use disorder. The participants were randomly assigned to an eight-week, six-session web-based relapse prevention program (an intervention group) or only web-based self-monitoring (a control group). The primary outcome was the duration of abstinence from a primary drug during the intervention and relapse risk. Secondary outcomes included motivation to change, self-efficacy, and money spent on drugs. The outcomes, except for the duration of abstinence during the intervention, were assessed at baseline, 2-, 5-, and 8-months. Program completion rate was also assessed.Results: No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes. The effect size of the duration of abstinence during the intervention was d = 0.42, which was comparable to previous studies. In the intervention group, about 26% did not complete the entire intervention.Conclusions: e-SMARPP failed to demonstrate efficacy, however, is potentially helpful for enhancing abstinence. The low attrition rate may suggest the acceptance and feasibility of the program. Further improvement of the program and evaluation in a full-scale trial are needed. [ABSTRACT FROM AUTHOR]

Background: The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.Objective: This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.Methods: The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).Results: The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.Conclusions: The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.Trial Registration: Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3. [ABSTRACT FROM AUTHOR]

Objective: Psychoeducation forms part of the current practice for ADHD; however, its efficacy is yet to be established. Method: Sixty-nine children/adolescents with ADHD were randomly assigned for their families to receive either a well-structured psychoeducation program (n = 35), or belong to a control group (treatment-as-usual, n = 34). Results: One-way analyses of variance showed a statistically significant Treatment × Time interaction, for ADHD total symptoms, inattention/cognition, and hyperactivity/impulsivity subdomains according to the parents, the first two with medium-large effect sizes. The effects of the intervention on the ADHD total and the inattention/cognition domain persisted after 6 months follow-up. No significant differences in teacher ratings were found; however, an improvement in clinical functioning as measured by clinicians was observed. Conclusion: This psychoeducation program has shown effectiveness in reducing ADHD symptoms when compared with treatment as usual. Psychoeducation needs to be considered as a valid and additional approach in ADHD. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy.Methods: Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later).Results: A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016).Conclusions: CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted. [ABSTRACT FROM AUTHOR]

Background and Aims: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.Methods: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.Results: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.Conclusions: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site. [ABSTRACT FROM AUTHOR]

Objectives: Trauma resuscitations are complex critical care events that present patient safety-related risk. Simulation-based leadership training is thought to improve trauma care; however, there is no robust evidence supporting the impact of leadership training on clinical performance. The objective of this study was to assess the clinical impact of simulation-based leadership training on team leadership and patient care during actual trauma resuscitations.Design: Randomized controlled trial.Setting: Harborview Medical Center (level 1 trauma center).Subjects: Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed.Interventions: Subjects were randomized to a 4-hour simulation-based leadership training (intervention) or standard orientation (control) condition.Measurements and Main Results: Participant-led actual trauma resuscitations were video recorded and coded for leadership behaviors and patient care. We used random coefficient modeling to account for the nesting effect of multiple observations within residents and to test for post-training group differences in leadership behaviors while controlling for pre-training behaviors, Injury Severity Score, postgraduate training year, and days since training occurred. Sixty participants completed the study. There was a significant difference in post-training leadership behaviors between the intervention and control conditions (b1 = 4.06, t (55) = 6.11, p < 0.001; intervention M = 11.29, SE = 0.66, 95% CI, 9.99-12.59 vs control M = 7.23, SE = 0.46, 95% CI, 6.33-8.13, d = 0.92). Although patient care was similar between conditions (b = 2.00, t (55) = 0.99, p = 0.325; predicted means intervention M = 62.38, SE = 2.01, 95% CI, 58.43-66.33 vs control M = 60.38, SE = 1.37, 95% CI, 57.69-63.07, d = 0.15), a test of the mediation effect between training and patient care suggests leadership behaviors mediate an effect of training on patient care with a significant indirect effect (b = 3.44, 95% CI, 1.43-5.80). Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001).Conclusions: Leadership training resulted in the transfer of complex skills to the clinical environment and may have an indirect effect on patient care through better team leadership. [ABSTRACT FROM AUTHOR]

Background: Photoactivated disinfection (PAD) could support the periodontal treatment outcome. The effect of the light emitting diode (LED) as an innovative light source in PAD is under discussion. The aim of this study was to evaluate the clinical and microbiological effect of adjunctive PAD in the treatment of periodontitis with a red LED as light source.Methods: Twenty patients with periodontitis completed this split-mouth study. The left and right side of the jaws were randomly assigned to either test or control group. After conservative periodontal treatment in both groups, the test group received two sessions of adjunctive PAD (red LED, 635 nm, photosensitive dye, 0.01% tolonium chloride), whereas the control group received no adjunctive PAD. The parameters of clinical periodontal examination-including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) and microbiological assays (PCR) were evaluated before and after treatment.Results: After 3 months, both treatment groups showed significant improvements regarding BOP, PD, and CAL compared to baseline, with no significant difference between control and treatment group. The recolonization of Porphyromonas gingivalis and Treponema denticola was reduced after adjuvant treatment, but not significantly.Conclusions: The positive effect of adjunctive PAD regarding clinical parameters was reported in recent trials. In this study and with the current settings, both treatment groups showed similar clinical results after initial periodontal treatment, without beneficial effect of adjunctive PAD. [ABSTRACT FROM AUTHOR]

Context: The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.Objectives: We examined the effect of two doses of prophylactic FSS on exertional dyspnea.Methods: In this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%-45% (high dose) or 15%-25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function.Results: Thirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change -1.42; 95% CI -2.37, -0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change -0.47; 95% CI -1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected.Conclusion: Prophylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials. [ABSTRACT FROM AUTHOR]

Objective: In vitro studies showed superior impression correctness for one-stage impressions. However, clinical data, especially clinical trials, are lacking in this matter. The aim of the study was to investigate the three-dimensional correctness of impressions for final restorations applying three different impression techniques. Method and Materials: Three impressions each were made from 48 patients with different techniques using metal stock trays. In a randomized order, one-stage putty-wash, two-stage putty-wash, and monophase impressions (respectively, Dimension Penta H and Garant L, Dimension Penta H Quick and Garant L Quick, Impregum Penta; 3M ESPE) were made with either polyvinyl siloxane or polyether materials. The double-cord technique was applied at all abutment teeth. Factors potentially influencing the correctness of the impressions were recorded. The precision of the impressions was three-dimensionally analyzed using the resulting gypsum models. Discrepancies between the impressions were calculated using the one-stage putty-wash impression as reference. Results: Discrepancies between the one-stage puttywash impressions and the monophase impressions are significantly lower compared with two-stage putty-wash impressions. The depth of the most subgingival portion of the preparation margin significantly influences the discrepancies between the impression techniques. Conclusion: In light of the major influence of clinical parameters on impression correctness, one-stage procedures should be favored. These findings support the results of in vitro investigations. [ABSTRACT FROM AUTHOR]

Objectives: To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia.Design: Prospective, randomized, controlled study.Setting: Thirty-three hospitals in China.Patients: A total of 710 adults 18-75 years old with severe community-acquired pneumonia.Interventions: Participants in the XueBiJing group received XueBiJing, 100 mL, q12 hours, and the control group received a visually indistinguishable placebo.Measurements and Main Results: The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]).Conclusions: In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay. [ABSTRACT FROM AUTHOR]

Background: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants.Methods: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight.Results: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008).Conclusions: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of tai chi exercise on cardiac and static lung function for older community-dwelling adults at risk of ischemic stroke. Methods: A total of 170 older community-dwelling adults (aged 55–75 years old) at risk of ischemic stroke were allocated to either tai chi training group (85 cases, five 60-min sessions of tai chi training per week for 12 weeks) or control group (85 cases, usual pbysical activity for 12 weeks) using a computer-generated randomization. The echocardiographic parameters of cardiac structure, cardiac function and static lung function were measured at baseline, after 12 weeks of intervention and additional 12-week follow-up period by a blinded professional staffmember using a color Doppler ultrasound imaging device or a cardiopulmonary function instrument. The t test and linear mixed model based on the intentionto-treat analysis principle was used to calculate the effect. The adverse effect was observed. Results: Most of echocardiographic parameters on the cardiac structure, cardiac function and static lung function between the tai chi group and control group did not have a significant difference either post 12-week intervention or additional 12-week follow-up period. Only three parameters involving in right ventricular diameter (P=0.024), main pulmonary artery diameter (P=0.002) and vital capacity maximum (P=0.036) were beneficial to be improved in the tai chi group compared to the control group by the analysis of mixed linear model. No adverse effects were found during the intervention period. Conclusion: The 12-week tai chi exercise did not have an obvious beneficial effect on cardiac structure, cardiac function and static lung function in older community-dwelling adults at risk of ischemic stroke. The study with a longer duration of intervention should be necessary. (Trial registration No. ChiCTR-TRC-13003601) [ABSTRACT FROM AUTHOR]

Background: Defense mechanisms play an important role in the development and maintenance of both health and psychopathology. Research is still in the early stages of investigating the specific relationships among diagnostic groups and defense mechanisms along with their response to different treatment types.Methods: For the present study a total of 47 outpatients diagnosed with depression or anxiety disorders were randomized to receive 25±3 sessions of cognitive-behavioral therapy with integrated elements of either emotion-focused therapy (CBT + EFT) or treatment components based on self-regulation theory (CBT + SR). An observer-rated method, the Defense Mechanism Rating Scale (DMRS) was used to code transcripts of the 1st, 8th, 16th and 24th session to assess change in defensive functioning.Results: Over the course of therapy, overall defensive functioning (ODF) as well as adaptive defenses increased significantly, whereas maladaptive and neurotic defenses did not change. At the beginning of treatment, the proportion of adaptive defenses and ODF was significantly higher in patients diagnosed with anxiety disorders than in patients with depressive disorders. However, depressed patients exhibited greater improvement in their defensive functioning over the course of therapy.Conclusions: Results support the view of defense mechanisms as a useful transdiagnostic and transtheoretical concept and supports the notion that change of defense mechanisms may be a relevant mechanism of change in psychotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care.Methods: In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire.Results: Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life.Conclusions: This person-centred intervention did not result in increased costs and dominated the standard medical care.Trial Registration: ClinicalTrials.gov (registration number: NCT02982746). [ABSTRACT FROM AUTHOR]

Abstract Objective To evaluate the effects of a supermarket meal bundling and electronic reminder intervention on food choices of families with children. Design Quasi-experimental (meal bundling) and randomized, controlled trial (electronic reminders). Setting Large supermarket in Maine during 40-week baseline and 16-week intervention periods in 2015–2016. Participants English-speaking adults living with at least 1 child aged ≤18 years (n = 300) with 25% of households participating in the Supplemental Nutrition Assistance Program. Intervention(s) (1) Four bundles of ingredients needed to make 8 low-cost healthful meals were promoted in the store through displays and point-of-purchase messaging for 4 weeks each; (2) weekly electronic messages based on principles from behavioral psychology were sent to study participants reminding them to look for meal bundles in the store. Main Outcome Measures (1) Difference in storewide sales and individual purchases of bundled items (measured using supermarket loyalty card data) from baseline to intervention in intervention vs control groups. Analysis Regressions controlling for total food spending and accounting for repeated measures. Results There were no differences in spending on bundled items resulting from the meal bundling intervention or the electronic reminders. Conclusions and Implications Overall, there was little impact of healthful meal bundles and electronic reminders on storewide sales or purchases of promoted items in a large supermarket. [ABSTRACT FROM AUTHOR]

Background: Negative symptoms are frequent in patients with schizophrenia and are associated with marked impairments in social functioning. The efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. The Positive Emotions Programme for Schizophrenia (PEPS) is designed to improve pleasure and motivation in schizophrenia patients by targeting emotion regulation and cognitive skills relevant to apathy and anhedonia. The main hypothesis of this study is that patients who attend 8 one-hour sessions of PEPS and treatment as usual (TAU) will have lower total apathy-avolition and anhedonia-asociality composite scores on the Scale for the Assessment of Negative Symptoms (SANS) than patients who attend only TAU.Methods: Eighty participants diagnosed with schizophrenia or schizoaffective disorder were randomized to receive either TAU or PEPS + TAU. The participants were assessed by independent evaluators before randomization (T0), in a post-test after 8 weeks of treatment (T1) and at a 6-month follow-up (T2).Results: The post-test results and 6-month follow-up assessments according to an intention-to-treat analysis showed that the apathy and anhedonia composite scores on the SANS indicated statistically greater clinical improvements in PEPS participants than in non-PEPS participants. In the post-test, anhedonia but not apathy was significantly improved, thus favouring the PEPS condition. These results were sustained at the 6-month follow-up.Conclusions: PEPS is an effective intervention to reduce anhedonia in schizophrenia. PEPS is a short, easy-to-use, group-based, freely available intervention that is easy to implement in a variety of environments (ClinicalTrials.gov ID: NCT02593058). [ABSTRACT FROM AUTHOR]