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Over the past decade, there has been rapid growth in the evidence for programs to prevent or reduce intimate partner violence (IPV)-the most common form of men's violence against women. IPV interventions targeting heterosexual couples have shown significant impact. However, our understanding of how these interventions achieve their impacts on violence-the mechanisms through which change occurs-remains limited. Using data from two follow-up rounds of a randomized controlled trial of the Bandebereho intervention in Rwanda, we constructed conceptually driven structural equation models to represent the processes by which hypothesized mediating variables linked treatment assignment to IPV. We found significant differences in the expected direction between the intervention and control participants on all mediating variables, including men's alcohol use, communication frequency, emotional closeness, frequency of quarreling, and men's attitudes related to gender and violence. Several mechanisms-more positive couple dynamics including emotional closeness and communication frequency; men's gender-equitable attitudes; men's alcohol use-accounted for the largest proportions of the effect of assignment to the Bandebereho intervention on IPV. Overall, our findings highlight that no one particular component is driving the reductions in violence; instead, the multiple components and pathways account for the intervention's effects, suggesting that the holistic nature of the intervention may be integral to its positive impact. The Bandebereho trial from which data was used in this analysis was registered on ClinicalTrials.gov prior to completion ( NCT02694627 ). [ABSTRACT FROM AUTHOR]

Background: Most currently used surgical robots have no force feedback; the next generation displays forces visually. A novel single-port robotic surgical system called FLEXMIN has been developed. Through an outer diameter of 38 mm, two instruments are teleoperated from a surgeon's control console including true haptic force feedback. One additional channel incorporates a telescope, another is free for special instrument functions.Methods: This randomized cross-over study analyzed the effect of haptic feedback on the application of intracorporeal forces. In a standardized experiment setup, the subjects had to draw circles with the surgical robot as gently as possible. The applied forces, the required time spans, and predefined error rates were measured.Results: Without haptic feedback, the maximum forces (median/IQR) were 6.43 N/2.96 N. With haptic feedback, the maximum forces were lower (3.57 N/1.94 N, p < 0.001). Also, the arithmetic means of the force progression (p < 0.001) and their standard deviations (p < 0.001) were lower. Not significant were the shorter durations and lower error rates. No sequence effect of force or duration was detected. No characteristic learning or fatigue curve was observed.Conclusions: In the experiment setup, the true haptic force feedback can reduce the applied intracorporeal robotic force to one-half when considering the aspects maximum, means, and standard deviation. Other test tasks are needed to validate the influence of force feedback on surgical efficiency and safety. [ABSTRACT FROM AUTHOR]

To conduct a pilot study of a group-based perinatal depression intervention, the Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology were randomized to a 6-week intervention or usual care group at their initial prenatal care visit. Measures of depressive symptomatology and maternal-fetal attachment were collected at baseline and 36 weeks gestation. At 12 weeks postpartum, participants completed a measure of depressive symptomatology, and an objective measure of maternal sensitivity was collected. Participants randomized to the intervention group completed an average of 5.2 sessions, and 70% of women completed all six sessions. Exploratory analyses showed that at 12 weeks postpartum, participants randomized to the intervention group had an 8.32-point decrease from baseline on the Edinburgh Postnatal Depression Scale (EPDS) as compared to a 4.59-point decrease among participants randomized to usual care. Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care. Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding), were higher at 12 weeks postpartum for women in the intervention group as compared to women in usual care (59.2 and 51.8, respectively). Our pilot study findings provide preliminary support for the benefits of a perinatal depression intervention, delivered in a group setting, on reducing depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity. Further research, conducted with larger samples, is necessary to determine the effect of this intervention on indicators of maternal attachment. [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]

Objective: We aimed to evaluate to what extent the results of registered randomized controlled trials (RCTs) assessing transarterial chemoembolization (TACE) for treating hepatocellular carcinoma (HCC) are publicly available.Methods: We searched the Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform, and primary registries for RCTs assessing TACE for treating HCC, registered between January 2008 and August 2018, that had exceeded their completion date by more than 1 year. We systematically searched PubMed, EMBASE, and Google Scholar for a publication as well as the registry for results. The main outcomes were the availability of results, and the time to the first availability of results (i.e., posted on the registry or published). Secondary outcomes were the proportion of results available at 12 and 36 months after completion.Results: Among 67 identified RCTs, including a total target number to 11,599 participants, 26 had publicly available results (39%; i.e., 42% of total target number of participants). Results of 25 RCTs (37%) were published, with only 3 having results posted on the registry and 2 with both published and posted results. The median (Q1-Q3) time from completion to the first public availability of results was 18 months (11-29). The cumulative percentages of RCTs with results available were 10% (95% CI, 3-17%) and 29% (95% CI, 17-39%) at 12 and 36 months, respectively, after completion.Conclusions: Despite the ethical commitments and societal expectations for disclosure of results, the availability of results of RCTs on TACE for treating HCC is very limited.Key Points: • Underreporting of trial results is a major cause of wasted medical research since inaccessible research results fail to help both patients and clinicians. • Transarterial chemoembolization (TACE) is the most common treatment for hepatocellular carcinoma (HCC) and has called for considerable research efforts. • Yet, almost two-thirds of randomized controlled trials assessing TACE for treating HCC did not yield any public results, either on the registry platform or in scientific journals. [ABSTRACT FROM AUTHOR]

Objective: To compare changes in microcirculation blood flow (MCBF) between pulsatile and continuous flow insufflation. Transanal total mesorectal excision (TaTME) was developed to improve the quality of the resection in rectal cancer surgery. The AirSeal IFS® insufflator facilitates the pelvic dissection, although evidence on the effects that continuous flow insufflation has on MCBF is scarce.Methods: Thirty-two pigs were randomly assigned to undergo a two-team TaTME procedure with continuous (n = 16) or pulsatile insufflation (n = 16). Each group was stratified according to two different pressure levels in both the abdominal and the transanal fields, 10 mmHg or 14 mmHg. A generalized estimating equations (GEE) model was used.Results: At an intra-abdominal pressure (IAP) of 10 mmHg, continuous insufflation was associated with a significantly lower MCBF reduction in colon mucosa [13% (IQR 11;14) vs. 21% (IQR 17;24) at 60 min], colon serosa [14% (IQR 9.2;18) vs. 25% (IQR 22;30) at 60 min], jejunal mucosa [13% (IQR 11;14) vs. 20% (IQR 20;22) at 60 min], renal cortex [18% (IQR 15;20) vs. 26% (IQR 26;29) at 60 min], and renal medulla [15% (IQR 11;20) vs. 20% (IQR 19;21) at 90 min]. At an IAP of 14 mmHg, MCBF in colon mucosa decreased 23% (IQR 14;27) in the continuous group and 28% (IQR 26;31) in the pulsatile group (p = 0.034).Conclusion: TaTME using continuous flow insufflation was associated with a lower MCBF reduction in colon mucosa and serosa, jejunal mucosa, renal cortex, and renal medulla compared to pulsatile insufflation. [ABSTRACT FROM AUTHOR]

Background: Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G.Methods: In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT.Results: In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups.Conclusion: NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO.Clinical Trials Registration: This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial. [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]

Purpose: To compare the efficacy of mild ovarian stimulation protocol and conventional controlled ovarian stimulation (COS) protocol for poor ovarian response (POR) patients undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).Methods: This single-center prospective randomized controlled trial conducted from September 2013 to September 2015, including 191 patients who met the Bologna criteria of POR. Ninety-seven patients allocated to the mild ovarian stimulation group (MS group) were stimulated according to the letrozole/antagonist protocol, while 94 patients in the controlled ovarian stimulation group (COS group) were stimulated according to a high dose of gonadotropin (Gn) combined with gonadotropin-releasing hormone agonist (GnRH-a) stop protocol. The cumulative live birth rate was the primary outcome. Chinese clinical trial number ChiCTR-TRC-13003454.Results: Comparing with the COS group, both the stimulation duration and the total gonadotropin dose were significantly shorter and lower in the MS group (P < 0.001). A higher number of retrieved oocytes (P = 0.003) and transferrable embryos (P = 0.029) were obtained in the COS group. The cumulative live birth rates (OR 1.103; 95% CI 0.53 to 2.28; P = 0.791) were comparable between the two groups.Conclusions: The increase of Gn dose during ovulation stimulation was associated with a higher number of transferrable embryos for POR patients, but this increase did not lead to a concomitant improvement of reproductive outcome, especially in terms of the cumulative live birth rate. Using a mild stimulation protocol was economically preferential while it was as effective as higher doses of Gn stimulation protocol in reproductive outcome for POR patients. [ABSTRACT FROM AUTHOR]

Background: Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD).Methods: In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance.Results: At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research.Conclusion: Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated. [ABSTRACT FROM AUTHOR]

Purpose: The newly developed "Herlev Hospital Empowerment of Relatives through More and Earlier information Supply" (HERMES) intervention systematically identifies cancer caregivers' unmet needs for information from health care professionals (HCPs) and offers them the information they lack. The aim of this study was to investigate the effect of the HERMES intervention on caregivers' perception of information, communication, attention and help from HCPs, fulfillment of care needs, and anxiety and depression.Methods: A randomized intervention study with immediate intervention in the intervention group and delayed intervention (after follow-up) in the control group among caregivers of cancer patients starting chemotherapy.Results: Totally 199 caregivers were included (intervention group, n = 101; control group, n = 98). No intervention effect was found on overall satisfaction with information from HCPs (p = 0.1687) measured by a single item from the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN) and chosen as primary outcome. However, positive effects were found on the CaTCoN subscales "Problems with the quality of information from and communication with HCPs" (p = 0.0279), "Lack of information from HCPs (HERMES)" (p = 0.0039), and "Lack of attention on the caregivers' wellbeing from HCPs" (p < 0.0001). No effect was found on the CaTCoN subscale "Need for help from HCPs", the Family Inventory of Needs subscale regarding fulfillment of care needs, or the Hospital Anxiety and Depression scale.Conclusions: Although no effect was found on overall satisfaction with information, the HERMES intervention had positive effects on the caregivers' experiences of the amount of information and attention given to them and the quality of information and communication.Trial Registration: ClinicalTrials.gov (Identifier: NCT02380469). [ABSTRACT FROM AUTHOR]

Background: During laparoscopic operations, the trocars are often out of the viewing field of the laparoscope. Blind insertion of laparoscopic instruments is potentially dangerous especially when they are pointed or hot. A guidance of the instrument to the target point has the potential to improve the safety of instrument insertion.Methods: In this study, the effect of a mechanical and an optical tool for guided instrument insertion into the abdominal cave was evaluated. The controlled prospective randomized study measured safety and efficiency of instrument insertion by 60 novices in an inanimate standardized box trainer. A post-test questionnaire based on the NASA Task Load Index prompted for the subjective impressions of the subjects.Results: Instrument insertion with optical guidance showed a shorter (p = 0.002) insertion time (median 87.5 s for nine insertions) compared with blind insertion (median 112.0 s for nine insertions). The error number with optical guidance (median 0.5) was lower (p = 0.064) compared with blind insertion (median 1.0). The mechanical guidance showed a shorter (p = 0.001) insertion time (median 89.0 s for nine insertions) and less (p = 0.044) touch errors (median 0) compared with blind insertion. The results of the two guidance tools (mechanical vs. optical guidance) showed no significant difference. In the questionnaire, 89% of the novices subjectively judged the mechanical guidance tool better than blind insertion. The assessments of optical compared to mechanical guidance turned out quite similar.Conclusions: In the experimental setup, instrument insertion with a guidance tool performed faster and safer compared with blind insertion. The subjective assessments confirmed the benefit of instrument guidance. [ABSTRACT FROM AUTHOR]

An independent, randomized controlled trial of the community-developed, multiple-component Relief Nursery prevention program was conducted with families with young children considered "at risk" for child abuse and neglect. This established program, currently operating at multiple sites in the state of Oregon, comprises an integrated package of prevention services to children and families, including early childhood education, home visiting, and parent education and support, as well as other interventions tailored to the needs of each particular family. Families who contacted the Relief Nursery for the first time were randomly assigned to one of two conditions, the Full Program condition, whose members had access to all services available from the Relief Nursery, or the Respite Care condition, whose members had access only to respite care and referrals to services provided by other community agencies. A primary caregiver in each family was interviewed prior to intervention and then every 6 months across a period of 2 years. Standardized measures were collected on a variety of risk and protective factors related to child abuse and neglect. Analyses were conducted at the end of the study period. Differences were found between the conditions in terms of perceived helpfulness and satisfaction with services and in terms of social support, in each case favoring the Full Program condition. Implications of the findings for future studies of multicomponent child abuse prevention programs with similar characteristics to the Relief Nursery are discussed. [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]

Objective: To compare the effect of contrast medium iodine concentration on contrast enhancement, heart rate, and injection pressure when injected at a constant iodine delivery rate in coronary CT angiography (CTA).Methods: One thousand twenty-four patients scheduled for coronary CTA were prospectively randomized to receive one of four contrast media: iopromide 300 mg I/ml, iohexol 350 mg I/ml, iopromide 370 mg I/ml, or iomeprol 400 mg I/ml. Contrast media were delivered at an equivalent iodine delivery rate of 2.0 g I/s. Intracoronary attenuation was measured and compared (per vessel and per segment). Heart rate before and after contrast media injection was documented. Injection pressure was recorded (n = 403) during contrast medium injection and compared between groups.Results: Intracoronary attenuation values were similar for the different contrast groups. The mean attenuation over all segments ranged between 384 HU for 350 mg I/ml and 395 HU for 400 mg I/ml (p = 0.079). Dose-length product (p = 0.8424), signal-to-noise ratio (all p > 0.05), time to peak (p = 0.324), and changes in heart rate (p = 0.974) were comparable between groups. The peak pressures differed: 197.4 psi for 300 mg I/ml (viscosity 4.6 mPa s), 229.8 psi for 350 mg I/ml (10.4 mPa s), 216.1 psi for 370 mg I/ml (9.5 mPa s), and 243.7 psi for 400 mg I/ml (12.6 mPa s) (p < 0.0001).Conclusion: Intravascular attenuation and changes in heart rate are independent of iodine concentration when contrast media are injected at the same iodine delivery rate. Differences in injection pressures are associated with the viscosity of the contrast media.Key Points: • The contrast enhancement in coronary CT angiography is independent of the iodine concentration when contrast media are injected at body temperature (37 °C) with the same iodine delivery rate. • Iodine concentration does not influence the change in heart rate when contrast media are injected at identical iodine delivery rates. • For a fixed iodine delivery rate and contrast temperature, the viscosity of the contrast medium affects the injection pressure. [ABSTRACT FROM AUTHOR]

Purpose: Multimodal analgesia has become an important concept in current pain management following total knee arthroplasty (TKA). However, controversy remains over what is the most accepted combination. In this study, the additional benefits of local infiltration of analgesia to femoral nerve block were evaluated.Methods: Forty patients were randomly allocated into a combined local infiltration of analgesia and femoral nerve block or femoral nerve block alone group. In the former, analgesic drugs consisting of ropivacaine and dexamethasone were injected into the peri-articular tissues, while the same amount of saline was injected into the femoral nerve block group. The primary outcome measure was the total amount of fentanyl consumption by the patient-controlled analgesia pump during the 48-h post-operative period.Results: A combination of local infiltration of analgesia and femoral nerve block had less total fentanyl consumption and a larger knee ROM at post-operative day 2 than femoral nerve block alone (p < 0.05). C-reactive protein levels in the combined treatment group were significantly lower than the femoral nerve block group at post-operative day 3 (p < 0.01). There was no difference between the two groups, post-operatively, on the visual analogue scale for pain at rest or while walking, quadriceps strength, timed up and go test, circumference of thigh, Knee Society Score, and Western Ontario and McMaster Universities Osteoarthritis Index.Conclusion: The addition of local infiltration of analgesia to femoral nerve block promoted post-operative pain relief and the recovery of knee ROM in the early post-operative period. This combination is an effective method for post-operative pain management after TKA.Level Of Evidence: Randomized controlled trial, Level I. [ABSTRACT FROM AUTHOR]

Purpose: Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. We hypothesized that the addition of conscious sedation would provide greater patient satisfaction with inguinal hernioplasty compared to local anesthesia alone.Methods: This trial was a single-centre, randomized, placebo-controlled, double-blinded trial where patients undergoing inguinal hernioplasty using local anaesthesia were randomized to receive local anaesthesia alone versus local anaesthesia and conscious sedation. The primary outcome of patient satisfaction was assessed using the Iowa Satisfaction with Anesthesia Scale (ISAS). The study was powered to detect a significant difference in ISAS scores between groups. Comparisons were made using T test and Chi square tests. A p value of less than 0.05 was considered significant.Results: There were 149 patients randomized: 78 to the local anesthesia (LA) group and 71 to the local anaesthesia and conscious sedation (LACS) group. For the primary outcome measure of patient satisfaction, the mean ISAS score was significantly greater in the LACS group (p = 0.009). The experience of pain and pain severity was greater in the LA group (p = 0.016; p = 0.0162 respectively). No statistically significant difference was found between groups with respect to operative time, time to discharge or postoperative complications.Conclusion: The use of conscious sedation with local anesthesia for inguinal hernioplasty is safe, results in less pain experience and severity and is associated with better patient satisfaction. The use of conscious sedation does not delay patient discharge. [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]

Purpose: Chronic pain, depression, and fatigue are common effects resulting from the cancer experience; new interventions are needed. This study examined the effect of Reimagine, an online symptom self-management curriculum that teaches coping skills, on key outcomes.Methods: Adult breast cancer survivors with chronic pain were recruited from the Army of Women volunteer registry for this randomized controlled trial and randomized 1:1 to Reimagine or usual care conditions. Electronic surveys collected demographic, clinical, and outcome data at baseline and 18 weeks post-intervention.Results: Participants (N = 89) were mean age 56.7 ± 8.7 years; 67% married; 58% employed; mean years since diagnosis 8.2 ± 6.6; and 89% were in remission or cured of their breast cancer. There was a significant difference in the change in depression scores for treatment (M = - 1.7, SD = 4.5) and usual care (M = 0.3, SD = 3.8) conditions; t(85) = - 2.3, p = .03. Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.0) and usual care (M = 1.2, SD = 6.6) conditions; t(87) = 2.2, p = .03. Most Reimagine users (94%) would recommend the curriculum to others.Conclusions: These results suggest that Reimagine has an effect on depression and fatigue symptoms for breast cancer survivors. Online programs can be a feasible and effective alternative to in-person support. Additional research is recommended with larger and more diverse samples. [ABSTRACT FROM AUTHOR]

Background: Although single-port laparoscopic cholecystectomy (SILC) is safe and effective, inherent surgeons' discomfort has prevented a large-scale adaptation of this technique. Recent advances in robotic technology suggest that da Vinci Single-Site™ cholecystectomy (dVSSC) may overcome this issue by reducing the stress load of the surgeon compared to SILC. However, evidence to objectively assess differences between the two approaches is lacking.Methods: 60 patients [36 women, 24 men (mean age 52 years)] with benign gallbladder disease were randomly assigned to dVSSC (n = 30) or SILC (n = 30) in this single-centre, single-blinded controlled trial. The primary endpoint was surgeon's stress load. Secondary endpoints included operating time, conversion rates, additional trocar placement, blood loss, length of hospital stay, procedure costs, health-related quality of life, cosmesis and complications. Data were collected preoperatively, during the hospital stay, and at 1 and 12 months' follow-up.Results: The dVSSC group showed a significant reduction of mental stress load of the surgeon compared to SILC [Subjective Mental Effort Questionnaire (SMEQ) score: median 25.0 (range 8-89) vs. 42.5 (range 13-110) points; p = 0.002] and a trend towards reduced physical stress load [Local Experienced Discomfort (LED) score: median 8 (range 2-27) vs. 12 (range 0-64) points; p = 0.088]. The length of hospital stay was longer in the SILC group [mean 3.06 (median 2; range 1-26) vs. 1.9 (median 2; range 1-4) days, p = 0.034] but overall hospital costs were higher for dVSSC [median 9734 (range 5775-16729) vs. 6900 (range 4156-99977) CHF; p = 0.001]. There were no differences in the rate of postoperative complications that required re-intervention (Dindo-Clavien grade ≥ IIIa; SILC n = 2 vs. dVSSC n = 0, p = 0.492) or other secondary endpoints.Conclusions: Da Vinci Single-Site™ cholecystectomy provides significant benefits over Single-Port Laparoscopic Cholecystectomy in terms of surgeon's stress load, matches the standards of the laparoscopic single-incision approach with regard to patients' outcomes but increases expenses. Clinicaltrials.gov registration-No.: NCT02485392. [ABSTRACT FROM AUTHOR]

Purpose: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.Methods: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.Results: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.Conclusions: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial Registration: JIVROSG-0402, JIVROSG-0807. [ABSTRACT FROM AUTHOR]

Purpose: The Moving to Opportunity (MTO) study is typically interpreted as a trial of changes in neighborhood poverty. However, the program may have also increased exposure to housing discrimination. Few prior studies have tested whether interpersonal and institutional forms of discrimination may have offsetting effects on mental health, particularly using intervention designs.Methods: We evaluated the effects of MTO, which randomized public housing residents in 5 cities to rental vouchers, or to in-place controls (N = 4248, 1997-2002), which generated variation on neighborhood poverty (% of residents in poverty) and encounters with housing discrimination. Using instrumental variable analysis (IV), we derived two-stage least squares IV estimates of effects of neighborhood poverty and housing discrimination on adult psychological distress and major depressive disorder (MDD).Results: Randomization to voucher group vs. control simultaneously decreased neighborhood % poverty and increased exposure to housing discrimination. Higher neighborhood % poverty was associated with increased psychological distress [BIV = 0.36, 95% confidence interval (CI) 0.03, 0.69] and MDD (BIV = 0.12, 95% CI - 0.005, 0.25). Effects of housing discrimination on mental health were harmful, but imprecise (distress BIV = 1.58, 95% CI - 0.83, 3.99; MDD BIV = 0.57, 95% CI - 0.43, 1.56). Because neighborhood poverty and housing discrimination had offsetting effects, omitting either mechanism from the IV model substantially biased the estimated effect of the other towards the null.Conclusions: Neighborhood poverty mediated MTO treatment on adult mental health, suggesting that greater neighborhood poverty contributes to mental health problems. Yet housing discrimination-mental health findings were inconclusive. Effects of neighborhood poverty on health may be underestimated when failing to account for discrimination. [ABSTRACT FROM AUTHOR]

Background: Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients.Aims: To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC.Methods: This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks. The primary efficacy endpoint was relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC).Results: An interim analysis was conducted after inclusion and follow-up of one-third of patients for the first phase of the study (n = 195). Relapse-free survival was not significantly different between the BFM and placebo groups (P = 0.643; hazard ratio 1.16; 95% CI 0.63-2.14, log-rank test), nor was the incidence of relapse. Therefore, the study was discontinued for lack of efficacy. An exploratory analysis of fecal samples from a subgroup of patients revealed no effects of either study beverage on intestinal microbiota, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. Three mild adverse events occurred for which a causal relationship with the study beverage could not be ruled out (placebo: abdominal bloating and stress in one patient; BFM: body odor in one patient).Conclusions: BFM had no effect on time to relapse in UC patients compared with placebo.Study Registration: UMIN000007593. [ABSTRACT FROM AUTHOR]

Background: General Surgery is currently the fastest growing specialty with regards to robotic surgical system utilization. Contrary to the experience in laparoscopy, simulator training for robotic surgery is not widely employed partly because robotic surgical simulators are expensive. We sought to determine the effect of a robotic simulation curriculum and whether robotic surgical skills could be derived from those psychomotor skills attained in laparoscopic training.Methods: Twenty-seven trainees with no prior robotic experience and limited laparoscopy exposure were randomly assigned to one of three training groups: no simulator training, training on a fundamentals of laparoscopic surgery (FLS™) standard box trainer, and training on a robotic computer based simulator (da Vinci Skills Simulator™). Baseline robotic surgical skills were assessed on the clinical robot docked to a standard FLS trainer box on two tasks-intracorporeal knot tying and peg transfer. Subjects subsequently underwent four 1-h long training sessions in their assigned training environment over a course of several weeks. Robotic surgical skills were reassessed on the robot on the same two tasks used to assess skills prior to training.Results: FLS training resulted in a greater score improvement than no training for both knot and peg scores. FLS training was also determined to result in greater score improvement than robotic simulator training for knot tying. There was no significant difference in peg transfer or knot tying scores when comparing robotic simulator training and no training.Conclusions: Robotic surgical skills can be in part derived from psychomotor skills developed in a laparoscopic trainer, especially for complex skills such as intracorporeal knot tying. Acquisition of robotic surgical skills may be enhanced by practice on a laparoscopic simulator using the FLS curriculum. This may be especially helpful when a robotic simulator is not available or is poorly accessible. [ABSTRACT FROM AUTHOR]

Objectives: We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts.Methods: We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were administered 2 weeks before and 2 weeks after aspiration sclerotherapy. The primary endpoint was proportional cyst diameter reduction (%) from baseline to 6 weeks. Secondary outcomes included long-term cyst reduction at 26 weeks, patient-reported outcomes including the polycystic liver disease-questionnaire (PLD-Q) and safety.Results: Thirty-four patients (32 females; 53.6 ± 7.8 years) were randomized between pasireotide or placebo. Pasireotide did not improve efficacy of aspiration sclerotherapy at 6 weeks compared to controls (23.6 % [IQR 12.6-30.0] vs. 21.8 % [9.6-31.8]; p = 0.96). Long-term cyst diameter reduction was similar in both groups (49.1 % [27.0-73.6] and 45.6 % [29.6-59.6]; p = 0.90). Mean PLD-Q scores improved significantly in both groups (p < 0.01) without differences between arms (p = 0.92).Conclusions: In patients with large symptomatic hepatic cysts, complementary pasireotide to aspiration sclerotherapy did not improve cyst reduction or clinical response.Key Points: • Complementary pasireotide treatment does not improve efficacy of aspiration sclerotherapy. • Cyst fluid reaccumulation after aspiration sclerotherapy is a transient phenomenon. • Aspiration sclerotherapy strongly reduces symptoms and normalizes quality of life. [ABSTRACT FROM AUTHOR]

Non-suicidal self-injury (NSSI) in childhood is not well documented, especially among youth with pediatric bipolar disorder (PBD). The current study evaluated prevalence and correlates of NSSI, and its impact on intervention response, in a randomized trial of Child- and Family-Focused Cognitive-Behavioral Therapy (CFF-CBT) versus Treatment As Usual (TAU), adjunctive to pharmacotherapy. This study included 72 children ages 7-13 (58% male) with PBD. NSSI and correlates were assessed at baseline; mood and psychiatric severity were measured longitudinally. NSSI was common: 31% endorsed NSSI behaviors; 10% reported thoughts of NSSI, in the absence of behaviors. Children engaging in NSSI reported higher depression, psychosis, suicidality, and hopelessness; lower self-esteem; and reduced family help-seeking in univariate analyses. In a multivariate logistic regression, high child depression and psychosis, and low family help-seeking, remained significantly associated with baseline NSSI. In mixed-effects regression models, presence of NSSI at baseline did not influence the response of depressive symptoms to treatment. Children who endorsed NSSI experienced steeper response trajectories for psychiatric severity, regardless of treatment group. Youth who denied NSSI showed poorer response to TAU for manic symptoms; mania trajectories in CFF-CBT were similar across youth. Thus, NSSI in PBD is common and associated with impairment. As children might engage in NSSI for different reasons, the function of NSSI should be considered in treatment. Since children without NSSI fared worse in TAU, it may be important to ensure that youth with PBD receive structured, intensive interventions. CFF-CBT was efficacious regardless of NSSI, and thus shows promise for high-risk children with PBD. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effects of a 12-week supervised exercise programme on lower-limb cutaneous microvascular reactivity in adults with venous leg ulceration.Methods: Thirty-eight adults with unilateral venous ulceration who were being treated with lower-limb compression therapy (58% male; mean age 65 years; median ulcer size 5 cm2) were randomly allocated to exercise or control groups. Exercise participants (n = 18) were invited to attend thrice weekly sessions of lower-limb aerobic and resistance exercise for 12 weeks. Cutaneous microvascular reactivity was assessed in the gaiter region of ulcerated and non-ulcerated legs at baseline and 3 months using laser Doppler fluxmetry coupled with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP). Cutaneous vascular conductance (CVC) was calculated as laser Doppler flux (AU)/mean arterial pressure (mmHg).Results: Thirty-seven participants completed follow-up assessments. Median session attendance was 36 (range 2-36). Analyses of covariance revealed greater peak CVC responses to ACh in the exercise group at 3 months in both the ulcerated (adjusted difference = 0.944 AU/mmHg; 95% CI 0.504-1.384) and non-ulcerated (adjusted difference = 0.596 AU/mmHg; 95% CI 0.028-1.164) legs. Peak CVC responses to SNP were also greater in the exercise group at 3 months in the ulcerated leg (adjusted difference = 0.882 AU/mmHg; 95% CI 0.274-1.491), but not the non-ulcerated leg (adjusted difference = 0.392 AU/mmHg; 95% CI - 0.377 to 1.161).Conclusion: Supervised exercise training improves lower-limb cutaneous microvascular reactivity in adults with venous leg ulceration. [ABSTRACT FROM AUTHOR]

A large proportion of children experience subclinical levels of anxiety and cognitive-behavioral therapy (CBT) aimed at preventing anxiety disorders is moderately effective. However, most at-risk children do not seek help or drop out of programs prematurely because of stigma, lack of motivation, and accessibility barriers. Applied games have received increased attention as viable alternatives and have shown promising results, but direct comparisons between applied games and the gold-standard CBT are lacking. Our aim was to investigate whether the applied game MindLight is as effective as CBT (i.e., Coping Cat) within an indicated prevention context. We conducted a randomized controlled non-inferiority trial with a sample of 174 children (7- to 12-year olds) with elevated levels of anxiety, comparing MindLight to CBT. Anxiety was assessed with self- and parent-reports at pre- and post-program, and at 3- and 6-month follow-ups. Intention-to-treat and completers-only confidence interval approach and latent growth curve modeling showed an overall significant quadratic decrease in child- and parent-reported anxiety symptoms over time and, as predicted, the magnitude of improvement was the same for MindLight and CBT. The within-group effect sizes were small to medium at post-test (- 0.32 to - 0.63), and medium to large (- 0.60 to - 1.07) at 3- and 6-month follow-ups. Furthermore, MindLight and CBT were rated equally anxiety inducing, difficult, and appealing; CBT was rated as more relevant to daily life than MindLight. The current study adds to the growing research on applied games for mental health and shows that these games hold potential as alternative delivery models for evidence-based therapeutic techniques. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the safety and clinical effectiveness of rhBMP-7 (or osteogenic protein-1) versus that of autogenous iliac crest bone graft (ICBG) in single-level posterolateral fusion (PLF) of the lumbar spine. A systematic search of all articles published through July 1, 2016 was conducted in databases such as PubMed, EMBASE, Scopus, and the Cochrane Collaboration Library. Randomized controlled trials (RCTs) that compared rhBMP-7 with ICBG for the treatment of single-level degenerative spondylolisthesis, provided the fusion rate, clinical success rate, safety and adverse events report, operation time, and hospital stay durations as the outcome were assessed. As a result, a total of five RCTs involving 539 patients met the inclusion criteria. The outcomes of subgroup analysis demonstrated that when compared with autogenous ICBG, rhBMP-7 appear to yield lower fusion rates in instrumented posterolateral fusion patients (RR = 0.76, 95% CI [0.60, 0.98], P = 0.03), despite the test for overall fusion rates suggested that there was no significant difference between the two groups (RR = 0.89, 95% CI [0.78, 1.02], P = 0.09). Patients treated with OP-1 had shorter operation times versus those treated with ICBG (WMD = -16.70,95% CI [-25.83, -7.57], P = 0.0003). Additionally, the outcomes demonstrated a lack of significant differences between rhBMP-7 and ICBG in terms of clinical success of ODI, overall adverse events, revision rates and duration of hospitalization. In conclusion, with the exception of reducing the operation time, our review suggests that the use of the rhBMP-7 instead of ICBG produce no any additional beneficial effect on the fusion rates, clinical success of ODI, overall adverse events, revision rates and duration of hospitalization in single level PLF. On the contrary, it appeared to yield lower fusion rate in the instrumented posterolateral fusion patients and cannot be recommended as an effective tool for this set of patients. [ABSTRACT FROM AUTHOR]

This paper presents findings from a multi-centre, double-blind, randomized controlled trial that tested the hypothesis that parent and youth mental health improvements would be superior in a family-based intervention for adolescent depression (BEST MOOD) compared to a treatment-as-usual supportive parenting program (PAST). Eligible participants were families with a young person aged between 12 and 18 years who met diagnostic criteria for a depressive disorder (major, minor or dysthymic). Participating families (N = 64; 73.4% of youth were female) were recruited in Victoria, Australia and allocated to treatment condition using a block randomization procedure (parallel design) with two levels of blinding. This paper reports on the trial's secondary outcomes on youth and parent mental health. General linear mixed models were used to examine the longitudinal effect of treatment group on outcome. Data were analyzed according to intention-to-treat; 31 families were analyzed in BEST MOOD, and 33 families in PAST. Parents in the BEST MOOD group experienced significantly greater reductions in stress and depressive symptoms than parents in the PAST group at 3-month follow-up. A greater reduction in parental anxiety was observed in the BEST MOOD group (d = 0.35) compared with PAST (d = 0.02), although the between-group difference was not significant. Both groups of youth showed similar levels of improvement in depressive symptoms at post-treatment (d = 0.83 and 0.80 respectively), which were largely sustained at a 3-month follow-up. The family-based BEST MOOD intervention appeared superior to treatment-as-usual (PAST) in demonstrating greater reductions in parental stress and depression. Both interventions produced large reductions in youth depressive symptoms. [ABSTRACT FROM AUTHOR]

Child outcomes due to a paid professional mentoring program, Friends of the Children (FOTC), were investigated across the first 5 years of an ongoing multi-site randomized controlled trial. Participants were 278 children attending kindergarten or first grade who were identified as "at risk" for adjustment problems during adolescence. The program was delivered through established nonprofit community-based organizations. Mentors were hired to work full time and were provided training, supervision, and support to work individually with small numbers of children. Recruitment took place across a 3-year period. Random assignment to the intervention condition or a services as usual control condition was conducted at the level of the individual, blocking on school and child sex. After the initial assessment, follow-up assessments were conducted every 6 months. Differences in growth curves across the elementary school years were examined in intent-to-treat analyses. Significant effects favoring FOTC were found in terms of caregiver ratings of positive school behavior and less trouble in school, with a trend for higher child behavioral and emotional strengths. Effect sizes were in the range typical in recent trials of youth mentoring. [ABSTRACT FROM AUTHOR]

Orphaned adolescents are a large and vulnerable population in sub-Saharan Africa, at higher risk for HIV than non-orphans. Yet prevention of new infection is critical for adolescents since they are less likely than adults to enter and remain in treatment and are the only age group with rising AIDS death rates. We report process evaluation for a randomized controlled trial (RCT) testing support to stay in school (tuition, uniform, nurse visits) as an HIV prevention strategy for orphaned Kenyan adolescents. The RCT found no intervention effect on HIV/HSV-2 biomarker outcomes. With process evaluation, we examined the extent to which intervention elements were implemented as intended among the intervention group (N = 412) over the 3-year study period (2012-2014), the implementation effects on school enrollment (0-9 terms), and whether more time in school impacted HIV/HSV-2. All analyses examined differences as a whole, and by gender. Findings indicate that school fees and uniforms were fully implemented in 94 and 96% of cases, respectively. On average, participants received 79% of the required nurse visits. Although better implementation of nurse visits predicted more terms in school, a number of terms did not predict the likelihood of HIV/HSV-2 infection. Attending boarding school also increased number of school terms, but reduced the odds of infection for boys only. Four previous RCTs have been conducted in sub-Saharan Africa, and only one found limited evidence of school impact on adolescent HIV/HSV-2 infection. Our findings add further indication that the association between school support and HIV/HSV-2 prevention appears to be weak or under-specified. [ABSTRACT FROM AUTHOR]

Design: The study's design was a cluster-randomized, matched-pairs, parallel trial of a behavior-based sexual assault prevention intervention in the informal settlements.Methods: The participants were primary school girls aged 10-16. Classroom-based interventions for girls and boys were delivered by instructors from the same settlements, at the same time, over six 2-h sessions. The girls' program had components of empowerment, gender relations, and self-defense. The boys' program promotes healthy gender norms. The control arm of the study received a health and hygiene curriculum. The primary outcome was the rate of sexual assault in the prior 12 months at the cluster level (school level). Secondary outcomes included the generalized self-efficacy scale, the distribution of number of times victims were sexually assaulted in the prior period, skills used, disclosure rates, and distribution of perpetrators. Difference-in-differences estimates are reported with bootstrapped confidence intervals.Results: Fourteen schools with 3147 girls from the intervention group and 14 schools with 2539 girls from the control group were included in the analysis. We estimate a 3.7 % decrease, p = 0.03 and 95 % CI = (0.4, 8.0), in risk of sexual assault in the intervention group due to the intervention (initially 7.3 % at baseline). We estimate an increase in mean generalized self-efficacy score of 0.19 (baseline average 3.1, on a 1-4 scale), p = 0.0004 and 95 % CI = (0.08, 0.39).Interpretation: This innovative intervention that combined parallel training for young adolescent girls and boys in school settings showed significant reduction in the rate of sexual assault among girls in this population. [ABSTRACT FROM AUTHOR]

Background: Hospitalization offers smokers an opportunity to quit smoking. Starting cessation treatment in hospital is effective, but sustaining treatment after discharge is a challenge. Automated telephone calls with interactive voice response (IVR) technology could support treatment continuance after discharge.Objective: To assess smokers' use of and satisfaction with an IVR-facilitated intervention and to test the relationship between intervention dose and smoking cessation.Design: Analysis of pooled quantitative and qualitative data from the intervention groups of two similar randomized controlled trials with 6-month follow-up.Participants: A total of 878 smokers admitted to three hospitals. All received cessation counseling in hospital and planned to stop smoking after discharge.Intervention: After discharge, participants received free cessation medication and five automated IVR calls over 3 months. Calls delivered messages promoting smoking cessation and medication adherence, offered medication refills, and triaged smokers to additional telephone counseling.Main Measures: Number of IVR calls answered, patient satisfaction, biochemically validated tobacco abstinence 6 months after discharge.Key Results: Participants answered a median of three of five IVR calls; 70% rated the calls as helpful, citing the social support, access to counseling and medication, and reminders to quit as positive factors. Older smokers (OR 1.36, 95% CI 1.20-1.54 per decade) and smokers hospitalized for a smoking-related disease (OR 1.65, 95% CI 1.21-2.23) completed more calls. Smokers who completed more calls had higher quit rates at 6-month follow-up (OR 1.49, 95% CI 1.30-1.70, for each additional call) after multivariable adjustment for age, sex, education, discharge diagnosis, nicotine dependence, duration of medication use, and perceived importance of and confidence in quitting.Conclusions: Automated IVR calls to support smoking cessation after hospital discharge were viewed favorably by patients. Higher IVR utilization was associated with higher odds of tobacco abstinence at 6-month follow-up. IVR technology offers health care systems a potentially scalable means of sustaining tobacco cessation interventions after hospital discharge.Clinical Trial Registration: ClinicalTrials.gov Identifiers NCT01177176, NCT01714323. [ABSTRACT FROM AUTHOR]

Background: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction.Methods: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery.Results: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far.Conclusions: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands. [ABSTRACT FROM AUTHOR]

Behavioral interventions are increasingly based on holistic approaches to health with an understanding that health-related behaviors are linked. A motivating example is provided by the Philani study, an intervention trial conducted to improve the health of South African mothers and their children. Inter-related health problems around maternal alcohol use, malnutrition, and HIV were addressed; multiple endpoints were targeted. The traditional hypothesis testing paradigm that tests significance on one primary outcome did not suffice. Past multiple endpoint studies have utilized a sign test on the number of estimated differences between treatment and control that favor the intervention. However, in order to preserve type 1 error, one must account for correlations among the outcomes. We propose an alternative approach that counts the number of significant treatment-control differences. Monte Carlo simulation is used to adjust for correlation, providing updated critical values and p values. Our method is implemented through an R package and applied to the Philani data to test the intervention's overall effect. [ABSTRACT FROM AUTHOR]

Background: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC).Methods: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727).Results: The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups.Conclusions: In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the efficacy of elcatonin injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with osteoporosis who have acute lumbar pain after experiencing new vertebral compression fractures. Two hundred twenty-eight Japanese female patients (mean age 77.3 years) with acute lumbar pain from osteoporotic vertebral fractures were randomly divided into two groups. Patients in one group were given an NSAID (NSAIDs group) and patients in the other group were given weekly intramuscular injections of 20 units of elcatonin (elcatonin group). All patients underwent follow-up examinations up to 6 weeks from the start of the trial. Outcome measures were the level of functional impairment according to the Japan Questionnaire for Osteoporotic Pain (JQ22), the Roland-Morris Disability Questionnaire (RDQ), and a visual analog scale (VAS) of pain intensity. Statistical analyses focused on (1) the time course of pain and functional level using linear mixed effects models to analyze the longitudinal data and (2) the effectiveness of elcatonin injection with mean difference values and 95 % confidence intervals. Significant differences were seen over time between the initial values and the postintervention values (4 and 6 weeks) in JQ22, RDQ, and VAS scores (effect size d > 0.4) in each group. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were -4.8 and -8.3 for the JQ22, -1.3 and -2.6 for the RDQ, and -11.3 and -11.5 for the VAS, shifted to elcatonin. Once weekly elcatonin injection was more effective than NSAIDs for treating acute lumbar pain and improving mobility in Japanese women with osteoporotic vertebral fractures. [ABSTRACT FROM AUTHOR]

This pilot randomized controlled trial (RCT) investigated benefits of omega-3 fatty acid supplementation and Individual-Family Psychoeducational Psychotherapy (PEP; a family-focused, cognitive-behavioral therapy) for behavior problems among youth with depression. Participants aged 7-14 with DSM-IV-TR depressive disorders (N = 72; 56.9 % male) were randomized to 1 of 4 treatment conditions: PEP + omega-3, PEP monotherapy (with pill placebo), omega-3 monotherapy, or placebo (without active intervention). At screen, baseline, and 2, 4, 6, 9, and 12 weeks post-baseline, parents completed the SNAP-IV, which assesses attention-deficit/hyperactivity disorder symptoms, oppositional defiant disorder symptoms, and overall behavior problems. At screen, baseline (randomization), 6 and 12 weeks, parents completed the Eyberg Child Behavior Inventory (ECBI), which includes Intensity and Problem scales for child behavior problems. Youth who had a completed SNAP-IV or ECBI for at least two assessments during treatment (n = 48 and 38, respectively) were included in analyses of the respective outcome. ClinicalTrials.gov.:NCT01341925. Linear mixed effects models indicated a significant effect of combined PEP + omega-3 on SNAP-IV Total (p = 0.022, d = 0.80) and Hyperactivity/Impulsivity trajectories (p = 0.008, d = 0.80), such that youth in the combined group saw greater behavioral improvement than those receiving only placebo. Similarly, youth in combined treatment had more favorable ECBI Intensity trajectories than youth who received no active treatment (p = 0.012, d = 1.07). Results from this pilot RCT suggest that combined PEP + omega-3 is a promising treatment for co-occurring behavior symptoms in youth with depression. [ABSTRACT FROM AUTHOR]

Multidimensional Treatment Foster Care for Preschoolers (MTFC-P) has thus far only been tested for diminishing behavior problems in the US. This study tested relative efficacy of MTFC-P on multiple outcomes against treatment as usual in the Netherlands (TAU; Study I), and regular foster care (Study II). The sample included 55 children that received MTFC-P, 23 children received TAU and 30 children from regular foster care (RFC). Changes in behavioral and relationship functioning, trauma symptoms, hypothalamic-adrenal-pituitary (HPA-) axis functioning, and caregiving stress were assessed via questionnaires, interviews, and salivary cortisol. Outcomes of Study I were evaluated using a randomized controlled design and quasi-experimental design, outcomes of Study II according to non-equivalent group comparison. No evidence was found for relative efficacy of MTFC-P over TAU. A treatment effect was found on trauma symptoms, in favor of TAU. Outcomes of Study II revealed that whereas caregiving stress and secure base distortions were significantly more severe at baseline in MTFC-P compared to RFC, post treatment differences were no longer significant. However, percentages of symptoms of disinhibited attachment and attachment disorder were nearly equal between groups at baseline, while post treatment percentages indicated significantly more symptoms in MTFC. In addition, results revealed a significant difference in the severity of externalizing problems post treatment, in favor of RFC. The results obtained within this study indicate that children in MTFC-P and usual treatment foster care in the Dutch context improved similarly, thus not showing the same advantages that MTFC-P has demonstrated in the US. Results should be interpreted with caution due to lower than planned power. Findings underscore the challenges of testing novel treatments across contexts with highly different child welfare provisions. [ABSTRACT FROM AUTHOR]

Background: All community-living older adults might benefit from integrated care, but evidence is lacking on the effectiveness of such services for perceived quality of care.Objective: To examine the impact of Embrace, a community-based integrated primary care service, on perceived quality of care.Design: Stratified randomized controlled trial.Participants: Integrated care and support according to the "Embrace" model was provided by 15 general practitioners in the Netherlands. Based on self-reported levels of case complexity and frailty, a total of 1456 community-living older adults were stratified into non-disease-specific risk profiles ("Robust," "Frail," and "Complex care needs"), and randomized to Embrace or control groups.Intervention: Embrace provides integrated, person-centered primary care and support to all older adults living in the community, with intensity of care dependent on risk profile.Measurements: Primary outcome was quality of care as reported by older adults on the Patient Assessment of Integrated Elderly Care (PAIEC). Effects were assessed using mixed model techniques for the total sample and per risk profile. Professionals' perceived level of implementation of integrated care was evaluated within the Embrace condition using the Assessment of Integrated Elderly Care.Key Results: Older adults in the Embrace group reported a higher level of perceived quality of care than those in the control group (B = 0.33, 95 % CI = 0.15-0.51, ES d = 0.19). The advantages of Embrace were most evident in the "Frail" and "Complex care needs" risk profiles. We found no significant advantages for the "Robust" risk profile. Participating professionals reported a significant increase in the perceived level of implementation of integrated care (ES r = 0.71).Conclusions: This study shows that providing a population-based integrated care service to community-living older adults improved the quality of care as perceived by older adults and participating professionals. [ABSTRACT FROM AUTHOR]

Long-term follow-up studies of selective parent training (PT) programs are scarce, particularly in the case of effectiveness trials conducted within regular care settings. This study evaluated the 2-year effects of 4 programs: Comet, Incredible Years, Cope, and Connect and differences in the rate of change among programs were investigated using Latent Growth Modeling (LGM). Participants were parents who had sought help at 30 local service sector units (e.g., child psychiatric clinics and social services centers) for major problems in managing their children's externalizing behavior. Parents of 749 children (63 % boys) with moderate levels of externalizing behavior, aged 3-12, were randomized to one of the 4 PT programs. Assessments included parent-reported measures of child externalizing, hyperactivity and inattention, as well as parenting practices, sense of competence, and parents' stress and depressive symptoms. At 2-year follow-up, there were no differences in any of the child outcomes among the programs. All programs had reduced externalizing behaviors with large effect sizes (d = 1.21 to d = 1.32), and negative parenting practices with moderate to large effect sizes (d = 0.49 to d = 0.83). LGM analyses showed that the 2 behavioral programs, Comet and Incredible Years, produced more rapid reductions in externalizing behavior during the course of the intervention than the non-behavioral program, Connect. Connect, however, was the only program where children continued to improve after the intervention. Overall, the results indicate that the 4 programs were equally effective in a clinical setting, despite differences in their theoretical origin. [ABSTRACT FROM AUTHOR]

Purpose: To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain.Methods: 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025.Results: At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p < 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p < 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group.Conclusions: In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life. [ABSTRACT FROM AUTHOR]

Gambling disorder (GD) is a prevalent condition for which no pharmacological treatment has yet been approved, although there is evidence that topiramate can reduce impulsivity in GD and craving in various addictive behaviors. The goal of this study was to investigate the effectiveness of topiramate combined with cognitive restructuring for GD in a two-center, randomized, double-blind clinical trial. Participants were individuals seeking outpatient treatment for GD (n = 30), treated with either topiramate or placebo combined with a brief cognitive intervention, over a 12-week period, the dose of topiramate being tapered up during the first 8 weeks. The main outcome measures were gambling craving, behavior, and cognitive distortions; impulsivity; depression and social adjustment. Topiramate proved superior to placebo in reducing gambling craving (P = 0.017); time and money spent gambling (P = 0.007 and P = 0.047, respectively); cognitive distortions related to gambling (P = 0.003); and social adjustment (P = 0.040). We found no significant effects on impulsivity or depression. These findings are in contrast with data from a previous clinical trial with topiramate for GD. In the current study, we found that topiramate affects features specifically related to gambling addiction and had no significant effect on associated phenomena such as impulsiveness and depression. We believe that this response could be due to synergistic interaction between topiramate and the cognitive intervention. [ABSTRACT FROM AUTHOR]

Purpose: Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants.Methods: A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH2O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events.Results: From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of -19% (95% CI -35 to -3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02-2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died.Conclusion: In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013). [ABSTRACT FROM AUTHOR]

Purpose: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial.Methods: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1.Results: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713-0.769]) in the taxane arm and 0.748 [0.722-0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789-0.834] vs. 0.772 [0.751-0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003).Conclusions: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm. [ABSTRACT FROM AUTHOR]

Purpose: We developed a short-interval, low-intensity, slow-jogging (SJ) program consisting of sets of 1 min of SJ at walking speed and 1 min of walking. We aimed to examine the effects of an easily performed SJ program on skeletal muscle, fat infiltration, and fitness in older adults.Methods: A total of 81 community-dwelling, independent, older adults (70.8 ± 4.0 years) were randomly assigned to the SJ or control group. The SJ group participants were encouraged to perform 90 min of SJ at their anaerobic threshold (AT) intensity and 90 min of walking intermittently per week. Aerobic capacity at the AT and sit-to-stand (STS) scores were measured. Intracellular water (ICW) in the legs was assessed by segmental multi-frequency bioelectrical impedance analysis. Subcutaneous (SAT) and intermuscular (IMAT) adipose tissue and muscle cross-sectional area (CSA) were measured at the mid-thigh using computed tomography.Results: A total of 75 participants (37 SJ group, 38 controls) completed the 12-week intervention. The AT and STS improved in the SJ group compared with the controls (AT 15.7 vs. 4.9 %, p < 0.01; STS 12.9 vs. 4.5 %, p < 0.05). ICW in the upper leg increased only in the SJ group (9.7 %, p < 0.05). SAT and IMAT were significantly decreased only in the SJ group (p < 0.01).Conclusion: The 12-week SJ program was easily performed by older adults with low skeletal muscle mass, improved aerobic capacity, muscle function, and muscle composition in older adults. [ABSTRACT FROM AUTHOR]

The Children's Attention-deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) tested the hypotheses that children and caregivers who received guideline-based treatment delivered through a hybrid telehealth service delivery model would experience greater improvements in outcomes than children and caregivers receiving treatment via a comparison delivery model. Here, we present caregiver outcomes. 88 primary care providers (PCPs) in seven geographically underserved communities referred 223 children (ages 5.5 - 12.9 years) to the randomized controlled trial. Over 22 weeks, children randomized to the CATTS service delivery model received six sessions of telepsychiatry and six sessions of caregiver behavior management training provided in person by community therapists who were trained and supervised remotely. Children randomized to the comparison Augmented Primary Care (APC) service model received management in primary care augmented by a single telepsychiatry consultation. Caregiver outcomes included changes in distress, as measured by the Patient Health Questionnaire (PHQ-9), Parenting Stress Index (PSI), Caregiver Strain Questionnaire (CSQ) and Family Empowerment Scale (FES). Caregivers completed five assessments. Multilevel mixed effects regression modeling tested for differences between the two service delivery models in caregiver outcomes from baseline to 25 weeks. Compared to caregivers of children in the APC model, caregivers of children in the CATTS service model showed statistically significantly greater improvements on the PHQ-9 (β = -1.41, 95 % CI = [-2.74, -0.08], p < .05), PSI (β = -4.59, 95 % CI = [-7.87, - 1.31], p < .001), CSQ (β = -5.41, 95 % CI = [- 8.58, -2.24], p < .001) and FES (β = 6.69, 95 % CI = [2.32, 11.06], p < .01). Improvement in child ADHD symptoms mediated improved caregiver scores on the PSI and CSQ. Improvement in child ODD behaviors mediated caregiver CSQ scores. The CATTS trial supports the effectiveness of a hybrid telehealth service delivery model for reducing distress in caregivers of children with ADHD and suggests a mechanism through which the service model affected caregiver distress. [ABSTRACT FROM AUTHOR]

Callous-unemotional (CU) traits and effortful control (EC) are personality and temperament traits implicated in early-onset antisocial trajectories. This secondary analysis of Hitkashrut's randomized controlled trial first tested parent training's effects on EC and CU traits while controlling for more general treatment effects on conduct problems (CP), and subsequently tested mediation by parenting. Prekindergarten teachers in three Israeli cities identified 209 3-5 year-old (163 boys; 46 girls) preschoolers with subclinical-clinical range conduct problems. All participants were Jewish ranging from ultra-orthodox to secular. They were assigned to 14-session co-parent training groups (n = 140 couples), or to minimal intervention control groups with referral to local services as necessary (n = 69 couples). We employed averaged indices of pre- and post-intervention questionnaires completed by both parents. The testing of all hypothesized models controlled for treatment effects on CP in order to strengthen the robustness of the analyses. We found significant concurrent treatment effects on CP and on either CU traits or EC. All effects were mediated by ineffective parenting (IP): a latent variable that was indicated by negative/inconsistent practices and perceived parenting inefficacy. This is the first demonstration of parenting mediated treatment effects on both EC and CU traits in a randomized controlled study conducted in everyday practice contexts. This finding supports a disruption model of change: the reduction of IP facilitates a caregiving environment that affects children's behavior and developing personality. The changing of personality and temperament characteristics implicated in early-onset pathways suggests an innovative prevention strategy for disruptive behavior disorders. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this post hoc analysis was to examine self-reported recovery following a post-discharge intervention and to focus on the moderators of this intervention programme.Methods: RCT using parallel group block randomisation, including 151 patients with ≤3 hospitalisations within the last 3 years, a GAF score ≤60, and aged 18-64 years, assessed at two psychiatric hospitals from Zurich, Switzerland, between September 2011 and February 2014. In the present study, the main outcome was the OQ-45 as assessed prior to discharge from the index hospitalisation and at 12-month follow-up. Participants received either the post-discharge intervention provided by a social worker or treatment as usual (TAU).Results: Patients in the intervention group showed substantially less recovery over the 12-month observation period than controls (d = 0.44). In the TAU group, 15.6 % remained clinically impaired at 12-month follow-up as opposed to 48.1 % in the intervention group (p = 0.001). Among participants in the intervention group, an interdisciplinary meeting of significant network members was associated with less recovery (d = 0.46). Involuntary index admission (d = 0.42) and high educational degree (d = 0.52) were significant moderators of the intervention. Both factors related to less recovery over time in the intervention group relative to TAU.Conclusions: According to the OQ-45, this psychosocial post-discharge intervention revealed an unintended negative effect on self-reported recovery over time. Specifically, the meeting of significant network members related to a moderate deteriorating effect, suggesting that the involvement of some carers, relatives, or friends may cause harm to the patient. Considering with reservation pending replication, these findings could have important implications for brief interventions targeted at patients' social networks.Funding: This study was supported by a private foundation.Trial Registration: ISRCTN58280620. [ABSTRACT FROM AUTHOR]