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To evaluate (1) the long-term efficacy of low-concentration atropine over 5 years, (2) the proportion of children requiring re-treatment and associated factors, and (3) the efficacy of pro re nata (PRN) re-treatment using 0.05% atropine from years 3 to 5. Randomized, double-masked extended trial. Children 4 to 12 years of age originally from the Low-Concentration Atropine for Myopia Progression (LAMP) study. Children 4 to 12 years of age originally from the LAMP study were followed up for 5 years. During the third year, children in each group originally receiving 0.05%, 0.025%, and 0.01% atropine were randomized to continued treatment and treatment cessation. During years 4 and 5, all continued treatment subgroups were switched to 0.05% atropine for continued treatment, whereas all treatment cessation subgroups followed a PRN re-treatment protocol to resume 0.05% atropine for children with myopic progressions of 0.5 diopter (D) or more over 1 year. Generalized estimating equations were used to compare the changes in spherical equivalent (SE) progression and axial length (AL) elongation among groups. (1) Changes in SE and AL in different groups over 5 years, (2) the proportion of children who needed re-treatment, and (3) changes in SE and AL in the continued treatment and PRN re-treatment groups from years 3 to 5. Two hundred seventy (82.8%) of 326 children (82.5%) from the third year completed 5 years of follow-up. Over 5 years, the cumulative mean SE progressions were –1.34 ± 1.40 D, –1.97 ± 1.03 D, and –2.34 ± 1.71 D for the continued treatment groups with initial 0.05%, 0.025%, and 0.01% atropine, respectively (P = 0.02). Similar trends were observed in AL elongation (P = 0.01). Among the PRN re-treatment group, 87.9% of children (94/107) needed re-treatment. The proportion of re-treatment across all studied concentrations was similar (P = 0.76). The SE progressions for continued treatment and PRN re-treatment groups from years 3 to 5 were –0.97 ± 0.82 D and –1.00 ± 0.74 D (P = 0.55) and the AL elongations were 0.51 ± 0.34 mm and 0.49 ± 0.32 mm (P = 0.84), respectively. Over 5 years, the continued 0.05% atropine treatment demonstrated good efficacy for myopia control. Most children needed to restart treatment after atropine cessation at year 3. Restarted treatment with 0.05% atropine achieved similar efficacy as continued treatment. Children should be considered for re-treatment if myopia progresses after treatment cessation. The author(s) have no proprietary or commercial interest in any materials discussed in this article. [ABSTRACT FROM AUTHOR]

To determine whether early switch to oral antibiotic treatment in adults with neutropenic sepsis at low risk of complications is non-inferior to switching later. This non-inferiority, parallel-group, randomized, open-label clinical trial enrolled UK adults hospitalized with neutropenic sepsis. Participants were randomly assigned to either switch to oral ciprofloxacin plus co-amoxiclav within 12–24 hours or to continue intravenous treatment for at least 48 hours. The primary outcome was a composite measure of treatment failure, 14 days after randomization. The non-inferiority margin was 15%. There were 129 participants from 16 centres and 125 were assessed for the primary outcome. Of these, 113 patients completed protocolized treatment and comprised the per-protocol population. In total, 9 (14.1%) of 64 patients in the standard care arm met the primary end point, compared with 15 (24.6%) of 61 in the early switch arm, giving a risk difference of 10.5% (1-sided 95% CI, −∞% to 22%; p 0.14). In the per-protocol population, 8 (13.3%) of the 60 patients in the standard care arm met the primary end point, compared with 9 (17%) of 53 in the intervention arm giving a risk difference of 3.7% (one-sided 95% CI, −∞% to 14.8%; p 0.59). Duration of hospital stay was shorter in the intervention arm (median 2 [inter-quartile range (IQR) 2–3] vs. 3 days [IQR 2–4]; p 0.002). Although non-inferiority of early oral switch was found in the per-protocol population, the intervention was not non-inferior in the intent-to-treat population. [ABSTRACT FROM AUTHOR]

Excessive and protracted lipolysis in adipose tissues of dairy cows is a major risk factor for clinical ketosis (CK). This metabolic disease is common in postpartum cows when lipolysis provides fatty acids as an energy substrate to offset negative energy balance. Lipolysis in cows can be induced by the canonical (hormonally induced) and inflammatory pathways. Current treatments for CK focus on improving glucose in blood (i.e., oral propylene glycol [PG], or i.v. dextrose). However, these therapies do not inhibit the canonical and inflammatory lipolytic pathways. Niacin (NIA) can reduce activation of the canonical pathway. Blocking inflammatory responses with cyclooxygenase inhibitors such as flunixin meglumine (FM) can inhibit inflammatory lipolytic activity. The objective of this study was to determine the effects of including NIA and FM in the standard PG treatment for postpartum CK on circulating concentrations of ketone bodies. A 4-group, parallel, individually randomized trial was conducted in multiparous Jersey cows (n = 80) from a commercial dairy in Michigan during a 7-mo period. Eligible cows had CK symptoms (lethargy, depressed appetite, and milk yield) and hyperketonemia (blood β-hydroxybutyrate [BHB] ≥1.2 mmol/L). Cows with CK were randomly assigned to 1 of 3 groups where the first group received 310 g of oral PG once per day for 5 d; the second group received PG for 5 d + 24 g of oral NIA once per day for 3 d (PGNIA); and the third group received PG for 5 d + NIA for 3 d + 1.1 mg/kg i.v. FM once per day for 3 d (PGNIAFM). The control group consisted of cows that were clinically healthy (HC; untreated; BHB <1.2 mmol/L, n = 27) matching for parity and DIM with all 3 groups. Animals were sampled at enrollment (d 0), and d 3, 7, and 14 to evaluate ketone bodies and circulating metabolic and inflammatory biomarkers. Effects of treatment, sampling day, and their interactions were evaluated using mixed effects models. Logistic regression was used to calculate the odds ratio (OR) of returning to normoketonemia (BHB <1.2 mmol/L). Compared with HC, enrolled CK cows exhibited higher blood concentrations of dyslipidemia markers, including nonesterified fatty acids (NEFA) and BHB, and lower glucose and insulin levels. Cows with CK also had increased levels of biomarkers of pain (substance P), inflammation, including lipopolysaccharide-binding protein, haptoglobin, and serum amyloid A, and proinflammatory cytokines IL-4, MCP-1, MIP-1α, and TNFα. Importantly, 72.2% of CK cows presented endotoxemia and had higher circulating bacterial DNA compared with HC. By d 7, the percentage of cows with normoketonemia were higher in PGNIAFM = 87.5%, compared with PG = 58.33%, and PGNIA = 62.5%. At d 7 the OR for normoketonemia in PGNIAFM cows were 1.5 (95% CI, 1.03–2.17) and 1.4 (95% CI, 0.99–1.97) relative to PG and PGNIA, respectively. At d 3, 7, and 14, PGNIAFM cows presented the lowest values of BHB (PG = 1.36; PGNIA = 1.24; PGNIAFM = 0.89 ± 0.13 mmol/L), NEFA (PG = 0.58; PGNIA = 0.59; PGNIAFM = 0.45 ± 0.02 mmol/L), and acute phase proteins. Cows in PGNIAFM also presented the highest blood glucose increment across time points and insulin by d 7. These data provide evidence that bacteremia or endotoxemia, systemic inflammation, and pain may play a crucial role in CK pathogenesis. Additionally, targeting lipolysis and inflammation with NIA and FM during CK effectively reduces dyslipidemia biomarkers, improves glycemia, and improves overall clinical recovery. [ABSTRACT FROM AUTHOR]

The aim of this double-blind, and randomized controlled clinical trial was to evaluate the 5-year clinical performance of posterior resin composite restorations placed with the incremental filling technique [IF] or the bulk-fill technique [BF]. Two different adhesive systems were used: etch-&-rinse (ER) or self-etch (SE). Posterior dental teeth of 72 participants (n = 236), with a cavity depth of at least 3 mm, were randomly divided into four groups. Restorations were applied with either Tetric N-Bond or Tetric N-Bond SE. The composite resin Tetric N-Ceram Bulk-Fill was placed either with IF or BF. Restorations were evaluated using FDI criteria at baseline and after 1, 2, 3, 4, and 5 years. Statistical analysis was performed using the Wilcoxon Signed rank test (a=0.05). Two hundred and four restorations were evaluated after 5 years. Eleven restorations were considered 'failed', ten due to fracture (4 IF and 6 BF) and one due to secondary caries (IF). The annual failure rate was 1.2% for BF and 1% for IF (p = 0.35). When comparing BF and IF, no significant differences were found for any of the parameters evaluated (p > 0.05). Regarding the adhesive systems, 44 and 51 restorations showed minor problems in terms of marginal adaptation and staining, with significantly more marginal discoloration when the self-etch adhesive was used (p = 0.002). The bulk-fill restorative technique showed good clinical behavior compared to the incremental filling technique, especially when using an etch-&-rinse adhesive, after 5 years of clinical evaluation. [Display omitted] • Bulk-fill technique had similar clinical behavior to incremental filling technique. • Use of etch & rinse adhesive reduced the risk of marginal staining after 5 years. • Minor not significant discrepancies in color match were shown between techniques. [ABSTRACT FROM AUTHOR]

To evaluate if an internet-delivered parent training program is noninferior to its group-delivered counterpart in reducing child disruptive behavior problems (DBP). This noninferiority randomized clinical trial enrolled families seeking treatment in primary care in Stockholm, Sweden, for DBP in a child 3-11 years of age. Participants were randomized to internet-delivered (iComet) or group-delivered (gComet) parent training. The primary outcome was parent-rated DBP. Assessments were made at baseline and 3, 6, and 12 months. Secondary outcomes included child and parent behaviors and well-being and treatment satisfaction. The noninferiority analysis was determined by a one-sided 95% CI of the mean difference between gComet and iComet using multilevel modeling. This trial included 161 children (mean age 8.0); 102 (63%) were boys. In both intention-to-treat and per-protocol analyses, iComet was noninferior to gComet. There were small differences in between-group effect sizes (d = −0.02 to 0.13) on the primary outcome with the upper limit of the one-sided 95% CI below the noninferiority margin at 3-, 6-, and 12-month follow-up. Parents were more satisfied with gComet (d = 0.49, 95% CI [0.26, 0.71]). At 3-month follow-up, there were also significant differences in treatment effect on attention-deficit/hyperactivity disorder symptoms (d = 0.34, 95% CI [0.07, 0.61]) and parenting behavior (d = 0.41, 95% CI [0.17, 0.65]) favoring gComet. At 12-month follow-up, there were no differences in any outcomes. Internet-delivered parent training was noninferior to group-delivered parent training in reducing child DBP. The results were maintained at 12-month follow-up. This study supports internet-delivered parent training being used as an alternative to group-delivered parent training in clinical settings. Randomized Controlled Trial of Comet via the Internet or in Group Format; https://www.clinicaltrials.gov/ ; NCT03465384. [ABSTRACT FROM AUTHOR]

Unsatisfactory responses to major depressive disorder (MDD) therapeutics available necessitated up-to-date treatment approaches. This study sought to investigate the efficacy and tolerability of adjunctive l -theanine, a green tea constituent with neuropsychotropic effects, for MDD. Sixty MDD (DSM-5) patients were equally assigned to receive sertraline (100 mg/d) plus either l -theanine (200 mg/d) or matched placebo in a six-week randomized, parallel-group, double-blind, placebo-controlled study. The participants were assessed using the Hamilton depression rating scale (HDRS) at baseline and weeks 2, 4, and 6. Changes in scores, early improvement, response and remission rates, and adverse events were compared between the groups. Twenty-five participants in each group, a total of 50 patients, completed the study. All baseline characteristics were similar between the groups. The general linear model repeated-measures analysis demonstrated a significant time-treatment interaction effect for HDRS during the trial (p -value = 0.014), indicating more remarkable symptom improvement in the l -theanine group. A greater reduction in HDRS scores was observed in the l -theanine group from baseline to weeks 2, 4, and 6 (p -values = 0.02, 0.03, and 0.01, respectively). All patients responded to sertraline plus l -theanine until week 6. l -theanine was superior to placebo regarding response to treatment and remission rates at week 6 (p -values = 0.05 and 0.02, respectively). The frequency of side effects was comparable between the groups. The small sample size and short study period were the limitations. l -theanine adjunct to sertraline outperforms placebo in treating MDD in a safe manner. Further long-term, large-scale studies are recommended to confirm this evidence. • l -theanine is an amino acid found naturally in green tea, black tea, and mushrooms. • It is beneficial and tolerable in depression, obtained from a gold-standard design. • l -theanine has been reported to modulate GABA, serotonin, and dopamine levels. • It may also exert effects through the glutamatergic and neuroimmune mechanisms. [ABSTRACT FROM AUTHOR]

Seizures are suspected to be side effects of antipsychotics. To examine a possible causal relationship, we compared the risk of seizures on second-generation antipsychotics to the risk on placebo in randomized controlled clinical trials (RCTs) across diagnostic groups. The primary outcome was any seizure reported as International Conference on Harmonisation-Good Clinical Practice (ICH-GCP)-defined serious adverse event (SAEs). The risk ratio (RR) with antipsychotics versus placebo was synthesized in a pairwise common effects Mantel-Haenszel meta-analysis. For 314 of 597 idenitified placebo-controlled RCTs information about all SAEs could be retrieved from publications, original investigators, pharmaceutical companies and the European Medical Agency. In those, 37 seizures occurred in 42,600 participants on antipsychotics (0.09%) and 28 in 25,042 participants on placebo (0.11%). The meta-analytic results (RR 0,68; 95% Confidence Interval 0.41-1.12) indicated a reduced risk on antipsychotics with a confidence interval including no difference (i.e. RR=1). Neither in sensitivity analyses (excluding events in the safety-follow-up of trials or first-generation antipsychotics; using odds ratios) nor in subgroup analyses (on specific antipsychotics, drug combinations, diagnostic categories, age groups, and study duration) there was evidence for an increased risk on antipsychotics, except for some weak indications of an increased risk on antipsychotics in older and/or demented participants (RRs 1.11 and 1.48, respectively, but with 95% CIs of 0.35-3.49 and 0.41-5.26 including no difference and subgroup tests with p=0.54 and p=0.66 not indicating differences between age groups or diagnostic categories). Consequently, there are no indications that second-generation antipsychotics cause seizures in middle-aged adults and children in most diagnostic groups; rather our results provide some weak evidence for a protective effect. However, there was no data on SAEs available for clozapine, for which observational studies provide the strongest associations with increased seizure rates, and for older and/or demented patients a small additional risk on antipsychotics cannot be excluded. [ABSTRACT FROM AUTHOR]

Psychotic depression has a high rate of relapse. The study aims were to identify a prediction model of risk of relapse of psychotic depression and examine whether predictors moderated the effect of treatment on relapse. One hundred and twenty-six men and women aged 18–85 years, who experienced sustained remission or near-remission of psychotic depression with sertraline plus olanzapine, participated in a 36-week randomized controlled trial that compared sertraline plus olanzapine with sertraline plus placebo in preventing relapse (NCT01427608). Cox regression analyses were performed to identify significant predictors of relapse and to model the combined role of significant predictors. Concordance statistic was calculated to determine the accuracy of the best fit multivariable models in predicting relapse. Finally, interaction terms were tested for each significant predictor to examine whether they moderated the effect of treatment on risk of relapse. Lifetime number of depressive episodes, severity of residual depressive symptoms at the time of randomization, and psychomotor disturbance both at acute enrollment when participants were depressed and at the time of randomization predicted risk of relapse. Multivariable models had 69–70% accuracy in predicting relapse. Psychomotor disturbance was associated with increased risk of relapse in the sertraline plus olanzapine group compared with sertraline plus placebo, whereas the other predictors did not moderate the effect of treatment on relapse. Future research is needed to determine whether a combination of clinical and biological variables can further increase the accuracy of prediction of relapse of psychotic depression. • Psychotic depression has a high rate of relapse. • Identify predictors and moderators of risk of relapse of remitted psychotic depression. • Lifetime number of depressive episodes, residual depressive symptoms, and psychomotor disturbance predicted relapse. • Multivariable models had 69–70% accuracy in predicting relapse. • Psychomotor disturbance moderated the effect of randomized treatment on relapse. [ABSTRACT FROM AUTHOR]

Background In animal studies, a meal containing Alaska pollack protein (APP) induces fast-twitch muscle hypertrophy. To our knowledge, no interventional studies have examined the benefits of APP intake on muscle mass and muscle weakness and the prevention of sarcopenia in older individuals. Objectives We evaluated the effects of APP intake on skeletal muscle mass, muscle strength, and physical performance among healthy community-dwelling older Japanese women. Methods In this double-blind randomized controlled trial, healthy women ≥ 65 y old were allocated to an APP or whey protein control (CON) group. Participants ingested test protein meals (5.0–5.1 g protein/serving) daily for 24 wk. Between-group differences in the change of skeletal muscle mass index (SMI) as the primary outcome and muscle strength as a secondary outcome were tested using multifrequency BIA and a handheld dynamometer, respectively, at baseline, and 4, 12, and 24 wk. The mean changes in the measured primary and secondary outcome variables from baseline to 4, 12, and 24 wk were compared using unpaired t tests. Results There were no between-group differences in nutritional status, food intake, or total energy and protein intakes at baseline, 12 wk, or 24 wk. The change in SMI was 0.12 kg/m2 (95% CI: 0.01, 0.23 kg/m2) and 0.11 kg/m2 (95% CI: 0.03, 0.19 kg/m2) greater in the APP group than in the CON group at 12 wk and 24 wk (P  ≤ 0.03) and knee extension strength was 0.07 Nm/kg BW (95% CI: 0.02, 0.12 Nm/kg BW) and 0.05 Nm/kg BW (95% CI: 0.00, 0.09 Nm/kg BW) higher in the APP group than in the CON group at these times (P  ≤ 0.015), respectively. The groups did not differ at 4 wk. Conclusions Daily intake of a meal containing APP compared with whey protein increases skeletal muscle mass and lower-extremity muscle strength in healthy older women, suggesting that an APP-containing meal may be useful in the prevention of sarcopenia in this group. This trial was registered at as UMIN000035718. [ABSTRACT FROM AUTHOR]

Patients with premenopausal breast cancer (PMBC) have been historically excluded from some clinical trials because of the limitations of using endocrine therapy (ET) in this population. We analyzed breast cancer randomized clinical trials (RCTs) to determine the rates of and factors associated with inclusion of PMBC patients to provide a benchmark for PMBC inclusion in RCTs moving forward. Using ClinicalTrials.Gov , we identified breast cancer phase III RCTs and extracted inclusion criteria and patient enrollment information. Multiple binary logistic regression modeling was used to assess trial-related factors that were associated with PMBC patient inclusion. Of 170 breast cancer RCTs identified, 131 (77.1%) included PMBC patients. Sixty-five (38.2%) trials analyzed patients with hormone-receptor-positive (HR+) and HER2-negative (HER2-) breast cancer, of which 31 (47.7%) allowed for enrollment of PMBC patients. Lower rates of PMBC inclusion were seen in trials that studied HR+/HER2-patients (47.7% PMBC inclusion in HR+/HER2-trials vs. 94.3% in non-HR+/HER2-trials, aOR 0.07 [95% CI: 0.02–0.19], p < 0.001) and in trials that randomized or mandated ET (44.4% in ET trials vs. 83.2% in non-ET trials, aOR 0.21 [95% CI: 0.10–0.83], p = 0.02). Trials studying chemotherapy (CT) were associated with inclusion of PMBC patients (100% in CT trials vs. 70.5% in non-CT trials, a OR 14.02 [95% CI: 1.54–127.91], p = 0.01). All surgical and radiation therapy clinical trials allowed for the inclusion of PMBC patients in their eligibility criteria. Breast cancer clinical trials should carefully select their enrollment criteria and consider inclusion of premenopausal patients when appropriate. • We investigated the inclusion of premenopausal breast cancer (PMBC) patients in clinical trials. • There was lower inclusion of PMBC in trials studying HR+/HER2-patients. • There was lower inclusion of PMBC in trials studying endocrine therapy. • Trials should carefully select their enrollment criteria and include PMBC patients when appropriate. [ABSTRACT FROM AUTHOR]

Background Probiotics may alleviate lactose maldigestion. Objectives The objective was to select a probiotic with high lactase activity and compare it with lactase and placebo in clinical trials. Methods Bacterial cultures were screened for lactase activity in a model of the upper gastrointestinal (GI) tract. Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) counts were adjusted in subsequent experiments to correspond to 4500 Food Chemicals Codex (FCC) units of lactase, the amount in the European Food Safety Authority (EFSA)-approved health claim. Two crossover clinical trials, Booster Alpha and Booster Omega, were performed in participants with lactose intolerance, where 2 × 1012 CFUs Bi-07, 4662 FCC lactase, or placebo was consumed simultaneously with a lactose challenge, with 1-wk washouts between challenges. The trial designs were identical except for the source of lactose. Breath hydrogen concentration (BHC) was measured to assess the effect of the investigational products on lactose digestion, for which incremental area under the curve (iAUC) was the primary outcome. Peak BHC, cumulative BHC, and GI symptoms were secondary outcomes. Results Bi-07 was superior to placebo in reducing BHC [iAUC, parts per million (ppm) ∙ h] in both trials (Booster Alpha: geometric least square mean ratio: 0.462; 95% CI: 0.249, 0.859; P =  0.016; Booster Omega: 0.227; 95% CI: 0.095, 0.543; P  = 0.001). Lactase was superior to placebo in Booster Alpha (0.190; 95% CI: 0.102, 0.365; P  < 0.001) but not Booster Omega (0.493; 95% CI: 0.210, 1.156; P  = 0.102). Noninferiority of Bi-07 compared with lactase was observed in Booster Omega (0.460; 95% CI: 0.193, 1.096; P  = 0.079; CI upper limit < 1.25 noninferiority margin). Odds of abdominal pain (compared with placebo: 0.32, P  = 0.036) and flatulence (compared with placebo: 0.25, P  = 0.007) were lower with lactase in Booster Alpha. Increased odds of nausea were seen with Bi-07 (compared with placebo: 4.0, P  = 0.005) in Booster Omega. Conclusions Bi-07 has high lactase activit y , and in 2 clinical trials, it supported lactose digestion in individuals with lactose intolerance. These trials were registered at clinicaltrials.gov as NCT03659747 (Booster Alpha) and NCT03814668 (Booster Omega). [ABSTRACT FROM AUTHOR]

Few clinical trials have evaluated the efficacy of psychotherapy for Intermittent Explosive Disorder (IED). The present study tested the efficacy of a cognitive behavioral intervention (versus supportive psychotherapy) among adults with IED. In this randomized clinical trial, 44 participants with IED (22 men and 22 women) aged 20-55 years completed twelve 50-minute individual sessions of either a multi-component cognitive behavioral intervention for IED (n = 19) or a time equated supportive psychotherapy (n = 25). At baseline, posttreatment, and 3-month follow-up, all participants received the Overt Aggression Scale-Modified, which was conducted by an interviewer who was blind to the participant's study condition. During these visits, participants also completed self-report measures of relational aggression (Self-Report of Relational Aggression and Social Behavior), anger (State-Trait Anger Expression Inventory-2), cognitive biases (e.g., Social Information Processing Questionnaire Attribution and Emotional Response Questionnaire), and associated symptoms (e.g., Beck Depression Inventory). Primary study outcomes were aggressive behavior and anger. Though participants in both treatments tended to improve over time, the cognitive behavioral intervention was superior to supportive psychotherapy in decreasing aggressive behavior and relational aggression. These findings support the efficacy of a multicomponent cognitive behavioral intervention in treating aggression in IED. [ABSTRACT FROM AUTHOR]

Several previous meta-analyses have been published, followed by additional randomized clinical trials investigating the effects of tranexamic acid (TXA) in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. As a result, the purpose of this research is to present an updated quantitative analysis of the existing literature and to further explicate its effectiveness. PubMed, Embase, Web of Science, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing the application of TXA and placebo in patients undergoing PLIF surgery from their establishment to December 31, 2021. Data on clinical outcomes, perioperative outcomes, and complications were collected. The summary statistics for continuous and dichotomous variables were derived as weighted mean difference (WMD) and relative risk (RR), respectively. A total of 12 studies enrolling 1088 participants were included in this meta-analysis. The combined results revealed that TXA can decrease intraoperative blood loss (WMD: −84.83, P < 0.0001), total blood loss (WMD: −189.93, P < 0.00001), hidden blood loss (WMD: −134.69, P = 0.002), postoperative drainage (WMD: −100.71, P < 0.00001), postoperative hemoglobin loss (WMD: 6.21, P < 0.00001), operative time (WMD: −3.80, P = 0.007), hospital stay (WMD: −1.86, P = 0.001), and transfusion rates (RR: 0.41, P < 0.00001) in PLIF without increasing the risk of thromboembolic events (RR: 0.80, P = 0.43). TXA can considerably decrease surgical blood loss, postoperative drainage, reduce operative times, hospital stays, and transfusion rates. Furthermore, the TXA group had lower postoperative hemoglobin drop values than the placebo group. [ABSTRACT FROM AUTHOR]

This exploratory analysis of the double-blind, phase 3, SCORPIO-SR trial assessed the effect of ensitrelvir in preventing post coronavirus disease 2019 (COVID-19) condition (PCC). Patients with mild-to-moderate COVID-19 were randomized (1:1:1) within 120 h of symptom onset; received 5-day oral ensitrelvir 125 mg (375 mg on day 1), 250 mg (750 mg on day 1), or a matching placebo once daily; and were assessed for the severity of typical PCC symptoms using a self-administered questionnaire. In total, 341, 317, and 333 patients were assessed in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively (mean age, 35.6–36.5 years; men, 53.3%–58.3%). On days 85, 169, and 337, ensitrelvir 125-mg treatment showed 32.7% (95% confidence interval [CI]: -30.6, 66.1), 21.5% (95% CI: -37.3, 55.6), and 24.6% (95% CI: -43.7, 60.9) reductions versus placebo, respectively, in the risk of any of the 14 acute-phase COVID-19 symptoms (at least one mild, moderate, or severe symptom with general health not returning to the usual level). Ensitrelvir 250-mg treatment showed 10.9% (95% CI: -67.0, 52.8), 9.5% (95% CI: -56.6, 48.0), and 30.6% (95% CI: -36.2, 65.5) risk reductions versus placebo on days 85, 169, and 337, respectively. Risk reductions were observed in any of the 4 neurological symptoms and were more pronounced among patients with high acute-phase symptom scores at baseline and among those with a baseline body mass index ≥25 kg/m2. Ensitrelvir treatment in the acute phase of COVID-19 may reduce the risk of various symptoms associated with PCC. jRCT2031210350. • Our results suggested that ensitrelvir may reduce the risk of persistent and/or late-onset COVID-19 symptoms. • The potential benefit of ensitrelvir was indicated irrespective of risk factors or vaccination status of patients. • The potential benefit was more pronounced among patients with high COVID-19 symptom scores at baseline or BMI of ≥25 kg/m2. • Further research is granted for the effect of ensitrelvir in preventing post COVID-19 condition. [ABSTRACT FROM AUTHOR]

We studied the short- and long-term effects of imatinib in hospitalized COVID-19 patients. Participants were randomized to receive standard of care (SoC) or SoC with imatinib. Imatinib dosage was 400 mg daily until discharge (max 14 days). Primary outcomes were mortality at 30 days and 1 year. Secondary outcomes included recovery, quality of life and long COVID symptoms at 1 year. We also performed a systematic review and meta-analysis of randomized trials studying imatinib for 30-day mortality in hospitalized COVID-19 patients. We randomized 156 patients (73 in SoC and 83 in imatinib). Among patients on imatinib, 7.2% had died at 30 days and 13.3% at 1 year, and in SoC, 4.1% and 8.2% (adjusted HR 1.35, 95% CI 0.47–3.90). At 1 year, self-reported recovery occurred in 79.0% in imatinib and in 88.5% in SoC (RR 0.91, 0.78–1.06). We found no convincing difference in quality of life or symptoms. Fatigue (24%) and sleep issues (20%) frequently bothered patients at one year. In the meta-analysis, imatinib was associated with a mortality risk ratio of 0.73 (0.32–1.63; low certainty evidence). The evidence raises doubts regarding benefit of imatinib in reducing mortality, improving recovery and preventing long COVID symptoms in hospitalized COVID-19 patients. • We found no short or long-term benefit from imatinib in hospitalized COVID-19. • Pooled evidence raises doubts regarding benefit of imatinib in reducing mortality. • Fatigue and sleeping problems common at 1 year after hospitalized COVID-19. [ABSTRACT FROM AUTHOR]

The excess neonatal adiposity is considered a risk factor for the development of childhood obesity and the birth weight is a marker of health throughout life. To evaluate the effect of a lifestyle intervention conducted among pregnant women with overweight on neonatal adiposity and birth weight. A total of 350 pregnant women were recruited and randomly allocated into the control (CG) and intervention (IG) groups. Pregnant women in the IG were invited to participate in three nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed foods, following the NOVA food classification system, which categorizes foods according to the extent and purpose of industrial processing, and the regular practice of physical activity. Neonatal adiposity was estimated using a previously validated anthropometric model. Adjusted linear regression models were used to measure the effect. Adopting the modified intention-to-treat principle, data from 256 neonates were analyzed for birth weight, and data from 163 for body composition estimation. The treatment had no effect on the proportion of fat mass [β 0.52 (95 % CI −1.03, 2.06); p =.51], fat-free mass [β −0.50 (95 % CI −2.45, 1.45); p =.61] or birth weight [β 53.23 (95 % CI −87.19, 193.64); p =.46]. In the present study, the lifestyle counselling used had no effect on neonatal adiposity or birth weight. Future studies should investigate the effect of more intensive interventions. • The intervention based on NOVA did not cause an undesirable effect on foetal development. • The nutritional intervention based on NOVA did not impair neonatal anthropometry. • Future research is needed to elucidate whether maternal lifestyle intervention can influence neonatal body composition. [ABSTRACT FROM AUTHOR]

Background: Lifestyle medicine (LM) is gaining increasing attention as a treatment option for anxiety, but the current state of evidence has not yet been systematically examined.Methods: Six electronic databases were systematically searched from inception to February 2022. Randomized controlled trials (RCTs) comparing the effects of multicomponent LM interventions on anxiety symptoms with either care-as-usual, waitlist, no intervention, or attention control group on anxiety symptoms were identified.Results: A total of 53 RCTs with 18,894 participants were included for qualitative synthesis, in which 45 RCTs with data available were included for meta-analysis. Multicomponent LM intervention was significantly more effective than the control groups in reducing anxiety symptoms at immediate posttreatment (d = 0.19, p < .001) and at short-term follow-up (d = 0.29, p < .001). However, no significant difference at medium-term was found (p = .14), whereas more studies are needed to study the long-term effects. The subgroup analyses suggested that baseline anxiety symptoms was a significant moderator, suggesting that those with moderate level of baseline anxiety symptoms appeared to have greater improvements (d = 0.66, p < .05).Limitations: Minimal anxiety symptoms at baseline contributed to the floor effect and influenced the degree of improvement. The included RCTs had a high risk of bias in general with potential publication bias detected.Conclusion: The findings of this meta-analysis provided support for the positive effects of multicomponent LM interventions for anxiety symptoms. Future research is needed to determine the long-term effects of multicimponent LM and the optimal baseline anxiety severity. [ABSTRACT FROM AUTHOR]

Several data indicate that the success of pharmacological treatment in major depressive disorder (MDD) is still unsatisfactory. The reasons for the low response and remission rates are multiple and depend on environmental and biological factors intrinsic to the disease and drug treatments. Pharmacogenetic (PG) tests have the potential to increase efficacy predicting outcome and to reduce antidepressant discontinuation due to side effects. Several studies investigated the utility of PG tests for antidepressants in MDD with interesting but contrasting results. To date most of them are observational studies with no comparator group, and few are randomized controlled trials (RCTs). The aim of this review is to provide an evaluation of the state of art on clinical methodologic features of RCTs with PG tests for antidepressant drugs in MDD, offering suggestions and favoring new insights that could be useful in the implementation of future trials. Several limitations concerning study design, generalization of results, duration of trials, patients group studied, and cost-effectiveness ratio were found, and a number of barriers have been noted in the adoption of PG tests into clinical practice. Despite some preliminary positive results, there is the need for larger and longer‐term RCT studies, with the goal to capture the real impact of PG tests, also with stratified analysis concerning MDD features in terms of severity and antidepressant treatment failures in different ethnicity cohorts. [ABSTRACT FROM AUTHOR]

Clinical trials are performed to determine the safety, efficacy, or effectiveness of a medical or surgical intervention. A clinical trial is, by definition, prospective in nature with a uniform treatment of a defined patient cohort. The outcomes assessment should also be uniform. Often a control group is included. At present, the number of neurosurgical clinical trials is increasing, and the study designs have become more sophisticated. Historically, the standard of neurosurgical care has evolved from the findings from many case series and retrospective comparative studies. However, in the present report, we have focused exclusively on prospective clinical trials. An urgent need exists to understand how clinical trials have been performed in the past and how they can be improved to advance our neurosurgical practice. In the present review, we have discussed the barriers, successes, and failures regarding prospective clinical trials in neurosurgery with an outlook to the future. [ABSTRACT FROM AUTHOR]

The UK neurosurgical community has a track record of delivering high-quality, practice-changing clinical research studies, facilitated by a robust clinical research infrastructure and close collaborations between neurosurgical centers. More recently, these large-scale studies have been conceived, developed, and delivered by neurosurgical trainees, working under the umbrella of the British Neurosurgical Trainee Research Collaborative (BNTRC). In this paper, we outline the current landscape of large-scale neurosurgical studies in the UK, focusing on the role of trainees in facilitating this research. Importantly, we focus on our experience of trainee-led studies, including the development of the network, current challenges, and future directions. We believe that a similar model can be applied in different settings and countries, which will drive up the quality of neurosurgical research, ultimately benefiting future neurosurgical patients. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled clinical trial was to evaluate the clinical survival and quality parameters of class-II restorations using a bulk-fill composite resin compared to a conventional nanohybrid composite resin in a split-mouth design. One hundred and twenty direct restorations were placed in stress bearing class II cavities (n = 60 test group: Filtek™ Bulk Fill Posterior and n = 60 control group: Filtek™ Supreme XTE) in adult permanent teeth. Survival and clinical quality were evaluated at baseline and after 3 years using modified World Dental Federation (FDI) criteria. Participants and clinical evaluators were blinded relating to the group assignment of the restorations. Seventeen restorations (14.2%) were lost to follow-up, leading to 51 restorations available for survival analysis in the test group and 52 restorations in the control group. Seven restorations showed unfavorable events and were classified as failure. Four bulk-fill restorations failed due to tooth infracture (n = 1), chipping fractures (n = 2) and recurrent decay (n = 1), whereas three conventional nanohybrid composite restorations failed due to adhesive failure (n = 1), tooth infracture (n = 1) and chipping as well as recurrent decay (n = 1). The mean annual failure rate was 2.4% and 1.8%, respectively. The difference between test and control group was not significant (p = 0.7). Data on the detailed assessment of FDI criteria were available for n = 48 and n = 49 restorations, respectively. No significant differences between the two groups could be found regarding the assessment of esthetic, functional and biological properties. Both materials showed similar clinical performance and survival. The use of bulk-fill composite proved to be an esthetically, functionally and biologically satisfactory alternative in the posterior dentition during the 3-year follow-up. [ABSTRACT FROM AUTHOR]

Background/purpose: To evaluate whether a shorter length (20 cm) of C-UCM has potential benefits, compared to immediate cord clamping (ICC), in very preterm babies.Methods: Inborn preterm infants less than 30 weeks of gestational age (GA) were randomly assigned to the 20-cm C-UMC and ICC groups. The primary outcome was the need for packed red blood cell (pRBC) transfusion before the 21st day of life. The secondary outcomes were short- and long-term outcomes related to premature birth.Results: Seventy-six neonates were randomized to the two groups. GA were 27.2 ± 1.8 and 27.5 ± 1.7 weeks (p = 0.389) and birth weights were 987 ± 269 and 1023 ± 313 g (p = 0.601) in the 20-cm C-UCM and ICC groups, respectively. There was no significant difference between the groups in terms of the need for pRBC transfusion before the 21st day of life (59.4% versus 71.8%, adjusted odds ratio [aOR] 0.311, 95% confidence interval [CI] 0.090-1.079). An increased prevalence of late-onset sepsis was observed in the 20-cm C-UCM group compared to the ICC group (21.6% versus 5.1%, aOR 5.434, 95% CI 1.033-23.580). The mortality rates were 13.5% and 2.6% in the 20-cm C-UCM and ICC groups, respectively (aOR 5.339, 95% CI 0.563-50.626). The neurodevelopmental outcomes at 2 years of corrected age between the groups were also not statistically significant.Conclusion: A 20-cm C-UCM showed no effect on reducing the incidence of pRBC transfusion in preterm babies with GA less than 30 weeks compared with ICC in this small-scale randomized controlled trial. [ABSTRACT FROM AUTHOR]

Working memory training for Attention-Deficit/Hyperactivity Disorder (ADHD) has focused on increasing working memory capacity, with inconclusive evidence for its effectiveness. Alternative training targets are executive working memory (EWM) processes that promote flexibility or bolster stability of working memory contents to guide behavior via selective attention. This randomized, placebo-controlled study was designed to assess feasibility, tolerability, and behavioral target engagement of a novel EWM training for ADHD. 62 ADHD-diagnosed adolescents (12–18 years) were randomized to EWM training or placebo arms for 20 remotely coached sessions conducted over 4–5 weeks. Primary outcome measures were behavioral changes on EWM tasks. Secondary outcomes were intervention tolerability, trial retention, and responsiveness to adaptive training difficulty manipulations. Linear regression analyses found intervention participants showed medium effect size improvements, many of which were statistically significant, on Shifting and Filtering EWM task accuracy and Shifting and Updating reaction time measures. Intervention participants maintained strong self-rated motivation, mood, and engagement and progressed through the adaptive difficulty measures, which was further reflected in high trial retention. The results suggest that these EWM processes show promise as training targets for ADHD. The subsequent NIMH R33-funded extension clinical trial will seek to replicate and extend these findings. • The study assessed a novel ADHD training intervention for executive working memory. • Double-blind, randomized, placebo-controlled trial of 62 adolescents with ADHD. • Clear target engagement evidence with improvements on task outcomes. • The intervention has promise and has advanced to subsequent NIMH-funded evaluation. [ABSTRACT FROM AUTHOR]

Leveraging military veterans' intimate relationships during treatment has the potential to concurrently improve posttraumatic stress disorder (PTSD) symptoms and relationship quality. Cognitive-Behavioral Conjoint Therapy (CBCT) and an 8-session Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) are manualized treatments designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among veterans. Intranasal oxytocin, which targets mechanisms of PTSD and relationship quality, may enhance the efficacy of bCBCT. The purpose of this 4-year clinical trial is to compare the outcomes of bCBCT augmented with intranasal oxytocin versus bCBCT plus placebo. We will also explore potential mechanisms of action: self-reported communication skills, empathy, and trust. We will recruit 120 dyads (i.e., veteran with PTSD and their intimate partner) from the VA San Diego Healthcare System. Veterans will be administered 40 international units of oxytocin (n = 60) or placebo (n = 60) 30 min before each of 8 bCBCT sessions delivered via telehealth. Clinical and functioning outcomes will be assessed at five timepoints (baseline, mid-treatment, post-treatment, and 3- and 6-month follow-up). Study findings will reveal the efficacy of oxytocin-assisted brief couple therapy for PTSD, which could serve as highly scalable option for couples coping with PTSD, as well as provide preliminary evidence of interpersonal mechanisms of change. ClinicalTrials.gov Identifier: NCT06194851 [ABSTRACT FROM AUTHOR]

Individuals with a history of moderate-severe traumatic brain injury (TBI) experience a significantly higher prevalence of insomnia compared to the general population. While individuals living with TBI have been shown to benefit from traditional insomnia interventions (e.g., face-to-face [F2F]), such as Cognitive Behavioral Therapy for Insomnia (CBT I), many barriers exist that limit access to F2F evidence-based treatments. Although computerized CBT-I (CCBT-I) is efficacious in terms of reducing insomnia symptoms, individuals with moderate-severe TBI may require support to engage in such treatment. Here we describe the rationale, design, and methods of a randomized controlled trial (RCT) assessing the efficacy of a guided CCBT-I program for reducing insomnia symptoms for participants with a history of moderate-severe TBI. This is an RCT of a guided CCBT-I intervention for individuals with a history of moderate-severe TBI and insomnia. The primary outcome is self-reported insomnia severity, pre- to post-intervention. Exploratory outcomes include changes in sleep misperception following CCBT-I and describing the nature of guidance needed by the Study Clinician during the intervention. This study represents an innovative approach to facilitating broader engagement with an evidence-based online treatment for insomnia among those with a history of moderate-severe TBI. Findings will provide evidence for the level and nature of support needed to implement guided CCBT-I. Should findings be positive, this study would provide support for a strategy by which to deliver guided CCBT-I to individuals with a history of moderate-severe TBI. • There is a high prevalence of sleep disorders, including insomnia, following moderate-severe traumatic brain injury (TBI). • Computerized Cognitive Behavioral Therapy for Insomnia (CCBT-I) may help address barriers to accessing traditional treatments for insomnia. • Individuals with moderate-severe TBI often have impairments that may interfere with the uptake of CCBT-I. • Provider supported CCBT-I may increase efficacy of CCBT-I among some cohorts, such as those with a history of moderate-severe TBI. • This is a randomized controlled trial of a CCBT-I intervention for individuals with current insomnia and a history of moderate-severe TBI. • Positive results could support the development of a stepped-care model of CCBT-I following moderate-severe TBI. [ABSTRACT FROM AUTHOR]

This study reviewed the literature about the diagnosis, antepartum surveillance, and time of delivery of fetuses suspected to be small for gestational age or growth restricted. Several guidelines have been issued by major professional organizations, including the International Society of Ultrasound in Obstetrics and Gynecology and the Society for Maternal-Fetal Medicine. The differences in recommendations, in particular about Doppler velocimetry of the ductus venosus and middle cerebral artery, have created confusion among clinicians, and this review has intended to clarify and highlight the available evidence that is pertinent to clinical management. A fetus who is small for gestational age is frequently defined as one with an estimated fetal weight of <10th percentile. This condition has been considered syndromic and has been frequently attributed to fetal growth restriction, a constitutionally small fetus, congenital infections, chromosomal abnormalities, or genetic conditions. Small for gestational age is not synonymous with fetal growth restriction, which is defined by deceleration of fetal growth determined by a change in fetal growth velocity. An abnormal umbilical artery Doppler pulsatility index reflects an increased impedance to flow in the umbilical circulation and is considered to be an indicator of placental disease. The combined finding of an estimated fetal weight of <10th percentile and abnormal umbilical artery Doppler velocimetry has been widely accepted as indicative of fetal growth restriction. Clinical studies have shown that the gestational age at diagnosis can be used to subclassify suspected fetal growth restriction into early and late, depending on whether the condition is diagnosed before or after 32 weeks of gestation. The early type is associated with umbilical artery Doppler abnormalities, whereas the late type is often associated with a low pulsatility index in the middle cerebral artery. A large randomized clinical trial indicated that in the context of early suspected fetal growth restriction, the combination of computerized cardiotocography and fetal ductus venosus Doppler improves outcomes, such that 95% of surviving infants have a normal neurodevelopmental outcome at 2 years of age. A low middle cerebral artery pulsatility index is associated with an adverse perinatal outcome in late fetal growth restriction; however, there is no evidence supporting its use to determine the time of delivery. Nonetheless, an abnormality in middle cerebral artery Doppler could be valuable to increase the surveillance of the fetus at risk. We propose that fetal size, growth rate, uteroplacental Doppler indices, cardiotocography, and maternal conditions (ie, hypertension) according to gestational age are important factors in optimizing the outcome of suspected fetal growth restriction. [ABSTRACT FROM AUTHOR]

Side effects (SEs) and adverse events (AEs) of bladder cancer (BC) treatment have become more prevalent and may impact the effectiveness of the prescribed therapy. Given, the substantial combination of various treatment types and interventions, it is crucial for the urologist and the team of specialists to discern the systematic and local SEs of these treatments for more awareness and vigilance. This was shown within randomized clinical trials (RCTs) which are complex, and their management needs many efforts. RCTs generate a big amount of knowledge that can serve as evidence for future clinical decision making. Current approaches do not discuss semantic integration of different resources. In this paper we propose a knowledge-based BC treatment effects and complication infrastructure (BCTECI) approach to reason and appraise the effectiveness of BC treatments within their related SEs. This optimized treatment outcomes. Referring to ontology features, a knowledge model with semantic queries and logic rules included evidence concluded from the assessed RCTs. Hence, this supports interoperability between RCTs resources and a common treatment ontology. For this, a comprehensive literature search of relevant RCTs was performed systematically in different electronic medical databases. All pertinent RCTs covering BC treatment cases and reporting prescriptions' effectiveness were included in BCTECI knowledge model. This study provided the required taxonomy and semanticization and evaluated the effectiveness of treatment outcomes. Furthermore, it extended the clinical evidence-based knowledge for AEs anticipation with a more efficient treatment prescription and showed whether SEs impact the effectiveness of a prescribed treatment until revocation. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the effect of different application techniques of ozone on the prevalence of postendodontic pain in patients undergoing single-visit root canal treatment. hundred eight patients with necrotic pulp in single-rooted teeth and apical periodontitis participated in the trial. A standard single-visit endodontics protocol was followed with 5.25% sodium hypochlorite and rotary nickel-titanium files. After shaping and cleaning, patients were randomly allocated into the following groups: group 1 (n = 21), ozone treatment with no activation (NA); group 2 (n = 22), ozone treatment with manual dynamic activation (MDA); group 3, (n = 21), ozone treatment with passive ultrasonic activation (PUA); group 4 (n = 23), ozone treatment with sonic activation (SA); and group 5 (n = 21), no ozone treatment (the control group). Patient levels of discomfort were recorded at 6 different time intervals using the visual analog scale (VAS). Comparison of the mean difference between the groups and time intervals was performed using 2-way analysis of variance followed by a post hoc Bonferroni test. The level of significance was set at 5%. VAS scores were highest for the control > NA > MDA > SA > PUA groups. A statistically significant reduction in VAS scores was observed in the PUA and SA groups in comparison with the NA, control, and MDA groups. Timewise comparison showed a highly significant decline in VAS scores at all time intervals (P <.001). Ultrasonic and sonic activation of ozone resulted in less pain in patients undergoing single-visit endodontics compared with no ozone treatment. [ABSTRACT FROM AUTHOR]

Background: Meru Health Program (MHP) is a therapist-guided, 8-week intervention for depression delivered via smartphone. The aim was to test its efficacy in patients with clinical depression in a Finnish university student health service.Methods: Patients (n=124, women 72.6%, mean age 25y) were stratified based on antidepressant status, and randomized into intervention group receiving MHP plus treatment as usual (TAU), and control group receiving TAU only. Depression, measured by the Patient Health Questionnaire-9 (PHQ-9) scale, was the primary outcome. After baseline (T0), follow-ups were at mid-intervention (T4), immediately post-intervention (T8); 3 months (T20), and 6 months (T32) post-intervention.Results: The intervention group and control group did not have significant differences in depression outcomes throughout end of treatment and follow-up. Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups. Post-hoc comparisons of patients on antidepressants showed significantly greater reduction in depression at T32 for MHP+TAU versus TAU (d=-0.73, p=0.01); patients not on antidepressants showed no between-group differences.Limitations: Limitations include unknown characteristics of TAU, potential bias from patients and providers not being blinded to treatment group, and failure to specify examination of differences by antidepressant status in the protocol.Conclusions: Most outcomes, including depression, did not significantly differ between MHP+TAU and TAU. Exploratory analysis revealed intervention effect at the end of the 6-month follow-up among patients on antidepressant medication. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the postoperative pain in patients after endodontic treatment using 8.25% sodium hypochlorite (NaOCl) compared with other concentrations and 2% chlorhexidine (CHX). In this double-blind randomized trial, 180 patients were evaluated who underwent a single session of endodontic treatment under irrigation with 2.5%, 5.25%, or 8.25% NaOCl or 2% CHX solutions. The presence of postoperative pain was assessed 24, 48, and 72 hours after treatment and recorded using the visual analog scale (VAS). A descriptive analysis, logistic regression, and Wald test were performed. Altogether 169 patients participated, of whom 107 were women, and the mean age was 38.1 ± 14.4 years. No significant differences occurred between the irrigants and the pain outcomes, not even for the use of postoperative pain medication and responses to VAS (P >.05). In the multivariate model including irrigants, after 24 hours or at any time, a significant difference (P <.05) remained in preparation time ≥10 minutes and the presence of overfilling. Also, in relation to the VAS, the overfilling presented significantly different results (P <.05). There was no significant difference in the presence of postoperative pain between the 8.25% NaOCl and the other irrigation solutions. However, the extended preparation time and the overfilling material were responsible for the increase of postoperative pain. [ABSTRACT FROM AUTHOR]

Background: The treatment effect of multi-component LM interventions on depressive symptoms has not yet been examined.Methods: We systematically searched six databases from inception to February 2020 to identify randomized controlled trials (RCTs) involving any multi-component LM interventions (physical activity, nutritional advice, sleep management, and/or stress management) on depressive symptoms relative to care as usual (CAU), waitlist (WL), no intervention (NI), or attention control (AC) comparisons.Results: Fifty studies with 8,479 participants were included. Multi-component LM interventions reduced depressive symptoms significantly relative to the CAU (p >.001; d = 0.20) and WL/NI (p > .01; d = 0.22) comparisons at immediate posttreatment. However, no significant difference was found when compared with AC. The intervention effects were maintained in the short-term (1- to 3-month follow-up) relative to the CAU comparison (p > .05; d = 0.25), but not in the medium- and long-term. The moderator analyses examining the effect of multi-component LM interventions compared with CAU suggested that the number of lifestyle factors adopted was a significant moderator. Although disease type was not a significant moderator, there was a tendency that the clinical effect of multi-component LM interventions was stronger (d = 0.45) in those diagnosed with major depression. No publication bias was detected.Limitations: Low number of RCTs available in some subgroup analyses prevented from finding meaningful effects. Results may not be extended to major depression, because data on secondary depression were captured.Conclusion: Multi-component LM interventions appeared to be effective in mitigating depressive symptoms; however, the magnitude of the clinical effect was small. Future research is needed to assess more comprehensive and individualized LM interventions which have a greater emphasis on motivational and compliance aspects and focus solely on individuals with depression. [ABSTRACT FROM AUTHOR]

Parenting of preterm infants presents unique challenges, particularly during their transition from hospital to home. Early discharge programs can assist parents during this critical period. However, the feasibility of delivering a family-focused online discharge program remains understudied. This study was conducted to investigate the impact of a family-focused online parenting support intervention on parents' sense of competence, depression, caregiving, social support, family functioning, and the weight and length of preterm infants. We conducted a single-blind, two-arm randomized controlled trial with a repeated-measures design. Participants were recruited from a specialized tertiary hospital in China between May and December 2022. Forty-five families were randomly assigned to the intervention group and 44 to the control group. The intervention included three components: (1) two one-hour group sessions and three 30-minute individual sessions of online parenting support; (2) two follow-up telephone calls (15–30 min each) post-discharge; and (3) access to online parenting resources. Primary outcomes included parenting sense of competence, parental care ability, and preterm infants' weight and length. Secondary outcomes included depression, social support, and family functioning. Measurements were taken at baseline, preterm infant discharge, one month post-discharge, and three months post-discharge. A generalized estimating equation model was employed based on the intention-to-treat principle for outcome comparison. Parents in the intervention group showed significant improvements in parenting sense of competence (P < 0.001), parental care ability (P < 0.001), depression (P < 0.001), and social support (P = 0.002). However, no statistically significant differences were observed in preterm infants' weight and length, or in family functioning (P > 0.05). Although the intervention did not affect preterm infants' outcomes, the positive enhancements in parenting sense of competence, care ability, depression, and social support indicate that online family-focused parenting support can effectively prepare parents for hospital discharge and the early transition period. [ABSTRACT FROM AUTHOR]

Background: Personality disorder (PD) may affect the efficacy of pharmacological interventions for mood disorders, but the extent to which this occurs is uncertain. We aimed to examine the available published evidence concerning the role of PD in pharmacological treatment outcomes of randomised controlled trials (RCTs) for adults with mood disorders (i.e. depressive and bipolar spectrum disorders).Methods: A systematic search of Cochrane Central Register of Controlled Clinical Trials, PubMed, EMBASE, PsycINFO, CINAHL Complete, and Google Scholar databases was undertaken to identify studies of interest. Data were independently extracted by two reviewers. The Cochrane Risk of Bias tool was used to assess methodological quality and risk of bias. A random effects model was utilised and statistical heterogeneity was assessed using the I2 statistic. This systematic review was registered with PROSPERO (CRD42018089279) and the protocol is published.Results: The search yielded 11,640 studies. Subsequent to removing duplicates, 9657 studies were screened at title and abstract stage and 1456 were assessed at full-text stage. Eighteen studies met criteria for inclusion in this review. Meta-analysis did not reveal a significant difference between groups for treatment outcome (standardised mean difference 0.22 [-0.09, 0.54]; I2: 69%, p=0.17) and remission (risk ratio 0.84 [0.64, 1.11]; I2: 51%, p=0.22).Limitations: This review was limited by lack of studies on bipolar disorder.Conclusion: PD comorbidity does not appear to affect treatment efficacy of pharmacological interventions for adults with mood disorders. [ABSTRACT FROM AUTHOR]

Objectives: Fibroids are the most common benign tumours found in the uterus and can cause various symptoms. In 20-50 % of the women, an intervention is required. When conservative options fail, invasive options such as hysterectomy, uterine artery embolization or myomectomy are eligible options. Ulipristal acetate (UPA) was launched as the sole available long term pharmaceutical treatment, with the potential to avoid surgery. It is suggested that UPA improves quality of life, reduces symptoms and fibroid volumes. However, UPA is an expensive medicine, is possibly associated with liver injury and has never been directly compared to surgical treatment. The aim of this trial is to compare UPA to surgical treatment on both effectiveness and cost-effectiveness. Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline. Secondary outcomes include quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference. Outcomes will be analysed according to intention-to-treat principle.Study Design: The MYOMEX-2 trial is an open-label, multicentre, non-inferiority randomized controlled trial. Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE). Fibroid symptoms may comprise (but are not limited to) heavy menstrual bleeding, bulk symptoms or pain. Patients are randomised 2:1 in a parallel group design between two treatment arms: 119 patients in the UPA group and 60 patients in the surgery group. Follow up comprises of online questionnaires, outpatient visits and phone appointments on several follow up moments, up to 24 months after surgery or start UPA.Registration Details: MYOMEX-2 trial; protocol version 4, date 22-02-2019; NTR6860; NL62638.029.18. All items from the World Health Organization Trial Registration Data Set are provided in the online supplementary file (Appendix-B). [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).Study Design: Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).Results: CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).Conclusions: Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function. [ABSTRACT FROM AUTHOR]

Objective: Ectopic pregnancy is a potentially life-threatening health problem that affects fertility and generates a significant economic burden. Optimal management, including when to choose methotrexate, and whether to do salpingectomy or salpingostomy, is still unclear. This study aimed to assess the quality and utility of research on ectopic pregnancy in the last three decades.Study Design: We analyzed the quantity, quality and utility of the published literature, including 6,309 articles published over a 30-year period. We searched PubMed for studies on ectopic pregnancy, with subsequent analysis utilizing bibliometric network maps. Consolidated Standards of Reporting Trials (CONSORT) guidelines and a newly adapted checklist for usefulness of research were applied to assess randomized controlled trial (RCT) quality.Results: The initial search returned 14,727 articles, of which, after filters of publication date (1987/01/01 to 2017/12/31), species (Human) and language (English) were applied, 6,309 articles remained. The number of publications each year remained relatively stable, with a mean number of 280 articles published three decades ago versus 248 articles published on average in the last decade. The 7,733 human species articles published between 1987-2017 were written in 27 different languages, with 82 % in English. Publications in 14 selected high-impact journals accounted for 26.5 % (1,673/6,309) of all articles, with on average 54 publications per year across three decades. An increase in systematic reviews and meta-analyses (+1000 %), and case reports (+53 %) was seen between 1987-2017, while the percentage of RCTs (-25 %) decreased. The analyzed RCTs were of moderate quality, and few addressed the most important clinical questions.Conclusion: In the last three decades, both the number of articles on ectopic pregnancy and the number of articles in high-impact journals have remained stable. Despite these constant numbers, the quality of RCTs was suboptimal and there was a decrease in the annual number of published RCTs, while the use of meta-analysis significantly amplified. This study suggests continued review of research practices and provides suggestions on how the quality of the published literature can be improved. [ABSTRACT FROM AUTHOR]

Depression following acute coronary syndrome is prevalent and associated with increased mortality and morbidity. Melatonin may function as a primary prophylactic antidepressant substance and alleviate depressive symptoms. The study was undertaken to determine if melatonin administered following an acute coronary syndrome (ACS) could prevent development of depression. The study was a double-blinded, placebo-controlled, multicenter, randomized clinical trial performed in five primary care cardiology departments at Zealand, Denmark. Included patients were adults patients, free of depression at baseline, included at the latest 4 weeks after acute coronary syndrome. Twenty-five mg melatonin or placebo was administered 1 h before participants' bedtime for 12 weeks. The primary outcome is Major Depression Inventory (MDI) measured every two weeks throughout the trial. Incidence of depression was apriori defined as MDI score ≥ 21 during the trial. Reported exploratory outcomes were patterns of dropout and safety outcomes. 1220 patients were screened and 252 participants were randomized in a 1:1 ratio. Baseline MDI score in the melatonin and placebo group were, respectively, 6.18 (CI 5.32–7.05) and 5.98 (CI 5.19–6.77). No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis. Cumulative events of depressive episodes during the 12 weeks were six in the melatonin group and four in the placebo group. A significant drop in depressive symptoms were present throughout the study period. No intergroup differences were present in dropouts or adverse events. Melatonin showed no prophylactic antidepressant effect following acute coronary syndrome. The non-significant results might be due to a type II error or melatonin might not be able to prevent development of depressive symptoms following ACS. [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]

• The fragility index (FI) was recently proposed to complement the p value and evaluate the robustness in the statistical significance of randomized clinical trials (RCTs), our study was the first to analyse the statistical fragility of RCTs related to femoral neck fractures. • Our study first reported an overall median FI of 3.5 through a comprehensive assessment of femoral neck fracture-related RCTs in 4 high-impact general medical journals and 25 leading peer-reviewed orthopaedic journals, implying that reversal of outcome in just 4 patients was sufficient to alter trial significance, demonstrating considerable fragility. • Our findings could change the grade of recommendation of the clinical practice guideline (CPG) on the management of hip fractures in older adults developed by the american academy of orthopaedic surgeons (AAOS), thereby influencing clinical decision making. • Our study recommend that the orthopaedic RCT report FI as a supplement for the p values to help readers draw reliable conclusions based on the fragility of the outcomes. P values were frequently misused and misinterpreted, the fragility index (FI) has been utilized to evaluate the robustness of randomized controlled trials (RCTs) as a complement to p-values. This study aimed to assess the statistical robustness of RCTs for femoral neck fractures through the utilization of the FI. We systematically reviewed PubMed, Cochrane Library, and Embase database to identify RCTs pertaining to femoral neck fractures published in the top 25 highest-impact orthopaedic journals and 4 high-impact general medical journals from January 1, 2000, to December 31, 2022. The FI was calculated for the dichotomous, categorical study outcomes in the identified RCTs using the Fisher exact test, with previously published methods. Spearman correlation analyses were used to evaluate potential associated factors associated with the FI. We identified 10 eligible RCTs with a median total sample size of 101 (IQR, 79.5 to 174.75) and a number of patients lost to follow-up of 19.5 (IQR, 4.5 to 28). The median FI was 3.5 (IQR, 1 to 14.25), implying that reversal of outcome in only 4 patients was sufficient to alter trial significance. The FI was less than the number of patients lost to follow-up in seven (70%) RCTs. P values were negatively associated with the FI, while the number of patients lost to follow-up and patients enroled were not statistically significantly associated with the FI. The RCTs pertaining to femoral neck fractures were not as statistically robust as previously thought and should be interpreted with caution. We recommend that the orthopaedic RCT report FI as a supplement for the P values to help readers draw reliable conclusions based on the fragility of the outcomes. [ABSTRACT FROM AUTHOR]

Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79–1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P =.06). The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures. [Display omitted] [ABSTRACT FROM AUTHOR]

During a quit attempt, high negative affect predicts relapse to smoking. In this study, we evaluated bidirectional longitudinal associations between smoking and negative affect among cancer patients treated with varenicline. Participants (N = 119, 50% female, Mage = 59 years) were smokers (≥5 cigarettes/week) who were diagnosed with cancer and were recruited for a 24-week trial of extended duration varenicline plus behavioral counseling; data for this secondary analyses were drawn from the 12-week open-label phase of the trial. Smoking was assessed via self-reported number of cigarettes in the past 24 h. Negative affect was assessed using the Positive and Negative Affect Scale (PANAS). Data were collected at pre-quit (week 0), target quit day (week 1), week 4, and week 12. We evaluated cross-lagged panel models for negative affect and smoking using PROC CALIS in SAS. Models were run separately for participants who were adherent (≥80% of medication taken) or nonadherent to varenicline. Among adherent participants (n = 96), smoking accounted for up to 22% of variance in subsequent negative affect throughout treatment. Cross-lagged associations were not observed between smoking and negative affect among non-adherent participants (n = 23). Negative affect did not predict subsequent smoking among either adherent or nonadherent participants. These results suggest that varenicline may attenuate abstinence-induced negative affect among cancer patients treated for nicotine dependence. [ABSTRACT FROM AUTHOR]

• Data on serotype specific PCV13 vaccine efficacy (VE) against CAP have not been published. • We analysed a randomised controlled trial of PCV13 against CAP among elderly adults. • Five of 13 vaccine serotypes had sufficient data for analysis. • Statistically significant VE was found for serotypes 3 and 7F and was positive for all five. Serotype-specific vaccine efficacy (VE) against adult community acquired pneumonia (CAP) remains poorly defined, yet such data are important for assessing the utility of adult pneumococcal conjugate vaccine (PCV) programs. We evaluated the Community Acquired Pneumonia Immunization Trial in Adults to assess serotype-specific VE for CAP. This parallel-arm randomized clinical trial assessed 13-valent PCV (PCV13) VE among community dwelling persons aged ≥65 years in The Netherlands. In the original analysis, PCV13 VE against first episodes of vaccine-type (VT) chest radiology confirmed CAP was 45.6% (95% confidence interval [CI] 21.8–62.5%). Unlike the original analysis, we included any subject that met a clinical definition of CAP regardless of radiographic findings. VT-CAP was identified by culture (sterile or non-sterile) or serotype-specific urinary antigen detection (SSUAD) test. Only the five serotypes with at least 10 episodes in the control arm, based on the original analysis, were included for VE assessment. Of 272 clinical CAP visits with VT serotypes identified, 253 (93%) were identified by SSUAD including 210 (77%) by SSUAD alone. VE was determined for serotypes 1, 3, 6A, 7F, and 19A, with total first episodes of, respectively, 27, 36, 25, 38, and 48. VE (95%CI) for the five evaluated serotypes against first clinical CAP episodes were: serotype 1, 20.0% (−83.1% to 65.8%); serotype 3, 61.5% (17.6–83.4%); serotype 6A, 33.3% (−58.6% to 73.2%); serotype 7F, 73.3% (40.5–89.4%); and serotype 19A, 45.2% (−2.2% to 71.5%). Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults. The VE point estimates and CIs for serotypes 1, 6A, and 19A were lower but consistent with the overall VT-CAP VE of 45.6% previously reported. These findings may be relevant in models to accurately account for the potential impact of adult PCV13 immunization. [ABSTRACT FROM AUTHOR]

The design of clinical trials on Hepatic Encephalopathy (HE) is not an easy task, in fact there are several issues related to the performance of clinical trials in HE that have impeded progress in the field, mainly because most of the studies on HE therapy were performed before the era of rigorous Randomized Controlled Trials (RCTs). In this review we discuss the major problems affecting previously published trials on HE treatments aiming to provide evidences, suggestions and indications to prepare well designed RCTs in three different settings: (1) management of hospitalized patients with episodic HE; (2) secondary prophylaxis in patients following an episode of HE; and (3) management of minimal/covert HE. [ABSTRACT FROM AUTHOR]

Background Context: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation.Purpose: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone.Design: This is a multicenter, randomized superiority study.Patient Sample: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study.Outcome Measures: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up.Methods: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support.Results: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up.Conclusions: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted. [ABSTRACT FROM AUTHOR]

Study Objective: To analyze the effect of enteral nutrition compared with parenteral nutrition in critically ill patients.Design: Systematic review and meta-analysis of randomized controlled trials.Setting: Intensive care unit.Patients: 23 trials containing 6478 patients met our inclusion criteria.Intervention: A systematical literature search was conducted to identify eligible trials in electronic databases including PubMed, Embase, Scopus, EBSCO and Cochrane Library. The primary outcome was mortality, the secondary outcomes were gastrointestinal complications, bloodstream infections, organ failures, length of stay in ICU and hospital. We performed a predefined subgroup analyses to explore the treatment effect by mean age, publication date and disease types.Main Results: The result showed no significant effect on overall mortality rate (OR 0.98, 95%CI 0.81 to 1.18, P = 0.83, I2 = 19%) and organ failure rate (OR 0.87, 95%CI 0.75 to 1.01, P = 0.06, I2 = 16%). The use of EN had more beneficial effects with fewer bloodstream infections when compared to PN (OR 0.59, 95%CI 0.43 to 0.82, P = 0.001, I2 = 27%) and this was more noteworthy in the subgroup analysis for critical surgical patients (OR 0.36, 95%CI 0.22 to 0.59, P < 0.0001, I2 = 0%). EN was associated with reduction in hospital LOS (MD -0.90, 95%CI -1.63 to -0.17, P = 0.21, I2 = 0%) but had an increase incidence of gastrointestinal complications (OR 2.00, 95%CI 1.76 to 2.27, P < 0.00001, I2 = 0%).Conclusion: For critically ill patients, the two routes of nutrition support had no different effect on mortality rate. The use of EN could decrease the incidence of bloodstream infections and reduce hospital LOS but was associated with increased risk of gastrointestinal complications. [ABSTRACT FROM AUTHOR]

Background: Depression is a prevalent disorder with a peak rate of onset in young adulthood from 18 to 25 years. To date, no review has systematically assessed the effectiveness of programs that aim to reduce depressive symptoms or diagnosis of depression in young adults.Method: A systematic search was performed in Cochrane, PubMed, PsycINFO and EMBASE. We performed a random-effects meta-analysis of the randomized controlled studies that compared an intervention for young adults (aged 18-25) without a diagnosis or history of depression and a control condition. Comparisons between intervention and control group outcomes were carried out at the post-intervention time point. We also compared intervention and control group outcomes at later follow-up time points where data were available.Results: Twenty-six randomized controlled trials among 2865 young adults were included in the analysis. The pooled effect size of the interventions versus control at post-intervention was g = 0.37 (95% CI: 0.28-0.47, NNT = 9) and heterogeneity was moderate I2 = 36 (95% CI: 11-64). There were no significant effects in terms of the type of delivery, focus of study, type of control, or type of support within the interventions.Limitations: The authors were unable to assess the effects of interventions on the onset of depression as none of the included studies measured incidence. The risk of bias was high in most studies (81%). Only one study included a follow-up of more than a year. Demographic factors were inconsistently reported in the included articles.Conclusion: While it was not possible to investigate the effects of interventions on depression incidence, some evidence was found for the effectiveness of preventative interventions in reducing depressive symptoms in young adults. Future research should address limitations of the current evidence base to allow stronger conclusions to be drawn. [ABSTRACT FROM AUTHOR]

Abstract Background Novel means of emergency department (ED) post-discharge communication—telephone callbacks and text messages—are increasingly being utilized to facilitate patient-oriented outcomes, such as ED revisits, patient adherence, and satisfaction. Objective The primary measure of interest is the rate of ED revisits in the week after discharge. The secondary measures of interests are rate of primary medical doctor (PMD) or specialist physician contact in the week after discharge and patient satisfaction. Methods Pilot randomized controlled trial with three groups: usual discharge; usual care + phone call 48 h after discharge asking if patients wanted to speak with a physician; or usual care + text message 48 h after discharge asking if patients wanted to speak with a physician. All participants received a 1-week assessment of patient satisfaction. ED revisit and contact with PMD or specialist physician within 7 days of discharge were obtained from electronic medical record and analyzed using χ2 test. Results Two hundred and fifty-one patients were enrolled and randomized (66 control, 103 phone, 82 text). Although the three groups did not show a statistically significant difference, the phone and text groups had similar and lower proportions of patients revisiting the ED (>50% reduction) and calling or visiting their PMD or specialist physician (approximately 30% reduction) than the control group (χ2 = 4.57, degrees of freedom [df] = 2, p = 0.10; χ2 = 1.36, df = 2, p = 0.51). There was no difference in patient satisfaction (χ2 = 2.88, df = 2, p = 0.24). Conclusions Patients who are contacted for ED follow-up by phone and text, though perhaps not more satisfied, may tend to revisit the ED and contact their PMD or specialty physician less often than patients receiving standard written discharge instructions. However, this pilot study is underpowered, so larger randomized studies are needed to confirm. [ABSTRACT FROM AUTHOR]

Highlights • CBT yielded greater symptom reduction than ABM when both were given standard doses. • However, rates of change were similar for both interventions on almost all measures. • Symptom change in CBT showed a reciprocal relationship with cognitive change. • Symptoms and attention away from threat were possibly related simultaneously in ABM. Abstract No studies have compared face-to-face cognitive-behavioral therapy (CBT) and attention bias modification (ABM) for social anxiety disorder (SAD) and their purported mechanisms. We asked: 1) Is CBT more effective than ABM? and 2) Are changes in attentional biases and cognitions temporally related to symptom change? Forty-three patients were randomly assigned to 8 sessions of ABM or up to 20 sessions of individual CBT. Intent-to-treat results revealed that CBT was superior to ABM in response rates and on symptom measures at endpoint, but not on other measures. No differences were found on measures in rates of change between CBT and ABM. Frequency of negative cognitions changed in both groups and negative beliefs changed only in CBT. Attentional bias did not change in either group. Cognitive changes bidirectionally correlated with symptom change in cross-lagged analyses in CBT, but not in ABM, suggesting a reciprocal relationship. Trial-level bias away from negative faces was simultaneously related to symptom change in ABM only. Results suggest that CBT is superior to ABM when administered at their typical doses, but raise questions given the similar rates of change. In addition, results support theories of cognitive change and raise questions about changes in attentional biases in CBT. [ABSTRACT FROM AUTHOR]

Abstract Objective Verify the efficacy of cognitive behavioral therapy (CBT) in adherence to the Mediterranean diet (MedDiet) in metabolic syndrome (MetS) patients. Design, Setting, Participants, and Intervention In the Multimodal Intervention Program for Patients with Metabolic Syndrome clinical trial, 79 MetS patients completed the intervention. Of those, 48 belonged to the experimental group and 31 to the control group. The intervention received by the experimental group was CBT; the control group followed usual care and attended a workshop on healthy lifestyle. Main Outcome Measure(s) and Analysis Anthropometric, biochemical, psychological, and lifestyle measures were taken before and after the intervention at 3 and 6 months. Analyses included paired t tests, ANOVA, and ANCOVA. Results The ANOVA results showed a statistically significant interaction between the 2 groups in waist circumference (P =.009), triglycerides (P =.015), and adherence to the MedDiet (P =.026). The ANCOVA results indicated between-group difference in waist circumference (P =.026 and.062 at 3 and 6 months, respectively), in triglycerides (P =.009 and.860 at 3 and 6 months, respectively), and in MedDiet (P =.024 and.273 at 3 and 6 months, respectively). Conclusions and Implications In interventions in which CBT was applied, significant improvements were observed in MetS patients, especially in adherence to the MedDiet. [ABSTRACT FROM AUTHOR]