Search

Age at first onset of depression as a clinical factor affecting cognitive improvement in late life depression was investigated. This is a secondary analysis of an eight-week randomized controlled trial involving 452 elderly patients treated by vortioxetine, duloxetine or placebo (1:1:1). Patients were subcategorized into early-onset (LLD-EO) and late-onset (LLD-LO) groups divided by onset age of 50. Cognitive performance was assessed by composite score of Digit Symbol Substitution Test (DSST) and the Rey Auditory Verbal Learning Test (RAVLT) tasks, while depressive symptoms were assessed by Montgomery–Åsberg Depression Rating Scale (MADRS). Vortioxetine and duloxetine exhibited advantages versus placebo in improving cognitive performance in the LLD-LO group, yet not in the LLD-EO group after eight weeks. Patients in the LLD-EO group showed overall advantage to placebo in depressive symptoms before endpoint (week 8) of treatment, while patients in the LLO-LO group showed no advantage until endpoint. Path analysis suggested a direct effect of vortioxetine (B = 0.656, p =.036) and duloxetine (B = 0.726, p =.028) on improving cognition in the LLD-LO group, yet in all-patients treated set both medications improved cognition indirectly through changes of depressive symptoms. Reliability of clinical history could raise caution as it was collected by subjective recall of patients. Age at first onset might affect cognitive improvement as well as change in depressive symptoms and its mediation towards cognitive improvement in late life depression treated with vortioxetine and duloxetine. • Vortioxetine and Duloxetine improved cognitive performance of elderly depressed patients with first onset after 50. • Patients with first depressive onset before 50 showed earlier symptomatic change than those with first onset after 50. • Vortioxetine and duloxetine showed direct treatment effect on improving cognition in patients with first episode after 50. [ABSTRACT FROM AUTHOR]

Preoperative planning in total hip arthroplasty (THA) involves utilizing radiographs or advanced imaging modalities, including computerized tomography scans, for precise prediction of implant sizing and positioning. This study aimed to compare 3-dimensional (3D) versus 2-dimensional (2D) preoperative planning in primary THA with respect to key surgical metrics, including restoration of the horizontal and vertical center of rotation (COR), combined offset, and leg length. This study included 60 patients undergoing primary THA for symptomatic hip osteoarthritis (OA), randomly allocated to either robotic arm–assisted or conventional THA. Digital 2D templating and 3D planning using the robotic software were performed for all patients. All measurements to evaluate the accuracy of templating methods were conducted on the preoperative computerized tomography scanogram, using the contralateral hip as a reference. Sensitivity analyses explored differences between 2D and 3D planning in patients who had superolateral or medial OA patterns. Compared to 2D templating, 3D templating was associated with less medialization of the horizontal COR (−1.2 versus −0.2 mm, P =.002) and more accurate restoration of the vertical COR (1.63 versus 0.3 mm, P <.001) with respect to the contralateral side. Furthermore, 3D templating was superior for planned restoration of leg length (+0.23 versus −0.74 mm, P =.019). Sensitivity analyses demonstrated that in patients who had medial OA, 3D planning resulted in less medialization of horizontal COR and less offset reduction. Conversely, in patients who had superolateral OA, there was less lateralization of horizontal COR and less offset increase using 3D planning. Additionally, 3D planning showed superior reproducibility for stem, acetabular cup sizes, and neck angle, while 2D planning often led to smaller stem and cup sizes. Our findings indicated higher accuracy in the planned restoration of native joint mechanics using 3D planning. Additionally, this study highlights distinct variances between the 2 planning methods across different OA pattern subtypes, offering valuable insights for clinicians employing 2D planning. [ABSTRACT FROM AUTHOR]

Exercise interventions show promise in the treatment of anxiety disorders, but effects on health-related quality of life (HR-QoL), work ability, and sick leave are little studied. We investigated these outcomes in a 12-week randomized controlled trial with a 1-year follow-up. Patients aged 18–65 (n = 222) with anxiety disorders from primary care centers in Gothenburg were randomized to a control group or one of two 12-week exercise intervention groups (low-intensity, [LI] and moderate/high-intensity, [HI]); 148 were evaluated at 12-weeks and 113 completed the 1-year follow-up. The EuroQol 5D (EQ5D; index and the visual analogue scale [VAS]), work ability score (WAS), presenteeism, and self-reported sick leave were assessed at baseline, 12 weeks, and 1 year. Improvements were defined by binary cut-offs for each scale. Binary logistic regression with odds ratios (OR) and 95 % confidence intervals (CI) were reported. There were improved scores for EQ5D and WAS in the HI group compared to controls after 12 weeks (EQ5D index: 4.74 [1.91–11.7], EQ5D-VAS 4.00, [1.65–9.72], WAS 3.41 [1.24–7.37]) and 1 year (EQ5D index: 3.05 [1.05–8.81], EQ5D-VAS 3.20 [1.16–8.84], WAS 5.50 [1.85–16.3]). Post-hoc analysis showed higher ORs in participants on antidepressants (n = 75) (12-week EQ5D index: OR 9.95 [2.85–34.8]) and significant improvements in EQ5D scores for both intervention groups after 1 year. There were no between-group differences for presenteeism or sick leave. Discontinuation was high, mostly early after randomization (n = 74), as is common for anxiety interventions. HI Exercise improves HR-QoL and work ability in anxiety patients, especially when combined with antidepressants. • High-intensity exercise improves health-related quality of life and work ability with long-lasting effects after 1 year. • There were trends suggesting a dose-response effect of exercise on health-related quality of life and work ability. • Exercise effects are greater in patients with antidepressant medication. • There were no between-group differences for presenteeism or sick leave. [ABSTRACT FROM AUTHOR]

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]

Insomnia, a prevalent sleep disorder in contemporary society, frequently coexists with other mental health conditions such as depression, schizophrenia, and obsessive-compulsive disorder. Sleep disorders can compromise daytime functioning and overall quality of life. While music has been explored as an adjunct therapy for insomnia, its efficacy in improving insomnia among students remains unclear. Seventy-five students, aged between 18 and 30 years with an average age of 20.97 years (SD: 1.92), presenting sleep issues were randomly allocated to one of three groups: the classical music group, the jazz music group, and the control group, each with 25 participants. Participants in the classical and jazz music group were instructed to listen to classical or jazz music for a minimum of 30 min preceding bedtime. This was paired with deep breathing and relaxation techniques, practiced two consecutive nights per week from 23:00 to 01:00 over a five-week intervention period. Conversely, participants in the control group were only directed to follow the deep breathing and relaxation techniques before sleep on two consecutive nights weekly. Insomnia severity with the Insomnia Severity Index (ISI), sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), depressive symptoms with the Beck Depression Inventory-II (BDI- II), and anxiety symptoms with the Self-rating Anxiety Scale (SAS). Measurements were taken at baseline, after the second week of intervention, at the intervention's conclusion (five weeks), and two months post-intervention (follow-up). 1. The music groups showed a significant difference in insomnia severity compared with the control group after five weeks of intervention(p <.05). 2. music groups exhibited significant enhancements in sleep quality relative to the control group after a five-week intervention (p <.05). 3. Regarding mood enhancement, music groups showed significant improvements in depression and anxiety symptoms compared to the baseline after the five-week intervention. Notably, the control group also displayed improvements in these symptoms post-intervention. 1. Integrating music into a consistent bedtime routine ameliorates sleep quality and insomnia severity. However, no specific genre of music emerged as the superior choice for pre-sleep listening. 2. While music can considerably enhance mood indicators like depression and anxiety, techniques such as deep breathing and mindfulness also contribute positively. 3. Incorporating music before sleep tangibly elevates overall quality of life and daytime functioning. ChiCTR2300073953. • The trial is the first to assess the impact of bedtime music combined with relaxation techniques in college students with insomnia. • Integrating music into a consistent bedtime routine ameliorates sleep quality and insomnia severity. • Incorporating music before sleep tangibly elevates overall quality of life and daytime functioning. [ABSTRACT FROM AUTHOR]

China's rapid urbanization has been associated with increased mental health challenges, especially in rural-to-urban migrant children. This study evaluates the effects of mindfulness and life-skills (LS) training on emotional regulation and anxiety symptoms from a randomized controlled trial aimed at improving the mental health of Chinese migrant children. Two intervention arms—mindfulness training (MT) and MT plus LS mentorship (MT + LS)—were compared to a waitlist control group of 368 migrant children aged 9–17 years. Volunteers were trained to deliver interventions to 285 migrant children in small groups of 15 for eight weeks weekly. Social integration varied: migrant children mixed with local children at public schools were considered highly integrated, those in migrant-only classrooms at public schools had intermediate levels of integration, and children in private migrant schools had low integration. Emotion regulation and anxiety symptoms were assessed preintervention, postintervention, and three months postintervention. Postintervention and compared to the control group, children with high social integration in the MT arm showed increased cognitive reappraisal ability (p <.05) but higher physical anxiety (p <.01). Children with high social integration in the MT + LS arm had lower anxiety symptoms of harm avoidance (p <.01) and physical anxiety (p <.05). Children with low social integration in the MT + LS arm showed lower cognitive reappraisal (p <.01) and poorer overall emotion regulation abilities (p <.01). Three months later, children with intermediate integration in the MT + LS arm had lower separation anxiety (p <.05) and harm avoidance anxiety (p <.05). No other groups showed significant improvements in emotion regulation or reducing in anxiety symptoms three months postintervention. Mindfulness and LS training may benefit Chinese migrant children who have higher levels of social integration but increase anxiety in those with lower social integration. Future research should consider the sociocultural context in which a treatment is implemented. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the clinical results of kinematic alignment (KA) with those of mechanical alignment (MA) in single-stage bilateral total knee arthroplasty. In this double-blinded randomized controlled trial, 65 patients who had bilateral knee osteoarthritis underwent simultaneous bilateral total knee arthroplasty. One knee was randomly selected to be operated on with the calipered-KA technique and the other with MA. The participants were assessed via the Oxford Knee Score, Western Ontario and McMaster Universities Osteoarthritis Index questionnaire, and visual analog scale before the surgery and the same plus the Forgotten Joint Score at their last follow-up visit, 2 years postoperatively. Maximum knee flexion and the time reaching maximum knee flexion, named the recovery time, were also recorded. Hip-knee-ankle angle, medial proximal tibial angle, and lateral distal femoral angle were measured before and after the surgery using 3-joint-view radiographs. At 2 years, there were significant differences between the KA and MA techniques in terms of duration of surgery, recovery time, and final Western Ontario and McMaster Universities Osteoarthritis Index, Forgotten Joint Score, and maximum flexion range in favor of KA (P <.05), but no significant difference in visual analog scale score or Oxford Knee Score. In patients who have a preferred knee, the KA knee was preferred over the MA knee by most patients. No prosthetic failure or revision was reported in either group. The KA technique yields acceptable functional outcomes compared to the MA technique. The KA technique was associated with a shorter surgery time, a faster recovery time, and higher patient satisfaction in 2-year follow-ups. Larger multicenter studies with longer follow-ups are warranted to confirm these findings. I. [ABSTRACT FROM AUTHOR]

The objectives of the current research were to evaluate the accuracy and reliability of continuous glucose monitoring (CGM) in patients undergoing cardiac surgery and assess the impact of preoperative liraglutide administration on perioperative glucose control as captured by CGM. This was a prospective, single-center, prespecified analysis of the GLOBE trial, a randomized controlled trial comparing preoperative liraglutide treatment to placebo in patients undergoing cardiac surgery. The work took place at a single-center academic hospital in the Netherlands. Twenty-five patients undergoing cardiac surgery were recruited from the hospital's cardiac surgery department. Participants received the Dexcom G5 CGM system from the day before surgery until discharge from the intensive care unit after surgery. Additionally, participants were randomized to receive either preoperative liraglutide or placebo. Arterial blood gas (ABG) glucose measurements were collected as a reference and matched to CGM readings to assess accuracy and reliability. In 240 paired CGM–ABG glucose measurements, the mean absolute relative difference was 14.4 ± 12.5%. Temporary sensor interruption occurred mainly intraoperatively (92% of patients). The median duration of intraoperative sensor interruption was 65 (48-95) minutes. Liraglutide increased glycemic time in range 72% versus 47% in the control group (absolute difference 25%, 95% confidence interval –41.4 to –8.9, p =.004). Despite intraoperative sensor interruption, CGM seems an accurate method for semi-invasive, real-time assessment of blood glucose levels. CGM can provide a detailed observation of the pre- and postoperative glycemic trajectory, demonstrating increased time in range following perioperative liraglutide treatment compared with placebo. [ABSTRACT FROM AUTHOR]

Non-invasive neurostimulation, including bright light therapy (BLT), repetitive transcranial magnetic (rTMS) and transcranial direct current stimulation (tDCS), has been shown to alleviate depressive symptoms in major depressive disorder (MDD). However, the efficacy of these interventions in addressing sleep disturbances in MDD patients remains a subject of debate. We aimed to conduct a meta-analysis of available randomized controlled trials (RCTs) to assess the effectiveness of non-invasive neurostimulation in improving sleep disturbances and depressive symptoms in MDD patients. Systematic searches for relevant RCTs were conducted in the databases PubMed, Cochrane Library, Web of Science, EMBASE, Wanfang and China National Knowledge Infrastructure up to January 2024. Data on outcomes comparable across the studies were meta-analyzed using Review Manager 5.3 and Stata 14. The pooled results were reported as standardized mean differences (SMD) with their respective 95% confidence intervals (CI). Our analysis encompassed 15 RCTs involving 1348 patients. Compared to sham or no stimulation, non-invasive neurostimulation significantly improved sleep quality (SMD -0.74, 95%CI -1.15 to −0.33, p = 0.0004) and sleep efficiency (SMD 0.35, 95%CI 0.10 to 0.60, p = 0.006). It also significantly reduced severity of depressive symptoms (SMD -0.62, 95%CI -0.90 to −0.35, p < 0.00001). Subgroup analysis further demonstrated that patients experiencing sleep improvements due to neurostimulation showed a marked decrease in depressive symptoms compared to the control group (SMD = −0.90, 95% CI [-1.26, −0.54], p < 0.0001). Current evidence from RCTs suggests that neurostimulation can enhance sleep quality and efficiency in individuals with MDD, which in turn may be associated with mitigation of depressive symptoms. CRD42023423844. [ABSTRACT FROM AUTHOR]

There is emerging literature regarding the efficacy of trauma-focussed writing therapies (TF-WTs) for posttraumatic stress. Such therapies have the potential to reduce posttraumatic stress symptoms (PTSS) in a brief time frame and can be delivered remotely. There remains a need for further research assessing the efficacy of different types of TF-WTs, as well comparing them to alternative control conditions not previously assessed. The present study assessed two TF-WTs that had differing writing instructions in comparison to an intervention that involved writing about positive experiences. Adult community participants (n = 83) with subthreshold or clinical PTSD symptoms were randomized to one of three conditions (two of which involved trauma-focussed writing, and the other involved writing about positive experiences). All conditions involved three weekly telehealth-delivered writing appointments. Outcomes were measured using the PTSD Checklist (PCL-5) and the Depression, Anxiety and Stress Scales (DASS-21), and were evaluated at baseline, one-week post-intervention, and five-weeks post-intervention. This trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR Protocol 12620001065987). There was no evidence that the two TF-WTs were more efficacious in reducing PTSS or producing clinically meaningful change in comparison to positive experiences writing. Instead, a significant reduction from baseline to follow-up in PTSS, depression, anxiety and stress was observed in all three conditions. The results should be interpreted with consideration of the modest sample size and absence of longer-term follow-up. Three-session trauma-focussed writing delivered via telehealth may not be superior to writing about positive experiences. • There is emerging evidence for the efficacy of brief, trauma-focussed writing interventions for posttraumatic stress. • Two trauma-focussed writing interventions were compared to writing about past positive experiences. • Trauma-focussed writing was not efficacious in comparison to writing about past positive experiences. • Writing about either past traumatic experiences or past positive experiences may reduce symptoms of posttraumatic stress. [ABSTRACT FROM AUTHOR]

Extending on previous findings that computerized Memory Specificity Training (c-MeST) improves memory specificity and depressive symptoms in Major Depressive Disorder (MDD) in adults, this study aimed to assess the effects of c-MeST in youth with MDD on memory specificity and depression in addition to other treatment. Participants aged 15–25 (N = 359, 76 % female; M age = 19.2, SD = 3.1), receiving predominantly psychological therapy or counseling (85 %) and/or antidepressants (52 %) were randomized to usual care and c-MeST or usual care. Cognitive and clinical outcomes were assessed at baseline and at one, three, and six-month follow-ups. The usual care and c-MeST group reported higher memory specificity at one-month (d = 0.42, p =.022), but not at three or six months (d 's < 0.15, p 's > 0.05). The rate of MDE was numerically lower in the c-MeST group at each follow-up time-point, but group was not a statistically significant predictor at one month (64 % usual care and c-MeST vs. 68 % usual care, OR = 0.81, p =.606), three months (67 % usual care and c-MeST vs. 72 % usual care, OR = 0.64, p =.327) or six months (55 % usual care and c-MeST vs. 68 % usual care, OR = 0.56, p =.266). The usual care and c-MeST group did report lower depressive symptoms at one month (d = 0.42, p =.023) and six-months (d = 0.84, p =.001), but not three-months (d = 0.13, p >.05). c-MeST may reduce symptoms in youth with MDD when provided alongside other treatments. However, there are significant limitations to this inference, including high attrition in the study and a need for more data on the acceptability of the intervention. • Overgeneral memory appears to maintain depressive symptoms. • Computerized memory specificity training (c-MeST) improved memory specificity. • Depressive symptoms were reduced at one and six-month follow-up. • The effects occurred in addition to receiving other mental health support. • C-MeST may be a beneficial adjunct for youth with major depressive disorder. [ABSTRACT FROM AUTHOR]

Sleep impairment following total knee arthroplasty (TKA) is common and may decrease patient satisfaction and recovery. Standardized postoperative recommendations for sleep disturbances have not been established. We aimed to assess whether melatonin use could promote healthy sleep and reduce sleep disturbance in the acute period following TKA. Patients undergoing primary, elective TKA between July 19, 2021 and January 4, 2024 were prospectively enrolled and randomized to receive either 5 mg of melatonin nightly or placebo for 14 days postoperatively. Participants recorded their nightly pain on the visual analog scale, the number of hours slept, and the number of night-time awakenings in a sleep diary starting the night of surgery (postoperative day [POD] 0). Sleep disturbance was assessed preoperatively and on POD 14 using the patient-reported outcome measurement information system sleep disturbance form. Epworth Sleepiness Scores were collected on POD 14 to assess sleep quality. Of the 138 patients enrolled, 128 patients successfully completed the study protocol, with 64 patients in each group. Melatonin patients trended toward more hours of sleep on POD 2 (placebo: 5.0 ± 2.4, melatonin: 5.8 ± 2.0, P =.084), POD 3 (placebo: 5.6 ± 2.2, melatonin: 6.3 ± 2.0, P =.075), and averaged over POD 1 to 3 (placebo: 4.9 ± 2.0, melatonin: 5.6 ± 1.8, P =.073), although no differences were observed on POD 4 or after. Fewer night-time awakenings in the melatonin group were observed on POD 1 (placebo: 4.4 ± 3.9, melatonin: 3.6 ± 2.4, P =.197), although this was not statistically significant. Preoperative and postoperative Patient-Reported Outcomes Measurement Information System Sleep Disturbance score increases were comparable for both groups (placebo: 4.0 ± 8.4, melatonin: 4.6 ± 8.2, P =.894). The melatonin (65.4%) and placebo (65%) groups demonstrated similar rates of increased sleep disturbance. Melatonin may promote longer sleep in the immediate postoperative period after TKA, although these benefits wane after POD 3. Disturbances in sleep should be expected for most patients, although melatonin may have an attenuating effect. Melatonin is safe and can be considered for TKA patients experiencing early sleep disturbances postoperatively. [ABSTRACT FROM AUTHOR]

Sleep disturbance is a common problem following total knee arthroplasty (TKA). The objective of this study was to determine if exogenous melatonin improves sleep quality following primary TKA. A randomized, double-blind, placebo-controlled trial was conducted. A total of 172 patients undergoing unilateral TKA for primary knee osteoarthritis were randomized to receive either 5 mg melatonin (n = 86) or 125 mg vitamin C placebo (n = 86) nightly for 6 weeks. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at 6 weeks and 90 days postoperatively. Secondary outcomes included 6-week and 90-day patient-reported outcome measures (PROMs), morphine milligram equivalents prescribed, medication compliance, adverse events, and 90-day readmissions. Mean PSQI scores worsened at 6 weeks before returning to the preoperative baseline at 90 days in both groups. There were no differences in PSQI scores between melatonin and placebo groups at 6 weeks (10.2 ± 4.2 versus 10.5 ± 4.4, P =.66) or 90 days (8.1 ± 4.1 versus 7.5 ± 4.0, P =.43). Melatonin did not improve the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, Lower Extremity Activity Scale, Visual Analog Scale for pain, or Veterans Rand 12 Physical Component Score or Mental Component Score at 6 weeks or 90 days. Poor sleep quality was associated with worse PROMs at 6 weeks and 90 days on univariate and multivariable analyses, but melatonin did not modify these associations. There were no differences in morphine milligram equivalents prescribed, medication compliances, adverse events, or 90-day readmissions between both groups. Exogenous melatonin did not improve subjective sleep quality or PROMs at 6 weeks or 90 days following TKA. Poor sleep quality was associated with worse patient-reported function and pain. Our results do not support the routine use of melatonin after TKA. [ABSTRACT FROM AUTHOR]

Postpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. This economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. Over 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (−176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. Results have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. This study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD. • First randomized trial on cost-utility of iCBT for prevention of PPD • Compared to the control group, the intervention yielded more QALYs and less costs over 14 months. • The intervention had a 97.6 % probability of cost-effectiveness at a WTP of EUR 20,000. • iCBT has the potential to be adopted as a cost-effective preventive strategy for PPD. [ABSTRACT FROM AUTHOR]

In an inpatient treatment center for pediatric obesity, the effectiveness of an emotion regulation (ER) training on top of the multidisciplinary obesity treatment (MOT) was tested by means of an RCT. The ER training was evaluated on primary outcomes: ER and emotional eating, and secondary outcomes: well-being and weight loss, taking into account pre, post, and follow-up measurements. Of the 115 10- to-14-year old adolescents with obesity (52.2% girls), 65 were allocated to the ER training. Physicians measured their height and weight objectively (4 times). Participants also filled out questionnaires on ER competencies (ER abilities and ER strategies), emotional eating and well-being (3 times). Significant pre-post interactions were found for "emotional awareness," "problem solving," and "evoking a positive mood." Moreover, the positive effects of the ER training on emotion regulation strategies were maintained at follow-up. Concerning well-being, no significant pre-post interaction effects were found but a significant interaction effect was found when comparing pre with follow-up. Analyses show a significant main effect of time on weight loss, but this was not qualified by a Time × Condition interaction effect. The current RCT study shows limited but promising effects of adding an ER training to the MOT. Further research should investigate whether the positive short-term effects will be maintained. [ABSTRACT FROM AUTHOR]

Preclinical studies support a protective role for aspirin in early diabetic retinopathy (DR), but the findings from randomized trials are limited. We present randomized evidence for the efficacy and safety of aspirin on DR outcomes. A substudy of the A Study of Cardiovascular Events in Diabetes (ASCEND) double-masked, randomized, placebo-controlled trial of 100 mg aspirin daily for the primary prevention of serious cardiovascular events in people with diabetes. Fifteen thousand four hundred eighty United Kingdom adults at least 40 years of age with diabetes. Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review were carried out. Log-rank methods were used for intention-to-treat analyses of time until the first primary efficacy and safety outcomes. The primary efficacy end point was the first record of referable disease after randomization, a composite of referable retinopathy or referable maculopathy based on the grading criteria defined by the United Kingdom National Screening Committee. The primary safety outcome was the first sight-threatening eye bleed, defined as clinically significant bleeding in the eye that resulted in unresolved visual loss or required an urgent intervention such as laser photocoagulation, vitreoretinal surgery, intraocular injection, or a combination thereof. Linkage data were obtained for 7360 participants (48% of those randomized in ASCEND). During the mean follow-up of 6.5 years, 539 participants (14.6%) experienced a referable disease event in the aspirin group, compared with 522 participants (14.2%) in the placebo group (rate ratio, 1.03; 95% confidence interval [CI], 0.91–1.16; P = 0.64). No statistically significant between-group difference was found in the proportions of sight-threatening eye bleed events (57 participants [0.7%] and 64 participants [0.8%], respectively; rate ratio, 0.89; 95% CI, 0.62–1.27). These data exclude any clinically meaningful benefits of aspirin for DR, but give reassurance regarding the ophthalmologic safety of aspirin. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. Multicenter randomized controlled trial. Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], –1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was –2.56 (95% CI, –3.80 to –1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were –14.30 ± 7.14 dB and –16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87–2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72–1.19; P = 0.54). Serious adverse events were rare. At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

This study aimed to implement and evaluate integrated, school-based nutrition intervention packages for adolescents in Dodoma, Tanzania. A cluster randomized controlled trial was conducted among six secondary schools in Dodoma, Tanzania. Two schools received the full-intervention package of school meals, nutrition education, school gardens, and community workshops. Two schools received the partial-intervention package without the school meals component. Two schools served as the controls and did not receive any intervention. The intervention was implemented over one academic year. The analytical sample included 534 adolescents aged 14 to 17 at baseline and 286 parents. Outcomes included nutrition knowledge, food preferences, diet quality, food insecurity, physical activity, growth, and anemia. Linear models were used to estimate mean differences, and logistic regression models were used to estimate odds ratios (ORs). Compared to the control, both the partial (OR: 0.59; 95% confidence interval [CI]: 0.35, 1.00) and full (OR: 0.49; 95% CI: 0.40, 0.59) interventions were associated with lower odds of poor diet quality among adolescents. Among the parents, both the partial (OR: 0.28; 95% CI: 0.20, 0.40) and full (OR: 0.28; 95% CI: 0.13, 0.58) interventions were associated with lower odds of poor diet quality. The partial (OR: 0.29; 95% CI: 0.18, 0.47) and full (OR: 0.47; 95% CI: 0.30, 0.72) interventions were associated with lower odds of adolescent overweight or obesity. School-based nutritional intervention packages incorporating multiple actions may improve the diet quality of adolescents and their household members and reduce the double burden of adolescent malnutrition. [ABSTRACT FROM AUTHOR]

To examine the impact of About Us , an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and the use of effective contraceptives, on improving behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution at 3- and 9-month follow-up, compared to services as usual. This was a multi-site, two-group, parallel, randomized-controlled trial with an intervention/comparison allocation ratio of 3:2 conducted at seven high schools in California between February 2018 and May 2021. Overall, our study did not find statistically significant evidence of improved behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution among participants (14–18 years old) randomized to the intervention group (n = 316) compared to services as usual (n = 217) during follow-up (group x time; p >.05). Exploratory within group analyses showed that, compared to baseline, at the 3-month follow-up, the prevalence of reporting having had sex increased in the control group relative to intervention group (+19% vs. +9%, p <.01). Our sub-group analyses showed that changes in condom use intentions scores differed across school sites (group x time x school; p <.01); mixed (positive and negative) trends were observed for intervention effect, and schools with positive intervention effect trends tended to have greater program participation. About Us did not show statistically significant positive impacts on primary or secondary outcomes as anticipated. Our exploratory findings show evidence of some promising trends of intervention effects at the school-level, suggesting a need for better tailored intervention components and/or delivery to address the unique environmental contexts of participants. Overall, the context of study implementation was negatively affected by the COVID-19 pandemic and challenges related to using a non-classroom delivery intervention approach. Combined, these factors may have contributed to the study null findings. Moreover, it is difficult to know (or determine) the intervention's impact under more ideal conditions (i.e., no COVID pandemic). [ABSTRACT FROM AUTHOR]

Dichotomous outcomes are frequently reported in orthopaedic research and have substantial clinical implications. This study utilizes the fragility index (FI) and fragility quotient (FQ) metrics to determine the statistical stability of outcomes reported in total joint arthroplasty randomized controlled trials (RCTs) relating to periprosthetic joint infection (PJI). The RCTs that reported dichotomous data related to PJI published between January 1, 2010, and December 31, 2022, were evaluated. The FI and reverse FI (RFI) were defined as the number of outcome event reversals required to reverse the significance of significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI or RFI by the respective sample size. There were 108 RCTs screened, and 17 studies included for analysis. A total of 58 outcome events were identified, with a median FI of 4 (interquartile range [IQR] 2 to 5) and associated FQ of 0.0417 (IQR 0.0145 to 0.0602). The 13 statistically significant outcomes had a median FI of 1 (IQR 1 to 2) and FQ of 0.00935 (IQR 0.00629 to 0.01410). The 45 nonsignificant outcomes had a median RFI of 4 (IQR 3 to 5) and FQ of 0.05 (IQR 0.0361 to 0.0723). The number of patients lost to follow-up was greater than or equal to the FI in 46.6% of outcomes. Statistical outcomes in RCTs analyzing PJI are fragile and may lack statistical integrity. We recommend a comprehensive fragility analysis, with the reporting of FI and FQ metrics, to aid in the interpretation of outcomes in the total joint arthroplasty literature. [ABSTRACT FROM AUTHOR]

Fragility analysis is a method of further characterizing outcomes in terms of the stability of statistical findings. This study assesses the statistical fragility of recent randomized controlled trials (RCTs) evaluating robotic-assisted versus conventional total knee arthroplasty (RA-TKA versus C-TKA). We queried PubMed for RCTs comparing alignment, function, and outcomes between RA-TKA and C-TKA. Fragility index (FI) and reverse fragility index (RFI) (collectively, "FI") were calculated for dichotomous outcomes as the number of outcome reversals needed to change statistical significance. Fragility quotient (FQ) was calculated by dividing the FI by the sample size for that outcome event. Median FI and FQ were calculated for all outcomes collectively as well as for each individual outcome. Subanalyses were performed to assess FI and FQ based on outcome event type and statistical significance, as well as study loss to follow-up and year of publication. The overall median FI was 3.0 (interquartile range, [IQR] 1.0 to 6.3) and the median reverse fragility index was 3.0 (IQR 2.0 to 4.0). The overall median FQ was 0.027 (IQR 0.012 to 0.050). Loss to follow-up was greater than FI for 23 of the 38 outcomes assessed. A small number of alternative outcomes is often enough to reverse the statistical significance of findings in RCTs evaluating dichotomous outcomes in RA-TKA versus C-TKA. We recommend reporting FI and FQ alongside P values to improve the interpretability of RCT results. [ABSTRACT FROM AUTHOR]

Despite increasing adoption of the direct anterior (DA) approach in total hip arthroplasty (THA), uncertainty persists regarding its outcomes beyond the 1-year mark in comparison to other approaches. We used the reverse fragility index (RFI) to evaluate the robustness of reported findings in the literature. We conducted a systematic review of randomized controlled trials (RCTs) comparing implant revision rates between DA and other approaches in THA, defined as all those different from DA. Our primary outcome was the RFI, which gauges the number of events needed for a nonsignificant result to become significant, in the revision rate between DA and other approaches. We also calculated the reverse fragility quotient by dividing the RFI by each study's sample size. Median values and interquartile ranges (IQRs) were displayed. A total of 10 RCTs with a total of 971 patients were included. The median RFI was 5 (IQR, 4 to 5), indicating the study's results would be statistically significant if the outcomes of 5 patients in 1 treatment arm were reversed. The median reverse fragility quotient was 0.049 (IQR, 0.04 to 0.057), indicating that a change of outcome in 4.9% of patients would render the revision rate significant. The median number of patients lost to follow-up was 4 (IQR, 0 to 7). Of the 10 RCTs, 6 had more patients lost to follow-up than their respective RFI values. Notable fragility was evidenced in most studies comparing DA to other approaches for THA. Surgeons should not solely rely on the P value to determine clinical significance and instead use multiple metrics. II. [ABSTRACT FROM AUTHOR]

• Randomized controlled trials of non-pharmacological interventions following concussion demonstrate moderate to good completeness. • Missing key components, particularly modifications, motivational strategies, and qualified supervisor limit accurate replication. • Reporting completeness has improved since Template for Intervention Description and Replication and Consensus on Exercise Reporting Template publication. • Publication in highly cited journals and low risk of bias do not guarantee reporting completeness. The study aimed to examine the reporting completeness of randomized controlled trials (RCTs) of non-pharmacological interventions following concussion. We searched MEDLINE, Embase, PsycInfo, CINAHL, and Web of Science up to May 2022. Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication (TIDieR), Consensus on Exercise Reporting Template (CERT), and international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) checklists. Additional information was sought my study authors where reporting was incomplete. Risk of bias (ROB) was assessed with the Cochrane ROB-2 Tool. RCTs examining non-pharmacological interventions following concussion. We included 89 RCTs (n = 53 high ROB) examining 11 different interventions for concussion: sub-symptom threshold aerobic exercise, cervicovestibular therapy, physical/cognitive rest, vision therapy, education, psychotherapy, hyperbaric oxygen therapy, transcranial magnetic stimulation, blue light therapy, osteopathic manipulation, and head/neck cooling. Median scores were: TIDieR 9/12 (75%; interquartile range (IQR) = 5; range: 5–12), CERT 17/19 (89%; IQR = 2; range: 10–19), and i-CONTENT 6/7 (86%; IQR = 1; range: 5–7). Percentage of studies completely reporting all items was TIDieR 35% (31/89), CERT 24% (5/21), and i-CONTENT 10% (2/21). Studies were more completely reported after publication of TIDieR (t 87 = 2.08; p = 0.04) and CERT (t 19 = 2.72; p = 0.01). Reporting completeness was not strongly associated with journal impact factor (TIDieR: r s = 0.27; p = 0.01; CERT: r s = –0.44; p = 0.06; i-CONTENT: r s = –0.17; p = 0.48) or ROB (TIDieR: r s = 0.11; p = 0.31; CERT: r s = 0.04; p = 0.86; i-CONTENT: r s = 0.12; p = 0.60). RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness, but are often missing key components, particularly modifications, motivational strategies, and qualified supervisor. Reporting completeness improved after TIDieR and CERT publication, but publication in highly cited journals and low ROB do not guarantee reporting completeness. [Display omitted] [ABSTRACT FROM AUTHOR]

Weight loss is reported with oral roflumilast, which is approved for chronic obstructive pulmonary disease (COPD). Recently, the drug has shown efficacy in psoriasis, a disease strongly linked to overweight/obesity. To describe the effects of oral roflumilast on body weight and cardio-metabolic parameters in patients with psoriasis. Posthoc analyses from the PSORRO study, where patients with moderate-to-severe plaque psoriasis were randomized 1:1 to oral roflumilast 500 μg once-daily or placebo for 12 weeks, followed by active, open-label treatment through week 24 in both groups. Changes in body weight, blood pressure, gastrointestinal symptoms, and laboratory tests were registered. No lifestyle or dietary interventions were applied. Forty-six patients were randomized. Baseline characteristics across groups were comparable; mean weight was 103.6 kg. In patients receiving roflumilast, median weight change was −2.6% and −4% at week 12 and 24, respectively. Corresponding numbers were 0.0% and 1.3% in patients initially allocated to placebo. Reduced appetite was more frequent with active therapy. No changes in blood pressure or laboratory tests were observed. Posthoc analyses and low numbers. Oral roflumilast induced weight loss and reduced appetite, which support the growing evidence of roflumilast as an attractive treatment alternative for patients with psoriasis. [ABSTRACT FROM AUTHOR]

Reverse total shoulder arthroplasty (RTSA) has seen increasing utilization as an effective intervention for a wide variety of shoulder pathologies. The scope and indications for growth are often driven by findings from randomized controlled trials (RCTs) guiding surgical decision-making for RTSA. In this study, we utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the robustness of outcomes reported in RCTs in the RTSA literature. PubMed, Embase, and MEDLINE were queried for RCTs (Jan. 1, 2010-Mar. 31, 2023) in the RTSA literature reporting dichotomous outcomes. The FI and rFI were defined as the number of outcome reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the sample size of each study. Subgroup analysis was performed based on outcome category. One hundred seventy-six RCTs were screened with 18 studies included. The median FI across 59 total outcomes was 4 (interquartile range [IQR]: 3-5) with an associated FQ of 0.051 (IQR: 0.029-0.065). Thirteen outcomes were statistically significant with a median FI of 3 (IQR: 1-4) and FQ of 0.033 (IQR: 0.012-0.066). Forty-six outcomes were nonsignificant with a median rFI of 4 (IQR: 3-5) and FQ of 0.055 (IQR: 0.032-0.065). The most fragile outcome category was revision/reoperations with a median FI of 2.50 (IQR: 1.00-3.25), followed by clinical score/outcome (median FI: 3.00), complications (median FI: 4.00), "other" (median FI: 4.00), and radiographic findings (median FI: 5.00). Notably, the number of patients lost to follow-up was greater than or equal to the FI for 59% of outcomes. The statistical findings in RTSA RCTs are fragile and should be interpreted with caution. Reversal of only a few outcomes, or maintaining postoperative follow-up, may be sufficient to alter significance of study findings. We recommend standardized reporting of P values with FI and FQ metrics to allow clinicians to effectively assess the robustness of study findings. [ABSTRACT FROM AUTHOR]

Angioedema due to acquired C1-inhibitor deficiency is a very rare but serious disease, with an estimated prevalence of 1 per 500,000 persons. There are no approved therapies to treat or prevent angioedema swelling in patients with this condition. Deucrictibant is a specific, orally bioavailable, competitive antagonist of the bradykinin B2 receptor currently under investigation for hereditary angioedema. Our aim was to assess the efficacy and safety of deucrictibant as acute and prophylactic treatment for angioedema due to acquired C1-inhibitor deficiency. A 2-part, randomized, double-blind, placebo-controlled crossover study was conducted. In Part 1, 4 consecutive angioedema attacks were treated with 3 doses of deucrictibant (10 mg, 20 mg, and 30 mg) or placebo. In Part 2, deucricibant, 20 mg, or placebo was administered twice daily for 2 treatment periods of 8 weeks. Three patients were enrolled; of those 3 patients, 1 completed both study parts and 2 completed only Part 2. In Part 1, a reduction in attack severity was observed in the 3 attacks treated with deucrictibant as opposed to an increase in severity of the attack treated with placebo. In Part 2, the individual mean monthly attack rates were 2.0, 0.6, and 1.0 during the placebo period and 0.0 across all patients during treatment with deucrictibant. There were no severe adverse events and 1 self-limiting treatment-emergent adverse event (abdominal pain). Deucrictibant has the potential to effectively and safely treat and prevent angioedema attacks due to acquired C1-inhibitor deficiency. [ABSTRACT FROM AUTHOR]

To explore the effectiveness of a nutritional intervention in rescuers who screened positive for depression. A randomized controlled trial design was employed. From June to August, 2022, 4,460 rescuers were screened using the Self-Rating Depression Scale (SDS), and 1,615 positive cases were identified. Thirty-one volunteers were recruited and randomly divided into a nutritional intervention group and a control group. The intervention group received health education and nutritional intervention (a compound paste therapy primarily composed of red roses and Seville orange flowers), while the control group received psychological education. SDS scores were assessed before and after the intervention. There was a statistically significant decline in SDS scores in the nutritional intervention group after the intervention (P < 0.05). Furthermore, the SDS scores of the intervention group were significantly lower than those of the control group, both before and after the intervention (P < 0.05). No severe adverse reactions were observed during safety evaluation. The nutritional intervention effectively reduced the depression scores in rescuers. Early nutritional intervention is recommended for rescuers who initially screen positive for depression. [ABSTRACT FROM AUTHOR]

Music therapy (MT) is proposed to enrich the acoustic environment of very preterm infants (VPT) on the neonatal intensive care unit during a vulnerable period of brain development. The objective of this study was to investigate the effect of MT on the white matter (WM) microstructure. It is hypothesized that MT affects WM integrity in VPT. Randomized controlled trial enrolling infants born <32 weeks' gestation. Infants were randomized to MT or standard care. Live MT was provided twice weekly from the second postnatal week onwards by a trained music therapist. At term equivalent age, participants underwent a cranial magnetic resonance imaging scan including sequences for diffusion tensor imaging analysis. Differences in WM microstructure were assessed using tract based spatial statistics with fractional anisotropy. Of 80 infants enrolled, 42 were eligible for diffusion tensor imaging analysis (MT: n = 22, standard care: n = 20). While primary tract based spatial statistics analysis revealed no significant differences between groups, post hoc analysis with uncorrected p -values and a significance threshold of p < 0.01 revealed significant fractional anisotropy differences in several WM tracts including the bilateral superior longitudinal fasciculus, the left forceps minor and left fasciculus uncinatus, the corpus callosum, the left external capsule, and the right corticospinal tract. Post hoc analysis results suggest an effect of MT on WM integrity in VPT. Larger studies including long-term outcome are necessary to confirm these effects of MT on WM microstructure and to assess its impact on clinical neurodevelopment. Clinical trial number DRKS00025753. • Music therapy (MT) has positive effects on preterm infants (e.g.vital parameters) • The effect of MT on neurodevelopment remains unclear • Randomized controlled trial analyzing its effect on white matter microstructure • Diffusion tensor imaging data was used to analyze its effect on cerebral white matter • Results increase evidence of effects of MT on the white matter microstructure [ABSTRACT FROM AUTHOR]

The aim of the study was to examine the effectiveness of digital storytelling as a therapeutic care intervention in paediatric day surgery. his study was conducted in a randomized controlled experimental design. Seventy-two voluntary children who were scheduled for day surgery and met the inclusion criteria for the study were included. Research data were collected using the Child's Descriptive Information Form, the Children's Emotional Manifestation Scale, and the State Anxiety Inventory for Children. The study group used digital storytelling to prepare for day surgery. State anxiety scores decreased over time in the study group. The digital storytelling intervention was found to be effective in reducing anxiety scores. In the control group, state anxiety scores were highest on the day of the surgery. Children in the control group experienced higher levels of anxiety on the day of the surgery compared to those in the study group. The high anxiety levels in the control group continued at a higher level even two weeks after surgery. Children in the control group exhibited more negative emotional behaviors on the day of the surgery. The digital storytelling intervention implemented in this research was found to be effective in reducing children's anxiety and negative emotional behaviors. Digital storytelling should be applied and adapted to various other areas of paediatric surgery. Its utilization is significant for nurses working in the field of day surgery. • Surgical procedures cause negative emotional behaviour and increased anxiety in children. • The use of a preoperative preparation programme in children reduces the negative consequences of surgical procedures. • Children's anxiety and negative emotional behaviour was reduced by the digital storytelling intervention. [ABSTRACT FROM AUTHOR]

This article aims to compare clinical efficacy of newly introduced PowerScope 2 appliance with Forsus FRD in the treatment of Skeletal Class II malocclusion. This randomized controlled trial studied 40 patients at two centers (20 patients at each center, divided into two groups of 10 patients each as Group 1: Forsus FRD and Group 2: PowerScope 2 appliance. The skeletal, dental, soft tissue, and airway changes were noted at T0 (pretreatment), T1 (preappliance therapy), and T2 (postappliance therapy). Acoustic Pharyngometry (Eccovision® Acoustic Pharyngometer) was done to ascertain changes in mean airway volume and area with both modalities noninvasively. Treatment duration and chairside time in appliance installation and removal were noted. Patient comfort was compared using a customized questionnaire survey. A significant change was observed in skeletal, dental, soft tissue, and airway parameters after treatment with both modalities (p -value <0.05 for all) with no significant intergroup difference (p -value >0.05). Chairside time spent in appliance insertion was significantly lower with PowerScope 2 appliance (10.33 min) as compared to the Forsus FRD appliance (18.28 min) (p -value <0.05). Visual Analogue Scale scores for parameters such as problems in mastication, problems in speech, and problems in oral hygiene maintenance were significantly lower with PowerScope 2 appliance as compared to the Forsus FRD appliance (p -value <0.05). Although both modalities are effective in the management of Class II malocclusion, the PowerScope 2 appliance scores better in terms of lesser chairside time in appliance installation and better patient comfort. [ABSTRACT FROM AUTHOR]

Pregnant women often experience anxiety due to pregnancy, negatively impacting their and their fetus' health. Non-pharmacological interventions, such as virtual reality (VR), could reduce anxiety levels, potentially impacting non-stress tests or the physiological responses of the pregnant woman and the fetus. A randomized clinical trial conducted between February and December 2022 involved 286 term pregnant women. They were divided into a VR intervention group (146 women) and a control group (140 women). The intervention consisted of 20 min of 3D glasses with images and sounds during a third-trimester nonstress test. Anxiety was measured using the Spielberg State-Trait Anxiety Inventory (STAI), alongside physiological parameters. The VR group exhibited lower anxiety levels compared to controls (STAI score: Rosenthal's r: −0.54, p = 0.01; state anxiety: Rosenthal's r: −0.40, p = 0.001; trait anxiety: Rosenthal's r: −0.41, p = 0.001). Within the VR group, there was a significant reduction in trait anxiety (Rosenthal's r, 1.27; p < 0.001) and total anxiety (Rosenthal's r, 1.63; p < 0.001) post-intervention, along with decreased systolic blood pressure (p < 0.001), diastolic blood pressure (p < 0.001), and maternal heart rate (p = 0.02). Future research could explore additional pregnancy-related variables, such as postpartum anxiety. The results confirm that the use of VR is beneficial for pregnant women and their fetuses, as it decreases anxiety levels, and improves physiological parameters such as blood pressure and maternal heart rate during the nonstress test. VR is a technique that is easy to integrate into the healthcare system due to its non-invasive and non-pharmacological nature. • Virtual reality has proven to be an effective technique in reducing anxiety of pregnant women during NST. • Anxiety is related to higher blood pressure and heart rate values in pregnant women during NST. • Blood pressure and heart rate in pregnant women improved when virtual reality was used as a therapy. [ABSTRACT FROM AUTHOR]

Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p =.886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = −7.217; p =.046; Cohens d = 0.33), but not depressive symptoms (B = −1.041; p =.607) than TAU. The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy. • Online emotion regulation training improved emotion regulation in depressed patients. • iERT did not reduce revictimization rates or depressive symptoms compared to TAU. • Violent victimization rates decreased substantially during psychotherapy. [ABSTRACT FROM AUTHOR]

Ivermectin is an antiparasitic drug administered to hundreds of millions of people worldwide. Fundamental research suggests that ivermectin is effective against coronavirus disease 2019 (COVID-19); therefore, we investigated the efficacy and safety of ivermectin as a COVID-19 treatment option. This multi-regional (Japan and Thailand), multicenter, placebo-controlled, randomized, double-blind, parallel-group, Phase III study evaluated the efficacy and safety of ivermectin in patients with mild COVID-19 (IVERMILCO Study). The participants took a specified number of the investigational product (ivermectin or placebo) tablets of, adjusted to a dose of 0.3–0.4 mg/kg, orally on an empty stomach once daily for three days. The primary efficacy endpoint was the time at which clinical symptoms first showed an improving trend by 168 h after investigational product administration. A total of 1030 eligible participants were assigned to receive the investigational product; 502 participants received ivermectin and 527 participants received a placebo. The primary efficacy endpoint was approximately 96 h (approximately four days) for both ivermectin and placebo groups, which did not show statistically significant difference (stratified log-rank test, p = 0.61). The incidence of adverse events and adverse drug reactions did not show statistically significant differences between the ivermectin and placebo groups (chi-square test, p = 0.97, p = 0.59). The results show that ivermectin (0.3–0.4 mg/kg), as a treatment for patients with mild COVID-19, is ineffective; however, its safety has been confirmed for participants, including minor participants of 12 years or older (IVERMILCO Study ClinicalTrials.gov number, NCT05056883.). [ABSTRACT FROM AUTHOR]

Our aim is to investigate the effects of the submucoperichondrial application of Platelet Rich Plasma (PRP) on nasal mucosal healing after septoplasty surgery. This prospective randomized observational study was conducted between July 2019 and February 2021, with 40 patients aged 18–60 years who underwent closed the only septoplasty operation for similar septal deviations. Patient divided into two group; 21 patients were placed in PRP group to which PRP was applied on all mucosal surface and submucoperichondrial area of septum and 19 patients were placed in control group to which saline solution was applied on same regions. Nasal obstruction score, mucociliary clearance time, presence of nasal crusting, and bleeding time were evaluated on 5th, 10th, 15th day after surgery and compared between groups. Intranasal crusting on day 10 was found to be lower in the PRP group (n :13 68.4 %) than control group (n :7 33.3 %) with a statistically significant difference (p = 0.028). The nasal obstruction score on day 10 and 15 were found to be lower in the PRP group (3,33 ± 2,75, 2,07 ± 2,20) (than the control group (5,44 ± 2,26, 3,37 ± 1,92) with a statistically significant difference (p = 0,003, p = 0,009). The mucociliary clearance rate was found to be higher and the bleeding time was found to be lower in the PRP group, but a statistically significant difference was not observed. Application of submucoperichondrial PRP could have beneficial effects on nasal mucosal repair, nasal crusting, and congestion after septoplasty surgery. [ABSTRACT FROM AUTHOR]

It is well known that socioeconomic and demographic variables can greatly affect health outcomes. Previous studies across medical and surgical subspecialties have demonstrated that these variables are frequently under-reported in randomized controlled trials (RCTs). No such study currently exists that examines rates of reporting of sociodemographic variables in shoulder arthroplasty RCTs. This study aims to present these rates and explore the impact of failing to report socioeconomic variables in shoulder arthroplasty RCTs. The PubMed database was queried for the term shoulder arthroplasty. Sixty-five RCTs from the past 10 years were identified for inclusion from 5 high-impact orthopedic surgery journals. Each RCT was analyzed for patient age and sex or gender as well as the following sociodemographic variables: race, ethnicity, insurance status, income, work status, and education. It was also noted whether each of the above variable was mentioned in the results section of the article. Data were presented in a descriptive fashion as well as analyzed using χ2 and Fisher exact tests where appropriate. From 2014 to 2023, the 65 shoulder arthroplasty RCTs published reported age in 40 of 65 (61.5%) in their results sections and 61 of 65 (93.8%) in any section. Sex or gender was reported in 27 of 65 (41.5%) in their results sections and 61 of 65 (93.8%) in any section. No articles included any sociodemographic variables in the results section. Reporting rates for sociodemographic variables in any section were as follows: race, 6 of 65 (9.2%); ethnicity, 5 of 65 (7.7%); work status, 4 of 65 (6.2%); and insurance status, 1 of 65 (1.5%). No studies included income or education of the enrolled patients. There was no difference in reporting sociodemographic variables by journal (P =.45) or by year of publication (P =.57). However, no study prior to 2020 included any sociodemographic variable (0 of 27, 0%), whereas from 2020 onward 6 studies included at least 1 (6 of 38, 15.8%). Sociodemographic variables were reported significantly less frequently than age and sex or gender (P =.001). Our study found sociodemographic variables are rarely reported in shoulder arthroplasty RCTs, whereas age and sex or gender are reported with great frequency. In order to understand the results of shoulder arthroplasty RCTs, apply their findings to the care of our patients, and address health disparities, we must ensure these studies include patient sociodemographic data. [ABSTRACT FROM AUTHOR]

The pathophysiology and the potential risks of placental transfusion (PT) differ substantially in preterm infants, necessitating specific studies in this population. This study aimed to evaluate the safety and efficacy of PT in preterm infants from the perspective of long-term neurodevelopmental outcomes. We conducted a systematic literature search using placental transfusion, preterm infant, and its synonyms as search terms. Cochrane Central Register of Controlled Trials, Medline, and Embase were searched until March 07, 2023. Two reviewers independently identified, extracted relevant randomized controlled trials, and appraised the risk of bias. The extracted studies were included in the meta-analysis of long-term neurodevelopmental clinical outcomes using fixed-effects models. A total of 5612 articles were identified, and seven randomized controlled trials involving 2551 infants were included in our meta-analysis. Compared with immediate cord clamping (ICC), PT may not impact adverse neurodevelopment events. No clear evidence was found of a difference in the risk of neurodevelopmental impairment (risk ratio [RR]: 0.89, 95% confidence interval [CI]: 0.76 to 1.03, P = 0.13, I2 = 0). PT was not associated with the incidence of cerebral palsy (RR: 1.23, 95% CI: 0.59 to 2.57, P = 0.79, I2 = 0). Analyses showed no differences between the two interventions in cognitive, language, and motor domains of neurodevelopment. From the perspective of long-term neurodevelopment, PT at preterm birth may be as safe as ICC. Future studies should focus on standardized, high-quality clinical trials and individual participant data to optimize cord management strategies for preterm infants after birth. [ABSTRACT FROM AUTHOR]

[Display omitted] • First trial using tDCS for Parkinsońs disease-related pain has been performed. • tDCS alleviates perceived pain and increases descending inhibitory systems in Parkinsońs disease patients. • Conditioned Pain Modulation could mediate pain relief in Parkinsońs disease. To evaluate the effects of transcranial direct current stimulation (tDCS) on Parkinson's disease (PD)-related pain. This triple-blind randomized controlled trial included twenty-two patients (age range 38–85, 10 male) with PD-related pain. Eleven subjects received ten sessions of 20 minutes tDCS over the primary motor cortex contralateral to pain at 2 mA intensity. Eleven subjects received sham stimulation. Outcome measures included changes in the Kinǵs Parkinsońs Pain Scale (KPPS), Brief Pain Inventory (BPI), widespread mechanical hyperalgesia (WMH), temporal summation of pain (TS), and conditioned pain modulation (CPM). Significant differences were found in KPPS between groups favoring the active-tDCS group compared to the sham-tDCS group at 15-days follow-up (p = 0.014) but not at 2 days post-intervention (p = 0.059). The active-group showed significant improvements over the sham-group after 15 days (p = 0.017). Significant changes were found in CPM between groups in favor of active-tDCS group at 2 days post-intervention (p = 0.002) and at 15 days (p = 0.017). No meaningful differences were observed in BPI or TS. tDCS of the primary motor cortex alleviates perceived PD-related pain, reduces pain sensitization, and enhances descending pain inhibition. This is the first study to test and demonstrate the use of tDCS for improving PD-related pain. [ABSTRACT FROM AUTHOR]

Preclinical studies support a protective role for omega-3 fatty acids (FAs) on diabetic retinopathy (DR), but these observations have not been confirmed in randomized trials. We present randomized evidence for the effects of omega-3 FAs on DR outcomes. A substudy of the A Study of Cardiovascular Events iN Diabetes (ASCEND) double-blind, randomized, placebo-controlled trial of 1 g omega-3 fatty acids (containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid) daily for the primary prevention of serious cardiovascular events, in 15 480 UK adults at least 40 years of age, with diabetes. Fifteen thousand four hundred eighty adults at least 40 years of age from the United Kingdom with diabetes from the ASCEND cohort. Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review. Log-rank and stratified log-rank methods were used for intention-to-treat analyses of time until the main outcomes of interest. The primary efficacy endpoint was time to the first postrandomization recording of referable disease, a composite of referable retinopathy (R 2 or R 3a/s) or referable maculopathy (M 1) based on the grading criteria defined by the United Kingdom National Screening Committee. Secondary and tertiary outcomes included the referable disease outcome stratified by the severity of DR at baseline, any progression in retinopathy grade, and incident diabetic maculopathy. Linkage data were obtained for 7360 participants (48% of those who were randomized in ASCEND). During their mean follow-up of 6.5 years, 548 participants (14.8%) had a referable disease event in the omega-3 FAs group, compared with 513 participants (13.9%) in the placebo group (rate ratio, 1.07; 95% confidence interval, 0.95–1.20; P = 0.29). There were no statistically significant between-group differences in the proportion of events for either of the secondary or tertiary outcomes. Representing the largest prospective test of its kind to date, these data exclude any clinically meaningful benefits of 1 g daily omega-3 FAs on DR. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

Integrating digital technologies into sexual health education can offer advantages for connecting with adolescents, particularly populations who may be underserved through common school-based approaches. This study assessed the effectiveness of In the Know , an in-person, group-based sexual health education program integrating digital technologies, codesigned with adolescents. The study design was a cluster randomized trial with 1,263 adolescents aged 13-19 in 95 cohorts, implemented in community-based organizations and schools throughout Fresno County, California. Participants completed a baseline survey and a follow-up survey 3 months later. Two-level mixed-effects regression models with random intercepts for cohort were used to estimate the intervention's impact on unprotected sex, use of clinical health services, knowledge of local sexual health services, technology use to find or schedule services, and sexual health knowledge at the 3-month follow-up. The average age of participants was 15.7 years, and the majority identified as Hispanic (71%). In adjusted analyses, intervention group participants were more likely to use clinical services (42.7% vs. 33.2%, p =.009) and reported greater sexual health knowledge at 3 months (57.6% of items answered correctly vs. 50.7%, p =.001). No significant differences were observed in the other outcomes by study group. In the Know participants demonstrated greater use of clinical health services and sexual health knowledge at 3 months. The study findings show the potential for incorporating user-centered design and technology into sexual health education to better support adolescents who may have limited access to this important information. [ABSTRACT FROM AUTHOR]

The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD). In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed. 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P <.001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P <.001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P <.001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events. Study limitations include the 8-week treatment period for this chronic condition. Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD. [ABSTRACT FROM AUTHOR]

• Parents caring for technology-dependent children at home must remain highly vigilant. • These parents report high stress levels and are at high risk for clinical depression. • A randomized controlled trial tested the Resourcefulness Intervention efficacy. • Intervention arm parents had significantly more improvement than the control arm. • Parents had significantly less perceived stress and improved physical/mental health. Parent caregivers of children who require lifesaving medical technology (e.g., mechanical ventilation, feeding tubes) must constantly maintain vigilance. Poor physical and psychological health can negatively impact their ability to do so. A two-arm randomized controlled trial was conducted with 197 parent caregivers of technology-dependent children (aged < 18 years) to test the efficacy of Resourcefulness Training 1 1 The Resourcefulness Training intervention is copyrighted by Dr. Jaclene A. Zausniewski, PhD, RN-BC, FAAN (1995). , a cognitive-behavioral intervention that teaches social (help-seeking) and personal (self-help) resourcefulness skills, in improving key outcomes including mental health-related quality of life (HRQOL), depressive cognitions and symptoms, perceived and physiological chronic stress, burden, and physical HRQOL at five-time points. Mixed-effects models using the intent-to-treat principle indicated statistically significant improvement with intervention participants at six and/or nine months postintervention for depressive cognitions, perceived stress, and physical HRQOL, controlling for covariates. Study findings support the efficacy of Resourcefulness Training to significantly decrease perceived stress and improve psychological/physical outcomes with these vulnerable caregivers. [ABSTRACT FROM AUTHOR]

• This study developed a nursing program based on Solution-focused brief therapy (SFBT) and tested its effects on self-care and mental health among older adults at risk of coronary heart disease. • The SFBT significantly improved older adults' self-care ability, including self-concept, self-skills, self-care awareness, and health knowledge. • The SFBT significantly reduced older adults' depressive symptoms and anxiety. • The SFBT could be widely applied among older adults to effectively prevent coronary heart disease and promote well-being in the future. This study tested the effectiveness of a nursing program developed based on Solution-Focused Brief Therapy (SFBT) in improving self-care skills and mental health among community-dwelling older adults at risk for coronary heart disease (CHD). A total of 120 older adults were randomly assigned to either an SFBT group or a control group. Participants' self-care ability, depressive symptoms, and anxiety at baseline and post-intervention were assessed using the Self-care Ability Scale for the Elderly (SASE), Self-Rating Depression Scale (SDS), and Self-Rating Anxiety Scale (SAS), respectively. The t-test, Mann-Whitney U, and chi-square tests were conducted for group comparisons. After 6 months of intervention, the intervention group had significantly higher self-concept, self-skills, self-care awareness, and health knowledge scores than the baseline and the control group (all P- values < 0.05). The intervention group had significantly lower depression and anxiety scores than the baseline and the control group (all P- values < 0.05). SFBT is effective in improving older adults' self-care and mental health and may be widely applied among older adults to prevent CHD and promote well-being in the future. [ABSTRACT FROM AUTHOR]

Dysphagia is a common complication in patients with oral cancer who have undergone free flap transplantation. The aim of this cluster randomized controlled trial was to evaluate the effect of personalized oral exercises on swallowing function in this group of patients. Eligible patients were randomly assigned to the intervention (n = 34) or control (n = 34) group. Intervention group patients received personalized oral exercises starting on day 6 after surgery. Swallowing function was evaluated on days 6 and 15, and at 1 month postoperative using the Mann Assessment of Swallowing Ability–Oral Cancer tool (MASA-OC). On day 15 and at 1 month after surgery, the total MASA-OC score (P = 0.003, P < 0.001) and the mouth opening (P = 0.001, P < 0.001) and lip seal (both P < 0.001) item scores showed a significantly greater improvement in the intervention group than in the control group. Moreover, the changes in salivation (P < 0.001) and tongue movement (P = 0.025) scores at 1 month after surgery were significantly greater in the intervention group than in the control group. There was no significant difference between the groups in the change in tongue strength scores on day 15 or at 1 month postoperative (P = 0.476, P = 0.223). Personalized oral exercises can improve swallowing function in patients with oral cancer after free flap transplantation. [ABSTRACT FROM AUTHOR]

To estimate the effect of the Making Proud Choices! (MPC) curriculum, one of the most popular evidence-based teen pregnancy prevention curricula being implemented nationwide. A cluster randomized trial was used to assign high schools to receive the MPC program or to serve as a standard care comparison group. The study took place in 15 schools in four cities in the United States. A total of 31 clusters and over 2,800 youth (predominantly in grades 9 and 10) were assigned to condition between 2016 and 2019. Student surveys administered at baseline and approximately 9 months after baseline were used to estimate the effects of MPC on risk and protective factors (knowledge, attitudes, self-efficacy) as well as sexual behavior outcomes. The evaluation showed several large, statistically significant, and favorable impacts on nearly all of the risk and protective factors for risky sexual behavior. In addition, the study found a favorable effect of MPC on reducing the number of episodes of sex in the past 3 months. The evaluation showed that MPC, as it is commonly implemented today, has evidence of effectiveness on improving both risk and protective factors, and sexual behavior outcomes. Based on these findings, MPC will continue to be seen as an evidence-based teen pregnancy prevention program for implementation through federal grant programs. [ABSTRACT FROM AUTHOR]

The objective of this study was to assess endo-sinus bone gain (ESBG) and bone density (BD) following maxillary sinus membrane elevation without graft (test) compared with maxillary sinus floor augmentation and 1:1 ratio of autogenous bone from the buccal antrostomy and deproteinized porcine bone mineral (control) using two- and three-dimensional radiographic methods. Forty healthy patients were randomly allocated to the test and control groups. Cone beam computed tomography scans were obtained at enrolment (T0), immediately after surgery (T1), at delivery of the prosthetic rehabilitation (T2), and 1 year after functional implant loading (T3). Mean differences were expressed with the 95% confidence interval. Significance was set at ≤ 0.05. ESBG and BD were significantly higher in the control group than test group at T1, T2, and T3 (P < 0.001). A significant decrease in ESBG and increase in BD was observed from T1 to T3 with both treatments (P < 0.001). There was a non-significant positive correlation of ESBG with implant protrusion length and non-significant negative correlation with residual bone height. In conclusion, test was associated with significantly lower ESBG and BD compared with control. However, the lower ESBG and BD did not appear to negatively affect the implant stability quotient or implant treatment outcome after 1 year of functional implant loading. [ABSTRACT FROM AUTHOR]

• SP is a recognized learning method in healthcare simulation. • This study showed no statistically significant difference between low fidelity mannequin and standardized patient in terms of technical skills. • SP is better than low-fidelity simulation in terms of soft skills perceived by students. The placement of a peripheral venous cannulation is a procedure that all healthcare providers must be able to perform. This study compared two simulation techniques of a peripheral venous cannulation (VC): low fidelity simulation (LFS) versus standardized patient (SP) in terms of efficiency. This crossover randomized trial compared LFS to SP in VC placement for 2nd year nursing students from the Honoris United Universities. Each student performed the VC on both the manikin's arm and the SP in random order. The main outcome measure was successful of VC after the second attempt. The secondary outcome measures were time to successful of VC, number of attempts, adherence to asepsis (Registered protocol number: PACTR202111766112898). One hundred sixty learners were needed (α = β = 5%, 20% difference between the two techniques and 53% for SC). We enrolled 172 students. No statistical difference was found concerning the main outcome measure: 135 (78.5%) versus 138 (80.2%) for respectively LFS versus SP (p:0.689), nor for the secondary outcome measures. Six out of nine non-technical skills variables had a statistically significant difference in favor of SP. No statistical difference was found concerning the main and secondary outcome measures. Registered protocol number: Pan African Clinical Trials register (PACTR202111766112898)—Date of first recruitment on February 2, 2022. [ABSTRACT FROM AUTHOR]

• There is no special program to improve the rational drug use level of nursing students in the nursing curriculum. • This study indicates, rational drug use program (RDUP) remarkably increased the level of RDU among nursing students. • This study demonstrates that web-based RDUP can be integrated into the nursing curriculum for increasing the RDU levels of nursing students. Rational drug use (RDU) is an issue that has global concerns for all health professionals. The aim of this study was to determine the effects of web-based rational drug use program (RDUP) for nursing students. A total of 224 nursing students were randomly assigned to the intervention (IG = 112) and control (CG = 112) groups. The IG received a 4-week web-based RDUP. Data were collected at baseline (T0), postintervention (in 1-week = T1), and postintervention (in 16-week = T2). The level of RDU was significantly higher in the IG than in the CG at T1 (F = 88.890; p<0.001; η2 = 0.287) and at T2 (F = 251.875; p<0.001; η2 = 0.533). Web-based RDUP was effective in level of rational drug use among nursing students. Therefore web-based RDUP should be included in the nursing curriculum. [ABSTRACT FROM AUTHOR]

Gum chewing has been found to improve oral function. Nevertheless, few randomized controlled trials have investigated the effects of gum-chewing exercises on oral function in older adults. This study aimed to examine the effect of gum-chewing exercises on oral function in older adults. This was a single-blind, randomized controlled trial, conducted from November 2021 to January 2022. A total of 130 participants were divided randomly into the intervention and control groups. The intervention group was told to chew experimental gums for one month, while the control group was instructed to chew experimental tablets for one month. Maximum bite force, occlusal contact areas, oral dryness, tongue pressure, tongue and lip functions (number of times each of the following syllables is pronounced per second:/pa/,/ta/, and/ka/), masticatory function, subjective masticatory function, and gum-chewing time were measured at baseline and one month following intervention to assess outcomes. One month following the intervention, tongue pressure was significantly higher in the intervention group than in the control group (P = 0.027). In the within-group comparisons, maximum bite force (P < 0.001), unstimulated saliva flow (P < 0.001), tongue and lip functions (/pa/: P < 0.001;/ta/: P < 0.001;/ka/: P < 0.001), color scale value (P = 0.019), and ΔE value (P = 0.024) were significantly increased in the intervention group. The results suggest that gum-chewing exercises can improve oral functions in older adults, although additional increases in masticatory load may be necessary to establish a more effective oral function training method using gum-chewing exercises in older adults. [ABSTRACT FROM AUTHOR]

Women with symptomatic pelvic organ prolapse are offered a choice of conservative and surgical treatment options. Two thirds of women choose a vaginal pessary, a support device inserted in the vagina. This article reports the finding of a randomized controlled trial published in 2023 evaluating the cost-effectiveness of self-management of pessary compared to clinic-based care. Women were recruited in 21 centres across the UK and 340 women were randomized to pessary self-management or clinic-based care. The primary outcome measure was prolapse-specific quality of life and secondary outcomes were generic quality of life, pelvic floor symptoms, sexual function, self-efficacy, pessary complications, pessary use and pessary confidence. Participants' health care resource use was measured. The trial showed that at 18 month follow-up self-management was not associated with better or worse quality of life than clinic-based care. Women in the self-management group reported fewer pessary complications and lower healthcare resource use. [ABSTRACT FROM AUTHOR]