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A novel antibody–drug conjugate, trastuzumab deruxtecan is a combination of a human epidermal growth factor receptor 2 (HER2)-targeting antibody and DNA topoisomerase I inhibitor used to treat HER2-low/positive advanced breast cancer. To determine its safety and efficacy in treating HER2-low/positive advanced breast cancer, we performed a meta-analysis of several randomized clinical trials (RCTs) including DESTINY-Breast02 (NCT03523585), DESTINY-Breast03 (NCT03529110), and DESTINY-Breast04 (NCT03734029). We searched PubMed, Embase, and the Cochrane Library for RCTs on the efficacy and safety of trastuzumab deruxtecan that were published before May 2023. The efficacy endpoints included median progressive-free survival (PFS), overall survival (OS), duration of response (DOR), overall response rate (ORR), and clinical benefit rate (CBR). The safety endpoints included treatment-related adverse events. Statistical analyses were performed using RevMan 5.4 software. To ensure transparency, this study was registered on the International Prospective Register of Systematic Reviews website (CRD42023414170). Three RCTs involving 1689 patients were included. Compared with physician-recommended and conventional treatments, trastuzumab deruxtecan exhibited statistically significant improvements in PFS, ORR, and CBR. The median OS and DOR failed to be combined; however, the analyzed studies showed that they were longer. The incidence of adverse events was generally higher with trastuzumab deruxtecan than with physician-recommended or conventional treatments. The results of this study suggest that trastuzumab deruxtecan is more effective in treating HER2-low/positive advanced breast cancer than physician-recommended or conventional treatments. However, trastuzumab deruxtecan-related adverse drug reactions should be closely monitored because of its higher incidence of adverse events. • HER2-targeted therapy is ineffective in locally advanced or metastatic disease. • Trastuzumab deruxtecan may improve function compared to traditional treatments. • We included 1689 breast cancer patients from three randomized clinical studies. • Verification of trastuzumab deruxtecan's efficacy and safety is needed. [ABSTRACT FROM AUTHOR]

The British Columbia Farmers' Market Nutrition Coupon Program (BC FMNCP) provides households with low incomes with coupons to purchase healthy foods from farmers' markets. To examine the impact of the BC FMNCP on the short-term household food insecurity, malnutrition risk, mental well-being, sense of community (secondary outcomes), and subjective social status (exploratory outcome) of adults with low incomes post-intervention and 16 weeks post-intervention. Secondary analyses from a pragmatic randomized controlled trial conducted in 2019 that collected data at baseline, post-intervention, and 16 weeks post-intervention. Adults ≥18 years with low incomes were randomized to an FMNCP group (n = 143) or a no-intervention control group (n = 142). Participants in the FMNCP group received 16 coupon sheets valued at $21 Canadian dollars (CAD)/sheet over 10 to 15 weeks to purchase healthy foods from farmers' markets and were eligible to participate in nutrition skill-building activities. Outcomes included short-term household food insecurity (modified version of Health Canada's 18-item Household Food Security Survey Module), malnutrition risk (Malnutrition Universal Screening Tool), mental well-being (Warwick-Edinburgh Mental Well-Being Scale), sense of community (Brief Sense of Community Scale), and subjective social status (MacArthur Scale of Subjective Social Status community scale). Mixed-effects linear regression and multinomial logistic regression examined between-group differences in outcomes post-intervention and 16 weeks post-intervention. The risk of marginal and severe short-term household food insecurity was lower among those in the FMNCP group compared with those in the control group (relative risk ratio [RRR] 0.15, P = 0.01 and RRR 0.16, P = 0.02) post-intervention, with sustained reductions in severe household food insecurity 16 weeks post-intervention (RRR 0.11, P = 0.01). No statistically significant differences were observed in malnutrition risk, mental well-being, sense of community, or subjective social status post-intervention or 16 weeks post-intervention. The BC FMNCP reduced short-term household food insecurity but was not found to improve malnutrition risk or psychosocial well-being among adults with low incomes compared with a no-intervention control group. [ABSTRACT FROM AUTHOR]

Central venous catheters are widely used in clinical practice, and the incidence of central venous catheter occlusion is between 25 % and 38 %. The turbulence caused by the pulsatile flushing technique is harmful to the vascular endothelium and may lead to phlebitis. The low-speed continuous infusion catheter technique is a new type of continuous infusion that ensures that the catheter is always in a keep-vein-open state by continuous low-speed flushing; hence, avoiding the problem of catheter occlusion. To investigate the effectiveness of the low-speed continuous infusion catheter technique and the routine care of double-lumen central venous catheters. This was a prospective, randomized, controlled, open-label trial. Patients were recruited from 14 medical institutions in China between February and June 2023. In total, 251 patients were recruited, with 125 in the intervention group and 126 in the control group. Patients who used double-lumen central venous catheters for infusion treatment were selected, and those who met the sampling criteria were randomly divided into intervention and control groups using the random envelope method. The intervention group used the low-speed continuous infusion catheter technique to maintain catheter patency, whereas the control group used routine care with a trial period of 7 days. The primary outcome was the occlusion rate. The secondary outcomes included nursing satisfaction and complication rates of the two groups. After 7 days, the rate of catheter occlusion was 28.0 % (35/125, 95 % confidence interval (CI):0.203, 0.367) in the intervention group and 53.97 % (68/126, 95 % CI: 0.449–0.629) in the control group, with a statistically significant difference (χ2 = 17.488, p < 0.001); at 3 days of intervention, the rate of catheter blockage was 8.0 % (10/125, 95 % CI: 0.039–0.142) in the intervention group and 23.8 % (30/126, 0.167–0.322) in the control group, with a statistically significant difference (χ2 = 11.707, p < 0.001). Nurse satisfaction was significantly higher in the intervention group (115/125, 92.0 %, 95 % CI: 0.858–0.961) than in the control group (104/126, 82.54 %, 95 % CI: 0.748–0.887) (χ2 = 5.049, p = 0.025). There were no statistically significant complication rates in either group (p = 0.622). The low-speed continuous infusion catheter technique helps maintain catheter patency, improves nurse satisfaction, and provides a high level of safety. Chinese Clinical Trial Registry (ChiCTR2200064007, www.chictr.org.cn). The first recruitment was conducted in February. https://www.chictr.org.cn/showproj.html?proj=177311. [ABSTRACT FROM AUTHOR]

• Only 6 % of randomized trials of antidepressants assess the prevention of relapse. • Only 28 % of randomized trials of antidepressants assess functional remission. • Most randomized trials of antidepressants have stringent eligibility criteria. • 84 % of randomized trials of antidepressants exclude older adults. • Modification of the design of trials of antidepressants should be considered. The purpose of this study was to analyze the key aspects of the design of contemporary placebo-controlled randomized clinical trials (RCTs) of antidepressants enrolling patients with major depressive disorder (MDD) aged 18 years or older, especially the outcome measures and the eligibility criteria. The study included 122 RCTs registered with ClinicalTrials.gov and started from 2008 through 2022. Most RCTs assessed only clinical remission, with proportion of trials with outcome measures related to functional remission being rather low (n = 34; 28 %). Clinical remission was mostly evaluated in acute phase of depression, and only 7 (6 %) trials assessed the prevention of relapse. Proportion of trials utilizing self-report questionnaires that provide important information complementary to clinician-rated scales was moderate (n = 66; 54 %). Another problem in included RCTs was common use of stringent eligibility criteria. For instance, minimal symtpom severity required for the patient's inclusion was listed in 104 RCTs (85 %), and 41 RCTs (34 %) excluded patients based on comorbid anxiety disorders. Most RCTs (n = 103; 84 %) excluded older patients, and only 6 (5 %) trials were dedicated exclusively to them. To ensure optimal development of clinical pharmacotherapy of MDD, the investigators should consider modification of some of the key aspects of the design of RCTs of antidepressants. [ABSTRACT FROM AUTHOR]

• This is the first cost-effectiveness analysis for yoga in patients with depression. • A yoga intervention was added to treatment as usual for young women with MDD. • Adding yoga was likely to be cost-effective compared to treatment as usual only. • This was mainly due to decreased work absenteeism. In a randomized controlled trial in the Netherlands, we studied the (cost)effectiveness of adding a mindful yoga intervention (MYI+TAU) to treatment as usual (TAU) for young women with major depressive disorder (MDD). In this paper, we present the results of the economic analyses. Societal costs and health outcomes were prospectively assessed during 15 months for all randomized participants (n = 171). Symptoms of depression (Depression Anxiety and Stress Scales; DASS) and quality adjusted life years (QALYs) were used as health outcomes in the economic analyses. Mean total societal costs during the 15 months of the study were €11.966 for the MYI+TAU group and €13.818 for the TAU group, differences in mean total societal costs were not statistically significant. Health outcomes (DASS and QALY) were slightly in favour of MYI+TAU, but differences between groups were not statistically significant. Combining costs and health outcomes in cost-effectiveness analyses indicated that MYI+TAU is likely to be cost-effective compared to TAU which was confirmed by sensitivity analyses. Although there were limitations in the cost-effectiveness analysis, findings from this study suggest that MYI+TAU warrants future attention for the potential to be cost-effective compared to TAU for young women with MDD. [ABSTRACT FROM AUTHOR]

• A home-delivered non-pharmacological intervention contributed to reducing the immediate total and social loneliness of homebound older adults. • The decrease in perceived social loneliness mediated the improvement of depressive symptom levels. • Social loneliness may be a relevant target of intervention to improve depressive symptomatology. The present study aimed to explore whether the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered ten-week cognitive-emotional intervention, was effective in reducing self-reported loneliness among homebound older adults presenting mild cognitive impairment and psychological symptomatology. Effects of HEPPI in total, social, and emotional loneliness, compared with a treatment-as-usual group, were investigated at post-intervention and 3-month follow-up. In addition, the potential role of social and emotional loneliness as mediators of the HEPPI impact on episodic memory and symptoms of depression and anxiety was examined. This study built upon the data of a previously conducted randomized controlled trial. Participants were randomly assigned to the HEPPI group (n = 98) or the treatment-as-usual group (n = 101) and completed baseline, post-intervention, and 3-month follow-up assessments, including measures of loneliness (UCLA - Loneliness scale), episodic memory (Wechsler Memory Scale-III), depressive symptoms (Geriatric Depression Scale-30), and anxiety symptoms (Geriatric Anxiety Inventory). Data were analyzed on an intention-to-treat basis employing linear mixed models and mediation analyses for repeated measures. ClinicalTrials.gov identifier: NCT05499767. Compared with usual care controls, the HEPPI participants reported a significant immediate decrease in total and social loneliness, but these effects were not maintained at a 3-month follow-up. The reduction in immediate perceived social loneliness significantly mediated the improvement of depressive symptoms. The current findings suggest that HEPPI potentially reduced total and social loneliness of the homebound older population immediately post-intervention, and such decrease in social loneliness may be a relevant mechanism for improving their short-term depressive symptomatology. [ABSTRACT FROM AUTHOR]

• Pedagogy focused interventions in developing contexts boost early literacy. • Lesson observations linked to assessments measure fidelity of scripted instruction. • Scripted lessons for under resourced teachers improve student reading in Madagascar. This paper evaluates the impacts of a Grade 1 literacy intervention, Mahay Mamaky Teny (MMT) translated to "I know how to read", implemented in Madagascar on student literacy outcomes. The intervention included teacher training and coaching on effective literacy-focused instructional routines and strategies, scripted lesson plans for teachers, and student learning materials. We employ a cluster-randomized controlled trial, at the school level, to identify the overall causal effects of the intervention on student literacy outcomes using the Early Grade Reading Assessment (EGRA) administered in the Malagasy language. We contribute to the evidence base by disentangling the effect of teacher adherence to scripted lessons from the overall effect of the intervention. We achieve this by linking classroom observation data to student reading assessment scores. Our results show that students in the intervention group outperform their control group counterparts on all EGRA subtasks including letter sound identification, syllable reading, oral reading fluency, and reading comprehension. Additionally, within the intervention group, we find that EGRA performance is significantly higher when teachers followed the scripted lessons than when teachers did not. [ABSTRACT FROM AUTHOR]

To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes). A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes. [ABSTRACT FROM AUTHOR]

Young offenders show high levels of substance use. Treatment programs within detention settings are less effective. Cognitive bias modification (CBM) is a promising supplement to substance use treatment. This study tests the effectiveness of CBM in young offenders to reduce cannabis and alcohol use, and delinquent recidivism. A randomized controlled trial added CBM to treatment as usual (TAU), among 181 youth in juvenile detention centers. In a factorial design, participants were randomly assigned to either active- or sham-training for two varieties of CBM, targeting attentional-bias (AtB) and approach-bias (ApB) for their most used substance. Substance use was measured with the Alcohol and Cannabis Use Disorder Identification Tests. Delinquent recidivism was measured with the International Self-Report Delinquency (ISRD) survey. At pretest, participants showed AtB but no ApB for both substances. For alcohol, a decrease was found in AtB in the active-training group. For cannabis, a decrease was found in AtB for both active- and sham-training groups. Regardless of condition, no effects were found on substance use or ISRD scores at follow-up. The sample is judicial, not clinical, as is the setting. TAU and participant goals are not necessarily substance related. Young offenders show a significant attentional-bias towards substance cues. CBM changed attentional-biases but not substance use. Combining CBM with a motivational intervention is advised. Follow-up research should better integrate CBM with running treatment programs. New developments regarding CBM task design could be used that link training better to treatment. • First implementation of Cognitive Bias Modification with detained juveniles. • Attentional biases found for alcohol and cannabis stimuli. • CBM training tasks successfully reduce attentional biases. • Substance use at follow-up is not significantly lower compared to sham-training. [ABSTRACT FROM AUTHOR]

Although cognitive behavioral group therapy (CBGT) is an effective treatment for social anxiety disorder, many socially anxious patients are still symptomatic after treatment. A possible improvement for CBGT could come from the more experiential group psychotherapy, psychodrama (PD). The integration of CBGT and PD (labeled CBPT) might offer an even more effective treatment than CBGT or PD alone. With the present study, we investigated first whether three kinds of group therapy (CBGT, PD, and CBPT) are superior to a waitlist (WL). Second, we investigated whether CBPT is more effective than CBGT or PD alone. One hundred and forty-four social anxiety patients were randomly assigned to three active conditions or a WL. After wait, WL-participants were randomized over the active treatment conditions. The results of a multilevel analysis showed that all treatments were superior to WL in reducing social anxiety complaints. Only CBGT and CBPT differed significantly from WL in reducing fear of negative evaluations. There were no significant differences between active conditions in any of the variables after treatment and after six-month follow up, neither were there significant differences in treatment dropout. First there is the lack of a long-term follow-up. Second, because of loss of participants, we did not reach the planned numbers in the active treatment groups in comparison to WL. Moreover, this study was not designed as a non-inferiority or equivalence trial. Although the integrative CBPT showed good results, it was not more effective than the other treatments. • All treatments were superior to the waiting list group in reducing social anxiety. • Compared to WL, CBGT and CBPT but not PD decreased fear of negative evaluation. • Comparing only active treatments, no treatment was superior to another treatment. [ABSTRACT FROM AUTHOR]

Treatments for eating disorders are moderately effective, with cognitive behavior therapy (CBT) providing the strongest evidence. However, it remains important to investigate other interventions, particularly for eating disorders with greater complexity (e.g., substantial comorbidity; trauma history) or for patients who have not responded adequately to previous treatments. This randomized controlled trial compared CBT against compassion-focused therapy for eating disorders (CFT-E), where half of the sample had a childhood trauma history. The study was pre-registered and adequately powered. A total of 130 patients were randomly assigned to CBT or CFT-E and were assessed at pre-treatment, post-treatment and one-year follow-up. The primary outcome measure was the total score on the Eating Disorder Examination-Interview (EDE), and secondary outcome measures were the Symptom Checklist-90, Inventory of Interpersonal Problems–64 and Post-Traumatic Symptom Scale. Attrition during treatment was low (13%), suggesting good acceptability. Eating pathology (EDE scores) reduced substantially overall, with large effect sizes, and there were no differences between therapies. However, at follow-up, for patients with a childhood trauma history, CFT-E maintained benefits better than CBT. Conclusion : While both CBT and CFT-E resulted in significant reductions in eating pathology, CFT-E showed superior maintenance of benefits for patients with a history of childhood trauma at one-year follow-up, underlining the necessity of tailored interventions for specific patient subgroups. • Lack of treatment studies for eating disorder patients with trauma histories. • First study comparing CFT and CBT for eating disorders. • Both treatments viable; CFT superior in long-term outcomes for patients with trauma histories. [ABSTRACT FROM AUTHOR]

Need-based care is a structured and standardized model that supports formal caregivers in nursing homes in delivering person-centered care by responding with tailored non-pharmacological interventions on residents' unmet needs as well as having positive effects on behavioral and psychological symptoms on residents with dementia. However, limited resources as well as the shortage of caregivers in nursing homes make the implementation of need-based care challenging, especially when it comes to finding ways to spend more time with residents. The aim of this study is to evaluate the impact of the implementation of need-based care in nursing homes on formal caregivers' wellbeing. A three-arm cluster randomized controlled trial was set up in 24 Belgian nursing homes: formal caregivers in the 'need-based care' group (intervention; n = 195) spent time twice a week with residents who had behavioral and psychological symptoms according to the principles of need-based care while formal caregivers in the 'time' group (n = 257) filled in the way they spent time twice a week; a third group delivered standard care (n = 299). An implementation strategy was built upon the Implementation Quality Framework and used in the 'need-based care group'. A total of 741 formal caregivers completed the digital questionnaire at one or more of the five time points (every nine weeks) between November 2021 and July 2022; they rated their sense of competence in dementia care, level of burnout, and, level of engagement. Moments of time were registered in a printed registration book. Only formal caregivers from the 'need-based care' group experienced a higher sense of competence in dementia care at time points three (p = 0.010) and four (p = 0.001) compared with baseline with an increase of respectively 1.5 (95 % confidence interval [0.25, 2.84]) and 2.4 (95 % confidence interval [0.77, 4.04]) points. No differences in scores on burnout and engagement were found. Despite challenging workforce circumstances in nursing homes, caregivers in the need-based care group as well as in the time group were able to spend time twice a week with residents with behavioral and psychological symptoms. No negative effects were found on formal caregivers' wellbeing after the implementation of need-based care in nursing homes. However, it requires strong leadership and the use of well-considered implementation strategies including reflective practice. Trial registration number ISRCTN56768265 (10/08/2023). [ABSTRACT FROM AUTHOR]

Although swallowing exercises are a fundamental treatment for dysphagia, few studies have evaluated the effectiveness of swallowing training in patients with Alzheimer's disease. We recruited 93 patients with Alzheimer's disease from three hospitals in Guangdong, China. This was a parallel armed randomized controlled trial that randomly assigned patients to intervention (n = 48) and control (n = 45) groups. The intervention group adopted systematic stepwise swallowing training for four weeks based on routine dysphagia care. The control group implemented routine dysphagia care, including diet and posture management and health education about swallowing dysfunction. The swallowing function was the primary outcome, which was assessed using the Water Swallowing Test and Standard Swallowing Assessment. An abnormal eating behavior questionnaire was used to assess the incidence of aberrant eating behavior in patients with Alzheimer's disease. The Mini-Nutritional Assessment Short Form and Barthel index were adopted to evaluate the nutritional status and ability to carry out daily activities between groups. SPSS software was used to perform the chi-square test, t -test, and generalized estimation equation for data analysis. We analyzed the effects of the stepwise swallowing training program using the generalized estimating equation method. The intervention group exhibited greater improvements in their swallowing function (Water Swallowing Test: β = − 3.133, 95 % CI: − 4.113, − 2.154, P < 0.001; Standard Swallowing Assessment: β = − 5.813, 95 % CI: − 7.782, − 3.844, P < 0.001), abnormal eating behaviors (abnormal eating behavior questionnaire: β = − 13.324, 95 % CI: − 21.643, − 5.005, P = 0.002), daily function (Barthel index: β = 11.280, 95 % CI: 4.021, 18.540, P = 0.002), and nutritional status (Mini-Nutritional Assessment Short Form: β = 2.402, 95 % CI: 1.313, 3.490, P < 0.001) over time than the routine-care group in the fourth week. Stepwise swallowing training is a safe and effective intervention for managing dysphagia and other related symptoms in patients with Alzheimer's disease. [ABSTRACT FROM AUTHOR]

• Multi-domain cognitive improvements were found following low-intensity rTMS. • The majority of cognitive improvements sustained at 6 months. • Cognitive improvements were not correlated with psychotic improvement. Cognitive impairments are a core symptom of schizophrenia. Although low-intensity repetitive transcranial magnetic stimulation (rTMS) also has cognitive improving effect like the commonly used high-intensity rTMS, it has not been applied in schizophrenia yet. To fill this gap, inpatients with schizophrenia were randomized to receive 20 sessions of daily adjunctive active low-intensity rTMS in 4 weeks, or sham treatment. At baseline, 4 weeks, and 6 months, the Positive and Negative Syndrome Scale (PANSS) was used to assess psychotic symptom severity, while the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Stroop Color and Word Test (SCWT) were used to assess cognitive functions. Compared to the sixty-nine patients receiving sham treatment, those fifty-nine patients receiving active rTMS performed better in all cognitive domains at post-treatment with small to large effect sizes. This superiority of active rTMS over sham treatment remained significant at 6-month follow-up, with small to large effect sizes, except for visuospatial function and delayed memory. The reduction in PANSS scores were not correlated with cognitive improvements. Our findings provide evidence for using low-intensity rTMS to ameliorate cognitive impairments in schizophrenia. More research are needed to determine the optimal intensity for each domain of cognitive functions. [ABSTRACT FROM AUTHOR]

Mindfulness apps have become popular tools for addressing symptoms of depression and anxiety. Since the publication of earlier meta-analyses evaluating the efficacy of mindfulness apps for depression and anxiety symptoms, over 20 randomized controlled trials (RCTs) have been conducted. There is a need for an updated meta-analysis that quantifies the effects of mindfulness apps on these symptoms and tests for potential moderators.. Random effects meta-analyses were conducted on 45 RCTs. Small, significant effect sizes were found for symptoms of depression (N comp = 46, N = 5852, g = 0.24, 95% CI = 0.17, 0.31, NNT = 13.57) and anxiety (N comp = 48, N = 6082, g = 0.28, 95% CI = 0.21, 0.35, NNT = 11.47) in favour of mindfulness apps over control groups. This effect was not explained by symptom deterioration in participants allocated to control groups. Effects remained stable when restricting analyses to lower risk of bias and larger sample trials. No significant moderators were observed, except trials that offered monetary compensation produced larger effects on depression. Non-significant effects were observed when comparing mindfulness apps to active therapeutic comparisons (g = −0.15 depression, g = 0.10 anxiety), though the number of studies was low. Growing evidence indicates that mindfulness apps can acutely reduce symptoms of depression and anxiety, although higher quality studies with longer follow-ups are needed. • Conducted a meta-analysis of 45 trials of mindfulness apps on depression and anxiety. • Mindfulness apps led to small improvements in depression and anxiety relative to controls. • Mindfulness was not significantly different to active therapeutic comparisons. • Mindfulness apps may help improve symptoms of depression and anxiety to a modest degree. [ABSTRACT FROM AUTHOR]

To investigate the effects of a temporal self-regulation theory-based intervention on self-management in hemodialysis patients. A randomized controlled trial was carried out in Lanzhou, China. Participants were randomly allocated to either the intervention group (n = 42) or control group (n = 42). The outcomes of self-management level, interdialytic weight gain, serum potassium and serum phosphorus were collected at baseline (T0), 1 month after intervention (T1), and 2 months after follow-up (T2). After intervention and follow-up, the self-management score of the intervention group was significantly higher than that of the control group, while the interdialytic weight gain, serum potassium, and serum phosphorus were significantly lower. The group and time interaction effects revealed that participants in the intervention group exhibited significantly greater improvement in self-management at T1 and T2. Interdialytic weight gain decreased significantly at T2. Serum potassium levels did not differ significantly at T1 or T2. The changes in serum phosphorus were both significant at T1 and T2. This study demonstrated that the temporal self-regulation theory-based intervention was effective in improving hemodialysis patients' self-management. The findings suggest popularizing and applying this intervention in the clinic to maintain the long-term effectiveness of the intervention effect. • The temporal self-regulation theory is effective in the education of HD patients. • The intervention promotes HD patients' self-management. • The intervention can maintain the effects in a period of time. [ABSTRACT FROM AUTHOR]

• We assessed chatbot effects on problem gambling, with or without therapist support. • Gambling problems were improved regardless of the presence or absence of therapist support. • Therapist support showed no additional effect on gambling symptoms. • Examining the appropriate intensity and modality of therapist support is needed. Internet-based interventions can be a promising option for individuals with problem gambling facing barriers to seeking help. This study aimed to directly compare the effects of therapist-guided Internet interventions with unguided ones on gambling-related behavior, cognition, and stage of change including help-seeking intention. We conducted a participant-blinded randomized controlled trial of therapist-guided versus unguided groups with a 12-week follow-up. Both groups received self-help chatbot-delivered cognitive behavioral therapy. Additionally, at baseline and weeks 1, 2, 3, and 4, the guided group received personalized feedback messages from therapists based on their gambling diary and questionnaire responses. The unguided group received reminders of assessments from research assistants. The primary outcome was the change in scores on the Gambling Symptoms Assessment Scale (G-SAS) over 12 weeks. Secondary outcomes included the stage of change including help-seeking intention, money wagered, gambling frequency, and gambling-related cognitions. We included 139 participants with a mean Problem Gambling Severity Index total score of 14.6 and a mean G-SAS total score of 27.0 who sought information about gambling problems. Both groups demonstrated substantial decreases in their G-SAS scores from baseline to week 12 (-10.2, 95% CI: −7.67 to −12.7 for the guided group, and 11.7, 95% CI: −9.05 to −14.3 for the unguided group). However, we did not find a significant between-group difference (1.49, 95% CI: −2.20 to 5.17). Regarding the stage of change including help-seeking intention, there were also no between-group differences. Minimum therapist support did not have an additive effect on the self-help chatbot intervention on gambling symptoms, behavior, and the stage of change including help-seeking intention. [ABSTRACT FROM AUTHOR]

To compare the short, medium, and long-term effects of balance exercises combined with either peroneal neuromuscular electrical stimulation (NMES) or peroneal transcutaneous electrical nerve stimulation (TENS) on dynamic postural control and patient reported outcome measures (PROMs) in patients with chronic ankle instability (CAI). Thirty-four participants with CAI were randomly assigned to a 12-session home based exercise program combined with NMES (Ex-NMES) or TENS (Ex- TENS). Baseline postural control was tested with the modified Star Excursion Balance Test (mSEBT) and time to stabilization (TTS) after a single-leg drop-jump. The self-reported function was measured using the Cumberland Ankle Instability Tool (CAIT), the Identification of Functional Ankle Instability (IdFAI), and the Sports subscale of the Foot and Ankle Ability Measure (FAAM Sport). Both groups showed significant improvements in all self-reported outcome measures at the 12-month follow-up. Subjects in the Ex-NMES group had significantly better IdFAI (-4.2 [95% CI −8.1, −0.2]) and FAAM Sport (13.7 [95% CI 2.2, 25.2]) scores at 6- and 12-month follow-up, respectively, compared to the Ex-TENS group. Medium to large between-group effect sizes were observed in self-reported functional outcomes and the mSEBT. The consistent trend of improvement in self-reported functional outcomes when training is combined with NMES compared with training with TENS may indicate a potential benefit that should be further investigated as a treatment for patients with CAI. [ABSTRACT FROM AUTHOR]

Digital game-based intervention programs represent a powerful tool for improving reading, whereas evidence for using digital tools to improve spelling is scarce. To fill this gap, we developed an adaptive digital game-based intervention that combines teaching phonological processing, graphene-phoneme-correspondence, and orthographic and morphological rules. Evaluation of the efficacy of a novel digital spelling intervention tool. Participants were 65 German speaking second- and third-graders with spelling disorder. A randomized controlled trial was conducted using a pre-test intervention post-test design. After pre-test children were randomly assigned to the experimental group or an active control group, receiving digitalized games for a period of 12 weeks. Data were analyzed using linear mixed effects models. Results showed intervention effects for precursor skills (i.e., phoneme-graphene mapping and phoneme awareness) and for trained and untrained words including trained spelling phenomena (generalization effect). Training effects were specific for spelling and did not transfer to reading. Participants and their parents also reported high levels of satisfaction with and usability of the intervention. Findings suggest that the training can be easily integrated into daily routine and that the intervention can supplement standard spelling instruction or can be used when learning therapy is not available. Results also support the idea that effective literacy intervention should be symptom-specific and adapted to the performance level of the child. • Intervention combines phonics with teaching orthographic and morphological rules. • Additional features of the training: adaptivity, immediate feedback, game elements. • The intervention improves precursor skills and spelling. • Training effects are specific to trained words and phenomena (generalization). • Users and their parents report high levels of satisfaction and usability. [ABSTRACT FROM AUTHOR]

• Pairwise meta-analysis＆network meta-analysis were performed, respectively. • Bayesian/frequentist network meta-analysis were also performed. • Risk bias was evaluated using the GRADE＆CINeMA. • Laser assisted MD is superior to MD alone in treating peri-implantitis. • Er:YAG/diode lasers gain better anti-inflammation＆aPDT gains better regeneration. Peri-implantitis is a major factor responsible for a decrease in the long-term success rate of implants. Conventional mechanical debridement (MD) is not efficient enough to clear plaque from the surface of rough-threaded implants. Additional laser therapy may compensate for this deficiency and promote tissue regeneration by photobiomodulation. To evaluate the efficacy and ranking of adjuvant laser therapy for peri-implantitis with regards to inflammation control and tissue regeneration, data analysis of diode laser, antimicrobial photodynamic therapy (aPDT) and solid-state laser (erbium-doped yttrium aluminium garnet laser (Er:YAG) and erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG)) for inflammation-related indicators, such as peri-implant probing depth (PPD), bleeding on probing (BOP), sulcular bleeding index (SBI), and plaque index (PLI), as well as regeneration-related indicators, such as clinical attachment level (CAL) and radiographic bone fill (RBF) were included in the systematic review and network meta-analysis. The EMBASE, Cochrane Library, Web of Science, and PubMed databases were searched till 12 March 2022 for records of randomised controlled blind clinical trials with a 24-week follow-up. World Health Organization-International Clinical Trial Registry Platform and ClinicalTrials.gov were used to revalidate the included trials and to search for completed but unpublished trials on 26 March 2022. We included four laser therapies for patients with peri-implantitis and bone defects, excluding single- or multi-arm clinical trials lacking laser-assisted MD. We extracted the general characteristics and associated outcomes from the included studies. The risk of bias was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions, and evidence certainty was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation framework (GRADE) and confidence in network meta-analysis (CINeMA).The primary outcomes of the pairwise meta-analysis were PPD, BOP, CAL, PLI, and RBF, whereas those of the network meta-analysis were PPD, SBI, CAL, PLI, and RBF; all estimated weighted mean differences were under a random effects model. The PROSPERO number for this study is CRD42022334800. A total of 18 studies with 901 participants were included. In the pairwise meta-analysis, MD with laser assistance performed better than MD alone for all outcomes. Among the outcomes, compared with MD alone, aPDT as an adjunct was significantly more effective in reducing BOP (weighted mean difference (WMD) = 8.20, 95% confidence interval (CI) range: 5.03–11.37), CAL (WMD = 0.44, 95% CI range: 0.40–0.48) and increasing RBF (WMD = 0.22, 95% CI range: 0.10–0.34), while diode laser as an adjunct (WMD = 0.28, 95% CI range: 0.08–0.47) was significantly more effective in PLI reduction. In network meta-analysis, aPDT as an adjunct was significantly more effective than MD alone in improving PPD (WMD = 0.67, 95% CI range: 0.44–0.87), CAL (WMD = 0.51, 95% CI range: 0.16–0.88) and RBF (WMD = 0.22, 95% CI range: 0.03–0.45). In terms of PPD reduction, both MD with adjuvant Er,Cr:YSGG and Er:YAG demonstrated significant advantages over adjuvant diode laser (WMD = 0.43, 95% CI range: 0.01–0.83 and WMD = 0.82, 95% CI range: 0.12–1.53, respectively) or MD alone (WMD = 0.69, 95% CI range: 0.44–0.9 and WMD = 1.09, 95% CI range: 0.49–1.68, respectively). The probability of optimal treatment from the Bayesian network meta-analysis exhibited that Er:YAG + MD (88.4%), Er:YAG + MD (76.6%), aPDT + MD (92.5%), and diode laser + MD (63.3%) ranked first in PPD, SBI, CAL, and PLI improvement in peri-implantitis, respectively. However, there was a contradiction between the Bayesian network meta-analysis (Er:YAG + MD: 45.9%) and frequentist network meta-analysis (aPDT + MD: 48.5%) for the best efficacy ranking probability of RBF. Of the 18 trials, the certainty of the evidence ranged from high to very low, with three (16.7%) rated as high risk of bias, 14 (77.8%) at moderate risk of bias, and one (0.6%) at low risk of bias. The current evidence suggests that laser-assisted MD is superior to MD alone in the treatment of peri-implantitis. Compared with other adjuvant laser therapies, Er:YAG and diode lasers were more effective in reducing inflammation, whereas aPDT could further achieve tissue regeneration for the treatment of peri-implantitis. [ABSTRACT FROM AUTHOR]

Online treatment delivery has the potential to increase access to evidence-based mental health care for children with anxiety disorders. Using a randomized controlled trial design, we evaluated the efficacy of Cool Kids Online, a family-based and therapist supported internet-delivered cognitive behavioral treatment (CBT) designed to target anxiety disorders in children. Ninety-five children aged 7–12 years with a DSM-5 anxiety disorder were randomly allocated to Cool Kids Online or a waitlist control. Children were assessed at baseline, week 11, and 6-months following treatment. Children in waitlist received treatment after week 11 and also completed assessments immediately and six months after treatment, allowing treatment maintenance to be evaluated for all children. Compared to waitlist, Cool Kids Online led to significantly greater remission of anxiety disorders (primary and all anxiety diagnoses) and greater reduction of caregiver-reported anxiety symptoms and interference at week 11. Child-reported anxiety symptoms and interference and child- and caregiver-reported depressive or externalizing symptoms did not differ significantly between conditions. Medium to large within-treatment effects were observed for all children from pre to post treatment with post treatment effects maintained until follow-up. Overall, the findings provide support for the efficacy of the program in treating anxiety. Cool Kids Online compared to waitlist for the remission of anxiety disorders in clinically anxious children; anzctr.org.au ; ACTRN12615000947505. • Online family-based cognitive behaviour therapy reduces child anxiety disorders. • Therapist support during online child anxiety programs may be important for change. • Cool Kids Online is a promising method to improve access to child anxiety treatment. [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]

Pair-matching in randomized controlled trials (RCTs) has received increased attention in criminology, the social sciences more generally, and medicine and public health, with a growing body of research demonstrating the design's benefits over "simple" RCTs. We carry out a review of matched-pair RCTs compared with simple RCTs to address a somewhat provocative yet fair question for evaluation research on crime and violence prevention interventions: Is it time for the use of pair-matching in all RCTs? At the heart of this question is the ability of the design to most efficiently and robustly compare like with like, thereby, improving confidence in observed effects of intervention trials. Several key findings emerge from the review. First, it is inadequate to examine or discuss RCTs as a single, uniform evaluation design. Here, the key organizing construct is the unit of allocation: individuals; groups of individuals (or clusters); and geographical places. Second, the advantages vastly outweigh the disadvantages for the use of matched-pair RCTs compared to simple RCTs, and most of the advantages hold for all three units of allocation. Third, pair-matching can be used with rather small samples (≥6 units) in cluster-based trials without compromising statistical power or degrees of freedom; less is known about individual- and place-based trials. Fourth, pair-matching cannot be used with some types of RCTs (e.g., cross-over) and is less amenable in other contexts (e.g., RCTs that enroll and randomize individuals on a rolling basis). Implications for evaluation research and public policy are discussed. • Pair-matching in RCTs has received increased attention in criminology and medicine. • Key organizing construct is unit of allocation: individuals; clusters; or geographical places. • Advantages vastly outweigh disadvantages for the use of matched-pair RCTs compared to simple RCTs. • Pair-matching can be used with small samples in cluster-based trials without compromising power. [ABSTRACT FROM AUTHOR]

Sleep disturbance is commonly reported among individuals meeting criteria for cannabis use disorder (CUD), and people who use cannabis frequently report sleep disturbance as a contributor to failed quit attempts. The purpose of this study was to measure sleep in individuals enrolled in treatment for CUD, and to determine whether use of hypnotic medication during treatment increased abstinence rates. The study enrolled 127 adults seeking treatment for CUD in a 12-week clinical trial and randomized to receive extended-release zolpidem (zolpidem-XR) or placebo. All participants received computerized behavioral therapy and abstinence-based contingency management. The study conducted in-home ambulatory polysomnography (PSG) assessments at baseline and during treatment to objectively measure sleep. Self-report measures of recent sleep, Insomnia Severity Index (ISI), and drug use (Timeline Follow-Back) were collected at each study visit, and the study confirmed self-reported abstinence via quantitative urine drug testing. Participants randomized to placebo, but not zolpidem-XR exhibited significant sleep disturbance during week 1 of treatment. Sleep disturbance emerged in the zolpidem-XR group after study medication was stopped at the end of treatment. Though participants assigned to the zolpidem-XR condition had qualitatively greater rates of abstinence compared with placebo (27 % versus 15 % negative at end of treatment), the difference was not statistically significant. Treatment retention was poor (about 50 % drop out in both groups) and medication adherence was a challenge without the use of contingent incentives. Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD. • Sleep disturbance is commonly reported among individuals with cannabis use disorder. • This RCT evaluated extended-release zolpidem for cannabis-related sleep disturbance. • Zolpidem-XR attenuated sleep disturbance but sleep problems re-emerged at EoT. • Zolpidem-XR resulted in non-significant improvement in cannabis abstinence relative to placebo. [ABSTRACT FROM AUTHOR]

To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. ClinicalTrials.gov identifier NCT05006872 ; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care. [ABSTRACT FROM AUTHOR]