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Adolescents with a visible difference to the face or body (e.g., due to a congenital condition, illness, or injury), may be at risk of elevated psychological distress. Young Person's Face IT (YPF), a web‐based psychosocial intervention, has displayed effectiveness, but no previous study has specifically evaluated its cost‐effectiveness. The aim of our study was to investigate whether YPF could be a cost‐effective alternative for psychosocial support to adolescents distressed by a visible difference, relative to care‐as‐usual (CAU). Within the context of a randomized controlled trial in Norway, 102 participants (43% boys) were allocated to intervention (n = 55) or waiting list control group (n = 47). Mean age was 13.9 years (SD = 1.71; range 11–18), and all self‐identified as experiencing distress related to a visible difference. Participants answered questionnaires including measures of health‐related quality of life and social anxiety at baseline and 3‐month follow‐up. A health economic evaluation using the method of cost‐utility analysis was performed, including quality‐adjusted life‐years (QALYs). Results indicated that the incremental cost‐effectiveness of YPF was 63,641 Norwegian kroner per QALYs gained, which is well within the acceptability threshold in the Norwegian healthcare sector. Hence, YPF could potentially be considered a cost‐effective intervention for adolescents experiencing distress related to a visible difference, but more research is needed that includes comparisons of YPF to other health‐ and societal resources and long‐term follow‐ups. Our study also constitutes an addition to research as, compared to interventions for somatic diseases, there is a lack of studies exploring the cost‐effectiveness of psychological interventions. [ABSTRACT FROM AUTHOR]

Objectives: Assess (a) the variability of behaviour problems in children with Hyperkinetic Disorder/Attention‐DeficitHyperactivity Disorder (HKD/ADHD) across a range of family situations and (b) the degree to which behaviour in each situation can be modified through a cognitive behavioural parent training (CBPT). Furthermore (c), compare the effectiveness of training in two different formats and (d) test the proposition that group treatment benefits behaviour in a wider range of situations than individual treatment. Method: A registered multicentre randomized controlled trial comparing individual and group parent training to treatment‐as‐usual (TAU) for N = 237 children with HKD/ADHD. A German version of the Home Situations Questionnaire (HSQ) was employed to examine behaviour problems across a range of family situations, treatment‐related changes post‐treatment and at 6‐month follow‐up, while controlling for medication status. Results: Parents reported considerable variance in severity of behaviour problems across situations. All groups improved with time, but individual and group CBPT led to significantly greater improvement than TAU in many family situations. Results present situation‐specific treatment trajectories and demonstrate somewhat greater impact of individual compared with group training in certain situations post‐training and 6 months later. Conclusions: CBPT clearly adds to TAU (with effect sizes in the small to moderate range depending on situation). Individual was somewhat more successful than group format (which did not succeed in a wider range of situations). HSQ situations reveal a differentiated picture of child behaviour and treatment results. Situation‐specific assessment with an instrument like the HSQ offers promising perspectives that invite further development. [ABSTRACT FROM AUTHOR]

Background: Pruritus is identified as an adverse drug reaction to arsenic trioxide, but the association of arsenic exposure with pruritus has not been investigated. Methods: A cross‐sectional study was conducted in Shimen, China. A Mendelian randomization analysis was conducted to confirm the causal relationship between genetically predicted percentages of monomethylated arsenic (MMA%) and dimethylated arsenic (DMA%) in urine with chronic pruritus in UK Biobank. A case–control study was then conducted to determine the biomarker for pruritus. Arsenite‐treated mice were used to confirm the biomarker, and von Frey test was used to induce scratching bouts. Last, a randomized, double‐blind, placebo‐controlled trial was conducted to test the efficacy of naloxone in arsenic‐exposed patients with pruritus in Shimen. Results: Hair arsenic (μg/g) showed a dose–response relationship with the intensity of itch in 1079 participants, with odds ratios (OR) of 1.11 for moderate‐to‐severe itch (p = 0.012). The Mendelian randomization analysis confirmed the causal relationship, with ORs of 1.043 for MMA% (p = 0.029) and 0.904 for DMA% (p = 0.077) above versus under median. Serum β‐endorphin was identified as a significant biomarker for the intensity of itch (p < 0.001). Consistently, treatment with arsenite upregulated the level of β‐endorphin (p = 0.002) and induced scratching bouts (p < 0.001) in mice. The randomized controlled trial in 126 participants showed that treatment with sublingual naloxone significantly relieved the intensity of itch in arsenic‐exposed participants in 2 weeks (β = −0.98, p = 0.04). Conclusion: Arsenic exposure is associated with pruritus, and β‐endorphin serves as a biomarker of pruritus. Naloxone relieves pruritus in patients with arseniasis. [ABSTRACT FROM AUTHOR]

Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID‐19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study. RIA assesses six study criteria: study retraction, prospective trial registration, adequate ethics approval, author group, plausibility of methods (e.g., randomization), and plausibility of study results. RIA was used in the Cochrane review as part of the eligibility check during screening of potentially eligible studies. Problematic studies were excluded and studies with open questions were held in awaiting classification until clarified. RIA decisions were made independently by two authors and reported transparently. Using the RIA tool resulted in the exclusion of >40% of studies in the first update of the review. RIA is a complementary tool prior to assessing "Risk of Bias" aiming to establish the integrity and authenticity of studies. RIA provides a platform for urgent development of a standard approach to identifying and managing problematic studies. [ABSTRACT FROM AUTHOR]

Ionic liquids (ILs) loading ketoconazole (KCZ) have shown better efficacy on rats with tinea pedis than the marketed Daktarin® but clinical studies are still lacking. In this study, we described the clinical translation of ILs containing KCZ (KCZ‐ILs) from the lab into the clinic and evaluated the efficacy and safety of KCZ‐ILs in patients with tinea pedis. Thirty‐six enrolled participants were randomized to receive either KCZ‐ILs (KCZ, 4.72 mg/g) or Daktarin® (control group; KCZ, 20 mg/g) topically twice daily, making the lesion be covered with a thin layer of medication. The randomized controlled trial lasted for 8 weeks including 4 weeks of intervention and 4 weeks of follow‐up. Primary efficacy outcome was the proportion of treatment success responders, defined as patients achieving negative mycological result and ≥60% relative reduction in total clinical symptom score (TSS) from baseline at week 4. Secondary outcomes mainly for evaluating the relapse of disease included the proportion of treatment success individuals at week 8 and fungal recurrence rate at weeks 2, 3, 4, and 8. After 4 weeks of medication, 47.06% of the KCZ‐ILs subjects were treatment successes compared with only 25.00% of those using Daktarin®. Throughout the trial period, KCZ‐ILs induced a significantly lower recurrence rate (52.94%) than that of control patients (68.75%). Furthermore, KCZ‐ILs were found to be safe and well‐tolerated. In conclusion, ILs loading only 1/4 KCZ dose of Daktarin® showed a better efficacy and safety profile in the management of tinea pedis, creating a new opportunity for the treatment of skin diseases caused by fungal infection and is worthy of clinical application. [ABSTRACT FROM AUTHOR]

This study aimed to compare the effectiveness of the Integrative Brief Systemic Intervention (IBSI), combining therapeutic work on marital and coparenting relationships with brief systemic therapy (BST‐as‐usual) for parent couples. Couples were randomly assigned to the IBSI (n = 51) or BST (n = 50). Both treatments were six‐session interventions and lasted about 6 months. Questionnaires on individual, marital, coparenting and family‐related functioning were completed before and after therapy, and at 6‐month follow‐up. A significant improvement in all areas of functioning was observed after treatment and maintained at follow‐up for both IBSI and BST‐as‐usual treatments. No significant differences in outcomes were found between the treatments. Additionally, women reported more distress overall than men, and this distress was reduced more significantly after therapy. Last, BST‐as‐usual couples requested more additional sessions compared to IBSI couples. This study extends the literature on couple therapy with parents. [ABSTRACT FROM AUTHOR]

Introduction: Suicide is a serious public health concern worldwide. Current psychological interventions targeting suicidal ideation and behavior are, however, limited and often lack convincing empirical support. Future‐Oriented Group Training (FOGT) targets crucial aspects of the suicidal process, thus possibly offering a promising intervention for suicidal ideation. This study aimed at investigating the short‐term and long‐term effects of FOGT on suicidal thoughts and related variables. Methods: A randomized controlled trial was conducted, comparing the intervention group (FOGT + treatment as usual (TAU)) to a control group (TAU) at pre and posttreatment and at a 12‐week follow‐up. Suicidal ideation was the primary outcome, while depressive symptoms, hopelessness, defeat, entrapment, worrying, and the ability for future‐oriented thinking were secondary outcomes. Results: When compared to the control group, the intervention group showed significant decreases in worrying at posttreatment and significant increases in future‐oriented thinking at follow‐up. Pre‐post analyses within the intervention group showed significant small‐to‐medium effects for primary as well as most secondary outcomes. Changes in suicidal ideation, depression, hopelessness, and future‐oriented thinking remained significant at follow‐up. Conclusion: This study provides promising empirical evidence for the use of FOGT for individuals with suicidal ideation. [ABSTRACT FROM AUTHOR]

Background: Studies have shown that blue mussel lipid extract (BMLE) has strong anti‐inflammatory activity in both rheumatoid arthritis patients and animal arthritis models. Chronic inflammation was closely related to type 2 diabetes mellitus (T2DM). Though the beneficial effects cannot be completely attributed to n−3 polyunsaturated fatty acids, the aim of this study was to investigate whether BMLE can improve glycemic traits of T2DM patients. Method: In a double‐blind randomized controlled trial, 133 Chinese T2DM participants were randomized to either fish oil (FO, n = 44), BMLE (n = 44), or corn oil (CO, n = 45) groups for 60 days. The participants were asked to take the corresponding oil capsules (two capsules per day, 0.8 g per capsule), which provided 1.6 g day−1 of FO (29.9% eicosapentaenoic acid + 20.4% docosahexaenoic acid), BMLE (20.7% eicosapentaenoic acid + 26.7% docosahexaenoic acid), or CO (53.5% linoleic acid). Results: The fasting serum concentration of insulin (P = 0.005) and the homeostasis model of insulin resistance (P = 0.026) were significantly decreased in the BMLE group, whereas no significant change was found in the FO or CO groups. There was no significant difference between groups on serum glycosylated hemoglobin. Tumor necrosis factor‐α was significantly decreased in the BMLE group (P = 0.003), but not in the FO or CO groups. A significant decrease of interleukin‐1β was observed in the BMLE and CO groups (P = 0.004 and P = 0.011 respectively), but not in the FO group. The total cholesterol was significantly decreased in the BMLE and CO groups (P < 0.001 and P < 0.001 respectively), but not in the FO group. Triacylglycerol was significantly decreased in the BMLE group (P = 0.007), but not in the FO or CO groups. High‐density lipoprotein cholesterol was significantly lower in the BMLE and CO groups than in the FO group (P = 0.003). Conclusion: Blue mussel lipid supplements improved glycemic traits, inflammatory cytokines, and lipids profile in Chinese T2DM patients (Chinese Clinical Trial Registration number: ChiCTR1900025617). © 2022 Society of Chemical Industry. [ABSTRACT FROM AUTHOR]

Background: Polycaprolactone (PCL) is a synthetic aliphatic polyester widely used in biomedical applications with biodegradability in the body and promotes cell proliferation and differentiation. A newly developed bilayered PCL membrane was developed for possibly being used as a membrane in guided bone regeneration (GBR). Purpose: To compare the clinical efficacy between a newly developed bilayered PCL membrane with a Cytoplast™ RTM collagen membrane for GBR with simultaneous implant placement. Materials and Methods: Twenty‐four patients were randomized to PCL or RTM group, and a total of 24 dental implants were placed. Primary outcomes were patient mean buccal bone thickness (BBT) immediately postimplantation and at 6 months using cone‐beam CT and soft tissue surface dimensional changes (STC) at crown insertion, 6 months, and 1 year after loading using intraoral scanner. Secondary outcomes included success rate, clinical parameters, healing index, implant stability, pink esthetic score, and marginal bone levels. Results: The percentage of reduced BBT at 6 months was 32.38%, 25.94%, and 23.96% in the test group and 34.42%, 14.75%, and 6.34% in the control group at the corresponding levels. The mean difference of changed BBT associated with PCL membrane, when compared to collagen membrane, at 6 months was −0.02 ± 0.18 mm (95% confidence interval [CI]: −0.40 to 0.35), 0.29 ± 0.28 mm (95% CI: −0.29 to 0.87), and 0.62 ± 0.38 mm (95% CI: −0.17 to 1.42) at 0, 2, and 4 mm from implant shoulder. Minimal loss of STC was observed in both groups up to 1 year of loading. The mean difference loss of surface dimensional change associated with PCL membrane, when compared to collagen membrane, at 1 year of loading was 0.31 ± 0.19 mm (95% CI: −0.07 to 0.70), 0.22 ± 0.26 mm (95% CI: −0.33 to 0.76), and 0.17 ± 0.30 mm (95% CI: −0.45 to 0.78) at 0, 2, and 4 mm from implant shoulder. None of these differences were statistically significant (unpaired t‐test, degrees of freedom [df] = 22; p > 0.05). Conclusion: Within the limits of this trial, both barrier membranes resulted in comparable outcomes for GBR with implant placement after 1 year in function. Further research is necessary with a larger sample size. [ABSTRACT FROM AUTHOR]

Rationale: Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives: The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design. Methods: Using the Pragmatic Explanatory Continuum Indicator Summary‐2 (PRECIS‐2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI). Interrater reliability was assessed by weighted κ‐coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results: We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p < 0.001). Higher sample sizes were correlated to a pragmatic design (odds ratio: 6.86, 95% CI: 1.64, 28.75; p = 0.04). Conclusion: Most RCT protocols were rated as intermediate in the pragmatic‐explanatory continuum. Future research may guide all stakeholders on how best to incorporate the level of pragmatism in the interpretation of the results so that the trials are more likely to be applicable in real‐world settings. [ABSTRACT FROM AUTHOR]

In a randomized controlled trial (RCT), it is possible to improve precision and power and reduce sample size by appropriately adjusting for baseline covariates. There are multiple statistical methods to adjust for prognostic baseline covariates, such as an ANCOVA method. In this paper, we propose a clustering‐based stratification method for adjusting for the prognostic baseline covariates. Clusters (strata) are formed only based on prognostic baseline covariates, not outcome data nor treatment assignment. Therefore, the clustering procedure can be completed prior to the availability of outcome data. The treatment effect is estimated in each cluster, and the overall treatment effect is derived by combining all cluster‐specific treatment effect estimates. The proposed implementation of the procedure is described. Simulations studies and an example are presented. [ABSTRACT FROM AUTHOR]

Objectives: The EndoRings device is a distal attachment consisting of two layers of circular flexible rings that evert mucosal folds. The aim of this study was to investigate whether EndoRing assisted colonoscopy (ER) improves polyp and adenoma detection compared to standard colonoscopy (SC). Methods: Multicenter, parallel group, randomized controlled trial. Results: Total of 556 patients randomized to ER (n = 275) or SC (n = 281). Colonoscopy completed in 532/556 (96%) cases. EndoRings removed in 74/275 (27%) patients. Total number of polyps in ER limb 582 vs. 515 in SC limb, P = 0.04. Total number of adenomas in ER limb 361 vs. 343 for SC limb, P = 0.49. A statistically significant difference in the mean number of polyps per patient in both the intention to treat (1.84 SC vs. 2.10 ER, P = 0.027) and per protocol (PP) (1.84 SC vs. 2.25 ER, P = 0.004). Conclusions: Our study shows promise for the EndoRings device to improve polyp detection. [ABSTRACT FROM AUTHOR]

A nonblinded randomized trial was conducted at two Canadian provincial outpatient addiction clinics that tested the effectiveness of a systemic congruence couple therapy (CCT) versus individual‐based treatment‐as‐usual (TAU) on nine clinical outcomes: (1) primary outcomes—alcohol use and gambling, psychiatric symptoms, and couple adjustment; (2) secondary outcomes—emotion regulation, substance use, depression, post‐traumatic stress symptoms, and life stress. Data of primary clients and partners (N = 46) were analyzed longitudinally across baseline, posttreatment (5 months), and follow‐up (8 months). Alcohol use disorder (95%) and gambling disorder (5%) were in the severe range at baseline, and co‐addiction was 27%. Psychiatric comorbidity was 100%, and 18% of couples were jointly addicted. Between‐group comparison favored CCT in primary outcomes with medium‐to‐large effect sizes (Cohen's h = 0.74–1.44). Secondary outcomes were also significantly stronger for CCT (Cohen's h = 0.27–1.53). Within‐group, for all primary outcomes, a significant proportion of symptomatic CCT clients and partners improved, converging with ANOVA results of large effect sizes (0.14–0.29). All secondary outcomes improved significantly in CCT with large effect sizes (0.14–0.50). TAU showed significant within‐group improvement in alcohol use, other substance use, and life stress with large effect sizes (0.16–0.40). Primary clients and partners made largely equivalent improvement within CCT and within TAU. Results were triangulated with clients' satisfaction ratings and counselors' reports. Overall, significant within‐group effects were detected for CCT both clinically and statistically and between‐group difference favored CCT. Future trials are required to validate these promising findings. [ABSTRACT FROM AUTHOR]

Objective: Platelet‐rich plasma（PRP), with different concentration of leukocytes, may lead to varying effects in the treatment of cartilage lesions. So far, current research has not shown enough evidence on this. To evaluate the clinical efficacy and safety of intra‐articular injection with pure platelet‐rich plasma (P‐PRP) versus those of leukocyte platelet‐rich plasma (L‐PRP) in treating knee cartilage lesions, we conducted a double‐blind, randomized controlled clinical trial with a larger sample and longer follow‐up period. Methods: From October 2019 to October 2020, 95 patients were invited to participate in our study, and 60 (63.2%) were randomized to P‐PRP (n = 30) or L‐PRP (n = 30) groups. Patients from the two groups were treated with knee intra‐articular injections of P‐PRP or L‐PRP. Visual analog scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were assessed using an unpaired t‐test for independent samples preoperatively and at 6 weeks, 12 weeks, 6 months, and 12 months after intervention. Results: We followed up 27 cases in the P‐PRP group and 26 cases in the L‐PRP group. No significant differences in VAS and WOMAC scores were found between the two groups before the intervention (p > 0.05). The WOMAC Pain and VAS‐Motions scores of the P‐PRP group were significantly lower than those of the L‐PRP group at 6 weeks after the intervention (p < 0.05). While the long‐term clinical efficacy of both injections was similar and weakened after 12 months, more adverse events were found in the L‐PRP group. Conclusions: The short‐term results demonstrate a positive effect in reducing pain and improving function in patients with knee cartilage lesions in the two groups. While the P‐PRP injection showed better clinical efficacy in the early phase of postoperative rehabilitation and resulted in fewer adverse events, long‐term follow‐up showed similar and weakened efficacy after 12 months. Trial Registration: ChiCTR1900026365. Registered on October 3, 2019, http://www.chictr.org.cn/showproj.aspx?proj=43911. [ABSTRACT FROM AUTHOR]

Background: Excessive noradrenergic signaling contributes to aversive symptoms of alcohol withdrawal that interfere with abstinence or reductions in harmful use. Methods: To address this aspect of alcohol use disorder, 102 active‐duty soldiers participating in command‐mandated Army outpatient alcohol treatment were randomized to also receive the brain‐penetrant alpha‐1 adrenergic receptor antagonist prazosin or placebo for 13 weeks. Primary outcomes were scores on the Penn Alcohol Craving Scale (PACS), standard drink units (SDUs) per day averaged over each week, % days of any drinking per week, and % days of heavy drinking per week. Results: PACS declines did not differ significantly between the prazosin and placebo groups in the overall sample. In the subgroup with comorbid PTSD (n = 48), PACS declines were significantly greater in the prazosin than in the placebo condition (p < 0.05). Baseline alcohol consumption was markedly reduced by the pre‐randomization outpatient alcohol treatment program, but the addition of prazosin treatment produced a greater slope of decline in SDUs per day compared to placebo (p = 0.01). Preplanned subgroup analyses were performed in soldiers with elevated baseline cardiovascular measures consistent with increased noradrenergic signaling. In soldiers with elevated standing heart rate (n = 15), prazosin reduced SDUs per day (p = 0.01), % days drinking (p = 0.03), and % days heavy drinking (p = 0.001) relative to placebo. In soldiers with elevated standing systolic blood pressure (n = 27), prazosin reduced SDUs per day (p = 0.04) and tended to reduce % days drinking (p = 0.056). Prazosin also reduced depressive symptoms and the incidence of emergent depressed mood more than placebo (p = 0.05 and p = 0.01, respectively). During the final 4 weeks of prazosin vs. placebo treatment that followed completion of Army outpatient AUD treatment, alcohol consumption in soldiers with elevated baseline cardiovascular measures increased in those receiving placebo but remained suppressed in those receiving prazosin. Conclusions: These results extend reports that higher pretreatment cardiovascular measures predict beneficial effects of prazosin, which may be useful for relapse prevention in patients with AUD. [ABSTRACT FROM AUTHOR]

Both forward and backward working memory span tasks have been used in cognitive training, but no study has been conducted to test whether the two types of trainings are equally effective. Based on data from a randomized controlled trial, this study (N = 60 healthy college students) tested the effects of backward span training, forward span training, and no intervention. Event‐related potential (ERP) signals were recorded at the pre‐, mid‐, and post‐tests while the subjects were performing a distractor version of the change detection task, which included three conditions (2 targets and 0 distractor [2T0D]; 4 targets and 0 distractor [4T0D]; and 2 targets and 2 distractors [2T2D]). Behavioral data were collected from two additional tasks: a multi‐object version of the change detection task, and a suppress task. Compared to no intervention, both forward and backward span trainings led to significantly greater improvement in working memory maintenance, based on indices from both behavioral (Kmax) and ERP data (CDA_2T0D and CDA_4T0D). Backward span training also improved interference control based on the ERP data (CDA_filtering efficiency) to a greater extent than did forward span training and no intervention, but the three groups did not differ in terms of behavioral indices of interference control. These results have potential implications for optimizing the current cognitive training on working memory. Both forward and backward memory span tasks have been used in cognitive training programs, but no study has explored whether their effects are the same. The current study found that both types of training may improve maintenance processes and that backward span training may also improve interference control, which suggests that adding more backward span training to the current available programs would make them more effective. [ABSTRACT FROM AUTHOR]

Aim: Radio‐Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID‐19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home‐based Radio‐Taiso. Methods: This assessor‐blind parallel randomized controlled trial included community‐dwelling Jolder Japanese adults with frailty and pre‐frailty. Fifty‐eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3–5‐min sessions of Radio‐Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health‐related quality of life (HR‐QoL), assessed using the modified short physical performance battery (SPPB) and the SF‐36, respectively. Results: Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention‐to‐treat analysis, there was no clinically significant difference in the change in SPPB score between groups (−0.4 points, 95% confidence interval [CI], −1.2, 0.3); however, the intervention group scored higher in the mental component of HR‐QoL than did the control group (3.4 points, 95% CI: −1.1, 7.8). Conclusions: The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR‐QoL as the primary outcome. Geriatr Gerontol Int 2023; 23: 32–37. [ABSTRACT FROM AUTHOR]

Summary: Background: Metformin for women with overweight or obesity during pregnancy has been evaluated in randomized trials to reduce adverse pregnancy and birth outcomes. The effect on longer‐term child health remains of interest. Objectives: To evaluate the effect of in‐utero exposure to metformin on child health compared with no exposure. Methods: We assessed children born to 513 women who participated in the Metformin in addition to dietary and lifestyle advice for pregnant women with overweight or obesity: the GRoW randomized trial, where women were randomized to receive either metformin or placebo during pregnancy. Child weight, height, anthropometry, diet, physical activity and neurodevelopment were assessed at six and 18 months and three to five years of age. The main outcome was BMI z‐score > 85th centile for age and sex. Results: The number of children with BMI >85th centile was similar between treatment groups at all time points. At 18 months and three to five years of age, more than half of the children had a BMI z‐score > 85th centile, indicating a high risk of childhood obesity. Conclusions: We did not show evidence of the benefit of metformin for children of women with overweight or obesity during pregnancy adding to the growing literature on the lack of effect of pregnancy interventions in reducing longer‐term risks of childhood obesity. [ABSTRACT FROM AUTHOR]

Aim: To assess the effect of periodontal treatment on HbA1c and diagnostic parameters of patients with metabolic syndrome (MetS). Materials and Methods: One hundred and fifty‐eight patients with MetS and moderate and severe periodontitis were included. They were randomized into a test group (n = 79), which received non‐surgical periodontal treatment, and a control group (n = 79), which received no treatment. Medical treatment was delivered to both groups. Clinical periodontal, anthropometric and serological parameters were assessed at baseline, 3 and 6 months. The main outcome was glycated haemoglobin (HbA1c) levels, and the secondary outcomes were changes in the MetS parameters, C‐reactive protein (CRP) and HOMA indexes. Results: Significant reductions in all periodontal parameters were observed in the test group, compared with the control group, at 3 and 6 months (p <.001). HbA1c levels, MetS parameters, CRP and HOMA indexes showed no significant differences between the test group and the control group at 3 and 6 months. Conclusions: Periodontal treatment led to a substantial reduction in periodontal inflammation, although there was no significant effect on the parameters used for MetS diagnosis in patients with early diagnosed and well‐controlled MetS. [ABSTRACT FROM AUTHOR]

In the infant mental health field, scant conceptual attention has been given to coparenting and family adaptations of non‐white family systems, with no evidence‐based, community‐informed coparenting interventions responsive to unmarried Black mothers' and fathers' life circumstances. This study examined 1‐year post‐partum child and family outcomes of a novel, modest dosage (six sessions) prenatal focused coparenting consultation (FCC) using randomized controlled trial methodology. One‐hundred‐thirty‐eight expectant families (one or both parents identified as Black/African American) were randomized to an intervention (N = 70) or treatment‐as‐usual (TAU; control) condition (N = 68). TAU families received navigational support in accessing existing community services for pregnant families. Intervention families received TAU plus 6 dyadic FCC sessions led by a Black male‐female Community Mentor team. When infants were three and 12 months old, parents reported on coparenting, father engagement, interparental aggression, depressive symptoms, and infant social and emotional adjustment. Intent‐to‐treat analyses focusing on 12‐month post‐partum data indicated significant intervention effects on coparenting, interparental psychological aggression, and infants' emotional adjustment. Improvement was also seen in depression and father engagement, with gains for both groups. Results suggest FCC delivered by same‐race Community Mentors to unmarried Black coparents transitioning to parenthood supports infant and family adaptation during the first year of life. [ABSTRACT FROM AUTHOR]

Background: 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non‐inferiority of OST compared to multi‐session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi‐center, non‐inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university‐based CYP well‐being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non‐inferiority and a nested cost‐effectiveness evaluation was assessed 6‐months post‐randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal‐based outcome measure, and EQ‐5DY and CHU‐9D, collected blind at baseline and six‐months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention‐to‐treat (ITT) and per‐protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale‐adjusted mean difference for CBT compared to OST ‐0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non‐inferiority limit of 0.4, suggesting that OST is non‐inferior to CBT. No between‐group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost‐saving alternative. [ABSTRACT FROM AUTHOR]

Image‐guided repetitive transcranial magnetic stimulation (rTMS) has shown clinical effectiveness in senior adults with co‐occurring depression and cognitive impairment, yet the imaging markers for predicting the treatment response are less investigated. In this clinical trial, we examined the efficacy and sustainability of 10 Hz rTMS for the treatment of depression and cognitive impairment in major neurocognitive disorder (NCD) patients and tested the predictive values of imaging‐informed radiomic features in response to rTMS treatment. Fifty‐five major NCD patients with depression were randomly assigned to receive a 3‐week rTMS treatment of either active 10 Hz rTMS (n = 27) or sham rTMS (n = 28). Left dorsolateral prefrontal cortex (DLPFC) was the predefined treatment target. Based on individual structural magnetic resonance imaging scans, surface‐based analysis was conducted to quantitatively measure the baseline radiomic features of left DLPFC. Severity of depression, global cognition and the serum brain‐derived neurotrophic factor (BDNF) level were evaluated at baseline, 3‐, 6‐ and 12‐week follow‐ups. Logistic regression analysis revealed that advanced age, higher baseline cognition and randomized group were associated with the remission of depression. Increased cortical thickness and gyrification in left DLPFC were the significant predictors of clinical remission and cognitive enhancement. A 3‐week course of 10 Hz rTMS is an effective adjuvant treatment for rapid ameliorating depressive symptoms and enhancing cognitive function. Pre‐treatment radiomic features of the stimulation target can predict the response to rTMS treatment in major NCD. Cortical thickness and folding of treatment target may serve as imaging markers to detect the responders. ChiCTR‐IOR‐16008191, registered on March 30, 2016. [ABSTRACT FROM AUTHOR]

Objective: To introduce a novel analytical approach for randomized controlled trials that are underpowered because of low participant enrollment or engagement.Data Sources: Reanalysis of data for 805 patients randomized as part of a pilot complex care intervention in 2015-2016 in a large delivery system. In the pilot randomized trial, only 64.6% of patients assigned to the intervention group participated.Study Design: A case study and simulation. The "Distillation Method" capitalizes on the frequently observed correlation between the probability of subjects' participation or engagement in the intervention and the magnitude of benefit they experience. The novel method involves three stages: first, it uses baseline covariates to generate predicted probabilities of participation. Next, these are used to produce nested subsamples of the randomized intervention and control groups that are more concentrated with subjects who were likely to participate/engage. Finally, for the outcomes of interest, standard statistical methods are used to re-evaluate intervention effectiveness in these concentrated subsets.Data Extraction Methods: We assembled secondary data on patients who were randomized to the pilot intervention for one year prior to randomization and two follow-up years. Data included program enrollment status, membership data, demographics, utilization, costs, and clinical data.Principal Findings: Using baseline covariates only, Generalized Boosted Regression Models predicting program enrollment performed well (AUC 0.884). We then distilled the full randomized sample to increasing levels of concentration and reanalyzed program outcomes. We found statistically significant differences in outpatient utilization and emergency department utilization (both follow-up years), and in total costs (follow-up year two only) at select levels of population concentration.Conclusions: By offering an internally valid analytic framework, the Distillation Method can increase the power to detect effects by redefining the estimand to subpopulations with higher enrollment probabilities and stronger average treatment effects while maintaining the original randomization. [ABSTRACT FROM AUTHOR]

Background: To assess the effectiveness and safety of laryngeal mask anesthesia (LMA) in thoracoscopic pulmonary wedge resection based on patient‐reported outcomes (PROs). Methods: This randomized controlled trial included 107 patients who underwent thoracoscopic pulmonary wedge resection between June 2017 and December 2021 for pulmonary nodule or pulmonary bullae. In one group, LMA was applied for general anesthesia, and in the other group, endotracheal intubation (ETT) was used. Results: A total of 107 patients were included in the study. The symptom assessment based on PROs showed that the incidence of pharyngodynia, trachyphonia, and cough were lower in the LMA group, while the postoperative gastrointestinal reaction did not significantly differ between the two groups. The pain score and global satisfaction score were significantly better in the LMA group. The satisfaction degree of anesthesia and the surgical field did not significantly differ between the two groups. The anesthesia recovery time, indwelling days of chest catheter, and postoperative hospital stay of the LMA group were all shorter, while the operation time, intraoperative blood loss and lowest intraoperative oxygen saturation did not significantly differ between the two groups. The highest intraoperative partial pressure of CO2 was significantly higher in the LMA group. The artery blood gas analysis after the operation did not significantly differ between the two groups. Conclusion: Compared with ETT, the application of LMA may demonstrate promising advantages in airway management for thoracoscopic pulmonary wedge resection. Registration No. of clinical trial (ChiCTR2000034905). [ABSTRACT FROM AUTHOR]

In biomedicine, randomized controlled trials are regarded as the gold standard of evidence owing to their ability to minimize confounding factors that may influence results. Randomized trials that are properly designed serve as a basis for drug regulation and national guideline development. Despite the many advantages of the study design, there are several misconceptions regarding randomized trials, particularly in oncology. These misconceptions include: the difficulty of designing and conducting a trial, the length of time necessary to complete a trial, the expense, appraisal and critique, pharmaceutical industry influence, and ethical standards. Furthermore, developing regulatory and strategic frameworks has the potential to enhance the randomized trial landscape. Such initiatives will focus on relevant clinical issues that persist in oncology, reducing duplicative and unethical trials and maximizing value‐based healthcare. Here, we address several misconceptions regarding randomized controlled trials and provide potential solutions to enhance their methodology and implementation. [ABSTRACT FROM AUTHOR]

Background: Oppositional Defiant Disorders (ODDs) and other Disruptive Behavior Disorders (DBDs) are common among children and adolescents in poverty‐impacted communities in sub‐Saharan Africa. Without early intervention, its progression into adulthood can result in dire consequences. We examined the impact of a manualized family strengthening intervention called Amaka Amasanyufu designed to reduce ODDs and other DBDs among school‐going children residing in low‐resource communities in Uganda. Methods: We used longitudinal data from the SMART Africa‐Uganda study (2016–2022). Public primary schools were randomized to: (1) Control condition (receiving usual care comprising generalized psychosocial functioning literature), 10 schools; (2) intervention delivered via parent peers (Amaka‐parents), 8 schools or; (3) intervention delivered via community healthcare workers (Amaka‐community), 8 schools. All the participants were blinded. At baseline, 8‐ and 16‐weeks postintervention initiation, caregivers completed the Iowa Conners Scale, which measured Oppositional Defiant Disorder (ODD) and Impairment Rating Scale to evaluate children's overall impairment and impaired functioning with peers, siblings, and parents; impaired academic progress, self‐esteem, and family functioning. Three‐level linear mixed‐effects models were fitted to each outcome. Pairwise comparisons of postbaseline group means within each time point were performed using Sidak's adjustment for multiple comparisons. Only children positive for ODD and other DBDs were analyzed. Results: Six hundred and thirty‐six children screened positive for ODDs and other DBDs (Controls: n = 243; Amaka‐parents: n = 194; Amaka‐community: n = 199). At 8 weeks, Amaka‐parents' children had significantly lower mean scores for overall impairment compared to controls, (mean difference: −0.71, p =.001), while Amaka‐community children performed better on ODD (mean difference: −0.84, p =.016). At 16 weeks, children in both groups were performing better on ODD and IRS than controls, and there were no significant differences between the two intervention groups. Conclusions: The Amaka Amasanyufu intervention was efficacious in reducing ODD and impaired functioning relative to usual care. Hence, the Amaka Amasanyufu intervention delivered either by Amaka‐community or Amaka‐parents has the potential to reduce negative behavioral health outcomes among young people in resource‐limited settings and improve family functioning. Trial registration: ClinicalTrials.gov, ID: NCT03081195. Registered on 16 March 2017. [ABSTRACT FROM AUTHOR]

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

Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

Conflicting evidence exists regarding the effectiveness of magnesium supplementation during pregnancy in gestational diabetes mellitus (GDM) patients. This meta‐analysis examines the effect of magnesium on glycemic indices and metabolic status in GDM. We searched databases for randomized controlled trials (RCTs) conducted, and after applying inclusion and exclusion criteria, a total of four RCTs were considered eligible for the analysis. Outcome parameters included markers for glycemic control and metabolic status. A total of four RCTs with 198 participants (control = 99; magnesium supplemented = 99) were selected for the analysis. Magnesium supplementation resulted in a significant reduction in markers of glycemic control—fasting plasma glucose (standard mean difference (μ^) = −0.83; 95% CI: [−1.13, –0.54]; p‐value <.0001), and insulin levels (μ^ = −0.95; 95% CI: [−1.38, −0.52]; p‐value <.0001). Also, Mg intake resulted in altered oxidative stress markers TAC (μ^ = 1.09; 95% CI: [0.10, 2.07]; p‐value =.03) of the pregnant women. No significant effect on GSH and CRP levels was observed. This study provides evidence of the positive effects of magnesium intervention on insulin sensitivity and oxidative stress in GDM patients. [ABSTRACT FROM AUTHOR]

Purpose This study was conducted to systematically examine the effect of decision support systems (DSSs) applied to patients with cancer on pain severity. Review methods: Systematic review and meta‐analysis. A search was done on Web of Science, Science Direct, PubMed, ProQuest, EBSCOhost/CINAHL Complete, Scopus, Springer Link, Cochrane Library, and Ovid databases, which covered a period until September 2021. Meta‐analysis of the data was conducted on the CMA 3 software package. Comprehensive reviews were conducted by two independent researchers in line with the PICOS criteria. The study was conducted according to the PRISMA checklist. Findings Five randomized controlled trials with 1.880 participants were included in this systematic review and meta‐analysis. In the study, visits, consultations, simulation of patient outcomes, telephone support, and email applications were employed for periods ranging from 6 weeks to 6 months. The evaluation of the meta‐analysis results indicated that DSSs had positive effects on pain severity in patients with cancer (Hedge's g = 0.22; p < 0.001). Conclusion: The findings of this systematic review and meta‐analysis show that DSSs can be used as an effective and comfortable technological application in reducing the severity of pain in patients with cancer. Clinical relevance: The use of DSSs for pain severity in patients with cancer is an effective method. In line with the findings of this systematic review and meta‐analysis, awareness and knowledge levels of all health disciplines about DSSs will increase. It is believed that the use of DSSs to improve patient‐centered care will be guiding. [ABSTRACT FROM AUTHOR]

The field of relationship science has called for more research on the impact of relationship education on child outcomes, yet studies in this area remain sparse, particularly regarding maternal and infant health at birth. Research on group prenatal care demonstrates that individual‐oriented group interventions have a positive impact on infant birth outcomes, suggesting the need to consider the impacts of other forms of group programming for women. The current study examined the impact of MotherWise, an individual‐oriented relationship education and brief case management/coaching program for minority and low‐income pregnant women, on birth outcomes. The study sample included 136 women who enrolled in a larger randomized controlled trial of MotherWise during early pregnancy. Although statistical power was limited due to the sample size and the effects were not outright significant at p < 0.05, results indicated that the effects of MotherWise on birth outcomes were small to moderate in size (0.23 for birthweight, 0.46 for preterm birth) and suggest important avenues for future tests of relationship education programs and their impacts on maternal and infant health. The current study suggests that relationship education during pregnancy could directly impact women's and infant's health. [ABSTRACT FROM AUTHOR]

The objective of this study was to examine differences in parenting, psychological well‐being, and economic outcomes between fathers receiving two different programs offered by Fathers & Families Support Center for economically disadvantaged fathers: (a) Family Formation (FF), a 6‐week/240‐h program focused on economic stability/mobility, responsible fatherhood, and healthy relationships, with case management and legal services; (b) Economic Stability (ES), a 4‐week/80‐h program focused only on economic stability with limited case management and legal services. A randomized controlled trial (RCT) was used to compare fathers in FF (n = 350) vs. ES (n = 342). Surveys were administered at enrollment and 3‐ and 12‐months postintervention. Linear and generalized linear mixed models were used to assess changes in program outcomes over time and across study groups. Four hundred and eighty‐two fathers responded to either follow‐up survey (251 FF, 231 ES). Nearly all (98%) were non‐white (93% Black, 5% other/mixed race) and were on average 34 years old. Approximately 46% attended ≥75% of program sessions (FF 48% vs. ES 44%). Both FF and ES groups experienced improvements in parenting, psychological well‐being, and financial outcomes after the programs, but changes in outcomes over time did not differ significantly by program. The lack of difference in outcomes between fathers in FF and ES groups could be due to a similar core focus on employment‐related curriculum for both groups. Gaining financial stability could have contributed to positive improvements in other fatherhood domains. Implications for future research and practice are discussed herein. [ABSTRACT FROM AUTHOR]

Over the past decades, a number of complementary treatments for schizophrenia have emerged. One of these is metacognitive training (MCT), which combines the principles of cognitive‐behavioral therapies, cognitive remediation, and psychoeducation into a hybrid approach placing emphasis on increasing metacognitive awareness. The aim of our study was to investigate the efficacy of MCT on symptom severity, and neurocognitive and social cognitive functioning in schizophrenia; also, attention was paid to the assessment of subjective acceptability. Forty‐six patients diagnosed with schizophrenia were included in our single‐blind randomized controlled trial, who were assigned to the intervention or control group. The intervention group was provided standard MCT, while the control group received treatment as usual. We assessed symptom severity and cognitive functions before and after the training, as well as after a 6‐month follow‐up period. Compared to the control group, the intervention group showed improvement in overall symptom severity, and positive and disorganized symptoms. Training participans showed further improvement at the follow‐up assessment. Regarding neurocognitive functions, improvement in visuospatial functions was observed between pre‐ and post‐intervention assessments compared to the control group. Patients showed excellent adherence, and evaluated the training as useful and interesting. In line with the results of previous studies, our results demonstrate the efficacy of MCT on symptom severity in schizophrenia. Improvements in cognitive functions that are closely related to the onset and prevalence of symptoms of schizophrenia were also found. [ABSTRACT FROM AUTHOR]

Objective: The primary aim was assessing the cost‐effectiveness of an internet‐based self‐help program, expert‐patient support, and the combination of both compared to a care‐as‐usual condition. Method: An economic evaluation from a societal perspective was conducted alongside a randomized controlled trial. Participants aged 16 or older with at least mild eating disorder symptoms were randomly assigned to four conditions: (1) Featback, an online unguided self‐help program, (2) chat or e‐mail support from a recovered expert patient, (3) Featback with expert‐patient support, and (4) care‐as‐usual. After a baseline assessment and intervention period of 8 weeks, five online assessments were conducted over 12 months of follow‐up. The main result constituted cost‐utility acceptability curves with quality‐of‐life adjusted life years (QALYs) and societal costs over the entire study duration. Results: No significant differences between the conditions were found regarding QALYs, health care costs and societal costs. Nonsignificant differences in QALYs were in favor of the Featback conditions and the lowest societal costs per participant were observed in the Featback only condition (€16,741) while the highest costs were seen in the care‐as‐usual condition (€28,479). The Featback only condition had the highest probability of being efficient compared to the alternatives for all acceptable willingness‐to‐pay values. Discussion: Featback, an internet‐based unguided self‐help intervention, was likely to be efficient compared to Featback with guidance from an expert patient, guidance alone and a care‐as‐usual condition. Results suggest that scalable interventions such as Featback may reduce health care costs and help individuals with eating disorders that are currently not reached by other forms of treatment. Public significance statement: Internet‐based interventions for eating disorders might reach individuals in society who currently do not receive appropriate treatment at low costs. Featback, an online automated self‐help program for eating disorders, was found to improve quality of life slightly while reducing costs for society, compared to a do‐nothing approach. Consequently, implementing internet‐based interventions such as Featback likely benefits both individuals suffering from an eating disorder and society as a whole. [ABSTRACT FROM AUTHOR]

Introduction: Cesarean scar defect (CSD) is a long‐term outcome of cesarean section (CS) and associated with numerous gynecological and obstetric problems. Previous studies indicate that infection may be a risk factor for CSD. Adjunctive azithromycin was shown to reduce the risk of postoperative infection in patients undergoing non‐elective primary cesarean delivery in labor or after the rupture of membranes compared with standard antibiotic prophylaxis. This study investigated the protective effect of adjunctive azithromycin in combination with single‐dose cephalosporin against CSD in women undergoing non‐elective cesarean delivery. Material and methods: A randomized, double‐blind, controlled clinical trial was conducted in a University hospital in Shanghai, China. A total of 242 women who underwent their first non‐elective CS were randomly assigned to receive 1500 mg cefuroxime sodium plus 500 mg intravenous azithromycin (n = 121; experimental group) or 1500 mg cefuroxime sodium plus a placebo (n = 121; placebo group). The primary outcome was CSD prevalence, as determined by transvaginal ultrasound and saline infusion sonohysterography within 6 months of delivery. Secondary outcomes were changes in infectious indicators (eg hypersensitive C‐reactive protein and procalcitonin), postoperative morbidity, and use of postoperative antibiotics. We also examined the operative procedure, pathogenic microorganism cultures, and fetal outcomes. Outcomes were compared between groups with the chi‐squared test, Fisher's exact test, or Student's t test. Results: Between May 2018 and May 2021, 121 women were randomized to each arm. Because the sonographic follow up was disrupted by the coronavirus disease 2019 pandemic and strict management policies, we merged the follow‐up time points (6 weeks and 6 months) into a single time period (6 weeks to 6 months); 104 and 108 women in the experimental and placebo groups, respectively, completed the first sonographic follow up. CSD was diagnosed by sonography in 34/104 (32.7%) and 50/108 (46.3%) patients in the experimental and placebo groups, respectively (relative risk 0.71, 95% confidence interval 0.50–0.99; p = 0.043). Characteristics of CSD and short‐term infection outcomes did not differ between groups. Conclusions: A single dose of intravenous 500 mg azithromycin adjunctive to single‐dose cefuroxime prophylaxis significantly reduced the incidence of CSD in women undergoing non‐elective CS. [ABSTRACT FROM AUTHOR]

Introduction: The incidence and mortality rates of esophageal carcinoma are higher than those of most malignancies in humans. Radical esophagectomy is the preferred treatment for early‐stage esophageal cancer. However, the extent of lymphadenectomy during radical esophagectomy remains controversial. Indocyanine green (ICG) is the most commonly used imaging agent for the diagnosis of tumors and metastatic lymph nodes in clinical settings. Thus, the main aim of this study was to evaluate pericancerous lymph nodes imaging in video‐assisted thoracoscopic surgery radical esophagectomy using a near‐infrared (NIR) ICG imaging system and to improve the detection rate of sentinel lymph nodes (SLNs) and overall survival of patients with esophageal cancer. Methods: This was a single‐center, prospective, randomized controlled clinical trial (allocation rate = 1:1). Forty treatment‐naive esophageal cancer patients were recruited and divided into two groups: the ICG and control groups. The inclusion criteria were age, absence of preoperative neoadjuvant therapy, elective surgery, and signed informed consent. Data of participants at four different time points (preoperation, intraoperation, postoperative 1 week and 3 months) were collected and recorded. The main endpoint of this study was to explore the accuracy and false‐negative rate of lymphadenectomy using NIR‐ICG fluorescence imaging and to identify the location of esophageal cancer SLN combined with postoperative pathological reports. Discussion: This trial will provide more evidence on the extent of lymph node dissection for esophageal cancer and contribute to the development of treatment guidelines for esophageal cancer. Trial registration number: NCT04615806. [ABSTRACT FROM AUTHOR]

Objectives: For suspected common bile duct stone (CBDS) missed on computed tomography (CT), there is no clear evidence on whether endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) is the better diagnostic tool. We aimed to compare the diagnostic accuracy of EUS and MRCP for cases of missed CBDS on CT. Methods: Patients suspected of having CBDS were enrolled and randomly allocated to the EUS or MRCP group. Upon the initial examination, those having CBDS or sludge formation underwent endoscopic retrograde cholangiopancreatography (ERCP), while those who were CBDS‐negative underwent a second examination with either MRCP or EUS, which was distinct from the initial diagnostic procedure. The primary outcome was diagnostic accuracy, and the secondary outcomes were diagnostic ability, detection rate and characteristics of CBDS in the second examination, and the frequency of adverse events. Results: Between April 2019 and January 2021, 50 patients were enrolled in the study. The accuracy was 92.3% for EUS and 68.4% for MRCP (P = 0.055). EUS showed 100% sensitivity, 88.2% specificity, 81.8% positive predictive value, and 100% negative predictive value, and MRCP showed 33.3% sensitivity, 84.6% specificity, 50% positive predictive value, and 73.3% negative predictive value. The CBDS detection rate in the second examination was 0% for MRCP after a negative EUS and 35.7% for EUS after a negative MRCP (P = 0.041). No adverse events occurred in any of the patients. Conclusions: Endoscopic ultrasound may be a superior diagnostic tool compared to MRCP for the detection of CBDS that are undetected on CT. (UMIN000036357). [ABSTRACT FROM AUTHOR]

Objective: A waiting‐list randomized controlled trial supported the effectiveness of the multimodal Untire app in reducing cancer‐related fatigue (CRF) in cancer patients and survivors. However, little is known about the causal mechanisms of different app components through which the intervention effect was achieved. We aim to examine whether specifically targeted factors (i.e., fatigue catastrophizing, depression, mindfulness, sleep, and physical activity) mediated the intervention effects of the Untire app on fatigue outcomes. Methods: Seven hundred ninety‐nine persons with CRF were randomized (2:1) into intervention (n = 519) and waiting‐list control (n = 280) groups. Self‐report data on the primary outcome fatigue severity and interference and the abovementioned potential mediators were collected at baseline and 12 weeks. Participants who completed the 12‐week assessment were included in the analyses (intervention = 159; control = 176). We performed longitudinal multi‐categorical multiple mediation analysis using PROCESS macro to examine whether the potential mediators explained the overall intervention effects. Results: Improvements in fatigue catastrophizing (bootstrap 95% CI (−0.110; −0.011)), depression (bootstrap 95% CI (−0.082; −0.004)), and mindfulness (bootstrap 95% CI (−0.082; −0.002)), significantly mediated the intervention effect on fatigue severity, whereas sleep quality (bootstrap 95% CI (−0.081; 0.009)), sleep disturbance (bootstrap 95% CI (−0.038; 0.029)), and physical activity (bootstrap 95% CI (−0.068; 0.000)) did not. Similar associations were found for fatigue interference. Conclusions: Untire app access reduces fatigue severity and interference mainly by decreasing fatigue catastrophizing, depression, and by increasing mindfulness. Supporting these psychological mechanisms is crucial for reducing fatigue among cancer patients and survivors. [ABSTRACT FROM AUTHOR]

Summary: To compare the effectiveness of family‐based behavioural social facilitation treatment (FBSFT) versus treatment as usual (TAU) in children with severe obesity. Parallel‐design, nonblinded, randomized controlled trial conducted at a Norwegian obesity outpatient clinic. Children aged 6–18 years referred to the clinic between 2014 and 2018 were invited to participate. Participants were randomly allocated using sequentially numbered, opaqued, sealed envelopes. FBSFT (n = 59) entailed 17 sessions of structured cognitive behavioural treatment, TAU (n = 55) entailed standard lifestyle counselling sessions every third month for 1 year. Primary outcomes included changes in body mass index standard deviation score (BMI SDS) and percentage above the International Obesity Task Force cut‐off for overweight (%IOTF‐25). Secondary outcomes included changes in sleep, physical activity, and eating behaviour. From pre‐ to posttreatment there was a statistically significant difference in change in both BMI SDS (0.19 units, 95% confidence interval [CI]: 0.10–0.28, p <.001) and %IOTF‐25 (5.48%, 95%CI: 2.74–8.22, p <.001) between FBSFT and TAU groups. FBSFT participants achieved significant reductions in mean BMI SDS (0.16 units, (95%CI: −0.22 to −0.10, p <.001) and %IOTF‐25 (6.53%, 95% CI: −8.45 to −4.60, p <.001), whereas in TAU nonsignificant changes were observed in BMI SDS (0.03 units, 95% CI: −0.03 to 0.09, p =.30) and %IOTF‐25 (−1.04%, 95% CI: −2.99 to −0.90, p =.29). More FBSFT participants (31.5%) had clinically meaningful BMI SDS reductions of ≥0.25 from pre‐ to posttreatment than in TAU (13.0%, p =.021). Regarding secondary outcomes, only changes in sleep timing differed significantly between groups. FBSFT improved weight‐related outcomes compared to TAU. [ABSTRACT FROM AUTHOR]

Background and Aims: Screening and brief interventions (SBI) in primary health‐care practices (PHCP) are effective in reducing reported alcohol consumption, but have not been routinely implemented. Most programs seeking to improve implementation rates have lacked a theoretical rationale. This study aimed to test whether a theory‐based intervention for PHCPs could significantly increase alcohol SBI delivery. Design Two‐arm, cluster‐randomized controlled, parallel, 12‐month follow‐up, trial. Setting: PHCPs in Portugal. Participants: Staff from 12 PHCPs (n = 222, 81.1% women): nurses (35.6%), general practitioners (28.8%), receptionists (26.1%) and family medicine residents (9.5%); patients screened for alcohol use: intervention n = 8062; controls n = 58. Intervention and Comparator: PHCPs were randomized to receive a training and support program (n = 6; 110 participants) tailored to the barriers and facilitators for implementing alcohol SBIs following the principles of the Behavior Change Wheel/Theoretical Domains Framework approach, or to a waiting‐list control (n = 6; 112 participants). Training was delivered over the first 12 weeks of the trial. Measurements The primary outcome was the proportion of eligible patients screened (unit of analysis: patient list). Secondary outcomes included the brief intervention (BI) rate per screen‐positive patient and the population‐based BI rate (unit of analysis: patient list), and changes in health providers' perceptions of barriers to implementation and alcohol‐related knowledge (unit of analysis: health provider). Findings The implementation program had a significant effect on the screening activity in the intervention practices compared with control practices at the 12‐month follow‐up (21.7% vs. 0.16%, intention‐to‐treat analysis, p = 0.003). Although no significant difference was found on the BI rate per screen‐positive patient (intervention 85.7% vs. control 63.6%, p = 0.55, Bayes factor = 0.28), the intervention was effective in increasing the population‐based BI rate (intervention 0.69% vs. control 0.02%, p = 0.006). Health providers in the intervention arm reported fewer barriers to SBI implementation and higher levels of alcohol‐related knowledge at 12‐month follow‐up than those in control practices. Conclusion: A theory‐based implementation program, which included training and support activities, significantly increased alcohol screening and population‐based brief intervention rates in primary care. [ABSTRACT FROM AUTHOR]

Aim: Alcoholism is the most prevalent substance use disorder in Japan; the estimated number of patients and high‐risk drinkers is in the millions. Although studies in the West have shown that cognitive behavioral therapy (CBT) is one of the most effective treatment strategies for alcoholic patients, there is a dearth of efficacy studies of CBT‐based intervention for those patients in the non‐Western setting. The aim of this study is to investigate the efficacy of a 12‐session CBT‐based relapse prevention program for Japanese alcoholic patients. Methods: Forty‐eight alcoholic patients (M = 36, F = 12) who were admitted to an addiction treatment unit were randomly allocated either to a 12‐session relapse prevention (RP) program (n = 24) or a 12‐session psychoeducation (PE) program (n = 24). Both treatment programs were conducted in a group format once a week for 12 weeks. Other aspects of inpatient treatment (group meetings, etc) were the same in both groups. Self‐rating scales, which measure behavioral and cognitive coping, coping response, self‐efficacy, and cognition of drinking, were administered at pretreatment, mid‐treatment, and posttreatment periods. The proportion of participants who relapsed at 3 and 6 months after discharge was evaluated. Results: Both RP and PE groups showed significant improvement in self‐efficacy and cognition of drinking at posttreatment. However, there were no significant differences in the self‐rating scales between both groups. In addition, there were no significant differences in relapse rate at 3 and 6 months after discharge between both groups. Conclusions: The 12‐session CBT‐based relapse prevention program and the psychoeducation program may be equally efficacious for alcoholic patients. Several factors that influenced the results are discussed. [ABSTRACT FROM AUTHOR]

Mental health nurses are exposed frequently to occupational stress and can experience a range of negative impacts on their well‐being and intention to stay in the nursing workforce. Promoting Resilience in Nurses (PRiN) is a strength‐based resilience education programme that incorporates evidence‐based cognitive behavioural and interpersonal approaches with post‐traumatic growth theory. A partially clustered randomized controlled trial at a large public mental health service will be used to examine the effects of PRiN on mental health nurses' coping self‐efficacy, resilience, well‐being, mental health, emotional regulation, post‐traumatic growth, workplace belonging, and turnover intention as compared to controls. Process evaluations are increasingly used to help understand and interpret trial results for complex interventions. This paper describes the protocol for an embedded mixed methods process evaluation that aims to evaluate the PRiN programme implementation and identify factors that may explain variation in participant outcomes in the trial. Data collection includes a programme participant satisfaction survey; a follow‐up semi‐structured interview with selected programme participants; a unit/team manager survey on barriers and facilitators to staff recruitment and programme participation; and a fidelity checklist completed by programme facilitators. Normalisation Process Theory will be used to inform data analysis and integration. The findings will provide insights into factors that affect programme implementation, particularly in the context of the COVID‐19 pandemic and may help explain differences in participant outcomes. Findings will also inform post‐trial programme sustainability as well as potential future upscale and adaptation for implementation across healthcare settings. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated the effect of the school‐based intervention Charge Your Brainzzz on adolescents' social‐cognitive determinants, sleep hygiene and sleep duration and quality. METHODS: A cluster‐randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post‐intervention (T1) and ±3 months post‐intervention (T2). Mixed model analyses were performed to estimate the effects on social‐cognitive determinants, sleep hygiene, and sleep outcomes. RESULTS: The intervention increased sleep knowledge post‐intervention (b = 1.91; 95%CI: 1.22‐2.60) and at follow up (b = 1.40; 95%CI: 0.70‐2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01‐0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01‐0.22) post‐intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes. CONCLUSIONS: The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep‐related behaviors, and adolescents' social and physical environment. CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the school‐based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918. [ABSTRACT FROM AUTHOR]

Summary: Background: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. Objective: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. Methods: A 3‐arm RCT was conducted in Australia, 2017–2019. Two arms involved the interventions using nurse‐led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z‐score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. Results: At 2 years, 797 mother–child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of −0.02 (95% CI: −0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of −0.03 (95% CI: −0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. Conclusion: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours. [ABSTRACT FROM AUTHOR]

Aims: To test whether the Stop‐tabac smartphone application (app) increased smoking cessation rates. Design A two‐arm, parallel‐group, individually randomized, double‐blind, controlled trial. Setting and Participants: A total of 5293 daily smokers (Stop‐tabac = 2639, control = 2654) enrolled on app stores and on the internet in 2019–20, who lived in France or Switzerland. Intervention and comparator: The Stop‐tabac application includes immediate feedback during episodes of craving and withdrawal; individually tailored counseling messages with notifications sent during 6 months; a discussion forum; fact sheets; modules on nicotine replacement therapy and e‐cigarettes; and calculators of cigarettes not smoked, money saved and days of life gained since quitting. The control application included five brief pages and calculators as above. Measurements Primary outcome: self‐reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), with non‐responders counted as smokers. Secondary outcome: self‐reported use of nicotine medications. Findings Participants were aged 36 years on average; 66% were women who smoked 15 cigarettes/day, and 64% screened positive for depression. Stop‐tabac participants used the app over a longer period than control participants (23 versus 11 days, P < 0.001). Smoking cessation rates after 6 months were 9.9% in the Stop‐tabac group versus 10.3% in the control group (odds ratio = 0.96, 95% confidence interval = 0.80–1.45, P = 0.63). Rates of use of nicotine medications after entry in the study were 38 versus 30% after 6 months (χ2 = 8.3, P = 0.004) in the Stop‐tabac and control groups. After 6 months, 26% of participants in the Stop‐tabac group and 8% in the control group said that the app helped them 'a lot' or 'enormously' to quit smoking (χ2 = 113, P < 0.001). Conclusions: In smokers enrolled on the app stores and the internet, allocation to the Stop‐tabac smoking cessation app did not increase smoking cessation rates, but increased rates of use of nicotine medications. [ABSTRACT FROM AUTHOR]

Aim: To test whether soft‐type block bone substitute used for guided bone regeneration (GBR) of peri‐implant defects leads to a different dimension of the augmented hard tissue than particulate bone substitute. Materials and Methods: In 40 patients, 40 two‐piece dental implants were placed >2 months after tooth extraction. Following random allocation, 20 peri‐implant bone dehiscences were grafted with a soft‐type block made of synthetic biphasic calcium phosphate (BCP) + collagen and 20 bone dehiscences with particulate BCP. All the sites were covered with a collagen membrane stabilized with titanium pins. Immediately after wound closure and after 6 months, the horizontal dimension (HD) of the augmented hard tissue was measured at the level of implant shoulder using cone beam computed tomography. During re‐entry at 6 months, the defect fill was clinically assessed. Results: At 6 months, the median HD measured 1.15 mm (mean: 1.31 mm) in the soft‐block group and 0.93 mm (mean: 1.05 mm) in the particulate group (p =.6). At 6 months, 7.1% of contained defects and 61.9% of non‐contained defects showed an incomplete vertical defect fill. Conclusions: Soft‐type block of BCP + collagen used for GBR of peri‐implant defects did not differ from particulate BCP regarding the dimension of the augmented hard tissue after 6 months of healing. [ABSTRACT FROM AUTHOR]

Background: Phototherapies could represent an efficient option for the treatment of atopic dermatitis (AD), but the evidences available for clinical choices were contradictory. Objective: This study aimed to evaluate the efficacy of different phototherapies on AD. Methods: This systematic review and network meta‐analysis included randomized controlled trials (RCTs) through searching keywords from PubMed, EMBASE, and the Cochrane library. We summarized different phototherapy types and scoring systems. Scoring Atopic Dermatitis (SCORAD) absolute score changes were estimated by mean differences (MDs) and standard deviations (SDs) and then included in the network meta‐analysis. The effect sizes of comparison of different phototherapies were presented as MDs and 95% confidence intervals (CIs). Egger's test was used to evaluate publication bias. Results: Eleven RCTs were included in the systematic review and 4 studies in the network meta‐analysis. Based on the pooled estimates, medium‐dose ultraviolet A1 (UVA1) cold light was superior to medium‐dose UVA1 (MD 8.92; 95% CI: 5.60‐12.24) but no significant difference between high‐dose (UVA1) and medium‐dose UVA1 cold light (MD 0.66; 95% CI: −5.57 to 6.90). Publication bias was not supported by Egger's test (P =.168). Conclusions: Due to possible long‐term adverse effects of high‐dose UVA1, medium‐dose UVA1 cold light appears to be the superior form for AD. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy of mirabegron in the treatment of erectile dysfunction concomitant with lower urinary tract symptoms in benign prostatic obstruction patients. Methods: In this randomized controlled trial, 55 sexually active lower urinary tract symptoms/benign prostatic obstruction patients with concomitant erectile dysfunction were randomly allocated in two groups: the first received mirabegron 50 mg plus doxazosin 2 mg once daily (mirabegron group) and the second received tolterodine 4 mg plus doxazosin 2 mg (tolterodine group) for 12 weeks. The evaluation was based on the International Index of Erectile Function questionnaire, Erection Hardness Score questionnaire, International Prostate Symptom Score, quality of life, uroflowmetry and post‐voiding residual. The therapeutic outcomes were assessed at 4 and 12 weeks compared with the baseline. Results: Only the mirabegron group achieved significant improvement in sexual functions after 4 and 12 weeks. By using ≥5 points difference from the baseline as a cut‐off point of change, there was a significant difference in change of direction of the International Index of Erectile Function‐15 total score in favor of the mirabegron group; after 12 weeks, the International Index of Erectile Function‐15 total score decreased in 0%, was unchanged in 8.3% and improved in 91.7% in the mirabegron group compared with 8.7%, 65.2% and 26.1%, respectively, in the tolterodine group (P < 0.001). Regarding the urinary characteristics, both groups showed significant improvement in the International Prostate Symptom Score, quality of life, and post‐voiding residual after 4 and 12 weeks, with no significant difference among them. Conclusion: Mirabegron improves urinary characteristics and the associated sexual dysfunction in patients with lower urinary tract symptoms/benign prostatic obstruction. [ABSTRACT FROM AUTHOR]

Aim: The objective of this study was to assess the impact of health care–initiated visits versus patient‐controlled flexible visits on clinical and patient‐reported outcomes in people with type 1 diabetes. Methods: The DiabetesFlex trial was a randomized controlled, pragmatic non‐inferiority 15‐month follow‐up study comparing standard care (face‐to‐face visits every 4 months) with DiabetesFlex (patient‐controlled flexible visits using patient‐reported, outcome‐based telehealth follow‐up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA1c from baseline to 15‐month follow‐up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score—five well‐being‐index (WHO‐5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score). Results: The adjusted mean difference in HbA1c between standard care and DiabetesFlex was similar and below the predefined non‐inferiority margin of 0.4% (−0.03% [95%CI: 0.15, 0.11]/−0.27 mmol/mol [−1.71, 1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO‐5 index of 4.5 (1.3, 7.3), participation score of 1.1 (0.5, 2.0), and decreased PAID score of −4.8 (−7.1, −2.6) compared with standard care. During follow‐up, DiabetesFlex participants actively changed 23% of face‐to‐face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%). Conclusion: Compared with standard care, flexible patient‐controlled visits combined with patient‐reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well‐being further improved diabetes‐related well‐being and decreased face‐to‐face visits while maintaining safe diabetes management. [ABSTRACT FROM AUTHOR]

Objective: There is limited evidence that adding an antidepressant to electroconvulsive therapy (ECT), compared with ECT monotherapy, improves outcomes. We aimed to determine whether the addition of nortriptyline to ECT enhances its efficacy and prevents post‐ECT relapse. Methods: We conducted a randomized, double‐blind, placebo‐controlled trial (RCT). Patients with major depressive disorder and an indication for ECT received either nortriptyline or placebo during a bilateral ECT course. Outcome measures were mean decrease in Hamilton Rating Scale for Depression (HRSD) score, response, remission, and time to response and remission. Patients who attained remission participated in a 1‐year follow‐up study with open‐label nortriptyline. Outcome measures were relapse and time to relapse. Results: We included 47 patients in the RCT. In the nortriptyline group, 83% showed response, 74% attained remission, and the mean decrease in HRSD score was 21.6 points. In the placebo group these figures were, respectively, 81% (p = 0.945), 73% (p = 0.928) and 20.7 points (p = 0.748). Thirty‐one patients participated in the follow‐up study. In patients who had received nortriptyline during the RCT, 47% relapsed at a mean of 34.2 weeks. Patients who had received placebo showed similar treatment results. In both study phases, no statistically significant differences between the nortriptyline and the placebo group were found. Conclusion: In our sample of severely depressed patients who were often medication resistant and suffering from psychotic depression, the addition of nortriptyline to ECT did not enhance its efficacy or prevent post‐ECT relapse. Encouragingly, even in these patients ECT was highly effective and relapse rates were relatively low. [ABSTRACT FROM AUTHOR]