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Background: Chronic back pain affected 619 million people globally in 2020 which accounts for a heavy disease burden causing tremendous productivity losses. Current therapies including ibuprofen, duloxetine, and opioids might cause side effects and even severe drug use disorders. Therefore, a non‐pharmacologic therapy with better or equivalent efficacy and fewer side effects is needed. Methods: We did a multi‐center, single‐blinded, randomized, positive drug controlled, clinical trial. Patients with chronic back pain in moderate severity were randomized into receiving hot stone massage or flurbiprofen plaster group. Both interventions were 2 weeks with a follow‐up of 4 weeks. The primary outcome was the change in the score of the Global Pain Scale (GPS) from baseline to week 2. Secondary outcomes included Numerical Rating Scale (NRS), Chronic Pain Acceptance Questionnaire (CPAQ), Pain Self‐Efficacy Questionnaire (PSEQ), Hospital Anxiety and Depression Scale (HADS), and Short Form‐36 (SF36) from baseline to week 2 and week 6. Exploratory outcome assessment included the muscle thickness measured by ultrasound. Any adverse event was monitored throughout the study period. Results: A total of 120 patients were enrolled in this trial. At 2 weeks GPS decreased significantly in the hot stone massage group compared to the flurbiprofen group (difference between groups = ‐8.1 points, 95% confidence interval [CI] ‐15.8 to ‐0.3, p = 0.047). Moreover, hot stone massage also showed more improvement at 2 weeks compared to flurbiprofen, including NRS (‐0.5 points, 95% CI ‐1.0 to ‐0.1, p = 0.029), PSEQ (5.4 points, 95% CI 0.5 to 10.2, p = 0.030), and mental component of Short Form‐36 (SF‐36) (1.7 points, 95% CI 0.4 to 2.9, p = 0.010), but not in CPAQ (p = 0.131), HADS (p = 0.303 for depression, p = 0.399 for anxiety), or SF‐36 (p = 0.129 for physical component, p = 0.246 for social component, p = 0.076 for fatigue component). A total of two participants in the hot stone massage group reported mild pain on skin surface when receiving the procedure at the first intervention session. [ABSTRACT FROM AUTHOR]

The persistent threat of tuberculosis (TB) on a global scale hasprompted a reevaluation of preventive strategies, with a particular focus onthe Bacille Calmette‐Guérin (BCG) vaccine's role in revaccination. Theresurgence underscores an urgent need for enhanced measures, prompting acritical examination of BCG revaccination strategies. Drawing from the researchof Paulo Cesar Pereira dos Santos and a synthesis of randomized controlledtrials (RCTs), this review identifies key considerations for refining BCGrevaccination's efficacy against Mycobacterium tuberculosis (MTB) andTB. The main body of this review integrates four principal domains essentialfor optimizing BCG revaccination: the timing of revaccination, the assessmentof various BCG strains, the evaluation of the vaccine's effectiveness on MTBand non‐tuberculous mycobacteria (NTM) strains, and the enhancement of RCTmethodologies. Determining the optimal revaccination timing is paramount forbolstering immunity, especially in regions with high TB prevalence. Theanalysis of different BCG strains provides insights into strain‐specificimmunogenicity, informing vaccine deployment strategies. Additionally,understanding the vaccine's impact on a range of mycobacterial infections iscrucial for its broader application in various microbial contexts. The reviewemphasizes the refinement of RCT designs to ensure robust and consistentoutcomes, facilitating the reproducibility of results in diverse settings. Itproposes a strategy that not only suggests modifications to revaccinationpractices to increase global TB prevention effectiveness but also calls forcontinuous research to improve BCG revaccination methodologies. The paperadvocates for a standardized, evidence‐driven approach to global TB preventionthat takes into account regional epidemiological differences. In conclusion,this review significantly contributes to the discourse on TB prevention,advocating for evidence‐based, standardized approaches that could potentiallytransform the role of BCG revaccination in global TB prevention efforts. Thefindings support current initiatives aimed at developing policies based onsolid evidence, ensuring the scientific integrity and practical relevance ofBCG revaccination strategies. [ABSTRACT FROM AUTHOR]

Financial education represents a powerful tool for improving economic literacy of citizens. This paper presents results from an experiment providing a group of 136 workers in an Italian university (administrative staff) an online, synchronous course. Classes were organized in 5 sessions of 2h each and covered basic topics about personal finance. The effectiveness of the course is assessed through a rigorous randomized controlled trial (RCT). In addition to the analysis of improvements in financial knowledge, financial self‐efficacy and the role of prior attitudes and behaviors were explored. Participants obtained post‐test scores statistically higher than individuals in the control group, with an average effect size of 0.55 SD. The effect is particularly relevant for participants starting with low levels of financial knowledge. Moreover, two novel findings emerge: financial self‐efficacy increases (0.51 SD) after the course, and pre‐treatment individuals' financial attitudes and behaviors shed further light on the financial learning process. [ABSTRACT FROM AUTHOR]

Background: Running retraining is commonly used in the management of medial tibial stress syndrome (MTSS) but evidence for its effectiveness is lacking. The primary aim of this study is to determine if the addition of running retraining to best standard care is beneficial in the management of runners with MTSS. Methods: This study is an assessor‐blinded and participant‐blinded, parallel‐group, randomised controlled trial. The trial will recruit 64 participants aged between 18 and 45 years, with a clinical diagnosis of MTSS that has affected their running participation for at least four weeks. Participants will be randomised to receive best standard care (control) or running retraining and best standard care (intervention group) over an 8‐week period. Best standard care will consist of load management advice, symptom management advice, footwear advice and a strengthening program. Running retraining will consist of a cue to reduce running step length. Outcomes will be measured at weeks 1, 2, 4 and 8. The primary outcome measure will be the University of Wisconsin Running Injury and Recovery Index at week 4. Secondary outcome measures include: (i) Exercise Induced Leg Pain Questionnaire—British Version, (ii) global rating of change scale, (iii) worst pain experienced during a run, (iv) weekly run volume, (v) reactive strength index score, (vi) single leg hop test, (vii) soleus single leg maximum voluntary isometric contraction, (viii) gastrocnemius single leg maximum voluntary isometric contraction, (ix) single leg plantar flexor endurance test, (x) running step length, and (xi) running step rate. Data will be analysed using the intention‐to‐treat principle. Discussion: This randomised controlled trial will evaluate if reducing running step length provides additional benefit to best standard care in the management of runners with MTSS over an 8‐week period. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12624000230550. [ABSTRACT FROM AUTHOR]

Objectives: Patients with traumatic brain injury (TBI) often suffer memory and cognitive impairments, and oxiracetam‐like drugs are considered to have a positive impact on these symptoms potentially. However, the efficacy and safety of L‐oxiracetam and oxiracetam in TBI patients have not been sufficiently investigated. Methods: The study adopts a multicenter, randomized, double‐blind, parallel‐group, phase 3 clinical trial design in 74 centers across 51 hospitals in China. A total of 590 TBI patients meeting criteria will be randomly allocated into three groups in a 2:2:1 ratio: L‐oxiracetam group, oxiracetam group, and placebo group. The treatment period is 14 days, with a follow‐up period of 90 days. The primary outcome measure is the change in the Loewenstein Occupational Therapy Cognitive Assessment score at 90 days after treatment. Secondary outcomes include changes in other cognitive assessments, neurological function, activities of daily living, and safety assessments. Discussion: There is no robust evidence to suggest that L‐oxiracetam and oxiracetam can enhance memory and cognitive function in patients with mild to moderate TBI. This study has the potential to answer this crucial clinical question. Trial registration: chinadrugtrials.org.cn, identifier CTR20192539; ClinicalTrials.gov, identifier NCT04205565. [ABSTRACT FROM AUTHOR]

To compare the analgesic efficacy and adverse events of proximal versus distal ACB for adults undergoing knee arthroplasty, we searched PubMed, Cochrane, Web of Science, and Embase to identify all eligible randomized controlled trials (RCTs). The study quality of the RCTs was evaluated using the Cochrane risk of bias assessment tool. Heterogeneity among studies was examined by Cochrane Q test. Our primary outcomes were pain intensity at rest/during movement and morphine consumption. Statistical analyses were conducted by RevMan Software. Seven eligible studies involving 400 subjects were included in this meta‐analysis with 202 participants in the proximal ACB group and 198 participants in the distal ACB group. The results demonstrated that proximal ACB provided significantly better pain relief at rest at 2 h (SMD −0.27, 95% CI −0.54 to −0.01, four trials, 222 participants, I2 = 0, p = 0.04) and 24 h (SMD −0.28, 95% CI −0.48 to −0.08, seven trials, 400 participants, I2 = 0, p = 0.006) following the surgery. We found no evidence of a difference in postoperative pain intensity at other timepoints. Furthermore, we noted no evidence of a difference in cumulative morphine consumption and occurrence of adverse events. Proximal ACB provides better pain relief and comparable adverse effects profile compared with distal ACB. The analgesic benefit offered by proximal ACB, however, did not appear to extend beyond the first 24 h. The overall evidence level was mostly low or very low, which requires more well‐organized multicenter randomized trials in the future. [ABSTRACT FROM AUTHOR]

Background: Hand eczema (HE) is a common and heterogeneous condition. It has a wide range of etiologies and clinical manifestations. In this study the efficacy of triamcinolone 0.1% cream and sulfur 2% creams was compared in treating patients with HE. Methods: This randomized, triple‐blind clinical trial was performed on 70 patients with HE (including 70 right and 70 left hands). In this study, two creams were used including triamcinolone 0.1% and sulfur 2.0%. Patients were treated with these creams twice a day (once in every 12 h) for 4 weeks. Follow‐up was 4 weeks after treatment. Hand Eczema Severity Index (HECSI), itching, dryness, burning sensation, and erythema scores were collected three times during the study and compared between treatment regimens. Results: Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, burning sensation, and erythema, and the therapeutic effects lasted for at least 4 weeks after cessation of topical treatment. Conclusion: Topical sulfur cream (2.0%) is as effective as triamcinolone (0.1%) cream in treatment of HE without any prominent adverse reactions. [ABSTRACT FROM AUTHOR]

Aim: To describe the protocol of a feasibility trial designed to test the preliminary effect of a 12‐week culturally appropriate physical activity programme on metabolic syndrome markers and quality of life in Ghanaian adults with type 2 diabetes (T2DM). Design: Feasibility randomised controlled trial. Methods: Through random allocation, 90 adults with T2DM will be allocated to either the control group (CG) (n = 45) or the intervention group (IG) (n = 45). The IG will receive the physical activity programme in addition to their usual diabetes care; those in the CG will receive their usual diabetes care. Measurements will be performed at baseline and 12‐week follow‐up. The primary outcome is a change in metabolic syndrome markers in the IG compared to the CG. Secondary outcomes are: (a) a change in quality of life in the IG compared to the CG, (b) the feasibility of implementation. Results: Findings will inform the design of a future large‐scale trial. Patient or Public Contribution: Patients with T2DM and their healthcare professionals contributed to this study protocol by participating in semi‐structured interviews towards the design of the physical activity programme. Clinical Trial Registration Number: The trial is registered in the Australian and New Zealand Clinical Trial Registry (registration number: ACTRN12622000323729p). [ABSTRACT FROM AUTHOR]

Background: To assess the frequency of patient‐reported outcomes (PROs) and non‐PROs in randomized controlled trials (RCTs) addressing head/neck cancers. Methods: We included RCTs about interventions to treat head/neck cancers. PubMed was searched on September 16, 2022 and included studies published during three periods (2000–2002, 2010–2012, and 2020–2022). Data on types of outcomes and instruments to measure them were extracted and organized into PROs and non‐PROs, and temporal trends for reporting outcomes were determined. Results: There was a reduction in the frequency of non‐PROs (40% to 22%) and an increase in PROs (5% to 19%) over 20 years. The frequency of reporting both non‐PROs and PROs seemed to be stable over the same period (55% to 58%). A great variety of instruments to measure PROs and non‐PROs was identified. Conclusions: There has been a growth in the types of PROs in more recent years, and they were more frequently reported in RCTs. However, head/neck cancer trials with a combination of PROs and non‐PROs were the most prevalent. [ABSTRACT FROM AUTHOR]

Background and purpose: In 2016, we concluded a randomized controlled trial testing 1 mg rasagiline per day add‐on to standard therapy in 252 amyotrophic lateral sclerosis (ALS) patients. This article aims at better characterizing ALS patients who could possibly benefit from rasagiline by reporting new subgroup analysis and genetic data. Methods: We performed further exploratory in‐depth analyses of the study population and investigated the relevance of single nucleotide polymorphisms (SNPs) related to the dopaminergic system. Results: Placebo‐treated patients with very slow disease progression (loss of Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised [ALSFRS‐R] per month before randomization of ≤0.328 points) showed a per se survival probability after 24 months of 0.85 (95% confidence interval = 0.65–0.94). The large group of intermediate to fast progressing ALS patients showed a prolonged survival in the rasagiline group compared to placebo after 6 and 12 months (p = 0.02, p = 0.04), and a reduced decline of ALSFRS‐R after 18 months (p = 0.049). SNP genotypes in the MAOB gene and DRD2 gene did not show clear associations with rasagiline treatment effects. Conclusions: These results underline the need to consider individual disease progression at baseline in future ALS studies. Very slow disease progressors compromise the statistical power of studies with treatment durations of 12–18 months using clinical endpoints. Analysis of MAOB and DRD2 SNPs revealed no clear relationship to any outcome parameter. More insights are expected from future studies elucidating whether patients with DRD2CC genotype (Rs2283265) show a pronounced benefit from treatment with rasagiline, pointing to the opportunities precision medicine could open up for ALS patients in the future. [ABSTRACT FROM AUTHOR]

Introduction: Treatment of pregnancy‐associated breast cancer is complex, as providers try to balance risks to the pregnant person and the developing fetus. Given increased case fatality and increasing incidence, there is a pressing need understand the efficacy and safety of different treatment regimens in this population; however, pregnant and lactating people have traditionally been excluded from participating in randomized controlled trials (RCTs). Given recent efforts to expand the inclusion criteria for oncology RCTs, this study aimed to review the inclusion/exclusion criteria of current breast cancer RCTs to assess what proportion of trials permitted enrollment of pregnant and lactating persons. Material and methods: We conducted a comprehensive search of ClinicalTrials.gov in January 2022 to identify interventional studies of breast cancer in adults that were actively recruiting. The primary outcomes were the exclusion of pregnant and lactating people. Results: The search identified 1706 studies, of which 1451 met eligibility criteria. Overall, 69.4% and 54.8% of studies excluded pregnant and lactating people, respectively. The exclusion of pregnant and lactating persons differed by study characteristics but extended across all trial designs, locations, phases and interventions. Exclusion of pregnant and lactating persons was most common in trials where the intervention was biological (86.3%), drug (83.5%) or radiation (81.5%). Conclusions: The exclusion of pregnant and lactating people from clinical trials contributes to evidence gaps in how to treat this population. A paradigm shift is needed that focuses on how research can be used to protect pregnant people from future harms, instead of protecting pregnant people from research‐related risks. [ABSTRACT FROM AUTHOR]

Aim: This study investigated the impact of an 8‐month daily‐guided intensive meditation‐based intervention (iMI) on persistent hallucinations/delusions and health‐related quality of life (QoL) in male inpatients with schizophrenia with treatment‐refractory hallucinations and delusions (TRHDs). Methods: A randomized controlled trial assigned 64 male inpatients with schizophrenia and TRHD equally to an 8‐month iMI plus general rehabilitation program (GRP) or GRP alone. Assessments were conducted at baseline and the third and eighth months using the Positive and Negative Syndrome Scale (PANSS), 36‐Item Short Form‐36 (SF‐36), and Five Facet Mindfulness Questionnaire (FFMQ). Primary outcomes measured PANSS reduction rates for total score, positive symptoms, and hallucinations/delusions items. Secondary outcomes assessed PANSS, SF‐36, and FFMQ scores for psychotic symptoms, health‐related QoL, and mindfulness skills, respectively. Results: In the primary outcome, iMI significantly improved the reduction rates of PANSS total score, positive symptoms, and hallucination/delusion items compared with GRP at both the third and eighth months. Treatment response rates (≥25% reduction) for these measures significantly increased in the iMI group at the eighth month. Concerning secondary outcomes, iMI significantly reduced PANSS total score and hallucination/delusion items, while increasing scores in physical activity and mindfulness skills at both the third and eighth months compared with GRP. These effects were more pronounced with an 8‐month intervention compared with a 3‐month intervention. Conclusions: An iMI benefits patients with TRHDs by reducing persistent hallucinations/delusions and enhancing health‐related QoL. Longer iMI duration yields superior treatment outcomes. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcers are the prevalent complication of diabetes mellitus, frequently culminating in arteriosclerosis of the lower extremities and consequent development of chronic wounds. The effectiveness of electroacupuncture (EA) as therapeutic intervention for promoting wound healing in this particular group of patients has been comprehensively assessed in this study. A randomized controlled trial involving 380 early diabetic patients with arteriosclerotic lesions of the lower limbs was conducted. Standard wound care plus EA was administered to the treatment group, while standard wound care alone was administered to the control group. The principal outcome assessed was the reduction in lesion size following the 8‐week treatment period. Pain scores, recuperation time, and quality of life (QoL) evaluations constituted secondary outcomes. In comparison to the control group, the treatment group exhibited a significantly greater reduction in wound size (p < 0.05). The treatment group exhibited significantly reduced pain scores and significantly higher QoL scores (p < 0.05). The duration of recovery did not vary substantially among the groups (p > 0.05). Electroacupuncture thus appeared to be an effective adjunctive treatment for early diabetic patients with lower limb arteriosclerotic lesions, promoting pain relief and quality of life. Additional investigation is necessary to validate these results and delve into the underlying mechanisms of action. [ABSTRACT FROM AUTHOR]

Children's burns are a major public health concern due to their long‐term physical, psychological, and social impacts, as well as their high financial burden. This study aimed to evaluate the effectiveness of a smartphone‐based educational program on outcomes of children with severe burns. This study was designed as a double‐blinded, randomized controlled trial (RCT) to test the effectiveness of a developed mobile application. A total of 93 participants were included in the final analysis. The participants were randomly assigned to either the intervention or control groups. Participants in both groups received usual self‐care training at discharge, but those in the intervention group used an Android‐based application for 2 months. The primary goal of the burn application was scar recovery, and the secondary goals were to increase child caregivers' satisfaction rate and decrease unplanned hospital readmissions. Data collection was conducted using valid and reliable questionnaires. Data were analysed using SPSS software. The study showed that the mobile application significantly affected the frequency of patient visits to the burn clinic and the satisfaction of caregivers of children with burns with the treatment process (p‐value <0.05). Also, there was a significant relationship between the duration of application use and wound healing status ((p‐value <0.001). These findings suggest that smartphone‐based educational programs can be valuable for optimizing care for children with severe burns. Further research is warranted to explore the long‐term impact of this intervention and its potential application in different healthcare settings. [ABSTRACT FROM AUTHOR]

We examined whether folate‐fortified maize (FFM) improves the health of rural women of childbearing age and whether the health intervention is associated with the consumer willingness‐to‐pay (WTP) for FFM. First, a randomized single‐blind FFM intervention trial was conducted in rural childbearing‐aged women. Participants (n = 55) consumed one stalk of either FFM (treatment group) or ordinary maize (control group) daily. This dietary intervention lasted for 2 months, during which we assessed the participants' serum folate levels at baseline, mid stage (after 1 month), and final stage (after 2 months) to evaluate the health effect of FFM. We found that the serum folate level in the treatment group (13.31 ng/mL) was 3.40 ng/mL higher than that in the control group (9.91 ng/mL) in the final stage of the study. These findings suggest that regular dietary FFM intake significantly increased serum folate levels in rural Chinese women. Second, we further expanded our study by involving 181 local rural women with similar demographic characteristics to participate in a Becker–DeGroot–Marschak (BDM) bidding experiment to measure their WTPs for FFM. Results showed that local consumers were willing to pay 2.82 Chinese Yuan (CNY) per stalk of FFM, approximately 1.21 CNY higher than the price of ordinary maize. And women who participated in and completed the intervention trial had a higher preference for FFM during the evaluation. We provide evidence on the health improvement effect of biofortified foods and shed light on the associated consumer valuation and policy implementation. [ABSTRACT FROM AUTHOR]

Introduction: Unhealthy alcohol use significantly contributes to viral non‐suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub‐Saharan Africa (SSA). Methods: As part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills‐based alcohol intervention among PWH with self‐reported unhealthy alcohol use (Alcohol Use Disorders Identification Test–Consumption [AUDIT‐C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non‐suppression, defined as either recent HIV viral non‐suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3‐month in‐person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (<400 copies/ml) at 24 weeks, and the secondary outcome was unhealthy alcohol use, defined by AUDIT‐C or phosphatidylethanol (PEth), an alcohol biomarker, ≥50 ng/ml at 24 weeks. Results: Between April and September 2021, 401 persons (198 intervention, 203 control) were enrolled from HIV clinics in Uganda (58%) and Kenya (27%) and alcohol‐serving venues in Kenya (15%). At baseline, 60% were virally suppressed. Viral suppression did not differ between arms at 24 weeks: suppression was 83% in intervention and 82% in control arms (RR: 1.01, 95% CI: 0.93–1.1). Among PWH with baseline viral non‐suppression, 24‐week suppression was 73% in intervention and 64% in control arms (RR 1.15, 95% CI: 0.93–1.43). Unhealthy alcohol use declined from 98% at baseline to 73% in intervention and 84% in control arms at 24 weeks (RR: 0.86, 95% CI: 0.79–0.94). Effects on unhealthy alcohol use were stronger among women (RR 0.70, 95% CI: 0.56–0.88) than men (RR 0.93, 95% CI: 0.85–1.01) and among participants with a baseline PEth⩽200 ng/ml (RR 0.68, 95% CI: 0.53–0.87) versus >200 ng/ml (RR 0.97, 95% CI: 0.92–1.02). Conclusions: In a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non‐suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV‐associated co‐morbidities. [ABSTRACT FROM AUTHOR]

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers. [ABSTRACT FROM AUTHOR]

Background: Genital self‐image (GSI) is a major barrier to reproductive and sexual health for women. This practical randomized trial aims to evaluate the effect of psychosexual counseling based on a cognitive‐behavioral approach to promoting GSI for reproductive‐age married Iranian women. Methods: Married women aged 15–49 years under the coverage of health centers will be invited to join the study. The study will be conducted using a multistage mixed method design in three phases. In the first phase, semi‐structured interviews with women and key informants will be conducted to understand better the GSI concept, the factors influencing it, and the interventions promoting it. Simultaneously, a literature review will be conducted by searching electronic databases to find the factors influencing GSI and the interventions to enhance it. In the second phase, the GSI‐related factors, sexual and reproductive health outcomes correlated with GSI, and intervention programs for promoting GSI in women will be extracted from the integration of qualitative study and literature review. Then, based on the expert panel's priority, a suitable program will be prepared. In the third phase, at first, a cross‐sectional study will be conducted to identify women with poor GSI and the factors relating to GSI, and then psychosexual counseling intervention will be performed. For the randomized controlled trial study, participants will be randomly allocated into two groups: (1) the intervention group and (2) the control group. Data will be collected using the Female Genital Self‐Image Scale and sexual and reproductive health outcomes correlated with GSI at baseline, immediate, and 2‐month follow‐up assessments. The impact of the intervention on the promotion of GSI will be evaluated. Discussion: This study provides a counseling program for promoting GSI. If this interventional program is successful, it has practical potential to be generalized for Iranian Women with poor GSI. [ABSTRACT FROM AUTHOR]

Background: Montelukast is a highly selective and specific cysteinyl leukotriene receptor antagonist used in the treatment of asthma. Whether montelukast as adjuvant therapy can significantly and safely treat adults with cough variant asthma (CVA) remains inconclusive. Aims: This meta‐analysis systematically evaluated the efficacy and safety of montelukast as an adjuvant treatment for adults with CVA. Materials and methods: Randomized controlled trials (RCTs) on montelukast combined with inhaled corticosteroids (ICS) and long‐acting β2 agonists (LABAs) to treat CVA in adults, from inception to March 6, 2023, were retrieved from the CNKI, Wanfang, VIP, CBM, PubMed, Embase, Cochrane Library, and Web of Science databases and Clinical Trials website. Review Manager (version 5.4) and Stata (version 15.0) were used to conduct the meta‐analysis. Results: A total of 15 RCTs were ultimately included in the meta‐analysis. It was established that montelukast as adjuvant therapy raised the total effective rate (RR = 1.20, 95% confidence interval [CI] [1.13, 1.27], P < 0.01) and improved the FEV1% (SMD = 0.91, 95% CI [0.40, 1.41], P < 0.01), PEF% (SMD = 0.63, 95% CI [0.38, 0.88], P < 0.01), FEV1 (SMD = 1.15, 95% CI [0.53, 1.77], P < 0.01), PEF (SMD = 0.64, 95% CI [0.42, 0.86], P < 0.01), and FEV1/FVC% (SMD = 0.76, 95% CI [0.51, 1.01], P < 0.01) and reduced the recurrence rate (RR = 0.28, 95% CI [0.15, 0.53], P < 0.01). The incidence of adverse reactions was higher in the montelukast auxiliary group compared to the control group but with no statistical difference (RR = 1.32, 95% CI [0.89, 1.96], P = 0.17). Conclusion: Existing evidence indicated that the use of montelukast as an adjuvant therapy had therapeutic efficacy superior to ICS + LABA alone for the treatment of adult patients with CVA. However, further research is needed, especially a combination of high‐quality long‐term prospective studies and carefully designed RCTs. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether use of ST analysis of the fetal electrocardiogram (STan) as an adjunct to continuous cardiotocography (CTG) reduces the rate of emergency Cesarean section (EmCS) compared with CTG alone. Methods: This was a randomized controlled trial of patients with a singleton fetus in cephalic presentation at ≥ 36 weeks' gestation, requiring continuous electronic fetal monitoring during labor at a tertiary maternity hospital in Adelaide, Australia, between January 2018 and July 2021. Participants were randomized to undergo CTG + STan or CTG alone. The calculated sample size was 1818 participants. The primary outcome was EmCS. Secondary outcomes included metabolic acidosis, a composite adverse perinatal outcome, and other maternal and neonatal morbidity and safety outcomes. Results: The present study enrolled 970 women, of whom 967 were included in the primary analysis. EmCS occurred in 107/482 (22.2%) deliveries in the CTG + STan arm and in 107/485 (22.1%) in the CTG arm (adjusted relative risk, 1.02 (95% CI, 0.81–1.27); P = 0.89). There was no difference in the rate of adverse maternal or neonatal outcomes between arms. Conclusions: The addition of STan as an adjunct to continuous CTG did not reduce the EmCS rate. The smaller‐than‐anticipated sample size meant that this study was underpowered to detect absolute differences of ≤ 5% and, therefore, this negative finding could be due to a Type‐2 error. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Aims: Misoprostol is a prostaglandin E1 analogue that is used to prevent nonsteroidal anti‐inflammatory drug (NSAID)‐induced gastrointestinal disorders. The aim of this systematic review and meta‐analysis was to evaluate whether use of misoprostol also decreases the risk of NSAID‐induced kidney injury. Methods: Randomized controlled trials that compared misoprostol vs. placebo in an adult patient population were selected. The primary outcome was kidney injury and the secondary outcome was severe adverse events. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Twelve studies were eligible for inclusion. Although the rates of kidney injury and severe adverse events did not differ significantly between misoprostol and placebo, a posthoc subgroup analysis that excluded studies in which different NSAIDs were used in the misoprostol and placebo groups suggested that misoprostol may reduce the risk of NSAID‐induced kidney injury (risk difference −0.09, 95% confidence interval −0.15 to −0.03, P <.01, I2 = 87%; evidence of very low certainty). Conclusion: There is limited evidence that misoprostol reduces the risk of NSAID‐induced kidney injury. Misoprostol possibly contributes to reducing the risk of kidney injury associated with chronic NSAID use. The findings of this meta‐analysis suggest further high‐quality clinical trials are warranted. [ABSTRACT FROM AUTHOR]

Introduction: Children born to mothers with gestational diabetes mellitus (GDM) are at risk of metabolic disturbances such as diabetes mellitus and overweight. However, few have examined the outcome of children whose mothers were at risk of GDM. The aim of the study was to investigate how mothers' risk of developing GDM affects physical health and neurodevelopment of the children at 7 years of age. Material and methods: This is a secondary analysis of a follow‐up study of a multicenter randomized controlled trial including 855 pregnant women, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital in Norway from 2007 to 2009. Risk factors for developing GDM included age >40 years, diabetes in near family, previous child with birthweight ≥4500 g and pre‐pregnancy body mass index (BMI) ≥25 kg/m2. Data on GDM risk factors were available for 750 women, who were divided into a risk group if they had one or more risk factors for developing GDM (n = 238) and a no risk (n = 512) group. At 7 years of age, 72 children born to mothers in the risk group and 194 children born to mothers in the no risk group participated. The children's height, weight and physical activity were reported by their parents. Neurodevelopmental outcomes were assessed by using the Five‐to‐Fifteen questionnaire, which includes motor skills, executive functions, perception, memory, language, social skills, and emotional/behavioral problems. Results: Most women had only one risk factor for GDM, and pre‐pregnancy overweight was the most prevalent risk factor. Children of mothers in the risk group had higher birthweight and length. At the 7‐year follow‐up, they had a higher weight and BMI, and the odds ratio of being overweight was 3.0 (95% confidence interval 1.1–8.3). There was no group difference in the children's physical activity and their neurodevelopmental outcomes were similar. Conclusions: We found higher BMI and increased risk of overweight in children born to mothers with one or more risk factors for developing GDM. A focus on preventing pre‐pregnancy overweight should be encouraged. [ABSTRACT FROM AUTHOR]

Aim: This study developed, implemented and tested the effectiveness of a music‐with‐movement exercise programme in improving the pain situations of older adults with chronic pain. Design: A pilot randomized controlled trial. Methods: This was a pilot randomized controlled trial. The intervention was an 8‐week music‐with‐movement exercise (MMEP) programme for older adults with chronic pain recruited in elders' community centres. The control group received the usual care and a pain management pamphlet. Outcome variables were pain intensity, pain self‐efficacy and pain interference, depression and loneliness. Results: Seventy‐one participants joined this study. Pain intensity was significantly reduced between the experimental group compared to the control group. The experimental group participants reported significant improvements in pain self‐efficiency, pain interference and reduced loneliness and depressive symptoms. However, no significant difference was observed between groups. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effects of mutual goal‐based continuous care program on the outcomes of patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI). Design: A single‐blinded randomized controlled trial. Methods: 87 patients with CHD after PCI in Hangzhou, Zhejiang, China, were randomly divided into study (n = 42) and control (n = 45) groups. The control group received 12‐week cardiac rehabilitation and routine care. The study group received routine care and cardiac rehabilitation and the 12‐week intervention program developed according to the goal attainment theory, including the mutual goal‐based face‐to‐face guidance, and every‐2‐week telephone follow‐ups. The self‐management behaviour, quality of life, unscheduled readmission rate, and satisfaction of patients were examined. Results: For the patients subjected to the developed continuous nursing program based on mutual goals, achievement rates of all dimension mutual goals were at high levels (from 80.21% to 98.41%), except for the weight control (60.94%). Moreover, according to the comparable base data, compared with the control group, the self‐management behaviour (study group 93.43 vs. control group 76.00), quality of life (QoL), and patients' satisfaction (study group 4.64 vs. control group 4.11) were higher, while the unscheduled readmission rate (study group 4.76% vs. control group 22.22%) was lower, in the study group, with statistically significant differences. [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]

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]

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]

Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16‐week randomized double‐blind, placebo‐controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS‐AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post‐treatment. Results: Both groups were comparable in age (mean = 74 ± 7.2 years in the placebo group and 75 ± 7.4 in the intervention group) and in other demographics. Sixty‐two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS‐cog) was the primary outcome. By week 16, the mean ADAS‐cog reduced from 24.48 to 20.30 (mean reduction = 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reduction = 1.18) for those in the placebo group. The difference in mean reduction of ADAS‐cog was −3.00 (95% confidence interval [CI] = −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t‐scores) pre‐ and post‐treatment between the intervention group (n = 7) and the placebo group (n = 11) was statistically significant (P < 0.001). Conclusion: In this randomized, double‐blind placebo‐controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants. [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]

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]

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]

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]

Conflicts between humans and mammalian predators are globally widespread and increasing, creating a long‐lasting challenge for conservation and local livelihoods. Protection interventions, which are essential to conflict mitigation, should be based on solid evidence of effectiveness produced by robust study designs. Yet, it is unclear what study designs have been used in predator‐targeted interventions and how they can be improved to provide best practices for replications. I examined how applications of five study designs (before‐after, before‐after‐control‐impact, control‐impact, crossover [i.e., the same randomly assigned study units acting as treatments and controls during alternating trials], and randomized controlled trial) have changed over time and how these changes are related to authors, predator species, countries, and intervention types (aversion, husbandry, mixed interventions, invasive management, lethal control, and noninvasive management). I applied multinomial regression modeling to 434 cases (28 predator species and 45 countries) from 244 studies published from 1955 to 2020. Study design was related only to intervention type. Less reliable before‐after and control‐impact studies were the most common (47.7% and 38.2% of cases, respectively), and their use increased over years as did all interventions. The contribution of the most robust before‐after‐control‐impact (7.4%), randomized controlled trial (5.3%), and crossover designs (1.4%) remained minor over time. Crossover is suitable for aversion, most husbandry techniques, and a few other interventions, but crossover interventions also have the most limitations in terms of applicability. Randomized controlled trial is generally applicable, but impractical or inappropriate for some interventions, and before‐after‐control‐impact appears to be the most widely applicable study design for predator‐targeted interventions. [ABSTRACT FROM AUTHOR]

Introduction: We systematically reviewed the efficacy and safety of Calcitonin Gene‐Related Peptide (CGRP) antagonists for migraine treatment. Methods: Various databases including PubMed, Embase, The Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), WanFang Data were electronically searched for randomized controlled trials (RCTs) on CGRP antagonists for migraine treatment since inception to March 2021. The trials were screened for inclusion, after which the methodological quality of the included trials was assessed. Then meta‐analysis was performed using the Revman 5.3 software. Results: A total of 26 RCTs involving 21,736 patients were included. The CGRP antagonists group included 13,635 patients while the control group included 8101 patients. Meta‐analysis showed that compared to the control group, CGRP antagonists were associated with various significant effects, including the following outcome indicators: (1) number of patients with ≥50% reduction from baseline in mean monthly migraine days (RR = 1.50, 95% CI [1.39,1.62], p <.00001); (2) number of patients with pain free at 2 h postdose (RR = 1.98, 95% CI [1.77, 2.20], p <.00001), and (3) number of patients with 2–24 h sustained pain free postdose (RR = 2.18, 95% CI [1.93, 2.46], p <.00001). However, the number of patients with any adverse events was significantly high in the antagonists group, relative to the control group (RR = 1.08, 95% CI [1.04, 1.12], p <.0001). Conclusions: CGRP antagonists are significantly effective for migraine treatment; however, they are associated with various adverse events. Due to limitations with regards to quantity and quality of the included studies, the above conclusions should be verified by more high quality studies. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the efficacy and safety of berberine as an adjuvant in treating antipsychotic‐associated weight gain and metabolic syndrome. Methods: One hundred thirteen participants with schizophrenia spectrum disorders who had developed metabolic syndrome were recruited. They were randomly assigned to berberine (600 mg/d, n = 58) or placebo (n = 55) groups for 12 weeks. The primary outcome was the change from baseline to week 12 in net weight. Secondary outcomes included body mass index, waist circumference, serum glucose and lipid profiles, and the severity of psychotic symptoms. Results: Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD], −0.75; 95% CI, −1.42 to −0.07 [P = 0.031, d = 0.41]) and 12 weeks (MD, –1.08; 95% CI, −1.76 to −0.40 [P = 0.002, d = 0.59]). Patients who received berberine also showed statistically significant improvements in end point in body mass index (MD, –0.41; 95% CI, −0.65 to −0.17 [P = 0.001, d = 0.64]), total cholesterol (MD, –0.58; 95% CI, −0.74 to −0.41 [P < 0.001, d = 1.31]), low‐density lipoprotein (MD, –0.52; 95% CI, −0.68 to −0.35 [P < 0.001, d = 1.19]), and glycated hemoglobin (MD, –0.09; 95% CI, −0.18 to 0 [P = 0.05, d = 0.37]). Berberine was well tolerated without serious adverse events and aggravation of psychotic symptoms compared with placebo. Conclusion: The findings suggest that berberine is effective in attenuating antipsychotic‐associated weight gain and metabolic syndrome. [ABSTRACT FROM AUTHOR]

Aims: To describe a study protocol for a randomized controlled trial which will evaluate the effectiveness of a gamified mobile health intervention for children in whole day surgery care. Design: A study protocol for a two‐arm randomized controlled trial. Methods: Participants will be randomly assigned to the intervention group (N = 62), in which patients receive routine care and play a mobile game designed for children or the control group (N = 62), in which patients receive routine care, including a mobile phone application that supports parents during the care path. The primary outcome is children's pre‐operative anxiety, while the secondary outcome measures included fear and postoperative pain, along with parental satisfaction and anxiety. Data collection started in August 2020. Results: The results of the ongoing randomized controlled trial will determine whether the developed gamified mobile health intervention can be recommended for hospital use, and whether it could be used to educate children about their surgical treatment to decrease anxiety. [ABSTRACT FROM AUTHOR]

Objective: The aim of the present study was to evaluate the effect of a brief version of the behavioral intervention Acceptance and Commitment Therapy (ACT) on reducing gingivitis and plaque levels after 18 weeks. Materials and methods: One hundred thirty‐five caries‐active young adults (18–25 years of age), recruited from two public dental clinics, participated in this parallel group randomized control trial (RCT). Participants in the intervention (n = 67) received two ACT sessions in combination with standard information on oral health, and participants allocated to the control group (n = 68) received standard information only. Gingivitis and plaque levels were recorded at baseline and at the 9‐ and 18‐week follow‐ups. The effect of the intervention versus standard information alone was analyzed by intention‐to‐treat and per protocol, applying the General Linear Model (GLM). Exploratory analyses for the intervention and control groups were conducted to evaluate the effect of gender and smoking habits on the gingivitis and plaque outcome. The CONSORT guidelines for RCT were followed. Results: A significant decrease in gingivitis and plaque levels was observed over time, irrespective of treatment allocation. However, the ACT intervention was not significantly more effective at reducing gingivitis and plaque scores than standard information alone, even though the intervention participants had maintained their improvement to a greater extent. The exploratory analysis revealed that females improved their gingivitis and plaque levels significantly more than the males in the intervention group (p = 0.025 for gingivitis and p = 0.013 for plaque). Conclusion: A brief ACT intervention was not proven to be more effective than standard information alone at improving oral health in a sample of young adults with poor oral health. However, ACT seems to have a positive effect on oral health among females. (TRN ISRCTN15009620). [ABSTRACT FROM AUTHOR]

Background: The potential effects of aerobic and resistance training in patients with severe chronic kidney disease (CKD) are not fully elucidated. This study investigated the effects of a home‐based exercise programme on physical functioning and health‐related quality of life (HRQOL) in patients with Stage 4 CKD, equivalent to estimated glomerular filtration rate of 15–30 mL/min/1.73 m2. Methods: Forty‐six patients with Stage 4 CKD (median age, 73 years; 33 men) were randomly assigned to exercise (n = 23) and control (n = 23) groups. Exercise group patients performed aerobic exercise at 40–60% peak heart rate thrice weekly and resistance training at 70% of one‐repetition maximum twice weekly at home for 6 months. Control patients received no specific intervention. Primary outcomes were distance in incremental shuttle walking test and HRQOL assessed using the Kidney Disease Quality of Life—Short Form questionnaire. Secondary outcomes included kidney function assessed with combined urea and creatinine clearance, urinary biomarkers, and anthropometric and biochemical parameters associated with CKD. Results: Improvement in incremental shuttle walking test was significantly greater in the exercise group compared with controls (39.4 ± 54.6 vs. −21.3 ± 46.1; P < 0.001). Among Kidney Disease Quality of Life domains, significant mean differences were observed between the exercise group and the control group in work status, quality of social interaction, and kidney disease component summary outcomes (12.76 ± 5.76, P = 0.03; 5.97 ± 2.59, P = 0.03; and 4.81 ± 1.71, P = 0.007, respectively). There were greater reductions in natural log (ln)‐transformed urinary excretion of liver‐type fatty acid‐binding protein, ln serum C‐reactive protein, and acylcarnitine to free carnitine ratio in the exercise group compared with controls, with significant between‐group differences of −0.579 ± 0.217 (P = 0.008), −1.13 ± 0.35 (P = 0.003), and −0. 058 ± 0.024 (P = 0.01), respectively. Conclusions: Our 6 month home‐based exercise programme improved aerobic capacity and HRQOL in patients with Stage 4 CKD, with possible beneficial effects on kidney function and CKD‐related parameters. [ABSTRACT FROM AUTHOR]

Objectives: To compare the short‐ and long‐term emotional distress (grief, anxiety and depressive symptoms) after early miscarriage and satisfaction with treatment between women randomized to expectant management vs vaginal misoprostol treatment. Methods: This was a preplanned analysis of data collected during a randomized controlled trial comparing expectant management with misoprostol treatment in women with early anembryonic or embryonic miscarriage and vaginal bleeding. If the miscarriage was not complete on day 31 after inclusion, surgical evacuation was recommended. The main outcomes were levels of anxiety and grief, depressive symptoms and client satisfaction with the treatment, which were assessed using the following validated psychometric self‐assessment instruments: Spielberger State–Trait Anxiety Inventory (STAI, Form Y), Perinatal Grief Scale (PGS), Montgomery–Åsberg Depression Rating Scale (MADRS‐S; self‐reported version) and Client Satisfaction Questionnaire (CSQ‐8). All women were assessed at four timepoints: on the day of randomization, on the day when the miscarriage was judged to be complete, and at 3 months and 14 months after complete miscarriage. The psychometric and client satisfaction scores were compared between the misoprostol group and the expectant‐management group at each assessment. Analysis was performed by the intention‐to‐treat principle. Results: Ninety women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment timepoints. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had a STAI‐state score of > 46 ('high level of anxiety'), and 9% (8/86) and 10% (9/91), respectively, had symptoms of moderate or severe depression (MADRS‐S score ≥ 20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild in both groups, with a median PGS score of 40.0 at 3 months and 37.0 at 14 months after complete miscarriage in both treatment groups. Four women treated with misoprostol and two women managed expectantly had a PGS score of > 90 (indicating deep grief) 3 months after complete miscarriage, while one woman managed expectantly had a PGS score of > 90 14 months after complete miscarriage. Women in both treatment groups were satisfied with their management, as indicated by a median CSQ‐8 score of > 25 at each assessment. More than 85% of participants in each of the two groups reported that they would recommend the treatment they received to a friend. Conclusions: The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on the management of early miscarriage. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Introduction: Major depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa. Methods: This was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time. Results: At 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time. Conclusions: Task‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824 [ABSTRACT FROM AUTHOR]

Objective: Metacognitive therapy (MCT) and cognitive–behavior therapy (CBT) are effective treatments for generalized anxiety disorder. In this study, we followed‐up patients who had previously participated in a randomized controlled trial of MCT compared against CBT. Method: We collected 9‐year follow‐up data on 39 out of 60 original patients (i.e., 65% response rate). Results: At 9 years, the recovery rates were 57% for MCT and 38% for CBT (completer analysis). Following MCT, 43% maintained their recovery status and a further 14% achieved recovery. Following CBT, the sustained recovery rate was 13%, while a further 25% achieved recovery. Patients in the MCT condition showed significantly more improvement with respect to symptoms of worry and anxiety. In the CBT group, 23.1% were re‐diagnosed with generalized anxiety disorder (GAD) compared with 9.5% in the MCT group. Conclusions: This follow‐up study showed a continuation of gains in both treatments at long‐term follow‐up, but with outcomes continuing to favor MCT and strengthening its comparative superiority. [ABSTRACT FROM AUTHOR]

We aimed to evaluate the quality of clinical evidence that substantiated approval of cancer medicines by the European Medicines Agency (EMA) in the last decade. We performed a systematic review and data synthesis of EMA documents in agreement with PRISMA guidelines. We included the European Public Assessment Reports, Summaries of Product Characteristics, and published randomized controlled trials (RCTs) on anti-cancer drugs approved by EMA from 2010 to 2019, and excluded drugs not indicated for targeting solid or hematological tumors and non-innovative treatments. We synthesized frequencies of approvals differentiating between unblinded and blinded RCTs with and without overall survival (OS) as a predefined primary outcome measure. We assessed the frequency of post-approval RCTs for indications without at least one RCT at the time of approval. Of 199 approvals, 159 (80%) were supported by at least one RCT, 63 (32%) by at least one RCT having OS as the primary or co-primary endpoint, 74 (37%) by at least one blinded RCT, and 30 (15%) by at least one blinded RCT having OS as the primary or co-primary endpoint. Whereas 40 approvals (20%) were not supported by any RCT and, of those, 9 (22%) were followed by a post-approval RCT. While the majority of approvals of cancer medicines approved by EMA was supported by at least one RCT, we noted substantial methodological heterogeneity of the studies. [ABSTRACT FROM AUTHOR]

Background: Visual hallucinations are common in patients with Parkinson's disease and represent probably the major independent predictor for cognitive deterioration and nursing home placement. Objective: To investigate if treatment of minor visual hallucinations in Parkinson's disease with rivastigmine delays the progression to psychosis. Methods: A multicenter, randomized, double‐blind, placebo‐controlled trial was conducted which aimed to recruit 168 patients with Parkinson's disease reporting minor visual hallucinations 4 weeks before it. Important exclusion criteria were Parkinson's disease dementia, current delirium, and treatment with antipsychotics or drugs that have significant anti‐cholinergic side effects. Subjects were randomized to rivastigmine capsules, 3–6 mg twice a day, or placebo for 24 months. The primary outcome was the time to Parkinson's disease psychosis, which was defined as the need to start with antipsychotics. Results: The trial was stopped prematurely because of slow recruitment. Ninety‐one patients were randomized: 46 patients were assigned to rivastigmine and 45 patients to placebo. No effect of rivastigmine could be demonstrated on the transition time to psychosis or dementia during the 24‐month follow‐up period. After 6 months of study treatment, cognition, mood, motor performance, and non‐motor performance did not differ significantly between the rivastigmine‐group and the placebo‐group. Conclusions: Because the study was terminated early, it was insufficiently powered to properly evaluate the primary outcome. The limited data of the study favor a wait and see approach instead of early treatment with rivastigmine in PD patients with minor VH. [ABSTRACT FROM AUTHOR]

Addressing the environmental impacts of large‐scale agriculture requires innovative approaches to conservation program design and evaluation. We used a randomized controlled trial and a sample of 2225 landowners in the Mississippi River Basin to test a new conservation program that targets a growing but overlooked population—nonoperating landowners (NOLs). To spur adoption of conservation practices on farmland rented out by NOLs, the program provided NOLs with ready‐to‐use lease language and a financial incentive. The program's design was informed by field work, the behavioral science literature, and the social science literature on barriers to conservation on farmland. We cannot detect an effect on conservation practices from the lease language or the incentive. The take‐up rate for the incentive was one‐tenth the expected rate based on NOL responses to a hypothetical offer in a survey. The results underscore the importance of assessing program performance by rigorously testing programs in real conservation settings. [ABSTRACT FROM AUTHOR]

Aim: To explore the effects of an educational‐ counselling programme based on the precede–proceed model during pregnancy on preventing post‐partum depression. Design: A randomized clinical trial (RCT) study. Method: 130 pregnant women were selected and randomly assigned to intervention and control groups. Data collection was carried out using questionnaires of predisposing, reinforcing and enabling factors, GHQ and Edinburgh Postnatal Depression Scale (EPDS). The Education programme was designed and performed in each group in a given weekday through four 60‐minute sessions. The whole intervention lasted for one month in all groups. The participants in the control group were given routine pregnancy care. Data were gathered before and after the intervention in both groups. Results: Independent t test showed a significant difference between the two groups in terms of the mean score of predisposing, reinforcing, enabling factors and post‐partum depression (p <.05). Regression tests indicated predisposing, reinforcing, enabling factors and general health as the most important factors associated with post‐partum depression (p <.05). The results supported the effectiveness of the educational intervention on reducing post‐partum depression and showed that implementing these training during pregnancy leads to a reduced level of post‐partum depression. [ABSTRACT FROM AUTHOR]

Background: Missing patient reported outcomes data threaten the validity of PRO‐specific findings and conclusions from randomized controlled trials by introducing bias due to data missing not at random. Clinical Research Associates are a largely unexplored source for informing understanding of potential causes of missing PRO data. The purpose of this qualitative research was to describe factors that influence missing PRO data, as revealed through the lived experience of CRAs. Methods: Maximum variation sampling was used to select CRAs having a range of experiences with missing PRO data from academic or nonacademic centers in different geographic locations of Canada. Semistructured interviews were audio‐recorded, transcribed verbatim, and analyzed according to descriptive phenomenology. Results: Eleven CRAs were interviewed. Analysis revealed several factors that influence missing PRO data that were organized within themes. PROs for routine clinical care compete with PROs for RCTs. Both the paper and electronic formats have benefits and drawbacks. Missing PRO data are influenced by characteristics of the instruments and of the patients. Assessment of PROs at progression of disease is particularly difficult. Deficiencies in center research infrastructure can contribute. CRAs develop relationships with patients that may help reduce missing PRO data. It is not always possible to provide sufficient time to complete the instrument. There is a need for field guidance and a motivation among CRAs to contribute their knowledge to address issues. Conclusion: These results enhance understanding of factors influencing missing PRO data and have important implications for designing operational solutions to improve data quality on cancer RCTs. [ABSTRACT FROM AUTHOR]

Aim: Randomized controlled trials (RCT) are the gold standard in surgical research, and case‐matched studies, such as studies with propensity score matching, are expected to serve as an alternative to RCT. Both study designs have been used to investigate the potential superiority of laparoscopic surgery to open surgery for rectal cancer, but it remains unclear whether there are any differences in the findings obtained using these study designs. We aimed to examine similarities and differences between findings from different study designs regarding laparoscopic surgery for rectal cancer. Methods: Systematic review and meta‐analyses. A comprehensive literature search was conducted using PubMed, Scopus, and Cochrane. RCT, case‐matched studies, and cohort studies comparing laparoscopic low anterior resection and open low anterior resection for rectal cancer were included. In total, 8 short‐term outcomes and 3 long‐term outcomes were assessed. Meta‐analysis was conducted stratified by study design using a random‐effects model. Results: Thirty‐five studies were included in this review. Findings did not differ between RCT and case‐matched studies for most outcomes. However, the estimated treatment effect was largest in cohort studies, intermediate in case‐matched studies, and smallest in RCT for overall postoperative complications and 3‐year local recurrence. Conclusion: Findings from case‐matched studies were similar to those from RCT in laparoscopic low anterior resection for rectal cancer. However, findings from case‐matched studies were sometimes intermediate between those of RCT and unadjusted cohort studies, and case‐matched studies and cohort studies have a potential to overestimate the treatment effect compared with RCT. [ABSTRACT FROM AUTHOR]

Complementary feeding diets in low‐ and middle‐income countries are generally inadequate to meet requirements for growth and development. Food‐based interventions may prevent nutrient inadequacies provided that they do not displace other nutrient‐rich foods. We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were provided an egg a day for 6 months or assigned to a control group. Dietary intake of complementary foods and drinks was assessed at baseline, 3‐month midline and 6‐month endline visits using a tablet‐based multipass 24‐h recall. Up to two repeat recalls were collected at each time point in a subsample of 100 children per treatment group. At midline and endline, usual energy intake from eggs was about 30 kcal/day higher in the egg group compared with controls (p < 0.0001). Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline. There was a comparable, but nonsignificant, greater total usual energy intake from complementary foods of 30 kcal/day at midline (p = 0.128) and 36 kcal/day at endline (p = 0.087). There also was a displacement of 7 kcal/day in legumes and nuts in children at endline (p = 0.059). At midline and endline, more than 80% of children in the egg group consumed a minimally diverse diet compared with 53% at midline and 60% at endline in the control group. This study illustrates that mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other complementary foods. [ABSTRACT FROM AUTHOR]