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Background: To date, evidence regarding the effectiveness and safety of individualized controlled ovarian stimulation (COS) compared with standard dose COS has been inadequate. Objectives: To evaluate the updated evidence from published randomized controlled trials (RCTs) about the efficacy and safety of individualized COS with different ovarian reserve test biomarkers or clinical experience versus standard dose COS. Search Strategy: Terms and descriptors related to COS, individualized or standard, and RCT were combined to search, and only English language studies were included. Conference abstracts and comments were excluded. Selection Criteria: RCTs with comparison between different individualized COS strategies and standard starting dose strategy were included. Data Collection and Analysis: Two reviews independently assessed the eligibility of retrieved citations in a predefined standardized manner. Relative risk (RRs) and the weighted mean difference (WMD) with 95% confidence intervals (CIs) were pooled using a random‐effects model on R software version 4.2.2. Main Results: Compared with the standard dose COS strategy in pairwise meta‐analysis, the individualized COS strategy was associated with a notable lower risk of ovarian hyperstimulation syndrome (OHSS; 174/2384 [7.30%] vs 114/2412 [4.73%], RR 0.66, 95% CI: 0.47–0.93, I2 = 46%), a significantly lower risk of hyperresponse to stimulation (hyperresponse; 476/2402 [19.82%] vs 331/2437 [13.58%], RR 0.71, 95% CI: 0.57–0.90, I2 = 61%), and a slightly longer ovarian stimulation days (duration of stimulation; WMD 0.20, 95% CI: 0.01–0.40, I2 = 66%). Bayesian network meta‐analysis also found that biomarker‐tailored strategy had a significantly lower risk of OHSS than standard dose strategy (OHSS; RR 0.63, 95% CI: 0.41–0.97, I2 = 47.5%). Conclusion: Compared with standard dose COS strategy, individualized COS strategy could significantly reduce the risks of OHSS and hyperresponse to stimulation, but the duration of stimulation was slightly longer. Trial Registration: PROSPERO: CRD42023358439. Synopsis: Individualized controlled ovarian stimulation (COS) strategy can significantly reduce the risk of ovarian hyperstimulation syndrome (OHSS) and hyperresponse to stimulation, but the duration of stimulation is slightly longer. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion This study aimed to develop and evaluate the efficacy and safety of Supine Daoyin, a TCM PR technique, in hospitalized patients with AECOPD.This is a multicenter, prospective, randomized, controlled trial involving AECOPD inpatients recruited from April 2021 to December 2023 in five tertiary hospitals in China. Participants were randomly assigned to 14 days of Supine Daoyin group or control group and evaluated at days 3, 7, and 14 (posttreatment). The primary outcomes were LOS and CCQ and secondary outcomes were 6MWD, 30‐STS, BI, Borg CR10, time on mechanical ventilation, SGRQ, mCOPD‐PRO, and mESQ‐COPD.Out of 369 participants screened, 228 were randomly assigned (Supine Daoyin group: n = 114; control group: n = 114). For primary outcomes, there was no significant between‐group difference in LOS (p > 0.05), but for CCQ the Supine Daoyin was superior to control at days 7 (p < 0.01) and 14 (p < 0.01). For secondary outcomes, Supine Daoyin groups showed robust and superior improvements in 6MWD, 30‐STS, BI, Borg CR10, SGRQ, mCOPD‐PRO, and mESQ‐COPD (all p < 0.05), but for time on mechanical ventilation there was no significant difference in two groups (p > 0.05).Supine Daoyin, a novel TCM PR technique, demonstrates safety and efficacy for AECOPD inpatients, yielding clinically meaningful improvements in health status, exercise capacity, and quality of life. This study offers a viable PR option for AECOPD patients with severe symptoms and limited mobility. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion ClinicalTrials The present study examined the effects of a nurse‐led family empowerment program on the quality of life of Palestinian pregnant adolescents.This was a randomized controlled trial with a two‐group pre−/post‐test design. The sample consisted of 58 pregnant adolescents recruited from six governmental primary health care clinics in Palestine. Participants were randomly allocated in equal numbers to either the control group (n = 29), which received routine care, or the experimental group (n = 29), which received both routine care and the study program. Data collection instruments included a demographic form and the WHO Quality of Life‐BREF (WHOQoL‐BREF). Data were collected twice: at 32 or 33 weeks' gestation to establish a baseline and at 36 or 37 weeks' gestation post‐test. Statistical analyses were performed and included descriptive statistics, chi‐square and t‐tests.The study findings indicated a significant increase in the mean quality of life scores of the experimental group in the post‐test compared to the pre‐test (P < 0.001). Additionally, pregnant adolescents in the experimental group demonstrated significantly higher post‐test QoL scores than those in the control group (P < 0.001).The nurse‐led family empowerment program emerges as a viable and efficacious alternative intervention for improving the quality of life among Palestinian pregnant adolescents.The study was registered with the NIH U.S. National Library of Medicine ClinicalTrials.gov on 01/09/2021 with the registration code NCT05031130. It can be accessed via this link: https://classic.clinicaltrials.gov/ct2/show/NCT05031130. [ABSTRACT FROM AUTHOR]

Background: Appendicitis is the commonest paediatric surgical emergency. Adult studies suggest non‐operative management (NOM) may have a place in care. There have been no adequately powered randomized controlled trials in children. Objective: to determine the safety and efficacy of NOM for paediatric simple appendicitis. Methods: A non‐inferiority randomized controlled trial was conducted comparing operative (OM) to NOM of SA in children aged five‐15 years. Primary outcome was treatment success (no unplanned or unnecessary operation, or complication) at 30 days and 12 months, with a non‐inferiority margin of 15%. (anzctr.org.au: ACTRN12616000788471). Results: From 11 June 2016 to 30 November 2020, 222 children were randomized: 94 (42.34%) to OM and 128 (57.66%) to NOM. Non‐inferiority of NOM was not demonstrated at either time point, with 45.67% of NOM patients subsequently undergoing operation. There was no significant difference in complications. Conclusions: While noninferiority was not shown, NOM was safe, with no difference in adverse outcomes between the two groups. Further research to refine the place of NOM of simple appendicitis in children is required, including nuanced patient selection, longer term evaluation, the place of choice, and the acceptability of the treatment for children and their carers. [ABSTRACT FROM AUTHOR]

Aims: The aim of this work was to measure the impact of P2P (i.e. peer‐to‐peer), a peer‐led smoking prevention intervention, on daily smoking prevalence of adolescents over 2 school years. Design: A cluster‐randomized controlled trial was performed over a 16‐month follow‐up (trial status: closed to follow‐up). P2P was implemented 1–3 and 13–15 months after baseline. Assessments took place at baseline and 4, 10 and 16 months after baseline. The research team, assessors and adolescents were blinded to the study‐arm assignment only at baseline. Setting: Fifteen vocational high schools in France were randomized into two clusters, using a 1:1 allocation ratio per French department (n intervention = 7, n control = 8). Participants: Participants comprised a sample of 2010 students in year 11 (i.e. 15–16 years) in vocational high schools. A total of 437 students could not be assessed at baseline (absent or left school), yielding a total sample of 1573 students (n intervention = 749, n control = 824). Intervention and comparator: The P2P programme trained voluntary students to become peer educators and design smoking prevention actions for their schoolmates in the intervention group (n = 945 students), compared with a passive control group (n = 1065 students). Measurements The primary outcome was change from baseline in the prevalence of self‐reported daily smoking (i.e. at least one cigarette per day) at 16 months. Findings The 'time × group' interaction indicated that, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 16 months [odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.20, 0.53]. Similarly, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 4 months (OR = 0.50, 95% CI = 0.30, 0.82) and 10 months (OR = 0.60, 95% CI = 0.37, 0.98). No adverse events of P2P2 were reported. Conclusions: A cluster‐randomized trial found evidence that the peer‐led P2P (peer‐to‐peer) smoking prevention intervention reduced the uptake of daily smoking among high school students in France over 16 months. [ABSTRACT FROM AUTHOR]

Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [ABSTRACT FROM AUTHOR]

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial. Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health‐related quality of life, and infant feeding practices. Analysis was by intention to treat. Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain‐discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm. Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence‐informed decisions about monitoring options should STan become more widely available. [ABSTRACT FROM AUTHOR]

Background Purpose Materials and Methods Results Conclusions Robot‐assisted implant surgery has emerged as a novel digital technology, and the accuracy need further assessment.This study aimed to compare the accuracy of single dental implant placement between a novel semi‐active robot‐assisted implant surgery (RAIS) method and the conventional free‐hand implant surgery (FHIS) method through a multicenter, randomized controlled clinical trial.Patients requiring single dental implant placement were recruited and randomized into RAIS and FHIS group. Deviations at the platform, apex, and angle between the planned and final implant positions were assessed in both groups. Additionally, the evaluation of instrument and surgical complications was examined.A total of 140 patients (median age: 35.35 ± 12.55 years; 43 males, 97 females) with 140 implants from four different research centers were included, with 70 patients (70 implants) in the RAIS group and 70 patients (70 implants) in the FHIS group. In the RAIS and FHIS groups, the median platform deviations were 0.76 ± 0.36 mm and 1.48 ± 0.93 mm, respectively (p < 0.001); median apex deviations were 0.85 ± 0.48 mm and 2.14 ± 1.25 mm, respectively (p < 0.001); and median angular deviations were 2.05 ± 1.33° and 7.36 ± 4.67°, respectively (p < 0.001). Similar significant difference also presented between RAIS and FHIS group in platform vertical/horizontal deviation, apex vertical/horizontal deviation. Additionally, implants with self‐tapping characteristics exhibited significantly larger deviations compared with those without self‐tapping characteristics in the RAIS group. Both RAIS and FHIS methods demonstrated comparable morbidity and safety pre‐ and post‐operation.The results indicated that the RAIS method demonstrated superior accuracy in single dental implant placement compared with the FHIS method. Specifically, RAIS exhibited significantly smaller deviations in platform, apex, and angular positions, as well as platform and apex vertical/horizontal deviations.This clinical trial was not registered prior to participant recruitment and randomization. https://www.chictr.org.cn/showproj.html?proj=195045. [ABSTRACT FROM AUTHOR]

Objective Materials and Methods Results Conclusion To compare fully guided flapless implant surgery using a light‐cured surgical guide (FG group) with partially guided open flap surgery (PG group) in the posterior maxilla when performing simultaneous sinus floor elevation in terms of the accuracy, time requirements, and patient/clinician‐reported outcomes (PROMs and CROMs).In this study, 56 tissue‐level implants were placed with crestal sinus floor elevation in 56 patients at single‐tooth sites, with 28 implants allocated to the PG group and 28 to the FG group. The deviations of the placed implants from the virtually planned positions were measured at the implant platform and apex and for the angular deviation. The presurgical preparation time and the duration of surgery were measured. PROMs and CROMs were made by administering questionnaires at multiple time points.Horizontal deviations at the platform and apex and the angular deviation were significantly smaller in the FG group than the PG group (p < .05). Presurgical preparation and surgery times were significantly shorter in the FG group (p < .001). Patient satisfaction and willingness to receive repeat treatment were significantly better in the FG group than in the PG group (p < .005 and .025, respectively). Clinicians were more satisfied in the FG group than the PG group (p < .05).When placing an implant with sinus floor elevation, the flapless approach using a fully guided surgical system can be more accurate, faster, and increase the satisfaction of both the clinician and patient compared to the partially guided surgery. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the quantity and quality of randomized controlled trials (RCTs) in hepatobiliary surgery and for identifying gaps in current evidences. Methods: A systematic search was conducted in MEDLINE (via PubMed), Web of Science, and Cochrane Controlled Register of Trials (CENTRAL) for RCTs of hepatobiliary surgery published from inception until the end of 2023. The quality of each study was assessed using the Cochrane risk‐of‐bias (RoB) tool. The associations between risk of bias and the region and publication date were also assessed. Evidence mapping was performed to identify research gaps in the field. Results: The study included 1187 records. The number and proportion of published randomized controlled trials (RCTs) in hepatobiliary surgery increased over time, from 13 RCTs (.0005% of publications) in 1970–1979 to 201 RCTs (.003% of publications) in 2020–2023. There was a significant increase in the number of studies with a low risk of bias in RoB domains (p <.01). The proportion of RCTs with low risk of bias improved significantly after the introduction of CONSORT guidelines (p <.001). The evidence mapping revealed a significant research focus on major and minor hepatectomy and cholecystectomy. However, gaps were identified in liver cyst surgery and hepatobiliary vascular surgery. Additionally, there are gaps in the field of perioperative management and nutrition intervention. Conclusion: The quantity and quality of RCTs in hepatobiliary surgery have increased over time, but there is still room for improvement. We have identified gaps in current research that can be addressed in future studies. [ABSTRACT FROM AUTHOR]

Background and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. Findings: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12- month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Resilience training has beneficial effects on the ability of undergraduate students to withstand adversity and stress. However, there are inconsistencies in the content and delivery approaches for resilience training. Given the increasing shifts towards computer‐assisted instruction, there is a need to develop and evaluate innovative approaches for resilience training. This study aimed to examine the efficacy of two versions of the Resilience Skills Enhancement (RISE) programme. A randomized controlled trial was used to evaluate the effects of blended learning (BL) and a self‐guided RISE programme on the resilience, social support, and learning outcomes of undergraduate students. One hundred and fourteen students were recruited and randomly allocated to receive either BL or the self‐guided RISE programme. The within‐group analyses indicated significant improvements in resilience scores for the BL (F = 37.74, p < 0.001) and self‐guided groups (F = 10.16, p < 0.001) with moderate (d = 0.62, 95% CI: 0.25, 1.00) to large effect sizes (d = 1.11, 95% CI: 0.71, 1.50) respectively. There were also significant differences across the three time points for social support scores for the BL (F = 4.50, p < 0.05) and self‐guided groups (F = 4.59, p < 0.05). Students in the BL group had considerable improvements in self‐efficacy of learning and performance (F = 5.42, p < 0.01) and meta‐cognitive self‐regulation scores (F = 5.91, p < 0.01). In the between‐group analyses, both BL and self‐guided RISE were comparable for resilience, social support, and learning scores (p > 0.05). The study provided preliminary evidence that both modes, BL and self‐guided RISE programme lead to positive effects on the resilience, social support, and learning scores of students. [ABSTRACT FROM AUTHOR]

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]

Introduction Materials and methods Results Conclusion Chronic actinic dermatitis (CAD) is an immunologically mediated photodermatosis that has been effectively treated with azathioprine and mycophenolate mofetil (MMF) in uncontrolled studies. We conducted a prospective randomized controlled trial to compare the efficacy and safety of azathioprine and MMF in CAD treatment, aiming to address existing evidence gaps.Consecutive CAD patients were randomized into two groups: azathioprine (Group A) or MMF (Group B) for 12 weeks. Primary outcomes included Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) at baseline and Week 12. Secondary outcomes included various clinicodemographic factors predictive of treatment response, defined at least a 75% reduction in EASI score (EASI75) by Week 12.The median (IQR) percentage reduction in EASI at 12 weeks was higher in Group B than in Group A [78.3% (75.0–83.30%) vs. 68.3% (31.2–80.10%), P = 0.034]. Baseline DLQI scores indicated a moderate impact on quality of life, with significant reductions by Week 12 in both groups and no intergroup differences at baseline (P = 0.291) or Week 12 (P = 0.599). Overall, 23 patients were classified as non‐responders, with more extended illness duration (P = 0.026) and outdoor occupations (P = 0.042) associated with poorer responses. Adverse effects were consistent with known profiles, with one patient discontinuing azathioprine due to hypersensitivity.Our study highlights the efficacy and safety of azathioprine and MMF in CAD treatment, with MMF showing superior outcomes. However, further research is warranted to explore emerging therapies and prognostic factors in CAD management. [ABSTRACT FROM AUTHOR]

Background Objectives Methods Results Conclusions Poor reporting quality and spin in randomized controlled trial (RCT) abstracts can lead to misinterpretation and distorted interpretation of results.This methodological study aimed to assess the reporting quality and spin among RCT abstracts on splint therapy for temporomandibular disorders (TMD) and explore the association between spin and potentially related factors.The authors searched PubMed for RCTs on splint therapy for TMD. The reporting quality of each abstract was assessed using the original 16‐item CONSORT for abstracts checklist. The authors evaluated the presence and characteristics of spin only in abstracts with nonsignificant primary outcomes according to pre‐determined spin strategies. Logistic regression analyses were performed to identify factors associated with the presence of spin.A total of 148 abstracts were included in the reporting quality evaluation. The mean overall CONSORT score (OCS) was 5.86 (score range: 0–16). Only interventions, objectives and conclusions were adequately reported. Of the 61 RCT abstracts included for spin analysis, spin was identified in 38 abstracts (62.3%), among which 32 abstracts (52.3%) had spin in the Results section and 21 (34.4%) had spin in the Conclusions section. A significantly lower presence of spin was found in studies with exact p‐value reporting (OR: 0.170; 95% CI: 0.032–0.887; p = .036) and a two‐arm comparison design (OR: 11.777; 95% CI: 2.171–63.877; p = .004).The reporting quality of RCT abstracts on splint therapy for TMD is suboptimal and the prevalence of spin is high. More awareness and joint efforts are needed to improve reporting quality and minimize spin. [ABSTRACT FROM AUTHOR]

Background: Nutritional strategies to maintain bone health in aging individuals are of great interest. Given the beneficial nutrient composition of walnuts, rich in alpha‐linolenic (the vegetable n‐3 fatty acid) and polyphenols, their regular consumption might be a dietary option to reduce age‐related bone loss. We determined whether daily walnut consumption improves bone mineral density (BMD) and circulating biomarkers of bone turnover. Methods: The Walnuts and Healthy Aging study (WAHA) is a two‐center, parallel, randomized controlled trial evaluating the effect of a diet enriched with walnuts at ≈15% energy compared with a control diet for 2 years on age‐related health outcomes in healthy men and women aged 63–79 years. Changes in BMD were a prespecified secondary outcome only at the Barcelona node of the trial, where 352 participants were randomized. Retention rate was 92.6%. Primary endpoints were 2‐year changes in BMD at the spine and the nondominant femoral neck, determined by dual‐energy X‐ray absorptiometry (DXA). Secondary endpoints were 2‐year changes in bone turnover biomarkers (adrenocorticotropic hormone, Dickkopf WNT signaling pathway inhibitor‐1, osteoprotegerin, osteocalcin, osteopontin, sclerostin, parathyroid hormone, and fibroblast growth factor‐23), which were quantified in 211 randomly selected participants. Results: The walnut diet versus the control diet had no effect on 2‐year changes in BMD at the spine (0.15% vs. 0.35%, p = 0.632) and femoral neck (−0.90% vs. −0.70%, p = 0.653), or on bone turnover biomarkers. Results were similar in participants treated or not with bone resorption inhibitors or those with or without osteoporosis/osteopenia at inclusion. Conclusions: Compared with the usual diet, a diet enriched with walnuts at 15% of energy for 2 years failed to improve BMD or circulating markers of bone metabolism in healthy older people. [ABSTRACT FROM AUTHOR]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [ABSTRACT FROM AUTHOR]

Objective: Theoretical models highlight body image disturbances as central to the maintenance of eating disorders, with empirical evidence finding negative body image to be a robust predictor of treatment nonresponse, relapse and symptom persistence. Accessible, scalable, and inexpensive interventions that can effectively target negative body image across the eating disorders are needed. We developed an online single session intervention (SSI) for negative body image and evaluated its acceptability and efficacy in a randomized controlled trial in individuals with recurrent binge eating. Method: Participants with recurrent binge eating were randomly assigned to the SSI (n = 99) or a waitlist (n = 101). Assessments were conducted at baseline, 4 week follow‐up, and 8 week follow‐up. Results: 81% of participants accessed the SSI, demonstrating reasonable uptake. However, issues with attrition were apparent; a 32% study dropout rate was observed at posttest, while a 58% dropout rate was observed at follow‐up. 87% of participants who completed satisfaction measures would recommend the SSI. SSI participants experienced greater improvements in negative body image at both 4 (d = −0.65) and 8 week (d = −0.74) follow‐up. Significant between‐group effects were also observed on most other secondary symptom measures, though no differences were found for motivations and help‐seeking beliefs and intentions. Conclusion: Body image‐focused self‐guided SSIs for recurrent binge are largely accepted by those who are retained in the trial, but are associated with significant attrition. Although SSIs are not intended to replace standard treatment, they may help with short‐term symptom management and could play an important role in eating disorder care. Public Significance: Single session interventions (SSI) are a potentially accessible, scalable, and cost‐effective way to deliver evidence‐based treatment content to people with eating disorders. This study shows that an online (SSI) designed to target body image among people with recurrent binge eating is accepted and produced short‐term symptom relief. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted in order to determine the effect on halitosis and the antibacterial effect against halitosis‐causing bacteria of the mouthwash made of the natural material, Glycyrrhiza uralensis (G. uralensis) extract. Materials and Methods: A randomized, double‐blind, placebo‐controlled study was conducted on 60 patients who visited M dental clinic located in Busan, South Korea, excluding those with systemic disease that may induce halitosis. There were 30 patients classified to the saline gargle group and the remaining 30 patients were classified to the G. uralensis extract gargle group. In addition, their level of halitosis and halitosis‐causing bacteria were measured. They visited the dental clinic on a fasted state at baseline before gargle application (Baseline), immediately after gargle application (Treatment) and 5 days after gargle application (After 5 Days). For clinical indicators, participants were tested for halitosis and bacteria immediately after waking up without brushing their teeth and without hydration. Results: The prevalence of halitosis decreased in the G. uralensis extract gargle group compared to the saline gargle group at Treatment and After 5 Days. In cases with pseudo halitosis, there was a significant decrease in halitosis‐causing bacteria when G. uralensis extract gargle was applied (p < 0.05). Conclusions: It was identified that using a mouthwash made with G. uralensis extract is effective for halitosis improvement and reduction of halitosis‐causing bacteria. Therefore, using a mouthwash containing G. uralensis extract, it will be effective in improving bad breath and oral hygiene will be possible. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion Clinical Trial Registration To determine the effectiveness of povidone‐iodine application after skin closure to prevent surgical site infection after an emergency cesarean section and to assess risk factors associated with surgical site infection.A randomized controlled trial enrolled 352 pregnant women who required emergency cesarean delivery at King Chulalongkorn Memorial Hospital, from August 2018 to March 2019. Participants were randomly assigned to receive the povidone‐iodine application at the incision after skin closure (n = 176) or without application (n = 176). Thirty‐day surveillance of complications and adverse effects was performed. The primary outcome was the incidence of surgical site infection, which was compared between groups using the chi‐squared test. The adjusted odds ratios (ORs) of the factors associated with surgical site infection were determined by logistic regression analysis.There were no significant differences in the incidence of surgical site infection and adverse effects between the povidone‐iodine and control groups (9.5% vs 7.1%, P = 0.430). The significant factor associated with surgical site infection was a long interval (≥60 min) from the administration of prophylactic antibiotics to the incision (adjusted OR 4.06, 95% CI 1.49–11.03).The application of povidone‐iodine after skin closure in an emergency cesarean section did not have the advantage of reducing the incidence of surgical site infection.This study was registered in TCTR registry on March 10, 2018 with trial identification number: TCTR20180310002 (https://www.thaiclinicaltrials.org/show/TCTR20180310002). The first participant was recruited on August 2, 2018. [ABSTRACT FROM AUTHOR]

ABSTRACT This study investigated the effectiveness of acceptance and commitment therapy (ACT) compared to treatment as usual in managing psychotic symptoms, emotional dysregulation, recovery and psychological flexibility in inpatients with primary psychoses. The Primary outcome assessed the positive and negative syndrome scale, while the secondary outcomes were to assess difficulties in the emotion regulation scale, recovery assessment scale and acceptance and action questionnaire. An open‐label, two‐arm parallel randomized controlled trial was conducted. Participants diagnosed with primary psychoses were randomly assigned to either the ACT (n = 33) or treatment‐as‐usual (n = 32) group. The intervention included six structured sessions of ACT. ACT significantly reduced psychotic symptoms from 128 to 104 (Z = 5.01) compared to treatment as usual from 130 to 117 (Z = 4.88). Emotional regulation improved significantly in the ACT group from 73 to 55 (Z = 4.835) compared to treatment as usual from 73 to 70 (Z = 2.406). Recovery increased in the ACT group from 50 to 88 (Z = 5.01) compared to treatment as usual from 51 to 61 (Z = 4.93). Psychological flexibility improved in the ACT group from 33 to 25 (Z = 4.98) compared to treatment as usual from 33 to 31 (Z = 4.75). Between‐group differences after intervention were significant for psychotic symptoms, emotional regulation, recovery and psychological flexibility (Z = 2.356, 4.652, 3.881 and 4.453, respectively). Accordingly, the current study demonstrates the effectiveness of ACT in reducing psychotic symptoms and improving emotional regulation, recovery and psychological flexibility in patients with primary psychoses. Integrating ACT into standard care protocols can enhance treatment outcomes, offering a comprehensive approach to managing complex mental health conditions.Trial Registration: ClinicalTrials.gov identifier: NCT06160869 [ABSTRACT FROM AUTHOR]

Background: Limited evidence exists regarding the effectiveness of pain relief and functional improvement in patients undergoing revision total hip replacement (THR). Furthermore, there are no clinical guidelines or consensus on optimal rehabilitation after revision THR. Purpose: The primary aim of this study was to compare the effectiveness of an exercise intervention targeting hip strengthening with standard community‐based rehabilitation in patients undergoing revision THR. Methods: This multicenter randomized controlled assessor‐blinded trial will be conducted at eight hospitals and multiple municipality rehabilitation centers in Denmark. A total of 84 patients undergoing revision THR are estimated to be allocated to either an exercise intervention targeting hip strengthening (NEMEX‐STR) or standard community‐based rehabilitation (Usual care). Recruitment was initiated in November 2022 and is expected to be completed by June 2024. The primary outcome is change in functional performance measured by the 30 s chair stand test, from baseline to 4 months after the start of intervention. Secondary outcomes include hip disability and osteoarthritis outcome score; 40 m fast‐paced walk test; 9‐step timed stair climb test; leg extensor muscle power; global perceived effect; and adverse events. Other outcomes include The International Physical Activity Questionnaires, pain intensity, and European quality of life—5 dimensions. An intention‐to‐treat approach will be used for analyzing changes in primary and secondary outcome measures. The trial was approved by the Central Denmark Region Committees on Health Research Ethics (Journal No 1‐10‐72‐134‐22) and registered on the Central Denmark Regions' internal list of research projects (Journal No 1‐16‐02‐285‐22). Discussion: To our knowledge, this study is the first to explore different rehabilitation programs after revision THR through a randomized controlled trial. The results will provide clinically relevant evidence for optimal rehabilitation after revision THR for improving functional performance, physical function, and quality of life, with great importance for patients, relatives, physiotherapists, and decision‐makers. ClinicalTrial.gov: NCT05657054. [ABSTRACT FROM AUTHOR]

Background: Blood plays an irreplaceable role in medical care. Low retention rate among blood donors is the major issue in China. Various functional motivations can encourage blood donors to participate in blood donation. Therefore, it is necessary to conduct research studies on re‐donate behavior based on functional motivations. This study aimed to evaluate the impact of social media intervention based on functional motivation, to discover effective intervention methods to improve re‐donate rate among nonregular blood donors. Methods: In 2022–2023, 726 adults aged 18–55 years were randomized into the intervention or control group. Over 6 months, the intervention group received science popularization via social media. After the follow‐up period, re‐donate rate and functional motivation were assessed. Statistical analyses included t‐test, chi‐square test, logistic regression analysis, and analysis of variance. Results: Five hundred and sixty‐eight participants completed the intervention survey. Overall, the repeat blood donation rate in the intervention group (18.1%) was significantly higher than the control group (4.2%) (p <.001). After the intervention, understanding, protection, sensation, and values motivation increased (p <.001). The changes in functional motivations vary across different age groups. In the 18–30 age group, understanding motivation increased (p <.001), while in the 31–45 and 46–55 age groups, protection motivation increased (p <.001). In the groups donating blood 3 time and 4 time, protection motivation increased (p <.05), and in the group donating blood 4 times, the values motivation increased (p <.05). Conclusion: Social media intervention based on functional motivation can effectively increase the re‐donate rate. Understanding, protection, sensation, and values motivations can directly influence the re‐donate behavior. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Background: Active surveillance (AS) is increasingly used to monitor patients with lower risk prostate cancer (PCa). The Prostate Cancer Active Lifestyle Study (PALS) was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with PCa on AS. Methods: Overweight/obese men (body mass index >25 kg/m2) diagnosed with PCa who elected AS were recruited. The intervention was a 6‐month, individually delivered, structured diet and exercise program adapted from the Diabetes Prevention Program with a 7% weight loss goal from baseline. Control participants attended one session reviewing the US Dietary and Physical Activity Guidelines. The primary outcome was change in glucose regulation from baseline to the end of the 6‐month intervention, which was measured by fasting plasma glucose, C‐peptide, insulin, insulin‐like growth factor 1, insulin‐like growth factor binding protein‐3, adiponectin, and homeostatic model assessment for insulin resistance. Results: Among 117 men who were randomized, 100 completed the trial. The mean percentage weight loss was 7.1% and 1.8% in the intervention and control arms, respectively (adjusted between‐group mean difference, −6.0 kg; 95% confidence interval, −8.0, −4.0). Mean percentage changes from baseline for insulin, C‐peptide, and homeostatic model assessment for insulin resistance in the intervention arm were −23%, −16%, and −25%, respectively, compared with +6.9%, +7.5%, and +6.4%, respectively, in the control arm (all p for intervention effects ≤.003). No significant between‐arm differences were detected for the other biomarkers. Conclusions: Overweight/obese men with PCa undergoing AS who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals with this reproducible lifestyle intervention and experienced improvements in glucose‐regulation biomarkers associated with PCa progression. The Prostate Cancer Active Lifestyle Study was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with prostate cancer undergoing active surveillance. Overweight/obese men with prostate cancer on active surveillance who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals and experienced improvements in glucose‐regulation biomarkers associated with prostate cancer progression. [ABSTRACT FROM AUTHOR]

Background: Understanding the influence of contextual factors (CFs) on interventions for mechanical neck pain (MNP) is essential for evidence‐based practice in physical therapy. However, the specific effects and synergies of combining different CFs remain unclear. Objective: The primary purpose of this study will be to determine if a CFs‐Enriched Standard Care (SC) approach is an effective treatment for MNP in terms of reducing pain and improving function. Methods: This will be an assessor‐blinded, 2‐group (1:1) randomised clinical trial (RCT) aiming to enrol 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of SC twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence. The primary outcomes will encompass changes in pain and disability after 4 weeks of treatment, with a follow‐up reassessment at week 12 post‐treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12‐week follow‐up will be reported for all outcomes, considering the difference from scores recorded at baseline. Results: We hypothesise that a 4‐week CFs‐Enriched SC approach will be superior to SC alone in terms of patient‐reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively. Conclusion: This RCT rigorously assesses the effect of purposeful manipulation of CFs during MNP treatment. By elucidating the role of these factors, our findings have the potential to significantly refine clinical practice in managing MNP, thereby enhancing patient care, and advancing the fields of physical therapy and rehabilitation. [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]

Objective: The objective was to assess the one year implant treatment outcome and patient‐related outcome measures (PROMs) following maxillary sinus floor augmentation (MSFA) with autogenous bone graft (ABG) from the zygomatic buttress (control) compared with 1:1 mixture of ABG and anorganic porcine bone mineral (APBM) (Test I) or biphasic bone graft material (BBGM) (Test II). Materials and Methods: Sixty healthy patients (34 females, 26 males) were randomly allocated to either control or test groups. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications, and PROMs using Oral Health Impact Profile‐14 combined with questionnaire assessing patient perception of peri‐implant soft tissue, prosthetic solution, implant function, and implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was.05. Results: All suprastructures and implants were well‐functioning after one year of functional implant loading. There was no significant difference between control and test groups in any of the applied outcome measures. The implant stability significantly increased from implant placement to abutment connection within all groups (p <.001). High patient satisfaction and significant improvement in oral health‐related quality of life was also reported within all groups. Conclusion: This study demonstrates that MSFA with composite grafts containing minimal amounts of ABG reveals comparable implant treatment outcomes as compared with ABG alone, after one year of functional implant loading. Extensive ABG harvesting in conjunction with MSFA therefore seems not to be needed. [ABSTRACT FROM AUTHOR]

Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [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]

Introduction: Childhood cancer survivors (CCS) are at risk of experiencing lower quality-of-life, fatigue, and depression. Few randomized controlled trials have studied the effect of physical activity (PA) on these in adult long-term CCS. This study investigated the effect of a 1-year individualized PA intervention on healthrelated quality-of-life (HRQOL), fatigue, and distress symptoms in adult CCS. Methods: The SURfit trial randomized 151 CCS =16 years old, <16 at diagnosis and =5 years since diagnosis, identified through the Swiss Childhood Cancer Registry. Intervention participants received personalized PA counselling to increase intense PA by =2.5 h/week for 1 year. Controls maintained usual PA levels. The authors assessed physical- and mental-HRQOL, fatigue, and distress symptoms at baseline, 3, 6, and 12 months. T-scores were calculated using representative normative populations (mean = 50, standard deviation = 10). Generalized linear mixed-effects models with intention-to-treat (ITT, primary), and three per-protocol allocations were used. Results: At 12 months, ITT (-3.56 larger decrease, 95% confidence interval -5.69 to -1.43, p = .001) and two per-protocol analyses found significantly lower fatigue. Physical-HRQOL improved significantly in two per-protocol analyses at 12 months. No other effects were found. Conclusion: SURfit showed that increased intense PA over 1 year improved fatigue in adult CCS. Survivors should be recommended PA to reduce the burden of late-effects. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [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]

Objective: This study aimed to investigate whether attentional control serves as a mediator for mindfulness‐based interventions for emotional distress, utilizing a randomized waitlist (WL)‐controlled design. Methods: A total of 498 participants with high emotional distress was recruited online and randomly assigned to a 49‐day online Mindfulness Intervention for Emotional Distress (MIED) group (N = 249) or a WL control group (N = 249). Levels of attentional control, anxiety and depression were assessed at baseline (T0), Week 3 (T3), Week 5 (T5) and Week 7 (postintervention, T7). Results: Linear mixed models revealed significant Group‐by‐Time interaction effects for attentional control (p < 0.001), anxiety (p < 0.001) and depression (p < 0.05). Latent growth curve analyses demonstrated a significant increase in attentional control and a decrease in anxiety and depression levels during the MIED programme. These changes becoming evident starting Week 3. Longitudinal mediation analyses revealed that the slope of attentional control significantly mediated the effects of the MIED programme on the slope of anxiety and depression levels. Further, attentional control level at Week 3 significantly mediates the effect of MIED programme on anxiety and depression levels at Weeks 5 and 7. Similarly, attentional control level at Week 5 significantly mediates the MIED programme's effects on anxiety and depression levels at Week 7. Conclusions: The present trial provides evidence suggesting that mindfulness interventions may alleviate emotional distress through the enhancement of attentional control. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2200064140 [ABSTRACT FROM AUTHOR]

Objective: Our ability to predict responsiveness to digital interventions for eating disorders has thus far been poor, potentially for three reasons: (1) there has been a narrow set of predictors explored; (2) prediction has mostly focused on symptom change, ignoring other aspects of the user journey (uptake, early engagement); and (3) there is an excessive focus on the unique effects of predictors rather than the combined contributions of a predictor set. We evaluated the univariate and multivariate effects of outcome predictors in the context of a randomized trial (n = 398) of digitally delivered interventions for recurrent binge eating. Method: Thirty baseline variables were selected as predictors, ranging from specific symptoms, to key protective factors, to technological acceptance, and to online treatment attitudes. Outcomes included uptake, early engagement, and remission. Univariate (d) and multivariate (D) standardized mean differences were calculated to estimate the individual and combined effects of predictors, respectively. Results: At the univariate level, few predictors produced an effect size larger than what is considered small (d >.20) across outcomes. However, our multivariate approach enhanced prediction (Ds =.65 to 1.12), producing accuracy rates greater than chance (63%–71% accuracy). Less than half of the chosen variables proved to be useful in contributing to predictions in multivariate models. Conclusion: Findings suggest that accuracy in outcome prediction from digitally delivered interventions may be better driven by the aggregation of many small effects rather than one or several largely influential predictors. Replication with different data streams (sensor, neuroimaging) would be useful. Public Significance: Our ability to predict who will and will not benefit from digital interventions for eating disorders has been poor. We highlight the viability of a multivariate approach to outcome prediction, whereby prediction may be better driven by the aggregation of many small effects rather than one or a few influential predictors. [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]

Summary: Weighted blankets are a non‐pharmacological intervention for treating sleep and anxiety problems in children with attention‐deficit/hyperactivity disorder. However, research on the efficacy of weighted blankets is sparse. The aim of this randomized controlled trial with a crossover design (4 + 4 weeks) was to evaluate the efficacy of weighted blankets on sleep among children with attention‐deficit/hyperactivity disorder and sleeping problems. Children diagnosed with uncomplicated Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition attention‐deficit/hyperactivity disorder with verified sleep problems were randomized to start with either a weighted blanket or a lighter control blanket. Data collection was performed at weeks 0, 4 and 8 using actigraphy, questionnaires and a daily sleep diary. T‐tests were used to evaluate efficacy. The study included 94 children with attention‐deficit/hyperactivity disorder (mean age 9.0 [sd 2.2] years; 54 [57.4%] boys). Weighted blankets had a significant effect on total sleep time (mean diff. 7.72 min, p = 0.027, Cohen's d = 0.24), sleep efficiency (mean diff. 0.82%, p = 0.038, Cohen's d = 0.23) and wake after sleep onset (mean diff. −2.79 min, p = 0.015, Cohen's d = −0.27), but not on sleep‐onset latency (p = 0.432). According to our exploratory subgroup analyses, weighted blankets may be especially beneficial for improving total sleep time in children aged 11–14 years (Cohen's d = 0.53, p = 0.009) and in children with the inattentive attention‐deficit/hyperactivity disorder subtype (Cohen's d = 0.58, p = 0.016). Our results suggest that weighted blankets may improve children's sleep and could be used as an alternative to pharmacological sleep interventions. [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]

External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack of consensus in this field. The objective of this study was to reach consensus on a definition of external validity and on criteria to assess the external validity of RCTs included in systematic reviews. A three‐round online Delphi study was conducted. The development of the Delphi survey was based on findings from a previous systematic review. Potential panelists were identified through a comprehensive web search. Consensus was reached when at least 67% of the panelists agreed to a proposal. Eighty‐four panelists from different countries and various disciplines participated in at least one round of this study. Consensus was reached on the definition of external validity ("External validity is the extent to which results of trials provide an acceptable basis for generalization to other circumstances such as variations in populations, settings, interventions, outcomes, or other relevant contextual factors"), and on 14 criteria to assess the external validity of RCTs in systematic reviews. The results of this Delphi study provide a consensus‐based reference standard for future tool development. Future research should focus on adapting, pilot testing, and validating these criteria to develop measurement tools for the assessment of external validity. [ABSTRACT FROM AUTHOR]

Objective: Although inpatient treatment is highly effective for patients with bulimia nervosa (BN), some patients show a resurgence of symptoms and relapse after discharge. Therefore, the aim of this study is to evaluate the efficacy of a guided smartphone‐based aftercare intervention following inpatient treatment to support recovery. Method: 172 female patients with BN (DSM‐5: 307.51) will be randomized to receive a 16‐week smartphone‐based aftercare intervention (German version of 'Recovery Record') with therapist feedback as an add‐on element to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline (discharge, T0), during the intervention (after 4 weeks, T1), post‐intervention (after 16 weeks, T2) and at 6‐month follow‐up (T3). Primary outcome will be remission at T2. Moderator and mediator analyses will investigate for whom the aftercare intervention suits best and how it works. Conclusions: This is the first randomized controlled trial to examine a guided smartphone‐based aftercare intervention following inpatient treatment of patients with BN. We expect that this innovative aftercare intervention is highly accepted by the patients and that it has the potential to support recovery after inpatient treatment and thereby could contribute to improving aftercare for patients with BN. Highlights: There are several studies reporting relapse rates for patients with bulimia nervosa (BN) after having received remission or abstinence at the end of treatment.This is the first randomized controlled trial (RCT) to investigate the effects of a guided smartphone‐based aftercare following inpatient treatment of patients with BN.If this innovative aftercare intervention is accepted by the patients and supports recovery after inpatient treatment for patients with BN, it could contribute to improving aftercare for patients with BN. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to test the hypothesis that use of NerveTrend™ mode of intermittent neuromonitoring (i‐IONM) during thyroidectomy may identify and prevent impending recurrent laryngeal nerve (RLN) injury. Methods: A randomized clinical trial. The primary outcome was prevalence of RLN injury on postoperative day 1. In NerveTrend™ group the i‐IONM stimulator was used for trending of amplitude and latency changes from initial vagal electromyographic baseline to tailor surgical strategy. Results: Some 264 patients were randomized into the intervention versus the control group, 132 patients each. RLN injury was found on postoperative day 1 in 5/264 (1.89%) nerves at risk (NAR) versus 12/258 (4.65%) NAR whereas staged thyroidectomy was used in 0/132 (0.00%) versus 6/132 (4.54%) patients (p = 0.067 and p = 0.029, respectively). Conclusion: The use of NerveTrend™ mode resulted in tendency towards reduced RLN injury on postoperative day 1 and significant decrease of need for a staged thyroidectomy. [ABSTRACT FROM AUTHOR]

The aim of this study protocol is to examine the effect of telephone‐assisted smoking cessation programme based on the information motivation behavioural skills model on the self‐efficacy, smoking behaviour, tumour recurrence and progression in patients diagnosed with non‐muscle‐invasive bladder cancer. A single‐center, single‐blind, parallel‐group, randomized control trial. The intervention group will receive telephone‐assisted smoking cessation programme, while no intervention will be applied to the control group. Face‐to‐face smoking cessation training will be provided for the information component of the programme, motivational interview will be conducted via WhatsApp for its motivation component. Motivational interviews will be undertaken in total of six sessions organized at two‐week intervals. The patients' chronic disease management self‐efficacy, smoking behaviour will be evaluated at the third, sixth, 12th months. Tumour recurrence, progression will be followed up by cystoscopy at the third, 12th months. This is a randomized controlled study protocol, results are not available at the time of the submission. All results will be reported on the completion of this study. This study protocol, will involve the implementation of comprehensive smoking cessation programme that is much needed for the target population around the world. It is expected that the use of this programme will increase the self‐efficacy of smokers with bladder cancer, decrease their smoking behaviour and amount of smoking, eliminate tumour recurrence. Smoking is the most important, modifiable risk factor for bladder cancer. In this study, it is expected that the implementation of telephone‐assisted smoking cessation programme based on the information–motivation–behavioural skills model will increase self‐efficacy in cancer management and decrease smoking behaviour, tumour recurrence in patients diagnosed with bladder cancer. In the literature, there is no smoking cessation programme based on this model intended for patients diagnosed with bladder cancer. [ABSTRACT FROM AUTHOR]

The Mediterranean diet (MD) is one of the healthiest and most sustainable food regimes. Nevertheless, MD diffusion is still limited, emphasizing the need to understand the psychosocial factors that could predict and promote its adoption. Starting from an integrated model of Theory of Planned Behavior (TPB) and Self‐Determination Theory (SDT), the present randomized controlled trial investigated the effect of manipulating motivation (autonomous vs. controlled) on intention and MD adherence behavior. Participants included 726 Italian adults randomly allocated to one of three conditions: autonomous motivation manipulation, controlled motivation manipulation, and control group. TPB variables were measured immediately after manipulation (T1), while MD adherence was evaluated 2 weeks later (T2). Results from multivariate analyses of variance highlighted that participants in the autonomous motivation condition reported higher intention and a more favorable cognitive attitude than control group participants. However, no change in behavior was found. Moreover, a path analysis with mediation effect showed that the impact of autonomous motivation condition versus control group on intention was mediated by cognitive attitude. Findings support the integration of TPB and SDT to encourage intention to adhere to the MD, also suggesting that prompting autonomous motivation may help to promote a greater diffusion of this healthy and sustainable dietary pattern. [ABSTRACT FROM AUTHOR]