Significant Treatment Effect Research Articles

Efficacy of Small Group Reading Intervention for Grade 2 and 3 Children With Reading Difficulties: A Cluster Randomized Controlled Trial

We examined whether Phonics + Set for Variability (S fV) reading intervention would lead to better irregular word reading compared to Phonics + Morphology within a cluster randomized control trial (RCT) design with a follow-up measurement. The participants were 273 Grade 2 and 3 students with reading difficulties (139 in the Phonics + S fV and 134 in the Phonics + Morphology) who received intervention in small groups (2–4 children), 4 times a week, 30 minutes each time, for 15 weeks. Results of hierarchical linear modeling showed that there was a significant effect of intervention on all reading outcomes (e.g., from pre- to posttest the effect sizes for Phonics + S fV ranged from g = 0.74 to 1.54 and for Phonics + Morphology from g = 0.75 to 1.49). Unexpectedly, there were no differences between the intervention conditions in any of the outcome variables, including irregular word reading and morphological awareness that the interventions partly focused on.

Calcium plus vitamin D supplementation during pregnancy has no impact on postpartum transient longitudinal changes in hip geometry in adolescent mothers: a secondary analysis of a randomised controlled trial.

We have previously demonstrated that calcium plus vitamin D supplementation during adolescent pregnancy reduces the magnitude of transient postpartum bone mass loss. In the present post hoc analysis, we further investigated the effect of calcium plus vitamin D supplementation during pregnancy in hip geometry throughout one year postpartum in Brazilian adolescents with low daily calcium intake (∼600 mg/d). Pregnant adolescents (14-19 years) were randomly assigned to receive calcium (600 mg/d) plus vitamin D3 (200 μg/d) or a placebo from 26 weeks of gestation until parturition. Dual-energy X-ray absorptiometry images were obtained at 5 (n 30 and 26 for calcium plus vitamin D and placebo, respectively), 20 (n 26 and 21) and 56 (n 18 and 12) weeks postpartum, and hip geometry parameters were analysed by Advanced Hip Assessment software. The effects of the intervention, time point and their interaction were assessed using repeated-measures mixed-effects models. No significant intervention effects or intervention × time interactions were observed on hip geometry parameters (P > 0·05). Time effects were observed in cross-sectional area, cross-sectional moment of inertia and section modulus parameters with decreases from the 5th to the 20th week postpartum followed by recovery from the 20th to the 56th week (P < 0·05). Our findings indicate that the postpartum period is associated with transient changes in the hip geometry of lactating adolescent mothers, regardless of the low calcium intake and the supplementation offered during pregnancy, suggesting that a physiological adaptation of these adolescents to low calcium intake is at play.

Treatment strategies for smartphone addiction: efficacy study of transcranial direct current stimulation and exergaming

ObjectiveSmartphone addiction is on the rise globally. This study aimed to compare the rehabilitative effects of transcranial direct current stimulation (tDCS) and exergames on smartphone addiction among college students. Additionally, we discussed the central mechanisms through changes in electroencephalography (EEG) to provide clinical insights.MethodsThirty-six participants were randomly assigned to three groups: control group, tDCS group (bilateral dorsolateral prefrontal cortex stimulation), and exergame group. The intervention lasted for 4 weeks with twice-weekly sessions. Outcome measures included the Smartphone Addiction Scale - Chinese Version (SAS-C), Iowa Gambling Task (IGT) net scores, and event-related potential (ERP) data collected during the IGT, focusing on P300 and feedback-related negativity (FRN) amplitudes.ResultsAll groups showed significant reductions in SAS-C scores post-intervention. Behaviorally, post-intervention scores improved, indicating significant effects of different interventions on participants’ strategy choices. P300 amplitudes increased significantly at outcome electrode sites for all groups, with the most notable increase in tDCS group FC2 and CP1. FRN amplitudes decreased significantly post-intervention in the control and tDCS groups, with significant differences between the two groups.ConclusionAll three interventions appeared to have alleviating effect on smartphone addiction. After 4 weeks, participants showed improved executive control and decision-making abilities. Specifically, significant effects were observed in the tDCS group, with increased P300 amplitudes in the frontal, parietal, and central regions, as well as FRN amplitudes in the central and frontal regions. This suggested that tDCS enhanced psychological resources and improved inhibition control capabilities.

Comparative efficacy of interpersonal psychotherapy and antidepressant medication for adult depression: a systematic review and individual participant data meta-analysis.

Interpersonal psychotherapy (IPT) and antidepressant medications are both first-line interventions for adult depression, but their relative efficacy in the long term and on outcome measures other than depressive symptomatology is unknown. Individual participant data (IPD) meta-analyses can provide more precise effect estimates than conventional meta-analyses. This IPD meta-analysis compared the efficacy of IPT and antidepressants on various outcomes at post-treatment and follow-up (PROSPERO: CRD42020219891). A systematic literature search conducted May 1st, 2023 identified randomized trials comparing IPT and antidepressants in acute-phase treatment of adults with depression. Anonymized IPD were requested and analyzed using mixed-effects models. The prespecified primary outcome was post-treatment depression symptom severity. Secondary outcomes were all post-treatment and follow-up measures assessed in at least two studies. IPD were obtained from 9 of 15 studies identified (N = 1536/1948, 78.9%). No significant comparative treatment effects were found on post-treatment measures of depression (d = 0.088, p = 0.103, N = 1530) and social functioning (d = 0.026, p = 0.624, N = 1213). In smaller samples, antidepressants performed slightly better than IPT on post-treatment measures of general psychopathology (d = 0.276, p = 0.023, N = 307) and dysfunctional attitudes (d = 0.249, p = 0.029, N = 231), but not on any other secondary outcomes, nor at follow-up. This IPD meta-analysis is the first to examine the acute and longer-term efficacy of IPT v. antidepressants on a broad range of outcomes. Depression treatment trials should routinely include multiple outcome measures and follow-up assessments.

Bleaching Gels and Light-Emitting Diodes: Comparison of Tooth Color Change.

To measure difference in tooth shade and color achieved via two different over-the-counter bleaching agents with and without their associated light-emitting diodes (LEDs). A total of 84 extracted human anterior teeth were randomly divided into seven groups. Gypsum models were made with 6 extracted teeth in an arch form (n = 12; 2 arches/group). Samples were kept hydrated throughout treatment (25°C). Bleaching treatment followed manufacturers' instructions with at least 1-h of rehydration between treatments. Control tooth arches were left untreated. L*a*b* values were measured with a Vita Easyshade (VITA North America, Yorba Linda, CA) three times per tooth using white and black backgrounds. ∆E (CIE 2000) was compared between and within treatment groups over time with ANOVA and post hoc Tukey (a = 0.05). Subgroup testing confirmed the data were normally distributed. Two-way ANOVA showed significant interaction between product (Control, Crest, Snow) and treatment (light only, product only, light and product) on ∆E values for black (p-value < 0.001, F = 15.28) and white (p-value < 0.001, F = 13.62) backgrounds. Post hoc pairwise Tukey tests showed a significant effect of light-and-product treatments in contrast to light- or product-only treatments. Repeated measures ANOVA of between-treatment change (∆E) by product showed significant interaction between time and treatment for Snow products (p < 0.001, F = 10.9) and independent effects of time and treatment for Crest products (Time: p-value < 0.001, Treatment: p-value < 0.01, F = 7.21) on a black background. On white backgrounds, only a significant effect of treatment was reported for both Snow (p-value < 0.01, F = 5.427) and Crest (p-value < 0.001, F = 5.61). Overall, a combination of light and gel produces significantly higher tooth color and shade change over time, with the highest change seen for Snow products. Many patients use over-the-counter tooth bleaching products because they are more cost effective and easier to access than in-office bleaching. However, these products may have adverse effects, such as increased sensitivity with repeated use, in addition to increased consumption of time and money. This project measured tooth shade between treatments which can help determine which product is most effective for at home use.

Role of anxiolytic medications in maintaining perioperative blood pressure in total hip arthroplasty surgeries: case-control retrospective study

Background: Elevated blood pressure (BP) measurements seen in patients having total hip arthroplasty (THA), pose a significant issue for surgeons. The study objective was to investigate the effectiveness of preoperative anxiolytic medications in the maintenance of blood pressure and reduction of total blood loss in patients undergoing THA surgeries. Methods: A retrospective case-control cohort study in a tertiary care university hospital included patients who had THA and had either primary managed hypertension or were non-hypertensive. 190 patients who underwent primary THR; 103 controls and 87 treatment group (Oral 3 mg Bromazepam). Pearson’s chi-square, independent sample t-test, paired samples t-test, and a two- way repeated measures analysis of variance (ANOVA) was utilized in the analysis. Results: Bromazepam group had a significantly lowered ratio of systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP) in the morning of the surgery (P&lt;0.05). Bromazepam also reduced the ratio of SBP and MAP in theaters before anesthesia (P&lt;0.05). A repeated measures ANOVA showed significant treatment effects for SBP and MAP but not DBP (P&lt;0.001 for both). SBP, DBP, and MAP showed a significant time-treatment effect (P&lt;0.001, 0.019, and&lt;0.001, respectively). Conclusions: Oral bromazepam (anxiolytic) aids in the regulation of blood pressure in individuals with well-managed hypertension and in healthy patients having total hip arthroplasty without apparent adverse effects related to the medication. This could potentially reduce the number of uncontrolled hypertension-related surgery delays and patients on the surgical waiting list.

The WE-RISE™ multi-domain intervention: a feasibility study for the potential reversal of cognitive frailty in Malaysian older persons of lower socioeconomic status

BackgroundCognitive frailty (CF) is an emerging concern among older persons, particularly within lower socioeconomic statuses (SES) populations. Currently, there is limited evidence on the potential reversibility of CF through multi-domain interventions within this demographic. This study aimed to investigate the effectiveness of the WE-RISE™ multi-domain intervention in addressing the potential reversibility of CF among community-dwelling older persons of lower SES, the intervention effects on multiple health dimensions, and to determine if WE-RISE™ is of low cost.MethodsThis 24-week randomised controlled trial included 55 community-dwelling older persons of lower SES with CF, who were randomised into either the WE-RISE™ intervention group (n = 27), or the control group receiving usual care (n = 28). The WE-RISE™ intervention comprised of 12 weeks of instructor led, community-based intervention, followed by 12 weeks of WE-RISE™@Home. CF status, cognitive and physical function, nutrition, disability, health-related quality of life, exercise self-efficacy and depression were assessed at baseline, 12th and 24th weeks. Changes in CF status was analysed descriptively, while intervention effects were analyzed with split plot ANOVA. The cost of the WE-RISE™ intervention was calculated using activity-based costing.ResultsAt baseline, all participants in both the intervention and control groups (100%) were classified as CF. Following 12 weeks of the WE-RISE™ intervention, 74.1% of participants in the experimental group no longer met the criteria for cognitive frailty, with 63% maintaining this improvement at 24 weeks. In contrast, the CF status of participants in the control group remained largely unchanged, with only 10.7% showing improvement at 12 weeks and falling to 3.6% at 24 weeks. Significant intervention effects were observed for cognition, physical function, body composition, disability, health-related quality of life and self-perceived exercise self-efficacy (p < 0.05) following participation in WE-RISE™. The cost per intervention session was RM4.06 (≈ RM3.88), and the cost per subject for 48 sessions was RM194.74 (≈ RM187.01).ConclusionThe WE-RISE™ multi-domain intervention has demonstrated potential in reversing CF among older persons of lower SES, leading to significant improvements across multiple health dimensions at a low cost. WE-RISE™ shows promise to enrich the well-being of ageing societies, contribute to societal health, and ensure equitable access to healthcare, supporting broader implementation by enhancing equitable access to health programs and addressing the needs of older persons, WE-RISE™.Trial registrationThis trial was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619001055190) on the 29th of July 2019 – retrospectively registered.

Sex differences in contextual fear conditioning and extinction after acute and chronic nicotine treatment

BackgroundChronic cigarette smokers report withdrawal symptomology, including affective dysfunction and cognitive deficits. While there are studies demonstrating sex specific withdrawal symptomology in nicotine-dependent individuals, literature examining the underlying biological mediators of this is scant and not in complete agreement. Therefore, in this study, we evaluated the sex specific effects of nicotine and withdrawal on contextual fear memory, a hippocampally dependent aspect of cognition that is disrupted in nicotine withdrawal.MethodsMale and female B6/129F1 mice (8–13 weeks old) were used in all experiments. For the acute nicotine experiment, mice received intraperitoneal saline or nicotine (0.5 mg/kg) prior to contextual fear conditioning and test. For the chronic nicotine experiment, mice received nicotine (18 mg/kg/day) or saline for 11 days, then underwent contextual fear conditioning and test. Following the test, mice underwent minipump removal to elicit withdrawal or sham surgery, followed by the fear extinction assay. Bulk cortical tissue was used to determine nicotinic acetylcholine receptor levels via single point [3H]Epibatidine binding assay. Gene expression levels in the dorsal and ventral hippocampus were quantified via RT-PCR.ResultsWe found that female mice had a stronger expression of contextual fear memory than their male counterparts. Further, following acute nicotine treatment, male, but not female, subjects demonstrated augmented contextual fear memory expression. In contrast, no significant effects of chronic nicotine treatment on fear conditioning were observed in either sex. When examining extinction of fear learning, we observed that female mice withdrawn from nicotine displayed impaired extinction learning, but no effect was observed in males. Nicotine withdrawal caused similar suppression of fosb, cfos, and bdnf, our proxy for neuronal activation and plasticity changes, in the dorsal and ventral hippocampus of both sexes. Additionally, we found that ventral hippocampus erbb4 expression, a gene implicated in smoking cessation outcomes, was elevated in both sexes following nicotine withdrawal.ConclusionsDespite the similar impacts of nicotine withdrawal on gene expression levels, fosb, cfos, bdnf and erbb4 levels in the ventral hippocampus were predictive of delays in female extinction learning alone. This suggests sex specific dysfunction in hippocampal circuitry may contribute to female specific nicotine withdrawal induced deficits in extinction learning.

Combined Assessment of Function and Survival to Demonstrate the Effect of Treatment on Progressive Supranuclear Palsy.

Progressive supranuclear palsy (PSP) is a rare and fatal neurodegenerative disorder for which there are currently no disease-modifying treatments. Recent trials of potential therapies had durations of 12 months, which may be insufficient because of nonrandom missingness due to death. Longer durations, incorporating PSP Rating Scale and survival, can reduce the potential for type II error. Selecting efficacy measures more sensitive to disease modification may facilitate identification of treatment effect. The objective of this study was to evaluate the simulated phase 3 PSP trial assessing the effect of disease-modifying intervention on a novel combined primary endpoint comprising function (PSP Rating Scale) and survival, the Combined Assessment of Function and Survival (CAFS), and to determine operating characteristics of the CAFS. To simulate PSP progression in the trial population, we developed models of PSP Rating Scale and survival using data from published clinical studies. These models were used to define operating characteristics of the CAFS for use in a phase 3 trial. The sample size determined (N = 384; 1:1 randomization) would provide >80% power to detect significant treatment effects on the CAFS compared with placebo. The CAFS provides good operating characteristics and increased power to detect moderate treatment effects on the PSP Rating Scale. We propose a trial design allowing potential detection of treatment effects at a preplanned interim analysis after participants complete 12 months of treatment, with assessment of effects of treatment (≤24 months) on survival. Use of the CAFS could provide a comprehensive and robust estimate of the clinical benefit of future therapies. © 2024 UCB. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

A newly developed small-molecule ErbB4 agonist reduces reactive cardiac fibrosis and adverse ventricular remodelling after myocardial infarction in a sex-specific manner

Abstract Background The beneficial effects of the neuregulin/ErbB pathway on the diseased heart have been well-established. The anti-fibrotic and cardioprotective aspects of neuregulin are largely attributable to the activation of the ErbB4 receptor. We recently developed a small-molecule selective ErbB4 agonist, which reduced collagen production in cultured fibroblasts and prevented oxidative-stress induced cardiomyocyte death in vitro. Purpose In order to evaluate the in vivo effects of this small-molecule ErbB4 agonist (referred to as compound, Cpd), we assessed its effect on left ventricular remodelling, cardiac fibrosis and cardiac function in a murine model of myocardial infarction (MI). Since there is a potential interaction between ErbB4 and the oestrogen receptor, we also aimed to evaluate whether these effects were sex-dependent. We hypothesised that Cpd would attenuate left ventricular remodelling, reduce cardiac fibrosis and help retain cardiac function in a sex-specific manner. Methods Mice were divided by sex and then further divided into three experimental groups: a sham group, an MI group receiving Cpd (MI/Cpd), and a control MI group receiving vehicle only (MI/Veh). MI was induced by ligating the left descending coronary artery. Seven days after MI, mice started treatment with either Cpd (2mg/kg/d) or its vehicle through subcutaneous osmotic minipumps. Cardiac ultrasound was performed weekly until mice were sacrificed after four weeks of treatment. Hearts were excised and stained with Masson’s trichrome to assess reactive cardiac fibrosis in the myocardium of the left ventricle, located remote from the infarction scar. A WGA-isolectinB4-DAPI immunofluorescent stain was performed to assess cardiomyocyte cross-sectional area in order to evaluate cardiomyocyte hypertrophy. Results In females (n=25), Cpd significantly decreased left ventricular end-diastolic volume compared to vehicle (LVEDV, Fig.1A, 80±23 µl vs.108±29 µl, p=0.045) and induced a slightly increased left ventricular ejection fraction (LVEF, Fig.1B, 32±12% vs. 22±9%, p=0.086). In addition, Cpd significantly reduced reactive interstitial fibrosis myocardium (Fig.1C, fibrotic area, 1.4±1.0% vs. vehicle: 3.8±3.1%, p=0.0363). In males (n=30), Cpd had no significant effects on either of the parameters mentioned above, (Fig.1E-G). There was no significant treatment effect in either group on cardiomyocyte cross sectional area (Fig.1D, Fig.1H). Conclusion Treatment with the novel small-molecule ErbB4 agonist attenuates left ventricular dilation and reactive interstitial fibrosis after MI in female mice, but not in males. These data support the premise that small molecule-induced ErbB4 activation is a potential new therapy for heart failure, especially in female patients. The mechanisms underlying the sex-dependent effects warrant further exploration.Figure 1

Impact of dapagliflozin on cardiometabolic outcomes after myocardial infarction according to baseline glycaemic status and body mass index: a DAPA-MI substudy

Abstract Background Dapagliflozin improved cardiometabolic outcomes compared with placebo following acute myocardial infarction (MI) in participants without prior diabetes mellitus (DM) or chronic heart failure (HF) in the DAPA-MI trial. Purpose To assess cardiometabolic outcomes in the DAPA-MI trial according to glycaemic status and body mass index (BMI) at randomisation (baseline). Methods Participants were categorised, according to their baseline HbA1c, as normoglycaemic (&amp;lt;5.7% [39 mmol/mol]) or having pre-DM (5.7-&amp;lt;6.5% [48 mmol/mol]). Those with HbA1c &amp;gt;6.5%, diagnosis of DM during hospitalisation, or missing HbA1c result were excluded. New-onset DM during follow-up was defined as either investigator-reported DM diagnosis or HbA1c &amp;gt;6.5%. Time to first occurrence of new-onset DM was assessed according to randomised treatment with dapagliflozin or placebo over median 11.6 months. Incidences of hospitalisation for HF (HHF), cardiovascular death/MI/stroke (MACE), first occurrence of NYHA class III or IV, and weight reduction &amp;gt;5% were assessed according to baseline HbA1c subgroup. Hazard ratios with 95% confidence intervals (CI) were determined using Cox proportional hazards models, stratified by country (UK and Sweden), including randomized treatment as covariate. Similar analyses were performed according to baseline BMI ranges &amp;lt;25, &amp;gt;25-&amp;lt;30, and &amp;gt;30 kg/m2. Results 3,425 out of 4,017 (85.3%) participants met the inclusion criteria, of whom 1,926 (56.2%) were normoglycemic and 1,499 (43.8%) had pre-DM at baseline. In those with normoglycaemia, new-onset DM during follow-up occurred in 6 (0.6%) and 15 (1.6%) participants assigned to dapagliflozin and placebo, respectively (HR 0.40, CI 0.15-1.03; P=0.06); in those with pre-DM, this outcome occurred in 77 (10.1%) and 97 (13.1%) participants, respectively (HR 0.74, CI 0.55-0.99; P&amp;lt;0.05), without significant interaction between the subgroups (P int=0.23)(Figure). A similar pattern was seen for new-onset DM during follow-up according to the BMI subgroup (P int=0.22), with greater absolute risk reduction seen in patients with obesity (5.0% vs. 9.8%, HR 0.52, 0.32-0.82; P&amp;lt;0.01)(Figure). There was no significant treatment effect or interaction according to baseline HbA1c for incidences of HHF or MACE, whereas first occurrence of NYHA class III or IV was reduced more with dapagliflozin versus placebo in the pre-DM subgroup (HR 0.38, CI 0.23-0.61; P&amp;lt;0.001) compared with the normoglycaemia subgroup (HR 0.87, CI 0.58-1.30; P=0.50; P int&amp;lt;0.01). Dapagliflozin increased the incidence of &amp;gt;5% weight loss in both HbA1c subgroups and all BMI subgroups with no significant interactions. Conclusions Dapagliflozin, compared with placebo, reduces the occurrence of new-onset DM following MI, regardless of baseline HbA1c or BMI and with greater absolute risk reduction in those with pre-DM or obesity. Dapagliflozin has a greater beneficial effect on HF symptom burden (NYHA class III-IV) in those with pre-DM versus normoglycaemia.

EvalDepApps: How to evaluate depression management based on evidence and end users

Abstract The use of apps is increasing in the field of mental health due to their ease of use and accessibility, although there is not enough evidence on their effectiveness and safety. EvalDepApps aims to develop an evaluation tool for depression management apps. A systematic review with meta-analysis (SRMA) was performed to evaluate the efficacy and safety of apps for depression, and to identify the evaluation criteria used. PRISMA methodology was followed. The MEDLINE, PsycINFO, and Embase databases were consulted. The risk of bias was assessed with the RoB2 scale. An online 2 rounds Delphi was carried out to prioritize the most relevant criteria identified. 44 people (26 professionals, 18 patients) were invited. They were asked to rate the importance of each criterion on a Likert scale (1 - 6). Those that obtained a high consensus were selected; those with a medium were submitted to the 2nd round. Empathization (6) and co-design (6) sessions were held with patients (23) and professionals (33) in Catalonia, the Canary Islands and Andalusia to identify what relevant aspects the tool should have. Twenty-nine studies were included in the SRMA (67% unclear bias), finding a significant effect of mHealth interventions in reducing depressive symptoms compared to non-active control (Hedges g = −0.62, 95% CI: −0.87 to − 0.37, I2 = 87%). In Round 1 of the Delphi (59% participation) 24 criteria obtained a high consensus, 20 a medium and 7 a low. In Round 2 (52% participation), 4 criteria reached high consensus. The empathy sessions showed that the actions most requested by patients were reduce anxiety, and information about their condition; for professionals, suicide prevention. Regarding co-design, it was proposed that the tool provide ranking of the apps, recommendation systems and a very visual format. The RSMA and Delphi guarantee that the tool will be based on scientific evidence and expert judgment, while empathization and co-design that it will fit with the needs of end users. Key messages • It is relevant to evaluate the quality of health apps, especially those addressed to vulnerable populations such as people with depression. • It is crucial that the development of evaluation tools for digital health interventions will be developed based on evidence-based but also includes end users.

Advancing mammography uptake among vulnerable groups: a systematic review of intervention strategies

Abstract With over 2 million cases diagnosed annually, breast cancer is a leading cause of cancer-related disability and mortality. Despite global efforts to implement mammography screening programs, uptake rates vary widely across settings due to socioeconomic factors and accessibility challenges. To improve participation, targeted interventions addressing barriers faced by underserved groups are essential for promoting inclusive screening and early detection. As part of the ENTER project, which aims to address disparities in breast cancer screening participation among women with low socioeconomic status (SES) in Flanders, Belgium, we conducted a systematic review and meta-analysis on the effectiveness of interventions to enhance mammography uptake. To explore the differential impact of interventions on mammography uptake among vulnerable groups, including individuals with low SES, underinsured, with immigrant background or part of an ethnic minority, subgroup analyses were performed. 7 databases were searched, resulting in the inclusion of 54 out of 9,366 papers for analysis. 14 types of interventions were identified. The meta-analysis showed significant pooled effects of interventions that increased mammography uptake [OR 1.8 (95%CI 1.6-2.2)], particularly among vulnerable populations [OR 2.2 (95%CI 1.7-2.8)]. The most effective interventions were educational interventions [OR 3.03 (95%CI 2.2-4.9); in vulnerable groups OR 2.7 (95%CI 1.9-3.9)]. As expected, interventions adapted to linguistic needs and culturally sensitive approaches showed a significant effect among vulnerable target groups [OR 2.9 (95%CI 1.1-7.9) and OR 2.5 (95%CI 1.1-5.6), respectively]. Reminders were also highly effective [OR 1.8 (95%CI 1.5-2.1); in vulnerable groups OR 2.5 (95%CI 1.9-3.1)]. This review underscores the critical role of targeted interventions in augmenting screening mammography uptake, particularly among vulnerable populations, where odds of participation can increase by up to 2-3 times. Key messages • Interventions adapted to the linguistic needs of the target population and culturally sensitive approaches, aligned with values and beliefs of a specific community, can greatly enhance screening rates. • Considering costs, practicality and impact, reminder letters with culturally and linguistically adapted content emerged as the most promising option for implementation in the ENTER project.

Effects of a 6-month aerobic exercise intervention on brain morphology in women with breast cancer receiving aromatase inhibitor therapy: a sub-study of the EPICC trial.

Physical exercise may increase brain volume and cortical thickness in late adulthood. However, few studies have examined the possibility for exercise to influence brain morphology in women treated for breast cancer. We conducted a nested sub-study within a randomized clinical trial to examine whether 6 months of moderate-intensity aerobic exercise in postmenopausal women with early-stage breast cancer influences brain morphology. We included twenty-eight postmenopausal women newly diagnosed with Stage 0-IIIa breast cancer (M age = 62.96 ± 5.40) who were randomized to either 45-60 min of supervised aerobic exercise 3 days/week (n = 16) or usual care (n = 12). Before beginning aromatase inhibitor aromatase inhibitor therapy, and the exercise intervention, and again at 6-month follow-up, volumetric and cortical thickness measures were derived from magnetic resonance imaging scans. There were no significant intervention effects on brain volume and cortical thickness. However, greater average exercise intensity (%) during the intervention was associated with greater post-intervention cortical volume, mean cortical thickness, precentral gyrus thickness, and superior parietal thickness (all p < 0.05). Finally, total supervised exercise time was associated with higher precentral gyrus thickness after the intervention (p = 0.042, R 2 = 0.263). The exercise intervention did not significantly affect brain volumes and cortical thickness compared to the control group. However, positive associations were found between exercise intensity and brain morphology changes after the 6-month intervention, indicating that exercise may reduce the vulnerability of the brain to the deleterious effects of breast cancer and its treatment.

Reproductive tract morphometry of Hyla rabbits fed diet containing graded levels of watermelon rind and wheat offal as absorbent

The evaluation of breeding and fertility potential of animals demands understanding of basic morphometric characteristics of their reproductive organs which, among other factors, may be affected by nutrition. This study was conducted to assess the effects of feeding graded levels of watermelon rind and wheat offal as absorbent on morphometric characteristics of the reproductive organs of Hyla rabbits. Forty-five Hyla rabbits of both sexes (15 bucks and 30 does) with nine animals per treatment (3 bucks and 6 does in each treatment) in a completely randomized design were randomly assigned to the dietary treatment containing 0 %, 10 %, 20 %, 30 %, and 40 % of watermelon rind and wheat offal. The data collected included weight and length of the reproductive tract of the rabbits. The morphometric characteristics of reproductive tract of the rabbits were not significantly affected by the dietary treatment, however, there were significant effect (p &gt; 0.05) of the dietary treatment on the weight of the left oviduct, paired oviduct, and the paired ovary of the rabbits. The experimental diets significantly affected (p &lt; 0.05) penis length and width, the right spermatic cord and the length of the right scrotal. The diets had no significant effect (p&lt;0.05) on the weight of reproductive tracts of buck except on the paired spermatic cord. The experimental diets can be a good alternative for the highly competitive and costly grains in the diet of Hyla rabbits without any adverse effect on the growth of reproductive organs and consequently on the fertility and other activities related to reproduction of Hyla rabbits. Keywords: morphology, rabbits, reproduction, watermelon rind, wheat offal

Levels of substitution of inorganic mineral to amino acids complexed minerals on old laying hens

This study was conducted with the objective of evaluating the impact of replacing inorganic mineral sources (IM) with amino acid complexed minerals (AACM) in laying hens’ diets on performance, egg quality, bone, and intestinal health. The effects of 4 different diets with varying levels of AACM substitution were evaluated on 400 Lohmann White hens aged 78–98 weeks. The control diet contained only IM sources at levels of 60, 60, 7, 40, 0.2, and 2 mg/kg of Zn, Mn, Cu, Fe, Se, and I, respectively. The other treatments were made by a total substitution of IM with AACM, as follows: AACM70–70% of IM levels; AACM50–50% of IM levels; and AACM40–40% of IM levels. Orthogonal polynomial contrasts and Dunnett’s test were used to determine their impact (P < 0.05). The treatment AACM40 improved egg production, egg weight, egg mass, and feed conversion ratio (P < 0.05). Hens that received AACM40 also produced the thickest eggshells and better tibial bone density (P < 0.01). Histomorphometry analyses demonstrated significant effects of AACM treatments. The optimal supplementation levels of 24, 24, 2.8, 16, 0.08, and 0.8 mg/kg of Zn, Mn, Cu, Fe, Se, and I, respectively.

A Stepped-Wedge, Cluster-Randomized, Multisite Study of Text Messaging Plus Peer Navigation to Improve Adherence and Viral Suppression Among Youth on Antiretroviral Therapy.

To address the need for improved virologic suppression among youth living with HIV (YLH) on antiretroviral treatment (ART), we evaluated peer navigation plus TXTXT daily text message ART reminders. YLH aged 15-24 on ART for at least 3 months at six research sites in four Nigerian cities. Using a stepped-wedge design, Cluster 1 was non-randomized, while Clusters 2 and 3 were randomized to sequences of routine care (control period) and 48 weeks of the combination intervention (intervention period). The primary endpoint was viral suppression (HIV-1 RNA <200 copies/mL) at week 48 of the intervention. Secondary endpoints included adherence measured by self-report (90% considered adherent). Post-hoc analysis assessed virologic control at <50 copies/mL and <1000 copies/mL. Generalized estimating equations determined the difference between intervention and control periods in the intention-to-treat population. We enrolled 558 YLH and followed 541 over time, mean age 18 years, 53.8% female, 71.7% perinatally infected, and 38.6% virologically non-suppressed at enrollment. For the primary endpoint, the intervention periods displayed a small, non-significant increase in viral suppression < 200 copies/mL (OR = 1.16 [0.88, 1.54], p = 0.297). There was a significant effect of the combination intervention on virologic control <1000 copies/mL (OR = 1.42 [1.03, 1.94], p = 0.030). Self-reported adherence also improved (OR = 2.07 [1.46, 2.95], p < 0.001). Peer navigation plus daily text message ART reminders demonstrated limited benefit among ART-experienced, predominantly perinatally-infected YLH, with no significant effect on viral suppression below 200 copies/mL despite improvement in self-reported adherence.

HED-Start: A Brief Positive Psychology Cluster-Randomized Controlled Trial to Improve Psychological Adjustment in Patients New on Hemodialysis.

Initiation onto hemodialysis marks a critical transition with intense psychosocial demands. Interventions using cognitive-behavioral therapy to improve distress have been variably effective but require trained staff and are typically delivered only to those who screen positive for clinically significant distress. Interventions guided by positive psychology are lacking. To investigate the effectiveness of a brief positive-skills RCT in improving psychological adjustment in new hemodialysis patients. Using a parallel (2:1) design, blinded cluster-randomized controlled trial (cRCT) design, incident patients (<6 months at NKF dialysis centers) undergoing hemodialysis were randomized to intervention or usual care (UC). HED-Start intervention comprised four group sessions delivered by healthcare staff on positive emotions, acceptance, and life-orientated goal setting. Measures were taken at baseline (pre-randomization) and at 12 weeks: distress/mood (HADS; SPANE); quality of life (KDQOL-SF, WHOQOL-BREF); benefit-finding (BFS, BIPQ); life-oriented skills (HEIQ, CD-RISC-2); self-efficacy (CD-SES). A total of 147 participants enrolled in the trial (response rate, 51.0%; retention [assessment], 90.5%). Study arms were comparable on all baseline and outcome variables except for age, diabetic nephropathy, and hypertensive nephrosclerosis which were subsequently controlled for. Repeated measures ANCOVAs (intention to treat) were used. HED-Start yielded significant reductions over time in depression, and increased quality of life, self-efficacy, benefit finding, and skills relative to UC (moderate effect sizes). Rates of clinically significant depression significantly decreased in HED-Start (p < .001) and increased in UC (p = .002). The significant positive effects of HED-Start, a low-intensity and cost intervention, on several adjustment indices, suggest that programs focusing on positive life skills can value add to existing renal care services.

Ultrasound-assisted process to improve proteins recovery from industrial canola and soybean byproducts

AbstractAn ultrasound-assisted process is proposed to obtain protein isolates from canola and soybean byproducts. A laboratory-scale probe system (24 kHz, 400W) was used for protein extraction and six levels of energy density were analyzed. Different mixtures of solvents (water, ethanol, methanol, acetone) and temperatures were tested for removing phenolic compounds, and the best results were obtained with ethanol-water (8:2 v/v) and energy density of 104 kJ/L, which minimize protein losses at that step. After extraction of phenolic compounds, samples were alkalinized (pH 12 or 9.5), subjected to ultrasound treatment and the protein precipitated at the isoelectric pH. The highest yield on protein extraction was obtained with 1:20 meal: NaOH solution ratio, applying 150 kJ/L at constant temperature (30 °C), increasing the protein recovery, 72.5% for canola meal and 37.5% for soybean meal, compared to the conventional method. The solubility of both isolates obtained with ultrasound improved ~ 50% at a pH close to neutral and basic, with an increase in free sulfhydryl groups, without significant effects of ultrasound treatment on the subunit fractions of the proteins. These results provide alternatives to develop protein isolates from an undervalued by-product, with better techno-functional properties that can be employed in the food industry.

Reproductive life and differentiated thyroid carcinoma in women: reciprocal influences on their respective outcome.

To analyze the reciprocal influences between female reproductive life and DTC management. Data on pregnancy outcome in DTC patients indicate that after conceiving, these women may need an increased L-T4 dose to maintain suppressed serum TSH levels. Nevertheless, this does not determine major harm in terms of pregnancy outcome. Analogously, the most recent findings obtained with the propensity score matching approach have confirmed that pregnancy does not significantly affect DTC clinical course and eventually tumor prognosis. A recent metanalysis and a large case-control study excluded a significant effect of radioactive iodine treatment (RAIT) on several reproductive variables in DTC patients, providing reassuring evidence that the current recommendations on RAIT for women of childbearing age are sufficiently well tolerated and do not affect fertility nor pregnancy rate. Overall, the most recent studies have provided sufficiently reassuring evidence that the occurrence of pregnancy and DTC management are of no reciprocal harm for adverse outcome in affected women of childbearing age. Thus, female DTC patients should be managed according to the individual response to treatment before pregnancy. When DTC diagnosis is made after conception, delaying surgery does not represent a harm in most patients.