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Background: Mindfulness-based interventions have been shown to effectively reduce anxiety, depression and pain in patients with chronic physical illnesses. Objectives: We assessed the potential effectiveness and cost-effectiveness of a specially adapted Skype distant-delivered mindfulness intervention, designed to reduce distress for people affected by primary and secondary progressive MS. Methods Forty participants were randomly assigned to the eight-week intervention (n = 19) or a waiting-list control group (n = 21). Participants completed standardised questionnaires to measure mood, impact of MS and symptom severity, quality of life and service costs at baseline, post-intervention and three-month follow-up. Results: Distress scores were lower in the intervention group compared with the control group at post-intervention and follow-up (p < 0.05), effect size −0.67 post-intervention and −0.97 at follow-up. Mean scores for pain, fatigue, anxiety, depression and impact of MS were reduced for the mindfulness group compared with control group at post-therapy and follow-up; effect sizes ranged from −0.27 to −0.99 post-intervention and −0.29 to −1.12 at follow-up. There were no differences in quality-adjusted life years, but an 87.4% probability that the intervention saves on service costs and improves outcome. Conclusions: A mindfulness intervention delivered through Skype video conferences appears accessible, feasible and potentially effective and cost-effective for people with progressive MS.

Background: Recent studies have demonstrated that brain activities using NIRS (near-infrared spectroscopy) at baseline during cognitive tasks (e.g., N-back task) can predict the cognitive benefits of a cognitive training. In this study, we investigated whether brain activities during brain training game (BT) at baseline would predict benefits to cognitive functions after the intervention period. Methods: In a four-week double-blinded randomized control trial (RCT) 72 young adults were randomly assigned to one of the two groups: participants in the BT group played specific game, called the Brain Age. Participants in an active control group (ACT) played the puzzle game Tetris. We measured brain activity during the training games using two channel NIRS before the intervention period. Cognitive functions were tested before and after the four-week intervention period. Results: The BT showed significant improvements in inhibition, processing speed, and working memory performance compared to ACT. The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed. Discussion: This randomized control trial first provides scientific evidence that DLPFC activities during BT at baseline can predict cognitive improvements after a four-week intervention period.

The Alzheimer's disease (AD) research field has entered a new era, where our fundamental understanding of the pathophysiology of AD and advances in biomarkers have not only allowed for earlier, timely, and accurate detection and diagnosis of the disease, but that amyloid removal has been shown to be associated with signals of slowing cognitive and functional decline. Although recent FDA‐approved amyloid plaque‐lowering monoclonal antibody therapies have shifted the trajectory of AD, additional treatment options will be key to further slowing clinical decline or stopping disease progression. Thus, new and emerging therapies for AD have created an evolving therapeutic landscape. The Alzheimer's Association Research Roundtable (AARR) Spring meeting held on May 23–34, 2023, brought together a broad array of scientific leaders from the AARR membership, academia, industry, and government and regulatory agencies to discuss the future of clinical trials in an era of regulator‐approved amyloid‐targeting therapies. Participants discussed lessons learned from other neurological diseases where disease‐modifying treatments were first approved and key considerations for future clinical trials, for example, trial population real‐world representativeness, duration, biomarker screening, efficacy endpoints, combination therapy, as well as overall trial design and the ethical and equity concerns that clinicians, patients, and their families face when considering clinical trial participation. Highlights The Alzheimer's Association Research Roundtable (AARR) convened leaders from industry and academia, as well as patients, clinicians, and government and regulatory agency scientists to discuss the topic, “Alzheimer's Disease Drug Development in an Evolving Therapeutic Landscape.” While recently approved amyloid‐targeting therapies show great promise in providing clinically meaningful outcomes for patients and families, additional treatments, and a better understanding of dosing and administration of these approved treatments, are needed to further slow and eventually prevent clinical decline in AD. Approved therapies will impact many aspects of clinical trial design including the use of placebo‐controls, participant re‐enrollment, safety monitoring, as well as biomarker selection. This exciting new era in AD research represents a hopeful future for clinicians, patients, and their care partners.

Background and objectives: The purpose of this study is to clarify the effects on the mental health of face-to-face exercise performed by an instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P) by randomized control trial. Materials and Methods: Among 120 subjects, 117 subjects were allocated to two groups with stratified randomization by sex (Group P: 58 subjects; Group L: 59 subjects). A 60-min health exercise class was held once per week for 12 consecutive weeks. The measurement items were mental health as a primary evaluation item and self-efficacy as a secondary evaluation item. Physical fitness was also measured using a new physical fitness test used in Japan. The 12-item general health questionnaire (GHQ-12) was used to measure mental health and the general self-efficacy scale (GSES) was used to measure self-efficacy. Results: After the intervention, 102 subjects were analyzed. The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L −0.7 (95% CI, −1.2 to −0.3) than Group P −0.1 (95% CI, −0.4 to 0.2) (p = 0.03). The changes in self-efficacy evaluated by GSES scores were significantly higher in Group P 5.3 (95% CI, 3.1 to 7.5) than Group L 1.3 (95% CI, −0.4 to 3.1) (p < 0.01). Conclusions: Compared with program exercises mainly using machines, face-to-face exercises performed by instructors improved mental health.

Guideline developers are increasingly dealing with more difficult decisions concerning whether to recommend complex interventions in complex and highly variable health systems. There is greater recognition that both quantitative and qualitative evidence can be combined in a mixed-method synthesis and that this can be helpful in understanding how complexity impacts on interventions in specific contexts. This paper aims to clarify the different purposes, review designs, questions, synthesis methods and opportunities to combine quantitative and qualitative evidence to explore the complexity of complex interventions and health systems. Three case studies of guidelines developed by WHO, which incorporated quantitative and qualitative evidence, are used to illustrate possible uses of mixed-method reviews and evidence. Additional examples of methods that can be used or may have potential for use in a guideline process are outlined. Consideration is given to the opportunities for potential integration of quantitative and qualitative evidence at different stages of the review and guideline process. Encouragement is given to guideline commissioners and developers and review authors to consider including quantitative and qualitative evidence. Recommendations are made concerning the future development of methods to better address questions in systematic reviews and guidelines that adopt a complexity perspective.

Abstract The onset of schizophrenia occurs during a period critical for development of social relationships and functional independence. As such, interventions that target the early course of illness have the potential to stave off functional decline and restore functioning to pre-illness levels. In this entirely remote study, people with recent-onset schizophrenia spectrum disorders (SSDs) participated in a 12-week randomized controlled trial to determine the efficacy of PRIME (personalized real-time intervention for motivational enhancement), a mobile-based digital health intervention designed to improve motivation and quality of life. Participants were randomized into the PRIME (n = 22) or treatment-as-usual/waitlist (TAU/WL) condition (n = 21) and completed assessments at baseline, post-trial (12 wk), and for people in the PRIME condition, 3 months after the end of the trial. After 12-weeks, WL participants received PRIME, resulting in a total sample of 38 participants completing PRIME. In PRIME, participants worked towards self-identified goals with the support of a virtual community of age-matched peers with schizophrenia-spectrum disorders as well as motivation coaches. Compared to the WL condition, people in the PRIME condition had significantly greater improvements in self-reported depression, defeatist beliefs, self-efficacy, and a trend towards motivation/pleasure negative symptoms post-trial, and these improvements were maintained 3 months after the end of trial. We also found that people in the PRIME condition had significantly greater improvements in components of social motivation post-trial (anticipated pleasure and effort expenditure). Our results suggest that PRIME has the potential to be an effective mobile-based intervention for improving aspects of mood and motivation in young people with SSDs.

Background Many infants worldwide are not breastfeeding according to WHO recommendations and this impacts on the health of women and children. Increasing breastfeeding is identified as a priority area supported by current policy targets. However, interventions are complex and multi-component and it is unclear which elements of interventions are most effective to increase breastfeeding in which settings. Breastfeeding counselling is often part of complex interventions but evidence is lacking on the specific effect of counselling interventions on breastfeeding practices. The aim of this systematic review is to examine evidence on effectiveness of breastfeeding counselling to inform global guidelines. Methods A systematic search was conducted of six electronic databases in January 2018. Randomised controlled trials comparing breastfeeding counselling with no breastfeeding counselling or different formulations of counselling were included if they measured breastfeeding practices between birth and 24 months after birth. Results From the 5180 records identified in searches and a further 11 records found by hand searching, 63 studies were included. Of these, 48 were individually-randomised trials and 15 were cluster-randomised trials. A total of 69 relevant comparisons were reported involving 33,073 women. There was a significant effect of counselling interventions on any breastfeeding at 4 to 6 weeks (Relative risk [RR] 0.85, 95% CI 0.77, 0.94) and 6 months (RR 0.92, 95% CI 0.87, 0.94). Greater effects were found on exclusive breastfeeding at 4 to 6 weeks (RR 0.79, 95% CI 0.72, 0.87) and 6 months (RR 0.84, 95% CI 0.78, 0.91). Counselling delivered at least four times postnatally is more effective than counselling delivered antenatally only and/or fewer than four times. Evidence was mostly of low quality due to high or unclear risk of bias of the included trials and high heterogeneity. Conclusions Breastfeeding counselling is an effective public health intervention to increase rates of any and exclusive breastfeeding. Breastfeeding counselling should be provided face-to-face, and in addition, may be provided by telephone, both antenatally and postnatally, to all pregnant women and mothers with young children. To inform scale-up globally there is a need to further understand the elements of breastfeeding interventions such as counselling and their effectiveness in different contexts and circumstances. Study registration This systematic review was registered in Prospero ( CRD42018086494 ).

We performed a systematic review and dose–response meta-analysis of randomised trials on the effects of olive oil consumption on blood lipids in adults. A systematic search was performed in PubMed, Scopus and Web of Science databases until May 2021. Randomised controlled trials (RCT) evaluating the effect of olive oil intake on serum total cholesterol (TC), TAG, LDL-cholesterol and HDL-cholesterol in adults were included. The mean difference (MD) and 95 % CI were calculated for each 10 g/d increment in olive oil intake using a random-effects model. A total of thirty-four RCT with 1730 participants were included. Each 10 g/d increase in olive oil consumption had minimal effects on blood lipids including TC (MD: 0·79 mg/dl; 95 % CI (−0·08, 1·66); I 2 = 57 %; n 31, GRADE = low certainty), LDL-cholesterol (MD: 0·04 mg/dl, 95 % CI (−1·01, 0·94); I 2 = 80 %; n 31, GRADE = very low certainty), HDL-cholesterol (MD: 0·22 mg/dl; 95 % CI (−0·01, 0·45); I 2 = 38 %; n 33, GRADE = low certainty) and TAG (MD: 0·39 mg/dl; 95 % CI (−0·33, 1·11); I 2 = 7 %; n 32, GRADE = low certainty). Levels of TC increased slightly with the increase in olive oil consumption up to 30 g/d (MD30 g/d: 2·76 mg/dl, 95 % CI (0·01, 5·51)) and then appeared to plateau with a slight downward curve. A trivial non-linear dose-dependent increment was seen for HDL-cholesterol, with the greatest increment at 20 g/d (MD20 g/d: 1·03 mg/dl, 95 % CI (−1·23, 3·29)). Based on existing evidence, olive oil consumption had trivial effects on levels of serum lipids in adults. More large-scale randomized trials are needed to present more reliable results.

Virtual reality (VR) is increasingly incorporated into psychotherapy, with the literature documenting its effectiveness in treating anxiety disorders, pain, and stress. Few studies have incorporated VR into mindfulness interventions. The present study examined the efficacy of VR in facilitating mindfulness. It was hypothesised that a brief mindfulness intervention integrated with VR would lead to a greater elevation in mindfulness than conventional mindfulness practice. Thirty-two adults (16 males) aged 18–65 (M = 27.25, SD = 6.04) were randomly allocated to either a control condition, in which participants listened to a mindfulness audio track, or an experimental condition, in which participants received mindfulness practice in a VR beach environment. The Toronto Mindfulness Scale (Lau et al. J clin psychol 62(12):1445–1467 2006) was used to assess two mindfulness factors: curiosity and decentring. Although participants in the experimental condition experienced an increase in mindfulness, VR was not significantly more effective in facilitating mindfulness overall, although the VR condition was characterised by a significantly greater increase in decentring. Replication and investigation of causative mechanisms is necessary to further understand the distinct increase in decentring observed during VR-enhanced mindfulness training in this study.

BackgroundBariatric surgery is a durable and effective way for the management of obesity and resolution of related comorbidities. The aim of this study is to evaluate the outcome of laparoscopic sleeve gastrectomy (LSG) and one-anastomosis gastric bypass (OAGB) over long term in a South Asian population.Materials and MethodsThis is a prospective randomised trial comparing the outcome of 100 and 101 LSG and OAGB patients respectively after 5-year follow-up. This study is in continuity with previous published papers with 1- and 3-year follow-up. 71 LSG and 73 OAGB patients followed at 5 years. The results of these patients were analysed and compared in terms of %EWL, comorbidity resolution and quality of life (QoL) at 5 years. Bariatric analysis reporting and outcome system (BAROS) was used to assess the outcome of patients.ResultsAt 5-year follow-up, both LSG and OAGB patients performed well and patients had significant improvement in BMI (kg/m2). The mean preoperative BMI of LSG and OAGB patients was 44.89 ± 7.94 and 45.32 ± 8.24, and their mean BMI at 5 years was 33.41 ± 6.02, 30.80 ± 3.40 respectively. At 5 years, %EWL was 55.95 ± 27.01 and 65.28 ± 13.98 for LSG and OAGB patients respectively. The QoL score of LSG and OAGB patients was 1.86 ± 0.56 and 2.35 ± 0.41 while comorbidity score was 1.84 ± 0.68 and 2.24 ± 0.62 respectively at 5 years.ConclusionsBoth LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.