Exercise is a common intervention for low back pain, but its effect sizes are small to modest. Social risk factors significantly influence health outcomes, yet their consideration in randomized controlled trials on exercise for low back pain is often neglected. Determining their relationship to outcomes may provide better insight into exercise effectiveness.

To assess the reporting of social risk factors (SRFs) in randomized controlled trials (RCTs) of exercise interventions for low back pain (LBP) in adults and explore associations between SRFs and outcomes.

Scoping Review.

The databases MEDLINE, CINAHL and Cochrane were searched for studies published between January 2014 to March 2025. RCTs were included if exercise was the primary intervention for LBP treatment and had a minimum follow-up of 12 weeks. A planned analysis of SRF and outcome associations was not conducted due to insufficient data.

A total of 10,292 studies were identified and 157 studies included. Fewer than half (47.1 %) reported any SRFs at baseline. Socioeconomic position (42.7 %) was most frequently reported, followed by social relationships (17.8 %), race/ethnicity/cultural context (8.3 %), residential/community context (1.3 %), and gender (0.6 %). Four studies incorporated SRFs in their outcome analyses; one examined associations with outcomes and found no significant association.

SRFs are underreported in RCTs of exercise interventions for LBP and are rarely analyzed in relation to primary outcomes, limiting our understanding of their impact. Future trials should prioritize collecting and reporting SRFs at baseline and incorporating them in outcome analyses to assess their influence on outcomes.

The need for pragmatic clinical trials evaluating therapeutic interventions in patients with neurological disease is continually increasing due to availability of multiple therapeutic interventions (comparative effectiveness), multifaceted approaches (multiple concurrent synergistic therapeutic interventions), and gaps in trial-specific and real-world population outcomes. Several designs for pragmatic trials are available, including individual randomized trials with pragmatic characteristics, cluster-randomized and non-randomized trials, and observational prospective cohort studies. Cluster trials may have parallel cluster and crossover (unidirectional, bidirectional, and alternating crossover) designs. There are unique aspects of consenting and data collection leveraging existing registries, electronic health records (EHRs), and claims data that make pragmatic trials most suited to study the effectiveness of therapeutic interventions in patients with neurological diseases in real-world settings. ANN NEUROL 2025;97:1022-1037.

The growing significance of generalization in psychiatric interventions stems from the need for effective and applicable treatments across diverse populations and settings. Addressing psychiatric disorders involves navigating the complex interplay of biological, cognitive, and behavioral factors, making it crucial to assess the transferability of interventions beyond controlled environments. To tackle this challenge, we propose a novel conceptual framework, the FIELD model (Function, Implement, Ecology, Level, and Durability). This model offers a comprehensive exploration of generalization by considering the function and tools used in interventions, the ecological contexts of their application, the various levels of impact, and the durability of effects over time. In this study, we explore the dimensions of the FIELD model, emphasizing the role of assessment tools as valuable indicators and the significance of effect sizes in quantifying the transfer of training effects. The FIELD model stands as a tool to enhance our understanding of psychiatric interventions, providing a systematic and nuanced approach to evaluate their generalization across diverse scenarios.

Supports for adaptive functioning in individuals with neurodevelopmental conditions (NDCs) is of umost importance to long-term outcomes. Artificial intelligence (AI)-assistive technologies has enormous potential to offer efficient, cost-effective, and personalized solutions to address these challenges, particularly in everday environments. This systematic review examines the existing evidence for using AI-assistive technologies to support adaptive functioning in people with NDCs in everyday settings. Searches across six databases yielded 15 studies meeting inclusion criteria, focusing on robotics, phones/computers and virtual reality. Studies most frequently recruited children diagnosed with autism and targeted social skills (47%), daily living skills (26%), and communication (16%). Despite promising results, studies addressing broader transdiagnostic needs across different NDC populations are needed. There is also an urgent need to improve the quality of evidence-based research practices. This review concludes that AI holds enormous potential to support adaptive functioning for people with NDCs and for personalized health support. This review underscores the need for further research studies to advance AI technologies in this field.

To identify empathy training models and the effects on psychological concerns in paid and unpaid caregivers of older people.

A systematic review was conducted. Searches for relevant articles were performed in the Embase, LILACS, PsycInfo, Pubmed, Scopus and Web of Science databases using the following search strategy: "Empathy AND (Education OR Training OR Intervention) AND Caregiver." No restrictions were imposed regarding language or year of publication.

Empathy training for caregivers of older people were performed in six studies, three of which identified a significant increase in empathy levels and consequent reduction in psychological concerns. Empathy training focused on aspects of empathy and/or the caregiver had significant effects on the outcome variables. Moreover, training conducted online, by telephone and/or in person can generate satisfactory results. The other three studies that conducted training with a focus on aspects of dementia and/or old age did not present any effect on the outcome variables.

Empathy training for caregivers of older people can increase levels of this ability, especially in the cognitive domain, as well as diminish psychological concerns caused by the negative impact of providing care.

Empathy training directed at empathic abilities and/or aspects of providing care can be effective at increasing levels of this ability. Moreover, training in different care contexts can minimize the negative impacts of providing care.

Asymptomatic high-grade carotid stenosis is an important therapeutic target for stroke prevention. For decades, the ACAS (Asymptomatic Carotid Atherosclerosis Study) and ACST (Asymptomatic Carotid Surgery Trial) trials provided most of the evidence supporting endarterectomy for patients with asymptomatic high-grade stenosis who were otherwise good candidates for surgery. Since then, transfemoral/transradial carotid stenting and transcarotid artery revascularization have emerged as alternatives to endarterectomy for revascularization. Advances in treatments against atherosclerosis have driven down the rates of stroke in patients managed without revascularization. SPACE-2 (Stent-Protected Angioplasty Versus Carotid Endarterectomy-2), a trial that included endarterectomy, stenting, and medical arms, failed to detect significant differences in stroke rates among treatment groups, but the study was stopped well short of its recruitment goal. CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) will be able to clarify whether revascularization by stenting or endarterectomy remains efficacious under conditions of intensive medical management. Transcarotid artery revascularization has a favorable periprocedural risk profile, but randomized trials comparing it to intensive medical management are lacking. Features like intraplaque hemorrhage on MRI and echolucency on B-mode ultrasonography can identify patients at higher risk of stroke with asymptomatic stenosis. High-grade stenosis with poor collaterals can cause hemispheric hypoperfusion, and unstable plaque can cause microemboli, both of which may be treatable risk factors for cognitive impairment. Evidence that there are patients with carotid stenosis who benefit cognitively from revascularization is presently lacking. New risk factors are emerging, like exposure to microplastics and nanoplastics. Strategies to limit exposure will be important without specific medical therapies.

In the present study, reduced toxicity (FluBu3) and myeloablative (BuCy) conditioning were compared in patients with AML who received first allogeneic HSCT in MRD-negative CR1. The study included 124 adult patients who underwent HSCT from an HLA-matched (8/8) sibling, unrelated, or 1-locus mismatched (7/8) unrelated donor (MMUD). The median age was 45 years and intermediate cytogenetics comprised majority (71.8%). The 2-year OS, RFS, CIR and NRM for BuCy (n = 78, 62.9%) and FluBu3 (n = 46, 37.1%) groups were 78.3% and 84.5% (p = 0.358), 78.0% and 76.3% (p = 0.806), 7.7% and 21.5% (p = 0.074) and 14.3% and 2.2% (p = 0.032), respectively. At the time of data cut-off, relapse and NRM were the main causes of HSCT failure in each of the FluBu3 and BuCy arms. Among patients, 75% of relapsed FluBu3 patients had high-risk features of either poor cytogenetics or FLT3-ITD mutation compared with 16.7% of BuCy patients. The majority of NRM in the BuCy group was due to GVHD (73%), half of whom received MMUD transplantation. To conclude, the FluBu3 reduced toxicity conditioning showed comparable post-transplant OS and RFS to BuCy and was associated with significantly reduced NRM that was offset by a trend towards higher risk of relapse even in MRD-negative CR1 population.

To investigate the effects of empathy training on psychological concerns and empathy in caregivers of older people.

A randomized, double-blind, crossover, clinical trial with follow-up was conducted online. Thirty paid and unpaid caregivers of older people from different regions of Brazil participated in an empathy training program. The caregivers answered a sociodemographic questionnaire and measures for the evaluation of empathy (affective and cognitive domains), burden, the impact of providing care as well as depressive symptoms and psychiatric symptoms before and immediately after training. Empathy and its domains were also assessed at three post-intervention follow-ups.

Empathy training diminished levels of psychological concerns. Moreover, an increase was found in levels of cognitive empathy 15, 30 and 60 days after the intervention.

Empathy training with a focus on cognitive empathy diminished psychological concerns in caregivers of older people and increased the levels of this ability over time. This intervention can be considered a coping strategy for negative impacts related to providing care.

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About one-fifth of cannabis users, the most commonly used illicit substance, have cannabis use disorder (CUD). Psychiatric disorders and suicide are more common in these patients, and the disability-adjusted life years were reported to be 0.69 million. Pharmacotherapy for CUD is an unmet public health need, as current evidence-based therapies have limited efficacy.

After explaining the pathophysiology of CUD, the effects of emerging pharmacological interventions in its treatment obtained from randomized controlled trials were reviewed in light of mechanisms of action. Superiority over control of cannabidiol, gabapentin, galantamine, nabilone plus zolpidem, nabiximols, naltrexone, PF-04457845, quetiapine, varenicline, and topiramate were observed through the cannabinoid, glutamatergic, γ-aminobutyric acidergic, serotonergic, noradrenergic, dopaminergic, opioidergic, and cholinergic systems. All medications were reported to be safe and tolerable.

Adding pharmacotherapy to psychotherapy is the optimal treatment for CUD on a case-by-case basis. Drug development to add to psychotherapy is the main path, but time and cost suggest repurposing and repositioning existing drugs. Considering sample size, follow-up, and effect size, further studies using objective tools are necessary. The future of CUD treatment is promising.

Randomized controlled trials (RCTs) have long been recognized as the gold standard for establishing causal relationships in clinical research. Despite that, various limitations of RCTs prevent its widespread implementation, ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria, amongst others. However, with the introduction of propensity score matching (PSM) as a retrospective statistical tool, new frontiers in establishing causation in clinical research were opened up. PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records, to create a matched sample of participants who received or did not receive the intervention based on their propensity scores, which takes into account characteristics such as age, gender and comorbidities. Given its retrospective nature and its use of observational data from existing sources, PSM circumvents the aforementioned ethical issues faced by RCTs. Majority of RCTs exclude elderly, pregnant women and young children; thus, evidence of therapy efficacy is rarely proven by robust clinical research for this population. On the other hand, by matching study patient characteristics to that of the population of interest, including the elderly, pregnant women and young children, PSM allows for generalization of results to the wider population and hence greatly increases the external validity. Instead of replacing RCTs with PSM, the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other. For example, in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial, the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol. Therefore, PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics, thus providing a fairer comparison for the impact of mannitol. This literature review reports the applications, advantages, and considerations of using PSM with RCTs, illustrating its utility in refining randomization, improving external validity, and accounting for non-compliance to protocol. Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients, while maintaining the robustness of randomization offered by RCTs.

As the life expectancy of individuals with intellectual disabilities (ID) continues to increase, there is an increased risk of developing dementia. While psychosocial interventions are gaining prominence, evidence is limited for people with both dementia and ID. This review discusses the effectiveness of direct psychosocial interventions and adaptations to facilitate delivery within this population.

The review followed the PRISMA guidelines. Five electronic databases, grey literature, and reference lists of included articles were searched for relevant studies. 10 eligible studies were appraised and analysed by narrative synthesis.

Ten distinct interventions were identified and categorised based on their purpose and delivery. All interventions were beneficial in improving a range of outcomes, though some studies were of low quality and most had small samples. Common adaptations included simplification of tasks and material, higher staff-to-client ratio, and alternative communication methods.

There is emerging evidence for several psychosocial interventions for people with ID and dementia, though further research is required on effectiveness and generalisability. The adaptations discussed may guide implementation into routine care and contribute to current policies and guidelines on improving ID and dementia care.

This systematic review aimed to determine which interventions increase physical activity (PA) and decrease sedentary behavior (SB) based on objective measures of movement behavior in individuals with stroke.

The PubMed (Medline), EMBASE, Scopus, CINAHL (EBSCO), and Web of Science databases were searched for articles published up to January 3, 2023.

The StArt 3.0.3 BETA software was used to screen titles, abstracts, and full texts for studies with randomized controlled trial designs; individuals with stroke (≥18 years of age); interventions aimed at increasing PA or decreasing SB; and objective measurement instruments.

Data extraction was standardized, considering participants and assessments of interest. The risk of bias and quality of evidence of the included studies were assessed.

Twenty-eight studies involving 1855 patients were included. Meta-analyses revealed that in the post-stroke acute/subacute phase, exercise interventions combined with behavior change techniques (BCTs) increased both daily steps (standardized mean difference [SMD]=0.65, P=.0002) and time spent on moderate-to-vigorous intensity physical activities (MVPAs) duration of PA (SMD=0.68, P=.0004) with moderate-quality evidence. In addition, interventions based only on BCTs increased PA levels with very low-quality evidence (SMD (low-intensity physical activity)=0.36, P=.02; SMD (MVPA)=0.56, P=.0004) and decreased SB with low-quality evidence (SMD=0.48, P=.03). In the post-stroke chronic phase, there is statistical significance in favor of exercise-only interventions in PA frequency (steps/day) with moderate-quality evidence (SMD=0.68, P=.002). In general, the risk of bias in the included studies was low.

In the acute/subacute phase after stroke, the use of BCTs combined with exercise can increase the number of daily steps and time spent on MVPA. In contrast, in the post-stroke chronic phase, exercise-only interventions resulted in a significant increase in daily steps.

This critical review of Kaddoura et al.'s article on sacubitril/valsartan in heart failure patients underscores the importance of considering potential adverse effects, including renal failure, hyperkalemia, angioedema, and increased reports of sudden cardiac death. It highlights the need for rigorous monitoring and precise treatment regimens, especially in diabetic heart failure patients. Additionally, the review questions the generalizability of the study's results to diverse healthcare settings and emphasizes the importance of grounded patient follow-up data for accurate long-term assessment. These considerations are vital for informed decision-making regarding sacubitril/valsartan use in heart failure management.

The recent coronavirus emergency raised the question of whether telerehabilitation could be as effective as conventional face-to-face intervention. The aim of the present study was to compared language and cognitive training delivered to patients from a distance, through telecommunication systems, for the same intervention conducted on a face-to-face mode in patients with multi domain amnestic MCI (md-aMCI). To this end, 30 patients diagnosed with md-aMCI took part in the present study. The participants divided into two groups; one group received conventional face-to-face training and the other group received Telerehabilitation training. Both groups received language training using paper and pencil tasks and cognitive training using the Rehacom software. The training lasted 15 weeks and was delivered twice a week, for 60 minutes per session. The conventional face-to-face mode had a significant impact on cognitive (delayed and working memory, processing speed, executive function, and attention) and language domains (naming, word recognition, and semantic fluency). The telerehabilitation method had a beneficial impact on delayed memory, naming, and semantic fluency. The results of our study provide evidence that both telerehabilitation and face-to-face language and cognitive training seem to have a positive impact in patients with md-aMCI, with face-to-face training improving more domains than telerehabilitation.

Fatigue is barrier of physical activity participation in adults with chronic conditions. However, physical activity alleviates fatigue symptoms. This systematic review and meta-analysis aimed to (1) synthesise evidence from randomised controlled trials (RCTs) exploring the effects of physical activity interventions on fatigue reduction and (2) evaluate their effectiveness. Medline/CINAHL/EMBASE/Web of Science and Scopus were searched up to June 24th, 2023. Two reviewers independently conducted study screening and selection (RCTs), extracted data and assessed risk of bias (RoB2). Outcome was the standardised mean difference (SMD) with 95% confidence intervals in fatigue between experimental and control groups. 38 articles met the inclusion criteria. Overall, physical activity interventions moderately reduced fatigue (SMD = 0.54, p < 0.0001). Interventions lasting 2-6 weeks demonstrated a larger effect on fatigue reduction (SMD = 0.86, p < 0.00001). Interventions with 18-24 sessions showed a large effect on fatigue reduction (SMD = 0.97, p < 0.00001). Aerobic cycling and combination training interventions had a large to moderate effect (SMD = 0.66, p = 0.0005; SMD = 0.60, p = 0.0010, respectively). No long-term effects were found during follow-up. Physical activity interventions moderately reduced fatigue among adults with chronic conditions. Duration, total sessions, and mode of physical activity were identified as key factors in intervention effectiveness. Further research is needed to explore the impact of physical activity interventions on fatigue.

The purpose of the present study was to explore whether Computer-Based Cognitive Training (C-BCT) versus Paper-Pencil Cognitive Training (P-PCT) is more beneficial in improving cognitive and language deficits in Greek patients living with Alzheimer's disease (pwAD). Twenty pwAD were assigned to two groups: (a) the C-BCT group, receiving a computer-based cognitive training program using the RehaCom software, and (b) the P-PCT group, which received cognitive training using paper and pencil. The cognitive training programs lasted 15 weeks and were administered twice a week for approximately one hour per session. The analyses of each group's baseline versus endpoint performance demonstrated that the P-PCT group improved on delayed memory, verbal fluency, attention, processing speed, executive function, general cognitive ability, and activities of daily living. In contrast, the C-BCT group improved on memory (delayed and working), naming, and processing speed. Comparisons between the two groups (C-BCT vs. P-PCT) revealed that both methods had significant effects on patients' cognition, with the P-PCT method transferring the primary cognitive benefits to real-life activities. Our findings indicate that both methods are beneficial in attenuating cognitive and language deficits in pwAD. The need for large-scale neurobehavioral interventions to further clarify this issue, however, remains a priority.

To synthesize existing evidence on the effectiveness of speech-language teleinterventions delivered via videoconferencing to users of augmentative and alternative communication (AAC) devices.

A systematic literature search was conducted in 10 electronic databases, from inception until August 2021. Included were speech-language teleinterventions delivered by researchers and/or clinicians via videoconferencing to users of AAC devices, without restrictions on chronological age and clinical diagnosis. The quality of the studies included in the review was appraised using the Downs and Black checklist and the Single-Case Experimental Design Scale; risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies - of Interventions and the single-case design risk of bias tools.

Six teleinterventions including 25 participants with a variety of conditions, such as Down syndrome, autism, Rett syndrome, and amyotrophic lateral sclerosis met the inclusion criteria. Five studies used a single-case experimental design and one was a cohort study. Teleinterventions included active consultation (n = 2), functional communication training (n = 2), brain-computer interface (n = 1), and both teleintervention and in-person intervention (n = 1). All teleinterventions reported an increase in participants' independent use of AAC devices during the training sessions compared to baseline, as well as an overall high satisfaction and treatment acceptability.

Speech-language teleinterventions for users of AAC devices show great potential for a successful method of service delivery. Future telehealth studies with larger sample sizes and more robust methodology are strongly encouraged to allow the generalization of results across different populations.

Individuals can learn to use augmentative and alternative communication (AAC) devices independently during tele-AAC interventions. Service providers and recipients reported an overall high satisfaction and acceptability for AAC services delivered via teleinterventions. Speech-language teleinterventions may be an effective method of providing AAC intervention services.

Parents living in deprived communities are more likely to report lower parental self-efficacy and wellbeing. Poor parental wellbeing and self-efficacy are known risk factors in the development of a range of health and behavioural problems in childhood, adolescence and adulthood. Parenting interventions are key to prevent adverse outcomes in children, however, the mechanisms by which parents learn to understand and support their children are still not well understood. This study evaluated the acceptability of Kids Matter, a parenting intervention targeting parents who are struggling with financial adversity. Secondarily, the relationship between parental wellbeing and and self-efficacy was examined. The present is a retrospective, consecutive case series design study, comparing routinely collected data at pre-intervention, post-intervention, and at 3-month follow-up. Descriptive frequencies were drawn to explore parents' impressions of the programme. Multivariate analysis of variance and regression modelling were used to evaluate associations between parental wellbeing and self-efficacy at different time points. Parents found the programme enjoyable and useful. The intervention led to significant improvements in parental wellbeing and self-efficacy. Improvements in parental wellbeing were significantly associated with improvements in self-efficacy. This study provides evidence of the acceptability and effectiveness of Kids Matter.

Evidence that a venetoclax (VEN)-combined regimen is effective in relapsed/refractory acute myeloid leukemia (R/R AML) is emerging. However, it is unknown how VEN-combined low intensity treatment compares to intensive chemotherapy (IC) in medically fit patients with R/R AML.

We compared AML patients who received IC (n = 89) to those who received a VEN in combination with hypomethylating agents or low dose cytarabine (VEN combination) (n = 54) as their first- or second-line salvage after failing anthracycline-containing intensive chemotherapy.

The median age was 49 years, and significantly more patients in the VEN combination group were in their second salvage and had received prior stem cell transplantation (SCT). Overall response rates including CR, CRi, and MLFS were comparable (44.0% for IC vs. 59.3% for VEN combination, p = 0.081), but VEN combination group compared to IC group tended to show lower treatment related mortality. The rate of bridging to SCT was the same (68.5%), but the percentage of SCT at blast clearance was significantly higher in the VEN-combined group (62.3% vs. 86.5%, p = 0.010). After median follow-up periods of 22.5 (IC) and 11.3 months (VEN combination), the median overall survival was 8.9 (95% CI, 5.4-12.4) and 12.4 months (95% CI, 9.5-15.2) (p = 0.724), respectively.

VEN combination provides a comparable anti-leukemic response and survival to salvage IC, and provide a bridge to SCT with better disease control in medically-fit patients with R/R AML.

To synthesise the effects of music intervention on the physical and psychological problems of adults receiving haemodialysis.

Adults receiving haemodialysis experience many physical and psychological problems. Music interventions may have beneficial effect on the management of these problems.

A systematic review and meta-analysis based on PRISMA 2020.

This study followed the Cochrane 2021 guideline. Eleven electronic databases were searched from inception to July 2021. Randomised controlled trials that assessed music intervention on haemodialysis-related physical and psychological problems were included. Two authors independently assessed risk of bias with the Cochrane Collaboration tool. The Comprehensive Meta-Analysis software version 3 was used for meta-analysis.

Sixteen randomised controlled trials were included. This meta-analysis demonstrated that music intervention had significant and large effect on physical outcomes such as breath rate, oxygen saturation, arteriovenous fistula puncture-related pain, itching, sleep quality as well as psychological outcomes such as state anxiety and stress. The study also found that music intervention had significant and medium effect on physical outcomes such as systolic and diastolic blood pressure, heart rate and pain, and psychological outcomes such as anxiety. Music intervention had no effect on physical outcomes such as body temperature and cramps, and psychological outcomes such as trait anxiety and depression. Subgroup analyses indicated that sessions of 4-6 are more effective for improving the systolic and diastolic blood pressure and heart rate than three sessions or less. It also found that music duration of 20 min or less is more effective in reducing anxiety compared to music duration of 30 min or more.

This study demonstrated that music intervention may partially improve haemodialysis-related physical and psychological problems.

This study will contribute to perform of music intervention for haemodialysis-related physical and psychological problems for health professionals, particularly nurses.

This study has been registered at PROSPERO (Registration No. CRD42021267463).

Body ideals conveyed by the media and by body comparisons often result in body dissatisfaction, which can cause risky health behaviours and eating disorders, especially in adolescents. We conducted a meta-analytic review of existing school-based interventions designed to enhance media literacy in order to reduce body dissatisfaction and to promote a positive body image. We included controlled trials examining children and adolescents from grade five to nine (age 10-15 years) after a manual search and a comprehensive literature search using PsycINFO, Medline, Web of Science, and CENTRAL. We computed average weighted effect sizes (Hedges' g) with the help of a random effects model and identified seventeen different programme evaluations with 7392 participants. We found a significantly larger effect on positive body image and media literacy in the intervention compared to control groups. However, heterogeneity was substantial for both outcomes. Results suggest that media literacy interventions have the potential to improve media literacy and reduce body dissatisfaction. Interventions that worked with the principle of induction of cognitive dissonance were the most effective.

Current research suggests that communication training programmes for caregivers of people living with dementia can benefit both parties by improving communication, quality of life and stress. Previous reviews in this area focus on mixed samples of formal and informal caregivers. This review aimed to evaluate current research for trainings specifically for informal caregivers, including the research quality and the key training components.

The review followed the PRISMA research reporting checklist. The electronic databases CINAHL, Embase, Medline and Psychinfo and reference lists of included literature were searched for studies relevant to the aims. Of the 45 identified studies, 36 were excluded based on pre-specified criteria. Nine studies were included in the final review and subject to quality appraisal using the Qualsyst tool.

The included studies' programmes averaged 5 to 6 hours in length over four to five sessions, were mostly face to face in both group and individual settings and were developed using various communication and psychological theories. Studies demonstrated variable quality and outcomes, making it difficult to identify optimal components. However, careful consideration of different factors enabled some suggestions for training dose, delivery method, content and outcomes to measure.

Communication training programmes can benefit people living with dementia and their informal caregivers in outcomes such as communication skills and quality of life. Suggestions are made on the training components that optimise these benefits.

Given the clear benefits on outcomes such as quality of life, there is a need for communication trainings to be offered in clinical contexts. However, given the limited pool of variable quality research and lack of accessible manuals, it is unlikely that this is the case. Consolidating and widening the evidence through further research is essential in making these trainings more widely available.

The best treatment for coronary artery disease (CAD) in patients with type 2 diabetes (DM2) and chronic kidney disease is unknown.

This retrospective study included MASS registry patients with DM2 and multivessel CAD, stratified by kidney function. Primary endpoint was combined of mortality, myocardial infarction, or additional revascularization.

Median follow-up was 9.5 years. Primary endpoint occurrences among strata 1 and 2 were 53.4% and 40.7%, respectively (P=.020). Mortality rates were 37.4% and 24.6% in strata 1 and 2, respectively (P<.001). We observed a lower rate of major adverse cardiovascular events (MACE) (P=.027 for stratum 1 and P<.001 for stratum 2) and additional revascularization (P=.001 for stratum 1 and P<.001 for stratum 2) for those in the surgical group. In a multivariate analysis, eGFR was an independent predictor of MACE (P=.034) and mortality (P=.020).

Among subjects with DM2 and CAD the presence of lower eGFR rate was associated with higher rates of MACE and mortality, irrespective of treatment choice. CABG was associated with lower rates of MACE in both renal function strata. eGFR was an independent predictor of MACE and mortality in a 10-year follow-up.

We are in the midst of transformative innovation in health care delivery and clinical trials in idiopathic pulmonary fibrosis (IPF). Health systems are uniquely positioned at the crossroad of these shifting paradigms, equipped with the resources to expand the research pipeline in IPF through visionary leadership and targeted investments. The authors hope that by prioritizing development of health information technology, supporting a broader range of clinical trial designs, and cultivating broad stakeholder engagement, health systems will generate data to address knowledge-evidence-practice gaps in IPF. This will continue to improve the ability to deliver high-quality, safe, and effective care.

There is still a lack of consensus about the best treatment of chondral defects of the knee. We conducted a systematic PRISMA review to evaluate clinical outcomes of Autologous Chondrocyte Implantation (ACI) and Mesenchymal Stem Cell (MSC) injections for the treatment of focal chondral defects of the knee.

A systematic review of literature was performed according to the PRISMA guidelines. All the articles reporting data on ACI and MSC treatments for chondral defects of the knee were considered for inclusion. The main databases were accessed: PubMed, Medline, CINAHL, Cochrane, Embase and Google Scholar. The statistical analysis was performed using the Review Manager Software.

In the p-ACI group (987 knees), the Cincinnati Score improved by 18.94% (p=0.1), VAS by 38% (p=0.01), Tegner score by 19.11% (p=0.03), Lysholm score by 22.40% (p=0.01), IKCD by 27.36% (p=0.003). In the c-ACI group (444 knees), the Cincinnati Score improved by 23.80% (p=0.08), KOOS by 23.48% (p=0.03), VAS by 33.2% (p=0.005), IKDC by 33.30% (p=0.005). In the m-ACI group (599 knees), the Cincinnati Score improved by 26.80% (p=0.08), KOOS by 31.59% (p=0.1), VAS by 30.43% (p=0.4), Tegner score by 23.1% (p=0.002), Lysholm score by 31.14% (p=0.004), IKCD by 30.57% (p<0.001). In the MSCs group (291 knees), the KOOS improved by 29.7% (p=0.003), VAS by 41.89% (p<0.001), Tegner score by 25.81% (p=0.003), Lysholm score by 36.96% (p<0.001), IKCD by 30.57% (p=0.001).

Both ACI and MSC therapies can be considered as a concrete solution to treat focal chondral defects of the knee.

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are more commonly used to prevent atrial fibrillation (AF) patients from thromboembolic events than vitamin K antagonists (VKAs). However, the gastrointestinal bleeding (GIB) risk in the Asian AF patients associated with NOACs in comparison with VKAs remained unaddressed. Materials and Methods: A systematic search of studies on NOACs and VKAs in the Asian AF patients was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov. The primary outcome was the hazard ratio (HR) of any GIB associated with NOACs versus VKAs. The secondary outcome was the GIB risks in different kinds of NOACs compared with VKAs. Results: This meta-analysis included two randomized controlled trials (RCTs) and four retrospective studies, comprising at least 200,000 patients in total. A significantly lower HR of GIB risks was found in all kinds of NOACs than VKAs in the Asian AF patients (HR: 0.633; 95% confidence interval: 0.535-0.748; p < 0.001). Additionally, the GIB risks of different NOACs were apixaban (HR: 0.392), edoxaban (HR: 0.603), dabigatran (HR: 0.685), and rivaroxaban (HR: 0.794), respectively. Conclusions: NOACs significantly reduced the risk of GIB in the Asian AF patients compared with VKAs. In the four NOACs compared with VKAs, apixaban probably had a trend of the least GIB risk. We need further head-to-head studies of different NOACs to confirm which NOAC is the most suitable for Asian AF patients and to know the optimal dosage regimen of different NOACs.

Over the last decades there has been a change in the way schooling is perceived recognizing that children's learning is closely linked to children's health. Children spend most of their time at school, which is often the place where problems are identified and interventions are offered, not only for treatment but also prevention. Embedding arts therapies into the educational system may help address children's emerging needs and have a positive impact on their wellbeing.

A pilot cross-over randomized controlled design was employed to investigate the effectiveness of an arts therapies intervention on a series of child- and teacher-reported outcome measures, specifically, health related quality of life (assessed using a HRQOL scale; EQ-5D-Y), wellbeing and life functioning (assessed using the child outcome rating scale; CORS), emotional and behavioral difficulties (assessed using the strengths and difficulties questionnaire; SDQ), as well as duration of sleep (assessed using Fitbits). Sample size calculations for future large-scale studies were also performed, and the sustained impact of the intervention was evaluated at 3, 6, and 12 months follow-up. The pluralistic theoretical and therapeutic framework of this intervention was informed by a systematic review on school-based arts therapies interventions and is presented in detail in the study protocol. Participants were 62 children with mild emotional and behavioral difficulties.

Improvements in HRQOL and CORS were greater in those engaged in the arts therapies intervention than the control groups and were maintained at the follow-up stages. Significant improvements were only found for duration of sleep (P = 0.002) and SDQ (P = 0.008). Minimal clinically important differences (MCIDs) as defined in the published protocol were found for CORS, SDQ and duration of sleep, but not HRQOL.

Findings indicate that the arts therapies interventions were having a clinically significant effect on life functioning, duration of sleep, emotional and behavioral difficulties. Findings also indicate a small effect size for health related quality of life, suggesting the intervention was having a small positive effect on this outcome measure. The study indicates that all outcome measures assessed here would be suitable for inclusion in a larger randomized controlled study utilizing these arts therapies interventions, and that a sample size of 225 participants would be required if these outcome measures were used.

Little is known about the long-term impact of telephone-based interventions to improve child diet. This trial aimed to assess the long-term effectiveness (after 5 years) of a telephone-based parent intervention in increasing children's fruit and vegetable consumption. Parents of 3-5 year olds were recruited from 30 Australian preschools to participate in a cluster randomised controlled trial. Intervention parents received four, weekly, 30-min support calls aimed at modifying the home food environment. Control parents received printed materials. Consumption was assessed using the Fruit and Vegetable subscale of the Children's Dietary Questionnaire (F&V-CDQ) (children) and daily servings of fruit and vegetables (children and parents) via parent telephone interview. Of the 394 parents who completed baseline, 57% (99 intervention, 127 control) completed follow-up. After 5-years, higher intervention F&V-CDQ scores, bordering on significance, were found in complete-case (+1.1, p = 0.06) and sensitivity analyses (+1.1, p = 0.06). There was no difference in parent or child consumption of daily fruit servings. Complete-case analysis indicated significantly higher consumption of child vegetable servings (+0.5 servings; p = 0.02), which was not significant in sensitivity analysis (+0.5 servings; p = 0.10). This telephone-based parent intervention targeting the family food environment may yield promising improvements in child fruit and vegetable consumption over a 5-year period.

While randomized controlled trials (RCTs) are the gold standard for evidence-based medicine, they do not always reflect real-world patient populations, limiting their generalizability and external validity. Real-world evidence (RWE), generated during routine clinical practice, is increasingly important in determining effectiveness outside of the tightly controlled conditions of RCTs, and is now recognized by regulatory bodies as a valuable complement to RCTs. Consequently, it is increasingly important for physicians to understand how RWE data can be used alongside clinical trial data. Here, we discuss the different types of real-world observational studies, outline the benefits and limitations of RWE, and, using examples from EGFR mutation-positive non-small-cell lung cancer, outline how RWE can be used to help inform treatment decisions.

Lifestyle factors heavily influence the development of cardiovascular disease (CVD); therefore, interventions delivering adequate lifestyle changes may improve the prognosis among patients at cardiovascular (CV) risk. Recently published research on the effectiveness of dietary and exercise intervention programmes, alone or combined, on reducing risk factors associated with CVD as well as preventing CV events have been now assessed.

Using the Medline database via PubMed, we searched for prospective studies published between January 2000 and January 2020 assessing the efficacy of dietary interventions alone or in combination with exercise on reducing CV risk factors or events in human adults at risk. Study quality was assessed using the American Dietetic Association Quality Criteria Checklist. From 934 articles, 21 prospective experimental design studies (15 randomized controlled trials (RCTs), one cluster RCT, and five quasi-experimental intervention studies with a control group) met inclusion and exclusion criteria. Most interventions improved at least some markers of CV risk and the most improvement was time devoted to physical activity increased. A low-fat intervention diet seemed to be effective only when coupled with moderate intensity exercise and weight loss, while a Mediterranean diet (MedDiet) intervention without physical activity, decreased both systolic and diastolic blood pressure, major CV events rate and risk of developing type 2 diabetes.

The MedDiet appears to have the most beneficial effect on CV events and increased hours of physical training are strongly related to greater improvement of risk factors; nevertheless, adherence to intervention is fundamental as it directly relates to health outcomes.

Older adults are especially susceptible to adverse effects of inappropriate medication therapy, and anticholinergic medications are common culprits for cognitive dysfunction due to their action on the central nervous system. Medication therapy management (MTM) interventions can aid in deprescribing and reducing inappropriate medication use in older adults. However, there is sparse literature on the long-term sustainability of these interventions.

To (a) investigate whether the deprescribing of anticholinergic medications during an 8-week randomized controlled trial (RCT) of a targeted MTM intervention is sustained at 1-year postintervention follow-up and (b) compare anticholinergic utilization trends in the study population with a large sample of similar individuals not exposed to the intervention.

Participants in the targeted MTM (tMTM) RCT had normal cognition or mild cognitive impairment and were recruited from enrollees in a longitudinal study at the University of Kentucky Alzheimer's Disease Center (ADC) and thus have pertinent medical information gathered approximately annually. In this posttrial observational follow-up, sustainability of the anticholinergic deprescribing intervention was assessed in participants in the RCT, and anticholinergic medication use trends were described from the RCT baseline (which occurred immediately following an ADC visit) to the next annual visit in all participants. Mean change in anticholinergic burden from RCT baseline to the next annual visit was estimated using analysis of covariance, and participants were compared with 2 external samples. Anticholinergic burden was measured using the Anticholinergic Drug Scale (ADS). The odds of decreasing baseline anticholinergic burden and number of total and strong anticholinergic medications at the follow-up study time point was assessed using logistic regression.

Of the deprescribing changes made during the initial RCT, 50% were sustained after 1 year. Participants in the tMTM trial reported decreases in the use of anticholinergic antihistamines and bladder agents (-6.5 and -4.4%, respectively), but there was no change in the use of anticholinergic agents targeted at the central nervous system. While the anticholinergic burden of RCT participants decreased over 1 year (adjusted mean ADS change [95% CI] = -0.33 [-0.72, 0.07]), it was not different than the change observed in 2 external samples at the trial center (-0.20 [-0.42, 0.02]) and nationally (-0.33 [-0.39, -0.26]). There were no statistically significant differences between trial participants and external samples in the odds of decreasing anticholinergic burden nor in decreasing the number of total, or strongly anticholinergic, medications at the 1-year follow-up.

This study demonstrates that the sustainability of deprescribing is limited to the period of intervention, rather than affording lasting effects even over periods as short as 1 year, which was demonstrated not only in the small group of RCT participants but also by comparison with external groups. Future work should extend the duration of intervention and follow-up periods for MTM interventions to allow further insights regarding the sustainability of deprescribing efforts in older adults.

The original trial was supported by a pilot study award from the University of Kentucky Center for Clinical and Translational Sciences (UL1TR000117). Additional support for this study was provided by the National Institutes of Health/National Institute on Aging (R01 AG054130). Jicha reports contract research for Esai, Biohaven, Alltech, Suven, Novartis, and Lilly. The other authors have nothing to disclose.

In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study.

We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores.

From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups.

In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.

Although randomized controlled trials (RCTs) are the gold standard for the assessment of clinical outcomes, long-term extension trials (LTEs) and observational cohorts may help generate evidence. Our goal was to compare the discontinuation rates of abatacept, rituximab, and tocilizumab in rheumatoid arthritis (RA) reported in different study designs.

A systematic review was conducted with searches in PubMed, Scopus, and the Cochrane Library, plus a manual search, for RCTs, LTEs, and observational cohorts reporting discontinuation rates by any of three causes (all-cause, inefficacy, adverse events). Meta-analyses with sensitivity analyses and meta-regressions were conducted.

Of the 111 studies included, 74 were RCTs (n = 55) or LTEs (n = 17) reporting data on abatacept (n = 33), rituximab (n = 10), and tocilizumab (n = 31) and 37 were observational cohort studies (abatacept = 11, rituximab = 8, tocilizumab = 18). The follow-up duration did not differ among the study designs. Discontinuation rates were similar among the drugs but varied among the study designs. Discontinuation rates were significantly higher in cohort studies than those in interventional studies for the three drugs. Sensitivity analyses could not identify patient characteristics associated with these differences. Meta-regression analyses demonstrated no correlation between study follow-up duration and discontinuation rates.

The discontinuation rates reported for non-anti-TNF drugs varied relative to the study design in which they were investigated. Regulatory agencies, price-setting entities, and evidence-gathering researchers should consider the effect of the real-life environment in their decisions and conclusions.

There is an increasing interest in the effect of nonpharmacological interventions on the course of patients with Alzheimer's disease (AD). The objective of the present study is to determine the benefits of a structured, multidomain, mostly computer-based, cognitive training (MCT) οn the cognitive performance of patients with early-stage AD.

Fifty patients with early-stage AD participated in the study. Patients were randomly allocated either to the training program group (n = 25) or to a wait list control group (n = 25). The training program group received computer-assisted MCT and linguistic exercises utilizing pen and paper supplemented by cognitive-linguistic exercises for homework. The duration of the MCT intervention program was 15 weeks, and it was administered twice a week. Each session lasted for approximately one hour. Objective measures of episodic memory, delayed memory, word recognition, attention, executive function, processing speed, semantic fluency, and naming were assessed at baseline and after the completion of the program in both groups.

Analysis showed that in controls, delayed memory and executive function had deteriorated over the observation period of 15 weeks, while the training group improved their performance in word recognition, Boston Naming Test (BNT), semantic fluency (SF), clock-drawing test (CDT), digit span forward (DSF), digit span backward (DSB), trail-making test A (TMT A), and trail-making test B (TMT B). Comparison between the training group and the controls showed that MCT had a significant beneficial effect in delayed memory, naming, semantic fluency, visuospatial ability, executive functions, attention, and processing speed.

The study provides evidence of a beneficial effect of MCT with an emphasis on cognitive-language performance of patients with early-stage AD. Considering the limited efficacy of current pharmacological therapies in AD, concurrent computer-based MCT may represent an additional enhancing treatment option in early-stage AD patients.

Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer).

A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining > 95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool.

Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one type of follow-up. There was no evidence of an association between the retention rates of participants in the PTFU period and the type of follow-up used. Costs of PTFU varied widely with data linkage being the most economical. It was not possible to assess associations between risk of bias during the in-trial period and proportions lost to follow-up during the PTFU period.

Data captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints.

Not applicable for PROSPERO registration.