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There are 200+ tested interventions for care partners (family, friends, and fictive kin) of people living with dementia (PLWD). But these interventions do not systematically cover relevant settings. Nor do these interventions affect all relevant outcomes that matter to people and healthcare systems. We present an evidence map of settings and outcomes from translated interventions to identify gaps. Of 190 studies identified, 31 unique interventions were retained in the evidence map. Identified setting gaps included studies set solely in hospitals/medical centers or set in multiple settings. Identified outcome gaps included interventions that improved care partner beliefs about providing care, care partner negative coping strategies, PLWD resources (e.g., social support), and PLWD coping strategies. Armed with an understanding of present gaps, we call on researchers to fill the identified gaps to ensure systematic coverage of settings and evaluation of outcomes that matter to people and healthcare systems.

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BACKGROUND: Although pulmonary hypertension (PH) and Eisenmenger's syndrome (ES) are common complications in adult congenital heart disease (ACHD), the frequency of diagnostic tests and the incidence of PH/ES in patients with ACHD in Japanese clinical practice are unclear. Therefore, we sought to clarify the frequency of diagnostic tests and incidence of PH/ES in patients with ACHD using the Medical Data Vision (MDV) database, the largest anonymized database of diagnosis procedure combination hospitals in Japan. METHODS: We conducted a retrospective cohort study using the MDV database (April 2008 to December 2021) of patients with ACHD (International Classificaiton of Diseases, 10th revision codes: Q203-204, Q210-213, Q250) aged ≥15 years. The frequency of laboratory/clinical tests and the incidence of PH/ES were calculated. Subgroup analyses were performed for the periods 2008-2015 and 2016-2021. RESULTS: Overall, 28219 ACHD patients were extracted from the MDV database (females 56.3%, males 43.7%; mean ± standard deviation age 44.7 ± 23.5 years). The mean ± standard deviation follow-up period was 2.5 ± 2.7 years. The frequencies of electrocardiography, ultrasonography, brain natriuretic peptide (BNP), N-terminal pro-BNP (NT-proBNP), right heart catheterization, and pulmonary function tests (DLCO) were 2149.8, 1054, 1233, 340, 40.0, and 6.0 per 1000 person-years, respectively. The incidence rate of PH/ES was 32.8 per 1000 person-years. The incidence rate of PH/ES increased from 24.6 to 46.7 per 1000 person-years from 2008-2015 to 2016-2021. CONCLUSION: We have clarified the frequency of diagnostic tests related to PH/ES and the incidence of PH/ES in patients with ACHD in clinical practice in Japan, including non-specialist institutions for PH.

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Patients are filtered by rigorously defined study selection criteria for recruitment into research; this is necessary to improve signal detection, improve internal validity, reduce study-related risks, and meet ethical standards. Research patients are assessed and managed in ways that differ from usual practice. So, neither patients nor the treatment environment resembles everyday patients treated in everyday practice. This diminishes the generalizability of study findings; that is, their external validity. There is, therefore, an increasing trend to conduct "real-world studies." In this context, "real-world patients" are those who are not filtered by restrictive study selection criteria, and "real-world settings" are those in which patients are managed with few study-related guidelines and restrictions. The elephant in the room is that the glamour associated with such real-world studies is an illusion. This is because real-world patients in one real-world setting can differ widely from real-world patients in another real-world setting. So, even in real-world studies, we can only generalize study findings to the population from which the sample was drawn and the setting in which the sample was managed. As a final note, many assessments in research, such as computerized or pen-and-paper neuropsychological tests, are not real-world measures as are, for example, measures of activities of daily living or quality of life.

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PURPOSE: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. MATERIALS AND METHODS: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. RESULTS: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). CONCLUSIONS: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. CLINICAL IMPACT: This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.

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OBJECTIVE: The aim of this paper is to provide a systematic review of research on physical exercise in real-world settings on executive function of typical children and adolescents. METHODS: The CNKI, WOS, PubMed, ScienceDirect, and SPORTDiscus databases were searched by computer. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included literature. Statistical analysis was performed using frequency and percentage and the χ2 test. RESULTS: A total of 49 articles was included. Acute (moderate intensity lasting 30-50 min) and long-term (interventions of moderate intensity of 30-50 min at least 3 times a week for 17 weeks or more) physical exercises in real-world settings have positive intervention effects on executive function. Furthermore, for acute interventions, closed skills are more efficient for inhibitory control, open skills are more efficient for working memory and cognitive flexibility, and open-continuous and closed-sequential skills are the most efficient; long-term interventions with open skills, sequential skills, and open-sequential skills are more effective. CONCLUSION: Physical exercise in real-world settings has a good promotion effect on typical children and adolescents, and motor skills with open and/or sequential attributes are more helpful in improving executive function.

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Today, computer vision algorithms are very important for different fields and applications, such as closed-circuit television security, health status monitoring, and recognizing a specific person or object and robotics. Regarding this topic, the present paper deals with a recent review of the literature on computer vision algorithms (recognition and tracking of faces, bodies, and objects) oriented towards socially assistive robot applications. The performance, frames per second (FPS) processing speed, and hardware implemented to run the algorithms are highlighted by comparing the available solutions. Moreover, this paper provides general information for researchers interested in knowing which vision algorithms are available, enabling them to select the one that is most suitable to include in their robotic system applications.

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BACKGROUND: In FRESCO trial, a phase III study of fruquintinib demonstrated a significant improvement on the overall survival (OS) of patients with metastatic colorectal cancer (mCRC) who failed to response to available standard treatments. The aim of the current study was to evaluate the safety and effectiveness of fruquintinib in Chinese mCRC patients in the real-world setting. METHODS: Patients with mCRC treated with fruquintinib at our hospital were retrospectively reviewed. Patient demographics, treatment, adverse events and survival data were collected. OS and progression-free survival (PFS) were estimated using the Kaplan-Meier method. RESULTS: In total, 76 patients were evaluated from December 2018 to January 2020. The median (range) age was 59.5 (34-86) years, ECOG PS 0-1/2 was 86.8%/13.2%, and 38 (50%)/30 (39.5%) patients had experienced more than two prior therapies for mCRC. The median treatment duration was 3.6 cycles. Treatment-related adverse events (TRAEs) resulted in dose reduction were 17.1% of the patients without any treatment discontinuation. The most common grade 3 or 4 TRAEs were hypertension (9.2%), hand-foot skin reaction (7.9%), thrombocytopenia (3.9%), anaemia (2.6%), increased ALT (1.3%), oral mucositis (1.3%), proteinuria (1.3%) and neutropenia (1.3%). The median PFS was 5.1 months (95% CI 3.8-6.4 months), and the median OS was 12.0 months (95% CI 8.0-16.1 months). In patients with hypertension or hypothyroidism, a survival extension approximate to 6 months was observed, but the difference is not yet statistically significant. CEA decreased after fruquintinib treatment could be considered as a potential predictor for better OS. CONCLUSION: The outcome of this real-life study was consistent with that of the randomised controlled trial. There were no new safety concerns. Future studies of fruquintinib should be conducted to identify patients who tend to obtain more benefits from fruquintinib alone or in combination with other agents.

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OBJECTIVE: Patients that undergo total hip replacement (THA) are at risk of revision surgery. This study evaluated the cumulative incidence of revision following a medial collared, triple tapered (MCTT) primary hip stem versus other implants in real-world settings using electronic medical records. METHODS: This was a retrospective cohort study that used the Mercy Healthcare Systems - Orthopedics Database (MHSOD) to identify ACTIS total hip system, a MCTT primary hip stem for THA, and any other primary THA between 2016 and 2020. A Kaplan-Meier analysis was conducted to evaluate the risk of revision over time between the MCTT hip stem and other implants. In order to control for the confounding, a multivariable Cox model was developed to evaluate the risk of revision between the two groups. RESULTS: There were 1213 patients treated with MCTT hip stem and 6916 patients treated with other implants. The Kaplan-Meier analysis showed statistically significant difference (p value = .006) in cumulative incidences for all-cause revisions between the MCTT hip stem and other implants. The cumulative incidence at 3 years was 1.08% (0.43-2.72%) for the MCTT hip stem, while it was 2.63% (2.19-3.16%) for other implants. After adjusting for patient demographics, clinical characteristics, prescribed medications, and surgeon characteristics, the multivariable Cox proportional hazard model showed the MCTT hip stem was statistically significantly associated with 57% lower risk of revisions compared with other implants (HR, 0.43; 95% CI, 0.19-0.97; p-value = .042). CONCLUSIONS: This real-world study found that the incidence of revision after treatment with MCTT primary hip stem was significantly lower than for other implants.

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Multiple sclerosis (MS) is a chronic autoimmune neurological disease that typically affects young adults, causing irreversible physical disability and cognitive impairment. Alemtuzumab, administered intravenously as 2 initial courses of 12 mg/day (5 consecutive days at baseline, and 3 consecutive days 12 months later), resulted in significantly greater improvements in clinical and MRI outcomes vs. subcutaneous interferon beta-1a over 2 years in patients with active relapsing-remitting MS (RRMS) who were either treatment-naive (CARE-MS I; NCT00530348) or had an inadequate response to prior therapy (CARE-MS II; NCT00548405). Efficacy with alemtuzumab was maintained over 7 years in subsequent extension studies (NCT00930553; NCT02255656), in the absence of continuous treatment and with a consistent safety profile. There is an increased incidence of autoimmune events in patients treated with alemtuzumab (mainly thyroid events, but also immune thrombocytopenia and nephropathy), which imparts a need for mandatory safety monitoring for 4 years following the last treatment. The risk management strategy for alemtuzumab-treated patients includes laboratory monitoring and a comprehensive patient education and support program that enables early detection and effective management of autoimmune events, yielding optimal outcomes for MS patients. Here we provide an overview of tools and techniques that have been implemented in real-world clinical settings to reduce the burden of monitoring for both patients and healthcare providers, including customized educational materials, the use of social media, and interactive online databases for managing healthcare data. Many practices are also enhancing patient outreach efforts through coordination with specialized nursing services and ancillary caregivers. The best practice recommendations for safety monitoring described in this article, based on experiences in real-world clinical settings, may enable early detection and management of autoimmune events, and help with implementation of monitoring requirements while maximizing the benefits of alemtuzumab treatment for MS patients.

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Trastuzumab is a milestone in the treatment of human epidermal growth factor receptor 2 positive (HER2+) breast cancer (BC), in both the early and metastatic settings. Over the last two decades, clinical trials have established the good safety profile of trastuzumab. Cardiotoxicity remains the most frequent adverse event, more commonly exemplified by an asymptomatic decline in the left ventricular ejection fraction rather than congestive heart failure. Results from several long-term (>5 years) safety analyses have been recently published, with the inherent evidence substantially confirming the findings from previous trials. The clinical experience gained over the years in the use of trastuzumab has also fueled a number of observational studies focused on the effectiveness of this drug in the real-world settings. We herein reviewed the evidence available from tree major databases, namely, PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), to explore and critically discuss key issues related to the long-term safety and effectiveness of trastuzumab in clinical practice.

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Many instrumental activities of daily living (IADLs), like cooking and managing finances and medications, involve finding efficiently and in a timely manner one or several objects within complex environments. They may thus be disrupted by visual search deficits. These deficits, present in Alzheimer's disease (AD) from its early stages, arise from impairments in multiple attentional and memory mechanisms. A growing body of research on visual search in AD has examined several factors underlying search impairments in simple arrays. Little is known about how AD patients search in real-world scenes and in real settings, and about how such impairments affect patients' functional autonomy. Here, we review studies on visuospatial attention and visual search in AD. We then consider why analysis of patients' oculomotor behavior is promising to improve understanding of the specific search deficits in AD, and of their role in impairing IADL performance. We also highlight why paradigms developed in research on real-world scenes and real settings in healthy individuals are valuable to investigate visual search in AD. Finally, we indicate future research directions that may offer new insights to improve visual search abilities and autonomy in AD patients.

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INTRODUCTION: This study evaluates an insulin dose titration model and factors that impact insulin dose adjustment in Chinese adults with type-2 diabetes, who receive basal insulin in real-world settings. MATERIAL AND METHODS: A total of 19,894 patients from the ORBIT study were included. These patients were divided into four groups, according to the type of insulin dose adjustment: no insulin titration (group A), self-titration (group B), physician-led insulin titration (group C), and combined physician and patient-led insulin titration (group D). Data were collected and compared at baseline and after six months of treatment. RESULTS: A total of 12,865 patients completed the visits and were included in the analysis. Among these patients, 3187 (24.8%), 1971 (15.3%), 5165 (40.1%), and 2542 (19.8%) patients were included in groups A, B, C, and D, respectively. The multivariate logistic regression analysis revealed that the duration of diabetes, body mass index, microvascular complications, inpatient days, HbA1C level, and self-monitoring of blood glucose (SMBG) were positively correlated with insulin titration in group B, C, and D, compared with group A. The number of inpatient days and outpatient visits were positively correlated with dose adjustment for physician-led titration, while this was negatively correlated for self-titration. Self-titration encouraged by physicians and home blood glucose monitoring were positively correlated with self-titration and the combined physician and patient-led titration. CONCLUSIONS: High HbA1C level, SMBG, long disease duration, microvascular complications, and the encouragement of physicians while initiating insulin use prompt patients to perform dose adjustments in real-world settings.

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BACKGROUND: Various tyrosine kinase signalling pathways affect the development and progression of colorectal cancer (crc). In clinical trials, regorafenib has been associated with a survival benefit in metastatic crc (mcrc). We assessed the safety and efficacy of regorafenib in real-world patients. METHODS: In a retrospective review of patients with mcrc treated with regorafenib at our institution from 2013 to 2015, patient demographics, treatment, and survival data were collected. Progression-free survival (pfs) and overall survival (os) were estimated using the Kaplan-Meier method. RESULTS: In total, 48 patients were offered regorafenib, and 35 (73%) started treatment. Of the patients who started regorafenib, 57% were men. Median age in the cohort was 61 years, and all patients had a performance status in the range 0-2. Time from diagnosis of mcrc to regorafenib treatment was more than 18 months in 71% of patients. Starting dose was 160 mg in 54% of the patients, 120 mg in 40%, and 80 mg in 6%. Dose reductions occurred in 34% of the patients, and interruptions, in 29%. Best response was progressive disease (60%) and stable disease (17%); response in the rest of the patients was unknown. The most common adverse events on regorafenib (any grade) were fatigue (57%), hyperbilirubinemia (43%), thrombocytopenia (37%), anorexia (31%), and hypertension (31%). The most common grade 3 or 4 adverse events were fatigue (29%), hypophosphatemia (17%), weight loss (11%), and hyperbilirubinemia (9%). Common reasons for discontinuing regorafenib included progressive disease (51%) and toxicity (26%). In patients treated with regorafenib, pfs was 2.4 months (95% confidence interval: 1.8 to 3.3 months) and os was 5.6 months (95% confidence interval: 3.7 to 8.9 months). No factors were associated with survival in univariate or multivariate analysis. CONCLUSIONS: In a real-world setting, regorafenib is associated with survival similar to that reported in the randomized controlled trials, but at the expense of toxicity leading to discontinuation in many patients. Future studies of regorafenib should focus on identifying the patients most likely to benefit and on minimizing toxicity.