Search

Natural history studies (NHS) can support regulatory decision-making at different stages of the drug product life cycle and are especially important in the context of rare diseases, which are associated with not only delayed or erroneous diagnoses but also a lack of approved treatments. Real-world evidence can fill knowledge gaps and support treatment decision-making, thereby benefiting affected patients. In this context, there are three important options for NHS design: retrospective, prospective, and cross-sectional. Each of these has been successfully used to support regulatory approval as external comparator arms (ECAs) for clinical studies, especially single-arm trials (SATs). While longitudinal data obtained from retrospective or prospective designs have been more commonly used and have been the focus of regulatory guidance documents, hybrid designs that combine retrospective and prospective data collection are particularly powerful for rare disease studies. This is due, in part, to the smaller number of patients impacted by each rare disease. In these settings, retrospective or prospective data collection alone may not be sufficient or fit-for-purpose for an external comparator. Rather, a strategic combination of all available data, regardless of timing, can deliver the right information of the desired quality and completeness to answer these important questions and support regulatory evidentiary needs. For instance, patients included in retrospective studies may differ from recently treated patients in terms of disease severity, disease variants, clinical management, or other important aspects of the disease that may impact patient outcomes. Further, retrospectively collected data may lack specific data elements required to achieve adequate comparison with the treated group in single-arm studies. In the context of prospective designs, the recruitment of sufficient new patients for prospective follow-up may not be feasible or may be prolonged due to the rarity of the disease. Further, the potential for premature truncation of patient follow-up may result in insufficient longitudinal data, or prospectively collected data alone may not provide insights into the disease course for specific groups of patients. In these situations, primary data collection in a prospective study may be supplemented with retrospectively collected data from chart reviews, registries, or electronic medical record databases, either for the same patients, in an ambispective design, or for a different set of patients. These hybrid designs allow for broader and more robust contextual information on the patient journey and the natural course of the disease to be obtained, which can improve the suitability of the data as an external comparator for SATs or studies that lack internal control in situations where a prospective design alone might not be sufficient. Because retrospective and prospective data, or any two data sources that are being combined, may differ in availability and quality, there are unique challenges alongside the strengths of these designs. In this paper, we discuss considerations for the design, analysis, and conduct of hybrid NHS intended as ECAs for single-arm studies in clinical development programs for rare diseases. [ABSTRACT FROM AUTHOR]

We examined the association between low‐calorie sweeteners (LCS) consumption during preconception, pregnancy, and breastfeeding and child health outcomes. A systematic search of electronic databases in PubMed, Embase, Cumulated Index to Nursing and Allied Health Literature, the Cochrane Library, Scopus, Web of Science, PsycINFO, ProQuest Health and Medical, ClinicalTrials.gov, and Google Scholar was conducted up to 21 September 2023. A random effects model with restricted maximum likelihood estimation was used for the meta‐analysis. Seventeen eligible studies were included. The standardised mean difference (SMD) and 95% confidence interval (CI) in birth weight between those who frequently consumed LCS (≥1 serve/day) during pregnancy and those who did not consume LCS was 0.04 (0.00, 0.08) (four cohort studies). Any LCS consumption during pregnancy compared with no consumption was not associated with birth weight [SMD (95% CI) = 0.03 (−0.03, 0.08)] (four cohort studies). Any LCS consumption during pregnancy was not associated with body mass index z‐scores. The weighted mean difference (95% CI) was 0.00 (−0.05, 0.06) at birth, 0.06 (−0.29, 0.40) at 6 months, −0.04 (−0.19, 0.10) at 1 year, 0.00 (−0.16, 0.17) at 3 years, and 0.10 (−0.15, 0.34) at 7 years of the child age, compared with no intake (five cohort studies). The odds of being overweight at 1 year among children exposed to LCS during pregnancy was 1.19 (OR [95% CI]: 1.19 [0.81, 1.58]) compared with unexposed children (two cohort studies). The effect sizes were not precise for all the outcomes as the 95% CI indicated the effect estimates could range from small protective to a higher risk. The effect of LCS consumption on child behaviour and cognition was inconsistent. There is not enough evidence to confirm LCS consumption during pregnancy affects birth weight and risk of overweight in children. However, frequent consumption increased birth weight and the risk of overweight at different ages, though the effects were imprecise. More robust research evidence is required as the quality of evidence is low. Key messages: Evidence regarding the effect of perinatal low‐calorie sweeteners (LCS) consumption and child health is limited and inconclusive.Our systematic review and meta‐analysis showed that any LCS consumption during pregnancy was not associated with birth weight and the risk of overweight in childhood. However, frequent LCS consumption during pregnancy was associated with a small but imprecise increase in birth weight and body mass index z‐score at different ages.Evidence regarding the effect of maternal LCS consumption on child behaviour, cognition, and the risk of other chronic disease is limited.The overall quality of the evidence remains low, warranting further high‐quality research. [ABSTRACT FROM AUTHOR]

The growing body of research on geotourism and geoheritage presents an opportunity to explore the applied strategies for achieving the sustainable development goals (SDGs). Geoheritage and geotourism have emerged as concepts that can contribute to these goals by promoting responsible tourism, conservation, and community development. This systematic review critically examines the interrelationships between "geoheritage" and "geotourism" approaches in relation to their integration with the SDGs and broader sustainability considerations within the scholarly domain. A total of 205 research articles, collected from the Scopus database over an 18-year period (2005 to October 2023) were initially identified. Following a comprehensive analysis, 40 articles were found to fully meet the objectives of the systematic literature review and were subsequently included in the main study. Utilizing a meticulous framework based on the PRISMA guidelines, this study scrutinizes and synthesizes these 40 peer-reviewed research articles. It explores the dynamics between geoheritage, geotourism, and their implications for advancing sustainability goals inherent in the SDGs across different landscapes. VOSviewer software was employed for various citation-related network analyses. The discussion features successful case studies in complex topographies such as volcanic regions, mining sites, and deserts that highlight practical strategies for promoting sustainability as suggested in the reviewed articles, while also revealing a notable gap in effective applied strategies. The findings showthat the prevailing trend favors inventory-centric investigations, primarily emphasizing quantitative analyses of the geosites. This focus limits the applied policies of geotourism and geoheritage for local communities and regions. The insights derived from this review serve as valuable guidance for both academic and non-academic stakeholders in formulating tactics that underscore the region's untapped geotouristic potential. Furthermore, the review's outcomes hold promise for contributing to the objectives of the Global Geopark Network, particularly in the area of sharing "geopark-related knowledge.". [ABSTRACT FROM AUTHOR]

In 1977, Michael Lipton introduced the Urban Bias Thesis as a framework for understanding how most economic policy initiatives have contributed to the overdevelopment of urban areas and the underdevelopment of rural areas. In Latin America, there has historically been a positive correlation between urbanization and mortality decline, as the region's health transition generally began in the main cities and tended to proceed more rapidly in countries with higher levels of urbanization. This paper seeks evidence of a residual urban bias in the region's mortality patterns. Using a sample of Latin American countries over the 2000–2010 period, I analyse the disparities in mortality patterns and avoidable causes of death by looking closely at urban and rural areas using continuum categories. The results indicate that the urban advantage does persist and that rural–urban mortality differentials have consistently favoured the largest cities. The metropolitan advantage in mortality is an outcome of lower mortality in causes of death that are avoidable through primary interventions. Even in scenarios of high mortality at younger adult ages (15–44), the metropolitan advantage remains, due primarily to unsuccessful efforts to reduce mortality in populations aged 45 years and over outside the main and large cities. [ABSTRACT FROM AUTHOR]

What is Known and Objective. Omalizumab is a humanized anti‐IgE antibody, which is used in the treatment of chronic spontaneous urticaria (CSU). This study aims to investigate the trends in the efficacy of omalizumab for CSU, focusing on temporal aspects, drug dosages, and sample sizes. Methods. Cochrane, OVID MEDLINE, Embase, Web of Science, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) from 1900 to January 2023. The primary outcome was the percentage of complete responders (defined as the weekly urticaria activity score as 0, UAS7 = 0). Secondary outcomes included the percentage of patients with UAS7 ≤ 6, the percentage of patients achieving a minimally necessary difference in weekly itch severity score (defined as a reduction from baseline in ISS7 of ≥5 points, ISS7 MID), and adverse events (AEs). A cumulative meta‐analysis was performed with pooled risk ratio (RR) and 95% confidence intervals (CI). Publication bias was assessed by the contour‐enhanced funnel plots with the trim‐and‐fill method, alongside Begg's and Egger's tests. Results and Discussion. Twelve randomized, placebo‐controlled studies encompassing 2166 patients were analyzed. Compared with the placebo group, the omalizumab group exhibited significant increases in the proportion of patients achieving UAS7 = 0 [RR 5.18, 95% CI (3.97, 6.75), I2 = 14%], UAS7 ≤ 6 [RR 3.21, 95% CI (2.69, 3.83), I2 = 30%], and ISS7 MID responders [RR 1.50, 95% CI (1.39, 1.63), I2 = 33%]. AEs were similar between the omalizumab group and placebo group [RR 0.96, 95% CI (0.89, 1.03), I2 = 4%]. What is New and Conclusion. The cumulative meta‐analysis confirmed that the efficacy outcomes for omalizumab have remained consistent over time, across different drug doses and sample sizes, with improved precision from newer studies. Omalizumab is confirmed to be safe and effective for CSU. It is also suggested to minimize redundant RCTs to conserve scientific and medical resources efficiently. [ABSTRACT FROM AUTHOR]

Objective: Intimate partner violence (IPV) perpetrators with alcohol and/or other drug use problems (ADUPs) have been identified as one of the main high-risk and highly resistant groups of perpetrators requiring special attention in intervention programs for IPV perpetrators. This randomized controlled trial (RCT) aimed to evaluate whether an individualized motivational plan adjusted to ADUPs (IMP-ADUPs) was superior to standard motivational strategies (IMP) in reducing ADUPs, and IPV and increasing treatment adherence in IPV perpetrators. Method: Data from a full sample of IPV perpetrators (n = 140) and a subsample of participants with ADUPs (n = 55) were collected at pre- and post-intervention and 12-month follow-up. Final outcomes included alcohol, cocaine, and cannabis use, self-reported IPV, risk of recidivism assessed by facilitators, and official IPV recidivism. Proximal outcomes included treatment adherence (stage of change, intervention dose, active participation, and dropout). Results: Both intent-to-treat (ITT) and per-protocol (PP) analyses were conducted. The IMP-ADUPs condition was superior to the IMP in reducing alcohol use at post-intervention in both the full sample and ADUPs subsample. The full sample of participants in the IMP-ADUPs condition were in a more advanced stage of change post-intervention and showed increased active participation during the intervention process than IMP participants. All participants were in a more advanced stage of change at post-intervention and reduced their alcohol use and their risk of recidivism at post-intervention and 12-month follow-up. Conclusions: These results underscore the need to develop individualized treatment approaches to address participants' risks and needs and promote their motivation to change. [ABSTRACT FROM AUTHOR]

Introduction: Echinococcosis is a chronic zoonotic disease caused by tapeworms of the genus Echinococcus. The World Health Organization (WHO) has identified encapsulated disease as one of 17 neglected diseases to be controlled or eliminated by 2050. There is no accurate, early, non-invasive molecular diagnostic method to detect echinococcosis. The feasibility of circulating free DNA as a diagnostic method for echinococcosis has yielded inconclusive results in a number of published studies. However, there has been no systematic evaluation to date assessing the overall performance of these assays. We report here the first meta-analysis assessing the diagnostic accuracy of cfDNA in plasma, serum, and urine for echinococcosis. Methods: We systematically searched PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), and WeiPu databases up to 17 January 2024, for relevant studies. All analyses were performed using RevMan 5.3, Meta-DiSc 1.4, Stata 17.0, and R 4.3.1 software. The sensitivity, specificity, and other accuracy indicators of circulating free DNA for the diagnosis of echinococcosis were summarized. Subgroup analyses and meta-regression were performed to identify sources of heterogeneity. Results: A total of 7 studies included 218 patients with echinococcosis and 214 controls (156 healthy controls, 32 other disease controls (non-hydatid patients), and 26 non-study-targeted echinococcosis controls were included). Summary estimates of the diagnostic accuracy of cfDNA in the diagnosis of echinococcosis were as follows: sensitivity (SEN) of 0.51 (95% CI: 0.45-0.56); specificity (SPE) of 0.99 (95% CI: 0.97-0.99); positive likelihood ratio (PLR) of 11.82 (95% CI: 6.74-20.74); negative likelihood ratio (NLR) of 0.57 (95% CI: 0.41-0.80); diagnostic ratio (DOR) of 36.63 (95% CI: 13.75-97.59); and area under the curve (AUC) value of 0.98 (95% CI: 0.96-1.00). Conclusion: Existing evidence indicates that the combined specificity of circulating cfDNA for echinococcosis is high. However, the combined sensitivity performance is unsatisfactory due to significant inter-study heterogeneity. To strengthen the validity and accuracy of our findings, further large-scale prospective studies are required. [ABSTRACT FROM AUTHOR]

Universal health coverage has been proposed as a strategy to improve health in low- and middle-income countries, but this depends on a good provision of health services. Under-5 mortality (U5M) reflects the quality of health services, and its reduction has been a milestone in modern society, reducing global mortality rates by more than two-thirds between 1990 and 2020. However, despite these impressive achievements, they are still insufficient, and most deaths in children under 5 can be prevented with the provision of timely and high-quality health services. The aim of this paper is to conduct a literature review on amenable (treatable) mortality in children under 5. This indicator is based on the concept that deaths from certain causes should not occur in the presence of timely and effective medical care. A systematic and exhaustive review of available literature on amenable mortality in children under 5 was conducted using MEDLINE/PubMed, Cochrane CENTRAL, OVID medline, Scielo, Epistemonikos, ScienceDirect, and Google Scholar in both English and Spanish. Both primary sources, such as scientific articles, and secondary sources, such as bibliographic indices, websites, and databases, were used. Results: The main cause of amenable mortality in children under 5 was respiratory disease, and the highest proportion of deaths occurred in the perinatal period. Approximately 65% of avoidable deaths in children under 5 were due to amenable mortality, that is, due to insufficient quality in the provision of health services. Most deaths in all countries and around the world are preventable, primarily through effective and timely access to healthcare (amenable mortality) and the management of public health programs focused on mothers and children (preventable mortality). [ABSTRACT FROM AUTHOR]

We develop a novel control function approach in models where the treatment variable has bunching at one corner of its support. This situation typically arises when the treatment variable is a constrained choice and some observations choose the corner solution. The method exploits distributional shape restrictions but makes no exclusion restrictions. We provide estimators and establish their asymptotic behavior, prove the convergence of the bootstrap, and develop tests of the identification assumptions. An application reveals that watching television has no effect on cognitive skills and a negative effect on noncognitive skills in children. [ABSTRACT FROM AUTHOR]

EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies. [ABSTRACT FROM AUTHOR]

Objective: To test for publication bias with alprazolam, the most widely prescribed benzodiazepine, by comparing its efficacy for panic disorder using trial results from (1) the published literature and (2) the US Food and Drug Administration (FDA). Methods: From FDA reviews, we included data from all phase 2/3 efficacy trials of alprazolam extended-release (Xanax XR) for the treatment of panic disorder. A search for matching publications was performed using PubMed and Google Scholar. Publication bias was examined by comparing: (1) overall trial results (positive or not) according to the FDA v. corresponding publications; (2) effect size (Hedges's g) based on FDA data v. published data. Results: The FDA review showed that five trials were conducted, only one of which (20%) was positive. Of the four not-positive trials, two were published conveying a positive outcome; the other two were not published. Thus, according to the published literature, three trials were conducted and all (100%) were positive. Alprazolam's effect size calculated using FDA data was 0.33 (CI95% 0.07–0.60) v. 0.47 (CI95% 0.30–0.65) using published data, an increase of 0.14, or 42%. Conclusions: Publication bias substantially inflates the apparent efficacy of alprazolam XR. [ABSTRACT FROM AUTHOR]

Gastrointestinal bleeding (GIB) is a common cause of urgent hospitalization in patients with cirrhosis. However, limited studies have examined the prevalence and risk of these complications based on etiology. This study aims to compare the occurrence and risk of cirrhosis complications on inpatient mortality between alcoholic cirrhosis (ALC) and other etiology-induced cirrhosis (NALC). This retrospective analysis included 7,159,694 patients. ALC was diagnosed based on ICD-10, while NALC included primary and secondary biliary cirrhosis, nonalcoholic steatohepatitis (NASH), and unspecified cirrhosis of the liver. GIB included bleeding from esophageal and gastric varices. Bivariate analyses using appropriate statistical tests were performed to compare the two groups. ALC patients had a significantly higher incidence of GIB compared with NALC patients (10.8% vs. 6.4%, p < 0.01), with an associated 60% higher risk of GIB than NALC patients (p < 0.01). ALC was associated with a higher prevalence of ascites (45.6% vs. 27.9%, p < 0.01) and hepatic encephalopathy (HE) (45.5% vs. 27.2%, p < 0.01) compared with NALC patients. The risk of ascites and HE was 2.2 times and 2.3 times higher, respectively, in ALC patients compared with NALC patients (p < 0.01). Furthermore, ALC patients had higher hospital mortality rates compared with NALC patients, with a 47% higher risk of hospital mortality after adjustment (p < 0.01). ALC patients also had prolonged hospital stays, higher charges, more emergency room (ER) visits, and more frequent esophagogastroduodenoscopy (EGD) requirements compared with those of NALC patients (p < 0.01). ALC patients have a significantly higher risk of developing GIB, ascites, and HE compared with NALC patients, leading to increased mortality and greater medical burden on hospitals. [ABSTRACT FROM AUTHOR]

Introduction: The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) announced conditions for using recombinant human interleukin-1 receptor antagonist (rhIL-1ra) to treat hospitalized patients with Coronavirus disease 2019 (COVID-19) and risk for progression. These decisions followed publication of the suPAR-guided Anakinra treatment for Validation of the risk and early Management OF seveRE respiratory failure by COVID-19 (SAVE-MORE) phase 3 clinical trial that yielded positive results. Methods: We conducted a literature review and theoretical analysis of IL-1 blockade as a therapy to treat COVID-19. Using a stepwise analysis, we assessed clinical applicability of the SAVE-MORE results and evaluated conceptual support for interleukin-1 suppression as a suitable approach to COVID-19 treatment. This therapeutic approach was then examined as an example of inflammation-suppressing measures used to treat sepsis. Results: Anakinra use as a COVID-19 therapy seems to rely on a view of pathogenesis that incorrectly reflects human disease. Since COVID-19 is an example of sepsis, COVID-19 benefit due to anti-inflammatory therapy contradicts an extensive history of unsuccessful clinical study. Repurposing rhIL-1ra to treat COVID-19 appears to exemplify a cycle followed by inflammation-suppressing sepsis treatments. A landscape of treatment failures is interrupted by a successful clinical trial. However, subsequent confirmatory study fails to replicate the positive data. Discussion: We suggest further experimentation is not a promising pathway to discover game-changing sepsis therapies. A different kind of approach may be necessary. [ABSTRACT FROM AUTHOR]

Background: Publishing study results in scientific journals has been the standard way of disseminating science. However, getting results published may depend on their statistical significance. The consequence of this is that the representation of scientific knowledge might be biased. This type of bias has been called publication bias. The main objective of the present study is to get more insight into publication bias by examining it at the author, reviewer, and editor level. Additionally, we make a direct comparison between publication bias induced by authors, by reviewers, and by editors. We approached our participants by e-mail, asking them to fill out an online survey. Results: Our findings suggest that statistically significant findings have a higher likelihood to be published than statistically non-significant findings, because (1) authors (n = 65) are more likely to write up and submit articles with significant results compared to articles with non-significant results (median effect size 1.10, BF10 = 1.09*107); (2) reviewers (n = 60) give more favourable reviews to articles with significant results compared to articles with non-significant results (median effect size 0.58, BF10 = 4.73*102); and (3) editors (n = 171) are more likely to accept for publication articles with significant results compared to articles with non-significant results (median effect size, 0.94, BF10 = 7.63*107). Evidence on differences in the relative contributions to publication bias by authors, reviewers, and editors is ambiguous (editors vs reviewers: BF10 = 0.31, reviewers vs authors: BF10 = 3.11, and editors vs authors: BF10 = 0.42). Discussion: One of the main limitations was that rather than investigating publication bias directly, we studied potential for publication bias. Another limitation was the low response rate to the survey. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Psicoterapia Cognitiva e Comportamentale is the property of Edizioni Centro Studi Erickson SpA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Acute lung injury/acute respiratory distress syndrome (ALI/ARDS), triggered by various pathogenic factors inside and outside the lungs, leads to diffuse lung injury and can result in respiratory failure and death, which are typical clinical critical emergencies. Severe acute pancreatitis (SAP), which has a poor clinical prognosis, is one of the most common diseases that induces ARDS. When SAP causes the body to produce a storm of inflammatory factors and even causes sepsis, clinicians will face a two-way choice between anti-inflammatory and anti-infection objectives while considering the damaged intestinal barrier and respiratory failure, which undoubtedly increases the difficulty of the diagnosis and treatment of SAP-ALI/ARDS. For a long time, many studies have been devoted to applying glucocorticoids (GCs) to control the inflammatory response and prevent and treat sepsis and ALI/ARDS. However, the specific mechanism is not precise, the clinical efficacy is uneven, and the corresponding side effects are endless. This review discusses the mechanism of action, current clinical application status, effectiveness assessment, and side effects of GCs in the treatment of ALI/ARDS (especially the subtype caused by SAP). [ABSTRACT FROM AUTHOR]

To date, nutritional epidemiology has relied heavily on relatively weak methods including simple observational designs and substandard measurements. Despite low internal validity and other sources of bias, claims of causality are made commonly in this literature. Nutritional epidemiology investigations can be improved through greater scientific rigor and adherence to scientific reporting commensurate with research methods used. Some commentators advocate jettisoning nutritional epidemiology entirely, perhaps believing improvements are impossible. Still others support only normative refinements. But neither abolition nor minor tweaks are appropriate. Nutritional epidemiology, in its present state, offers utility, yet also needs marked, reformational renovation. Changing the status quo will require ongoing, unflinching scrutiny of research questions, practices, and reporting—and a willingness to admit that "good enough" is no longer good enough. As such, a workshop entitled "Toward more rigorous and informative nutritional epidemiology: the rational space between dismissal and defense of the status quo" was held from July 15 to August 14, 2020. This virtual symposium focused on: (1) Stronger Designs, (2) Stronger Measurement, (3) Stronger Analyses, and (4) Stronger Execution and Reporting. Participants from several leading academic institutions explored existing, evolving, and new better practices, tools, and techniques to collaboratively advance specific recommendations for strengthening nutritional epidemiology. [ABSTRACT FROM AUTHOR]

There is consensus around the value of conducting literature reviews across disciplines; however, little attention has been given to the potential(s) of engaging in a qualitative methodological literature review (QMLR). This article examines the possibilities of engaging in a QMLR by showing how it can inform qualitative research practice. After overviewing the history of literature reviews, we offer a series of questions that can inform and be integrated into a QMLR. We then demonstrate how such reviews can serve as an opportunity for qualitative inquirers to critically engage with the methodological literature with the intent of better understanding, enacting, and generating new methodological practices. [ABSTRACT FROM AUTHOR]

Objectives Several theories predict changes in individuals' economic preferences across the life span. To test these theories and provide a historical overview of this literature, we conducted meta-analyses on age differences in risk, time, social, and effort preferences as assessed by behavioral measures. Methods We conducted separate meta-analyses and cumulative meta-analyses on the association between age and risk, time, social, and effort preferences. We also conducted analyses of historical trends in sample sizes and citation patterns for each economic preference. Results The meta-analyses identified overall no significant effects of age for risk (r  = −0.02, 95% CI [−0.06, 0.02], n  = 39,832) and effort preferences (r  = 0.24, 95% CI [−0.05, 0.52], n  = 571), but significant effects of age for time (r  = −0.04, 95% CI [−0.07, −0.01], n  = 115,496) and social preferences (r  = 0.11, 95% CI [0.01, 0.21], n  = 2,997), suggesting increased patience and altruism with age, respectively. Equivalence tests, which compare these effects to practically important ones (i.e. r  = |0.1|), however, suggest that all effects are of trivial significance. The analyses of temporal trends suggest that the magnitude of effects and sample sizes have not changed significantly over time, nor do they dramatically affect the extent that articles are cited. Discussion Overall, our results contrast with theories of aging that propose general age effects for risk and effort preferences, yet provide some but tenuous support for those suggesting age-related changes in time and social preferences. We discuss implications for theory development as well as future empirical work on economic preferences. [ABSTRACT FROM AUTHOR]

Copyright of Laboratory Animal & Comparative Medicine is the property of Laboratory Animal & Comparative Medicine Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The experience of math anxiety can have detrimental effects on students’ math performance, and researchers have in recent years tried to design interventions aiming at reducing math anxiety. This meta-analysis aimed to examine the effectiveness of math anxiety interventions in reducing math anxiety and improving math performance. The meta-analysis comprised 50 studies and included 75 effect sizes. On average, the effect sizes were moderate (g = -0.467) for reducing math anxiety and improving math performance (g = 0.502). Interventions that focused on Cognitive support or regulating Emotions were effective both in reducing math anxiety and improving math performance. In addition, longer interventions and interventions targeting students older than 12 had the biggest decrease in math anxiety. Study quality was not related to intervention outcomes. [ABSTRACT FROM AUTHOR]

Copyright of Marketing of Scientific & Research Organizations / Marketing Instytucji Naukowych i Badawczych is the property of Sciendo and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Mortality in Slovakia has long been characterized by significant regional differences. One of the important factors of these differences is the influence of the quality and scope of the provided health care. We can express quality itself indirectly through the concept of avoidable mortality. Within it, deaths from lung, colorectal and breast tumors have an important position. A detailed analysis of the level of mortality, spatial differences for these groups of causes of death in Slovakia has not yet been carried out. In addition, in the contribution, we also try to identify, through specialized mortality tables and the concept of years of life lost, how these deaths shorten life expectancy and what losses affect human resources. The obtained results confirmed the persistence of regional differences, where the worst situation is primarily in the north and south of Slovakia. Moreover, these differences do not change significantly over time. This indirectly signals not only the regionally differentiated quality of care provided, but also the problems associated with prevention and personal responsibility for health. [ABSTRACT FROM AUTHOR]

A Systematic Literature Review on The Fishermen's Knowledge of Integrating Fishing and Tourism Activities [ABSTRACT FROM AUTHOR]

The formation of disinfection byproducts (DBPs) in finished drinking water is an ongoing challenge for public health agencies and water utilities. The Fourth Unregulated Contaminant Monitoring Rule data were used to assess the prevalence and drivers of haloacetic acids (HAAs)—a class of DBPs—in New York State's (NYS) public water systems, with a focus on total measured (HAA9), regulated (HAA5), brominated (HAA6Br), and unregulated (HAA4) HAAs. The concentrations of all HAA groups in NYS are found to be similar to those nationally, with HAA4 composing approximately 20% of HAA9. Concentrations of all HAA groups are lowest in groundwater and highest in surface waters across NYS systems. Higher total organic carbon (TOC) concentrations lead to elevated HAA9 and HAA5, while higher bromide concentrations favor more HAA4 and HAA6Br. HAA4 concentrations are well predicted with pre‐oxidation/disinfection types, HAA5, TOC, and bromide concentrations, with an adjusted R2 of 70%. [ABSTRACT FROM AUTHOR]

This is the protocol for a Campbell systematic review. The objectives are as follows: (1) To evaluate the reporting quality of systematic reviews published in Chinese social science journals against the PRISMA and MOOSE standards; (2) To evaluate the methodology quality of systematic reviews published in Chinese social science journals against the AMSTAR‐2 and DART standards; and (3) To analyze other characteristics of systematic reviews published in Chinese social science journals using content analysis. [ABSTRACT FROM AUTHOR]

Patients in randomized controlled trials (RCTs) must be successfully randomized to reduce or eliminate bias. Because pre-treatment symptoms have prognostic significance in cancer patients, qualitative and quantitative tools were developed to assess similarity of baseline pre-treatment symptoms across different treatment arms of RCTs as one measure of randomization success. Clinician-reported symptom data from two colorectal cancer RCTs, CO.20 and CO.17, were used to demonstrate the utility of a qualitative visualization tool and quantitative machine learning K-means tool, which grouped patients into clusters using baseline symptoms. Qualitatively, reflection bar graphs (RBGs) visualized potential imbalances in baseline symptoms (i) across treatment arms and (ii) by corresponding patient clusters identified within each treatment arm. RBGs found that the treatment arms for both RCTs had similar symptom profiles, while the lack of significant differences in the proportions of patients in each cluster across treatment arms further confirmed successful randomization. This paper details the creation of visualization, machine-learning, and statistical tools to compare baseline symptoms across RCT treatment arms, demonstrating that the CO.20 and CO.17 trials were successfully randomized by baseline symptoms and are comparable. These tools can therefore be implemented easily to ensure an extra layer of quality assurance of the randomization process for study assessment. [ABSTRACT FROM AUTHOR]

In this article, we review prevention of serious adverse clinical outcomes and treatment side effects in patients with neuromuscular disorders including myopathies and myasthenia gravis. While neither of these entities is preventable, their course can often be modified, and severe sequelae may be prevented, with the identification of risk factors and proactive attention toward treatment planning. [ABSTRACT FROM AUTHOR]

The recognition of pain and the treatments used for it are vital for all practitioners. Many types of pain can be treated in a locoregional fashion, which has significant implications not just for any individual patient but for society as a whole. These treatments are most effective when performed in a minimally invasive, image-guided fashion. Interventional radiologists should play a central role in providing these lifestyle-limiting treatments. This article describes the medications most typically used for spinal and extra-axial treatments in the management of patients in pain. [ABSTRACT FROM AUTHOR]

Background: Executive function will gradually decline with the increase of age, which will have a negative impact on the quality of life and general health. Exercise intervention can improve executive function and prevent its deterioration, but the evidence from randomized controlled trials is not consistent. Aim: To assess the effect of exercise intervention on executive function of healthy middle-aged and elderly people, and briefly describe its mechanism. Methods: A search was conducted using PubMed, Web of science and EBSCO. The searches were limited to English articles published from January 2010 to January 2022. The information is extracted from searched articles included or excluded based on certain criteria. Results: The search returned 2,746 records, of which 11 articles were included in the systematic review, and 8 articles were supplemented according to the references included and related reviews. The results show that different types of exercise intervention have positive effects on the executive function of the middle-aged and elderly people. The intervention prescriptions inmost studies are executed in medium to low frequency, medium intensity and medium duration, while only 11% of the studies were followed up. Conclusions: The intervention, which was executed twice a week with 30-60min single intervention time and over 12 weeks total duration, showed a good intervention effect. Exercise intervention is to improve executive function by affecting the activation of brain network and the synthesis of neurotransmitters. [ABSTRACT FROM AUTHOR]

Functional electrical stimulation (FES) is widely used in neurorehabilitation to improve patients' motion ability. It has been verified to promote neural remodeling and relearning, during which FES has to produce an accurate movement to obtain a good efficacy. Therefore, many studies have focused on the relationship between FES parameters and the generated movements. However, most of the relationships have been established in static contractions, which leads to an unsatisfactory result when applied to dynamic conditions. Therefore, this study proposed a FES control strategy based on the surface electromyography (sEMG) and kinematic information during dynamic contractions. The pulse width (PW) of FES was determined by a direct transfer function (DTF) with sEMG features and joint angles as the input. The DTF was established by combing the polynomial transfer functions of sEMG and joint torque and the polynomial transfer functions of joint torque and FES. Moreover, the PW of two FES channels was set based on the muscle synergy ratio obtained through sEMG. A total of six healthy right-handed subjects were recruited in this experiment to verify the validity of the strategy. The PW of FES applied to the left arm was evaluated based on the sEMG of the right extensor carpi radialis (ECR) and the right wrist angle. The coefficient of determination (R 2) and the normalized root mean square error (NRMSE) of FES-included and voluntary wrist angles and torques were used to verify the performance of the strategy. The result showed that this study achieved a high accuracy (R 2 = 0.965 and NRMSE = 0.047) of joint angle and a good accuracy (R 2 = 0.701 and NRMSE = 0.241) of joint torque reproduction during dynamic movements. Moreover, the DTF in real-time FES system also had a nice performance of joint angle fitting (R 2 = 0.940 and NRMSE = 0.071) and joint torque fitting (R 2 = 0.607 and NRMSE = 0.303). It is concluded that the proposed strategy is able to generate proper FES parameters based on sEMG and kinematic information for dynamic movement reproduction and can be used in a real-time FES system combined with bilateral movements for better rehabilitation. [ABSTRACT FROM AUTHOR]

Copyright of Przegląd Pedagogiczny is the property of Kazimierza Wielki University in Bydgoszcz and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The aim of this systematic review is to examine the effects of different anesthetic drugs and protocols on hepatic functions. The liver is a very important organ since it is directly involved in biotransformation of the drugs used in anesthesia. Comprehensive understanding of anesthetic drugs and their effects on hepatic functions remains fundamental to a successful anesthesia. Understanding the connections that exist between anesthetic drugs and liver function remains essential for a safe anesthesia both during the surgery and in the post-operative period. Almost all anesthetic drugs depend on hepatic biotransformation into their metabolites that can be transported and excreted by the kidneys. If the liver enzymes are altered, the biotransformation of the drugs will be decreased and the recovery from the anesthesia prolonged. [ABSTRACT FROM AUTHOR]

Copyright of Biblios is the property of University of Pittsburgh, University Library System and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Although histories of cognitive behaviour therapy have begun to appear, their use with people with psychosis diagnoses has received relatively little attention. In this article, we elucidate the conditions of possibility for the emergence of cognitive behaviour therapy for psychosis (CBTp) in England between 1982 and 2002. We present an analysis of policy documents, research publications and books, participant observation, and interviews with a group of leading researchers and senior policy actors. Informed by Derksen and Beaulieu's articulation of social technologies, we show how CBTp was developed and stabilised through the work of a variety of overlapping informal, academic, clinical, professional, and policy networks. The profession of clinical psychology played a key role in this development, successfully challenging the traditional 'division of labour' where psychologists focused on 'neurosis' and left 'psychosis' to psychiatry. Following Abbott's systems approach to professions, we identify a number of historical factors that created a jurisdictional vulnerability for psychiatry while strengthening the jurisdictional legitimacy of clinical psychology in providing psychological therapies to service users with psychosis diagnoses. The National Institute for Health and Clinical Excellence played a significant role in adjudicating jurisdictional legitimacy, and its 2002 schizophrenia guidelines, recommending the use of psychological therapies, marked a radical departure from the psychiatric consensus. Our analysis may be of wider interest in its focus on social technologies in a context of jurisdictional contestation. We discuss the implications of our study for the field of mental health and for the relationship between clinical psychology and psychiatry. [ABSTRACT FROM AUTHOR]

A meta-analysis is substantial for integrating the findings of all related studies into one consistent research to establish a knowledge bank of a common issue. Although several studies have examined the impact of the individual aspect of human capital on farmers' technical efficiency, the composite impact was not synthesized. Therefore, our analysis examines the key determinants driving systematic variations in technical efficiency estimates from 268 food-crop farming studies published recently in peer-reviewed journals. Our results have supported our hypothesis that human capital increases farming efficiency. The studies' location indicates the importance of farmer beliefs, trust in their institutions and land accumulation to increase food-crop farmer technical efficiency. Our findings contribute to the applied agricultural economics literature by theoretically systematizing literature on human capital in accordance with social and natural capitals in agricultural productivity and empirically validating the technical efficiency in food-crop farming studies toward developing agricultural sustainability in harmony with our biosphere. [ABSTRACT FROM AUTHOR]

Aim: To assess the beneficial and adverse effects on the dental and periodontal issues of periodontal-orthodontic treatment of teeth with pathological tooth flaring, drifting, and elongation in patients with severe periodontitis. Materials and methods: Nine databases were searched in April 2020 for randomized/non-randomized clinical studies. After duplicate study selection, data extraction, and risk-of-bias assessment, random-effect meta-analyses of mean differences (MDs) and their 95% confidence intervals (CIs) were performed, followed by subgroup/meta-regression analyses. Results: A total of 30 randomized and non-randomized clinical studies including 914 patients (29.7% male; mean age 43.4 years) were identified. Orthodontic treatment of pathologically migrated teeth was associated with clinical attachment gain (-0.24 mm; seven studies), pocket probing depth reduction (-0.23 mm; seven studies), marginal bone gain (-0.36 mm; seven studies), and papilla height gain (-1.42 mm; two studies) without considerable adverse effects, while patient sex, gingival phenotype, baseline disease severity, interval between periodontal and orthodontic treatment, and orthodontic treatment duration affected the results. Greater marginal bone level gains were seen by additional circumferential fiberotomy (two studies; MD = -0.98 mm; 95% CI = -1.87 to -0.10 mm; p = .03), but the quality of evidence was low. Conclusions: Limited evidence of poor quality indicates that orthodontic treatment might be associated with small improvements of periodontal parameters, which do not seem to affect prognosis, but more research is needed. [ABSTRACT FROM AUTHOR]

Background: Mindfulness meditation has become a common method for reducing stress, stress-related psychopathology and some physical symptoms. As mindfulness programs become ubiquitous, concerns have been raised about their unknown potential for harm. We estimate multiple indices of harm following Mindfulness-Based Stress Reduction (MBSR) on two primary outcomes: global psychological and physical symptoms. In secondary analyses, we estimate multiple indices of harm on anxiety and depressive symptoms, discomfort in interpersonal relations, paranoid ideation and psychoticism. Methods: Intent-to-treat analyses with multiple imputations for missing data were used on pre- and post-test data from a large, observational dataset (n = 2155) of community health clinic MBSR classes and from MBSR (n = 156) and waitlist control (n = 118) participants from three randomized controlled trials conducted contemporaneous to community classes in the same city by the same health clinic MBSR teachers. We estimate the change in symptoms, proportion of participants with increased symptoms, proportion of participants reporting greater than a 35% increase in symptoms, and for global psychological symptoms, clinically significant harm. Results: We find no evidence that MBSR leads to higher rates of harm relative to waitlist control on any primary or secondary outcome. On many indices of harm across multiple outcomes, community MBSR was significantly preventative of harm. Conclusions: Engagement in MBSR is not predictive of increased rates of harm relative to no treatment. Rather, MBSR may be protective against multiple indices of harm. Research characterizing the relatively small proportion of MBSR participants that experience harm remains important. [ABSTRACT FROM AUTHOR]

Copyright of América Latina Hoy is the property of Ediciones Universidad de Salamanca and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Socio‐economic inequalities in amenable mortality rates are increasing across Europe, which is an affront to universal healthcare systems where the numbers of, and inequalities in, amenable deaths should be minimal and declining over time. However, the fundamental causes theory proposes that inequalities in health will be largest across preventable causes, where unequally distributed resources can be used to gain an advantage. Information on individual‐level inequalities that may better reflect the fundamental causes remains limited. We used the Scottish Longitudinal Study, with follow‐up to 2010 to examine trends in amenable mortality by a range of socio‐economic position measures. Large inequalities were found for all measures of socio‐economic position and were lowest for educational attainment, higher for social class and highest for social connection. To reduce inequalities, amenable mortality needs to be interpreted both as an indicator of healthcare quality and as a reflection of the unequal distribution of socio‐economic resources. [ABSTRACT FROM AUTHOR]

Intractable, chronic abdominal pain from upper abdominal malignant and benign diseases is a significant challenge for healthcare providers and burden on the healthcare system. While opioid analgesics are commonly used to provide pain relief, the adverse effects of chronic opioid use cannot be overlooked. Celiac plexus neurolysis via chemical or thermal means represents an alternative minimally invasive approach to provide palliative pain relief and increase patients' quality of life. Through the use of computed tomography guidance, celiac plexus neurolysis can be performed by accurately targeting the celiac plexus, while minimizing risks to adjacent structures. Historically, celiac plexus neurolysis was performed via instillation of ethanol or phenol; however, within the past decade cryoablation has gained increasing use with potentially fewer side effects. [ABSTRACT FROM AUTHOR]