A systematic review of the epidemiology evidence on talc and cancer.

Over the past several decades, there have been many epidemiology studies on talc and cancer published in the scientific literature, and several reviews and meta-analyses of talc and respiratory, female reproductive, and stomach cancers, specifically. To help provide a resource for the evaluation of talc as a potential human carcinogen, we applied a consistent set of examination methods and criteria for all epidemiology studies that examined the association between talc exposure (by various routes) and cancers (of various types). We identified 30 cohort, 35 case-control, and 12 pooled studies that evaluated occupational, medicinal, and personal-care product talc exposure and cancers of the respiratory system, the female reproductive tract, the gastrointestinal tract, the urinary system, the lymphohematopoietic system, the prostate, male genital organs, and the central nervous system, as well as skin, eye, bone, connective tissue, peritoneal, and breast cancers. We tabulated study characteristics, quality, and results in a systematic manner, and evaluated all cancer types for which studies of at least three unique populations were available in a narrative review. We focused on study quality aspects most likely to impact the interpretation of results. We found that only one study, of medicinal talc use, evaluated direct exposure measurements for any individuals, though some used semi-quantitative exposure metrics, and few studies adequately assessed potential confounders. The only consistent associations were with ovarian cancer in case-control studies and these associations were likely impacted by recall and potentially other biases. This systematic review indicates that epidemiology studies do not support a causal association between occupational, medicinal, or personal talc exposure and any cancer in humans.

Open science practices in the false memory literature.

In response to the replication crisis in psychology, the scientific community has advocated open science practices to promote transparency and reproducibility. Although existing reviews indicate inconsistent and generally low adoption of open science in psychology, a current-day, detailed analysis is lacking. Recognising the significant impact of false memory research in legal contexts, we conducted a preregistered systematic review to assess the integration of open science practices within this field, analysing 388 publications from 2015 to 2023 (including 15 replications and 3 meta-analyses). Our findings indicated a significant yet varied adoption of open science practices. Most studies (86.86%) adhered to at least one measure, with publication accessibility being the most consistently adopted practice at 73.97%. While data sharing demonstrated the most substantial growth, reaching about 75% by 2023, preregistration and analysis script sharing lagged, with 20-25% adoption in 2023. This review highlights a promising trend towards enhanced research quality, transparency, and reproducibility in false memory research. However, the inconsistent implementation of open science practices may still challenge the verification, replication, and interpretation of research findings. Our study underscores the need for a comprehensive adoption of open science to improve research reliability and validity substantially, fostering trust and credibility in psychology.

[Psychedelic and dissociative agents in psychiatry: challenges in the treatment]. / Psychedelika und Dissoziativa in der Psychiatrie: Herausforderungen in der Behandlung.

With the discovery of the antidepressive effects of ketamine and the increasing withdrawal of the pharmaceutical industry from the development of new psychotropic drugs, the psychiatric research into the clinical application of hallucinogens in psychiatry has literally blossomed in the last two decades. Promising results for various treatment approaches with psychedelic agents, such lysergic acid diethylamide (LSD) and psilocybin, and dissociative agents, such as ketamine and esketamine, have raised great hopes among researchers, clinicians and patients in recent years, so that there was already talk of a new era in psychiatry. As one of the first of these substances, in December 2019 intranasal esketamine was approved in the USA and the EU for the treatment of treatment-resistant depression and Switzerland followed in 2020. Recently, psilocybin was approved in Australia, Canada and Switzerland for compassionate use in exceptional cases for the treatment of depression, while large approval studies with various psychedelic agents are currently ongoing worldwide. The medical application of psychedelic agents and ketamine/esketamine is considered to be safe; however, as with all new forms of treatment it is of crucial importance that, in addition to the hopes, the specific challenges of these new treatment approaches must also be carefully considered and assessed. Excessive expectations and an insufficient risk-benefit estimation are detrimental to the patients and the reputation of the treating physician. Although a possible paradigm shift in the care of mental health is already being discussed, this review article consciously concentrates on the possible risks of treatment and the methodological weaknesses of the studies carried out so far.

Development, explanation, and presentation of the Physical Literacy Interventions Reporting Template (PLIRT).

BACKGROUND: The physical literacy (PL) concept integrates different personal (e.g., physical, cognitive, psychological/affective, social) determinants of physical activity and has received growing attention recently. Although practical efforts increasingly adopt PL as a guiding concept, latest evidence has shown that PL interventions often lack specification of important theoretical foundations and basic delivery information. Therefore, the goal of the present study was to develop an expert-based template that supports researchers and practitioners in planning and reporting PL interventions. METHODS: The development process was informed by Moher et al.'s guidance for the development of research reporting guidelines. We composed a group of ten distinguished experts on PL. In two face-to-face meetings, the group first discussed a literature-driven draft of reporting items. In the second stage, the experts anonymously voted and commented on the items in two rounds (each leading to revisions) until consensus was reached. RESULTS: The panel recommended that stakeholders of PL initiatives should tightly interlock interventional aspects with PL theory while ensuring consistency throughout all stages of intervention development. The Physical Literacy Interventions Reporting Template (PLIRT) encompasses a total of 14 items (two additional items for mixed-methods studies) in six different sections: title (one item), background and definition (three items), assessment (one item each for quantitative and qualitative studies), design and content (five items), evaluation (one item plus one item each for quantitative and qualitative studies), discussion and conclusion (two items). CONCLUSION: The PLIRT was designed to facilitate improved transparency and interpretability in reports on PL interventions. The template has the potential to close gaps between theory and practice, thereby contributing to more holistic interventions for the fields of physical education, sport, and health.

Radiomics in precision medicine for gastric cancer: opportunities and challenges.

OBJECTIVES: Radiomic features derived from routine medical images show great potential for personalized medicine in gastric cancer (GC). We aimed to evaluate the current status and quality of radiomic research as well as its potential for identifying biomarkers to predict therapy response and prognosis in patients with GC. METHODS: We performed a systematic search of the PubMed and Embase databases for articles published from inception through July 10, 2021. The phase classification criteria for image mining studies and the radiomics quality scoring (RQS) tool were applied to evaluate scientific and reporting quality. RESULTS: Twenty-five studies consisting of 10,432 patients were included. 96% of studies extracted radiomic features from CT images. Association between radiomic signature and therapy response was evaluated in seven (28%) studies; association with survival was evaluated in 17 (68%) studies; one (4%) study analyzed both. All results of the included studies showed significant associations. Based on the phase classification criteria for image mining studies, 18 (72%) studies were classified as phase II, with two, four, and one studies as discovery science, phase 0 and phase I, respectively. The median RQS score for the radiomic studies was 44.4% (range, 0 to 55.6%). There was extensive heterogeneity in the study population, tumor stage, treatment protocol, and radiomic workflow amongst the studies. CONCLUSIONS: Although radiomic research in GC is highly heterogeneous and of relatively low quality, it holds promise for predicting therapy response and prognosis. Efforts towards standardization and collaboration are needed to utilize radiomics for clinical application. KEY POINTS: • Radiomics application of gastric cancer is increasingly being reported, particularly in predicting therapy response and survival. • Although radiomics research in gastric cancer is highly heterogeneous and relatively low quality, it holds promise for predicting clinical outcomes. • Standardized imaging protocols and radiomic workflow are needed to facilitate radiomics into clinical use.

Network analysis studies in patients with eating disorders: A systematic review and methodological quality assessment.

INTRODUCTION: Network psychometrics has been enthusiastically embraced by researchers studying eating disorders (ED), but a rigorous evaluation of the methodological quality of works is still missing. This systematic review aims to assess the methodological quality of cross-sectional network analysis (NA) studies conducted on ED clinical populations. METHODS: PRISMA and PICOS criteria were used to retrieve NA studies on ED. Methodological quality was evaluated based on five criteria: variable-selection procedure, network estimation method, stability checks, topological overlap checks, and handling of missing data. RESULTS: Thirty-three cross-sectional NA studies were included. Most studies focused on populations that were female, white and, with an anorexia nervosa (AN) diagnosis. Depending on how many criteria were satisfied, 27.3% of studies (n = 9) were strictly adherent, 30.3% (n = 10) moderately adherent, 33.3% (n = 11) sufficiently adherent, and 9.1% (n = 3) poorly adherent. Missing topological overlap checks and not reporting missing data represented most unreported criteria, lacking, respectively, in 63.6% and 48.5% of studies. CONCLUSIONS: Almost all reviewed cross-sectional NA studies on ED report those methodological procedures (variable-selection procedure, network estimation method, stability checks) necessary for a network study to provide reliable results. Nonetheless these minimum reporting data require further improvement. Moreover, elements closely related to the validity of an NA study (controls for topological overlap and management of missing data) are lacking in most studies. Recommendations to overcome such methodological weaknesses in future NA studies on ED are discussed together with the need to conduct NA studies with longitudinal design, to address diversity issues in study samples and heterogeneity of assessment tools. PUBLIC SIGNIFICANCE: The present work aims to evaluate the quality of ED NA studies to support applications of this approach in ED research. Results show that most studies adopted basic procedures to produce reliable results; however, other important procedures linked to NA study validity were mostly neglected. Network methodology in ED is extremely promising, but future studies should consistently include topological overlap control procedures and provide information on missing data.

INTRODUCCIÓN: La psicometría de red ha sido aceptada con entusiasmo por los investigadores que estudian los trastornos de la conducta alimentaria (TCA), pero aún falta una evaluación rigurosa de la calidad metodológica de los trabajos. Esta revisión sistemática tiene como objetivo evaluar la calidad metodológica de los estudios de análisis de redes transversales (NA) realizados en poblaciones clínicas de TCA. MÉTODOS: Se utilizaron los criterios PRISMA y PICOS para recuperar los estudios de NA en TCA. La calidad metodológica se evaluó con base en 5 criterios: procedimiento de selección de variables, método de estimación de red, comprobaciones de estabilidad, comprobaciones de superposición topológica, manejo de datos faltantes. RESULTADOS: Se incluyeron 33 estudios transversales de NA. La mayoría de los estudios se centraron en poblaciones que eran mujeres, blancas y con un diagnóstico de anorexia nerviosa (AN). Dependiendo de cuántos criterios se cumplieron, el 27,3% de los estudios (n = 9) fueron estrictamente adherentes, el 30,3% (n = 10) moderadamente adherentes, el 33,3% (n = 11) suficientemente adherentes, el 9,1% (n = 3) poco adherentes. La falta de controles topológicos de superposición y el no reportar los datos faltantes representó la mayoría de los criterios no reportados, faltando respectivamente en el 63,6% y el 48,5% de los estudios. CONCLUSIONES: Casi todos los estudios transversales revisados de NA sobre TCA reportaron aquellos procedimientos metodológicos (procedimiento de selección de variables, método de estimación de red, comprobaciones de estabilidad) necesarios para que un estudio de red proporcione resultados confiables. No obstante, estos datos mínimos de presentación de reportes requieren mejoras adicionales. Además, en la mayoría de los estudios faltan elementos estrechamente relacionados con la validez de un estudio de NA (controles para la superposición topológica y el manejo de los datos faltantes). Las recomendaciones para superar tales debilidades metodológicas en futuros estudios de NA sobre los TCA son discutidos junto con la necesidad de realizar estudios de NA con diseño longitudinal, para abordar los problemas de diversidad en las muestras de estudio y la heterogeneidad de las herramientas de evaluación.

A meta-analysis of the effects of social-cognitive training in schizophrenia: The role of treatment characteristics and study quality.

OBJECTIVES: This meta-analysis was designed to assess the effects of social-cognitive training (SCT) and whether study quality, treatment approach, treatment context, and sample characteristics influence these effects. METHODS: Electronic databases were searched up to 5 August 2020 using variants of keywords: 'social cognition', 'training', 'rehabilitation', 'remediation', and 'schizophrenia'. Methodological moderators were extracted through the Clinical Trials Assessment Measure and verified by authors. This study was pre-registered on PROSPERO (CRD42020154026). RESULTS: Forty-two controlled trials with 1,868 participants were identified. The meta-analysis revealed moderate effects on emotion recognition, mental state attribution, and social perception. No significant effects were evident on psychiatric symptoms or social functioning. A small signal was evident for the generalization of treatment gains to executive function. Moderator analyses revealed that studies of lower methodological quality reported larger effects, and samples with lower mean years of education were associated with larger effects of SCT on mental state attribution. Treatment effects did not differ by other moderator variables such as treatment context and intervention types. CONCLUSIONS: SCT benefits people with schizophrenia on a variety of social-cognitive outcomes. Differences in baseline symptoms, gender distribution, antipsychotic medication dose, IQ, and other sample features did not create barriers to treatment benefits. Future studies should aim to enhance the generalization of training effects on broader clinical outcomes.

Study quality and efficacy of psychological interventions for posttraumatic stress disorder: a meta-analysis of randomized controlled trials.

BACKGROUND: Research indicates that higher study quality may be associated with smaller treatment effects. Yet, knowledge about the association between study quality and treatment efficacy for posttraumatic stress disorder (PTSD) is limited. We aimed at evaluating the efficacy of psychological interventions for adult PTSD and the association between study quality and treatment effects. METHODS: We conducted a systematic search to identify randomized controlled trials (RCTs) that examined the efficacy of psychological interventions for chronic PTSD symptoms in adult samples with at least 70% of patients being diagnosed with PTSD by means of a structured interview. We assessed study quality using the following eight criteria from prior research: N ⩾ 50, all patients met criteria for PTSD, a treatment manual was used, therapists were trained, treatment integrity was checked, intent-to-treat analyses were applied, randomization was conducted by an independent party, and treatment outcome was conducted by blind assessors. RESULTS: The search resulted in 136 RCTs with 8978 patients. Active treatment conditions were largely effective in reducing PTSD symptoms at posttreatment and follow-up (Hedges' g = 1.09 and 0.81, respectively) when compared to passive control conditions. The comparison to active control conditions at posttreatment and follow-up resulted in medium effect sizes. A total of 14 trials met all study quality criteria and these trials produced large effect sizes when compared to passive control conditions at posttreatment and follow-up. CONCLUSIONS: Overall, study quality was not significantly associated with effect size. The findings indicate that psychological interventions can effectively reduce PTSD symptoms irrespective of study quality.

Systematic review of the potential respiratory carcinogenicity of metallic nickel in humans.

The inhalation of dust containing certain nickel compounds has been associated with an increased risk of lung and nasal cancers in occupational studies of workers who process or refine sulfidic nickel ores and are exposed to relatively high levels of mixtures of water-soluble, sulfidic, oxidic, and/or metallic forms of nickel. We conducted a systematic review of the potential carcinogenicity of metallic nickel, focusing on cancers of the respiratory tract. We evaluated the quality and risk of bias (RoB) of the relevant epidemiology, experimental animal, and in vitro mechanistic studies using the National Toxicology Program's Office of Health Assessment and Translation (OHAT) RoB Rating Tool. We then used a systematic review protocol based on the OHAT approach to critically assess whether metallic nickel should be considered a human respiratory carcinogen. Our evaluation of the epidemiology studies indicates that there is no substantive evidence of increased respiratory cancer risk in workers exposed predominantly to metallic nickel. Animal evidence indicates that metallic nickel does not increase the incidence of respiratory tumors in rodents exposed by inhalation. The in vitro studies are limited in value, as they bypass normal clearance mechanisms. Nevertheless, the mechanistic evidence indicates that metallic nickel is not mutagenic but can induce DNA strand breaks under certain conditions. Based on a standard framework for assessing causality, we conclude that the evidence does not support a causal relationship between metallic nickel exposure and respiratory cancer in humans.

Quality is Critical for Meaningful Synthesis of Afterschool Program Effects: A Systematic Review and Meta-analysis.

Afterschool programs are designed to promote academic achievement and youth development as well as mitigate risk for students who attend. Systematic reviews have reported that afterschool programs are associated with increased academic proficiency, school bonding, prosocial behavior, and decreased problem behavior. However, the majority of meta-analyses that report on these outcomes limit their samples to only rigorously conducted studies, which is not representative of the larger literature base. This systematic review and meta-analysis is designed to extend the literature by meta-analyzing a comprehensive sample of studies and examine the impact of study quality on meta-analytical results. A comprehensive literature and effect size extraction process search yielded 130 effect sizes from 30 studies that examined the effects of afterschool programs on secondary students' academic achievement and social / behavioral development. The majority of studies were unpublished reports, and study quality in the sample represented a high risk of bias. The results confirm the hypothesis that the inclusion of lower quality studies significantly impacts overall outcomes in comparison to prior meta-analyses that have limited samples. As such, it is imperative that researchers and practitioners increase the rigor of study design across individual program evaluations so that fewer reports will be excluded. This will improve future meta-analytic outcomes by ensuring a more representative sample of the literature base. Only through improved rigor of study design will a more clear understanding of program impacts on secondary students be possible.

The Relationship Between Study Quality and the Effects of Supplemental Reading Interventions: A Meta-Analysis.

Empirical studies investigating supplemental reading interventions for students with or at-risk for reading disabilities in the early elementary grades have demonstrated a range of effect sizes. Identifying the findings from high quality research can provide greater certainty of findings related to the effectiveness of supplemental reading interventions. This meta-analysis investigated how four variables of study quality (study design, statistical treatment, Type I error, and fidelity of implementation) were related to effect sizes from standardized measures of foundational reading skills and language/comprehension. The results from 88 studies indicated that year of publication was a significant predictor of effect sizes for both standardized measures of foundational reading skills and language/comprehension, with more recent studies demonstrating smaller effect sizes. Results also demonstrated that with the exception of research design predicting effect sizes on foundational reading skills measures, study quality was not related to the effects of supplemental reading interventions. Implications for research and practice are discussed.

Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review.

BACKGROUND: Clinical trials are most informative for evidence-based decision making when they consistently measure and report outcomes of relevance to stakeholders. We aimed to assess the scope and consistency of outcomes reported in trials for hemodialysis. STUDY DESIGN: Systematic review. SETTING & POPULATION: Adults requiring maintenance hemodialysis enrolled in clinical trials. SELECTION CRITERIA: All Cochrane systematic reviews of interventions published by August 29, 2016, and the trials published and registered in ClinicalTrials.gov since January 2011. INTERVENTIONS: Any hemodialysis-related interventions. OUTCOMES: Frequency and characteristics of the reported outcome domains and measures. RESULTS: From the 362 trials, we extracted and classified 10,713 outcome measures (a median of 21 [IQR, 10-39] per trial) into 81 different outcome domains, of which 42 (52%) were surrogate; 25 (31%), clinical; and 14 (17%), patient reported. The number of outcome measures reported significantly changed over time. The 5 most commonly reported domains were all surrogates: phosphate (125 [35%] trials), dialysis adequacy (120 [33%]), anemia (115 [32%]), inflammatory markers (114 [31%]), and calcium (109 [30%]). Mortality, cardiovascular diseases, and quality of life were reported very infrequently (73 [20%], 44 [12%], and 32 [9%], respectively). LIMITATIONS: For feasibility, we included a sampling frame that included only trials identified in Cochrane systematic reviews or ClinicalTrials.gov. CONCLUSIONS: Outcomes reported in clinical trials involving adults receiving hemodialysis are focused on surrogate outcomes, rather than clinical and patient-centered outcomes. There is also extreme multiplicity and heterogeneity at every level: domain, measure, metric, and time point. Estimates of the comparative effectiveness of available interventions are unreliable and improvements over time have been inconsistent.

Influence of blinding on treatment effect size estimate in randomized controlled trials of oral health interventions.

BACKGROUND: Recent methodologic evidence suggests that lack of blinding in randomized trials can result in under- or overestimation of the treatment effect size. The objective of this study is to quantify the extent of bias associated with blinding in randomized controlled trials of oral health interventions. METHODS: We selected all oral health meta-analyses that included a minimum of five randomized controlled trials. We extracted data, in duplicate, related to nine blinding-related criteria, namely: patient blinding, assessor blinding, care-provider blinding, investigator blinding, statistician blinding, blinding of both patients and assessors, study described as "double blind", blinding of patients, assessors, and care providers concurrently, and the appropriateness of blinding. We quantified the impact of bias associated with blinding on the magnitude of effect size using a two-level meta-meta-analytic approach with a random effects model to allow for intra- and inter-meta-analysis heterogeneity. RESULTS: We identified 540 randomized controlled trials, included in 64 meta-analyses, analyzing data from 137,957 patients. We identified significantly larger treatment effect size estimates in trials that had inadequate patient blinding (difference in treatment effect size = 0.12; 95% CI: 0.00 to 0.23), lack of blinding of both patients and assessors (difference = 0.19; 95% CI: 0.06 to 0.32), and lack of blinding of patients, assessors, and care-providers concurrently (difference = 0.14; 95% CI: 0.03 to 0.25). In contrast, assessor blinding (difference = 0.06; 95% CI: -0.06 to 0.18), caregiver blinding (difference = 0.02; 95% CI: -0.04 to 0.09), principal-investigator blinding (difference = - 0.02; 95% CI: -0.10 to 0.06), describing a trial as "double-blind" (difference = 0.09; 95% CI: -0.05 to 0.22), and lack of an appropriate method of blinding (difference = 0.06; 95% CI: -0.06 to 0.18) were not associated with over- or underestimated treatment effect size. CONCLUSIONS: We found significant differences in treatment effect size estimates between oral health trials based on lack of patient and assessor blinding. Treatment effect size estimates were 0.19 and 0.14 larger in trials with lack of blinding of both patients and assessors and blinding of patients, assessors, and care-providers concurrently. No significant differences were identified in other blinding criteria. Investigators of oral health systematic reviews should perform sensitivity analyses based on the adequacy of blinding in included trials.

Testing and refining the Science in Risk Assessment and Policy (SciRAP) web-based platform for evaluating the reliability and relevance of in vivo toxicity studies.

The Science in Risk Assessment and Policy (SciRAP) web-based platform was developed to promote and facilitate structure and transparency in the evaluation of ecotoxicity and toxicity studies for hazard and risk assessment of chemicals. The platform includes sets of criteria and a colour-coding tool for evaluating the reliability and relevance of individual studies. The SciRAP method for evaluating in vivo toxicity studies was first published in 2014 and the aim of the work presented here was to evaluate and develop that method further. Toxicologists and risk assessors from different sectors and geographical areas were invited to test the SciRAP criteria and tool on a specific set of in vivo toxicity studies and to provide feedback concerning the scientific soundness and user-friendliness of the SciRAP approach. The results of this expert assessment were used to refine and improve both the evaluation criteria and the colour-coding tool. It is expected that the SciRAP web-based platform will continue to be developed and enhanced to keep up to date with the needs of end-users.

Effectiveness of Mindfulness- and Relaxation-Based eHealth Interventions for Patients with Medical Conditions: a Systematic Review and Synthesis.

PURPOSE: This systematic review aims to summarize eHealth studies with mindfulness- and relaxation-based interventions for medical conditions and to determine whether eHealth interventions have positive effects on health. METHOD: A comprehensive search of five databases was conducted for all available studies from 1990 to 2015. Studies were included if the intervention was mainly technology delivered and included a mindfulness- or relaxation-based intervention strategy and if patients with a medical condition were treated. Treatment effects were summarized for different outcomes. RESULTS: A total of 2383 records were identified, of which 17 studies with 1855 patients were included in this systematic review. These studies were conducted in patients with irritable bowel syndrome, chronic fatigue syndrome, cancer, chronic pain, surgery, and hypertension. All but one study were delivered online through a web-based platform; one study delivered the intervention with iPods. The studies indicate that mindfulness- and relaxation-based eHealth interventions can have positive effects on patients' general health and psychological well-being. No effects were found for stress or mindfulness. Only five studies reported economic analyses of eHealth interventions without any clear conclusion. CONCLUSION: There is some evidence that mindfulness- and relaxation-based eHealth interventions for medical conditions can have positive effects on health outcomes. Therefore, such interventions might be a useful addition to standard medical care. No app studies were retrieved, even though a vast number of smartphone apps exist which aim at increasing users' health. Therefore, more studies investigating those health apps are needed.

Cochrane's risk of bias tool in the context of psychotherapy outcome research.

The Cochrane risk of bias tool (RoB) is a widely used measure for methodological quality of randomized controlled trials. This paper discusses RoB's rationale and risk of bias domains, reports on its application in current psychotherapy meta-analyses, and offers comments regarding the application of RoB in the context of psychotherapy outcome research. Our suggestions include focusing on patient's and therapist's expectations when judging the domain "blinding of personnel and participants" and paying greater attention to the domain "selective outcome reporting" and to matters of "treatment implementation."

A systematic review of economic evaluations of treatments for patients with epilepsy.

The increasing number of treatment options and the high costs associated with epilepsy have fostered the development of economic evaluations in epilepsy. It is important to examine the availability and quality of these economic evaluations and to identify potential research gaps. As well as looking at both pharmacologic (antiepileptic drugs [AEDs]) and nonpharmacologic (e.g., epilepsy surgery, ketogenic diet, vagus nerve stimulation) therapies, this review examines the methodologic quality of the full economic evaluations included. Literature search was performed in MEDLINE, EMBASE, NHS Economic Evaluation Database (NHS EED), Econlit, Web of Science, and CEA Registry. In addition, Cochrane Reviews, Cochrane DARE and Cochrane Health Technology Assessment Databases were used. To identify relevant studies, predefined clinical search strategies were combined with a search filter designed to identify health economic studies. Specific search strategies were devised for the following topics: (1) AEDs, (2) patients with cognitive deficits, (3) elderly patients, (4) epilepsy surgery, (5) ketogenic diet, (6) vagus nerve stimulation, and (7) treatment of (non)convulsive status epilepticus. A total of 40 publications were included in this review, 29 (73%) of which were articles about pharmacologic interventions. Mean quality score of all articles on the Consensus Health Economic Criteria (CHEC)-extended was 81.8%, the lowest quality score being 21.05%, whereas five studies had a score of 100%. Looking at the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), the average quality score was 77.0%, the lowest being 22.7%, and four studies rated as 100%. There was a substantial difference in methodology in all included articles, which hampered the attempt to combine information meaningfully. Overall, the methodologic quality was acceptable; however, some studies performed significantly worse than others. The heterogeneity between the studies stresses the need to define a reference case (e.g., how should an economic evaluation within epilepsy be performed) and to derive consensus on what constitutes "standard optimal care."

Framework for the quantitative weight-of-evidence analysis of 'omics data for regulatory purposes.

A framework for the quantitative weight-of-evidence (QWoE) analysis of 'omics data for regulatory purposes is presented. The QWoE framework encompasses seven steps to evaluate 'omics data (also together with non-'omics data): (1) Hypothesis formulation, identification and weighting of lines of evidence (LoEs). LoEs conjoin different (types of) studies that are used to critically test the hypothesis. As an essential component of the QWoE framework, step 1 includes the development of templates for scoring sheets that predefine scoring criteria with scores of 0-4 to enable a quantitative determination of study quality and data relevance; (2) literature searches and categorisation of studies into the pre-defined LoEs; (3) and (4) quantitative assessment of study quality and data relevance using the respective pre-defined scoring sheets for each study; (5) evaluation of LoE-specific strength of evidence based upon the study quality and study relevance scores of the studies conjoined in the respective LoE; (6) integration of the strength of evidence from the individual LoEs to determine the overall strength of evidence; (7) characterisation of uncertainties and conclusion on the QWoE. To put the QWoE framework in practice, case studies are recommended to confirm the relevance of its different steps, or to adapt them as necessary.

Systematic comparison of study quality criteria.

Approaches for the systematic review and evaluation of chemical toxicity are currently being reconsidered, with a specific focus on the evaluation of individual studies and their integration into the overall body of evidence. This renewed interest has arisen, in part, as a result of several prominent reviews of these approaches by special committees of the National Research Council (NRC), among others. We conducted a critical evaluation of several available frameworks for evaluating study quality. We assessed the criteria separately for human, animal, and in vitro studies as well as for systematic reviews. We then evaluated commonalities across disciplines. We also considered the potential implications of applying criteria frameworks and how they bear on fundamental risk assessment questions. We found that the available frameworks within each discipline differed in terms of their intended purpose and level of guidance for decision making. All the frameworks across disciplines shared common themes, however, including the adequate reporting of specific details of study conditions and design/protocol, selection and randomization of study groups (where applicable), outcome assessment methods and applicability (e.g., validity and reliability), avoidance of selective reporting, and the consideration of potential confounders or bias. We identified the most informative study quality considerations, which will enable researchers to implement more objective and standardized methods for evaluating studies and, ultimately, improve risk assessment methods.