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JNCI Cancer Spectrum Mar 2019Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given... (Review)
Review
BACKGROUND
Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given to the adequacy of reporting and interpretation. This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting.
METHODS
We searched PubMed through August 2017 to identify studies that evaluated surrogate endpoints using the meta-analyses of RCTs in oncology. Both individual patient data (IPD) and aggregate data (AD) meta-analyses were included for the review.
RESULTS
Eighty meta-analyses were identified: 22 used IPD and 58 used AD from multiple RCTs. We observed variability and reporting deficiencies in both IPD and AD meta-analyses, especially on reporting of trial selection, endpoint definition, study and patient characteristics for included RCTs, and important statistical methods and results. Based on these findings, we proposed a checklist and recommendations to improve completeness, consistency, and transparency of reports of meta-analytic surrogacy evaluation. We highlighted key aspects of the design and analysis of surrogate endpoints and presented explanations and rationale why these items should be clearly reported in surrogacy evaluation.
CONCLUSIONS
Our reporting of surrogate endpoint evaluation using meta-analyses (ReSEEM) guidelines and recommendations will improve the quality in reporting and facilitate the interpretation and reproducibility of meta-analytic surrogacy evaluation. Also, they should help promote greater methodological consistency and could also serve as an evaluation tool in the peer review process for assessing surrogacy research.
PubMed: 31360890
DOI: 10.1093/jncics/pkz002 -
Schizophrenia Bulletin Oct 2017Individuals with schizophrenia are burdened with impairments in functional outcome, despite existing interventions. The lack of understanding of the neurobiological... (Meta-Analysis)
Meta-Analysis Review
Individuals with schizophrenia are burdened with impairments in functional outcome, despite existing interventions. The lack of understanding of the neurobiological correlates supporting adaptive function in the disorder is a significant barrier to developing more effective treatments. This research conducted a systematic and meta-analytic review of all peer-reviewed studies examining brain-functional outcome relationships in schizophrenia. A total of 53 (37 structural and 16 functional) brain imaging studies examining the neural correlates of functional outcome across 1631 individuals with schizophrenia were identified from literature searches in relevant databases occurring between January, 1968 and December, 2016. Study characteristics and results representing brain-functional outcome relationships were systematically extracted, reviewed, and meta-analyzed. Results indicated that better functional outcome was associated with greater fronto-limbic and whole brain volumes, smaller ventricles, and greater activation, especially during social cognitive processing. Thematic observations revealed that the dorsolateral prefrontal cortex, anterior cingulate, posterior cingulate, parahippocampal gyrus, superior temporal sulcus, and cerebellum may have role in functioning. The neural basis of functional outcome and disability is infrequently studied in schizophrenia. While existing evidence is limited and heterogeneous, these findings suggest that the structural and functional integrity of fronto-limbic brain regions is consistently related to functional outcome in individuals with schizophrenia. Further research is needed to understand the mechanisms and directionality of these relationships, and the potential for identifying neural targets to support functional improvement.
Topics: Adult; Brain; Employment; Humans; Independent Living; Interpersonal Relations; Middle Aged; Schizophrenia; Young Adult
PubMed: 28204755
DOI: 10.1093/schbul/sbx008 -
Value in Health : the Journal of the... Jun 2015Decision-analytic modeling (DAM) has been increasingly used to aid decision making in health care. The growing use of modeling in economic evaluations has led to... (Review)
Review
BACKGROUND
Decision-analytic modeling (DAM) has been increasingly used to aid decision making in health care. The growing use of modeling in economic evaluations has led to increased scrutiny of the methods used.
OBJECTIVE
The objective of this study was to perform a systematic review to identify and critically assess good practice guidelines, with particular emphasis on contemporary developments.
METHODS
A systematic review of English language articles was undertaken to identify articles presenting guidance for good practice in DAM in the evaluation of health care. The inclusion criteria were articles providing guidance or criteria against which to assess good practice in DAM and studies providing criteria or elements for good practice in some areas of DAM. The review covered the period January 1990 to March 2014 and included the following electronic bibliographic databases: Cochrane Library, Cochrane Methodology Register and Health Technology Assessment, NHS Economic Evaluation Database, MEDLINE, and PubMed (Embase). Additional studies were identified by searching references.
RESULTS
Thirty-three articles were included in this review. A practical five-dimension framework was developed that describe the key elements of good research practice that should be considered and reported to increase the credibility of results obtained from DAM in the evaluation of health care.
CONCLUSIONS
This study is the first to critically review all available guidelines and statements of good practice in DAM since 2006. The development of good practice guidelines is an ongoing process, and important efforts have been made to identify what is good practice and to keep these guidelines up to date.
Topics: Decision Support Techniques; Guidelines as Topic; Humans; Research Design
PubMed: 26091606
DOI: 10.1016/j.jval.2014.12.014 -
PharmacoEconomics Jul 2016Numerous economic evaluations using decision-analytic models have assessed the cost effectiveness of treatments for Alzheimer's disease (AD) in the last two decades. It... (Review)
Review
BACKGROUND
Numerous economic evaluations using decision-analytic models have assessed the cost effectiveness of treatments for Alzheimer's disease (AD) in the last two decades. It is important to understand the methods used in the existing models of AD and how they could impact results, as they could inform new model-based economic evaluations of treatments for AD.
OBJECTIVE
The aim of this systematic review was to provide a detailed description on the relevant aspects and components of existing decision-analytic models of AD, identifying areas for improvement and future development, and to conduct a quality assessment of the included studies.
METHODS
We performed a systematic and comprehensive review of cost-effectiveness studies of pharmacological treatments for AD published in the last decade (January 2005 to February 2015) that used decision-analytic models, also including studies considering patients with mild cognitive impairment (MCI). The background information of the included studies and specific information on the decision-analytic models, including their approach and components, assumptions, data sources, analyses, and results, were obtained from each study. A description of how the modeling approaches and assumptions differ across studies, identifying areas for improvement and future development, is provided. At the end, we present our own view of the potential future directions of decision-analytic models of AD and the challenges they might face.
RESULTS
The included studies present a variety of different approaches, assumptions, and scope of decision-analytic models used in the economic evaluation of pharmacological treatments of AD. The major areas for improvement in future models of AD are to include domains of cognition, function, and behavior, rather than cognition alone; include a detailed description of how data used to model the natural course of disease progression were derived; state and justify the economic model selected and structural assumptions and limitations; provide a detailed (rather than high-level) description of the cost components included in the model; and report on the face-, internal-, and cross-validity of the model to strengthen the credibility and confidence in model results. The quality scores of most studies were rated as fair to good (average 87.5, range 69.5-100, in a scale of 0-100).
CONCLUSION
Despite the advancements in decision-analytic models of AD, there remain several areas of improvement that are necessary to more appropriately and realistically capture the broad nature of AD and the potential benefits of treatments in future models of AD.
Topics: Alzheimer Disease; Cognitive Dysfunction; Cost-Benefit Analysis; Decision Support Techniques; Disease Progression; Humans; Models, Economic
PubMed: 26899832
DOI: 10.1007/s40273-016-0392-1 -
Drug Metabolism Reviews May 2015Synthetic cannabinoids (SC), originally developed as research tools, are now highly abused novel psychoactive substances. We present a comprehensive systematic review... (Review)
Review
Synthetic cannabinoids (SC), originally developed as research tools, are now highly abused novel psychoactive substances. We present a comprehensive systematic review covering in vivo and in vitro animal and human pharmacokinetics and analytical methods for identifying SC and their metabolites in biological matrices. Of two main phases of SC research, the first investigated therapeutic applications, and the second abuse-related issues. Administration studies showed high lipophilicity and distribution into brain and fat tissue. Metabolite profiling studies, mostly with human liver microsomes and human hepatocytes, structurally elucidated metabolites and identified suitable SC markers. In general, SC underwent hydroxylation at various molecular sites, defluorination of fluorinated analogs and phase II metabolites were almost exclusively glucuronides. Analytical methods are critical for documenting intake, with different strategies applied to adequately address the continuous emergence of new compounds. Immunoassays have different cross-reactivities for different SC classes, but cannot keep pace with changing analyte targets. Gas chromatography and liquid chromatography mass spectrometry assays - first for a few, then numerous analytes - are available but constrained by reference standard availability, and must be continuously updated and revalidated. In blood and oral fluid, parent compounds are frequently present, albeit in low concentrations; for urinary detection, metabolites must be identified and interpretation is complex due to shared metabolic pathways. A new approach is non-targeted HRMS screening that is more flexible and permits retrospective data analysis. We suggest that streamlined assessment of new SC's pharmacokinetics and advanced HRMS screening provide a promising strategy to maintain relevant assays.
Topics: Animals; Biotransformation; Brain; Cannabinoids; Chromatography, Liquid; Humans; Illicit Drugs; Liver; Mass Spectrometry; Molecular Structure; Organ Specificity; Substance Abuse Detection; Tandem Mass Spectrometry; Tissue Distribution
PubMed: 25853390
DOI: 10.3109/03602532.2015.1029635 -
Journal of Experimental Psychology.... Sep 2018Many behaviors posing significant risks to public health are characterized by repeated decisions to forego better long-term outcomes in the face of immediate... (Meta-Analysis)
Meta-Analysis Review
Many behaviors posing significant risks to public health are characterized by repeated decisions to forego better long-term outcomes in the face of immediate temptations. Steeply discounting the value of delayed outcomes often underlies a pattern of impulsive choice. Steep delay discounting is correlated with addictions (e.g., substance abuse, obesity) and behaviors such as seatbelt use and risky sexual activity. As evidence accumulates suggesting steep delay discounting plays a causal role in these maladaptive behaviors, researchers have begun testing methods for reducing discounting. In this first systematic and comprehensive review of this literature, the findings of 92 articles employing different methodologies to reduce discounting are evaluated narratively and meta-analytically. Although most of the methods reviewed produced significant reductions in discounting, they varied in effect sizes. Most methods were ideal for influencing one-off choices (e.g., framing and priming manipulations), although other successful manipulations, such as episodic future thinking, could be incorporated into existing therapies designed to produce longer-lasting changes in decision-making. The largest and longest-lasting effects were produced by learning-based manipulations, although translational research is needed to determine the generality and clinical utility of these methods. Methodological shortcomings in the existing literature and suggestions for ameliorating these issues are discussed. This review reveals a variety of methods with translational potential, which, through continued refinement, may prove effective in reducing impulsive choice and its associated maladaptive decisions that negatively impact quality of life. (PsycINFO Database Record
Topics: Choice Behavior; Delay Discounting; Humans; Impulsive Behavior; Public Health; Risk-Taking
PubMed: 30148386
DOI: 10.1037/xge0000462 -
Annals of Epidemiology May 2017Malignant mesothelioma most commonly arises in the pleura and peritoneum but also occurs rarely at other anatomical sites with mesothelial tissue, namely, the... (Review)
Review
PURPOSE
Malignant mesothelioma most commonly arises in the pleura and peritoneum but also occurs rarely at other anatomical sites with mesothelial tissue, namely, the pericardium and tunica vaginalis testis (TVT). This review provides a better understanding of the epidemiology of mesothelioma of these extrapleural sites.
METHODS
We conducted a systematic review of the epidemiologic and clinical literature on pericardial mesothelioma and mesothelioma of the TVT. We also analyzed U.S. Surveillance, Epidemiology, and End Results cancer registry data to describe incidence patterns of these malignancies.
RESULTS
An etiologic role of asbestos exposure has been hypothesized for pericardial and TVT mesotheliomas, but no analytical case-control epidemiologic studies exist to test this relationship. A substantial proportion of cases with these malignancies report no known asbestos exposure. In large occupational cohorts with heavy asbestos exposures, no cases of pericardial or TVT mesothelioma have been reported. Trends in the incidence of these malignancies do not match those of pleural mesothelioma, which correspond to historical trends of commercial asbestos use. A male preponderance of pericardial mesothelioma is not evident.
CONCLUSIONS
In the absence of analytic epidemiologic studies, the etiologic role of environmental risk factors for mesothelioma of the pericardium and TVT remains elusive.
Topics: Asbestos; Female; Heart Neoplasms; Humans; Male; Mesothelioma; Middle Aged; Occupational Diseases; Pericardium; Registries; Testicular Neoplasms; Testis; United States
PubMed: 28527639
DOI: 10.1016/j.annepidem.2017.04.001 -
Trauma, Violence & Abuse Dec 2022Belongingness is a basic human need. The violation of this need has been described in numerous studies on intimate partner violence (IPV). However, it has not been... (Review)
Review
Belongingness is a basic human need. The violation of this need has been described in numerous studies on intimate partner violence (IPV). However, it has not been conceptually defined. Therefore, this study aimed to develop and analyze the concept of social abuse in intimate partner relationships. A hybrid model of concept analysis was used for this study consisting of three phases: theoretical, fieldwork, and analytic. In the theoretical phase, a systematic literature review was performed to obtain a working definition of social abuse. In total, 20 articles that met the inclusion criteria were included in the analysis. The findings from the theoretical phase were refined and confirmed by qualitative data collected from the fieldwork phase. In the analytical phase, four attributes of social abuse emerged: cutting off the victim's social relations, limiting the victim's social engagement, interfering with the victim's social relations, and closely watching the victim's social interactions. Possessiveness, escalating suspicion, allegations of infidelity, and fear that the victim will leave were identified as antecedents of social abuse in perpetrators. Additionally, the experience of social abuse had negative consequences on victims' social relationships, mental health, and help-seeking behaviors. This study extends the theoretical framework of IPV and implies a strong need to educate victims and their social acquaintances on social abuse.
Topics: Humans; Crime Victims; Sexual Partners; Intimate Partner Violence; Interpersonal Relations
PubMed: 34000902
DOI: 10.1177/15248380211013140 -
Psychological Assessment Jun 2017We know surprisingly little about the interrater reliability of forensic psychological opinions, even though courts and other authorities have long called for known... (Meta-Analysis)
Meta-Analysis Review
We know surprisingly little about the interrater reliability of forensic psychological opinions, even though courts and other authorities have long called for known error rates for scientific procedures admitted as courtroom testimony. This is particularly true for opinions produced during routine practice in the field, even for some of the most common types of forensic evaluations-evaluations of adjudicative competency and legal sanity. To address this gap, we used meta-analytic procedures and study space methodology to systematically review studies that examined the interrater reliability-particularly the field reliability-of competency and sanity opinions. Of 59 identified studies, 9 addressed the field reliability of competency opinions and 8 addressed the field reliability of sanity opinions. These studies presented a wide range of reliability estimates; pairwise percentage agreements ranged from 57% to 100% and kappas ranged from .28 to 1.0. Meta-analytic combinations of reliability estimates obtained by independent evaluators returned estimates of κ = .49 (95% CI: .40-.58) for competency opinions and κ = .41 (95% CI: .29-.53) for sanity opinions. This wide range of reliability estimates underscores the extent to which different evaluation contexts tend to produce different reliability rates. Unfortunately, our study space analysis illustrates that available field reliability studies typically provide little information about contextual variables crucial to understanding their findings. Given these concerns, we offer suggestions for improving research on the field reliability of competency and sanity opinions, as well as suggestions for improving reliability rates themselves. (PsycINFO Database Record
Topics: Humans; Insanity Defense; Mental Competency; Reproducibility of Results
PubMed: 28594221
DOI: 10.1037/pas0000388 -
Journal of Dental Research Mar 2021Clinicians frequently stress the importance of maintaining good oral health for multiple reasons, including its link to systemic health. Because periodontal treatment...
Clinicians frequently stress the importance of maintaining good oral health for multiple reasons, including its link to systemic health. Because periodontal treatment reduces inflammation in oral tissues, some hypothesize it may positively affect systemic outcomes by reducing inflammation in the body. A significant number of systematic reviews (SRs) and meta-analyses (MAs) have evaluated the effect of periodontal treatment on systemic outcomes. However, inconsistent findings and questionable methodological rigor make drawing conclusions difficult. We conducted a systematic review of reviews that studied the effect of nonsurgical periodontal treatment on systemic disease outcomes. We report on outcomes evaluated, categorizing them as biomarkers, and surrogate or clinical endpoints. In addition, we used A MeaSurement Tool to Access systematic Reviews 2 (AMSTAR 2) to evaluate the methodological quality of the reviews. Of the 52 studies included in our review, 21 focused on diabetes, 15 on adverse birth outcomes, 8 on cardiovascular disease, 3 each on obesity and rheumatoid arthritis, and 2 on chronic kidney disease. Across all studies, surrogate endpoints predominated as outcomes, followed by biomarkers and, rarely, actual disease endpoints. Ninety-two percent of studies had "low" or "critically low" AMSTAR 2 confidence ratings. Criteria not met most frequently included advance registration of the protocol, justification for excluding individual studies, risk of bias from individual studies being included in the review, and appropriateness of meta-analytical methods. There is a dearth of robust evidence on whether nonsurgical periodontal treatment improves systemic disease outcomes. Future reviews should adhere more closely to methodological guidelines for conducting and reporting SRs/MAs than has been the case to date. Beyond improved reviews, additional rigorous research on whether periodontal treatment affects systemic health is needed. We highlight the potential of large-scale databases containing matched medical and dental record data to inform and complement future clinical research studying the effect of periodontal treatment on systemic outcomes.
Topics: Biomarkers; Diabetes Mellitus; Humans; Research Report
PubMed: 33089733
DOI: 10.1177/0022034520965958