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Systematic Reviews Oct 2023Since 1997, several meta-analyses (MAs) of placebo-controlled randomised efficacy trials of homoeopathy for any indication (PRETHAIs) have been published with different...
BACKGROUND AND OBJECTIVE
Since 1997, several meta-analyses (MAs) of placebo-controlled randomised efficacy trials of homoeopathy for any indication (PRETHAIs) have been published with different methods, results and conclusions. To date, a formal assessment of these MAs has not been performed. The main objective of this systematic review of MAs of PRETHAIs was to evaluate the efficacy of homoeopathic treatment.
METHODS
The inclusion criteria were as follows: MAs of PRETHAIs in humans; all ages, countries, settings, publication languages; and MAs published from 1 Jan. 1990 to 30 Apr. 2023. The exclusion criteria were as follows: systematic reviews without MAs; MAs restricted to age or gender groups, specific indications, or specific homoeopathic treatments; and MAs that did not assess efficacy. We searched 8 electronic databases up to 14 Dec. 2020, with an update search in 6 databases up to 30 April 2023. The primary outcome was the effect estimate for all included trials in each MA and after restricting the sample to trials with high methodological quality, according to predefined criteria. The risk of bias for each MA was assessed by the ROBIS (Risk Of Bias In Systematic reviews) tool. The quality of evidence was assessed by the GRADE framework. Statistical analyses were performed to determine the proportion of MAs showing a significant positive effect of homoeopathy vs. no significant difference.
RESULTS
Six MAs were included, covering individualised homoeopathy (I-HOM, n = 2), nonindividualised homoeopathy (NI-HOM, n = 1) and all homoeopathy types (ALL-HOM = I-HOM + NI-HOM, n = 3). The MAs comprised between 16 and 110 trials, and the included trials were published from 1943-2014. The median trial sample size ranged from 45 to 97 patients. The risk of bias (low/unclear/high) was rated as low for three MAs and high for three MAs. Effect estimates for all trials in each MA showed a significant positive effect of homoeopathy compared to placebo (5 of 5 MAs, no data in 1 MA). Sensitivity analyses with sample restriction to high-quality trials were available from 4 MAs; the effect remained significant in 3 of the MAs (2 MAs assessed ALL-HOM, 1 MA assessed I-HOM) and was no longer significant in 1 MA (which assessed NI-HOM).
DISCUSSION
The quality of evidence for positive effects of homoeopathy beyond placebo (high/moderate/low/very low) was high for I-HOM and moderate for ALL-HOM and NI-HOM. There was no support for the alternative hypothesis of no outcome difference between homoeopathy and placebo. The available MAs of PRETHAIs reveal significant positive effects of homoeopathy beyond placebo. This is in accordance with laboratory experiments showing partially replicable effects of homoeopathically potentised preparations in physico-chemical, in vitro, plant-based and animal-based test systems.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42020209661. The protocol for this SR was finalised and submitted on 25 Nov. 2020 and registered on 26 Dec. 2020.
Topics: Humans; Bias; Homeopathy; Research Design; Meta-Analysis as Topic; Randomized Controlled Trials as Topic
PubMed: 37805577
DOI: 10.1186/s13643-023-02313-2 -
Journal of Neuroscience Methods Jul 2022Brain computer interaction based on EEG presents great potential and becomes the research hotspots. However, the insufficient scale of EEG database limits the BCI system...
Brain computer interaction based on EEG presents great potential and becomes the research hotspots. However, the insufficient scale of EEG database limits the BCI system performance, especially the positive and negative sample imbalance caused by oddball paradigm. To alleviate the bottleneck problem of scarce EEG sample, we propose a data augmentation method based on generative adversarial network to improve the performance of EEG signal classification. Taking the characteristics of EEG into account in wasserstein generative adversarial networks (WGAN), the problems of model collapse and poor quality of artificial data were solved by using resting noise, smoothing and random amplitude. The quality of artificial data was comprehensively evaluated from verisimilitude, diversity and accuracy. Compared with the three artificial data methods and two data sampling methods, the proposed ERP-WGAN framework significantly improve the performance of both subject and general classifiers, especially the accuracy of general classifiers trained by less than 5 dimensional features is improved by 20-25%. Moreover, we evaluate the training sets performance with different mixing ratios of artificial and real samples. ERP-WGAN can reduced at least 73% of the real subject data and acquisition cost, which greatly saves the test cycle and research cost.
Topics: Brain; Brain-Computer Interfaces; Databases, Factual; Electroencephalography; Research Design
PubMed: 35513171
DOI: 10.1016/j.jneumeth.2022.109621 -
Journal of Biopharmaceutical Statistics Nov 2021Multisource exchangeability models (MEMs), a BayeTsian approach for dynamically integrating information from multiple clinical trials, are a promising approach for...
Multisource exchangeability models (MEMs), a BayeTsian approach for dynamically integrating information from multiple clinical trials, are a promising approach for gaining efficiency in randomized controlled trials. When the supplementary trials are considerably larger than the primary trial, care must be taken when integrating supplementary data to avoid overwhelming the primary trial. In this paper, we propose "capping priors," which controls the extent of dynamic borrowing by placing an cap on the effective supplemental sample size. We demonstrate the behavior of this technique via simulation, and apply our method to four randomized trials of very low nicotine content cigarettes.
Topics: Bayes Theorem; Computer Simulation; Humans; Research Design; Sample Size
PubMed: 35129422
DOI: 10.1080/10543406.2021.1998100 -
Western Journal of Nursing Research Oct 2021Evaluating engagement in a research partnership can capture the success and impact of the research team-stakeholder partnerships. This article describes the...
Evaluating engagement in a research partnership can capture the success and impact of the research team-stakeholder partnerships. This article describes the Stakeholder-Centric Instrumentation Process (SCIP), an iterative method to develop an evaluation that reflects research team-stakeholder collective values, language, and priorities. We describe our implementation of the SCIP and provide the Stakeholder-Centric Engagement Evaluation, an evaluation developed in collaboration with our advisory committee. Mean scores across three administrations of the tool remained constant. We monitored responses received from our advisory committee during each administration for changes in scores that guided refinements to our stakeholder engagement strategy. Face validity and acceptability questions showed high satisfaction for the tool's time required to complete, ( = 4.50, = 0.86), clarity ( = 4.56, = 0.78), and relevance ( = 4.67, = 0.49) (maximum score = 5). The SCIP methodology and the Stakeholder-Centric Engagement Tool can be used during study planning and data collection to capture research team-stakeholder collaborations that reflect stakeholder priorities.
Topics: Humans; Research Design; Stakeholder Participation
PubMed: 33896283
DOI: 10.1177/01939459211004274 -
Schizophrenia Bulletin Aug 2021Few studies address publication and outcome reporting biases of randomized controlled trials (RCTs) in psychiatry. The objective of this study was to determine...
Few studies address publication and outcome reporting biases of randomized controlled trials (RCTs) in psychiatry. The objective of this study was to determine publication and outcome reporting bias in RCTs funded by the Stanley Medical Research Institute (SMRI), a U.S. based, non-profit organization funding RCTs in schizophrenia and bipolar disorder. We identified all RCTs (n = 280) funded by SMRI between 2000 and 2011, and using non-public, final study reports and published manuscripts, we classified the results as positive or negative in terms of the drug compared to placebo. Design, outcome measures and statistical methods specified in the original protocol were compared to the published manuscript. Of 280 RCTs funded by SMRI between 2000 and 2011, at the time of this writing, three RCTs were ongoing and 39 were not performed. Among the 238 completed RCTs, 86 (36.1%) reported positive and 152 (63.9%) reported negative results: 86% (74/86) of those with positive findings were published in contrast to 53% (80/152) of those with negative findings (P < .001). In 70% of the manuscripts published, there were major discrepancies between the published manuscript and the original RCT protocol (change in the primary outcome measure or statistics, change in a number of patient groups, 25% or more reduction in sample size). We conclude that publication bias and outcome reporting bias is common in papers reporting RCTs in schizophrenia and bipolar disorder. These data have major implications regarding the validity of the reports of clinical trials published in the literature.
Topics: Biomedical Research; Data Interpretation, Statistical; Humans; Outcome Assessment, Health Care; Psychiatry; Publication Bias; Randomized Controlled Trials as Topic; Research Design
PubMed: 33860793
DOI: 10.1093/schbul/sbab040 -
Behavior Research Methods Feb 2022Meta-analysis is a powerful and important tool to synthesize the literature about a research topic. Like other kinds of research, meta-analyses must be reproducible to... (Review)
Review
Meta-analysis is a powerful and important tool to synthesize the literature about a research topic. Like other kinds of research, meta-analyses must be reproducible to be compliant with the principles of the scientific method. Furthermore, reproducible meta-analyses can be easily updated with new data and reanalysed applying new and more refined analysis techniques. We attempted to empirically assess the prevalence of transparency and reproducibility-related reporting practices in published meta-analyses from clinical psychology by examining a random sample of 100 meta-analyses. Our purpose was to identify the key points that could be improved, with the aim of providing some recommendations for carrying out reproducible meta-analyses. We conducted a meta-review of meta-analyses of psychological interventions published between 2000 and 2020. We searched PubMed, PsycInfo and Web of Science databases. A structured coding form to assess transparency indicators was created based on previous studies and existing meta-analysis guidelines. We found major issues concerning: completely reproducible search procedures report, specification of the exact method to compute effect sizes, choice of weighting factors and estimators, lack of availability of the raw statistics used to compute the effect size and of interoperability of available data, and practically total absence of analysis script code sharing. Based on our findings, we conclude with recommendations intended to improve the transparency, openness, and reproducibility-related reporting practices of meta-analyses in clinical psychology and related areas.
Topics: Humans; Meta-Analysis as Topic; Prevalence; Psychosocial Intervention; Reproducibility of Results; Research Design
PubMed: 34173943
DOI: 10.3758/s13428-021-01644-z -
PloS One 2023Sarcoidosis is a rare systemic inflammatory granulomatous disease of unknown cause. It can manifest in any organ. The incidence of sarcoidosis varies across countries,...
INTRODUCTION
Sarcoidosis is a rare systemic inflammatory granulomatous disease of unknown cause. It can manifest in any organ. The incidence of sarcoidosis varies across countries, and by ethnicity and gender. Delays in the diagnosis of sarcoidosis can lead to extension of the disease and organ impairment. Diagnosis delay is attributed in part to the lack of a single diagnostic test or unified commonly used diagnostic criteria, and to the diversity of disease manifestations and symptom load. There is a paucity of evidence examining the determinants of diagnostic delay in sarcoidosis and the experiences of people with sarcoidosis related to delayed diagnosis. We aim to systematically review available evidence about diagnostic delay in sarcoidosis to elucidate the factors associated with diagnostic delay for this disease in different contexts and settings, and the consequences for people with sarcoidosis.
METHODS AND ANALYSIS
A systematic search of the literature will be conducted using PubMed/Medline, Scopus, and ProQuest databases, and sources of grey literature, up to 25th of May 2022, with no limitations on publication date. We will include all study types (qualitative, quantitative, and mixed methods) except review articles, examining diagnostic delay, incorrect diagnosis, missed diagnosis or slow diagnosis of all types of sarcoidosis across all age groups. We will also examine evidence of patients' experiences associated with diagnostic delay. Only studies in English, German and Indonesian will be included. The outcomes we examine will be diagnostic delay time, patients' experiences, and factors associated with diagnostic delay in sarcoidosis. Two people will independently screen the titles and abstracts of search results, and then the remaining full-text documents against the inclusion criteria. Disagreements will be resolved with a third reviewer until consensus is reached. Selected studies will be appraised using the Mixed Methods Appraisal Tool (MMAT). A meta-analysis and subgroup analyses of quantitative data will be conducted. Meta-aggregation methods will be used to analyse qualitative data. If there is insufficient data for these analyses, a narrative synthesis will be conducted.
DISCUSSION
This review will provide systematic and integrated evidence on the diagnostic delay, associated factors, and experiences of diagnosis delay among people with all types of sarcoidosis. This knowledge may shed light on ways to improve diagnosis delays in diagnosis across different subpopulations, and with different disease presentations.
ETHICS AND DISSEMINATION
Ethical approval will not be required as no human recruitment or participation will be involved. Findings of the study will be disseminated through publications in peer-reviewed journals, conferences, and symposia.
TRIAL REGISTRATION
PROSPERO Registration number: CRD42022307236. URL of the PROSPERO registration: https://www.crd.york.ac.uk/PROSPEROFILES/307236_PROTOCOL_20220127.pdf.
Topics: Humans; Delayed Diagnosis; Ethnicity; Incidence; Meta-Analysis as Topic; Research Design; Sarcoidosis; Systematic Reviews as Topic
PubMed: 36812191
DOI: 10.1371/journal.pone.0269762 -
Research on Aging 2020(2007) called on the research community to disseminate its work on cognitive aging and cognitive health. The purpose of this scoping review was to (1) identify... (Review)
Review
(2007) called on the research community to disseminate its work on cognitive aging and cognitive health. The purpose of this scoping review was to (1) identify terminology that cognitive, social, and behavioral scientists use to describe cognitive aging and cognitive health, in association with dementia and Alzheimer's disease, among older adults; (2) demonstrate how such terms are defined; and (3) illustrate how these constructs are measured in research settings. Empirical studies published 2007-2018 were examined for terminology, definitions, disciplinary orientation, and measurement mechanisms. Analysis of the corpus and a detailed review of the terms "cognitive impairment" and "mild cognitive impairment" reveal that formal definitions are provided infrequently and measurement of constructs ranges widely. Overall, the variability in terminology, definitions, and measures reflects a need for greater specificity in research communication, such that cross-disciplinary collaboration can be facilitated.
Topics: Aged; Alzheimer Disease; Cognition; Cognitive Aging; Cognitive Dysfunction; Dementia; Humans; Observational Studies as Topic; Research Design; Terminology as Topic
PubMed: 32195637
DOI: 10.1177/0164027520911284 -
Behavior Research Methods Dec 2019We describe a general method that allows experimenters to quantify the evidence from the data of a direct replication attempt given data already acquired from an...
We describe a general method that allows experimenters to quantify the evidence from the data of a direct replication attempt given data already acquired from an original study. These so-called replication Bayes factors are a reconceptualization of the ones introduced by Verhagen and Wagenmakers (Journal of Experimental Psychology: General, 143(4), 1457-1475 2014) for the common t test. This reconceptualization is computationally simpler and generalizes easily to most common experimental designs for which Bayes factors are available.
Topics: Bayes Theorem; Data Interpretation, Statistical; Humans; Research Design
PubMed: 30105445
DOI: 10.3758/s13428-018-1092-x -
BMJ Open Oct 2023Reference intervals and reference curves provide clinicians with a point of reference when evaluating patients' laboratory test results. In practical applications, the...
INTRODUCTION
Reference intervals and reference curves provide clinicians with a point of reference when evaluating patients' laboratory test results. In practical applications, the 2.5th and 97.5th percentiles of healthy reference population are typically used as lower and upper reference limits. Guidelines outlining analytical and methodological steps involved in reference intervals and curves estimation are available and there have been large-scale world-wide initiatives to provide reference intervals and curves for children. However, there is a lack of synthesised evidence regarding the results of such initiatives in general, but specifically in iron-related biomarkers, ferritin (in serum and plasma) and haemoglobin. Objectives of this review are to identify studies that have produced reference intervals and curves for ferritin and haemoglobin in paediatric populations and to synthesise all available evidence. We also aim to quantify heterogeneity across reference intervals and curves and identify and elucidate sources of heterogeneity, including heterogeneity in the methods employed in their development.
METHODS AND ANALYSIS
Using a comprehensive search strategy, we will identify eligible studies. Following electronic databases will be searched from inception: EMBASE, MEDLINE, SCOPUS and The Cochrane Library. We will also perform grey literature search to capture unpublished reference intervals and curves from healthy cohorts. Two researchers will independently screen retrieved citations against eligibility criteria in two stages, focusing first on titles and abstracts and then on full-text articles. Studies that provide reference intervals and curves for ferritin and haemoglobin for paediatric population will be eligible. Data extraction will include study characteristics, characteristics of reference population, methodological and analytical considerations and estimated reference intervals and curves. We will consider narrative synthesis and quantitative synthesis when appropriate.
ETHICS AND DISSEMINATION
Ethical approval is not required as data from already published studies will be used. Results will be disseminated through peer-reviewed publications and conference presentations.
PROSPERO REGISTRATION NUMBER
CRD42023399802.
Topics: Humans; Child; Ferritins; Systematic Reviews as Topic; Meta-Analysis as Topic; Hemoglobins; Peer Review; Research Design; Review Literature as Topic
PubMed: 37793936
DOI: 10.1136/bmjopen-2023-073783