scholarly journals Stepwise-hierarchical pooled analysis: a synergistic interpretation of meta-analysis including randomized and observational studies: A methodologic study (Preprint)

2021 ◽  
Author(s):  
In-Soo Shin ◽  
Chai Hong Rim
Keyword(s):  
Effect Size ◽  
Observational Studies ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Pooled Analysis ◽  
Grey Zone ◽  
True Effect ◽  
Logical Method ◽  
Three Stages ◽  
Meta Analyses

BACKGROUND The necessity of meta-analyses including observational studies has been discussed in the literature, but a synergistic analysis method combining randomised and observational studies has not been reported. OBJECTIVE This study introduces a logical method for clinical interpretation. METHODS Observational studies differ in validity depending on the degree of the confounders’ influence. Combining interpretations might be challenging, especially if the statistical directions are similar but the magnitude of the pooled results are different, between randomised and observational studies (grey zone). We designed a stepwise-hierarchical pooled analysis, a method of analysing distribution trends as well as individual pooled results by dividing included studies into at least three stages (e.g. all studies, balanced studies, and randomised studies), to overcome such hindrances. RESULTS According to the model, the validity of hypothesis are mostly based on the pooled results of randomised studies (the highest stage). In addition, ascending patterns where effect size and statistical significance increase gradually with stage, strengthen the validity of the hypothesis; in this case, the effect size of observational studies is lower than that of the true effect (e.g. because of uncontrolled effect of negative confounders). Descending patterns where decreasing effect size and statistical significance gradually weaken the validity of the hypothesis suggest that the effect size and statistical significance of observational studies is larger than the true effect (e.g. because of researchers’ bias). These are described in more detail in the main text as four descriptive patterns. CONCLUSIONS We recommend using the stepwise-hierarchical pooled analysis for meta-analyses involving randomised and observational studies. CLINICALTRIAL NA

Addendum to the Acknowledgements: Stepwise-Hierarchical Pooled Analysis for Synergistic Interpretation of Meta-analyses Involving Randomized and Observational Studies: Methodology Development (Preprint)

2021 ◽  
Author(s):  
In-Soo Shin ◽  
Chai Hong Rim
Keyword(s):  
Effect Size ◽  
Observational Studies ◽  
Statistical Significance ◽  
Pooled Analysis ◽  
Analysis Method ◽  
Methodology Development ◽  
True Effect ◽  
Randomized Studies ◽  
Logical Method ◽  
Meta Analyses

UNSTRUCTURED The necessity of including observational studies in meta-analyses has been discussed in the literature, but a synergistic analysis method for combining randomized and observational studies has not been reported. Observational studies differ in validity depending on the degree of the confounders’ influence. Combining interpretations may be challenging, especially if the statistical directions are similar but the magnitude of the pooled results are different between randomized and observational studies (the ”gray zone”). To overcome these hindrances, in this study, we aim to introduce a logical method for clinical interpretation of randomized and observational studies. We designed a stepwise-hierarchical pooled analysis method to analyze both distribution trends and individual pooled results by dividing the included studies into at least three stages (eg, all studies, balanced studies, and randomized studies). According to the model, the validity of a hypothesis is mostly based on the pooled results of randomized studies (the highest stage). Ascending patterns in which effect size and statistical significance increase gradually with stage strengthen the validity of the hypothesis; in this case, the effect size of the observational studies is lower than that of the true effect (eg, because of the uncontrolled effect of negative confounders). Descending patterns in which decreasing effect size and statistical significance gradually weaken the validity of the hypothesis suggest that the effect size and statistical significance of the observational studies is larger than the true effect (eg, because of researchers’ bias). We recommend using the stepwise-hierarchical pooled analysis approach for meta-analyses involving randomized and observational studies.

Can Reliance be Placed on a Single Meta-Analysis?

1990 ◽  
Vol 24 (3) ◽  
pp. 405-415 ◽  
Author(s):  
Nathaniel McConaghy
Keyword(s):  
Literature Review ◽  
Effect Size ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Effect Sizes ◽  
Control Groups ◽  
Consistent Finding ◽  
Placebo Controls ◽  
Effect Of Treatment ◽  
Meta Analyses

Meta-analysis replaced statistical significance with effect size in the hope of resolving controversy concerning evaluation of treatment effects. Statistical significance measured reliability of the effect of treatment, not its efficacy. It was strongly influenced by the number of subjects investigated. Effect size as assessed originally, eliminated this influence but by standardizing the size of the treatment effect could distort it. Meta-analyses which combine the results of studies which employ different subject types, outcome measures, treatment aims, no-treatment rather than placebo controls or therapists with varying experience can be misleading. To ensure discussion of these variables meta-analyses should be used as an aid rather than a substitute for literature review. While meta-analyses produce contradictory findings, it seems unwise to rely on the conclusions of an individual analysis. Their consistent finding that placebo treatments obtain markedly higher effect sizes than no treatment hopefully will render the use of untreated control groups obsolete.

scholarly journals Low statistical power in biomedical science: a review of three human research domains

2017 ◽  
Vol 4 (2) ◽  
pp. 160254 ◽  
Author(s):  
Estelle Dumas-Mallet ◽  
Katherine S. Button ◽  
Thomas Boraud ◽  
Francois Gonon ◽  
Marcus R. Munafò
Keyword(s):  
Effect Size ◽  
Statistical Power ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Average Power ◽  
Biomedical Science ◽  
Significant Finding ◽  
Biomedical Sciences ◽  
True Effect Size ◽  
Meta Analyses

Studies with low statistical power increase the likelihood that a statistically significant finding represents a false positive result. We conducted a review of meta-analyses of studies investigating the association of biological, environmental or cognitive parameters with neurological, psychiatric and somatic diseases, excluding treatment studies, in order to estimate the average statistical power across these domains. Taking the effect size indicated by a meta-analysis as the best estimate of the likely true effect size, and assuming a threshold for declaring statistical significance of 5%, we found that approximately 50% of studies have statistical power in the 0–10% or 11–20% range, well below the minimum of 80% that is often considered conventional. Studies with low statistical power appear to be common in the biomedical sciences, at least in the specific subject areas captured by our search strategy. However, we also observe evidence that this depends in part on research methodology, with candidate gene studies showing very low average power and studies using cognitive/behavioural measures showing high average power. This warrants further investigation.

scholarly journals Cannons and sparrows II: the enhanced Bernoulli exact method for determining statistical significance and effect size in the meta-analysis of k 2 × 2 tables

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Lawrence M. Paul
Keyword(s):  
Effect Size ◽  
Type I Error ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Statistical Error ◽  
Exact Method ◽  
Type I ◽  
Exact Test ◽  
Inverse Variance ◽  
Meta Analyses

Abstract Background The use of meta-analysis to aggregate the results of multiple studies has increased dramatically over the last 40 years. For homogeneous meta-analysis, the Mantel–Haenszel technique has typically been utilized. In such meta-analyses, the effect size across the contributing studies of the meta-analysis differs only by statistical error. If homogeneity cannot be assumed or established, the most popular technique developed to date is the inverse-variance DerSimonian and Laird (DL) technique (DerSimonian and Laird, in Control Clin Trials 7(3):177–88, 1986). However, both of these techniques are based on large sample, asymptotic assumptions. At best, they are approximations especially when the number of cases observed in any cell of the corresponding contingency tables is small. Results This research develops an exact, non-parametric test for evaluating statistical significance and a related method for estimating effect size in the meta-analysis of k 2 × 2 tables for any level of heterogeneity as an alternative to the asymptotic techniques. Monte Carlo simulations show that even for large values of heterogeneity, the Enhanced Bernoulli Technique (EBT) is far superior at maintaining the pre-specified level of Type I Error than the DL technique. A fully tested implementation in the R statistical language is freely available from the author. In addition, a second related exact test for estimating the Effect Size was developed and is also freely available. Conclusions This research has developed two exact tests for the meta-analysis of dichotomous, categorical data. The EBT technique was strongly superior to the DL technique in maintaining a pre-specified level of Type I Error even at extremely high levels of heterogeneity. As shown, the DL technique demonstrated many large violations of this level. Given the various biases towards finding statistical significance prevalent in epidemiology today, a strong focus on maintaining a pre-specified level of Type I Error would seem critical. In addition, a related exact method for estimating the Effect Size was developed.

scholarly journals Bayesian Hypothesis Testing and Estimation under the Marginalized Random-Effects Meta-Analysis Model

2020 ◽  
Author(s):  
Robbie Cornelis Maria van Aert ◽  
Joris Mulder
Keyword(s):  
Hypothesis Testing ◽  
Random Effects ◽  
Effect Size ◽  
Meta Analysis ◽  
Bayes Factors ◽  
Estimation Methods ◽  
True Effect Size ◽  
Bayesian Hypothesis Testing ◽  
True Effect ◽  
Meta Analyses

Meta-analysis methods are used to synthesize results of multiple studies on the same topic. The most frequently used statistical model in meta-analysis is the random-effects model containing parameters for the average effect, between-study variance in primary study's true effect size, and random effects for the study specific effects. We propose Bayesian hypothesis testing and estimation methods using the marginalized random-effects meta-analysis (MAREMA) model where the study specific true effects are regarded as nuisance parameters which are integrated out of the model. A flat prior distribution is placed on the overall effect size in case of estimation and a proper unit information prior for the overall effect size is proposed in case of hypothesis testing. For the between-study variance in true effect size, a proper uniform prior is placed on the proportion of total variance that can be attributed to between-study variability. Bayes factors are used for hypothesis testing that allow testing point and one-sided hypotheses. The proposed methodology has several attractive properties. First, the proposed MAREMA model encompasses models with a zero, negative, and positive between-study variance, which enables testing a zero between-study variance as it is not a boundary problem. Second, the methodology is suitable for default Bayesian meta-analyses as it requires no prior information about the unknown parameters. Third, the methodology can even be used in the extreme case when only two studies are available, because Bayes factors are not based on large sample theory. We illustrate the developed methods by applying it to two meta-analyses and introduce easy-to-use software in the R package BFpack to compute the proposed Bayes factors.

scholarly journals Canons and Sparrows II*: The Enhanced Bernoulli Exact Method for Determining Statistical Significance and Effect Size in the Meta-Analysis of k 2 x 2 Tables

2021 ◽  
Author(s):  
Lawrence Marc Paul
Keyword(s):  
Effect Size ◽  
Type I Error ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Statistical Error ◽  
Type I ◽  
Exact Test ◽  
Strong Focus ◽  
Inverse Variance ◽  
Meta Analyses

Abstract BackgroundThe use of meta-analysis to aggregate the results of multiple studies has increased dramatically over the last 40 years. For homogeneous meta-analysis, the Mantel-Haenszel technique has typically been utilized. In such meta-analyses, the effect size across the contributing studies of the meta-analysis differ only by statistical error. If homogeneity cannot be assumed or established, the most popular technique developed to date is the inverse-variance DerSimonian & Laird (DL) technique [1]. However, both of these techniques are based on large sample, asymptotic assumptions. At best, they are approximations especially when the number of cases observed in any cell of the corresponding contingency tables is small.ResultsThis research develops an exact, non-parametric test for evaluating statistical significance and a related method for estimating effect size in the meta-analysis of k 2 x 2 tables for any level of heterogeneity as an alternative to the asymptotic techniques. Monte Carlo simulations show that even for large values of heterogeneity, the Enhanced Bernoulli Technique (EBT) is far superior at maintaining the pre-specified level of Type I Error than the DL technique. A fully tested implementation in the R statistical language is freely available from the author. In addition, a second related exact test for estimating the Effect Size was developed and is also freely available.ConclusionsThis research has developed two exact tests for the meta-analysis of dichotomous, categorical data. The EBT technique was strongly superior to the DL technique in maintaining a pre-specified level of Type I Error even at extremely high levels of heterogeneity. As shown, the DL technique demonstrated many large violations of this level. Given the various biases towards finding statistical significance prevalent in epidemiology today, a strong focus on maintaining a pre-specified level of Type I Error would seem critical.

scholarly journals Dissertation R.C.M. van Aert

2018 ◽  
Author(s):  
Robbie Cornelis Maria van Aert
Keyword(s):  
Publication Bias ◽  
Effect Size ◽  
Meta Analysis ◽  
Original Study ◽  
The Other ◽  
Effect Sizes ◽  
True Effect Size ◽  
True Effect ◽  
Meta Analyses ◽  
Q Statistic

More and more scientific research gets published nowadays, asking for statistical methods that enable researchers to get an overview of the literature in a particular research field. For that purpose, meta-analysis methods were developed that can be used for statistically combining the effect sizes from independent primary studies on the same topic. My dissertation focuses on two issues that are crucial when conducting a meta-analysis: publication bias and heterogeneity in primary studies’ true effect sizes. Accurate estimation of both the meta-analytic effect size as well as the between-study variance in true effect size is crucial since the results of meta-analyses are often used for policy making. Publication bias distorts the results of a meta-analysis since it refers to situations where publication of a primary study depends on its results. We developed new meta-analysis methods, p-uniform and p-uniform*, which estimate effect sizes corrected for publication bias and also test for publication bias. Although the methods perform well in many conditions, these and the other existing methods are shown not to perform well when researchers use questionable research practices. Additionally, when publication bias is absent or limited, traditional methods that do not correct for publication bias outperform p¬-uniform and p-uniform*. Surprisingly, we found no strong evidence for the presence of publication bias in our pre-registered study on the presence of publication bias in a large-scale data set consisting of 83 meta-analyses and 499 systematic reviews published in the fields of psychology and medicine. We also developed two methods for meta-analyzing a statistically significant published original study and a replication of that study, which reflects a situation often encountered by researchers. One method is a frequentist whereas the other method is a Bayesian statistical method. Both methods are shown to perform better than traditional meta-analytic methods that do not take the statistical significance of the original study into account. Analytical studies of both methods also show that sometimes the original study is better discarded for optimal estimation of the true effect size. Finally, we developed a program for determining the required sample size in a replication analogous to power analysis in null hypothesis testing. Computing the required sample size with the method revealed that large sample sizes (approximately 650 participants) are required to be able to distinguish a zero from a small true effect.Finally, in the last two chapters we derived a new multi-step estimator for the between-study variance in primary studies’ true effect sizes, and examined the statistical properties of two methods (Q-profile and generalized Q-statistic method) to compute the confidence interval of the between-study variance in true effect size. We proved that the multi-step estimator converges to the Paule-Mandel estimator which is nowadays one of the recommended methods to estimate the between-study variance in true effect sizes. Two Monte-Carlo simulation studies showed that the coverage probabilities of Q-profile and generalized Q-statistic method can be substantially below the nominal coverage rate if the assumptions underlying the random-effects meta-analysis model were violated.

scholarly journals Coordinate Based Random Effect Size meta-analysis of neuroimaging studies

2016 ◽  
Author(s):  
CR Tench ◽  
Radu Tanasescu ◽  
WJ Cottam ◽  
CS Constantinescu ◽  
DP Auer
Keyword(s):  
Effect Size ◽  
Error Control ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Random Effect ◽  
Simulated Data ◽  
Real Data ◽  
Type 1 Error ◽  
Meta Analyses

1AbstractLow power in neuroimaging studies can make them difficult to interpret, and Coordinate based meta‐ analysis (CBMA) may go some way to mitigating this issue. CBMA has been used in many analyses to detect where published functional MRI or voxel-based morphometry studies testing similar hypotheses report significant summary results (coordinates) consistently. Only the reported coordinates and possibly t statistics are analysed, and statistical significance of clusters is determined by coordinate density.Here a method of performing coordinate based random effect size meta-analysis and meta-regression is introduced. The algorithm (ClusterZ) analyses both coordinates and reported t statistic or Z score, standardised by the number of subjects. Statistical significance is determined not by coordinate density, but by a random effects meta-analyses of reported effects performed cluster-wise using standard statistical methods and taking account of censoring inherent in the published summary results. Type 1 error control is achieved using the false cluster discovery rate (FCDR), which is based on the false discovery rate. This controls both the family wise error rate under the null hypothesis that coordinates are randomly drawn from a standard stereotaxic space, and the proportion of significant clusters that are expected under the null. Such control is vital to avoid propagating and even amplifying the very issues motivating the meta-analysis in the first place. ClusterZ is demonstrated on both numerically simulated data and on real data from reports of grey matter loss in multiple sclerosis (MS) and syndromes suggestive of MS, and of painful stimulus in healthy controls. The software implementation is available to download and use freely.

How to Detect Publication Bias in Psychological Research

2019 ◽  
Vol 227 (4) ◽  
pp. 261-279 ◽  
Author(s):  
Frank Renkewitz ◽  
Melanie Keiner
Keyword(s):  
Publication Bias ◽  
Effect Size ◽  
Statistical Power ◽  
Type I Error ◽  
Psychological Research ◽  
Type I ◽  
True Effect Size ◽  
Questionable Research Practices ◽  
True Effect ◽  
Meta Analyses

Abstract. Publication biases and questionable research practices are assumed to be two of the main causes of low replication rates. Both of these problems lead to severely inflated effect size estimates in meta-analyses. Methodologists have proposed a number of statistical tools to detect such bias in meta-analytic results. We present an evaluation of the performance of six of these tools. To assess the Type I error rate and the statistical power of these methods, we simulated a large variety of literatures that differed with regard to true effect size, heterogeneity, number of available primary studies, and sample sizes of these primary studies; furthermore, simulated studies were subjected to different degrees of publication bias. Our results show that across all simulated conditions, no method consistently outperformed the others. Additionally, all methods performed poorly when true effect sizes were heterogeneous or primary studies had a small chance of being published, irrespective of their results. This suggests that in many actual meta-analyses in psychology, bias will remain undiscovered no matter which detection method is used.

scholarly journals Predictability of rotational tooth movement with orthodontic aligners comparing software-based and achieved data: A systematic review and meta-analysis of observational studies

2021 ◽  
pp. 146531252110272
Author(s):  
Despina Koletsi ◽  
Anna Iliadi ◽  
Theodore Eliades
Keyword(s):  
Effect Size ◽  
Tooth Movement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Patient Treatment ◽  
Qualitative Synthesis ◽  
Meta Analyses ◽  
Enamel Reduction

Objective: To evaluate all available evidence on the prediction of rotational tooth movements with aligners. Data sources: Seven databases of published and unpublished literature were searched up to 4 August 2020 for eligible studies. Data selection: Studies were deemed eligible if they included evaluation of rotational tooth movement with any type of aligner, through the comparison of software-based and actually achieved data after patient treatment. Data extraction and data synthesis: Data extraction was done independently and in duplicate and risk of bias assessment was performed with the use of the QUADAS-2 tool. Random effects meta-analyses with effect sizes and their 95% confidence intervals (CIs) were performed and the quality of the evidence was assessed through GRADE. Results: Seven articles were included in the qualitative synthesis, of which three contributed to meta-analyses. Overall results revealed a non-accurate prediction of the outcome for the software-based data, irrespective of the use of attachments or interproximal enamel reduction (IPR). Maxillary canines demonstrated the lowest percentage accuracy for rotational tooth movement (three studies: effect size = 47.9%; 95% CI = 27.2–69.5; P < 0.001), although high levels of heterogeneity were identified (I2: 86.9%; P < 0.001). Contrary, mandibular incisors presented the highest percentage accuracy for predicted rotational movement (two studies: effect size = 70.7%; 95% CI = 58.9–82.5; P < 0.001; I2: 0.0%; P = 0.48). Risk of bias was unclear to low overall, while quality of the evidence ranged from low to moderate. Conclusion: Allowing for all identified caveats, prediction of rotational tooth movements with aligner treatment does not appear accurate, especially for canines. Careful selection of patients and malocclusions for aligner treatment decisions remain challenging.

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