Potential effects of lowering the threshold of statistical significance in the field of chronic rhinosinusitis – A meta-research on published randomized controlled trials over last decade

Purpose. To use the meta-analytic approach to examine the effects of diet (D), aerobic exercise (E), or both (DE) on non-high-density lipoprotein cholesterol (non-HDL-C) in adults. Methods. Randomized controlled trials in adults ≥18 years of age were included. A mixed-effect model was used to combine effect size (ES) results within each subgroup and to compare subgroups (Qb). Heterogeneity was examined using the Q and I2 statistics, and 95% confidence intervals (CI) were also calculated. Statistical significance was set at P≤0.05, while a trend for statistical significance was set between P>0.05, and ≤0.10. Results. A statistically significant exercise minus control group decrease in non-HDL-C was found for DE (7 ESs, 389 participants, x¯=-11.1 mg/dL, 95% CI=−21.7 to −0.6, P=0.04, Q=2.4, P=0.88, I2=0%), a trend for the D group (7 ESs, 402 participants, x¯=−8.5 mg/dL, 95% CI=−18.6 to 1.6, P=0.10, Q=0.76, P=0.99, I2=0%), and no change for the E group (7 ESs, 387 participants, x¯=3.0 mg/dL, 95% CI=−7.1 to 13.1, P=0.56, Q=0.78, P=0.99, I2=0%). Overall, no statistically significant between-group differences were found (Qb=4.1, P=0.12). Conclusions. Diet combined with aerobic exercise may reduce non-HDL-C among adults in some settings.

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COVID-19 and Vitamin D (Co-VIVID Study): a systematic review and meta-analysis of randomized controlled trials

10.1101/2021.08.22.21262216 ◽

2021 ◽

Author(s):

Seshadri Reddy Varikasuvu ◽

Balachandar Thangappazham ◽

Hemanth Raj

Keyword(s):

Vitamin D ◽

Randomized Controlled Trials ◽

Literature Search ◽

Meta Analysis ◽

Statistical Significance ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Individual Outcomes ◽

Vitamin D Levels

Background: Vitamin D levels have been reported to be associated with COVID-19 susceptibility, severity and mortality events.. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the use of vitamin D intervention on COVID-19 outcomes. Methods: Literature search was conducted using PubMed, Cochrane library, and ClinicalTrials.gov databases (latest search on August 5, 2021). We included RCTs reporting the use of vitamin D intervention to control/placebo group in COVID-19. Two independent researchers did literature search, abstracted data, and the risk of bias assessment. Results: A total of 6 RCTs with 551 COVID-19 patients were included. The overall collective evidence pooling all the outcomes across all RCTs indicated the beneficial use of vitamin D intervention in COVID-19 (relative risk, RR = 0.60, 95% CI 0.40 to 0.92, Z=2.33, p=0.02, I2 = 48%). However, no statistical significance was observed for individual outcomes of ICU care (RR = 0.11, 95% CI 0.15 to 1.30, Z=1.48, p=0.14, I2 = 66%) and mortality (RR = 0.78, 95% CI 0.25 to 2.40, Z=0.66, p=0.02, I2 = 33%), though decreased rates were noted. The rates of RT-CR positivity was significantly decreased in the intervention group as compared to the non-vitamin D groups (RR = 0.46, 95% CI 0.24 to 0.89, Z=2.31, p=0.02, I2 = 0%). Conclusion: COVID-19 patients supplemented with vitamin D are more likely to demonstrate fewer rates of ICU admission, mortality events and RT-PCR positivity. However, no statistical significance has been achieved for individual outcomes of ICU and deaths. More RCTs and completion of ongoing trials largely needed to precisely establish the association between vitamin D use and COVID-19.

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Effects of a proposal to alter the statistical significance threshold on previously published orthopaedic trauma randomized controlled trials

Injury ◽

10.1016/j.injury.2019.08.012 ◽

2019 ◽

Vol 50 (11) ◽

pp. 1934-1937 ◽

Cited By ~ 2

Author(s):

Austin L. Johnson ◽

Sheridan Evans ◽

Jake X. Checketts ◽

Jared T. Scott ◽

Cole Wayant ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Statistical Significance ◽

Controlled Trials ◽

Orthopaedic Trauma ◽

Randomized Controlled ◽

Significance Threshold

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Short Dental Implants (≤7mm) Versus Longer Implants in Augmented Bone Area: A Meta-Analysis of Randomized Controlled Trials

The Open Dentistry Journal ◽

10.2174/1874210601812010354 ◽

2018 ◽

Vol 12 (1) ◽

pp. 354-365 ◽

Cited By ~ 7

Author(s):

Priscila N. Uehara ◽

Victor Haruo Matsubara ◽

Fernando Igai ◽

Newton Sesma ◽

Marcio K. Mukai ◽

...

Keyword(s):

Survival Rate ◽

Bone Loss ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Statistical Significance ◽

Controlled Trials ◽

Bone Area ◽

Marginal Bone Loss ◽

Randomized Controlled ◽

Short Implants

Aim: The aim of this systematic review was to compare the survival rate and the marginal bone loss between short implants (≤7 mm) placed in the atrophic area and longer implants placed in the augmented bone area of posterior regions of maxillaries. Methods: Electronic search using three databases was performed up to May 2017 to identify Randomized Controlled Trials (RCT) assessing short implants survival with a minimal follow-up of 12 months post-loading. For the meta-analysis, a Risk Difference (RD) with the 95% Confidence Interval (CI) was used to pool the results of implant failure rate for each treatment group. For the marginal bone changes, Mean Differences (MD) with 95% CI were calculated. Results: Seven randomized controlled trials met the inclusion criteria, being included in qualitative and quantitative analyses. The RD between the short implant group and the control group was -0.02 (95% CI: -0.04 to 0.00), I2=0 and Chi2=3.14, indicating a favorable survival rate for short implant, but with no statistical significance (p=0.09). Discussion: For marginal bone loss, the mean difference was -0,13 (95%CI: -0.22 to -0.05), favoring the test group with statistical significance (p=0.002). The studies showed more heterogeneity for bone loss compared to survival rate. Short and longer implants showed similar survival rates after one year of loading, however the marginal bone loss around short implants was lower than in longer implants sites. Conclusion: Placement of implants ≤7 mm of length was found to be a predictable alternative for the rehabilitation of atrophic posterior regions, avoiding all the disadvantages intrinsic to bone augmentation procedures.

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Pridopidine for the Improvement of Motor Function in Patients With Huntington's Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Frontiers in Neurology ◽

10.3389/fneur.2021.658123 ◽

2021 ◽

Vol 12 ◽

Author(s):

Shujun Chen ◽

Tianyu Liang ◽

Tao Xue ◽

Shouru Xue ◽

Qun Xue

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Huntington's Disease ◽

Huntington’S Disease ◽

Meta Analysis ◽

Statistical Significance ◽

Controlled Trials ◽

Efficacy And Safety ◽

Motor Score ◽

Randomized Controlled

Background: Huntington's disease (HD) is a progressive neurodegenerative disorder. Generally, it is characterized by deficits in cognition, behavior, and movement. Recent studies have shown that pridopidine is a potential and effective drug candidate for the treatment of HD. In the present study, we performed a meta-analysis to evaluate the efficacy and safety of pridopidine in HD.Methods: The MEDLINE, EMBASE, CENTRAL, and Clinicaltrials.gov databases were searched for randomized controlled trials (RCTs) which had that evaluated pridopidine therapy in HD patients.Results: We pooled data from 1,119 patients across four RCTs. Patients in the pridopidine group had a significantly lower Unified Huntington's Disease Rating Scale (UHDRS)-modified Motor Score (mMS) (MD −0.79, 95% CI = −1.46 to −0.11, p = 0.02) than those in the placebo group. Additionally, no differences were observed in the UHDRS-Total Motor Score (TMS) (MD −0.91. 95% CI = −2.03 to 0.21, p = 0.11) or adverse events (RR 1.06, 95% CI = 0.96 to 1.16, p = 0.24) in the pridopidine and placebo groups. In the subgroup analysis, the short-term (≤12 weeks) and long-term (>12 weeks) subgroups exhibited similar efficacy and safety with no statistical significance in TMS, mMS, or adverse events. However, TMS (MD −1.50, 95% CI = −2.87 to −0.12, p = 0.03) and mMS (MD −1.03, 95% CI = −1.87 to −0.19, p = 0.02) were observed to be improved significantly when the dosage of pridopidine ≥90 mg/day. Additionally, pridopidine (≥90 mg/day) increased total adverse events (RR 1.11, 95% CI = 1.00 to 1.22, p = 0.04) compared with placebo. On this basis, we analyzed the incidence of various adverse events when the dosage was ≥90 mg/day. Nonetheless, these results were within the acceptable threshold, although patients developed symptoms, such as nasopharyngitis and insomnia.Conclusion: Pridopidine improved mMS and had no statistical significance in association with TMS or adverse events. Pridopidine (≥90 mg/day) improved TMS and mMS but increased adverse events, such as nasopharyngitis and insomnia. More RCTs were expected to assess pridopidine in HD.

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What Keeps Older People out of Nursing Homes? A Meta-Analysis

Innovation in Aging ◽

10.1093/geroni/igab046.1958 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. 510-510

Author(s):

Joseph Gaugler ◽

Rachel Zmora ◽

Colleen Peterson ◽

Lauren Mitchell ◽

Robyn Birkeland ◽

...

Keyword(s):

Nursing Home ◽

Older People ◽

Randomized Controlled Trials ◽

Older Persons ◽

Meta Analysis ◽

Statistical Significance ◽

Nursing Home Admission ◽

Controlled Trials ◽

Fee For Service ◽

Randomized Controlled

Abstract Perhaps one of the most examined, and costly, health transitions older people experience is nursing home admission. In addition to the financial costs nursing home admission poses to older people, their families, and other payers (e.g., the public), institutionalization is linked with a range of negative outcomes and represents a loss of independence and quality of life to many older persons. The current meta-analysis attempted to synthesize all available randomized controlled trials available to ascertain which intervention approaches appeared to prevent nursing home entry for older adults. The MEDLINE, PsycInfo, CINAHL, Cochrane, and EMBASE databases were searched to August, 2020. Abstracts were screened (N = 28,120) to identify randomized controlled trials of interventions to prevent or delay nursing home admission as well as systematic reviews. Identified studies were cross-referenced until the point of saturation, resulting in 1,786 studies for additional inclusion/exclusion screening. Following a consensus-based review among the authors that included risk of bias, 323 randomized controlled trials were included in the meta analysis. Although several intervention modalities appeared protective against nursing home admission and approached statistical significance, preliminary results suggest that comprehensive geriatrics assessment (pooled OR = .69, 95% CI: .50, .95) and specialized, inpatient geriatrics care (pooled OR: .77, 95% CI: .59, .99) were most consistent in helping to prevent institutionalization among older persons. The findings emphasize the importance of geriatrics when delivering optimal care to older persons. Integrating such approaches more effectively into a largely fee-for-service healthcare paradigm remain a critical challenge.

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Comparison of the participation rate between CT colonography and colonoscopy in screening population: a systematic review and meta-analysis of randomized controlled trials

British Journal of Radiology ◽

10.1259/bjr.20190240 ◽

2020 ◽

Vol 93 (1105) ◽

pp. 20190240 ◽

Cited By ~ 1

Author(s):

He Zhu ◽

Fudong Li ◽

Ke Tao ◽

Jing Wang ◽

Carissa Scurlock ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Ct Colonography ◽

Meta Analysis ◽

Statistical Significance ◽

Participation Rate ◽

Statistical Evidence ◽

Controlled Trials ◽

Randomized Controlled ◽

Screening Population ◽

The Difference

Objective: To compare the participation rate between CT colonography (CTC) and colonoscopy in screening population in randomized controlled trials (RCTs). Methods: A search was performed using the PubMed, Web of Science, and Cochrane databases. RCTs that included screening populations and reported participation number were assessed. Cochrane risk of bias tool was used to assess the bias and quality. Risk ratio (RR) was used to present the results. The non-participation rate was analyzed to verify the results of participation rate. Results: Five of 760 studies, with a total of 15,974 invitees, were included. The participation rate was higher at CTC (28.8%) than colonoscopy (20.8%), although the difference did not reach statistical significance (RR = 1.26; p = 0.070; I2 = 90.3%). The non-participation rate at CTC was significantly lower than colonoscopy (RR = 0.92; p = 0.012; I2 = 86.7%). Subgroup analysis suggested both the participation and non-participation rate were with significant difference between reduced/no cathartic preparation CTC and colonoscopy. Cumulative meta-analysis showed both the participation rate and non-participation rate exhibited a trend over time and sample size. Conclusion: The participation rate was higher at CTC than colonoscopy, although the difference did not reach statistical significance. But the non-participation rate was with statistical difference. Screening population seemed more likely to participate the reduced/no cathartic preparation CTC. Statistical evidence was provided for more large RCTs are needed in the future. Advances in knowledge: The screening populations seem more likely to participate in the CTC, especially the reduced/no cathartic preparation CTC. The statistical evidence was provided for more large RCTs are needed in the future.

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Antithrombotic Therapy Recommendations in the European Society of Cardiology Guidelines: How Robust Are the Randomized Controlled Trials Underpinning Them?

TH Open ◽

10.1055/s-0041-1725043 ◽

2021 ◽

Vol 05 (02) ◽

pp. e125-e133

Author(s):

Catarina M. dos Santos ◽

Luísa Prada ◽

Cláudio David ◽

João Costa ◽

Joaquim J. Ferreira ◽

...

Keyword(s):

Randomized Controlled Trials ◽

European Society ◽

Antithrombotic Therapy ◽

Statistical Significance ◽

Controlled Trials ◽

Coronary Syndrome ◽

Randomized Controlled ◽

Number Of Patients ◽

Esc Guidelines ◽

European Society Of Cardiology

Abstract Introduction Criticisms have been raised against the sole use of p-value in interpreting results from randomized controlled trials (RCTs). Additional tools have been suggested, like the fragility index (FI), a measure of a trial's robustness/fragility, and derivative measures. The FI is the minimum number of patients who would have to be converted from nonevents to events, in the group with the least events, for a result to lose statistical significance. Objective This study aimed to evaluate RCT supporting European Society of Cardiology (ESC) guidelines regarding antithrombotics, using the FI and FI-related measures. Methods FI, fragility quotient (FQ), and FI minus LTF lost to follow-up (FI − LTF) were calculated for the RCT underpinning recommendations regarding antithrombotic therapy from the updated ESC guidelines. LTF was compared with FI. Results were calculated for the total group of studies, as per guideline and as per recommendation type. Results Overall, 61 studies were included. The median FI was 24.5 (interquartile range [IQR]: 9.0–60.0) and median FQ was 0.0035 (IQR: 0.0019–0.0056). Median FI − LTF was 2.0 (IQR: 0.0–38.0). Twenty (32.8%) of the studies had one primary or main safety outcome with LTF exceeding FI. Peripheral arterial disease guideline and chronic coronary syndrome guideline had the lowest (2.5; IQR: 1.8–3.3) and the highest (48.5; IQR: 23.8–73.0) FI, respectively. Conclusion The median FI suggests robustness of clinical trials evaluating antithrombotic drugs cited in the guidelines, but about one-third of them had LTF larger than FI. This emphasizes the need for assessing trials' robustness when constructing guidelines.

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Abstract 17852: Epinephrine Does Not Impact Survival and May Worsen Neurological Outcomes in Out-of-hospital Cardiac Arrest: Meta-analysis of Randomized Control Trials

Circulation ◽

10.1161/circ.132.suppl_3.17852 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Sayf Altabaqchali ◽

Shashi Kumar ◽

Emad Aziz ◽

Eyal Herzog ◽

Cody William ◽

...

Keyword(s):

Cardiac Arrest ◽

Randomized Controlled Trials ◽

Life Support ◽

Meta Analysis ◽

Statistical Significance ◽

Outcome Data ◽

Controlled Trials ◽

Neurological Outcomes ◽

Randomized Controlled ◽

Hospital Cardiac Arrest

Background: Advanced cardiac life support is a corner stone in the management of cardiac arrest and epinephrine is an important part of its armamentarium. Randomized controlled trials and observational studies have demonstrated inconsistent results regarding the benefits of epinephrine in out-of-hospital cardiac arrest. We conducted a meta-analysis to evaluate mortality and neurological outcomes. Methods: All randomized controlled trials regarding out of hospital cardiac resuscitation were sought using PubMed and Scopus databases from 1963 until June 2015. We calculated the chances of patients surviving to hospital admission and through discharge as well as having a good neurological outcome. Data was analyzed with RevMan 5.2 software. Results: Epinephrine was found to be associated with a higher rate of hospital arrival but not survival to discharge. Epinephrine also had numerically less favorable neurologic outcomes neurological but despite that this was seen in all trials this did not reach statistical significance (OR 0.71, CI95% 0.45-1.12, p 0.14). Conclusion: There is no data to support the use of epinephrine in out-of-hospital cardiac arrest patients. Increased unjustified financial and perhaps social costs seem to be present. Larger randomized controlled trials are needed.

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Assessing the Reporting and Scientific Quality of Meta-Analyses of Randomized Controlled Trials of Treatments for Anxiety Disorders

Annals of Pharmacotherapy ◽

10.1345/aph.1l204 ◽

2008 ◽

Vol 42 (10) ◽

pp. 1402-1409 ◽

Cited By ~ 7

Author(s):

Basil G Bereza ◽

Márcio Machado ◽

Thomas R Einarson

Keyword(s):

Anxiety Disorders ◽

Randomized Controlled Trials ◽

Statistical Significance ◽

Controlled Trials ◽

Scientific Quality ◽

Randomized Controlled ◽

Manual Search ◽

Item Checklist ◽

Meta Analyses

Background: Mela-analyses of randomized controlled trials (RCTs) constitute the highest level of evidence, but their usefulness depends on their quality. Objective: To assess tho reporting and scientific quality of meta-analyses of RCTs on treatments for anxiety disorders. Methods: Criteria for peer-reviewed, full-text retrieval included meta-analyses of RCTs of drugs versus active ingredient placebo, standard care, or psychotherapy. Sample populations were required to meet Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases and Related Health Problems diagnostic criteria for anxiety disorders. Two reviewers independently searched EMBASE, EBM Reviews. Ovid MEDLINE, Ovid HealthSTAR, and International Pharmaceutical Abstracts from inception to August 2007. Search terms Included meta-analysis, randomized controlled trials, anxiety, anxiolytic, anti-depressant/antidepressant, and pharmacotherapy, without language restrictions. References and reviews were searched manually. Quality was assessed independently by 2 raters, using the Quality of Reporting of Meta-anatyses (QUOROM) and the Overview Quality Assessment Questionnaire (OQAQ). The QUOROM was used to assess the reporting quality of the study, using an 18-item checklist, and the scientific quality was assessed with the OQAQ's 10-item checklist, Kendall's - measured Interrater reliability with statistical significance at p less than or equal to 0.01. Means and standard deviations described the overall quality. A time series analysis was performed. Results: A total of 136 titles and abstracts were reviewed; 48 were retrieved, including 6 from the manual search. Thirty-two were excluded (not pooled analyses, inappropriate condition/treatment, duplications), leaving 16 studies published between 1995 and 2007. Agreement was high: t = 0.801 (p < 0.01) for QUOROM and 0.834 (p < 0.01) for OQAQ. QUOROM quality scored 61% ± 19%. Overall, the results sections of the studies scored lowest, while the introduction and discussion sections scored highest. The overall scientific qualify was 58% ± 28%. Most studies appropriately linked results to priman/ objectives but did not report how bias was avoided or how study validity was assessed. Quality Increased nonsignificantly over time. Conclusions: Reporting/scientific quality was considered less than fair-to-good. Stakeholders should strive for higher scientific quality of meta-analyses.

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