VP04 The Influence Of Sponsorship On The Treatment Effects Of Trials

2019 ◽  
Vol 35 (S1) ◽  
pp. 76-76
Author(s):  
Chiara Arienti ◽  
Negrini Stefano ◽  
Bruno Da costa ◽  
Susan Armijo-Olivo
Keyword(s):  
Effect Size ◽  
Treatment Effects ◽  
Conflicts Of Interest ◽  
Data Extraction ◽  
Research Process ◽  
Decision Makers ◽  
Sensitivity Analyses ◽  
Significant Difference ◽  
Public Money ◽  
Meta Analyses

IntroductionLimited public money is available for funding research and the majority of clinical research undertaken is funded by industry. Mechanisms to regulate conflicts of interest within the research process have been implemented. However, these policies by themselves do not protect against potential sponsorship bias that would affect research results to inform decision makers when using the results of these trials. Therefore, the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of RCTs.MethodsThis was a meta-epidemiological study. A random sample of RCTs included in meta-analyses of physical therapy (PT) area were identified. Data extraction including assessments of appropriate influence of funders was conducted independently by two reviewers. To determine the association between biases related to sponsorship biases and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach.ResultsWe analysed 393 trials included in forty-three meta-analyses. The most common sources of sponsorship for this sample of PT trials were government (n = 205, 52.16 percent) followed by academic (n = 44, 11.2 percent), and industry (n = 39, 10 percent). The funding was not declared in a high percentage of the trials (n = 85, 22 percent). The influence of the trial sponsor was assessed as being appropriate in 246 trials (63 percent) and considered inappropriate/unclear in 147 (37 percent) of them. There was a significant difference in effects estimates between trials with appropriate and inappropriate influence of funders (ES= 0.15; 95% CI -0.03, 0.33;). Trials with inappropriate/unclear influence of funders tended to have on average a larger effect size than those with appropriate influence of fundingConclusionsTreatment effect size estimates were 0.15 larger in trials with lack of appropriate influence of funders. Systematic reviewers should perform sensitivity analyses based on appropriateness of influence of sponsorship in included trials.

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.

scholarly journals Leishmanicidal effects of resveratrol and its derivatives: a systematic review and meta-Analysis

2020 ◽  
Author(s):  
Nasrin Amiri Dashatan ◽  
Marzieh Ashrafmansouri ◽  
Mehdi Koushki ◽  
Nayebali Ahmadi
Keyword(s):  
Systematic Review ◽  
Publication Bias ◽  
Data Extraction ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Protective Effects ◽  
Random Effects Models ◽  
Important Health ◽  
Mean Differences ◽  
Meta Analyses

Abstract Background Leishmaniasis is one of the most important health problems worldwide. The evidence has suggested that resveratrol and its derivatives have anti-leishmanial effects; however, the results are inconsistent and inconclusive. The aim of this study was to assess the effect of resveratrol and its derivatives on the Leishmania viability through a systematic review and meta-analysis of available relevant studies. Methods The electronic databases PubMed, ScienceDirect, Embase, Web of Science and Scopus were queried between October 2000 and April 2020 using a comprehensive search strategy. The eligible articles selected and data extraction conducted by two reviewers. Mean differences of IC50 (concentration leading to reduction of 50% of Leishmania) for each outcome was calculated using random-effects models. Sensitivity analyses and prespecified subgroup were conducted to evaluate potential heterogeneity and the stability of the pooled results. Publication bias was evaluated using the Egger’s and Begg’s tests. We also followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for this review. Results Ten studies were included in the meta-analysis. We observed that RSV and its derivatives had significant reducing effects on Leishmania viability in promastigote [24.02 µg/ml; (95% CI 17.1, 30.8); P < 0.05; I2 = 99.8%; P heterogeneity = 0.00] and amastigote [18.3 µg/ml; (95% CI 13.5, 23.2); P < 0.05; I2 = 99.6%; P heterogeneity = 0.00] stages of Leishmania. A significant publication bias was observed in the meta-analysis. Sensitivity analyses showed a similar effect size while reducing the heterogeneity. Subgroup analysis indicated that the pooled effects of leishmanicidal of resveratrol and its derivatives were affected by type of stilbenes and Leishmania species. Conclusions Our findings clearly suggest that the strategies for the treatment of leishmaniasis should be focused on natural products such as RSV and its derivatives. Further study is needed to identify the mechanisms mediating this protective effects of RSV and its derivatives in leishmaniasis.

scholarly journals Jingtong Granule: A Chinese Patent Medicine for Cervical Radiculopathy

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Liguo Zhu ◽  
Jinghua Gao ◽  
Jie Yu ◽  
Minshan Feng ◽  
Jinyu Li ◽  
...  
Keyword(s):  
Treatment Effects ◽  
Data Extraction ◽  
Meta Analysis ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Pain Scores ◽  
Study Selection ◽  
Significant Difference ◽  
Methodological Assessment ◽  
Neck Disability

Objective. This paper systematically assessed the efficacy and safety of Jingtong granule (JG) for cervical radiculopathy (CR).Methods. Randomized controlled trials comparing JG with no intervention, placebo, or conventional therapies were retrieved. The trials testing JG combined with conventional therapies versus conventional therapies were also enrolled. Study selection, methodological assessment, data extraction, and analysis were conducted in accordance with the Cochrane standards. The strength of evidence was evaluated according to GRADE approach.Results. Three trials with 400 participants were included. Methodological quality was evaluated as generally low. One study found that JG showed significant difference on decreasing pain scores compared with placebo. Meta-analysis indicated that JG plus conventional analgesic exhibited a significant immediate effect on the pain scores (WMD = 1.63; 95% CI: 1.29 to 1.98;P<0.00001). Additionally, JG combined with analgesic presented beneficial immediate effect on neck disability index. However, the treatment effects of JG demonstrated in the trials were not large, and the safety of JG was unproven. Finally the evidence level was evaluated to be low.Conclusions. Our results indicated that JG showed some potential benefits for CR. Nevertheless, treatment effects are uncertain due to both the methodological concerns and the very modest reported improvements.

scholarly journals metaCOVID: An R-Shiny application for living meta-analyses of COVID-19 trials

2021 ◽  
Author(s):  
Theodoros Evrenoglou ◽  
Isabelle Boutron ◽  
Anna Chaimani
Keyword(s):  
Evidence Synthesis ◽  
Source Code ◽  
Decision Makers ◽  
Sensitivity Analyses ◽  
Preventive Interventions ◽  
Primary Interest ◽  
Link Type ◽  
R Shiny ◽  
Meta Analyses ◽  
Shiny Application

Abstract“Living” evidence synthesis is of primary interest for decision-makers to overcome the COVID-19 pandemic. The COVID-NMA provides open-access living meta-analyses assessing different therapeutic and preventive interventions. Data are posted on a platform (https://covid-nma.com/) and analyses are updated every week. However, guideline developers and other stakeholders also need to investigate the data and perform their own analyses. This requires resources, time, statistical expertise, and software knowledge. To assist them, we created the “metaCOVID” application which, based on automation processes, facilitates the fast exploration of the data and the conduct of analyses tailored to end-users needs. metaCOVID has been created in R and is freely available as an R-Shiny application. The application conducts living meta-analyses for every outcome. Several options are available for subgroup and sensitivity analyses. The results are presented in downloadable forest plots. metaCOVID is freely available from https://covid-nma.com/metacovid/ and the source code from https://github.com/TEvrenoglou/metaCovid.

scholarly journals Usability of Mobile Health Apps for Postoperative Care: Systematic Review

10.2196/19099 ◽  
2020 ◽  
Vol 3 (2) ◽  
pp. e19099
Author(s):  
Ben Patel ◽  
Arron Thind
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Mobile Health ◽  
Conflicts Of Interest ◽  
Data Extraction ◽  
Measurement Tool ◽  
Validated Questionnaire ◽  
System Usability Scale ◽  
Meta Analyses ◽  
Mhealth Apps

Background Mobile health (mHealth) apps are increasingly used postoperatively to monitor, educate, and rehabilitate. The usability of mHealth apps is critical to their implementation. Objective This systematic review evaluates the (1) methodology of usability analyses, (2) domains of usability being assessed, and (3) results of usability analyses. Methods The A Measurement Tool to Assess Systematic Reviews checklist was consulted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was adhered to. Screening was undertaken by 2 independent reviewers. All included studies were assessed for risk of bias. Domains of usability were compared with the gold-standard mHealth App Usability Questionnaire (MAUQ). Results A total of 33 of 720 identified studies were included for data extraction. Of the 5 included randomized controlled trials (RCTs), usability was never the primary end point. Methodology of usability analyses included interview (10/33), self-created questionnaire (18/33), and validated questionnaire (9/33). Of the 3 domains of usability proposed in the MAUQ, satisfaction was assessed in 28 of the 33 studies, system information arrangement was assessed in 11 of the 33 studies, and usefulness was assessed in 18 of the 33 studies. Usability of mHealth apps was above industry average, with median System Usability Scale scores ranging from 76 to 95 out of 100. Conclusions Current analyses of mHealth app usability are substandard. RCTs are rare, and validated questionnaires are infrequently consulted. Of the 3 domains of usability, only satisfaction is regularly assessed. There is significant bias throughout the literature, particularly with regards to conflicts of interest. Future studies should adhere to the MAUQ to assess usability and improve the utility of mHealth apps.

scholarly journals Usability of Mobile Health Apps for Postoperative Care: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Ben Patel ◽  
Arron Thind
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Mobile Health ◽  
Conflicts Of Interest ◽  
Data Extraction ◽  
Measurement Tool ◽  
Validated Questionnaire ◽  
System Usability Scale ◽  
Meta Analyses ◽  
Mhealth Apps

BACKGROUND Mobile health (mHealth) apps are increasingly used postoperatively to monitor, educate, and rehabilitate. The usability of mHealth apps is critical to their implementation. OBJECTIVE This systematic review evaluates the (1) methodology of usability analyses, (2) domains of usability being assessed, and (3) results of usability analyses. METHODS The A Measurement Tool to Assess Systematic Reviews checklist was consulted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was adhered to. Screening was undertaken by 2 independent reviewers. All included studies were assessed for risk of bias. Domains of usability were compared with the gold-standard mHealth App Usability Questionnaire (MAUQ). RESULTS A total of 33 of 720 identified studies were included for data extraction. Of the 5 included randomized controlled trials (RCTs), usability was never the primary end point. Methodology of usability analyses included interview (10/33), self-created questionnaire (18/33), and validated questionnaire (9/33). Of the 3 domains of usability proposed in the MAUQ, satisfaction was assessed in 28 of the 33 studies, system information arrangement was assessed in 11 of the 33 studies, and usefulness was assessed in 18 of the 33 studies. Usability of mHealth apps was above industry average, with median System Usability Scale scores ranging from 76 to 95 out of 100. CONCLUSIONS Current analyses of mHealth app usability are substandard. RCTs are rare, and validated questionnaires are infrequently consulted. Of the 3 domains of usability, only satisfaction is regularly assessed. There is significant bias throughout the literature, particularly with regards to conflicts of interest. Future studies should adhere to the MAUQ to assess usability and improve the utility of mHealth apps.

Lack of Reproducibility in Addiction Medicine

2019 ◽  
Author(s):  
Mopileola Tomi Adewumi ◽  
Nam Vo ◽  
Daniel Tritz ◽  
Jason Beaman ◽  
Matt Vassar
Keyword(s):  
Conflicts Of Interest ◽  
Data Extraction ◽  
Research Integrity ◽  
Data Availability ◽  
Addiction Medicine ◽  
Cross Sectional ◽  
Funding Sources ◽  
Current State ◽  
Meta Analyses ◽  
Substance Related Disorders

Background and aims: Credible research emphasizes transparency, openness, and reproducibility. These characteristics are fundamental to promoting and maintaining research integrity. This aim of this study was to evaluate the current state of transparency and reproducibility in the field of addiction science. Design: Cross-sectional designMeasurements: This study used the National Library of Medicine catalog to search for all journals using the subject terms tag: Substance-Related Disorders [ST]. Journals were then searched via PubMed in the timeframe of January 1, 2014 to December 31, 2018 and 300 publications were randomly selected. A pilot-tested Google form containing reproducibility/transparency characteristics was used for data extraction by two investigators who performed this process in a duplicate and blinded fashion. Findings: Slightly more than half of the publications were open access (152/293, 50.7%). Few publications had pre-registration (7/244, 2.87%), material availability (2/237, 1.23%), protocol availability (3/244 ,0.80%), data availability (28/244, 11.48%), and analysis script availability (2/244, 0.82%). Most publications provided a conflict of interest statement (221/293, 75.42%) and funding sources (268/293, 91.47%). One replication study was reported (1/244, 0.04%). Few publications were cited (64/238, 26.89%) and 0 were excluded from meta-analyses and/or systematic reviews.Conclusion: Our study found that current practices that promote transparency and reproducibility are lacking, and thus, there is much room for improvement. First, investigators should preregister studies prior to commencement. Researchers should also make the materials, data, analysis script publicly available. To foster reproducibility, individuals should remain transparent about funding sources for the project and financial conflicts of interest. Research stakeholders should work together toward improved solutions on these matters. With these protections in place, the field of addiction medicine can lead in dissemination of information necessary to treat patients.

OP52 Use Of Intention To Treat And Magnitude Of Treatment Effects

2019 ◽  
Vol 35 (S1) ◽  
pp. 12-13
Author(s):  
Susan Armijo-Olivo ◽  
Bruno Da costa ◽  
Chiara Arienti ◽  
Negrini Stefano
Keyword(s):  
Missing Data ◽  
Treatment Effects ◽  
Data Extraction ◽  
Outcome Data ◽  
Risk Of Bias ◽  
Intention To Treat ◽  
Perform Sensitivity Analysis ◽  
Meta Analyses ◽  
Drop Outs

IntroductionIntention to treat (ITT) is a gold standard strategy to analyze the results of randomized controlled trials (RCTs). ITT analysis has been considered a methodological indicator of the quality of clinical trials. The extent to which the use of ITT is related to the treatment effects observed in RCTs has not been rigorously explored. Therefore, the main objective of this study was to determine the association between biases related to attrition and missing data and the use of intention to treat principle, and changes in effect size estimates in RCTs.MethodsThis was a meta-epidemiological study. A random sample of RCTs included in meta-analyses was identified. Data extraction including assessments of the use of intention to treat principle, missing data and drop-outs was conducted independently by two reviewers. To determine the association between biases related to attrition, missing data, and the use of intention to treat and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach.ResultsThree-hundred and ninety-three trials included in 43 meta-analyses, analyzing 44,622 patients contributed to this study. From these, 134 trials (34.1%) used ITT and 218 (55.5%) did not use ITT. Trials which did not use the ITT principle, or which were assessed as having an inappropriate control of incomplete outcome data (based on the Cochrane risk of bias tool) tended to underestimate the treatment effect when compared with trials with adequate use of ITT (ES= -0.13; 95%CI -0.26, -0.01) or trials which were assessed as having an appropriate control of incomplete outcome (ES= -0.18; 95%CI -0.29, -0.08).ConclusionsOur results suggest that when evaluating risk of bias of primary RCTs, systematic reviewers should pay attention to these biases since they could underestimate treatment effects. Systematic reviewers should perform sensitivity analysis including trials with low risk of bias in these domains.

Parent and Friend Social Support and Adolescent Hope

2016 ◽  
Vol 26 (2) ◽  
pp. 224-240 ◽  
Author(s):  
Noreen E. Mahon ◽  
Adela Yarcheski
Keyword(s):  
Social Support ◽  
Health Status ◽  
Effect Size ◽  
School Nurses ◽  
Quality Score ◽  
Inclusion Criteria ◽  
Significant Difference ◽  
The Mean ◽  
Meta Analyses ◽  
Doctoral Dissertations

The purpose of this study was to conduct two meta-analyses. The first examined social support from parents in relation to adolescent hope, and the second examined social support from friends in relation to adolescent hope. Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for the literature reviewed, nine published studies or doctoral dissertations completed between 1990 and 2014 met the inclusion criteria. Using meta-analytic techniques and the mean weighted r statistic, the results indicated that social support from friends had a stronger mean effect size (ES = .31) than social support from parents (ES = .21); there was a statistically significant difference between the two ESs. Two of the four moderators for the parent social support–adolescent hope relationship were statistically significant. They were quality score and health status. Implications for school nurses and nurses in all settings are addressed, and conclusions are drawn based on the findings.

scholarly journals Internet- and Mobile-Based Interventions for Mental and Somatic Conditions in Children and Adolescents

2020 ◽  
Vol 48 (1) ◽  
pp. 33-46 ◽  
Author(s):  
Matthias Domhardt ◽  
Lena Steubl ◽  
Harald Baumeister
Keyword(s):  
Mental Disorders ◽  
Children And Adolescents ◽  
Effect Size ◽  
Treatment Effects ◽  
Meta Analysis ◽  
Mental Healthcare ◽  
Quality Ratings ◽  
Meta Review ◽  
Mean Differences ◽  
Meta Analyses

Abstract. This meta-review integrates the current meta-analysis literature on the efficacy of internet- and mobile-based interventions (IMIs) for mental disorders and somatic diseases in children and adolescents. Further, it summarizes the moderators of treatment effects in this age group. Using a systematic literature search of PsycINFO and MEDLINE/PubMed, we identified eight meta-analyses (N = 8,417) that met all inclusion criteria. Current meta-analytical evidence of IMIs exists for depression (range of standardized mean differences, SMDs = .16 to .76; 95 % CI: –.12 to 1.12; k = 3 meta-analyses), anxiety (SMDs = .30 to 1.4; 95 % CI: –.53 to 2.44; k = 5) and chronic pain (SMD = .41; 95 % CI: .07 to .74; k = 1) with predominantly nonactive control conditions (waiting-list; placebo). The effect size for IMIs across mental disorders reported in one meta-analysis is SMD = 1.27 (95 % CI: .96 to 1.59; k = 1), the effect size of IMIs for different somatic conditions is SMD = .49 (95 % CI: .33 to .64; k = 1). Moderators of treatment effects are age (k = 3), symptom severity (k = 1), and source of outcome assessment (k = 1). Quality ratings with the AMSTAR-2-checklist indicate acceptable methodological rigor of meta-analyses included. Taken together, this meta-review suggests that IMIs are efficacious in some health conditions in youths, with evidence existing primarily for depression and anxiety so far. The findings point to the potential of IMIs to augment evidence based mental healthcare for children and adolescents.

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