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PloS One 2023Previously, we reviewed 1052 randomized-controlled trial abstracts presented at the American Society of Anesthesiologists annual meetings from 2001-2004. We found...
The relationship between study findings and publication outcome in anesthesia research following implementation of mandatory trial registration: A systematic review of publication bias.
Previously, we reviewed 1052 randomized-controlled trial abstracts presented at the American Society of Anesthesiologists annual meetings from 2001-2004. We found significant positive publication bias in the period examined, with the odds ratio for abstracts with positive results proceeding to journal publication over those with null results being 2.01 [95% confidence interval: 1.52, 2.66; P < 0.001]. Mandatory trial registration was introduced in 2005 as a required standard for publication. We sought to examine whether mandatory trial registration has decreased publication bias in the anesthesia and perioperative medicine literature. We reviewed all abstracts from the 2010-2016 American Society of Anesthesiologists meetings that reported on randomized-controlled trials in humans. We scored the result of each abstract as positive or null according to a priori definitions. We systematically searched for any subsequent publication of the studies and calculated the odds ratio for journal publication, comparing positive vs null studies. We compared the odds ratio from the 2010-2016 abstracts (post-mandatory trial registration) with the odds ratio from the 2001-2004 abstracts (pre-mandatory trial registration) as a ratio of odds ratios. We defined a 33% decrease in the odds ratio as significant, corresponding to a new odds ratio of 1.33. We reviewed 9789 abstracts; 1049 met inclusion criteria as randomized-controlled trials, with 542 (51.7%) of the abstracts going on to publication. The odds ratio for abstracts with positive results proceeding to journal publication was 1.28 [95% CI: 0.97, 1.67; P = 0.076]. With adjustment for sample size and abstract quality, the difference in publication rate between positive and null abstracts was statistically significant (odds ratio 1.34; 95% CI: 1.02, 1.76; P = 0.037). The ratio of odds ratios, comparing the odds ratio from the 2010-2016 abstracts (post-mandatory trial registration) to the odds ratio from the 2001-2004 abstracts (pre-mandatory trial registration), was 0.63 (95% CI: 0.43, 0.93); P = 0.021). We present the first study in the anesthesia and perioperative medicine literature that examines and compares publication bias over two discrete periods of time, prior to and after the implementation of mandatory trial registration. Our results suggest that the amount of publication bias has decreased markedly following implementation of mandatory trial registration. However, some positive publication bias in the anesthesia and perioperative medicine literature remains.
Topics: Humans; Publication Bias; Anesthesiology; Anesthesia; Sample Size; Odds Ratio
PubMed: 37235595
DOI: 10.1371/journal.pone.0282839 -
Systematic Reviews Aug 2017Producing high-quality, relevant systematic reviews and keeping them up to date is challenging. Cochrane is a leading provider of systematic reviews in health. For... (Review)
Review
BACKGROUND
Producing high-quality, relevant systematic reviews and keeping them up to date is challenging. Cochrane is a leading provider of systematic reviews in health. For Cochrane to continue to contribute to improvements in heath, Cochrane Reviews must be rigorous, reliable and up to date. We aimed to explore existing models of Cochrane Review production and emerging opportunities to improve the efficiency and sustainability of these processes.
METHODS
To inform discussions about how to best achieve this, we conducted 26 interviews and an online survey with 106 respondents.
RESULTS
Respondents highlighted the importance and challenge of creating reliable, timely systematic reviews. They described the challenges and opportunities presented by current production models, and they shared what they are doing to improve review production. They particularly highlighted significant challenges with increasing complexity of review methods; difficulty keeping authors on board and on track; and the length of time required to complete the process. Strong themes emerged about the roles of authors and Review Groups, the central actors in the review production process. The results suggest that improvements to Cochrane's systematic review production models could come from improving clarity of roles and expectations, ensuring continuity and consistency of input, enabling active management of the review process, centralising some review production steps; breaking reviews into smaller "chunks", and improving approaches to building capacity of and sharing information between authors and Review Groups. Respondents noted the important role new technologies have to play in enabling these improvements.
CONCLUSIONS
The findings of this study will inform the development of new Cochrane Review production models and may provide valuable data for other systematic review producers as they consider how best to produce rigorous, reliable, up-to-date reviews.
Topics: Databases, Bibliographic; Editorial Policies; Humans; Information Storage and Retrieval; Quality Control; Review Literature as Topic
PubMed: 28760162
DOI: 10.1186/s13643-017-0542-3 -
A systematic review and novel classification of listing tools to improve medication in older people.European Journal of Clinical... May 2019Suboptimal drugs therapy is a threat to older people, and listing tools providing guidance are developed to address this problem. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Suboptimal drugs therapy is a threat to older people, and listing tools providing guidance are developed to address this problem.
METHODS
A systematic review was performed to identify and analyze such tools published until February 2018. A novel categorization was developed to separate patient-in-focus listing approaches (PILA) providing disease-related positive and negative guidance from drug-oriented, mostly negative listing approaches (DOLA, DOLA+: with disease specification).
RESULTS
In total, 76 tools were identified; only 9 were classified as PILA, 26 as DOLA, and 38 as DOLA+. Three DOLA(+) only address dementia. Most tools were developed in Europe or the USA and address community-dwellers. Thirty-two utilized a Delphi process, and only 10 provide a scoring system. Twenty tools utilize a questionnaire but no structured guidance or answers. Importantly, only 12 interventional clinical trials were identified reporting not only medication quality measures, but also clinical endpoints (e.g. falls, adverse drug reactions, hospitalization). For PILA, 4 trials showed positive, one negative clinical effects of a controlled intervention, for DOLA(+) 1 was positive, 7 negative (Fisher's exact test p < 0.05).
DISCUSSION
An abundance of listing tools has been created. DOLAs that may be applied without intricate patient knowledge prevail over PILAs by sevenfold; unfortunately their clinical validation seems to be far less successful than that of patient-initiated approaches.
CONCLUSION
Drug therapy in older people has to be tailored to their individual, very divergent needs; tools requiring detailed medical knowledge about the patient as the starting point for medication optimization provide the best support.
Topics: Age Factors; Aged; Delivery of Health Care; Health Services for the Aged; Humans; Multimorbidity; Publications
PubMed: 30683971
DOI: 10.1007/s00228-019-02634-z -
PloS One 2020We examined the data reported in the studies for comparison of osteopontin (OPN) levels in tuberculosis and healthy participants, and to discuss whether OPN could be... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
We examined the data reported in the studies for comparison of osteopontin (OPN) levels in tuberculosis and healthy participants, and to discuss whether OPN could be extended to disease diagnosis, severity assessment and therapeutic effect monitering.
METHODS
A systematic literature search was conducted in PubMed, EMBASE, Scopus, the Cochrane Library, Web of Science, the China National Knowledge Infrastructure (CNKI) and WanFang databases. The pooled risk estimates were shown in standardized mean difference (SMD) with 95% confidence interval (CI) for OPN levels. The random effect model was used according to the test of heterogeneity among studies. Subgroup analyses and meta-regression models were performed to identify the possible sources of heterogeneity.
RESULTS
17 retrospective studies with 933 tuberculosis participants and 786 healthy controls were finally included in this article. In the primary meta-analysis, higher serum/plasma OPN levels were found in tuberculosis patients (SMD = 2.58, 95%CI = 2.09~3.08, P<0.001). Besides, pooled results from positive acid-fast bacilli (AFB) staining and imaging-severe tuberculosis group demonstrated higher OPN concentrations (SMD = 0.90, 95%CI = 0.58~1.21, P<0.001; SMD = 1.11, 95%CI = 0.90~1.33, P<0.001; respectively), and OPN levels decreased after two months of standard anti-tuberculosis therapy (SMD = 2.10, 95%CI = 1.36~2.85, P<0.001).
CONCLUSIONS
Elevated serum/plasma OPN levels may be associated with an increased risk of tuberculosis, while further well-designed studies are needed. Moreover, OPN could be considered as a potential biomarker for tuberculosis surveillance and severity assessment.
Topics: Adult; Female; Humans; Male; Middle Aged; Osteopontin; Publication Bias; Publications; Severity of Illness Index; Sputum; Tuberculosis
PubMed: 33264357
DOI: 10.1371/journal.pone.0242702 -
Osteoarthritis and Cartilage Sep 2018Discontinuation and nonpublication are causes for concern in highly funded research areas of prevalent medical conditions. The aim of our study is to evaluate the rate...
OBJECTIVE
Discontinuation and nonpublication are causes for concern in highly funded research areas of prevalent medical conditions. The aim of our study is to evaluate the rate of discontinuation and nonpublication in osteoarthritis randomized controlled clinical trials.
DESIGN
We used the ClinicalTrials.gov advanced search using the keyword "osteoarthritis" for phase 3 or phase 4 clinical trials in adults. Two investigators then independently screened the search results by registered title, condition, study design, and completion date. We then performed a systematic search to determine the publication status of the study.
RESULTS
Our final analysis included 273 studies. Our analysis of these studies included 243 (89%) completed and 30 (11%) discontinued trials. A total of 121,307 (92%) and 10,368 (8%) patients participated in completed and discontinued trials, respectively. Following our searches of PubMed, Embase, and Google Scholar, we identified 67 of the 243 (27.6%) studies as completed but having not reached publication in manuscript form.
CONCLUSIONS
If discontinuation and non-publication rates in osteoarthritis trials continue to be sub-optimal, already scarce research resources will continue to be wasted. One possible explanation for the witnessed nonpublication that warrants further investigation is the issue of publication bias or selective reporting bias, two known problems that decrease research productivity and ethics.
Topics: Female; Humans; Male; Osteoarthritis; Prevalence; Publication Bias; Publications; Randomized Controlled Trials as Topic; Research Design; Selection Bias; United States
PubMed: 29883614
DOI: 10.1016/j.joca.2018.05.019 -
BMC Oral Health Sep 2023The review aims to determine the risk predictability of mutans streptococci in the development of carious lesions in children with primary dentition. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The review aims to determine the risk predictability of mutans streptococci in the development of carious lesions in children with primary dentition.
METHODS
Longitudinal observational studies with at least 6 months follow-up and evaluating mutans streptococci presence in caries-free children under 6 years of age for the development of any cavitated or non-cavitated carious lesion. Six databases and grey literature were searched without any restrictions. Risk of bias was evaluated using the New Castle Ottawa scale for longitudinal studies, and the certainty of the evidence was evaluated by Grading of Recommendations Assessment, Development and Evaluation using GRADEpro software. Meta-analysis was performed using a random effect (DerSimonian and Laird, DL) model, and heterogeneity was evaluated using tau-squared, I statistics and prediction interval. Sensitivity analysis was performed to assess the relationship between the mutans streptococci presence at baseline and the caries development, according to the sample and methods used for the microbiological assessment and the length of follow-up of the studies. Publication bias was checked by funnel plot using a random effect (DerSimonian and Laird, DL) model.
RESULTS
Twelve studies met the inclusion criteria and were included in the review. Four studies received a maximum of 9 stars, and among the remaining eight studies, six received 8 stars and the rest two studies were assigned 7 stars in the risk of bias scale. After pooling the results quantitatively, odds ratio (OR) was found to be 4.13 (95% CI: 3.33, 5.12), suggesting that children with mutans streptococci had 4 times higher odds of developing caries later (p < 0.001). Four studies were pooled to compare future caries experience among children with and without mutans streptococci at baseline, obtaining standardized mean difference (SMD) of 0.85 (95% CI: 0.33, 1.37), indicating a large effect (p < 0.001). Certainty of evidence was found to be moderate, and no publication bias was reported by the funnel plot criteria of symmetry.
CONCLUSIONS
Presence of mutans streptococci in a preschool child is a risk predictor for future caries experience. Early identification of children with increased caries-risk may facilitate in implementation of appropriate preventive strategies.
Topics: Humans; Child, Preschool; Dental Caries; Databases, Factual; Odds Ratio; Publication Bias; Software; Streptococcus mutans
PubMed: 37679718
DOI: 10.1186/s12903-023-03346-8 -
BMJ Open Sep 2017This systematic review and meta-analysis provides a quantitative summary of the literature exploring the relationship between maternal diet quality during pregnancy and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This systematic review and meta-analysis provides a quantitative summary of the literature exploring the relationship between maternal diet quality during pregnancy and child cognitive and affective outcomes. We investigate whether there are indications for robust associations and aim to identify methodological strengths and challenges of the current research to provide suggestions of improvement for future research.
DESIGN AND PARTICIPANTS
Relevant studies were identified through a systematic literature search in relevant databases. All studies investigating maternal diet quality during pregnancy in relation to child cognitive or affective functioning in children of elementary school age or younger were assessed for inclusion.
RESULTS
18 relevant studies, comprising 63 861 participants were identified. The results indicated a small positive association between better maternal diet quality during pregnancy and child functioning. We observed publication bias and significant heterogeneity between studies, where type of diet classification, publication year and outcome domain together accounted for about 30% of this heterogeneity. Trim and fill analysis substantiated the presence of publication bias for studies in the affective domain and showed an adjusted effect size of Hedge's g=0.088 (p=0.0018) (unadjusted g=0.093 (p=0.03)). We observed no publication bias in the cognitive domain, where results indicated a slightly larger effect size (g=0.14 (p<0.0001)) compared with that of the affective domain. The overall summary effect size was g=0.075 (p<0.0001) adjusted for publication bias (unadjusted g=0.112 (p=0.0001)). Child diet was not systematically controlled for in the majority of the studies.
CONCLUSION
The results indicated that a better maternal diet quality during pregnancy has a small positive association with child neurodevelopment, with more reliable results seen for cognitive development. These results warrant further research on the association between maternal diet quality during pregnancy and cognitive and affective aspects of child neurodevelopment, whereby it is crucial that future studies account for child diet in the analysis.
Topics: Affect; Child; Child Development; Cognition; Diet; Female; Food Quality; Humans; Pregnancy; Pregnancy Outcome; Publication Bias
PubMed: 28947450
DOI: 10.1136/bmjopen-2017-016777 -
Plastic and Reconstructive Surgery Jan 2016Well-conducted systematic reviews have a critical role in informing evidence-based decision-making in plastic surgery. The authors' objective was to assess the... (Review)
Review
BACKGROUND
Well-conducted systematic reviews have a critical role in informing evidence-based decision-making in plastic surgery. The authors' objective was to assess the methodologic quality of systematic reviews in the plastic surgery literature.
METHODS
The authors systematically assessed all systematic reviews in 10 high-impact plastic surgery journals using MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from 2003 to 2013. These were evaluated for methodologic quality using A Measurement Tool to Assess Systematic Reviews (AMSTAR), a validated 11-point instrument.
RESULTS
After removal of duplicates and screening titles and abstracts, 190 systematic reviews met eligibility criteria. The majority of systematic reviews were published in Plastic and Reconstructive Surgery (n = 88). The most common domain covered was reconstruction (17.9 percent). Using AMSTAR, the median score was 4 (interquartile range, 2.25 to 6.00) on a scale of 1 to 11. No increase in AMSTAR score was observed with time (p = 0.18). Almost half of all systematic reviews (48.4 percent) included at least two independent data extractors, and less than one-third of them (15.3 percent) searched unpublished studies or provided a list of both included and excluded studies (14.8 percent). The methodologic quality of included primary studies was evaluated in 35.3 percent.
CONCLUSIONS
Systematic reviews in plastic surgery demonstrated inadequate adherence to methodologic standards of quality, which raises concerns about validity. There has been an increase in the number of systematic reviews published in plastic surgery over the past decade, yet there has been no significant improvement observed in methodologic quality.
Topics: Decision Making; Humans; Periodicals as Topic; Publishing; Plastic Surgery Procedures; Surgery, Plastic
PubMed: 26710056
DOI: 10.1097/PRS.0000000000001898 -
Journal of the Medical Library... Apr 2021The decisions and processes that may compose a systematic search strategy have not been formally identified and categorized. This study aimed to (1) identify all...
OBJECTIVE
The decisions and processes that may compose a systematic search strategy have not been formally identified and categorized. This study aimed to (1) identify all decisions that could be made and processes that could be used in a systematic search strategy and (2) create a hierarchical framework of those decisions and processes.
METHODS
The literature was searched for documents or guides on conducting a literature search for a systematic review or other evidence synthesis. The decisions or processes for locating studies were extracted from eligible documents and categorized into a structured hierarchical framework. Feedback from experts was sought to revise the framework. The framework was revised iteratively and tested using recently published literature on systematic searching.
RESULTS
Guidance documents were identified from expert organizations and a search of the literature and Internet. Data were extracted from 74 eligible documents to form the initial framework. The framework was revised based on feedback from 9 search experts and further review and testing by the authors. The hierarchical framework consists of 119 decisions or processes sorted into 17 categories and arranged under 5 topics. These topics are "Skill of the searcher," "Selecting information to identify," "Searching the literature electronically," "Other ways to identify studies," and "Updating the systematic review."
CONCLUSIONS
The work identifies and classifies the decisions and processes used in systematic searching. Future work can now focus on assessing and prioritizing research on the best methods for successfully identifying all eligible studies for a systematic review.
Topics: Internet; Publications
PubMed: 34285663
DOI: 10.5195/jmla.2021.1086 -
Health Technology Assessment... Oct 2008To identify the expected delay between publication of conference abstracts and full publication of results from trials of new anti-cancer agents for breast cancer and to... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To identify the expected delay between publication of conference abstracts and full publication of results from trials of new anti-cancer agents for breast cancer and to identify whether there are any apparent biases in publication and reporting.
DATA SOURCES
Major electronic databases were searched to identify randomised controlled trials (RCTs) of the selected interventions for the treatment of breast cancer.
REVIEW METHODS
A systematic review was conducted according to standard methods. Data were extracted from the included studies using a predesigned and piloted data extraction template.
RESULTS
Six anti-cancer treatments for breast cancer were included in the review: docetaxel, paclitaxel, trastuzumab, gemcitabine, lapatinib and bevacizumab. The literature searches generated 1556 references, from which 71 publications were retrieved and screened for inclusion. Screening identified 41 publications of 18 RCTs with at least one arm of treatment meeting the inclusion criteria for the review. Of the 18 included RCTs, only four publications (from three RCTs) reported the same outcomes in both an abstract and a full publication. Time between the abstract and full publication was 5 months in two cases, 7 months in one case and 19 months in one case (overall mean delay = 9 months). Eleven trials were identified that have not currently published in a full publication the data presented in an abstract or conference proceeding. The duration between publication of the abstracts and the end of August 2007 varied from 3 months to 38 months (mean delay 16.5 months). The longest delays in publication were for trials investigating gemcitabine (38 months) or bevacizumab (33 months). Observational analysis of the published and unpublished trials did not indicate any particular biases in terms of whether positive results were more likely to be fully published than non-significant ones.
CONCLUSIONS
It was surprising that only three of the 18 relevant RCTs had one or more full papers that reported the same outcome measures (and stage of analysis) as an earlier conference abstract. However, a limitation of this review is the small number of studies included. With a larger sample size than that in the present report, investigation into the effect of publication delay on decision-making might be feasible. Future research should include extension of this work to other anti-cancer drugs and investigation into the reasons for lengthy delays to full publication noted for some trials.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Breast Neoplasms; Consensus Development Conferences as Topic; Databases, Bibliographic; Deoxycytidine; Docetaxel; Female; Humans; Lapatinib; Paclitaxel; Publication Bias; Publishing; Quinazolines; Randomized Controlled Trials as Topic; Taxoids; Technology Assessment, Biomedical; Time; Trastuzumab; Gemcitabine
PubMed: 18831948
DOI: 10.3310/hta12320