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ABSTRACT:
SUBMITTER: Yang J
PROVIDER: S-EPMC9233186 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication.Small sample that included earliest results posted to the database.Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.Agency for Healthcare Research and Quality.
| S-EPMC4617780 | biostudies-literature
Project description:ImportanceClinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature.ObjectiveTo assess whether inconsistencies in reported data exist between ophthalmic literature and clinical trial registries.Design, setting, and participantsIn this retrospective, cross-sectional study, interventional clinical trials published from January 1, 2014, to December 31, 2014, in the American Journal of Ophthalmology, JAMA Ophthalmology, and Ophthalmology were reviewed. Observational, retrospective, uncontrolled, and post hoc reports were excluded, yielding a sample size of 106 articles. Data collection was performed from January through September 2016. Data review and adjudication continued through January 2017.Main outcomes and measuresIf possible, articles were matched to registry entries listed in the ClinicalTrials.gov database or in 1 of 16 international registries indexed by the World Health Organization International Clinical Trials Registry Platform version 3.2 search engine. Each article-registry pair was assessed for inconsistencies in design, results, and funding (each of which was further divided into subcategories) by 2 reviewers and adjudicated by a third.ResultsOf 106 trials that met the study criteria, matching registry entries were found for 68 (64.2%), whereas no matching registry entries were found for 38 (35.8%). Inconsistencies were identified in study design, study results, and funding sources, including specific interventions in 8 (11.8%), primary outcome measure (POM) designs in 32 (47.1%), and POM results in 48 (70.6%). In addition, numerous data pieces were unreported, including analysis methods in 52 (76.5%) and POM results in 38 (55.9%).Conclusions and relevanceClinical trial registries were underused in this sample of ophthalmology clinical trials. For studies with registry data, inconsistency rates between published and registered data were similar to those previously reported for general medical literature. In most cases, inconsistencies involved missing data, but explicit discrepancies in methods and/or data were also found. Transparency and credibility of published trials may be improved by closer attention to their registration and reporting.
| S-EPMC6512264 | biostudies-literature
Project description:BackgroundThere are increasing calls for patient involvement in sharing health research results, but no evidence-based recommendations to guide such involvement. Our objectives were to: (1) conduct a systematic review of the evidence on patient involvement in results sharing, (2) propose evidence-based recommendations to help maximize benefits and minimize risks of such involvement and (3) conduct this project with patient authors.MethodsTo avoid research waste, we verified that no systematic reviews were registered or published on this topic. We co-created, with patients, a PRISMA-P-compliant protocol. We included peer-reviewed publications reporting the effects of patient involvement in preparing peer-reviewed publications or results summaries from health research studies. We searched (9/10/2017) MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews, and secondary information sources (until 11/06/2018). We assessed the risk of bias in eligible publications and extracted data using standardized processes. To evaluate patient involvement in this project, we co-created a Patient Authorship Experience Tool.ResultsAll nine eligible publications reported on patient involvement in preparing publications; none on preparing results summaries. Evidence quality was moderate. A qualitative synthesis of evidence indicated the benefits of patient involvement may outweigh the risks. We have proposed 21 evidence-based recommendations to help maximize the benefits and minimize the risks when involving patients as authors of peer-reviewed publications. The recommendations focus on practical actions patient and non-patient authors can take before (10 recommendations), during (7 recommendations) and after (4 recommendations) manuscript development. Using the Patient Authorship Experience Tool, both patient and non-patient authors rated their experience highly.ConclusionsBased on a systematic review, we have proposed 21 evidence-based recommendations to help maximize the benefits and minimize the risks of involving patients as authors of peer-reviewed publications.
| S-EPMC7313171 | biostudies-literature
Project description:This article discusses the open-identity label, i.e., the practice of disclosing reviewers' names in published scholarly books, a common practice in Central and Eastern European countries. This study's objective is to verify whether the open-identity label is a type of peer-review label (like those used in Finland and Flanders, i.e., the Flemish part of Belgium), and as such, whether it can be used as a delineation criterion in various systems used to evaluate scholarly publications. We have conducted a two-phase sequential explanatory study. In the first phase, interviews with 20 of the 40 largest Polish publishers of scholarly books were conducted to investigate how Polish publishers control peer reviews and whether the open-identity label can be used to identify peer-reviewed books. In the other phase, two questionnaires were used to analyze perceptions of peer-review and open-identity labelling among authors (n = 600) and reviewers (n = 875) of books published by these 20 publishers. Integrated results allowed us to verify publishers' claims concerning their peer-review practices. Our findings reveal that publishers actually control peer reviews by providing assessment criteria to reviewers and sending reviews to authors. Publishers rarely ask for permission to disclose reviewers' names, but it is obvious to reviewers that this practice of disclosing names is part of peer reviewing. This study also shows that only the names of reviewers who accepted manuscripts for publication are disclosed. Thus, most importantly, our analysis shows that the open-identity label that Polish publishers use is a type of peer-review label like those used in Flanders and Finland, and as such, it can be used to identify peer-reviewed scholarly books.
| S-EPMC6433260 | biostudies-literature
Project description:Study Design: Scoping review Objective: To study the design, clinical setting and outcome measures used in spinal cord injury rehabilitation publications. Methods: A literature search on PubMed and Medline was conducted focusing on articles published between 1990-2016 and using "traumatic SCI", "functional outcomes", "rehabilitation", "work" and "return to work" as outcomes. Studies were categorized based on design (intervention, including RCTs vs. non-intervention studies), settings (inpatient vs. outpatient vs. transition), and outcome measures used (impairment vs. function vs. participation/integration vs. quality of life vs. symptoms). Work-related studies were categorized independently. Results: Five hundred forty-four articles met the inclusion criteria. Of these, 234 were interventional studies, including 23 RCTs. Studies were evenly divided among inpatient, outpatient and transition settings. Of the 234 interventional studies, 143 used functional evaluations. Sixty-one different functional instruments were used, with a predominant use of the Functional Independence Measure (61 times) and an additional use of SCI-specific measures, i.e. Spinal Cord Independence Measure and Craig Handicap Assessment and Reporting Technique (13 times each). Fifty-one studies measured mobility, while only three measured hand functions. The work-related sub-analysis revealed 32 intervention studies (no RCTs), of which 15 used functional evaluations and only three focused on tetraplegia. Conclusion: Our study revealed a paucity of intervention trials and RCTs, indicating a dearth of knowledge that would be needed to establish evidence-based practice guidelines. This is particularly true for tetraplegia. While standard measures of function were frequently used, providing valuable data, there is no consensus about what exact outcome measure to use. Using newer measurement techniques, for instance based on the application of item response theory, should be considered to enhance uniformity.
| S-EPMC7480523 | biostudies-literature
Project description:ObjectivesWomen in oral health science face similar societal issues and challenges as those in other STEMM careers, and gender disparities continue to exist as evidenced by fewer women represented as first and last authors in scientific publications. Pre-prints may serve as a conduit to immediately disseminating one's work, bypassing the arduous peer review process and its associated inherent biases. Therefore, the purpose of this study was to 1] compare the gender of first and last authors in pre-print versus peer reviewed publications, 2] examine the composition of first and last author pairs as stratified by publication type, and 3] examine the correlation between woman authorship and institutional geographic location and publication metrics stratified by publication type.MethodsThe keyword "oral health" was used to search for publications in BioRxiv and Pubmed in the years 2018 and 2019. Gender of first and last authors were determined, and its frequency was considered as the primary outcome. Additionally, the geographic location of the author's associated institution and publication metrics measured by Altmetrics score were extracted. Data was descriptively summarized by frequencies and percentages. Chi-square analysis was conducted for categorical variables which included the relationship between gender and publication type as well as gender and region of author's associated institution. Binomial regression analysis was conducted to analyze the relationship between gender and Altmetrics.ResultsWoman first authors comprised 40.3% of pre-prints and 64.5% of peer reviewed publications [p<0.05]. Woman last authors comprised 31.3% of pre-prints and 61.5% of peer reviewed publications [p<0.05]. When analyzing the relationships between first and last author, the Man-Man pairing represented 47.7% of the pre-print publications and the Woman-Woman pairing comprised a majority of the of the peer review publications at 47.5%. All results were statistically significant with a p-value <0.05. No significant correlation was found between region of institution or Altmetrics and gender of first or last authors [p>0.05].ConclusionFor the first time in oral health science, it was found that women show higher representation as first and last author positions in peer reviewed publications versus pre-prints.
| S-EPMC8648106 | biostudies-literature
Project description:ImportanceOphthalmology-residency selection committees require robust metrics to review applicants. Participation in research activities is a core component of the application process for its perceived association with future academic productivity.ObjectiveTo evaluate the correlation between the number of preresidency peer-reviewed publications (PPPs) and subsequent peer-reviewed publications or career choices of ophthalmology residency graduates.Design, setting, and participantsIn this cross-sectional study, names of ophthalmology residency graduates were obtained. PubMed-indexed publication records were generated and publications were categorized as preresidency, intraresidency, and postresidency. First author and journal publications with an impact factor (IF) score of 3 or more were recorded. Current academic and community-based career statuses were designated. Names were obtained from cohort and alumni lists on residency program websites or by emailing program directors. Participants included US Accreditation Council for Graduate Medical Education-accredited ophthalmology residency graduates from 2013 to 2016.Main outcomes and measuresThe primary outcome measure was association of PPPs with later publications, first authorship, and journal publications with an IF score of 3 or more. The secondary outcome measure was difference in characteristics associated with academic vs community-based ophthalmologist.ResultsA total of 964 ophthalmologists (52% of graduates) were studied and most (85.5%) had PubMed-indexed publications. First authorship (ρ = 0.71; 95% CI, 0.67-0.74; P < .001) had a strong positive correlation with intraresidency publications, while journal publications with an IF score of 3 or more (ρ = 0.56; 95% CI, 0.51-0.60; P < .001) and PPPs (ρ = 0.38; 95% CI, 0.32-0.43; P < .001) had moderate and weak positive correlations, respectively. For postresidency publications, journal publications with an IF score of 3 or more (ρ = 0.86; 95% CI, 0.84-0.87; P < .001) had the strongest positive correlation followed by first authorship (ρ = 0.77; 95% CI, 0.74-0.79; P < .001) and PPPs (ρ = 0.26; 95% CI, 0.20-0.31; P < .001). Preresidency (t = 3.3; P = .001), intraresidency (t = 4.1; P < .001), postresidency (t = 7.5; P < .001), first author (t = 6.6; P < .001), and journal publications with an IF score of 3 or more (t = 5.9; P < .001) were greater for academic ophthalmologists compared with community-based ophthalmologists.Conclusions and relevancePreresidency publication history is at least weakly correlated with future publications or work in an academic setting among ophthalmologists. Multiple factors associated with academic productivity were evaluated; however, adjustment for multiple analyses was not done and further testing is required to prove whether these factors are predictive.
| S-EPMC9857534 | biostudies-literature
Project description:BackgroundOutdoor air pollution is a major threat to global public health that needs responsible participation of researchers at all levels. Assessing research output is an important step in highlighting national and international contribution and collaboration in a certain field. Therefore, the aim of this study was to analyze globally-published literature in outdoor air pollution - related respiratory health.MethodOutdoor air pollution documents related to respiratory health were retrieved from Scopus database. The study period was up to 2017. Mapping of author keywords was carried out using VOSviewer 1.6.6.ResultsSearch query yielded 3635 documents with an h-index of 137. There was a dramatic increase in the number of publications in the last decade of the study period. The most frequently encountered author keywords were: air pollution (835 occurrences), asthma (502 occurrences), particulate matter (198 occurrences), and children (203 occurrences). The United States of America ranked first (1082; 29.8%) followed by the United Kingdom (279; 7.7%) and Italy (198; 5.4%). Annual research productivity stratified by income and population size indicated that China ranked first (22.2) followed by the USA (18.8). Analysis of regional distribution of publications indicated that the Mediterranean, African, and South-East Asia regions had the least contribution. Harvard University (92; 2.5%) was the most active institution/organization followed the US Environmental Protection Agency (89; 2.4%). International collaboration was restricted to three regions: Northern America, Europe, and Asia. The top ten preferred journals were in the field of environmental health and respiratory health. Environmental Health Perspective was the most preferred journal for publishing documents in outdoor pollution in relation to respiratory health.ConclusionResearch on the impact of outdoor air pollution on respiratory health had accelerated lately and is receiving a lot of interest. Global research networks that include countries with high level of pollution and limited resources are highly needed to create public opinion in favor of minimizing outdoor air pollution and investing in green technologies.
| S-EPMC5984296 | biostudies-literature
Project description:BackgroundPeer-reviewed scientific publications and congress abstracts are typically written by scientists for specialist audiences; however, patients and other non-specialists are understandably interested in the potential implications of research and what they may mean for them. Plain language summaries (PLS)-summaries of scientific articles in easy-to-read language-are emerging as a valuable addition to traditional scientific publications. Co-creation of PLS with the intended audience is key to ensuring a successful outcome, but practical guidance on how to achieve this has been lacking.MethodsBuilding on the Patient Engagement (PE) Quality Guidance previously developed by Patient Focused Medicines Development (PFMD), a multi-stakeholder working group (WG) of individuals with patient engagement experience and/or expertise in PLS was established to develop further activity-specific guidance. PLS guidance was developed through a stepwise approach that included several rounds of co-creation, public consultation (two rounds), internal review and a final external review. The iterative development process incorporated input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). Feedback from each step was consolidated by the WG and used for refining the draft guidance. The final draft was then validated through external consultation.ResultsThe WG comprised 14 stakeholders with relevant experience in PE and/or PLS. The WG developed a set of 15 ethical principles for PLS development. These include the necessity for objective reporting and the absence of any promotional intent, the need for balanced presentation, the importance of audience focus, the need to apply health literacy principles, and the importance of using inclusive and respectful language. The first public consultation yielded 29 responses comprising 478 comments or edits in the shared draft guidance. The second public consultation was an online survey of 14 questions which had 32 respondents. The final 'How-To' Guide reflects feedback received and provides a rational, stepwise breakdown of the development of PLS.ConclusionsThe resulting 'How-To' Guide is a standalone, practical, ready-to-use tool to support multi-stakeholder co-creation of PLS.
| S-EPMC9164486 | biostudies-literature
Project description:BackgroundQuantitative data are lacking on published malaria research. The purpose of the study is to characterize trends in malaria-related literature from 1990 to 2009 in 11 Asian-Pacific countries that are committed to malaria elimination as a national goal.MethodsA systematic search was conducted for articles published from January 1990 to December 2009 in PubMed/MEDLINE using terms for malaria and 11 target countries (Bhutan, China, North Korea, Indonesia, Malaysia, Philippines, Solomon Islands, South Korea, Sri Lanka, Thailand and Vanuatu). The references were collated and categorized according to subject, Plasmodium species, and whether they contained original or derivative data.Results2,700 articles published between 1990 and 2009 related to malaria in the target countries. The annual output of malaria-related papers increased linearly whereas the overall biomedical output from these countries grew exponentially. The percentage of malaria-related publications was nearly 3% (111/3741) of all biomedical publications in 1992 and decreased to less than 1% (118/12171; p < 0.001) in 2009. Thailand had the highest absolute output of malaria-related papers (n = 1211), followed by China (n = 609) and Indonesia (n = 346). Solomon Islands and Vanuatu had lower absolute numbers of publications, but both countries had the highest number of publications per capita (1.3 and 2.5 papers/1,000 population). The largest percentage of papers concerned the epidemiology and control of malaria (53%) followed by studies of drugs and drug resistance (47%). There was an increase in the proportion of articles relating to epidemiology, entomology, biology, molecular biology, pathophysiology and diagnostics from the first to the second decade, whereas the percentage of papers on drugs, clinical aspects of malaria, immunology, and social sciences decreased.ConclusionsThe proportion of malaria-related publications out of the overall biomedical output from the 11 target Asian-Pacific countries is decreasing. The discovery and evaluation of new, safe and effective drugs and vaccines is paramount. In addition the elimination of malaria will require operational research to implement and scale up interventions.
| S-EPMC3118956 | biostudies-literature