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A systematic review of the processes used to link clinical trial registrations to their published results.

ABSTRACT: Studies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links.PubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration identifier was available in the bibliographic database or publication, or manual when linkage required inference or contacting of trial investigators. The number of links identified by each process was extracted where available. Linear regression was used to determine whether the proportions of links available via automatic processes had increased over time.In 43 studies that examined cohorts of registry entries, 24 used automatic and manual processes to find articles; 3 only automatic; and 11 only manual (5 did not specify). Twelve studies reported results for both manual and automatic processes and showed that a median of 23% (range from 13 to 42%) included automatic links to articles, while 17% (range from 5 to 42%) of registry entries required manual processes to find articles. There was no evidence that the proportion of registry entries with automatic links had increased (R 2?=?0.02, p?=?0.36). In 39 studies that examined cohorts of articles, 21 used automatic and manual processes; 9 only automatic; and 2 only manual (7 did not specify). Sixteen studies reported numbers for automatic and manual processes and indicated that a median of 49% (range from 8 to 97%) of articles had automatic links to registry entries, and 10% (range from 0 to 28%) required manual processes to find registry entries. There was no evidence that the proportion of articles with automatic links to registry entries had increased (R 2?=?0.01, p?=?0.73).The linkage of trial registries to their corresponding publications continues to require extensive manual processes. We did not find that the use of automatic linkage has increased over time. Further investigation is needed to inform approaches that will ensure publications are properly linked to trial registrations, thus enabling efficient monitoring of trial reporting.

SUBMITTER: Bashir R

PROVIDER: S-EPMC5494826 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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A systematic review of the processes used to link clinical trial registrations to their published results.

Bashir Rabia R Bourgeois Florence T FT Dunn Adam G AG

Systematic reviews 20170703 1

<h4>Background</h4>Studies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links.<h4>Methods</h4>PubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration ident ...[more]

PMID: 28669351

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Project description:Background: Since the coronavirus disease 2019 (COVID-19) outbreak was first reported in December 2019, many independent trials have been planned that aim to answer similar questions. Tools allowing researchers to review studies already underway can facilitate collaboration, cooperation and harmonisation. The Infectious Diseases Data Observatory (IDDO) has undertaken a living systematic review (LSR) to provide an open, accessible and frequently updated resource summarising characteristics of COVID-19 study registrations. Methods: Review of all eligible trial records identified by systematic searches as of 3 April 2020 and initial synthesis of clinical study characteristics were conducted. In partnership with Exaptive, an open access, cloud-based knowledge graph has been created using the results. Results: There were 728 study registrations which met eligibility criteria and were still active. Median (25 th, 75 th percentile) sample size was 130 (60, 400) for all studies and 134 (70, 300) for RCTs. Eight lower middle and low income countries were represented among the planned recruitment sites. Overall 109 pharmacological interventions or advanced therapy medicinal products covering 23 drug categories were studied. Majority (57%, 62/109) of them were planned only in one study arm, either alone or in combination with other interventions. There were 49 distinct combinations studied with 90% (44/49) of them administered in only one or two study arms. The data and interactive platform are available at https://iddo.cognitive.city/. Conclusions: Baseline review highlighted that the majority of investigations in the first three months of the outbreak were small studies with unique treatment arms, likely to be unpowered to provide solid evidence. The continued work of this LSR will allow a more dependable overview of interventions tested, predict the likely strength of evidence generated, allow fast and informative filtering of relevant trials for specific user groups and provide the rapid guidance needed by investigators and funders to avoid duplication of efforts.

Project description:ObjectivesTo identify published closed-loop Bayesian mixed treatment comparisons (MTCs) and to summarise characteristics regarding their conduct and reporting.DesignSystematic review.MethodsWe searched multiple bibliographic databases (January 2006-31 July 2011) for full-text, English language publications of Bayesian MTCs comparing the effectiveness or safety of ?3 interventions based on randomised controlled trials and having at least one closed loop. Methodological and reporting characteristics of MTCs were extracted in duplicate and summarised descriptively.ResultsWe identified 34 Bayesian MTCs spanning 13 clinical areas. Publication of MTCs increased over the 5-year period; with 76.5% published during or after 2009. MTCs included a mean (±SD) of 35.9±30.1 trials (n=33 459±71 233 participants) and 8.5±4.3 interventions (85.7% pharmacological). Non-informative and informative prior distributions were reported to be used in 44.1% and 8.8% of MTCs, respectively, with the remainder failing to specify the prior used. A random-effects model was used to analyse the networks of trials in 58.5% of MTCs, all using WinBUGS; however, code was infrequently provided (20.6%). More than two-thirds of MTCs (76.5%) also conducted traditional meta-analysis. Methods used to evaluate convergence, heterogeneity and inconsistency were infrequently reported, but from those providing detail, methods appeared varied. MTCs most often used a binary effect measure (85.3%) and ranking of interventions based on probability was common (61.8%), although rarely displayed in a figure (8.8% of MTCs). MTCs were published in 24 different journals with a mean impact factor of 9.20±8.71. While 70.8% of journals imposed limits on word counts and 45.8% limits on the number of tables/figures, online supplements/appendices were allowed in 79.2% of journals. Publication of closed-loop Bayesian MTCs is increasing in frequency, but details regarding their methodology are often poorly described. Efforts in clarifying the appropriate methods and reporting of Bayesian MTCs should be of priority.

Project description:ObjectivesDue to the rapid spread of COVID-19 worldwide, many countries have designed clinical trials to find efficient treatments. We aimed to critically report the characteristics of all the registered and published randomized clinical trials (RCTs) conducted on COVID-19, and summarize the evaluation of potential therapies developed in various regions.Evidence acquisitionWe comprehensively searched PubMed, Cochrane Library, Web of Science, Scopus, and Clinicaltrial.gov databases to retrieve all the relevant studies up to July 19, 2021, in conformity with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart. We included all English-language published/registered RCTs on COVID-19, and excluded non-RCT, in-vitro/in-vivo, editorials, and review studies. Two reviewers independently evaluated all the records, and then analyzed by using SPSS 17.ResultsWithin 3018 included studies, 2801 (92.8%) and 217 (7.2%) were registered or published RCTs consisting of about 600 synthetic drugs. Herbal medicines have been studied in 23 trials (10.6%) among the published RCTs and in 357 registered RCTs (12.7%). Hydroxychloroquine 23 (10.6%) and convalescent plasma 194 (6.9%) alone or in combination with other agents were the most frequently used interventions in published and registered RCTs, respectively. Most published RCTs have been conducted in Western Pacific Region (WPRO) (50 trials, 23.0%) including 45 trials from China. Also, a greater proportion of registered RCTs have been conducted in the Region of the Americas (PAHO) (885 trials, 31.6%) including 596 RCTs from the United States (U.S). Globally, 283 registered trials have been conducted to assess new developed vaccines for COVID or previously established for other disorders.ConclusionThe present study highlighted the wide range of potential therapeutic agents in published and registered COVID-19 clinical trials across a wide range of regions. However, it is urgently required to global coordination in order to conduct more well-designed trials and progress in discovering safe and effective treatments.

Project description:ImportanceClinical researchers are obligated to present results objectively and accurately to ensure readers are not misled. In studies in which primary end points are not statistically significant, placing a spin, defined as the manipulation of language to potentially mislead readers from the likely truth of the results, can distract the reader and lead to misinterpretation and misapplication of the findings.ObjectiveTo determine the level and prevalence of spin in published reports of cardiovascular randomized clinical trial (RCT) reports.Data sourceMEDLINE was searched from January 1, 2015, to December 31, 2017, using the Cochrane highly sensitive search strategy.Study selectionInclusion criteria were parallel-group RCTs published from January 1, 2015, to December 31, 2017 in 1 of 6 high-impact journals (New England Journal of Medicine, The Lancet, JAMA, European Heart Journal, Circulation, and Journal of the American College of Cardiology) with primary outcomes that were not statistically significant were included in the analysis.Data extraction and synthesisAnalysis began in August 2018. Data were extracted and verified by 2 independent investigators using a standard collection form. In cases of disagreement between the 2 investigators, a third investigators served as arbitrator.Main outcomes and measuresThe classifications of spin type, severity, and extent were determined according to predefined criteria. Primary clinical outcomes were divided into safety of treatment, efficacy of treatment, and both.ResultsOf 587 studies identified, 93 RCT reports (15.8%) met inclusion criteria. Spin was identified in 53 abstracts (57%; 95% CI, 47%-67%) and 62 main texts of published articles (67%; 95% CI, 57%-75%). Ten reports (11%; 95% CI, 6%-19%) had spin in the title, 35 reports (38%; 95% CI, 28%-48%) had spin in the results section, and 50 reports (54%; 95% CI, 44%-64%) had spin in the conclusions. Among the abstracts, spin was observed in 38 results sections (41%; 95% CI, 31%-51%) and 45 conclusions sections (48%; 95% CI, 38%-58%).Conclusions and relevanceThis study suggests that in reports of cardiovascular RCTs with statistically nonsignificant primary outcomes, investigators often manipulate the language of the report to detract from the neutral primary outcomes. To best apply evidence to patient care, consumers of cardiovascular research should be aware that peer review does not always preclude the use of misleading language in scientific articles.

Project description:Background: Posterior reversible encephalopathy syndrome (PRES) is a rare clinical and radiological entity characterized by a typical brain edema. Although several case reports have described PRES in a context of poisoning, to our knowledge, a comprehensive assessment has not been performed. The aim of this systematic review was to raise awareness on poisoning-specific PRES features and to encourage consistent and detailed reporting of substance abuse-and drug overdose-associated PRES. Methods: Medline/PubMed, Web of Science, and PsycINFO were screened through May 31, 2019, to systematically identify case reports and case series describing PRES associated with poisoning (i.e., alcohol, drugs, illicit drugs, natural toxins, chemical substances) in accidental context, intentional overdose, and substance abuse. The methodological quality of eligible case reports/series was assessed. Patients and exposure characteristics were recorded; relevant toxicological, radiological, and clinical data were extracted. Results: Forty-one case reports and one case series reporting 42 unique cases were included. The median time to PRES onset from the start of exposure was 3 days (IQR 2-10). Acute high blood pressure, visual disturbance, and seizure were reported in 70, 55, and 50% of patients, respectively. The initial clinical presentation was alertness disorders in 64% of patients. Nine patients (21%) required mechanical ventilation. One-third of patients had at least one risk factor for PRES such as chronic hypertension (17%) or acute/chronic kidney failure (24%). The main imaging pattern (67%) was the combination of classical parieto-occipital edema with another anatomical region (e.g., frontal, basal ganglia, posterior fossa involvement). Vasogenic edema was found in 86% of patients. Intracranial hemorrhage occurred in 14% of patients. Both brain infarction and reversible cerebral vasoconstriction syndrome were diagnosed in 5% of patients. Three patients (12%, 3/25) had non-reversible lesions on follow-up magnetic resonance imaging. The median time required to hospital discharge was 14 days (IQR 7-18). Mortality and neurological recurrence rate were null. Conclusions: Comorbidities such as chronic hypertension and kidney failure were less frequent than in patients with other PRES etiologies. Imaging analysis did not highlight a specific pattern for poisoning-induced PRES. Although less described, PRES in the context of poisoning, which shares most of the clinical and radiological characteristics of other etiologies, is not to be ignored.

Project description:BackgroundThe Unified Medical Language System (UMLS) has been a critical tool in biomedical and health informatics, and the year 2021 marks its 30th anniversary. The UMLS brings together many broadly used vocabularies and standards in the biomedical field to facilitate interoperability among different computer systems and applications.ObjectiveDespite its longevity, there is no comprehensive publication analysis of the use of the UMLS. Thus, this review and analysis is conducted to provide an overview of the UMLS and its use in English-language peer-reviewed publications, with the objective of providing a comprehensive understanding of how the UMLS has been used in English-language peer-reviewed publications over the last 30 years.MethodsPubMed, ACM Digital Library, and the Nursing & Allied Health Database were used to search for studies. The primary search strategy was as follows: UMLS was used as a Medical Subject Headings term or a keyword or appeared in the title or abstract. Only English-language publications were considered. The publications were screened first, then coded and categorized iteratively, following the grounded theory. The review process followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.ResultsA total of 943 publications were included in the final analysis. Moreover, 32 publications were categorized into 2 categories; hence the total number of publications before duplicates are removed is 975. After analysis and categorization of the publications, UMLS was found to be used in the following emerging themes or areas (the number of publications and their respective percentages are given in parentheses): natural language processing (230/975, 23.6%), information retrieval (125/975, 12.8%), terminology study (90/975, 9.2%), ontology and modeling (80/975, 8.2%), medical subdomains (76/975, 7.8%), other language studies (53/975, 5.4%), artificial intelligence tools and applications (46/975, 4.7%), patient care (35/975, 3.6%), data mining and knowledge discovery (25/975, 2.6%), medical education (20/975, 2.1%), degree-related theses (13/975, 1.3%), digital library (5/975, 0.5%), and the UMLS itself (150/975, 15.4%), as well as the UMLS for other purposes (27/975, 2.8%).ConclusionsThe UMLS has been used successfully in patient care, medical education, digital libraries, and software development, as originally planned, as well as in degree-related theses, the building of artificial intelligence tools, data mining and knowledge discovery, foundational work in methodology, and middle layers that may lead to advanced products. Natural language processing, the UMLS itself, and information retrieval are the 3 most common themes that emerged among the included publications. The results, although largely related to academia, demonstrate that UMLS achieves its intended uses successfully, in addition to achieving uses broadly beyond its original intentions.

Dataset Information

A systematic review of the processes used to link clinical trial registrations to their published results.

Publications

A systematic review of the processes used to link clinical trial registrations to their published results.

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