Dataset Information

Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections.

ABSTRACT: Objective: Clinical trials are the source of evidence. ClinicalTrials.gov is valuable for analyzing current conditions. Until now, the state of drug interventions for heart infections is unknown. The purpose of this study was to comprehensively assess the characteristics of trials on cardiac-related infections and the status of drug interventions. Methods: The website ClinicalTrials.gov was used to obtain all registered clinical trials on drug interventions for cardiac-related infections as of February 16, 2019. All registration studies were collected, regardless of their recruitment status, research results, and research type. Registration information, results, and weblink-publications of those trials were analyzed. Results: A total of 45 eligible trials were evaluated and 86.7% of them began from or after 2008 while 91.1% of them adopted interventional study design. Of all trials, 35.6% were completed and 15.6% terminated. Besides, 62.2% of interventional clinical trials recruited more than 100 subjects. Meanwhile, 86.7% of the eligible trials included adult subjects only. Of intervention trials, 65.8% were in the third or fourth phase; 78.1% adopted randomized parallel assignment, containing two groups; 53.6% were masking, and 61.0% described treatment. Moreover, 41.5% of the trials were conducted in North America while 29.3% in Europe. Sponsors for 40.0% of the studies were from the industry. Furthermore, 48.9% of the trials mentioned information on monitoring committees, 24.4% have been published online, and 13.3% have uploaded their results. Drugs for treatments mainly contained antibiotics, among which glycopeptides, ?-lactams, and lipopeptides were the most commonly studied ones in experimental group, with the former ones more common. Additionally, 16.2% of the trials evaluated new antimicrobials. Conclusions: Most clinical trials on cardiac-related infections registered at ClinicalTrials.gov were interventional randomized controlled trials (RCTs) for treatment. Most drugs focused in trials were old antibiotics, and few trials reported valid results. It is necessary to strengthen supervision over improvements in results, and to combine antibacterial activity with drug delivery regimens to achieve optimal clinical outcomes.

SUBMITTER: Ma LL

PROVIDER: S-EPMC6624234 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections.

Ma Lin-Lu LL Qiu Yang Y Song Mei-Na MN Chen Yun Y Qu Jian-Xin JX Li Bing-Hui BH Zhao Ming-Juan MJ Liu Xin-Can XC

Frontiers in pharmacology 20190705

<b>Objective:</b> Clinical trials are the source of evidence. ClinicalTrials.gov is valuable for analyzing current conditions. Until now, the state of drug interventions for heart infections is unknown. The purpose of this study was to comprehensively assess the characteristics of trials on cardiac-related infections and the status of drug interventions. <b>Methods:</b> The website ClinicalTrials.gov was used to obtain all registered clinical trials on drug interventions for cardiac-related infe ...[more]

PMID: 31333470

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Project description:OBJECTIVE:To measure the association between receipt of specific infection prevention interventions and procedure-related cardiac implantable electronic device (CIED) infections. DESIGN:Retrospective cohort with manually reviewed infection status. SETTING:Setting: National, multicenter Veterans Health Administration (VA) cohort. PARTICIPANTS:Sampling of procedures entered into the VA Clinical Assessment Reporting and Tracking-Electrophysiology (CART-EP) database from fiscal years 2008 through 2015. METHODS:A sample of procedures entered into the CART-EP database underwent manual review for occurrence of CIED infection and other clinical/procedural variables. The primary outcome was 6-month incidence of CIED infection. Measures of association were calculated using multivariable generalized estimating equations logistic regression. RESULTS:We identified 101 procedure-related CIED infections among 2,098 procedures (4.8% of reviewed sample). Factors associated with increased odds of infections included (1) wound complications (adjusted odds ratio [aOR], 8.74; 95% confidence interval [CI], 3.16-24.20), (2) revisions including generator changes (aOR, 2.4; 95% CI, 1.59-3.63), (3) an elevated international normalized ratio (INR) >1.5 (aOR, 1.56; 95% CI, 1.12-2.18), and (4) methicillin-resistant Staphylococcus colonization (aOR, 9.56; 95% CI, 1.55-27.77). Clinically effective prevention interventions included preprocedural skin cleaning with chlorhexidine versus other topical agents (aOR, 0.41; 95% CI, 0.22-0.76) and receipt of ?-lactam antimicrobial prophylaxis versus vancomycin (aOR, 0.60; 95% CI, 0.37-0.96). The use of mesh pockets and continuation of antimicrobial prophylaxis after skin closure were not associated with reduced infection risk. CONCLUSIONS:These findings regarding the real-world clinical effectiveness of different prevention strategies can be applied to the development of evidence-based protocols and infection prevention guidelines specific to the electrophysiology laboratory.

Project description:BackgroundMany clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations.MethodsWe conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis.ResultsEligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario.ConclusionsBefore the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Project description:ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.DesignWe used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009-2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2 or Fisher exact test.ResultsIn the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.ConclusionsContrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.

Project description:ObjectiveTo address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Materials and methodsAny clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.ResultsOut of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.DiscussionAlthough standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.

Dataset Information

Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections.

Publications

Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections.

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