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Clinical trials registries are underused in the pregnancy and childbirth literature: a systematic review of the top 20 journals.

ABSTRACT: Systematic reviews and meta-analyses that do not include unpublished data in their analyses may be prone to publication bias, which in some cases has been shown to have deleterious consequences on determining the efficacy of interventions.We retrieved systematic reviews and meta-analyses published in the past 8 years (January 1, 2007-December 31, 2015) from the top 20 journals in the Pregnancy and Childbirth literature, as rated by Google Scholar's h5-index. A meta-epidemiologic analysis was performed to determine the frequency with which authors searched clinical trials registries for unpublished data.A PubMed search retrieved 372 citations, 297 of which were deemed to be either a systematic review or a meta-analysis and were included for analysis. Twelve (4 %) of these searched at least one WHO-approved clinical trials registry or clinicaltrials.gov.Systematic reviews and meta-analyses published in pregnancy and childbirth journals do not routinely report searches of clinical trials registries. Including these registries in systematic reviews may be a promising avenue to limit publication bias if registry searches locate unpublished trial data that could be used in the systematic review.

SUBMITTER: Yerokhin VV

PROVIDER: S-EPMC5073738 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Clinical trials registries are underused in the pregnancy and childbirth literature: a systematic review of the top 20 journals.

Yerokhin Vadim V VV Carr Branden K BK Sneed Guy G Vassar Matt M

BMC research notes 20161021 1

<h4>Background</h4>Systematic reviews and meta-analyses that do not include unpublished data in their analyses may be prone to publication bias, which in some cases has been shown to have deleterious consequences on determining the efficacy of interventions.<h4>Methods</h4>We retrieved systematic reviews and meta-analyses published in the past 8 years (January 1, 2007-December 31, 2015) from the top 20 journals in the Pregnancy and Childbirth literature, as rated by Google Scholar's h5-index. A ...[more]

PMID: 27769265

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Project description:BACKGROUND:For every maternal death, 20 to 30 women are estimated to have morbidities related to pregnancy or childbirth. Much of this burden of disease is in women in low- and middle-income countries. Maternal multimorbidity can include physical, psychological and social ill-health. Limited data exist about the associations between these morbidities. In order to address all health needs that women may have when attending for maternity care, it is important to be able to identify all types of morbidities and understand how each morbidity influences other aspects of women's health and wellbeing during pregnancy and after childbirth. METHODS:We systematically reviewed published literature in English, describing measurement of two or more types of maternal morbidity and/or associations between morbidities during pregnancy or after childbirth for women in low- and middle-income countries. CINAHL plus, Global Health, Medline and Web of Science databases were searched from 2007 to 2018. Outcomes were descriptions, occurrence of all maternal morbidities and associations between these morbidities. Narrative analysis was conducted. RESULTS:Included were 38 papers reporting about 36 studies (71,229 women; 60,911 during pregnancy and 10,318 after childbirth in 17 countries). Most studies (26/36) were cross-sectional surveys. Self-reported physical ill-health was documented in 26 studies, but no standardised data collection tools were used. In total, physical morbidities were included in 28 studies, psychological morbidities in 32 studies and social morbidities in 27 studies with three studies assessing associations between all three types of morbidity and 30 studies assessing associations between two types of morbidity. In four studies, clinical examination and/or basic laboratory investigations were also conducted. Associations between physical and psychological morbidities were reported in four studies and between psychological and social morbidities in six. Domestic violence increased risks of physical ill-health in two studies. CONCLUSIONS:There is a lack of standardised, comprehensive and routine measurements and tools to assess the burden of maternal multimorbidity in women during pregnancy and after childbirth. Emerging data suggest significant associations between the different types of morbidity. SYSTEMATIC REVIEW REGISTRATION NUMBER:PROSPERO CRD42018079526.

Project description:IntroductionPatient registries, 'organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time', are potentially valuable sources of data for supporting regulatory decision-making, especially for products to treat rare diseases. Nevertheless, patient registries are greatly underused in regulatory assessments. Reasons include heterogeneity in registry design and in the data collected, even across registries for the same disease, as well as unreliable data quality and data sharing impediments. The Patient Registries Initiative was established by the European Medicines Agency in 2015 to support registries in collecting data suitable to contribute to regulatory assessments, especially post-authorisation safety and effectiveness studies.MethodsWe conducted a qualitative synthesis of the published observations and recommendations from an initiative-led multi-stakeholder consultation and four disease-specific patient registry workshops. We identified the primary factors facilitating the use of registry data in regulatory assessments. We generated proposals on operational measures needed from stakeholders including registry holders, patients, healthcare professionals, regulators, marketing authorisation applicants and holders, and health technology assessment bodies for implementing these.ResultsTen factors were identified as facilitating registry use for supporting regulatory assessments of medicinal products. Proposals on operational measures needed for implementation were categorised according to three themes: (1) nature of the data collected and registry quality assurance processes; (2) registry governance, informed consent, data protection and sharing; and (3) stakeholder communication and planning of benefit-risk assessments.ConclusionsThese are the first explicit proposals, from a regulatory perspective, on operational methods for increasing the use of patient registries in medicines regulation. They apply to registry holders, patients, regulators, marketing authorisation holders/applicants and healthcare stakeholders broadly, and their implementation would greatly facilitate the use of these valuable data sources in regulatory decision-making.

Project description:BackgroundMedical journals use Twitter to engage and disseminate their research articles and implement a range of strategies to maximize reach and impact.ObjectiveThis study aims to systematically review the literature to synthesize and describe the different Twitter strategies used by medical journals and their effectiveness on journal impact and readership metrics.MethodsA systematic search of the literature before February 2020 in four electronic databases (PubMed, Web of Science, Scopus, and ScienceDirect) was conducted. Articles were reviewed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines.ResultsThe search identified 44 original research studies that evaluated Twitter strategies implemented by medical journals and analyzed the relationship between Twitter metrics and alternative and citation-based metrics. The key findings suggest that promoting publications on Twitter improves citation-based and alternative metrics for academic medical journals. Moreover, implementing different Twitter strategies maximizes the amount of attention that publications and journals receive. The four key Twitter strategies implemented by many medical journals are tweeting the title and link of the article, infographics, podcasts, and hosting monthly internet-based journal clubs. Each strategy was successful in promoting the publications. However, different metrics were used to measure success.ConclusionsFour key Twitter strategies are implemented by medical journals: tweeting the title and link of the article, infographics, podcasts, and hosting monthly internet-based journal clubs. In this review, each strategy was successful in promoting publications but used different metrics to measure success. Thus, it is difficult to conclude which strategy is most effective. In addition, the four strategies have different costs and effects on dissemination and readership. We recommend that journals and researchers incorporate a combination of Twitter strategies to maximize research impact and capture audiences with a variety of learning methods.

Project description:IntroductionResearch on research is key to enhancing efficacy in trial methodology. Clinical trials involving women during pregnancy and childbirth are limited, with a paucity of data guiding evidence-based practice. Following a prioritisation exercise that highlighted the top-ten unanswered recruitment questions, this qualitative evidence synthesis was designed specifically to focus on the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials within the context of recruitment during pregnancy and childbirth.MethodsThe synthesis was undertaken using Thomas and Harden's three stage thematic synthesis method and reported following the ENTREQ guidelines. Using a pre-determined SPIDER strategy, we conducted a comprehensive search of databases; Pubmed, CINAHL, PsycINFO, EMBASE, and grey searches for records until January 2019. We included all reports of qualitative data on recruiter's experiences, perceptions, views of recruiting women during pregnancy and childbirth to clinical trials. Altogether 13,401 records were screened, resulting in 31 full-text reviews, of which five were eligible for inclusion. Quality was appraised using CASP. Data were extracted onto a specifically defined form. We used thematic synthesis to identify descriptive and analytical themes, and to interpret and generate theory. Confidence was assessed using GRADE-CERQual. The review protocol is publicly available (OSF https://osf.io/g4dt9/).ResultsFive papers (representing four individual studies) from two different countries were included. All studies focused on the experiences of trial recruiters in the maternity setting. We identified four analytical themes; Recruitment through a clinician's lens, Recruiters judgement on acceptability, From protocol to recruiters lived experience, Framing recruitment in context. These were linked by an overarching theme combining beliefs and power.ConclusionThe overarching theme combining beliefs and power links the experiences and perceptions of recruiters. This synthesis shows a gap between the trial design study protocol and the recruiter's lived experience. Strategies such as collaborative trial design, mitigating gatekeeping behaviours, and training may support recruiters in their endeavour.

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Clinical trials registries are underused in the pregnancy and childbirth literature: a systematic review of the top 20 journals.

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Clinical trials registries are underused in the pregnancy and childbirth literature: a systematic review of the top 20 journals.

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