An analysis of data sources and study registries used in systematic reviews

Nick, J; Sarpy, Nancy L.

doi:10.1111/wvn.12614

Cited by 3 publications

(1 citation statement)

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“…9 Implications for policy and practice Clinical trial registries are an increasingly important source for results, with the potential to help systematic reviews and other evidence searches, [51][52][53][54] but despite recommendations 65 66 they are often underutilised. [67][68][69][70][71][72][73][74][75][76] The 2012 EU reporting guidelines, which governed reporting of results to EUCTR, operated under a soft requirement approach, where reporting was mandatory but compliance was voluntary, with no sanctions for failing to report. 77 This approach led to a well reported discrepancy between commercial and non-commercial reporting compliance.…”

Section: Open Access Open Accessmentioning

confidence: 99%

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

DeVito,

Morley,

Smith

et al. 2024

bmjmed

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ObjectiveTo identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.DesignCross sectional audit study.SettingEUCTR protocols and results sections, data extracted 1-3 December 2020.PopulationRandom sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).Main outcome measuresProportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.ResultsIn the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1).ConclusionsEUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.

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Section: Open Access Open Accessmentioning

confidence: 99%

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

DeVito,

Morley,

Smith

et al. 2024

bmjmed

View full text Add to dashboard Cite

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An analysis of data sources and study registries used in systematic reviews

Nick

Sarpy

2022

Worldviews Ev Based Nurs

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Background: Reporting standards for data sources in systematic reviews (SRs) have been developed, yet research shows varying compliance in the methods section.When this happens, replication of search results is difficult and creates ambiguous and biased data sources. Aims:This study captured author practices in choosing English and non-Englishlanguage databases, listing all the databases searched, and incorporating study registries as part of the search strategy.Methods: Using an analytic, cross-sectional, study design, volunteer data collectors (n = 107) searched one of two assigned English language platforms for SRs on specified health conditions. All the data sources found in the methods section of each SR were documented and analyzed for patterns using bibliographic techniques. Results:The final sample size of the SRs reviewed was N = 199. The mean number of data sources seen in the SRs was 3.9 (SD 2), with a range of 1-10. Eighteen records (9%) used a single data source to conduct the SRs. Four leading language platforms were seen in the SRs: English (100% of occurrences), up to 8% used Chinese data sources, and 4% included Spanish or Portuguese. The four most frequently used data sources were: (1) Medline (98%), (2) Embase (65%), (3) Cochrane Library (56%), and (4) Web of Science (33%). The percentage of SRs listing study registries was 30%.Linking Evidence to Action: Strategies to reduce bias and increase the rigor and reliability of SRs include comprehensive search practices by exploring non-Englishlanguage databases, using multiple data sources, and searching study registries. By following PRISMA-S guidelines to report data sources correctly, reproducibility can be accomplished.

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The Impact of Standardization of Intravenous Medication on Patient Safety and Quality of Healthcare: A Systematic Review

Alharthi,

Alshagrawi

2024

TOPHJ

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Background Intravenous (IV) drugs are essential in today's healthcare systems for providing patients with accurate and timely therapy in a variety of clinical situations. However, administering IV drugs is intrinsically difficult and fraught with error-proneness, which may seriously compromise patient safety and the standard of medical treatment. One important tactic to reduce these hazards and improve overall patient care is the adoption of standardized procedures for IV drug delivery. This systematic literature review aims to thoroughly investigate and summarize the body of knowledge about the effects of IV drug standardization on patient safety and the caliber of healthcare delivery. Methods We used a systematic review approach to examine the impact of standardized intravenous medicine on patient safety and healthcare quality. Guided by the PRISMA framework, we searched articles specifically discussing the standardization of intravenous medication and its implications on patient safety and healthcare quality and related peer-reviewed articles in two major academic databases, PubMed and Google Scholar, based on predetermined eligibility criteria. JBI tool was employed to evaluate the quality of the included studies. Results A total of 112 studies were selected from the two major databases, PubMed and Google Scholar, 61 and 51 studies, respectively. After applying the eligibility criteria, 8 studies were finalized for the systematic review. The outcomes showed a variety of clinical settings demonstrate the importance of standardization, and they argue for the maintenance of a focus on the use of standardized procedures in healthcare settings. Conclusion The study findings provide compelling evidence in favor of the implementation and ongoing focus on standardized medication concentrations as a critical tactic to enhance patient safety and improve the standard of healthcare. Thus, the creation and use of standardized procedures should be given top priority by healthcare institutions as they advance because they will remain essential to the pursuit of healthcare excellence.

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An analysis of data sources and study registries used in systematic reviews

Cited by 3 publications

References 51 publications

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

An analysis of data sources and study registries used in systematic reviews

The Impact of Standardization of Intravenous Medication on Patient Safety and Quality of Healthcare: A Systematic Review

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