Registration of randomized controlled trials in nursing journals (original) (raw)
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Nursing Outlook, 2008
In the era of evidence-based practice (EBP), Randomized Controlled Trials (RCTs) may provide the best evidence of the efficacy of nursing interventions and yet the quality of RCT reporting in nursing literature has not been evaluated. The purposes of this study were to apply the Consolidated Standards of Reporting Trials (CONSORT) statement to published reports of nursing science, examine how adequately the published reports adhere to the statement, and examine the effect of the adoption of CONSORT on the quality of the RCT published reports. One hundred RCTs from 2002-2005 were identified from 4 nursing journals. Articles were randomly assigned to 4 reviewers and the quality of the published reports was evaluated using a modified CONSORT checklist. There was no difference between the 4 journals in the quality of the published reports of RCTs based on the modified CONSORT checklist employed (F ؍ 1.27, P .)92.؍ The quality of reporting of RCTs improved significantly in the only journal, Nursing Research, to adopt the CONSORT statement during the study period (t ,07.2-؍ P .)10.؍ Adoption of CONSORT is recommended as it may lead to an overall improvement in quality of reporting of RCTs in nursing journals. The profession may also wish to explore the use or development of standards similar to CONSORT but ones more appropriate for the types of research typical of that published by nurse scientists.
Journal of Psychosomatic Research, 2011
Objective: The most reliable evidence for evaluating healthcare interventions comes from welldesigned and conducted randomized controlled trials (RCTs). The extent that published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The CONSORT statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrolment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioural health journals. Method: Eligible studies were primary or secondary reports of RCTs published in Annals of
Improve Quality of Reporting Randomized Controlled Trials in Nursing Research: CONSORT Statement
International Journal of Applied Science, 2023
Randomized Controlled Trials (RCTs) are regarded as the most reputable source of evidence that provides the best guide of the effectiveness of nursing interventions during the Evidence-Based Practice (EBP) period and, however, yet in the nursing literature, have not been evaluated the quality of reporting RCT. Practical and conceptual challenges to the EBP nursing movement have been. The limited available scientific evidence on the efficacy of many nursing practices is one of the serious concerns. EBP requests that study evidence from RCTs and other forms of intervention studies that are still limited in nursing be synthesized. On the other hand, comprehensive evaluations, meta-analyses, and systematic reviews performed in nursing are also limited compared to other disciplines, such as psychology and medicine. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a guideline developed to improve the quality of reporting randomized controlled trials (RCTs) in healthcare research, including nursing research. The statement consists of a checklist of 25 items that should be included in reporting RCTs. Applying the declaration of the CONSORT statement to nursing and healthcare provider studies, the adequacy of the published reports adhere to the statement and how the content of the published RCTs is being influenced by the adoption of CONSORT on the quality of reporting RCT. Evidence-based practice is rooted in solid evidence that the assumption (science-based nursing) in patient care should be supported by sound evidence. It is important that nursing professionals use the CONSORT statement to review, publish, and utilize their reports of nursing clinical and gather the best evidence to support their clinical practice of use and their decision-making.
2011
Objective: The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Methods: Eligible studies were primary or secondary reports of RCTs published in
Perspectives in Clinical Research
In response to the Food and Drug Administration Modernization Act of 1997, the National Institutes of Health launched the ClinicalTrials.gov website in 2000. [1] In the same year, the Declaration of Helsinki stated for the first time that "The Purpose: The International Committee of Medical Journal Editors mandates trial registration as a precondition for publication. Growing evidence indicates that information in registry may not correlate with eventual publication. The present study was carried out with the objective of comparing content of Randomized Controlled Trials (RCTs) published in one year in the Journal of the American Medical Association (JAMA), with the information contained in trial registries. Methods: All RCTs published in JAMA in 2013 were included. 11 data set items were matched for content between registry entry and published RCT: Title, Primary and Secondary Objectives, Study type, Inclusion and Exclusion Criteria, Treatment Age Group, Follow up, Sample Size, Primary and Secondary Outcomes. A fully correct match was scored 2, partially correct 1 and incorrect 0. Thus, maximum possible score for each paper was number of items multiplied by 2, i.e., 22. Results: The median [range] total score achieved by RCTs was 15. No RCT achieved a perfect score of 22. The largest proportion of RCTs reported secondary objectives, study type, treatment age group, follow up, sample size and primary outcomes fully correctly. However, only 13.5 %, 12 % and 13.5 % of RCTs were a perfect match with registry entries in terms of title, primary objective and secondary outcomes respectively. Almost three quarters did not match perfectly in selection criteria. Conclusion: There exist discrepancies between trial registration and published paper even in a high impact factor journal. Both authors and editors should adhere to CONSORT guidelines to ensure transparency of published research.
Trends in RCT nursing research over 20 years: mind the gap
British journal of nursing (Mark Allen Publishing)
Randomised controlled trial (RCT) literature plays a fundamental role in informing evidence-based medicine and nursing. This paper aims to track geographical and temporal trends in the publication of RCTs in nursing over the past 20 years by means of a bibliometric analysis. The PubMed database was searched for articles published from 1 January 1991 to 31 October 2011 and satisfying this search strategy: nursing [MeSH Terms] AND (RCT OR trial* OR 'experimental study' OR randomised OR randomisation) AND (English[lang]). Abstracts were reviewed to assess whether they met the criteria for an RCT. A manual search of information on country of origin was carried out and Journal Citation Reports® was used to allocate journals to subject areas. RCT methodology is increasingly drawing the attention of nursing researchers worldwide. However, there is a large disparity in research productivity, at least in terms of number of published RCTs in the English language and listed on PubMed, ...