Implementing common data elements across studies to advance research

Cohen, Marlene Z.; Thompson, Cheryl A.; Yates, Bernice C.; Zimmerman, Lani; Pullen, Carol H.

doi:10.1016/j.outlook.2014.11.006

Cited by 37 publications

(35 citation statements)

References 12 publications

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“…However, these six included studies have used different types of cognitive‐behavioural interventions and different assessment instruments to measure effectiveness, which make the identification of best practices challenging. Therefore, in the future, using common assessment tools to measure occupational stress across studies would allow for a combination of data from multiple investigations, which can potentially increase the impact of the findings or expand the population to which the findings can be generalized …”

Section: Discussionmentioning

confidence: 99%

“…Therefore, in the future, using common assessment tools to measure occupational stress across studies would allow for a combination of data from multiple investigations, which can potentially increase the impact of the findings or expand the population to which the findings can be generalized. 29 In terms of MBI, this review included three studies that evaluated MBI with regard to managing occupational stress among nurses working in ICUs. 10,23,25 The consensus across these three studies was that the MBI is effective in reducing stress among critical care nurses These findings were consistent with an updated systematic review which found that MBSR and MBCT are effective in reducing occupational stress, depression, and anxiety affecting the mental health of employees.…”

Section: Discussionmentioning

confidence: 99%

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Stress management interventions for intensive and critical care nurses: A systematic review

Alkhawaldeh

Soh

Mukhtar

et al. 2019

Nursing in Critical Care

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Background The level of occupational stress of nurses working in intensive and critical care units is high. Although many studies have assessed the effectiveness of stress management interventions among intensive and critical care nurses, the methodological quality of these studies remains unclear. Purpose The purpose of this review was to summarize and appraise the methodological quality of primary studies on interventions for management of occupational stress among intensive and critical care nurses. Methods This review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. A comprehensive literature search was conducted to identify primary studies that assessed the effectiveness of interventions in managing occupational stress among intensive and critical care nurses using multiple databases from January 2009 to June 2019. Results Twelve studies published between 2011 and 2019 were eligible for inclusion. These included studies were classified as being of good or fair quality. The consensus across the included studies was that, compared with control condition, cognitive‐behavioural skills training and mindfulness‐based intervention were more effective in reducing occupational stress among intensive and critical care unit nurses. Conclusion Further research should focus on methodologically strong studies by blinding the outcome assessors, using Randomized Controlled Trial (RCT) design with an active control group, using standardized assessment tools, and reporting enough details about the stress management intervention‐related adverse events. Relevance to clinical practice This review demonstrates the need for high methodological quality studies to rigorously evaluate the effectiveness of stress management interventions before it can be recommended for use in clinical practice to reduce stress in intensive and critical care unit nurses. In addition, attention should be given to developing research protocols that place more emphasis on interventions aimed at the organization level to address the growing problem of occupational stress among intensive and critical care nurses.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Stress management interventions for intensive and critical care nurses: A systematic review

Alkhawaldeh

Soh

Mukhtar

et al. 2019

Nursing in Critical Care

View full text Add to dashboard Cite

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“…Ultimately, by incorporating CDEs into research protocols, and depositing data generated in an accessible, common data repository, nursing researchers and others will have the opportunity to address more complex questions and advance the field in a way not possible when individuals work alone or in silos (Cohen, Thompson, Yates, Zimmerman, & Pullen, 2015; Corwin et al, 2014). …”

Section: Common Data Elementmentioning

confidence: 99%

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis

Corwin

Moore

Plotsky

et al. 2017

J of Nursing Scholarship

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Purpose The purpose of this article is to describe the outcomes of a collaborative initiative to share data across five schools of nursing in order to evaluate the feasibility of collecting common data elements (CDEs) and developing a common data repository to test hypotheses of interest to nursing scientists. This initiative extended work already completed by the National Institute of Nursing Research CDE Working Group that successfully identified CDEs related to symptoms and self-management, with the goal of supporting more complex, reproducible, and patient-focused research. Design Two exemplars describing the group’s efforts are presented. The first highlights a pilot study wherein data sets from various studies by the represented schools were collected retrospectively, and merging of the CDEs was attempted. The second exemplar describes the methods and results of an initiative at one school that utilized a prospective design for the collection and merging of CDEs. Methods Methods for identifying a common symptom to be studied across schools and for collecting the data dictionaries for the related data elements are presented for the first exemplar. The processes for defining and comparing the concepts and acceptable values, and for evaluating the potential to combine and compare the data elements are also described. Presented next are the steps undertaken in the second exemplar to prospectively identify CDEs and establish the data dictionaries. Methods for common measurement and analysis strategies are included. Findings Findings from the first exemplar indicated that without plans in place a priori to ensure the ability to combine and compare data from disparate sources, doing so retrospectively may not be possible, and as a result hypothesis testing across studies may be prohibited. Findings from the second exemplar, however, indicated that a plan developed prospectively to combine and compare data sets is feasible and conducive to merged hypothesis testing. Conclusions Although challenges exist in combining CDEs across studies into a common data repository, a prospective, well-designed protocol for identifying, coding, and comparing CDEs is feasible and supports the development of a common data repository and the testing of important hypotheses to advance nursing science. Clinical Relevance Incorporating CDEs across studies will increase sample size and improve data validity, reliability, transparency, and reproducibility, all of which will increase the scientific rigor of the study and the likelihood of impacting clinical practice and patient care.

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“…Objectives of the CDE project include: (1) to identify common data elements used in clinical research; (2) to present data elements in standard, widely available formats; (3) to establish common definitions and validate permissible values and ranges to guide researchers in selecting CDEs most applicable to studies; (4) to standardize case report forms and other instruments; and (5) to provide standardized information to researchers for database development. Common data elements can accelerate the pace of clinical research for rare diseases by rendering data more comparable and facilitating multi-center and international efforts [12]. …”

Section: Approaches For Assessing Cognition and Behaviormentioning

confidence: 99%

Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions

Shapiro

Bernstein

Adams

et al. 2016

Molecular Genetics and Metabolism

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Well-defined and reliable clinical outcome assessments are essential for determining whether a drug provides clinically meaningful treatment benefit for patients. In 2015, FDA convened a workshop, “Assessing Neurocognitive Outcomes in Inborn Errors of Metabolism.” Topics covered included special challenges of clinical studies of inborn errors of metabolism (IEMs) and other rare diseases; complexities of identifying treatment effects in the context of the dynamic processes of child development and disease progression; and the importance of natural history studies. Clinicians, parents/caregivers, and participants from industry, academia, and government discussed factors to consider when developing measures to assess treatment outcomes, as well as tools and methods that may contribute to standardizing measures. Many issues examined are relevant to the broader field of rare diseases in addition to specifics of IEMs.

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Implementing common data elements across studies to advance research

Cited by 37 publications

References 12 publications

Stress management interventions for intensive and critical care nurses: A systematic review

Stress management interventions for intensive and critical care nurses: A systematic review

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis

Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions

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