Dataset Information

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

ABSTRACT:

Objective

To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.

Study design and setting

We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.

Results

Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.

Conclusion

Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

SUBMITTER: von Niederhausern B

PROVIDER: S-EPMC5513422 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

von Niederhäusern Belinda B Schandelmaier Stefan S Mi Bonde Marie M Brunner Nicole N Hemkens Lars G LG Rutquist Marielle M Bhatnagar Neera N Guyatt Gordon H GH Pauli-Magnus Christiane C Briel Matthias M

PloS one 20170717 7

<h4>Objective</h4>To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.<h4>Study design and setting</h4>We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical researc ...[more]

PMID: 28715491

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Dataset Information

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

Objective

Study design and setting

Results

Conclusion

Publications

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

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