Date Published: June 7, 2018
Publisher: Public Library of Science
Author(s): Belinda von Niederhäusern, Gordon H. Guyatt, Matthias Briel, Christiane Pauli-Magnus, Matthew J. Page
Abstract: BackgroundCompelling evidence has demonstrated that a large proportion of investment in biomedical research is wasted; this waste is avoidable. Academic institutions have, thus far, shown limited response to recommendations for increasing value and reducing waste. We formulated an academic response by (i) achieving consensus across a wide range of stakeholder groups on a comprehensive framework for quality of patient-oriented clinical research and (ii) highlighting first successful examples of its operationalization to facilitate waste-reducing strategies at academic institutions.Methods and findingsBased on a systematic review of quality definitions, concepts, and criteria in the medical literature (systematic MEDLINE search up to February 15, 2015, with independent and in duplicate article selection) and on stakeholder websites from 13 countries (Australia, Austria, Canada, France, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland, United Kingdom, and United States), we systematically developed a comprehensive framework for the quality of clinical research. We identified websites through personal contacts with experts in clinical research or public health who also suggested, for each country, websites of the following 7 stakeholder groups: patient organizations; academic research infrastructures; governmental bodies; regulatory agencies; ethics committees; the pharmaceutical industry; and funding agencies. In addition, we searched websites of inter- or supranational bodies involved in clinical research until no further insights emerged. After consolidation of the identified definitions, concepts, and criteria of quality in a basic framework structure, we conducted 4 rounds of an adapted online Delphi process among the same 7 stakeholder groups from 16 countries. The Delphi process ultimately achieved consensus on structure and content. The framework addresses 5 study stages (concept, planning and feasibility, conduct, analysis and interpretation, and reporting and knowledge translation) and includes the following dimensions: (i) protection of patient safety and rights, (ii) relevance/patient centeredness and involvement, (iii) minimization of bias (internal validity), (iv) precision, (v) transparency/access to data, and (vi) generalizability (external validity) of study results. These dimensions interact with 2 promoters—infrastructure and sustainability through education—that include a set of factors that may enhance all listed quality dimensions. Each quality dimension contains specific questions and explanatory items that guide quality assessment at each research stage from conceptualization of the research question through reporting and knowledge translation of study results. In the last survey round, Delphi participants from 9 countries (Austria, Australia, Canada, Germany, Italy, the Netherlands, Switzerland, UK, and US) agreed on the structure, content, and wording of the research stages, quality dimensions, specific questions, and descriptive examples of the final framework. In Switzerland, INQUIRE has resulted in a roadmap that guides initiatives to increase value within the Swiss Clinical Trial Organization network and through affiliated researchers.ConclusionsWe present a framework based on a consensus of different stakeholder groups guiding the practical assessment of clinical research quality at all stages of a research project. Operationalization of this common structure will support the increase of value by guiding academic institutions and researchers in developing quality enhancement initiatives, from posing the right research question to the transparent publication of results.
Partial Text: Clinical research should generate trustworthy evidence that informs decision-making in clinical practice, health policy, and further research . Evidence on the sources and extent of waste in research has, however, highlighted problematic research question selection, poor study design and execution, and non-publication and selective reporting [2–6]. Clinical research stakeholders have expressed concerns that the current model for conducting studies is unaffordable, unsustainable, and, for the generation of new knowledge, seriously flawed [1,7–13]. Low-quality clinical research not only may result in invalid data or distorted outcomes , but is also unethical and compromises patients’ safety and rights. In 2014, the “Increasing Value, Reducing Waste” series in The Lancet [8–13] provided a compelling body of evidence for sources of waste in biomedical research, including patient-oriented clinical research. The authors made 17 recommendations and formed an alliance (the Reduce Research Waste and Reward Diligence [REWARD] campaign; https://www.thelancet.com/campaigns/efficiency/statement) to increase value, involving stakeholders that include funders, regulators, journal editors, academic institutions, and researchers.
This study is reported according to the Standards for Reporting Qualitative Research (SRQR, http://www.equator-network.org/reporting-guidelines/srqr/) as described in S6 Appendix.
The INQUIRE framework defines clinical research quality based on the consensus of key international stakeholder groups. The framework represents a well-developed academic answer to the lack of a common definition of research quality, and the challenge of research waste. As a common structure for operationalizing the assessment of quality of clinical research at academic institutions, INQUIRE will facilitate implementation of waste reduction and value increasing initiatives. To take the field forward, we encourage the research community and interested stakeholder groups to apply the framework, generate evidence on its utility, and transparently and openly share their approaches.