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

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.

Environmental assessment at worksites after a multilevel intervention to promote activity and changes in eating: the PACE project.

OBJECTIVE: To evaluate changes in the worksite environment in response to a multilevel intervention over a 2-year period. METHODS: Worksites were recruited in the greater Seattle area, and 34 were randomized to intervention or comparison condition. The intervention was based on the ecological model, with a framework of defined phases of intervention that included worksite-wide events implemented in partnership with employee-based advisory boards. The assessment of the worksite environment used a modification of the Checklist of Health Promotion Environments at Worksites. Subscales were developed using baseline data only. The intervention effect on different aspects of the worksite environment was estimated using logistic regression with robust estimating procedures. RESULTS: Only changes in the physical activity and nutrition information environments were significantly associated with the intervention. CONCLUSIONS: This article provides one of the first attempts at using environmental assessment in the evaluation of worksite interventions.