Erica Cruvinel1, Kimber P Richter2, Catherine Stoney3, Sonia Duffy4, Jeffrey Fellows5, Kathleen F Harrington6, Nancy A Rigotti7, Scott Sherman8, Hilary A Tindle9, Theresa I Shireman10, Donna Shelley11, Lisa Waiwaiole5, Sharon Cummins12. 1. Department of Psychology, Federal University of Juiz de Fora, Minas Gerais, Brazil. Electronic address: ecruvinel@yahoo.com.br. 2. Department of Preventive Medicine and Public Health and The University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas. 3. National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland. 4. College of Nursing, Ohio State University, Columbus, Ohio; Department of Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan. 5. Kaiser Permanente Center for Health Research, Portland, Oregon. 6. Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama. 7. Department of Medicine and Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 8. Departments of Population Health, Medicine and Psychiatry; New York University School of Medicine, New York, New York. 9. Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee. 10. Department of Health Services, Policy, and Practice, Brown University, Providence, Rhode Island. 11. Department of Population Health, New York University School of Medicine, New York, New York. 12. Department of Family Medicine and Public Health, University of California, San Diego, California.
Abstract
INTRODUCTION: It is important to consider the degree to which studies are explanatory versus pragmatic to understand the implications of their findings for patients, healthcare professionals, and policymakers. Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions. The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of seven NIH-funded trials designed to identify effective programs that can be widely implemented in routine clinical practice. METHODS: A cross-sectional analysis of CHART trial study designs was conducted to place each study on the pragmatic-explanatory continuum. After reliability training, six raters independently scored each CHART study according to ten PRagmatic Explanatory Continuum Indicator Summary (PRECIS) dimensions, which covered participant eligibility criteria, intervention flexibility, practitioner expertise, follow-up procedures, participant compliance, practitioner adherence, and outcome analyses. Means and SDs were calculated for each dimension of each study, with lower scores representing more pragmatic elements. Results were plotted on "spoke and wheel" diagrams. The rating process and analyses were performed in October 2014 to September 2015. RESULTS: All seven CHART trials tended toward the pragmatic end of the spectrum, although there was a range from 0.76 (SD=0.23) to 1.85 (SD=0.58). Most studies included some explanatory design elements. CONCLUSIONS: CHART findings should be relatively applicable to clinical practice. Funders and reviewers could integrate PRECIS criteria into their guidelines to better facilitate pragmatic research. CHART study protocols, coupled with scores reported here, may help readers improve the design of their own pragmatic trials.
INTRODUCTION: It is important to consider the degree to which studies are explanatory versus pragmatic to understand the implications of their findings for patients, healthcare professionals, and policymakers. Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions. The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of seven NIH-funded trials designed to identify effective programs that can be widely implemented in routine clinical practice. METHODS: A cross-sectional analysis of CHART trial study designs was conducted to place each study on the pragmatic-explanatory continuum. After reliability training, six raters independently scored each CHART study according to ten PRagmatic Explanatory Continuum Indicator Summary (PRECIS) dimensions, which covered participant eligibility criteria, intervention flexibility, practitioner expertise, follow-up procedures, participant compliance, practitioner adherence, and outcome analyses. Means and SDs were calculated for each dimension of each study, with lower scores representing more pragmatic elements. Results were plotted on "spoke and wheel" diagrams. The rating process and analyses were performed in October 2014 to September 2015. RESULTS: All seven CHART trials tended toward the pragmatic end of the spectrum, although there was a range from 0.76 (SD=0.23) to 1.85 (SD=0.58). Most studies included some explanatory design elements. CONCLUSIONS: CHART findings should be relatively applicable to clinical practice. Funders and reviewers could integrate PRECIS criteria into their guidelines to better facilitate pragmatic research. CHART study protocols, coupled with scores reported here, may help readers improve the design of their own pragmatic trials.
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