Practical Clinical Trials for Translating Research to Practice: Design and Measurement Recommendations

Rationale:There is a pressing need for practical clinical trials (PCTs) that are more relevant to clinicians and decision-makers, but many are unaware of these trials. Furthermore, such trials can be challenging to conduct and to report. Objective:The objective of this study was to build on the seminal paper by Tunis et al (Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–1632.) and to provide recommendations and examples of how practical clinical trials can be conducted and the results reported to enhance external validity without sacrificing internal validity. Key Issues:We discuss evaluating practical intervention options, alternative research designs, representativeness of samples participating at both the patient and the setting/clinician level, and the need for multiple outcomes to address clinical and policy implications. Conclusions:We provide a set of specific recommendations for issues to be reported in PCTs to increase their relevance to clinicians and policymakers, and to help reduce the gap between research and practice.

[1]  P. Basch.  Quality of health care delivered to adults in the United States. , 2003, New England Journal of Medicine.

[2]  M. Raebel,et al.  The Long-term Outcomes of Sibutramine Effectiveness on Weight (LOSE Weight) study: evaluating the role of drug therapy within a weight management program in a group-model health maintenance organization. , 2004, The American journal of managed care.

[3]  D. Rubin,et al.  The central role of the propensity score in observational studies for causal effects , 1983 .

[4]  Michael J. Goodman,et al.  Relationship between modifiable health risks and short-term health care charges. , 1999, JAMA.

[5]  A. Stewart,et al.  Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. , 1999, Medical care.

[6]  R. Goodman,et al.  Developing and Evaluating a Cardiovascular Risk Reduction Project. , 1997 .

[7]  R. Glasgow,et al.  Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. , 2003, American journal of public health.

[8]  L W Green,et al.  From research to "best practices" in other settings and populations. , 2001, American journal of health behavior.

[9]  B. Flay.  Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. , 1986, Preventive medicine.

[10]  Milton C. Weinstein,et al.  Recommendations for Reporting Cost-effectiveness Analyses , 1996 .

[11]  D. Barlow,et al.  Single Case Experimental Designs: Strategies for Studying Behavior Change , 1976 .

[12]  R. Kaplan.  The significance of quality of life in health care , 2004, Quality of Life Research.

[13]  P. Dolan,et al.  Using the person trade-off approach to examine differences between individual and social values. , 1998, Health economics.

[14]  P. Nutting,et al.  Practice-based research networks answer primary care questions. , 1999, JAMA.

[15]  K. Lorig,et al.  Long-Term Randomized Controlled Trials of Tailored-Print and Small-Group Arthritis Self-Management Interventions , 2004, Medical care.

[16]  R. Glasgow,et al.  Implementation, generalization and long-term results of the "choosing well" diabetes self-management intervention. , 2002, Patient education and counseling.

[17]  W. Shadish,et al.  Experimental and Quasi-Experimental Designs for Generalized Causal Inference , 2001 .

[18]  D. Berwick.  Disseminating innovations in health care. , 2003, JAMA.

[19]  P. Fishman,et al.  Health care costs among smokers, former smokers, and never smokers in an HMO. , 2003, Health services research.

[20]  Pierre-Andre La Chance,et al.  Cost-effectiveness of a hospital-based smoking cessation intervention. , 1998, Medical care.

[21]  Russell E. Glasgow,et al.  Take Heart II: Replication of a Worksite Health Promotion Trial , 1997, Journal of Behavioral Medicine.

[22]  Alastair Baker,et al.  Crossing the Quality Chasm: A New Health System for the 21st Century , 2001, BMJ : British Medical Journal.

[23]  S. Satya‐Murti.  Evidence-based Medicine: How to Practice and Teach EBM , 1997 .

[24]  Kurt C Stange,et al.  One minute for prevention: the power of leveraging to fulfill the promise of health behavior counseling. , 2002, American journal of preventive medicine.

[25]  Lisa M Klesges,et al.  Behavior change intervention research in healthcare settings: a review of recent reports with emphasis on external validity. , 2002, American journal of preventive medicine.

[26]  L. Beilin,et al.  Controlled comparison of retention and adherence in home- vs center-initiated exercise interventions in women ages 40-65 years: The S.W.E.A.T. Study (Sedentary Women Exercise Adherence Trial). , 2003, Preventive medicine.

[27]  Eva Nick,et al.  The dependability of behavioral measurements: theory of generalizability for scores and profiles , 1973 .

[28]  Russell E Glasgow,et al.  Translating research to practice: lessons learned, areas for improvement, and future directions. , 2003, Diabetes care.

[29]  Mark W. Lipsey,et al.  Design Sensitivity: Statistical Power for Experimental Research. , 1989 .

[30]  R. Senf.  Tactics of Scientific Research: Evaluating Experimental Data in Psychology , 1962 .

[31]  S. Fowler,et al.  Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. , 2002 .

[32]  C. Basch,et al.  Avoiding Type III Errors in Health Education Program Evaluations: A Case Study , 1985, Health education quarterly.

[33]  S. Wilson.  Methods for the economic evaluation of health care programmes , 1987 .

[34]  Katrina M. Krause,et al.  Primary care: is there enough time for prevention? , 2003, American journal of public health.

[35]  D. Stryer,et al.  Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. , 2003, JAMA.

[36]  Laurence H. Baker,et al.  Clinical Trials: Design, Conduct, and Analysis , 1987 .

[37]  Paul A Estabrooks,et al.  Beginning with the application in mind: Designing and planning health behavior change interventions to enhance dissemination , 2005, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[38]  R. Glasgow,et al.  A brief smoking cessation intervention for women in low-income planned parenthood clinics. , 2000, American Journal of Public Health.

[39]  David Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials , 2001, Annals of Internal Medicine.

[40]  M. Halloran,et al.  Cost-effectiveness of a routine varicella vaccination program for US children. , 1994, JAMA.

[41]  G H Guyatt,et al.  Users' guides to the medical literature: XXII: how to use articles about clinical decision rules. Evidence-Based Medicine Working Group. , 2000, JAMA.

[42]  Lisa M Klesges,et al.  The future of health behavior change research: What is needed to improve translation of research into health promotion practice? , 2004, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[43]  L. Delbeke.  Quasi-experimentation - design and analysis issues for field settings - cook,td, campbell,dt , 1980 .

[44]  R. Glasgow,et al.  Evaluating the public health impact of health promotion interventions: the RE-AIM framework. , 1999, American journal of public health.