An International Perspective on Improving the Quality and Potential of Behavioral Clinical Trials

详细信息    查看全文

• 作者：Simon L. Bacon (1) (2) (3)
  Kim L. Lavoie (1) (4)
  Gregory Ninot (5) (6)
  Susan Czajkowski (7)
  Kenneth E. Freedland (8)
  Susan Michie (9)
  Paul Montgomery (10)
  Lynda H. Powell (11)
  Bonnie Spring (12)
  for the International Behavioural Trials Network (IBTN)
  
• 关键词：Behavioral trials ; Clinical trials ; Control groups ; Methodology ; Outcomes ; Treatment fidelity ; International Behavioural Trials Network
• 刊名：Current Cardiovascular Risk Reports
• 出版年：2015
• 出版时间：January 2015
• 年：2015
• 卷：9
• 期：1
• 全文大小：176 KB
• 参考文献：1. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095鈥?28. CrossRef
  2. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990鈥?010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163鈥?6. CrossRef
  3. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990? 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2197鈥?23. CrossRef
  4. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990鈥?010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2224鈥?0. CrossRef
  5. Mozaffarian D, Wilson PWF, Kannel WB. Beyond established and novel risk factors: lifestyle risk factors for cardiovascular disease. Circulation. 2008;117(23):3031鈥?. CrossRef
  6. Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000;343(1):16鈥?2. CrossRef
  7. Folsom AR, Yatsuya H, Nettleton JA, et al. Community prevalence of ideal cardiovascular health, by the American Heart Association definition, and relationship with cardiovascular disease incidence. J Am Coll Cardiol. 2011;57(16):1690鈥?. CrossRef
  8. Spring B, Moller AC, Colangelo LA, et al. Healthy lifestyle change and subclinical atherosclerosis in young adults: Coronary Artery Risk Development in Young Adults (CARDIA) study. Circulation. 2014;130(1):10鈥?. CrossRef
  9. Critchley JA, Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart disease. JAMA. 2003;290(1):86鈥?7. CrossRef
  10. Moullec G, Laurin C, Lavoie KL, Ninot G. Effects of pulmonary rehabilitation on quality of life in chronic obstructive pulmonary disease patients. Curr Opin Pulm Med. 2011;17(2):62鈥?1. CrossRef
  11. Gordon L, Graves N, Hawkes A, Eakin E. A review of the cost-effectiveness of face-to-face behavioural interventions for smoking, physical activity, diet and alcohol. Chronic Illn. 2007;3(2):101鈥?9. CrossRef
  12. Kangas M, Bovbjerg DH, Montgomery GH. Cancer-related fatigue: a systematic and meta-analytic review of non-pharmacological therapies for cancer patients. Psychol Bull. 2008;134(5):700鈥?1. CrossRef
  13. Langford DJ, Lee K, Miaskowski C. Sleep disturbance interventions in oncology patients and family caregivers: a comprehensive review and meta-analysis. Sleep Med Rev. 2012;16(5):397鈥?14. CrossRef
  14. Gage JD, Everett KD, Bullock L. A review of research literature addressing male partners and smoking during pregnancy. J Obstet Gynecol Neonatal Nurs. 2007;36(6):574鈥?0. CrossRef
  15. Turner L, Shamseer L, Altman D, Schulz K, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev. 2012;1(1):60. CrossRef
  16. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Brit Med J. 2010;340(340):698鈥?02. / This paper provides the details of the elements of the CONSORT Statement which are key to reporting randomised clinical trials.
  17. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Int Med. 2008;148(4):295鈥?09. CrossRef
  18. Montgomery P, Grant S, Hopewell S, et al. Protocol for CONSORT-SPI: an extension for social and psychological interventions. Implement Sci. 2013;8(1):99. CrossRef
  19. Chan A-W, Tetzlaff JM, G酶tzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Brit Med J. 2013;346:e7586. CrossRef
  20. Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81鈥?5. / The Behavior Change Technique Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an International Consensus for the Reporting of Behavior Change Interventions. CrossRef
  21. Michie S, van Stralen M, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42. CrossRef
  22. Hoffmann TC, Glasziou PP, Boutron I, et al. (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. Brit Med J. 348.
  23. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010;1(1):6鈥?0.
  24. Greenwald P, Cullen JW. The new emphasis in cancer control. J Natl Cancer Inst. 1985;74(3):543鈥?1.
  25. Czajkowski SM, Powell LH, Adler N, et al. From ideas to efficacy: the ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2014. This paper outlines the key elements of the ORBIT behavioural intervention development model which provides a usable framework for intervention development and testing.
  26. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research council guidance. Brit Med J. 2008;337:a1655. CrossRef
  27. Wade DT. Outcome measures for clinical rehabilitation trials: impairment, function, quality of life, or value? Am J Phys Med Rehabil. 2003;82(10):S26鈥?1. CrossRef
  28. Moncher FJ, Prinz RJ. Treatment fidelity in outcome studies. Clin Psychol Rev. 1991;11(3):247鈥?6. CrossRef
  29. Montgomery P, Underhill K, Gardner F, Operario D, Mayo-Wilson E. The Oxford Implementation Index: a new tool for incorporating implementation data into systematic reviews and meta-analyses. J Clin Epidemiol. 2013;66(8):874鈥?2. CrossRef
  30. Guydish J, Campbell BK, Manuel JK, et al. Does treatment fidelity predict client outcomes in 12-Step Facilitation for stimulant abuse? Drug Alcohol Depend. 2014;134:330鈥?. CrossRef
  31. Perepletchikova F, Treat TA, Kazdin AE. Treatment integrity in psychotherapy research: analysis of the studies and examination of the associated factors. J Consult Clin Psychol. 2007;75(6):829鈥?1. CrossRef
  
• 作者单位：Simon L. Bacon (1) (2) (3)
  Kim L. Lavoie (1) (4)
  Gregory Ninot (5) (6)
  Susan Czajkowski (7)
  Kenneth E. Freedland (8)
  Susan Michie (9)
  Paul Montgomery (10)
  Lynda H. Powell (11)
  Bonnie Spring (12)
  for the International Behavioural Trials Network (IBTN)
  
  1. Montreal Behavioural Medicine Centre, H么pital du Sacr茅-C艙ur de Montr茅al, Montreal, Quebec, Canada
  2. Centre de r茅adaptation Jean-Jacques-Gauthier, H么pital du Sacr茅-C艙ur de Montr茅al, Montreal, Quebec, Canada
  3. Department of Exercise Science, Concordia University, Montreal, Quebec, Canada
  4. Department of Psychology, Universit茅 du Qu茅bec 脿 Montr茅al, Montreal, Quebec, Canada
  5. Epsylon Research Unit, University of Montpellier, Montpellier, France
  6. iCEPS, University of Montpellier, Montpellier, France
  7. National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA
  8. Department of Psychiatry, Washington University School of Medicine, St. Louis, USA
  9. Department of Clinical, Educational and Health Psychology, University College London, London, UK
  10. Centre for Evidence-Based Intervention, Oxford University, Oxford, UK
  11. Department of Preventive Medicine, Rush University Medical Center, Chicago, USA
  12. Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA
  
• ISSN：1932-9563

文摘

Healthy behaviors (e.g., eating a healthy diet, engaging in regular physical activity, smoking cessation) are associated with a reduction in the incidence and mortality of chronic non-communicable diseases (NCDs), including cardiovascular disease. There have been many examples of health behavior interventions leading to improvements in NCDs and their risk factors, such as hypertension. However, despite their potential benefits, the uptake of existing behavioral interventions has been limited. Among many barriers to implementation of behavioral treatments are concerns about methodological inadequacies. The current manuscript discusses recent advances in frameworks for the development of interventions, the reporting of trials and their protocols, and areas which need further work. The goal of this article is to increase awareness and encourage further debate about how best to promote high-quality behavioral intervention research.