Abstract
Decisions are like double-edged swords: they always come with benefits and downsides. That is, any decision in life bears desirable and undesirable consequences, even if the latter only involves the time it takes to make or think about the decision, which can be considered the harm of decision making. Therefore, it is impossible to adhere to the Hippocratic Oath’s concept of “primum non nocere,” which is frequently interpreted as “never do harm.” The guiding principle for health care decision making should be to ensure that there is, in summary, more benefit than harm—in other words, “to do no net harm” (“primum non net nocere”). Practice guidelines support decision making and, as a consequence, would require the explicit consideration of both desirable and undesirable consequences, and assigning due considerations depending on the magnitude and importance of the consequences. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group (http://www.gradeworkinggroup.org) has made these considerations more explicit when developing health care recommendations. This article briefly summarizes the work of the GRADE working group based on examples of its application in the field of allergy and asthma, and provides an outlook for advances in the field of guideline development. These developments focus on funding of guidelines and handling conflict of interest, working with observational and diagnostic test accuracy studies, developing appropriate group processes, and the integration of values and preferences in the formulation of recommendations.
Similar content being viewed by others
References
Papers of particular interest, published recently, have been highlighted as: •Of importance •• Of major importance
Terracciano L, Brozek J, Compalati E, Schunemann H. GRADE system: new paradigm. Curr Opin Allergy Clin Immunol. 2010;10(4):377–83.
• Guyatt GH, Oxman AD, Schunemann HJ, Tugwell P, Knotterus A. GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. J Clin Epidemiol. 2010 Dec 23. This is an introduction to a detailed series on GRADE and guideline development. It includes guidance from question development to group processes.
Schunemann HJ, Best D, Vist G, Oxman AD. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. CMAJ. 2003;169(7):677–80.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490.
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–6.
•• Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126(3):466–76. These are the new ARIA guidelines developed using the GRADE approach.
Schunemann HJ, Hill SR, Kakad M, Vist GE, Bellamy R, Stockman L, et al. Transparent development of the WHO rapid advice guidelines. PLoS Med. 2007;4(5):e119.
Barbui C, Dua T, van Ommeren M, Yasamy MT, Fleischmann A, Clark N, et al. Challenges in developing evidence-based recommendations using the GRADE approach: the case of mental, neurological, and substance use disorders. PLoS Med. 2010;7(8).
Fiocchi A, Schunemann HJ, Brozek J, Restani P, Beyer K, Troncone R, et al. Diagnosis and Rationale for Action Against Cow's Milk Allergy (DRACMA): a summary report. J Allergy Clin Immunol. 2010;126(6):1119–28 e12.
Fiocchi A, Brozek J, Schunemann H, Bahna SL, von Berg A, Beyer K, et al. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guidelines. Pediatr Allergy Immunol. 2010;21 Suppl 21:1–125.
Schunemann HJ, Woodhead M, Anzueto A, Buist S, Macnee W, Rabe KF, et al. A vision statement on guideline development for respiratory disease: the example of COPD. Lancet. 2009;373(9665):774–9.
Eichacker PQ, Natanson C, Danner RL. Surviving sepsis–practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med. 2006;355(16):1640–2.
Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD, Hale RW, et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA. 2009;301(13):1367–72.
Lurie P, Almeida CM, Stine N, Stine AR, Wolfe SM. Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings. JAMA. 2006;295(16):1921–8.
Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA. 2009;301(4):429–31.
Lo B, Fields M. Conflict of interest in medical research, education and practice. Washington: The National Academies Press, Institute of Medicine; 2009.
Lo B, Fields M. Principles for identifying and assessing conflicts of interest. Conflict of interest in medical research, education and practice. Washington: National Academies Press, Institute of Medicine; 2009.
Schunemann H, Osborne M, Moss J, Manthous C, Wagner G, Sicilian L, et al. An official American Thoracic Society Policy statement: managing conflict of interest in professional societies. Am J Respir Crit Care Med. 2009;180(6):564–80.
Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290(7):921–8.
Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167–70.
Bradbury J. Storm over WHO-ISH hypertension guidelines. Lancet. 1999;353(9152):563.
Horton R. WHO: the casualties and compromises of renewal. The Lancet. 2002;359:1605–11.
Laing R, Waning B, Gray A, Ford N, Thoen E. 25 years of the WHO essential medicines lists: progress and challenges. Lancet. 2003;361(9370):1723–9.
McCarthy M. Critics slam draft WHO report on homeopathy. The Lancet. 2005;366(9487):705.
Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA. 1999;281(20):1900–5.
Grilli R, Magrini N, Penna A, Mura G, Liberati A. Practice guidelines developed by specialty societies: the need for a critical appraisal. Lancet. 2000;355(9198):103–6.
Baverstock K. A time to ask what you want of WHO. Brit Med J. 2003;327(7406):111.
Lantos PM, Charini WA, Medoff G, Moro MH, Mushatt DM, Parsonnet J, et al. Final report of the Lyme disease review panel of the infectious diseases society of America. Clin Infect Dis. 2010;51(1):1–5.
Boyd EA, Baumann M, Curtis JR, Field M, Jaeschke R, Osborne M, et al., editors. Guideline Funding and Conflicts of Interest. The American Thoracic Society; 2011 (in press).
Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284(17):2209–14.
Campbell EG. Doctors and drug companies–scrutinizing influential relationships. N Engl J Med. 2007;357(18):1796–7.
Jacobs AK, Lindsay BD, Bellande BJ, Fonarow GC, Nishimura RA, Shah PM, et al. Task force 3: disclosure of relationships with commercial interests: policy for educational activities and publications. J Am Coll Cardiol. 2004;44(8):1736–40.
Schunemann HJ, Hill SR, Kakad M, Bellamy R, Uyeki TM, Hayden FG, et al. WHO Rapid Advice Guidelines for pharmacological management of sporadic human infection with avian influenza A (H5N1) virus. Lancet Infect Dis. 2007;7(1):21–31.
Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, et al. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med. 2010;152(11):738–41.
Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336(7651):995–8.
Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003;327(7429):1459–61.
Glasziou P, Chalmers I, Rawlins M, McCulloch P. When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007;334(7589):349–51.
Schunemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, et al. GRADE: assessing the quality of evidence for diagnostic recommendations. ACP J Club. 2008;149(6):2.
Schunemann HJ, Fretheim A, Oxman AD. Improving the use of research evidence in guideline development: 10. Integrating values and consumer involvement. Health Res Policy Syst. 2006;4:22.
Krahn M, Naglie G. The next step in guideline development: incorporating patient preferences. JAMA. 2008;300(4):436–8.
Oxman AD, Bjorndal A, Becerra-Posada F, Gibson M, Block MA, Haines A, et al. A framework for mandatory impact evaluation to ensure well informed public policy decisions. Lancet. 2010;375(9712):427–31.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010;63(12):1308–11.
Guyatt G, Oxman AD, Akl E, Kunz R, Vist G, Brozek J, et al. GRADE guidelines 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol/ 2010.
Disclosure
Dr. Schünemann is a member of the GRADE Working Group (currently co-chair) that developed the GRADE approach.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Schünemann, H.J. Guidelines 2.0: Do No Net Harm—The Future of Practice Guideline Development in Asthma and Other Diseases. Curr Allergy Asthma Rep 11, 261–268 (2011). https://doi.org/10.1007/s11882-011-0185-8
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11882-011-0185-8