Skip to main content
Log in

Guidelines 2.0: Do No Net Harm—The Future of Practice Guideline Development in Asthma and Other Diseases

  • Published:
Current Allergy and Asthma Reports Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: •Of importance •• Of major importance

  1. Terracciano L, Brozek J, Compalati E, Schunemann H. GRADE system: new paradigm. Curr Opin Allergy Clin Immunol. 2010;10(4):377–83.

    Article  PubMed  Google Scholar 

  2. • 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.

  3. 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.

    PubMed  Google Scholar 

  4. 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.

    Article  PubMed  Google Scholar 

  5. 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.

    Article  PubMed  Google Scholar 

  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.

  7. 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.

    Article  PubMed  Google Scholar 

  8. 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).

  9. 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.

    Google Scholar 

  10. 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.

    PubMed  Google Scholar 

  11. 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.

    Article  PubMed  Google Scholar 

  12. Eichacker PQ, Natanson C, Danner RL. Surviving sepsis–practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med. 2006;355(16):1640–2.

    Article  PubMed  CAS  Google Scholar 

  13. 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.

    Article  PubMed  CAS  Google Scholar 

  14. 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.

    Article  PubMed  CAS  Google Scholar 

  15. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA. 2009;301(4):429–31.

    Article  PubMed  CAS  Google Scholar 

  16. Lo B, Fields M. Conflict of interest in medical research, education and practice. Washington: The National Academies Press, Institute of Medicine; 2009.

    Google Scholar 

  17. 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.

    Google Scholar 

  18. 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.

    Article  PubMed  Google Scholar 

  19. 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.

    Article  PubMed  Google Scholar 

  20. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167–70.

    Article  PubMed  Google Scholar 

  21. Bradbury J. Storm over WHO-ISH hypertension guidelines. Lancet. 1999;353(9152):563.

    Article  Google Scholar 

  22. Horton R. WHO: the casualties and compromises of renewal. The Lancet. 2002;359:1605–11.

    Article  Google Scholar 

  23. 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.

    Article  PubMed  Google Scholar 

  24. McCarthy M. Critics slam draft WHO report on homeopathy. The Lancet. 2005;366(9487):705.

    Article  Google Scholar 

  25. 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.

    Article  PubMed  CAS  Google Scholar 

  26. 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.

    Article  PubMed  CAS  Google Scholar 

  27. Baverstock K. A time to ask what you want of WHO. Brit Med J. 2003;327(7406):111.

    Article  Google Scholar 

  28. 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.

    Article  PubMed  Google Scholar 

  29. 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).

  30. Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284(17):2209–14.

    Article  PubMed  CAS  Google Scholar 

  31. Campbell EG. Doctors and drug companies–scrutinizing influential relationships. N Engl J Med. 2007;357(18):1796–7.

    Article  PubMed  CAS  Google Scholar 

  32. 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.

    Article  PubMed  Google Scholar 

  33. 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.

    Article  PubMed  CAS  Google Scholar 

  34. 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.

    PubMed  Google Scholar 

  35. 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.

    Article  PubMed  Google Scholar 

  36. 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.

    Article  PubMed  Google Scholar 

  37. Glasziou P, Chalmers I, Rawlins M, McCulloch P. When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007;334(7589):349–51.

    Article  PubMed  Google Scholar 

  38. 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.

    PubMed  Google Scholar 

  39. 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.

    Article  PubMed  Google Scholar 

  40. Krahn M, Naglie G. The next step in guideline development: incorporating patient preferences. JAMA. 2008;300(4):436–8.

    Article  PubMed  CAS  Google Scholar 

  41. 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.

    Article  PubMed  Google Scholar 

  42. 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.

    Article  PubMed  Google Scholar 

  43. 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.

Download references

Disclosure

Dr. Schünemann is a member of the GRADE Working Group (currently co-chair) that developed the GRADE approach.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Holger J. Schünemann.

Rights and permissions

Reprints 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

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11882-011-0185-8

Keywords

Navigation