Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Dec 4:9:184.
doi: 10.1186/s13012-014-0184-y.

Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach

Marcel Mertz  1   2 , Daniel Strech  3
Affiliations

Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach

Marcel Mertz et al. Implement Sci. .

Abstract

Background: Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs.

Methods: The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach.

Results: The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs.

Conclusions: If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed should serve as a basis for further discussion on how to reach these goals. It breaks open the black box of what ethicists implicitly do when they develop recommendations. Further, interdisciplinary discussion and pilot tests are needed to explore the minimal requirements that guarantee a simplified procedure which is still acceptable and does not become mere window dressing.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Visualization of step 1.
Figure 2
Figure 2
Visualization of step 2.
Figure 3
Figure 3
Visualization of steps 3 and 4.
Figure 4
Figure 4
Visualization of step 5.
Figure 5
Figure 5
Visualization of step 6.
See this image and copyright information in PMC

References

    1. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–926. doi: 10.1136/bmj.39489.470347.AD. - DOI - PMC - PubMed
    1. Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, Lewis SZ, Nathanson I, Jaeschke R, Schunemann H. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med. 2010;152(11):738–741. doi: 10.7326/0003-4819-152-11-201006010-00254. - DOI - PubMed
    1. Harding E, Pettinari CJ, Brown D, Hayward M, Taylor C. Service user involvement in clinical guideline development and implementation: learning from mental health service users in the UK. Int Rev Psychiatry. 2011;23(4):352–357. doi: 10.3109/09540261.2011.606802. - DOI - PubMed
    1. IOM: Clinical practice guidelines we can trust. Washington D.C.: National Academies Press, Institute of Medicine (IOM); 2011.
    1. Foundation ABIM, ACP–ASIM Foundation, European Federation of Internal Medicine Medical professionalism in the new millennium: a physicians' charter. Lancet. 2002;359(9305):520–522. doi: 10.1016/S0140-6736(02)07684-5. - DOI - PubMed

LinkOut - more resources