Holger J. Schünemann, MD, PhD, MSc; Lubna A. Al-Ansary, MBBS, MSc; Frode Forland, MD, DPH; Sonja Kersten, MSc; Jorma Komulainen, MD, PhD; Ina B. Kopp, MD; Fergus Macbeth, MA, DM; Susan M. Phillips, BSc (Hons), DPhil; Craig Robbins, MD, MPH; Philip van der Wees, PT, PhD; Amir Qaseem, MD, PhD, MHA; for the Board of Trustees of the Guidelines International Network *
Disclaimer: The 2012 to 2014 Guidelines International Network (G-I-N) Board of Trustees (BoT) is responsible for the content of this article. This article does not necessarily reflect the views or policies of the membership of the G-I-N.
Acknowledgment: The authors thank members of the 2012 to 2014 G-I-N BoT who all commented on this manuscript. For more about contributions, see the Appendix.
Financial Support: From the academic institutions of the authors and the G-I-N's operating budget.
Disclosures: Dr. Schünemann reports that G-I-N paid for travel to BoT meetings outside the submitted work. He has researched and written policies on COI management. He recognized attachments to his views early in this process and emphasized approaching the policies and procedures of all organizations with an open mind. He has no affiliation with an institution or affiliation that has an interest in promulgating a specific view on COIs. Dr. Kersten reports that Integraal Kankercentrum Nederland is a government-funded organization; she received nonfinancial support as a member of the G-I-N BoT outside the submitted work. Dr. van der Wees reports that he was the Chair of the G-I-N from 2010 to 2012. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1885.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: Holger J. Schünemann, MD, PhD, MSc, Department of Clinical Epidemiology & Biostatistics, McMaster University, Health Science Center Room 2C16, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; e-mail, email@example.com.
Current Author Addresses: Dr. Schünemann: Department of Clinical Epidemiology & Biostatistics, McMaster University, Health Science Center Room 2C16, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.
Ms. Al-Ansary: Department of Family & Community Medicine, College of Medicine, King Saud University, PO Box 2925, Riyadh 11461, Saudi Arabia.
Dr. Forland: Department of International Public Health, Norwegian Institute of Public Health, Marcus Thranes Gate 6, 0473 Oslo, Norway.
Dr. Komulainen: Finnish Medical Society Duodecim, PO Box 713, Kalevankatu 3 B, 00101 Helsinki, Finland.
Dr. Kopp: Association of the Scientific Medical Societies in Germany–Institute for Medical Knowledge Management, Philipp University of Marburg, Karl-von-Frisch-Street 1, 35043 Marburg, Germany.
Ms. Kersten: Integraal Kankercentrum Nederland, Godebaldkwartier 419, 3511 DT Utrecht, the Netherlands.
Dr. Macbeth: Wales Cancer Trials Unit, Cardiff University, Cardiff CF14 4YS, United Kingdom.
Dr. Phillips: Therapeutic Guidelines, 473 Victoria Street, West Melbourne, Victoria 3003, Australia.
Dr. Robbins: Colorado Permanente Medical Group, 16290 East Quincy Avenue, Aurora, CO 80015.
Dr. van der Wees: Radboud University Medical Center, Scientific Institute for Quality of Healthcare (IQ healthcare), Celsus, Academy for Sustainable Healthcare, PO Box 9101, 114 IQ Healthcare, 6500 HB Nijmegen, the Netherlands.
Dr. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Author Contributions: Conception and design: H.J. Schünemann, P. van der Wees, F. Forland, F. Macbeth, A. Qaseem.
Analysis and interpretation of the data: H.J. Schünemann, F. Macbeth, A. Qaseem.
Drafting of the article: H.J. Schünemann, F. Macbeth.
Critical revision of the article for important intellectual content: H.J. Schünemann, L.A. Al-Ansary, F. Forland, S. Kersten, J. Komulainen, I.B. Kopp, F. Macbeth, S.M. Phillips, P. van der Wees, C. Robbins.
Final approval of the article: H.J. Schünemann, L.A. Al-Ansary, F. Forland, J. Komulainen, I.B. Kopp, F. Macbeth, S.M. Phillips, P. van der Wees, C. Robbins, A. Qaseem.
Provision of study materials or patients: H.J. Schünemann, I.B. Kopp, F. Macbeth, S.M. Phillips.
Administrative, technical, or logistic support: H.J. Schünemann.
Collection and assembly of data: H.J. Schünemann.
Conflicts of interest (COIs) have been defined by the American Thoracic Society as “a divergence between an individual's private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual's professional actions or decisions are motivated by personal gain, such as direct financial, academic advancement, clinical revenue streams, or community standing.” In the context of guideline development, the concerns are not simply about identifying and disclosing direct financial or indirect COIs. Despite this recognition, the management of COIs in guidelines is often unsatisfactory. In response to requests from its international membership and informed by existing syntheses of the evidence and policies of international organizations, the Guidelines International Network Board of Trustees developed guidance on the disclosure of interests and management of COIs. Current approaches are relatively similar throughout the guideline development community, with an increasing recognition of the importance of disclosing and managing indirect COIs. Although there are differences in detail among the approaches, the similarities allow for the formulation of 9 core principles for managing COIs. In formulating these principles, the Guidelines International Network Board of Trustees recognizes that COIs cannot be totally avoided when panel members are being chosen for certain guidelines or in certain settings; thus, the important issue is the management of COIs in a fair, judicious, transparent manner.
Table. Types and Examples of Conflicts of Interest in Guidelines
Appendix Table 1. “Weight” of potential conflict of interest based on “value.”**
Appendix Table 2. Relevance to the topic.*
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Brian F. Leas, Craig A. Umscheid
Center for Evidence-based Practice, University of Pennsylvania Health System
November 2, 2015
Conflict of Interest:
The authors’ employer is an institutional member of Guidelines International Network (GIN), and the authors serve on the host committee (BFL, CAU) and scientific committee (CAU) for GIN’s 2016 annual conference.”
Guidelines international network: principles for disclosure of interests and management of conflicts in guidelines
We commend the Guidelines International Network (G-I-N) for highlighting the challenges associated with disclosure and management of conflicts of interest (COIs) during guideline development.1 We especially applaud G-I-N for drawing attention to nonfinancial indirect COIs, including personal ideologies or characteristics, that may influence an individual’s perspective and potentially warrant disclosure. But there is a related dilemma that guideline panels, as well as authors and journal editors, should consider when addressing nonfinancial indirect COIs: balancing the need for transparency with respect for privacy. We encountered this challenge recently when performing a systematic review2 examining the association between Jewish ritual circumcision with direct oral suction and neonatal herpes simplex virus infection. We decided to volunteer private details about ourselves and our families that we believed would be important to readers:“B. F. L. is an adherent of Orthodox Judaism, and is not affiliated with the religious sects that commonly practice direct oral suction during circumcision… B. F. L. and his sons underwent ritual Jewish circumcision, without direct oral suction. C. A. U. is a non-practicing Roman Catholic whose wife affiliates with secular Judaism. C. A. U. and his son were circumcised by pediatricians in the hospital setting.”Revealing such personal details is certainly uncommon. In our situation, we disclosed this information to be transparent about our perspectives given the controversial nature of the practice and related cultural and religious significance. However, in the six published studies included in our review, none of the 36 original authors disclosed their circumcision status or religious affiliation, or that of their families. Similarly, recent guidance from the American Academy of Pediatrics’ Task Force on Circumcision included no such disclosures.3 Our disclosure was sufficiently novel that it attracted media attention.4Disclosure of private medical information, or personal characteristics such as faith, race, sexual orientation, or political preferences, is not mandated by guideline panels or journal editorial policies. Moreover, guideline end-users and the scientific community at large do not usually expect this type of transparency. However, rigorous scientific methods and diligent guideline panels cannot realistically eliminate the impact of personal traits or experiences, nor should they necessarily strive to do so. Although G-I-N has taken an important step towards addressing nonfinancial indirect COIs, adequate guidance regarding disclosure of these COIs remains lacking. We encourage the scientific, publishing, and bioethics communities to foster further discussion of how to expand consideration of nonfinancial indirect COIs while respecting individual privacy.References1. Schunemann HJ, Al-Ansary L, Forland F, et al. Guidelines international network: principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med. 2015; 163:548-553.2. Leas BF and Umscheid CA. Neonatal herpes simplex virus type 1 infection and Jewish ritual circumcision with oral suction: a systematic review. J Pediatric Infect Dis Soc. 2015; 4(2):126-131.3. American Academy of Pediatrics Task Force on Circumcision. Technical report: male circumcision. Pediatrics. 2012;130(3):e756-e785.4. Burling S. Research examines infection and a method of circumcision. Philadelphia Inquirer. July 31, 2014.
Humphreys H, Mac Lellan K
Royal College of Surgeons in Ireland, Beaumont Hospital and the Department of Health, Dublin, Ireland
Balancing conflicts of interest
TO THE EDITOR: We read with interest the study by Schünemann and colleagues (1), given our role in Ireland in the prioritisation and quality assurance of guidelines for national endorsement (2). Direct financial conflicts of interest (COIs) are easy to understand given that those involved benefit financially, and may conflict with a national or professional recommendation. Funding for research should be included as an indirect financial COI, whether from commercial, national or charitable sources, as this has the capacity to enhance professional careers and may predispose a guideline developer to the products or perspectives of the funder.Addressing indirect COIs can be challenging, especially where there is a limited number of guideline developers. The National Clinical Effectiveness Committee (NCEC) in Ireland has a major role in patient safety under the remits of guideline prioritisation, endorsement, quality assurance, and audit (2). While international studies and data are used in guideline development and international peer review is mandatory, we are dependent on a small pool of practitioners. Many of those involved would have indirect COIs, e.g. being acknowledged experts and providing professional leadership. Nonetheless, they bring to guideline development considerable expertise, wisdom and importantly may also have implementation and operational accountability responsibilities. Those who financially benefit directly such as through having stock options, and those with a strong vested interest, e.g. being clearly identified as having disproportionately strong views, should be excluded. However, for those with indirect COIs, the balance may be in retaining them in guideline development but in ensuring that there is transparency in terms of the nature of the indirect COIs. Ideally, the strength of the scientific evidence should inform the recommendations and balance any strong views. Unfortunately, the quality of evidence may sometimes not be sufficient to achieve that and it is therefore essential that all involved should transparently declare all potential COIs to ensure that the process is not compromised.The ultimate aim is to promote high quality clinical practice informed and directed by the evidence. The underlying processes should be ethical, transparent and appropriate. Such processes must also be proportionate, such that those who have important contributions to make and who may by virtue of clinical leadership or operational responsibilities be key to implementation, are not excluded from the process. References1. Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in Guidelines. Ann Intern Med 2015; 163: 548-553.2. National Clinical Effectiveness Committee. www.health.gov.ie/patient-safety/ncec
Bruce Davidson, MD, MPH
University of Washington
November 19, 2015
The Annals’ new Guidelines International Network (GIN) interest group statement (1) discards the Institute of Medicine conclusions and attempts to equate “members with direct financial” COIs and members with “relevant indirect COIs”, writing they should not be included in guideline development, but can be if “managed”. Where this is practiced, an expert medical scientist in an area would be perceived similarly conflicted to a physician or PhD-holder taking tens of thousands of dollars from a company. The latter have influenced guidelines a long time. The Chair of GIN neglects to disclose he is an institutional colleague of plenty of guidelines writers with direct financial conflicts, whom he and co-authors may now cover with their GIN article by lumping together cash gains with the scholarly production of medical scientists. Does Dr Schunemann believe that this benefit for his very own university colleagues with cumulative earnings in the hundreds of thousands is not a personal conflict of interest for him? Inherent to science are skepticism about one’s own results, modesty regarding their meaning, and openness to other viewpoints. Expert guideline panelists who love research, those who seek institutional promotion and fame, those who take money from outside companies—either consistently display these qualities, or they don’t and should be removed as panelists. The GIN committee’s equating the scholarly work of clinical medicine with taking money from outside commercial entities is a cynical undermining of honest medical scientists at every institution. It has no ethical or professional legitimacy. Sincerely yours,Bruce L Davidson MD, MPH, FACP 1. 1. Schunemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB et al. Guidelines International Network: Principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med 2015;163:548-553.
Holger Schünemann, on behalf of authors of the original article
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
December 16, 2015
Conflict of Interest:
The author is a member of the Guideline International Network (GIN) Board of Trustees. No financial interests or relationships exists that is relevant to this response letter.
Principles for Disclosure of Interests and Management of Conflicts in Guidelines: desirable and undesirable action and consequences
To the editor,We thank Drs. Humphrey and Mac Lellan for their comment on the Guideline International Network (GIN) Principles for Conflict of Interest Declaration and Management (1). The authors request that for panel members with indirect conflicts of interest the balance must be in retaining them in guideline development but in ensuring that there is transparency in terms of the nature of the indirect conflicts of interest. They also state that ideally the strength of the scientific evidence should inform the recommendations and balance any strong views. We agree with these demands and have laid those out in the article as published. We emphasize that transparent processes and evaluating the certainty in (or strength or quality of) the evidence are key issues in developing trustworthy recommendations (2). However, in addition to weighing the certainty of the scientific evidence other factors that determine the strength and direction of a recommendation should be considered transparently which inevitably require additional judgments such as use of resources, values and preferences and equity considerations (3, 4). We also agree that key leaders should not be excluded from the process as long as the potential interests or conflicts of interest can be managed. However, in many situations there is a large pool of potential contributors to choose from and those with the least potential for conflicts rather than those with clear and declared interests should be chosen in guideline panels.Dr. Leas and Umscheidt comment on the disclosure of non-financial conflicts of interest. They comment on the level of personal details that should be revealed in clinical practice guidelines. We feel that the disclosure of private medical information might not be relevant or kept on file if it leads to inappropriate consequences such as discrimination. Moreover, a solution to addressing the issue of intellectual conflicts and non-direct financial conflicts of interest may be to describe that certain views or personal traits were present without necessarily disclosing them. Furthermore, we agree that additional guidance regarding disclosure of non-financial conflicts of interest would be helpful. In our article on the principles of declaration and management of conflicts of interest, we do describe several of those potential strategies. Again we thank both author teams for the interest they have expressed in our work.*Original authors who confirmed agreement with this response letter in a timely fashion: Forland F, Kersten S, Komulainen J, Kopp IB, MacBeth F, Phillips SM, Robbins C, Qaseem A. 1. Schunemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163(7):548-53.2. Schunemann HJ, Wiercioch W, Etxeandia I, Falavigna M, Santesso N, Mustafa R, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42.3. World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis Interim policy guidance http://apps.who.int/iris/bitstream/10665/137334/1/WHO_HTM_TB_2014.23_eng.pdf?ua=1&ua=1 Accessed 8 Dec 2014.; 2014.4. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance http://apps.who.int/iris/bitstream/10665/75146/1/9789241548441_eng.pdf . Accessed 8 Dec 2014.; 2013.
Alexander Nast, MD
Head of Guidelines Committee of the European Dermatology Forum, Divison of Evidence based Medicine, Charité - Universtitätsmedizin Berlin, Berlin Germany
December 21, 2015
No interest - no motivation.
Guidelines international network: principles for disclosure of interests and management of conflicts in guidelinesTO THE EDITOR:I read with great interest the publication on “GINs principles for disclosure of interests and the management of conflicts”. Applying the principles to the currently broad spectrum of different guidelines systems is a challenge. As a main requirement, Schuenemann et al are asking for a limitation of member with indirect conflict of interests (COIs) and for an exclusion of members with direct COIs. The definition of indirect is very broad, including “gaining clinical income from the recommendation” would apply to almost anybody working in that field in case of any frequent disease or widely used intervention. Excluding or limiting the number of such panel members leaves us with the question of who is supposed to write guidelines in the future? From where do we get these ideal guideline panel members without any indirect or direct COI, who are willing to extract study results into long GRADE tables, to travel and to sit through extensive consensus conferences?If an ideal guidelines group consists of more than fifty percent non specialists in the field without any interest in the guidelines topic, how are we going to motivate them to work on the guidelines? If we are envisaging a system where a neurosurgeon is heading a dermatological guideline group, 60% of the guidelines team consist of health economists, master in public health, health scientists and doctors from other specialties, someone will have to pay them for spending their time with “pimples, pustules and scaling”; where they would usually show no interest in. Since support from pharmaceutical company is critical, public funding or funding from health insurance comes into play. However, are these institutions free from COIs? And what do we do in countries such as Germany, where no such money can be obtained easily from the government or health insurance companies? And even if government agencies did provide financial support, is it really the right path for the future to hand over control to government run guidelines agencies, where we could assume that cost cutting is likely to be the primary interest. In an ideal world, with abundant independent funding, given to an independent group with a good mixture of experts in the field (who always will have some interests / conflicts of interest in their topic) and “neutral” members employed for their work may work, unfortunately, up to now I am not aware of any country where such ideal conditions exist.Keeping this in mind, I consider the GIN principles a valuable stimulus, but we should be careful to expect worldwide immediate adaption of these principles and should be particularly careful in judging guidelines developed from groups not following the principle as “conflicted” or not “trustworthy”.
William R. Phillips, MD, MPH
University of Washington
January 6, 2016
American Academy of Family Physicians Pioneered Full Disclosure in Clinical Guidelines
TO THE EDITOR:With the publication of principles for disclosing and managing conflicts of interests in clinical guidelines, the Guidelines International Network (1) has done a service to the developers and users of clinical practice guidelines and to the patients they serve. The pioneering work in this area was done by the American Academy of Family Physicians, which published in 1994 the first international call for explicit declaration of conflicts of interest in the development of clinical practice guidelines (2). William R. Phillips, MD, MPH1. Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163:548-553. doi:10.7326/M14-18852. Phillips WR. Clinical policies: making conflicts of interest explicit. JAMA. 1994;272(19):1479. [PMID: 7966829] doi:10.1001/jama.1994.03520190021010.
Schünemann HJ, Al-Ansary LA, Forland F, et al, for the Board of Trustees of the Guidelines International Network. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163:548–553. doi: https://doi.org/10.7326/M14-1885
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