Figures
Abstract
Objective
To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies.
Methods
Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards.
Results
The survey identified 29 organisations from 19 countries that met the inclusion criteria. From these organisations, 19 policies were eligible for inclusion in the content analysis. Over one-third of the policies (7/19, 37%) did not report or did not clearly report whether disclosure was a prerequisite for membership of the guideline panel. Strategies for the prevention of COI such as divestment were mentioned by only two organisations. Only 21% of policies (4/19) used criteria to determine whether an interest constitutes a COI and to assess the severity of the risk imposed.
Conclusions
The finding that some organisations, in contradiction of widely available standards, still do not have COI policies publicly available is concerning. Also troubling were the findings that some policies did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest. This in addition to the variability encountered in content and accessibility of COI policies may cause confusion and distrust among guideline users. It is in the interest of guideline users and developers to design an agreed-upon, comprehensive, clear, and accessible COI policy.
Citation: Morciano C, Basevi V, Faralli C, Hilton Boon M, Tonon S, Taruscio D (2016) Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis. PLoS ONE 11(11): e0166485. https://doi.org/10.1371/journal.pone.0166485
Editor: Joel Lexchin, York University, CANADA
Received: August 3, 2016; Accepted: October 28, 2016; Published: November 15, 2016
Copyright: © 2016 Morciano et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting Information files.
Funding: CM received funds from the European Union's Seventh Framework Programme under the Rare-Bestpractices project www.rarebestpractices.eu; Project Ref.: n° 305690. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
Introduction
The problem of conflict of interest (COI) in health care guidelines has received growing attention from health care guideline developers and users in recent years. Inadequate management of COI can result in bias and have important implications for public confidence in both the guidelines and the organisations that produce them [1–5]. In response to this problem, numerous recommendations for improving the identification and management of COI in guideline development have been issued [6–12]. The U.S. Institute of Medicine (IOM) and Guidelines International Network (G-I-N), a global network of individuals and organisations interested in guidelines [www.g-i-n.net/about-g-i-n], have both produced standards for creating trustworthy guidelines [13–16] which include guiding principles to identify and manage COI. The importance of recording and addressing COI is also reflected in the appraisal criteria of AGREE II [17], an international tool for assessing the quality and reporting of health care guidelines.
Research on COI in guidelines has focused mainly on compliance with IOM and AGREE II standards [18–21] as well as on the prevalence of COI among members of guideline development groups [20,22–29]. Findings suggest that adherence to these standards is poor [18–21] and COI are both common [19,20,23,25–29] and rarely disclosed [23,26,27,29].
For guideline developers, a first step in addressing COI is to have relevant policies and procedures in place. To our knowledge only one previous study [30] has surveyed and examined the content of the COI policies of guideline developers. This cross-sectional study of 37 organisations producing a ‘large’ number of guidelines (defined as five or more guidelines listed in the National Guidelines Clearinghouse in 2009–2010) compared COI policies to IOM standards. Only 17 (17/37, 46%) of the guideline developers studied had a COI policy for guidelines in place and not one policy adhered to all 7 relevant IOM standards [14]. The study was limited to English-language guideline developers and nearly two-thirds of these organisations (24/37, 65%) were in the United States, with the remainder representing four other countries: Canada (5), the United Kingdom (5), New Zealand (2), and the Netherlands (1).
This study expands upon previous research to examine the COI policies of an international sample that includes non-English-language guideline developers.
Objectives
The aim of our study was to assess whether and how organisations address COI issues related to guideline development, and to identify and quantify problematic areas of underreporting.
We set out to capture a cross-sectional sample of worldwide guideline development organisations and to examine the content of their policies on COI available in English, French, Spanish and Italian through a predefined data abstraction instrument.
Methods
Selection of guideline development organisations
Between September 2014 and June 2015 we conducted an Internet search and content analysis of the COI policies of organisations who have a programme of health care guideline development covering a wide range of health topics i.e. a programme not limited to a particular disease or condition or to group or subgroup of diseases or conditions.
We obtained a preliminary list of 53 organisations by searching in the G-I-N database (http://www.g-i-n.net/membership/members-around-the-world) filtered by “activities” and “guideline development” (accessed September 25, 2014).
This list was integrated with a list of organisations obtained through an evidence inventory [31] of surveys of guideline developer organisations. We performed the evidence inventory to list what surveys were available on guideline developer organisations. Studies were sought from MEDLINE (1 January 2009 to 1 August 2014) and limited to English language (S1 Table). The search identified 217 articles. One author (CM) screened the titles and abstracts of all retrieved articles. A survey of European guideline developers was found and included [32] with one companion report [33]. We also included an article [34] which listed guideline handbooks/manuals to identify further guideline developers.
From these studies 60 additional organisations were identified, of which 21 were duplicates, leaving a sample of 92 organisations (S2 Table). In order to identify a manageable subsample of organisations that had the potential to produce guidelines with the most wide-ranging impacts on health, we pragmatically restricted our sample further to exclude organisations whose guideline programmes are limited to single disease areas or single health professions.
Identification of COI policies
We searched the websites of included organisations for documents that described the guideline development process (manuals, handbooks, methodology articles, webpages), disclosure of relationships of interest (DOI) forms, and any other available documents that mentioned COI issues related to guideline development and available in English, French, Italian or Spanish, with no date restrictions. We did not contact organisations directly to obtain additional information, but used only information publicly available.
We aimed to include documents that addressed COI in guideline development and that provided data for at least two of the items included in each of the following overarching items of the data abstraction instrument: “Information required for disclosure of financial and nonfinancial relationships” and “Procedures for collecting, reviewing disclosure of relationships of interest and managing conflict of interest” (Table 1). We called a document meeting these criteria a “COI policy”. In the content analysis we distinguished the term “relationship (financial and nonfinancial) of interest” and “conflict of interest”. The term “relationship of interest” refers to any interest or activity requested to be declared that may be judged to constitute a COI. Consequently we used the term “disclosure of relationships of interest” to indicate the step that precedes the review of DOI.
Data extraction and analysis
We developed a 24-item data abstraction instrument (Table 1) based on recommendations and standards of COI proposed by the IOM [13,14] and G-I-N [15]. The types of financial relationships and nonfinancial relationships considered in this study were based on those listed by IOM [13,14] and G-I-N [15].
One author (CM) abstracted information on each organisation and each COI policy into the predefined template and those data were checked by a second author (CF, ST). When there was disagreement regarding the content of a particular COI policy this was resolved by discussion. If the policy was updated during the period of data collection, we updated the abstracted information. Where disclosure forms were publicly available, data from these were integrated with the data extracted from the policies. Where inconsistencies were found, the information in the policy prevailed.
Results
Twenty-six organisations were excluded from the 92 identified as their remit was restricted to single disease specialties or single professional groups (S2 Table). Of the 66 remaining organisations, 11 were subsequently excluded because they did not provide documents on guideline development in English, French, Italian, or Spanish; 15 because they did not provide publicly accessible documents on guideline development or COI issue guideline related; 5 because their website was not found or not accessible and 6 because they were not guideline developers.
The documents of the remaining 29 organisations (Table 2) were assessed for the presence of a COI policy according to our definition. Of these organisations 21 were governmental, 4 were not for profit and 4 were professional associations. Ten organisations (10/29, 34%) were excluded from content analysis for the following reasons: 8 because their documents did not mention or provided insufficient information on COI, 1 because its handbook referred to an included parent organisation’s COI policy and 1 because its handbook was superseded by the handbook of its collaborating organisation. In the end 19 COI policies were included in the content analysis from 13 countries and 1 intergovernmental organisation. Fig 1 provides a description of the inclusion of organisations at each stage.
Conflict of interest policies
The 19 COI policies were accessible in various formats. Many organisations included their policy in a guideline handbook [37,41,44,45,47,63,65–68] (10/19, 53%). Six organisations [48,56,57,59,61,64] (6/19, 32%) posted their COI policies on their website as a stand alone document. Three of these provided additional information about management of COI in their guideline handbook [49,58,62] with reference to the COI policy posted in the website. The remainder of the organisations included information on COI policy on a webpage as a flow chart [43] or in a methodological article posted on the organisation’s website [35,40] (Table 2).
The date of the COI policy was determined by considering the date of the document itself if published as stand alone document or of the corresponding date of the handbook/manual, methodological article, or webpage where the COI policy was included. The date of the 18 policies for which a date could be determined ranged from 2007 to 2014. Of the 18 policies 7 were published in 2014 (7/18, 39%), 5 were dated between 2011–2013 (5/18, 28%) and 6 were dated prior 2011 (6/18, 33%). Around one third of the policies (Table 3) [37,40,41,43,63,67] (6/19, 32%) did not report a definition of the term “conflict of interest” and the remaining policies provided heterogeneous definitions.
Disclosure of relationships of interest
All included policies outlined categories of financial relationships but characterization of specific types of nonfinancial relationships was lacking in some cases [39,40,43,47,63] (4/19, 21%) (Table 4). Policies varied in the categories of information that need to be disclosed and in whether or not disclosures were limited to information relevant to the content/topic of the guideline.
Concerning the item “who is required to report on relationships of interest”, all policies stated that a declaration is collected from members of the guideline development group/panel/committee but a minority [37,44,58,59,61,62,68] (5/19, 26%) detailed additional disclosures from staff involved in a standard guideline development process, for example, guideline methodologists, systematic review team, reviewers and advisors. In contrast, policies were much more likely [35,37,39,40,44,45,48,49,57,58,59,61,62,64–68] (14/19, 74%) to require the disclosure of close personal relationships.
Procedures for collecting, reviewing DOI and managing COI
The majority of policies explicitly reported that DOI is requested before appointment of the members of the guideline development group [37,39,40,44,47,48,49,57–59,64–68] (12/19, 63%), while the remaining seven policies [35,41,43,45,55,56,61–63] (7/19, 37%) did not report or were unclear as to whether this important practice was actually used (Table 5).
Regarding the item “who reviews DOI and makes decision” of the 16 organisations reporting on this issue [35,37,39,40,44,45,47–49,55–59,61,62,64–68] (16/19, 84%) the chair and/or the members of the guideline development group were the most cited responsible entity [35,37,44,45,47,57–59,61,62,64–66] (11/16, 69%). In contrast, only 2 organisations [67,68] (2/16, 13%) appeared to rely exclusively on a committee as an independent entity to review DOI and to devise a management plan across the entire guideline development process.
All organisations reported procedures for exclusion of members with conflicts but divestment was considered a requirement only by 2 organisations [39,40,57] (2/19, 11%), and prohibition of specific relationships by 3 organisations [37,39,40,67]. Only 4 policies [44,48,49,58,59,68] (4/19, 21%) specified an “assessment of risk”, defined as a procedure and criteria to assess whether a relationship of interest constitutes a COI and to evaluate the potential harm of the COI identified [13].
Procedures for recording and public disclosure of DOI
The majority of organisations reported a description of the procedures to record DOI [37,41,43–45,47–49,55–59,61,62,64,66–68] (15/19, 79%) whereas four did not address this issue [35,39,40,63,65] (4/19, 21%) (Table 5).
Of those policies that described activities to record DOI, the original completed DOI forms were reported to be publicly accessible on the website and/or in the published guideline by seven organisations [37,44,47,48,49,57,64,66] (7/15, 47%) with some exceptions. For example, one organisation stated DOI will be made public on the organisation website but”exception to this requirement will be by Chief Executive Officer in appropriate circumstances” [57].
Two organisations published in the guideline and/or website a summary of the DOI information [61,62,68] while other two [55,56,67] kept this information confidential although one of these mentioned the possibility of access upon request under state law [67].
Discussion
We found that of the 29 organisations corresponding to our eligibility criteria we were not able to identify COI policies for approximately one in four organisations (8/29, 28%). Failure of guideline developer organisations to adopt a publicly accessible COI policies related to guideline development has also been reported elsewhere in literature. For example, in the above mentioned cross-sectional study of Norris et al. [30] only 46% of the 37 surveyed organisations had a COI policy directly related to health care guidelines. These findings along with the data from our study suggest that the absence of a COI policy might be one of the reason behind the phenomenon of underreporting of COI in guidelines [23,26,27,29] as well as the observed uneven adherence to current standards on COI in guidelines [18–21].
We also found that many organisations provided no or unclear information pertaining to some items of our data abstraction instrument. In our view, a particularly troubling area in which COI policies need to be improved is that of guideline panel selection and composition. More attention to this issue has been advocated to reduce of the potential for COI to create bias [10,12,28]. Nevertheless, in our investigation about one-third of the policies did not report or did not clearly report whether disclosure was a prerequisite for panel selection. Additionally, preventive strategy such as divestment [13,15] and prohibition [13] were rarely mentioned.
A second key area in which COI policies need to be improved is the management of the disclosed information, particularly regarding the practices of “the assessment of risk” which is defined as “practices and criteria used to determine if a relation of interest constitutes a COI and to assess the potential for harm of the COI identified” [13]. It is encouraging that the policies surveyed were directed at the most common relationships of interest in support of the identification of COI. However a policy for systematic and transparent management of the disclosed information was uncommon. Few organisations clearly stated what practices and criteria were used to determine whether a relation of interest constitutes a COI and to assess the potential for harm of the COI identified. The translation of the disclosed information into a decision or measures taken to limit the likelihood of undue influence of COI is a critical step. This step should be explicit and transparent to reduce the flexibility of the organisations in addressing financial and nonfinancial ties as well as to assure the ability of the informed reader to appraise the validity of decisions on COI issue.
In terms of the management and monitoring of the disclosed information IOM recommends that organisations should create a COI committee (Recommendation 3.1) [13]. In this regard we found that few organisations have felt the need or identified the necessary resources to have a dedicated infrastructure to act as a third party providing independent review of DOI and managing COI across all the phases of guideline development process.
Most organisations relied on the same group of individuals who develop the guidelines to handle the disclosed cases. This is of particular concern if considered in the context of the evidence of guideline chairs and panel members with a high proportion of conflicts [20,25]. Apart from an improved consistency in decisions taken across guidelines, in our view a “conflict of interest committee” could avoid administrative burden for the chair, co-chair and members of the guideline group and more importantly could consistently implement procedures for the monitoring and enforcement of the policies.
Furthermore our study underlines the issue of variation across policies in keeping with the findings of Norris et al. [30]. We found that the policies varied in their content, for example in the definition of COI (when provided), in the categories and details of the information required to be disclosed, in the time frame for disclosure, in establishing or not establishing a threshold, and in detailing who is required to declare a relationship of interest. Our sample included organisations from 13 countries and one intergovernmental organisation, so this variation in part probably reflects cultural, legal and administrative differences across countries as well as differences in organisational values and interests.
We noted that the policies were also variable in format and accessibility across the organisations, limiting the ability of the guideline user to obtain a clear and complete picture of the strategy to address COI throughout the guideline development process. An important finding is that less than half of the included organisations reported that the information from completed DOI forms was publicly accessible without restriction. Again, notwithstanding cultural, legal and administrative issues, the guideline user has the right to assess the completeness of the disclosure of COI as well as the consistency with which the policy is implemented.
This study contributes to the literature on the quality of guidelines by demonstrating, using an innovative sampling method and highly detailed data extraction, that COI remains an area that requires attention from guideline users and improvement from many guideline development organisations. The study confirms previous research that has drawn the same conclusions about COI from different samples of guidelines. The study also has some limitations that deserve comment.
First, organisations may have practices which are not fully reflected in the written COI policies or do have policy but not publicly available. However, we decided to rely only on information on COI policies publicly accessible on website since we consider accessibility an essential element of a transparent COI policy. As pointed out by IOM, COI policies should be comprehensible and accessible to the individuals and institutions that may be affected [13]. We recommend that the organisations that disseminate their own health care guidelines should provide public information on their strategies to identify and manage COI through an understandable and accessible policy.
Second, information about the policies and information about COI within the policies might be incomplete. We experienced several difficulties in locating COI policies from websites and in obtaining a complete and clear picture of the actual information required to be disclosed, the process of reviewing and the management of COI for the entire guideline development process. Some organisations published their COI policies as a complete self-contained document on their website, whereas others included information on identification and management of COI in their guideline methodology document. In some instances information was interspersed among diverse parts of the guideline methodological document, the disclosure of interest form and other supporting policies. Given the unstructured nature of the documents retrieved we checked as far as possible for presence of information about COI. We also encountered problems in the interpretation and coding of the information (e.g., on what should be disclosed) given that there is not an agreed taxonomy of terms relating to COI.
Third, we restricted our study to organisations that produce guidelines on a wide range of health topics and we excluded some professional organisations, which may limit the generalizability of our results. However, we would argue that our inclusion criteria would bias the sample towards organisations with greater resources for guideline development and therefore, if anything, our results would underestimate the extent of the problem of inadequate COI management. However our study has the strength of including 29 organisations from 19 different countries and one intergovernmental organisation in the sample and a content analysis of documents in four different languages. In terms of countries and languages represented, this may be a more representative sample of guideline development organisations than those obtained in other studies of COI in guidelines.
Conclusions
The finding that some organisations despite the recommendations and standards issued respectively in 2009 [13], 2011 [14] and 2012 [15] still do not have COI policies publicly available is concerning. Also troubling was the failure of many policies to clearly report on critical steps of obtaining, managing and communicating disclosure of relationships of interest. These problems in addition to the existing variation among policies may increase the scope for inconsistency in addressing COI issues; furthermore, unclear and incomplete COI policies may confuse readers, erode public confidence, and decrease trust in guidelines and the organisations that produce them. Thus, it is in the interest of guideline users and developers to promote strong adherence to the standards available on COI in conjunction with better scientific journal policies so that every guideline is completed by a harmonized, complete, understandable, and accessible COI policy.
Supporting Information
S1 Table. Search strategy for evidence inventory of surveys of guideline developer organisations.
https://doi.org/10.1371/journal.pone.0166485.s001
(DOCX)
S2 Table. List of 92 guideline developer organisations.
https://doi.org/10.1371/journal.pone.0166485.s002
(DOCX)
Author Contributions
- Conceptualization: CM VB.
- Data curation: CM CF ST.
- Formal analysis: CM CF ST.
- Funding acquisition: CM DT.
- Investigation: CM CF ST.
- Methodology: CM VB MHB.
- Project administration: CM.
- Supervision: CM.
- Visualization: CM CF.
- Writing – original draft: CM.
- Writing – review & editing: CM VB CF MHB DT.
References
- 1. Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. J Med Ethics. 2009 May;35(5):283–8. pmid:19407031
- 2. Lenzer J. French guidelines are withdrawn after court finds potential bias among authors. BMJ. 2011 Jun 24;342:d4007. pmid:21705408
- 3. McSweegan E. Lyme disease and the politics of public advocacy. Clin Infect Dis. 2008 Dec 15;47(12):1609–10. pmid:19025374
- 4. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. 2009 Feb 25;301(8):868–9. pmid:19244197
- 5. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA. 2009 Jan 28;301(4):429–31. pmid:19176446
- 6. Akl EA, El-Hachem P, Abou-Haidar H, Neumann I, Schünemann HJ, Guyatt GH. Considering intellectual, in addition to financial, conflicts of interest proved important in a clinical practice guideline: a descriptive study. J Clin Epidemiol. 2014 Nov;67(11):1222–8. pmid:24970099
- 7. Boyd EA, Bero LA. Improving the use of research evidence in guideline development: 4. Managing conflicts of interests. Health Res Policy Syst. 2006 Dec 1;4:16. pmid:17140441
- 8. 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 Jun 1;152(11):738–41. pmid:20479011
- 9. Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, De Angelis CD, et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA. 2009 Apr 1;301(13):1367–72. pmid:19336712
- 10. Lenzer J, Hoffman JR, Furberg CD, Ioannidis JP, Guideline Panel Review Working Group. Ensuring the integrity of clinical practice guidelines: a tool for protecting patients. BMJ. 2013 Sep 17;347:f5535. pmid:24046286
- 11. Schünemann HJ, 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 Sep 15; 180(6): 564–80. pmid:19734351
- 12. Sniderman AD, Furberg CD. Pluralism of viewpoints as the antidote to intellectual conflict of interest in guidelines. J Clin Epidemiol. 2012 Jul;65(7):705–7. pmid:22542359
- 13.
Institute of Medicine (IOM). Conflict of Interest in Medical Research, Education, and Practice. Washington, D.C.: The National Academies Press; 2009.
- 14.
Institute of Medicine (IOM). Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press; 2011.
- 15. Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012 Apr 3;156(7):525–31. pmid:22473437
- 16. 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 Oct 6;163(7):548–53. pmid:26436619
- 17. 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. CMAJ. 2010 Dec 14;182(18):E839–42. pmid:20603348
- 18. Holmer HK, Norris SL, Ogden LA, Burda BU, Fu R. Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus. PLoS One. 2013 Oct 14;8(10):e75284. pmid:24155870
- 19. Feuerstein JD, Akbari M, Gifford AE, Cullen G, Leffler DA, Sheth SG, et al. Systematic review: the quality of the scientific evidence and conflicts of interest in international inflammatory bowel disease practice guidelines. Aliment Pharmacol Ther. 2013 May;37(10):937–46. pmid:23550536
- 20. Kung J, Miller RR, Mackowiak PA. Failure of clinical practice guidelines to meet institute of medicine standards: Two more decades of little, if any, progress. Arch Intern Med. 2012 Nov 26;172(21):1628–33. pmid:23089902
- 21. Knai C, Brusamento S, Legido-Quigley H, Saliba V, Panteli D, Turk E, et al. Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe. Health Policy. 2012 Oct;107(2–3):157–67. pmid:22795610
- 22. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002 Feb 6;287(5):612–7. pmid:11829700
- 23. Bindslev JB, Schroll J, Gøtzsche PC, Lundh A. Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study. BMC Med Ethics. 2013 May 3;14:19. pmid:23642105
- 24. Mendelson TB, Meltzer M, Campbell EG, Caplan AL, Kirkpatrick JN. Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med. 2001 Mar 28; 171: 577–84.
- 25. Moynihan RN, Cooke GP, Doust JA, Bero L, Hill S, Glasziou PP. Expanding disease definitions in guidelines and expert panel ties to industry: a cross-sectional study of common conditions in the United States. PLoS Med. 2013 Aug;10(8):e1001500. pmid:23966841
- 26. Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ. 2011 Oct 11; 343:d5621. pmid:21990257
- 27. Norris SL, Holmer HK, Ogden LA, Burda BU. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One. 2011;6(10):e25153. pmid:22039406
- 28. Norris SL, Burda BU, Holmer HK, Ogden LA, Fu R, Bero L, et al. Author's specialty and conflicts of interest contribute to conflicting guidelines for screening mammography. J Clin Epidemiol. 2012 Jul;65(7):725–33. pmid:22498428
- 29. Norris SL, Holmer HK, Ogden LA, Selph SS, Fu R. Conflict of interest disclosures for clinical practice guidelines in the national guideline clearinghouse. PLoS One. 2012;7(11):e47343. pmid:23144816
- 30. Norris SL, Holmer HK, Burda BU, Ogden LA, Fu R. Conflict of interest policies for organisations producing a large number of clinical practice guidelines. PLoS One. 2012;7(5):e37413. pmid:22629391
- 31.
Hartling L, Guise J-M, Kato E, Anderson J, Aronson N, Belinson S, et al. EPC Methods: An Exploration of Methods and Context for the Production of Rapid Reviews. Research White Paper. (Prepared by the Scientific Resource Center under Contract No. 290-2012-00004-C.) AHRQ Publication No. 15-EHC008-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2015.
- 32. Legido-Quigley H, Panteli D, Brusamento S, Knai C, Saliba V, Turk E, et al. Clinical guidelines in the European Union: mapping the regulatory basis, development, quality control, implementation and evaluation across member states. Health Policy. 2012 Oct;107(2–3):146–56. pmid:22939646
- 33.
Legido-Quigley H, Panteli D, Car J, McKee M, Busse R, editors. Clinical guidelines for chronic condition in the European Union. European observatory on health system and policies. Geneva, World Health Organization; 2013 (Observatory Studies Series 30).
- 34. Schünemann 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 Feb 18;186(3):E123–42. pmid:24344144
- 35. Qaseem A, Snow V, Owens DK, Shekelle P, Clinical Guidelines Committee of the American College of Physicians. The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med. 2010 Aug 3; 153(3):194–9. pmid:20679562
- 36.
Federaal Kenniscentrum voor de Gezondheidszorg (Belgian Health Care Knowledge Centre). Process book. Available: http://processbook.kce.fgov.be/ Last access: 15 June 2015.
- 37.
Canadian Task Force on Preventive Health Care. Procedure Manual; March 2014. Available: http://canadiantaskforce.ca/files/procedural-manual-en.pdf Last access: 15 June 2015.
- 38.
Umscheid CA, Agarwal RK, Brennan PJ, for the Healthcare Infection Control Practices Advisory Committee (HICPAC). Updating the Guideline Methodology of the Healthcare Infection Control Practices Advisory Committee (HICPAC). Available: http://www.cdc.gov/hicpac/guidelineMethod/guidelineMethod.html Last access: 17 June 2015.
- 39.
Ahmed F. U.S. Advisory Committee on Immunization Practices Handbook for Developing Evidence-based Recommendations. Version 1.2. Atlanta, GA: Centers for Disease Control and Prevention (CDC); 2013. Available: http://www.cdc.gov/vaccines/acip/recs/grade/downloads/handbook.pdf Last access: 17 June 2015.
- 40. Smith JC, Snider DE, Pickering LK, Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45–9. Available: http://www.cdc.gov/vaccines/acip/committee/index.html Last access: 17 June 2015. pmid:19124820
- 41.
Centro National de Excelentia Tecnólogica en Salud. Metodología para la Integración de Guías de Práctica Clínica; 2007. Available: http://www.cenetec.salud.gob.mx/descargas/gpc/METODOLOGIA_GPC.pdf Last accessed: 17 June 2015.
- 42.
Conseil Scientifique du Domaine de la Santé. Procédures pour l’établissement et la diffusion de référentiels de bonne pratique par le Conseil Scientifique. Available: http://www.conseil-scientifique.lu/index.php?id=27 Last access: 17 June 2015.
- 43.
Finnish Medical Society Duodecim Current Care Guidelines. Disclosure of COI; 2014. Available: http://www.terveysportti.fi/xmedia/ccs/process/Sidonnaisuudet.html Last access: 17 June 2015.
- 44.
Instituto de Evaluación Tecnológica en Salud. Guía Metodológica para la elaboración de Guías de Práctica Clínica con Evaluación Económica en el Sistema General de Seguridad Social en Salud; 2014. Available: http://www.iets.org.co/Manuales/Manuales/Gu%C3%ADa%20Metodol%C3%B3gica%20Elaboraci%C3%B3n%20de%20GPC%20con%20Evaluaci%C3%B3n%20Econ%C3%B3mica%20en%20el%20Sist%20Seguridad%20Social%20y%20Salud-Versi%C3%B3n%20final%20completa.pdf Lat access: 17 June 2015.
- 45.
German Association of the Scientific Medical Societies (AWMF), Standing Guidelines Commission. AWMF Guidance Manual and Rules for Guideline Development, 1st Edition 2012. English version. Available: http://www.awmf.org/fileadmin/user_upload/Leitlinien/AWMF-Regelwerk/AWMF-Guidance_2013.pdf Last access: 17 June 2015.
- 46.
German Medical Association (GMA), National Association of Statutory Health Insurance Physicians (NASHIP), Association of the Scientific Medical Societies (AWMF). National Program for Disease Management Guidelines. Method Report. 4th edition. 2010. Available: http://www.leitlinien.de/mdb/downloads/nvl/methodik/mr-engl-aufl-4-version-1.pdf Last access: 17 June 2015.
- 47.
Grupo de trabajo sobre GPC Elaboración de Guías de Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico. Madrid: Plan Nacional para el SNS del MSC. Instituto Aragonés de Ciencias de la Salud-I+CS; (2007). Available: http://www.guiasalud.es/emanuales/elaboracion/documentos/Manual%20metodologico%20-%20Elaboracion%20GPC%20en%20el%20SNS.pdf Last access: 17 June 2015.
- 48.
Haute Autorité de Santé. Guide des déclarations d’intérêts et de gestion des conflits d’intérêts. Guide de prévention et de gestion des conflits d’intérêts adopté par le Collège le 24 juillet 2013. Available: http://www.has-sante.fr/portail/upload/docs/application/pdf/guide_dpi.pdf Last access: 17 June 2015.
- 49.
Haute Autorité de Santé. Guide Mèthodologique. Élaboration de recommandations de bonne pratique; 2010. Mise à jour: Mars 2015. Available: http://www.has-sante.fr/portail/upload/docs/application/pdf/2011-01/guide_methodologique_recommandations_pour_la_pratique_clinique.pdf Last access: 17 June 2015.
- 50. Davino-Ramaya C, Krause LK, Robbins CW, Harris JS, Koster M, Chan W, et al. Transparency matters: Kaiser Permanente's National Guideline Program methodological processes. Perm J. 2012 Winter;16(1):55–62. Available: http://www.kpihp.org/wp-content/uploads/2013/07/KPStories-v2n2-ClinicalGuidelines-FINAL.pdf Last access: 17 June 2015. pmid:22529761
- 51.
Ministerio de Salud. Norma técnica para la elaboratión de Guías de Práctica Clínica; 2006. Available: http://bvs.minsa.gob.pe/local/MINSA/1176_DGSP196.pdf Last access: 17 June 2015.
- 52.
Ministerio de Salud y Protección Social. Guía Metodológica para la elaboración de Guías de Atención Integral en el Sistema General de Seguridad Social en Salud colombiano; 2010. Available: www.minsalud.gov.co/Documentos%20y%20Publicaciones/GUIA%20METODOLOGICA%20PARA%20LA%20ELABORACI%C3%93N%20DE%20GU%C3%8DAS%20DE%20ATENCI%C3%93N%20INTEGRAL.pdf Last access: 17 June 2015.
- 53.
Socialstyrelsen (National Board of Health and Welfare). Guideline process. Available: http://www.socialstyrelsen.se/nationalguidelines/howwedrawuptheguidelines Last access: 17 June 2015.
- 54.
King Saud bin Abdulaziz University for Health Sciences, National and Gulf Center for Evidence Based Health Practice. Guidance for Clinical Practice Guideline Development, Adaptation and Endorsement; 2008. Available:http://ngcebm.ksau-hs.edu.sa/images/content/NGCEBHC-Draft-3-CPG-Guidance.pdf Last access: 17 June 2015.
- 55.
National Clinical Effectiveness Committee. Guideline developers manual; 2013. Available: http://health.gov.ie/wpcontent/uploads/2015/01/ncec_guideline_development_manual_january13.pdf Last access: 17 June 2015.
- 56.
National Clinical Effectiveness Committee Policy on transparency and management of conflicts of interest; 2012. Available: http://health.gov.ie/patient-safety/ Last access: 17 June 2015.
- 57.
National Health and Medical Research Council. Guideline Development and Conflicts of Interest: Identifying and Managing Conflicts of Interest of Prospective Members and Members of NHMRC Committees and Working Groups Developing Guidelines; 2012. Available: http://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nh155_coi_policy_120710.pdf Last access: 17 June 2015.
- 58.
National Institute for Health and Care Excellence. Developing NICE guidelines: the manual; 2015. Available: http://www.nice.org.uk/article/pmg20/resources/non-guidance-developing-nice-guidelines-the-manual-pdf Last access: 17 June 2015.
- 59.
National Institute for Health and Care Excellence. Code of practice for declaring and dealing with conflicts of interest; 2014. Available: https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/Code-of-practice-for-declaring-and-managing-conflicts-of-interest.pdf Last access: 17 June 2015.
- 60.
National Institute of Quality and Innovations (Národný Inštitút Kvality a Inovácií). A guideline developers’ handbook; 2005. Available: http://www.quality.healthnet.sk/EBM/Guidelines_development_handbook_Slovak_version_v1.pdf Last access: 17 June 2015.
- 61.
Scottish Intercollegiate Guidelines Network. Policy on Declaration of Competing Interests. Available: http://www.sign.ac.uk/pdf/doi-policy.pdf Last access: 17 June 2015.
- 62.
Scottish Intercollegiate Guidelines Network. SIGN 50—A guideline developer’s handbook; 2014. Available: http://www.sign.ac.uk/pdf/sign50.pdf Last access: 17 June 2015.
- 63.
Sistema Nazionale Linee Guida. Il Programma nazionale per le linee guida. Manuale metodologico. Come produrre, diffondere e aggiornare raccomandazioni per la pratica clinica; maggio 2004. Available: http://www.snlg-iss.it/cms/files/Manuale_PNLG_0.pdf Last access: 17 June 2015.
- 64.
Therapeutic Guidelines. Limited conflict of interest policy; 2014. Available: http://www.tg.org.au/uploads/PDFs/ConflictOfInterestPolicy_19Feb2014.pdf Last access: 17 June 2015.
- 65.
Universidad Nacional de Colombia, Instituto de Investigaciones clinicas, Facultad de Medicina. Guía Metodológica para la elaboración de Guías de Práctica Clínica con Evaluación Económica en el Sistema General de Seguridad Social en Salud Colombiano. Available: http://www.gets.unal.edu.co/manual_gpc.html Last access: 17 June 2015.
- 66.
Estonian Health Insurance Fund, University of Tartu Ministry of Social Affair, WHO. Estonian handbook for guidelines development; 2011. Available: http://www.ut.ee/en and http://whqlibdoc.who.int/publications/2011/9789241502429_eng.pdf Last access: 17 June 2015.
- 67.
U.S. Preventive Services Task Force. Procedure manual; March 2014 (AHRQ publication NO.08-05118-EF). Available: http://www.uspreventiveservicestaskforce.org/Page/Name/methods-and-processes Last access: 17 June 2015.
- 68.
World Health Organization. Handbook for guideline development; 2014. Available: http://www.who.int/kms/handbook_2nd_ed.pdf Last access: 17 June 2015.
- 69. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993 Aug 18;329(8):573–6. pmid:8336759
- 70. Detsky AS. Sources of bias for authors of clinical practice guidelines. CMAJ. 2006 Oct 24;175(9):1033, 1035. pmid:17060643