Journal of Thrombosis and Haemostasis, 12: 1744–1745
DOI: 10.1111/jth.12708
COMMENTARY
Guidance, guidelines, and communications J . D . D O U K E T I S and J . I . W E I T Z Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada
To cite this article: Douketis JD, Weitz JI. Guidance, guidelines, and communications. J Thromb Haemost 2014; 12: 1744–5. See also Di Nisio M, Carrier M, Lyman GH, Khorana AA, for the Subcommittee on Haemostasis and Malignancy. Prevention of venous thromboembolism in hospitalized medical cancer patients: guidance from the SSC of the ISTH. This issue, pp 1746–9.
What is the G&G Committee? ‘The only thing to do with good advice is pass it on: it is never of any use to oneself.’ Oscar Wilde Through the Scientific and Standardization Committee (SSC), the International Society on Thrombosis and Haemostasis (ISTH) has a long tradition of publishing ‘communications’ that inform laboratory methodology and clinical outcome definitions. Recently, the ISTH published ‘clinical guidance’ documents that provide clinicians with expert advice on difficult patient management issues. In the future, the ISTH may embark on the development of ‘clinical guidelines,’ which formally summarize evidence in diagnostic or therapeutic areas. For a typical reader of the Journal, the mere mention of ‘guidance,’ ‘guidelines,’ and ‘communications’ in the opening paragraph of an article may invoke some head-scratching and the following questions: How do these terms differ, why is such a distinction important and, perhaps most stridently, why should I bother reading this article? Before addressing these questions, we first want to inform you about the newly formed Guidance and Guidelines (G&G) Committee, whose goal is to advance the knowledge translation activities of the ISTH. We will then highlight the differences among guidance, guideline, and communication documents and identify the need for this distinction. Overall, we want to encourage ISTH members to participate in G&G Committee activities so as to translate emerging knowledge in our field into action.
Correspondence: Jim D. Douketis, Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada. Tel.: +1 905 521 6178; fax: +1 905 308 7214. E-mail: [email protected] Received 18 August 2014 Manuscript handled by: F. R. Rosendaal Final decision: F. R. Rosendaal, 18 August 2014
The G&G Committee is a Standing Committee of the ISTH. This committee evolved from the Guidance Committee, which, under the capable leadership of the past SSC Chair, Dr. Gerhard Johnson, initiated the development of guidance documents in 2011. The first of these documents focused on a common clinical problem: the duration of anticoagulant therapy for unprovoked venous thromboembolism [1]. The G&G Committee will continue to promote the development of clinical guidance documents but has revamped the process so as to simplify the proposal, development, and publication of such documents. Moreover, the Journal has a dedicated Associate Editor, Dr. Marcel Levi, to handle guidance documents. The G&G Committee also has created standard operating procedures to review and endorse appropriate clinical guidelines developed by other medical societies. This committee will also help to identify appropriate ISTH members to work with sister organizations to co-develop clinical guidelines, befitting the multidisciplinary makeup of the ISTH. Finally, the G&G Committee will serve as the vehicle for development of clinical practice guidelines if, in the future, the ISTH embarks on this course. What is a clinical guidance document? These documents aim to address a clinically important topic (diagnostic, therapeutic, or laboratory based) of broad clinical interest for which high-quality evidence, typically from randomized trials, is lacking or is unlikely to be developed. Such documents are written by a team that includes established experts in the field and they are meant to complement clinical guidelines. As an example, in this issue of the Journal, the clinical guidance paper by Di Nisio and colleagues addresses the prevention of venous thromboembolism in medical patients with cancer, a topic of broad clinical interest wherein evidence from high-quality randomized trials is limited [2]. Other pertinent clinical guidance topics may include measuring the anticoagulant effect of the novel oral anticoagulants, © 2014 International Society on Thrombosis and Haemostasis
Guidelines, guidance, and communications 1745
managing refractory thrombocytopenia, and treating thrombosis in unusual sites. Overall, clinical guidance documents remain anchored on the best available evidence but incorporate expert opinion to provide simple and actionable advice for practicing clinicians. What is the distinction between a clinical guideline and a clinical guidance document? Unlike a guidance document, a clinical guideline addresses a topic in which there is moderate- to high-quality evidence to inform best practices (i.e., data from welldesigned randomized controlled trials), uses a structured process to summarize the evidence (i.e., systematic review), and provides a standardized method to express a recommendation (i.e., grades of evidence). To produce clinical guidelines, a rigorous 146-item checklist must be followed [3]. Moreover, clinical guidelines rarely address areas of practice where the evidence is sparse as this necessitates invoking expert opinion, which guidelines tend to avoid. What is an SSC communication, and how does it differ from clinical guidance? An SSC communication is neither of the above and addresses a topic primarily aimed at standardization in laboratory or clinical practice or research methodologies. The G&G committee will not be involved in communications, which are the purview of the SSC. Examples of SSC communications include standardized assay methods for measuring the anticoagulant activity of oral factor Xa inhibitors, the ISTH bleeding assessment tool, and methodology for potency labeling of clotting factor concentrates [4,5]. How can you get involved in clinical guidance and other G&G Committee activities? Ideas for potential clinical guidance documents can originate from either an SSC subcommittee, often prompted by the subcommittee chair/co-chairs, or the broader ISTH membership. Ideas for topics can be sent to subcommittee chairs or directly to the G&G Committee. ISTH members can also participate in G&G Committee activities as reviewers of guidelines that have been or are being developed by other medical societies and by updating existing clinical guidance documents. More explicit instructions about developing guidance documents are found on the
© 2014 International Society on Thrombosis and Haemostasis
ISTH website (www.isth.org) under the ‘Publications’ and, then, ‘Guidance Documents’ tabs. The G&G Committee also provides a conduit for educational and other scholarly opportunities for members involved with the ISTH Young Professionals Group. As the chair and co-chair of the G&G Committee, we encourage ISTH members to capitalize on this important facet of knowledge translation: a critical element of our activities. Please join us in this venture. Acknowledgements The authors thank the members of the G&G committee for their review of the manuscript: Drs. Andreas Greinacher, Nigel Key, Marcel Levi, David Lillicrap, Gordon Lowe, Alok Srivastava, and Alberto Tosetto. Disclosure of Conflicts of Interests The authors state that they have no conflicts of interest.
References 1 Baglin T, Bauer K, Douketis J, Buller H, Srivastava A, Johnson G, SSC of the ISTH. Duration of anticoagulant therapy after a first episode of an unprovoked pulmonary embolus or deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost 2012; 10: 698–702. 2 Di Nisio M, Carrier M, Lyman GH, Khorana AA, The SSC Subcommittee on Haemostasis and Malignancy. Prevention of Venous Thromboembolism in Hospitalized Medical Cancer Patients: guidance from the SSC of the ISTH. J Thromb Haemost 2014; 12: 1746–9. 3 Sch€ unemann HJ, Wiercioch W, Etxeandia I, Falavigna M, Santesso N, Mustafa R, Ventresca M, Brignardello-Petersen R, Laisaar KT, Kowalski S, Baldeh T, Zhang Y, Raid U, Neumann I, Norris SL, Thornton J, Harbour R, Treweek S, Guyatt G, Alonso-Coello P, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ 2014; 186: E123–42. 4 Baglin T, Hillarp A, Tripodi A, Elalamy I, Buller H, Ageno W. Measuring oral direct inhibitors of thrombin and factor Xa: a recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2013; 11: 756–60. 5 Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D, on behalf of the ISTH/SSC Joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost 2010; 8: 2063–5.
DOI: 10.1111/jth.12708
COMMENTARY
Guidance, guidelines, and communications J . D . D O U K E T I S and J . I . W E I T Z Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada
To cite this article: Douketis JD, Weitz JI. Guidance, guidelines, and communications. J Thromb Haemost 2014; 12: 1744–5. See also Di Nisio M, Carrier M, Lyman GH, Khorana AA, for the Subcommittee on Haemostasis and Malignancy. Prevention of venous thromboembolism in hospitalized medical cancer patients: guidance from the SSC of the ISTH. This issue, pp 1746–9.
What is the G&G Committee? ‘The only thing to do with good advice is pass it on: it is never of any use to oneself.’ Oscar Wilde Through the Scientific and Standardization Committee (SSC), the International Society on Thrombosis and Haemostasis (ISTH) has a long tradition of publishing ‘communications’ that inform laboratory methodology and clinical outcome definitions. Recently, the ISTH published ‘clinical guidance’ documents that provide clinicians with expert advice on difficult patient management issues. In the future, the ISTH may embark on the development of ‘clinical guidelines,’ which formally summarize evidence in diagnostic or therapeutic areas. For a typical reader of the Journal, the mere mention of ‘guidance,’ ‘guidelines,’ and ‘communications’ in the opening paragraph of an article may invoke some head-scratching and the following questions: How do these terms differ, why is such a distinction important and, perhaps most stridently, why should I bother reading this article? Before addressing these questions, we first want to inform you about the newly formed Guidance and Guidelines (G&G) Committee, whose goal is to advance the knowledge translation activities of the ISTH. We will then highlight the differences among guidance, guideline, and communication documents and identify the need for this distinction. Overall, we want to encourage ISTH members to participate in G&G Committee activities so as to translate emerging knowledge in our field into action.
Correspondence: Jim D. Douketis, Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada. Tel.: +1 905 521 6178; fax: +1 905 308 7214. E-mail: [email protected] Received 18 August 2014 Manuscript handled by: F. R. Rosendaal Final decision: F. R. Rosendaal, 18 August 2014
The G&G Committee is a Standing Committee of the ISTH. This committee evolved from the Guidance Committee, which, under the capable leadership of the past SSC Chair, Dr. Gerhard Johnson, initiated the development of guidance documents in 2011. The first of these documents focused on a common clinical problem: the duration of anticoagulant therapy for unprovoked venous thromboembolism [1]. The G&G Committee will continue to promote the development of clinical guidance documents but has revamped the process so as to simplify the proposal, development, and publication of such documents. Moreover, the Journal has a dedicated Associate Editor, Dr. Marcel Levi, to handle guidance documents. The G&G Committee also has created standard operating procedures to review and endorse appropriate clinical guidelines developed by other medical societies. This committee will also help to identify appropriate ISTH members to work with sister organizations to co-develop clinical guidelines, befitting the multidisciplinary makeup of the ISTH. Finally, the G&G Committee will serve as the vehicle for development of clinical practice guidelines if, in the future, the ISTH embarks on this course. What is a clinical guidance document? These documents aim to address a clinically important topic (diagnostic, therapeutic, or laboratory based) of broad clinical interest for which high-quality evidence, typically from randomized trials, is lacking or is unlikely to be developed. Such documents are written by a team that includes established experts in the field and they are meant to complement clinical guidelines. As an example, in this issue of the Journal, the clinical guidance paper by Di Nisio and colleagues addresses the prevention of venous thromboembolism in medical patients with cancer, a topic of broad clinical interest wherein evidence from high-quality randomized trials is limited [2]. Other pertinent clinical guidance topics may include measuring the anticoagulant effect of the novel oral anticoagulants, © 2014 International Society on Thrombosis and Haemostasis
Guidelines, guidance, and communications 1745
managing refractory thrombocytopenia, and treating thrombosis in unusual sites. Overall, clinical guidance documents remain anchored on the best available evidence but incorporate expert opinion to provide simple and actionable advice for practicing clinicians. What is the distinction between a clinical guideline and a clinical guidance document? Unlike a guidance document, a clinical guideline addresses a topic in which there is moderate- to high-quality evidence to inform best practices (i.e., data from welldesigned randomized controlled trials), uses a structured process to summarize the evidence (i.e., systematic review), and provides a standardized method to express a recommendation (i.e., grades of evidence). To produce clinical guidelines, a rigorous 146-item checklist must be followed [3]. Moreover, clinical guidelines rarely address areas of practice where the evidence is sparse as this necessitates invoking expert opinion, which guidelines tend to avoid. What is an SSC communication, and how does it differ from clinical guidance? An SSC communication is neither of the above and addresses a topic primarily aimed at standardization in laboratory or clinical practice or research methodologies. The G&G committee will not be involved in communications, which are the purview of the SSC. Examples of SSC communications include standardized assay methods for measuring the anticoagulant activity of oral factor Xa inhibitors, the ISTH bleeding assessment tool, and methodology for potency labeling of clotting factor concentrates [4,5]. How can you get involved in clinical guidance and other G&G Committee activities? Ideas for potential clinical guidance documents can originate from either an SSC subcommittee, often prompted by the subcommittee chair/co-chairs, or the broader ISTH membership. Ideas for topics can be sent to subcommittee chairs or directly to the G&G Committee. ISTH members can also participate in G&G Committee activities as reviewers of guidelines that have been or are being developed by other medical societies and by updating existing clinical guidance documents. More explicit instructions about developing guidance documents are found on the
© 2014 International Society on Thrombosis and Haemostasis
ISTH website (www.isth.org) under the ‘Publications’ and, then, ‘Guidance Documents’ tabs. The G&G Committee also provides a conduit for educational and other scholarly opportunities for members involved with the ISTH Young Professionals Group. As the chair and co-chair of the G&G Committee, we encourage ISTH members to capitalize on this important facet of knowledge translation: a critical element of our activities. Please join us in this venture. Acknowledgements The authors thank the members of the G&G committee for their review of the manuscript: Drs. Andreas Greinacher, Nigel Key, Marcel Levi, David Lillicrap, Gordon Lowe, Alok Srivastava, and Alberto Tosetto. Disclosure of Conflicts of Interests The authors state that they have no conflicts of interest.
References 1 Baglin T, Bauer K, Douketis J, Buller H, Srivastava A, Johnson G, SSC of the ISTH. Duration of anticoagulant therapy after a first episode of an unprovoked pulmonary embolus or deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost 2012; 10: 698–702. 2 Di Nisio M, Carrier M, Lyman GH, Khorana AA, The SSC Subcommittee on Haemostasis and Malignancy. Prevention of Venous Thromboembolism in Hospitalized Medical Cancer Patients: guidance from the SSC of the ISTH. J Thromb Haemost 2014; 12: 1746–9. 3 Sch€ unemann HJ, Wiercioch W, Etxeandia I, Falavigna M, Santesso N, Mustafa R, Ventresca M, Brignardello-Petersen R, Laisaar KT, Kowalski S, Baldeh T, Zhang Y, Raid U, Neumann I, Norris SL, Thornton J, Harbour R, Treweek S, Guyatt G, Alonso-Coello P, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ 2014; 186: E123–42. 4 Baglin T, Hillarp A, Tripodi A, Elalamy I, Buller H, Ageno W. Measuring oral direct inhibitors of thrombin and factor Xa: a recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2013; 11: 756–60. 5 Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D, on behalf of the ISTH/SSC Joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost 2010; 8: 2063–5.
