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Original Research: Education, Research, And Quality Improvement |

Applying New Strategies for the National Adaptation, Updating, and Dissemination of Trustworthy GuidelinesNorwegian Adaptation of Clinical Guidelines: Results From the Norwegian Adaptation of the Antithrombotic Therapy and the Prevention of Thrombosis, 9th Ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines FREE TO VIEW

Annette Kristiansen, MD; Linn Brandt, MD; Thomas Agoritsas, MD; Elie A. Akl, MD, PhD, MPH; Eivind Berge, MD, PhD; Anne Flem Jacobsen, MD, PhD; Lars-Petter Granan, MD, PhD; Sigrun Halvorsen, MD, PhD; Gordon Guyatt, MD, FCCP; Per Olav Vandvik, MD, PhD
Author and Funding Information

From the Department of Internal Medicine (Drs Kristiansen, Brandt, and Vandvik), Innlandet Hospital Trust, Gjøvik, Norway; Institute for Health and Society (Drs Kristiansen, Brandt, and Vandvik), Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Internal Medicine (Drs Kristiansen and Brandt), Deaconess Hospital, Oslo, Norway; Department of Clinical Epidemiology and Biostatistics (Drs Agoritsas, Akl, and Guyatt), McMaster University, Hamilton, ON, Canada; Department of Internal Medicine (Dr Akl), American University of Beirut, Beirut, Lebanon; Department of Internal Medicine (Dr Berge), Oslo University Hospital, Ullevål, Oslo, Norway; Department of Obstetrics and Gynaecology (Dr Flem Jacobsen), Department of Physical Medicine and Rehabilitation (Dr Granan), Department of Pain Management and Research (Dr Granan), Division of Emergencies and Critical Care, and Department of Cardiology B (Dr Halvorsen), Oslo University Hospital, Oslo, Norway; Oslo Sports Trauma Research Center (Dr Granan), Norwegian School of Sport Sciences, Oslo, Norway; and Norwegian Knowledge Centre for the Health Services (Dr Vandvik), Oslo, Norway.

CORRESPONDENCE TO: Annette Kristiansen, MD, Department of Internal Medicine, Sykehuset Innlandet HF, Gjøvik, Norway; e-mail: annettekrist@gmail.com


Part of this article has been presented in poster form at the 2012 G-I-N Conference, August 22-25, 2012, Berlin, Germany.

FUNDING/SUPPORT: Innlandet Hospital Trust, the Southern and Eastern Norway Regional Health Authority, and the Norwegian Research Council have provided research grants. The Norwegian Medical Association has provided grants to support completion of the adaptation process.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;146(3):735-761. doi:10.1378/chest.13-2993
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BACKGROUND:  The Antithrombotic Therapy and the Prevention of Thrombosis, 9th Edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) represent trustworthy international guidelines for antithrombotic treatment and thromboprophylaxis. We describe major changes to the format and content resulting from applying new strategies for guideline adaptation and dissemination.

METHODS:  A Norwegian guideline panel of 46 experts completed a structured and systematic adaptation process, updated the recommendations based on new evidence, and rewrote the recommendations in an electronic multilayered presentation format. We published the adapted guideline using the web-based Making GRADE the Irresistible Choice Guideline Authoring and Publication Platform.

RESULTS:  We applied a novel presentation format to 333 recommendations from 11 of the 15 management chapters in AT9 and condensed and restructured them into 249 recommendations in a multilayered format. We added additional relevant information, such as 29 best-practice statements about new oral anticoagulants and practical information sections for 121 recommendations. Common reasons for modifications included feasibility of the recommendations in a national context, disagreement with applied baseline risk estimates, and reevaluation of the balance between the benefits and harms of interventions in relation to assumed typical patient preferences and values. The adapted guideline was published and disseminated online in November 2013.

CONCLUSIONS:  New strategies for adapting, updating, and disseminating trustworthy guidelines proved feasible and will provide Norwegian health-care professionals and patients with up-to-date guidance tailored to national circumstances.

Figures in this Article

The Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9)1 provide comprehensive and rigorous guidance for the treatment of surgical and nonsurgical patients and, therefore, are well suited for adaptation to individual jurisdictions. The Norwegian adaptation of AT9 was performed through the collaborative projects we describe in this article.

Using Grading of Recommendations Assessment, Development, and Evaluation to Make Recommendations

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) provides a transparent and systematic framework for assessing and grading the available research evidence and for moving from evidence to recommendations.2,3 Currently, > 70 organizations worldwide have adopted GRADE. Guideline developers rigorously applying the GRADE methodology should consider four factors when making recommendations: the balance between the benefits and harms of the various interventions, confidence in the estimates of effects, patient preferences and values, and resource use.

In GRADE, recommendations are categorized as strong or weak.4 The strength of a recommendation reflects a guideline panel’s confidence that desirable outcomes of an intervention outweigh undesirable outcomes. A strong recommendation is, thus, defined by a clear imbalance between the benefits and harms of an intervention and should be applied to nearly all patients. A weak recommendation reflects either a closer balance between benefits and harms or a lack of confidence in estimates of effect but should still be considered for the majority of patients.

Making GRADE the Irresistible Choice

The Making GRADE the Irresistible Choice (MAGIC) research program5 has brought together a multidisciplinary team of guideline developers, clinicians, methodologists, interaction designers, and programmers. We developed a framework and built innovative solutions to address current limitations in the development, updating, and dissemination of clinical practice guidelines, embedding it into the web-based Making GRADE the Irresistible Choice Guideline Authoring and Publication Platform (MAGICapp). Adapting AT9 to a Norwegian setting represented an opportunity to apply and evaluate the feasibility of our proposed adaptation process; develop guidelines in a new presentation format; and publish them through our platform. The remaining aspects of the MAGIC framework will be tested in the near future, including integration of guidelines into electronic health records and strategies for dynamic updating and production of semiautomated electronic decision aids linked to individual recommendations for use during patient consultations.

Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence

Responding to the need for improvement in the presentation, dissemination, and uptake of evidence-based guidelines, the GRADE working group initiated the European Union-funded Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) project in 2011.6 The DECIDE and MAGIC groups have collaborated to develop a multilayered presentation format to meet various needs at the point of care and to facilitate shared decision-making. The first, or top, layer of the format comprises the recommendation and its strength, a key information section presenting the four factors considered when moving from evidence to recommendation, and a short rationale. The development and evaluation of the multilayered format will be presented in a separate article.

Through three separate articles, we outline the details of the adaptation process7 and updating strategy.8 In this article , we summarize the end results of our adaptation of AT9 to a Norwegian guideline.

When adapting AT9, the Norwegian guideline panels followed a predefined five-step adaptation process and taxonomy for evaluating individual recommendations tailored to GRADE guidelines.7 During an initial planning meeting, the editorial committee overseeing the process selected 11 of the 15 management chapters in AT9 to adapt on the basis of available human resources and which topics were expected to have the largest impact on clinical practice. The editorial committee comprised three methods experts, all members of the MAGIC research program, and four content experts.

The guideline panel members reviewed their respective chapters, formally recording their initial assessment of the need to exclude, modify, or develop new recommendations. As the head of the panel, the chapter editor collected these written statements and compiled them while identifying disagreements during the process. The panels then met face to face once or twice and continued the deliberations through a series of e-mail discussions.

When considering modifying a recommendation, the panels took into account the national context, including the availability of recommended interventions; other existing guidelines in extensive use in Norway; and assumed preferences and values of Norwegian patients. They adhered to the GRADE methodology and, for each modification, consulted with the designated methods expert.

All panel members adduced new evidence identified through their clinical work. In addition, colleagues at McMaster University conducted systematic searches for new evidence using McMaster PLUS (Premium Literature Service) database entries from November 2010 to May 2013. The chapter editors screened the updated feeds, focusing on evidence that could potentially require modifications or new recommendations. During development of new recommendations, the methods experts performed the initial evidence assessment and rating according to GRADE, providing the panels with a tabular evidence summary as the basis for further discussions in which the methods experts actively participated.

The chapter editors wrote the first draft of the adapted chapter, explicitly stating how and why the recommendations were modified through a rationale statement and an adaptation disclaimer. The editorial committee invited user representatives, relevant specialty associations in Norway, and the American College of Chest Physicians (CHEST) to provide feedback on the adapted guideline. The chapter editors were primarily responsible for reading the feedback and assessing the need for adjustments. If major adjustments were potentially necessary, the chapter editors consulted with the panels and methods experts.

The editorial committee elected to exclude three of the original chapters: diagnosis of DVT, treatment and prevention of heparin-induced thrombocytopenia, and antithrombotic therapy in neonates and children, excluding the latter two because they cover topics of low prevalence in Norway. The committee initially planned to adapt the chapter on diagnosis of DVT, but the assigned chapter editor withdrew from the project due to time constraints. Because of delayed recruitment of an editor for the chapter on antithrombotic and thrombolytic therapy for valvular disease, this chapter will be adapted during 2014.

The panels adapted 333 recommendations, excluding 30, modifying 131, and adding practical information on dosage, contraindications, and risk scores for 121. The panels often made modifications because of the feasibility of applying the recommendation in a Norwegian setting. Interventions excluded across chapters because they are not readily available in Norway were cilostazol, triflusal, and intermittent pneumatic compression devices. For most recommendations, low-dose unfractionated heparin was excluded in preference for the commonly used subcutaneous low-molecular-weight heparin (LMWH), the latter in general having a slightly better risk-benefit profile and not requiring regular blood monitoring. Tables 1 and 2 present the major and minor modifications made.918

Table Graphic Jump Location
TABLE 1  ] New Recommendations and Major Modifications in the Adapted Guideline

ACS = acute coronary syndrome; AF = atrial fibrillation; ASA = aspirin; AT9 = Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines; CHA2DS2-VASc = congestive heart failure, hypertension, age > 75 y, age between 65 and 74 y, stroke/transient ischemic attack/thromboembolism, vascular disease (previous myocardial infarction, peripheral arterial disease, or aortic plaque), diabetes mellitus, female; COX2 = cyclooxygenase-2; IE = Internationale Einheiten (International Units); INR = international normalized ratio; IPCD = intermittent pneumatic compression device; LDUH = low-dose unfractionated heparin; LMWH = low-molecular-weight heparin; NOAC = novel anticoagulant; NSAID = nonsteroidal antiinflammatory drug; PCI = percutaneous coronary intervention; PE = pulmonary embolism; THA = total hip arthroplasty; TIA = transient ischemic attack; TKA = total knee arthroplasty; UFH = unfractionated heparin; VKA = vitamin K antagonist.

Table Graphic Jump Location
TABLE 2  ] Minor Modifications in the Adapted Guideline

CAD = coronary artery disease; DES = drug-eluting stent; GFR = glomerular filtration rate; HAS-BLED = hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly (> 65 y), drugs/alcohol concomitantly; HFS = hip fracture surgery; IVC = inferior vena cava; LV = left ventricular; MI = myocardial infarction; NORRISK = Norwegian risk model for cardiovascular mortality; PTS = postthrombotic syndrome; r-tPA = recombinant tissue-type plasminogen activator; SC = subcutaneous. See Table 1 legend for expansion of other abbreviations.

The panels spent a substantial amount of time focusing on two major issues: (1) finding credible baseline estimates, preferably based on Norwegian data and (2) reevaluating the balance between the benefits and harms of interventions in relation to assumed typical patient preferences and values. As examples of deliberations made, we outline in the following sections the results of the adaptation for two of the chapters. Readers can access an English translation of these at www.magicapp.org/public.

Prevention of VTE in Orthopedic Surgery Patients

AT9 gives a strong recommendation in favor of thromboprophylaxis for 10 to 14 days after major orthopedic surgery and a weak recommendation for extended prophylaxis for up to 35 days.19 It did not risk stratify the recommendations.

In reviewing the recommendation, the Norwegian panel noted that the baseline risk of VTE following major orthopedic surgery is somewhat uncertain. Improvements in both surgical technique and postoperative care have led to a decline in the baseline risk of VTE during the past decade.20,21 Scant data exist on current baseline risk because most patients receive some form of prophylaxis. Standard practice in Norway traditionally has been to provide nearly all patients with thromboprophylaxis for 14 to 35 days.

The guideline panel approached this problem through two strategies. It applied incidence data on VTE from a meta-analysis on new oral anticoagulants vs LMWH, taking into account the relative risk reduction provided by LMWH.22,23 In parallel, the panel collected data on VTE incidence following major orthopedic surgery from the National Patient Registry in Norway from 2009 to 2012. The registry contains a nationwide population-based clinical database with data on all inpatient consultations at government-run hospitals in Norway. Diagnoses are classified according to the International Classification of Diseases, Tenth Revision, and the Norwegian Classification of Medical Procedures. Each patient’s condition can be traced and cross-referenced.

The panel used the same approach here and calculated the baseline risk by applying the relative risk reduction provided by heparins to the registry data. To avoid underestimating the baseline risk, the panel assumed that all patients were given the most effective prophylaxis for a full 35 days.

The panel first opted to use the registry data to estimate new baseline risks. The review process, however, identified that the reported incidence of postoperative DVT was implausible when seen in relation to the incidence of pulmonary emboli. Suspecting an underreporting of DVT, the panel applied data from the meta-analysis and subsequently modified the baseline risk estimate of VTE, finally using an estimated risk of VTE for 5 weeks after major orthopedic surgery in 19 per 1,000 patients for its effect estimate calculations. On the basis of this estimate, 10 fewer patients will experience a VTE with thromboprophylaxis at the cost of two additional major bleeds. About two-thirds of the events would occur during the first 2 weeks following surgery.23

The Norwegian panel considered the absolute benefits of prophylaxis to outweigh the risk of bleeding and the associated burden for the first 10 days and, thus, gave a recommendation in favor of thromboprophylaxis. It suggested against extended prophylaxis, inferring the belief that most patients would find the burden of extended prophylaxis too large in the face of the small benefit (1,000 patients anticoagulated for 25 days to prevent three VTEs).

The panel undertook lengthy discussions and chose to make both recommendations weak, reflecting the remaining uncertainty regarding the true baseline risk and typical preferences and values. To address these uncertainties and to further facilitate tailored application at the point of care, the panel developed a new recommendation for the treatment of patients at moderate to high risk of thrombosis as assessed by the Charlson Comorbidity Index24 or the American Society of Anesthesiologists classification. For such patients, the panel made a strong recommendation in favor of thromboprophylaxis for 10 days, followed by a weak recommendation for extended prophylaxis up to 35 days following surgery.

VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy

Inconclusive evidence exists regarding the baseline risk of VTE in pregnant women with antithrombin deficiency, with the recommendation in AT9 being based on a meta-analysis that included only 33 women with antithrombin deficiency and a positive family history of VTE.25 AT9 estimated baseline risk for pregnant women with antithrombin and protein C or S deficiency as 20 per 1,000 antepartum and postpartum, with a reduction to seven per 1,000 treated with thromboprophylaxis and no increase in the number of major bleeds. On the basis of these absolute effect estimates, AT9 provides a weak recommendation in favor of antepartum vigilance and postpartum prophylaxis in women with a positive family history of VTE and a weak recommendation against any prophylaxis in women with no family history (baseline risk seven per 1,000 women).

Traditionally, nearly all women with antithrombin deficiency in Norway have received antepartum and postpartum thromboprophylaxis. The Norwegian panel did not find more trustworthy data regarding the baseline risk of VTE. In the end, it opted to apply the risk estimate provided in AT9 for an isolated population of pregnant women with antithrombin deficiency and a positive family history at 30 per 1,000 pregnancies. Based on an absolute risk reduction of 17 per 1,000 pregnancies, the panel believed that most women would prefer thromboprophylaxis and, thus, concluded with a weak recommendation in favor of antepartum and postpartum prophylaxis.

The panel made a similar value assessment about the use of prophylaxis following a cesarean section in women at increased risk of VTE. AT9 suggests prophylaxis at a baseline risk of 30 per 1,000 pregnancies. The Norwegian panel believed that most women would find the burden of treatment acceptable at an absolute risk reduction of eight VTEs per 1,000 women treated, meaning at a baseline risk of 15 per 1,000, at the cost of 11 more major bleeds. However, the panel gave a weak recommendation, acknowledging that the individual patient might value the balance between the advantages and disadvantages of the treatment differently.

New Presentation Format Through Use of the MAGICapp

The panels restructured, collapsed, and rewrote 333 original recommendations from AT9 into 249 recommendations in the multilayered presentation format. Clinicians can access the guideline online or downloaded as a web application for smartphones and tablets.

Through use of the MAGICapp, the guideline content is structured, tagged, and stored directly in a database. The format provides the end user with the recommendations as the first information presented, with the underlying evidence and background information directly linked to each individual recommendation (Fig 1). Each recommendation includes an adaptation disclaimer and a reference list for that individual recommendation, including the PubMed ID and digital object identifier. We provide an account of panel members’ financial and intellectual conflicts of interest in the background section of each chapter.

Figure Jump LinkFigure 1  Multilayered guideline format.Grahic Jump Location

As a result of the cumbersome road to final publication of the adapted guideline, as detailed in the first article of this series,7 one of the leaders of the guideline endeavor established the Norwegian Society for Thrombosis and Hemostasis in the spring of 2013. The society aims to promote knowledge of hemostasis and thrombosis within the medical profession; promote evidence-based clinical care, research, and teaching in the field; and contribute to interdisciplinary collaboration. The society’s first major step toward these goals is the development and publication of the Norwegian Guideline for Antithrombotic Therapy and Thromboprophylaxis.

By rewriting, updating, and adapting AT9 to a national context, the recommendations should be more acceptable and applicable in a Norwegian setting. The most visible alteration is the restructuring of the recommendations into a multilayered format that ensures transparency and facilitates quick-and-easy access. Users can access the adapted guideline online or off-line as a web application for tablets and smartphones. We are currently developing an efficient search engine within the application. These efforts, together with our future plans and additional dissemination strategies outlined in the first article of this series,7 aim to increase implementation.2630

Future Plans and Research

The use of a web-based authoring and publication platform holds great potential for keeping the guideline up to date. We are in the process of testing several strategies that will enable guideline developers to receive evidence feeds related to their predefined clinical questions, thus facilitating dynamic updating of the guideline.31 Ensuing modifications will automatically be relayed to all electronic outputs of the guideline.

We plan to monitor and evaluate the uptake and implementation of the adapted guideline. End users can provide comments and feedback directly through the MAGICapp. We will track actual use of the guideline through use of website analytics tools and direct observation of clinicians use of guidelines in real-life patient encounters. The MAGIC team will continue to research improved presentation formats in collaboration with the DECIDE project.

The pairing of the Norwegian guideline group with the MAGIC team provided an opportunity to test the frameworks and tools developed by the MAGIC research program and DECIDE project. New strategies for adapting trustworthy guidelines in the new format proved feasible in the context of the Norwegian guideline.

Author contributions: A. K. and P. O. V. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. A. K. was the principal investigator. A. K. contributed to the study concept, design, and ethical approval, drafting of the manuscript, and editing and final approval of the manuscript; L. B., T. A., E. A. A., E. B., A. F. J., L.-P. G., S. H., and G. G. contributed to the editing and final approval of the manuscript; and P. O. V. contributed to the study concept, design, and ethical approval and editing and final approval of the manuscript.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Drs Akl, Guyatt, and Vandvik participated in the writing of the American College of Chest Physicians original guideline (Antithrombotic Therapy and Prevention of Thrombosis, 9th ed). Dr. Halvorsen has received speakers honoraria from AstraZeneca plc, Eli Lilly and Co, Bayer AG, Boehringer Ingelheim GmbH, and Bristol-Myers Squibb. Drs Kristiansen, Brandt, Vandvik, and Guyatt are members of the nonprofit organization MAGIC. Drs Agoritsas, Berge, Flem Jacobsen, and Granan have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Role of sponsors: The sponsors had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript.

Other contributions: The authors thank all panel members for their efforts to complete the Norwegian adaptation of AT9 and the organizations that provided feedback on the guideline. The authors specially thank the Norwegian Directorate of Health for its contributions throughout this project.

AT9

Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines

DECIDE

Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence

GRADE

Grading of Recommendations Assessment, Development, and Evaluation

LMWH

low-molecular-weight heparin

MAGIC

Making GRADE the Irresistible Choice

MAGICapp

Making GRADE the Irresistible Choice Guideline Authoring and Publication Platform

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Figures

Figure Jump LinkFigure 1  Multilayered guideline format.Grahic Jump Location

Tables

Table Graphic Jump Location
TABLE 1  ] New Recommendations and Major Modifications in the Adapted Guideline

ACS = acute coronary syndrome; AF = atrial fibrillation; ASA = aspirin; AT9 = Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines; CHA2DS2-VASc = congestive heart failure, hypertension, age > 75 y, age between 65 and 74 y, stroke/transient ischemic attack/thromboembolism, vascular disease (previous myocardial infarction, peripheral arterial disease, or aortic plaque), diabetes mellitus, female; COX2 = cyclooxygenase-2; IE = Internationale Einheiten (International Units); INR = international normalized ratio; IPCD = intermittent pneumatic compression device; LDUH = low-dose unfractionated heparin; LMWH = low-molecular-weight heparin; NOAC = novel anticoagulant; NSAID = nonsteroidal antiinflammatory drug; PCI = percutaneous coronary intervention; PE = pulmonary embolism; THA = total hip arthroplasty; TIA = transient ischemic attack; TKA = total knee arthroplasty; UFH = unfractionated heparin; VKA = vitamin K antagonist.

Table Graphic Jump Location
TABLE 2  ] Minor Modifications in the Adapted Guideline

CAD = coronary artery disease; DES = drug-eluting stent; GFR = glomerular filtration rate; HAS-BLED = hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly (> 65 y), drugs/alcohol concomitantly; HFS = hip fracture surgery; IVC = inferior vena cava; LV = left ventricular; MI = myocardial infarction; NORRISK = Norwegian risk model for cardiovascular mortality; PTS = postthrombotic syndrome; r-tPA = recombinant tissue-type plasminogen activator; SC = subcutaneous. See Table 1 legend for expansion of other abbreviations.

References

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