Living systematic reviews: 4. Living guideline ... - Health Advance

Journal of Clinical Epidemiology

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REVIEW ARTICLE

Living systematic reviews: 4. Living guideline recommendations Elie A. Akla,*, Joerg J. Meerpohlb, Julian Elliottc, Lara A. Kahaled, Holger J. Sch€ unemanne, on behalf of the Living Systematic Review Network a

Department of Internal Medicine and Clinical Research Institute, American University of Beirut, Beirut, Lebanon b Cochrane Germany, Medical Center - University of Freiburg, Freiburg, Germany c Department of Infectious Diseases and Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia d Clinical Research Institute, American University of Beirut, Beirut, Lebanon e Department of Medicine and Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada Accepted 17 August 2017; Published online xxxx

Abstract While it is important for the evidence supporting practice guidelines to be current, that is often not the case. The advent of living systematic reviews has made the concept of ‘‘living guidelines’’ realistic, with the promise to provide timely, up-to-date and high-quality guidance to target users. We define living guidelines as an optimization of the guideline development process to allow updating individual recommendations as soon as new relevant evidence becomes available. A major implication of that definition is that the unit of update is the individual recommendation and not the whole guideline. We then discuss when living guidelines are appropriate, the workflows required to support them, the collaboration between living systematic reviews and living guideline teams, the thresholds for changing recommendations, and potential approaches to publication and dissemination. The success and sustainability of the concept of living guideline will depend on those of its major pillar, the living systematic review. We conclude that guideline developers should both experiment with and research the process of living guidelines. Ó 2017 Published by Elsevier Inc. Keywords: Living systematic review; Living guidelines; Updating systematic reviews; Updating guidelines; Prioritizing recommendations

1. Introduction This is the fourth and last paper in a series of papers discussing the emerging field of living systematic reviews (Box 1). In this paper, we specifically focus on the concepts of living practice guidelines and living recommendations. The Institute of Medicine defines clinical practice guidelines as ‘‘statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’’ [1]. Guidelines are intended to support clinicians and their patients in making health-related choices to optimize health outcomes [1]. A typical guideline includes several recommendations, each addressing alternative management options in a specific population. Two of the main factors determining the

Conflicts of interest: The authors declare no financial conflict of interest. They are all interested in the field of living guidelines and involved in projects to develop living guidelines. * Corresponding author. Tel.: þ961 1 374374. E-mail address: [email protected] (E.A. Akl). http://dx.doi.org/10.1016/j.jclinepi.2017.08.009 0895-4356/Ó 2017 Published by Elsevier Inc.

recommendation’s strength (i.e., strong, conditional) and direction (i.e., in favor or against) are the balance of benefits and harms and the certainty or quality of supporting evidence [2e4]. These two factors are judged based on a systematic review of the most current evidence on the relative benefits and harms of the alternative management options under consideration [5]. Systematic reviews also inform about other factors determining the strength of recommendation (e.g., values and preferences, costs, equity, acceptability, feasibility) [6,7]. A recommendation is as up to date as the search date of the systematic reviews providing evidence for the different criteria considered in developing recommendations [3,4]. One study found that the median ‘‘survival’’ of reviews (i.e., period over which they remain up to date) in an area with a relatively high rate of publication (i.e., cardiovascular disease) was 2.9 years (95% confidence interval: 1.1e5.3) [8]. Moreover, some reviews were already out of date by the time of their publication [8]. Given a guideline is based on a set of systematic reviews, some of its recommendations would be out of date by the time of the guideline publication [9e11]. This problem is accentuated when factoring in the additional amount of time needed to

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What is new? Living guidelines aim to provide timely advice for decision-makers by optimizing the guideline development process. This optimized process will allow updating individual recommendations as soon as new relevant evidence becomes available. Guideline developers need to prioritize the recommendations to switch to the living status, according to explicit criteria. Developing living guidelines will require both workflows to support them and close collaboration between living systematic review and living guideline teams. Challenges to the implementation of living guidelines include setting the thresholds for changing recommendations and potential approaches to publication and dissemination. The success and sustainability of the concept of living guideline will depend on those of its major pillar, the living systematic reviews

move from the evidence to the recommendations and to publish the guidelines. Also, an increasing number of recommendations would become out of date as time elapses postguideline publication. Indeed, a study of clinical guidelines developed in the Spanish National Health System found that a fifth of recommendations were out of date at 3 years postpublication [10]. The current model of updating recommendations is to update the entire guideline at specific time intervals (e.g., at 3 years) following its publication [12]. This approach has two major limitations. First, some of the recommendations will get out of date after varying periods of time (directly correlated to the supporting systematic reviews becoming out of date) (Fig. 1A). This negatively affects the validity of these recommendations. The second

Box 1 Series of papers on living systematic reviews ‘‘Living systematic reviews: 1. Introductiondthe why, what, when, and how’’ ‘‘Living systematic reviews: 2. Combining human and machine effort’’ ‘‘Living systematic reviews: 3. Statistical methods for updating meta-analyses’’ ‘‘Living systematic reviews: 4. Living guideline recommendations’’

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limitation is that for some recommendations, efforts invested in their update will be wasted as the underlying evidence will not change. This negatively affects the efficiency of the process. As Fig. 1 shows, with any frequency of update of the whole guidelines, there will be recommendations that go out of date prior to the update (decreasing validity). There will also be recommendations that are revisited in vain as they are still up to date (decreasing efficiency). The frequency of update will affect the distribution of these two types of recommendation. Conducting more frequent updates of the whole guideline will enhance validity but negatively impact efficiency (Fig. 1B). Conducting less frequent updates will enhance efficiency but negatively impact validity (Fig. 1C). We hypothesize that the process living guidelines will lead to more valid recommendations, while potentially improving efficiency of guideline development. Although guideline developers have been discussing the concept of living guidelines [12e17], a systematic review of methodological handbooks did not identify specific instructions for conducting them [18]. In the first paper of the series, we define a living systematic review as a systematic review which is continually updated, incorporating relevant new evidence as it becomes available. In practice, this means continual surveillance for new research evidence through ongoing or frequent searches and the inclusion of relevant new information into the review in a timely manner, so that the findings of the systematic review remain current. In this paper, we define living guidelines and discuss when they are appropriate, the workflows required to support them, the collaboration between living systematic reviews and living guideline teams, the thresholds for changing recommendations, and potential approaches to publication and dissemination. 2. Definition of living guidelines Box 2 provides the definitions for the concepts of living systematic reviews living practice guideline and living recommendation: The ultimate aim is to provide timely and trustworthy advice for decision-makers. One implication of the definition of the living practice guideline is that the unit of update becomes the individual recommendation and not the whole guideline, which is likely to make the process less onerous. In other terms, the different recommendations included in the guideline will get updated at different times. Thus, we are referring to living recommendations in the context of guidelines. The second implication is that the living recommendation should build on an existing, high-quality recommendation developed using the standard guideline development methods [19] (base recommendation). Fig. 2 illustrates the living guideline process. Typically, it would start by developing a ‘‘base recommendation’’ using standard guideline development methods. In parallel, a literature surveillance process is put in place. The identification


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Fig. 1. The current model of updating recommendations. (A) The periods of time recommendations remain up to date after guideline publication. (B) More frequent updates of the whole guideline. (C) Less frequent updates of the whole guideline. The horizontal lines in (A), (B), and (C) represent individual recommendations in the guideline; their lengths represent the periods of time these recommendations remain up to date. The red vertical lines in (B) and (C) represent the time of update of the whole guideline; the red stars indicate that the corresponding recommendation is out of date by the time of the guideline update. (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)

of new evidence would trigger the process for the living systematic review and of its Evidence Profile, for the living Evidence to Decision (EtD) table, and subsequently for the living recommendation (more details below).

3. When are living guidelines appropriate? Adopting a living guideline process will require the prioritization of recommendations to switch to the living status, in order to maximize the value of the approach [20]. The prioritization criteria for living recommendations resemble those proposed by Elliott et al. for prioritizing living systematic review (Elliott et al., this issue) and include: 1. The recommendation is a priority for decisionmaking. This could be affected by a high prevalence of the condition, high rates of associated morbidity and mortality, known variation in practice, and interest in emerging interventions and diagnostic tools. 2. There is a reasonable chance that the existing recommendation changes with the emergence of new Box 2 Definitions Living systematic review: a systematic review which is continually updated, incorporating relevant new evidence as it becomes available. Living practice guideline: an optimization of the guideline development process to allow updating of individual recommendations as soon as relevant new evidence becomes available. Living recommendation: a recommendation which is updated as soon as relevant new evidence becomes available.

evidence. This is the case when the strength of the existing recommendation is conditional (as opposed to being strong) due to the evidence not being of high certainty. This is a scenario where the consideration of emerging evidence may increase the certainty of evidence, subsequently enhancing the strength of the recommendation. 3. There is likely to be new research evidence. Active research addressing the recommendation of interest is ongoing with a reasonable likelihood of findings being published over the period when the living guideline process is implemented. At the same time, it is important to keep in mind that recommendations in the same guidelines might not be totally independent from each other. For example, the recommendation to treat with option A might depend on the recommendation to apply test X. If the recommendation to apply test X is changed, this might impact on the treatment recommendation. So, the interdependency of these two recommendations would require both to be living recommendations to ensure simultaneous updating. When at least one of the above listed criteria for switching a recommendation into a living status cease to apply, the authors could switch back from the living guideline process to the standard guideline development methods, for individual recommendations or entire guidelines. 4. Workflows required to support living guidelines Several guideline handbooks and publications have proposed different approaches for the guideline development and update processes [18]. A review of these proposals found that they overlap to a large extent and proposed a checklist (the Guidelines Development Checklist) of 18 topics and 146 items [5]. Living guidelines do not represent

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Box 3 Elements necessary for producing living recommendations

Living Living Living Living Living Living Living

systematic review Evidence Profile Evidence to Decision (EtD) table guideline panel peer review process publication and dissemination budget

a new approach but rather an optimization of the standard guideline development methods (e.g., following the Guidelines Development Checklist) to allow updating of individual recommendations as soon as new relevant evidence becomes available. While Box 3 lists the elements necessary for producing living recommendations, we detail the main elements here: 1. Living systematic review: this is the most essential requirement for a living guideline process. As defined in the first paper of this series (Elliott et al., this issue), a living systematic review is a process that uses continual surveillance of the literature to allow updating of a systematic review with new evidence as it becomes available.

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2. ‘‘Living summary tables’’: guideline panels rely on standardized summary tables to make the judgments required for developing recommendations. The first type of tables is the Evidence Profile, which provides for each outcome of interest the statistical information on the effects on health benefits and harms of the alternative interventions and the detailed assessment of the certainty of supporting evidence [21,22]. Appendix 1 at www.jclinepi.com shows an example of an Evidence Profile taken from the first Cochrane living systematic review [23]. The second type of table is the Evidence to Decision (EtD) table, which provides for each recommendation the information on the factors needed to judge the strength and direction of that recommendation [3,4]. These factors include the health effects of interventions, the certainty of evidence, resource use, impact on equity, and acceptability of the intervention, among others. Appendix 2 at www.jclinepi.com shows an example of an EtD table. Updating these tables as soon as new evidence emerges is needed to swiftly relay the findings of the living systematic reviews to guideline panels in a form that allows them to reconsider the recommendation, hence the suggestion of using the term ‘‘living summary tables.’’ 3. ‘‘Living guideline panel’’ (or ‘‘on-call guideline panel’’): typically, recruiting a guideline panel is time-consuming in terms of establishing contact, agreeing on the terms of reference, collecting and

Fig. 2. The main steps of the living guideline process, focused on the unit of update, that is, the living recommendation.


managing conflicts of interest information, and training. Also, convening a panel meeting requires time due to scheduling challenges. A living guideline process can circumvent those challenges by recruiting ahead of time panel members committed to making themselves available within a very short notice, whenever the updating process is triggered. This implies that virtual meetings would be more feasible than in person meetings. Also, a living guideline panel would likely be engaged for more frequent periods of times, compared with a standard guideline panel. It is also likely that the membership of the panel will change over time. This raises the challenge of preserving the ‘‘institutional memory’’ of the group. 4. ‘‘Living peer review process’’ (or ‘‘on-call peer reviewers’’): similarly to recruiting panelists, recruiting peer reviewers may be time-consuming and their response may not be timely. A living guideline process could recruit a larger number of reviewers than needed and ensure their commitment to a timely review. The guideline developer could minimize the involvement of the reviewers and provide them with advance notice (e.g., as soon as the updating process is triggered). Also, any internal (e.g., professional society’s) or external (e.g., governmental) review and approval processes or periods of public comment need to be carefully planned and weaved into the guideline timeline. 5. Collaboration between living systematic reviews and living guideline teams A smooth workflow between the team conducting the living guideline and the team producing the living systematic reviews should be ensured to maximize efficiency. That would require both coordinated, and ideally integrated, work processes between the two teams, and the integration of tools and platforms used for systematic reviewing and guideline development [24]. This may raise some funding and logistical challenges. 6. Thresholds for changing recommendations When engaged in a living guideline process, a living guideline panel might want to be prudent in not setting the threshold for changing the recommendations too low (i.e., with relatively small changes in effect estimates). First, and as discussed in the third paper of this series (Simmonds et al., this issue), there might be an increased risk of false positive findings when a living systematic reviews leads to frequent updates of the meta-analyses. A false positive result may lead to inappropriate change in the direction and/or strength of the recommendation. This may in turn lead to harmful practices while potentially increasing resource use. A later correction of the false

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positive results leading to reverting the change in the recommendation may negatively impact the trustworthiness of the guidelines. Second, frequently updated recommendations may pose significant challenges for dissemination and implementation. On the other hand, the living guideline panel should not be too prudent. Setting the threshold to change a recommendation too high may diminish the potential benefits of living recommendations. Better understanding of how to establish these thresholds will be informed by methods to identify signals for the need to update systematic reviews [25,26], methods for repeated meta-analyses (Simmonds et al., this issue), and the increasing experiences with living systematic reviews and living recommendations. 7. Approaches to publication and dissemination A living recommendation can provide timely advice only if it is published and disseminated in a timely way. While publishing and disseminating individual recommendations (or cluster of recommendations) can be based on available guidance [27,28], they still pose several challenges [29]. One major challenge is the availability of a platform that allows publishing updates of individual recommendations (or cluster of recommendations). Another challenge is to ensure that users can clearly identify the latest version of the recommendation. At the same time, the guideline developer should provide access to the historical information related to the previous versions of the recommendation, including content information (i.e., the Evidence Profile and the EtD table) and process information (e.g., members of the guideline panel and their conflicts of interest declarations). Another set of challenges, common to living systematic reviews and living guidelines, relates to authorship indexing and versioning (Elliott et al., this issue) For example, should authors who contributed to the original or earlier update remain authors on the latest one? Where guidelines are published in journal article form, should the updated recommendation be indexed with or separately from the original publication, and how should the citations of the update be allocated? Addressing these questions requires clear rules and agreements among authors and between the guideline developer and the journal. In terms of dissemination, digital online guideline documents (e.g., on websites, databases, or online textbooks) would allow any change in the recommendation to be reflected in real time. However, this does not necessarily ensure that the target user is aware of this change. Potential solutions include a push mechanism and linking living guidelines to information systems at the point of care, like electronic medical record and decision support tools. So, in an ideal world, as soon as a living systematic reviews triggers a change in a living recommendation, this change would be reflected in the online living guideline document and in the linked downstream systems.

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8. Conclusion

References

Living guidelines aim to provide timely advice for decision-makers by optimizing the guideline development process to allow updating individual recommendations as soon as new relevant evidence becomes available. Guideline developers will need to prioritize the recommendations to switch the living status, according to explicit criteria. Implementing living guidelines will require both workflows to support them and close collaboration between living systematic reviews and living guideline teams. Several challenges will face the implementation of living guidelines such as setting the thresholds for changing recommendations and potential approaches to publication and dissemination. Implementing living guidelines will also bring budget as well as logistical challenges to organizations, particularly when maintaining a relatively large number of living recommendations. Eventually, the success and sustainability of the concept of living guideline will depend on those of its major underpinning, the living systematic reviews. Guideline developers need to experiment with living guidelines while developing and refining the needed tools and processes. Efforts to build on include human and machine enablers of living systematic reviews (Thomas et al., this issue), formalizing guidelines in a computerinterpretable form [30], and semantic technologies [24]. There is also a need to develop a research agenda to better understand the strengths and limitations of the approach, particularly in terms of feasibility, validity, cost, and efficiency relative to the standard approach.

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Acknowledgments The authors would like to thank the members of the Living Systematic Reviews network for their comments on the paper, particularly Linn Brandt, Itziar Etxeandia, Kurinchi Gurusamy, Andrew Maas, Laura Martınez Garcıa, Stefania Mondello, Zachary Munn, Nicole Skoetz, Anneliese Synnot, Tari Turner, and Luke Wolfenden. We would like to acknowledge Cochrane Canada center and the GRADE center at McMaster University for financially supporting a meeting on the subject in May 2017. The Living Systematic Review Network is supported by funding from Cochrane and the Australian National Health and Medical Research Council (Partnership Project grant APP1114605). Authors’ contributions: E.A.A. and J.J.M. conceived and designed the experiments. E.A.A., J.J.M., J.E., L.A.K., and H.J.S. wrote the article.

Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.jclinepi.2017.08.009.

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