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GUIDE-M by Mind Map: GUIDE-M
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GUIDE-M

To facilitate uptake, the process of guideline development may consider seven guideline implementability domains across three core tactics: 1) the Developers of Content, 2) Creating Content and 3) Communicating Content. Ensuring Transparency in reporting the methods used and decisions made throughout the guideline development process, is an important element that cuts across the overall GUIDE-M and its components.Considering and bringing together the appropriate “Developers of Content” is an important aspect of the guideline development process.  Addressing stakeholder involvement of guidelines during development facilitates their uptake, and concerns the appropriate composition of knowledgeable, relevant and unbiased expertise of the guideline development group. It also involves clearly defining target end users and seeking the views and preferences of the target population (e.g., patients, public) during guideline development. Further, it involves ensuring the group members’ credibility and disclosure of potential conflicts of interest. Reporting all these details in the guideline ensures transparency. Under “Creating Content”, there are two domains of guideline implementability that are interrelated but not necessarily sequential.  The sub-domains of ‘Evidence Synthesis’ represent the compilation of the evidentiary base: HOW – execution of methods to develop evidence base, WHAT – completeness of reporting the evidence base, and WHEN – currency of the evidence base (i.e., guideline updating). After gathering, synthesizing, and appraising the evidence, guideline developers need to formulate the recommendations through a ‘Deliberations and Contextualization’ process. While formulating the recommendations according to the evidentiary base, guideline developers also need to acknowledge aspects of Clinical Applicability (clinical, patient and implementation relevance), Values (of providers, patients/clients, populations/society, policy, guideline development groups), and Feasibility (local applicability, resources, novelty) through their considered judgments.  Reporting all these details in the guideline ensures transparency. Once the content is created, it is important to ensure that “Communicating Content” is done as effectively as possible. This can be achieved by fine-tuning the ‘Language’ and ‘Format’ of the guideline and its recommendations. To optimize the Language of a guideline and in turn its uptake, the language used in recommendations has to be simple, clear, and persuasive. In addition, guideline developers can focus on the formatting aspects of the guideline, which includes the various components within a guideline document, its presentation, and the consideration of multiple, different versions of the final guideline document, to optimize its uptake.

1. Developers of Content

Bringing together members of the guideline development group, or “Developers of Content”, involves considering three domains to ensure an appropriate group composition:  Comprehensive (i.e., that clinical experts, members of the target population, decision-makers and methodologists are all represented); Knowledgeable and Credible membership; and Competing Interests (i.e., collecting and disclosing any financial, professional/academic or advocate conflicts of interest of members).

Comprehensive

COMPREHENSIVE: Addressing stakeholder involvement of guidelines during development facilitates their uptake, and concerns the appropriate composition and relevant and unbiased expertise. Members of the guideline development group need to represent a variety of interests to ensure the groups comprehensiveness, these include: clinical experts, target populations, decision-makers and methodologists.

Knowledgeable and Credible

KNOWLEDGEABLE AND CREDIBLE: Credible guidelines are those that are widely known, authoritative, influential, often national(1, 2), and are published in respected sources(1). To make guidelines more credible, guidelines should provide clear information about the background and expertise of the guideline development group(3) as well as their competing interests(4, 5). Personalizing interactions involving opinion leaders is important(2). When developing guidelines for primary care routine practice, the involvement of multidisciplinary panels is likely more applicable and may be less susceptible to stakeholder bias(3). Pharmaceutical industry contributions to the development of guidelines can undermine its credibility(1). 1. Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: A quality driven approach for translating evidence into action. . Otolaryngology Head Neck Surg. 2009;140(6 Suppl 1):S1-S43. 2. Rashidian A, Eccles MP, Russell I. Falling on stony ground? A qualitative study of implementation of clinical guidelines' prescribing recommendations in primary care. Health policy. 2008;85(2):148-61. 3. Horvath AR, Kis E, Dobos E. Guidelines for the use of biomarkers: principles, processes and practical consideration. Scandinavian Journal of Clinical and Laboratory Investigations. 2010;70(1):109-16. 4. AGREE Next Steps Consortium. The AGREE II Instrument 2009 April, 30, 2014. Available from: www.agreetrust.org . 5. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G. AGREE II: Advancing guideline development, reporting and evaluation in health care Canadian Medical Association Journal. 2010;182(18):E839-42.

Competing Interests

COMPETING INTERESTS: Recommendations based on expert opinion alone may be prone to conflicts of interest because just as clinical researchers have conflicts of interest, expert clinicians are also those who are likely to receive honoraria, speakers bureau, consulting fees, or research support from industry(1). In such circumstances, any potential conflicts of interest should be clearly disclosed because they could inappropriately affect how recommendations were formulated(1, 2). Transparency mandates explicit statements about the reasons for developing a policy, and explanation of how contributing factors were weighted(3). The competing interests of guideline development group members should be recorded and addressed(3-5). These should also include funding sources(2), a statement about editorial independence, and an explicit statement that the views or interests of the funding body have not influenced the content of the guideline(4, 5). In particular, it should provide enough detail for users to determine whether and how the views or interests of the funding source may have influenced final recommendations(2). 1. Chou R. Using evidence in pain practice. Part I: Assessing quality of systematic reviews and clinical practice guidelines. Pain Medicine. 2008;9(5):518-30. 2. Horvath AR, Kis E, Dobos E. Guidelines for the use of biomarkers: principles, processes and practical consideration. Scandinavian Journal of Clinical and Laboratory Investigations. 2010;70(1):109-16. 3. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC, Jr. Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines. JAMA: The Journal of the American Medical Association. 2009;301(8):831-41. 4. AGREE Next Steps Consortium. The AGREE II Instrument 2009 April, 30, 2014. Available from: www.agreetrust.org. 5. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G. AGREE II: Advancing guideline development, reporting and evaluation in health care Canadian Medical Association Journal. 2010;182(18):E839-42.

3. Communicating Content

Once the content of guidelines is created, the focus of the guideline development process can shift to ensuring the content is communicated effectively by addressing two domains of guideline implementability.  “Communicating Content” involves fine-tuning guideline recommendations with effective (i) Language (i.e., to ensure the language of recommendations is simple, clear and persuasive) and (ii) Format (i.e., by including specific components; refining presentation with effective layout and structure; and representing the final guideline in multiple versions for different users and purposes).

Language

LANGUAGE: Simplicity can be achieved by avoiding complexity and information overload. Complexity occurs when recommendations are composed of many different elements or require multiple action types (1-3), are overly elaborate (containing a multitude of decision trees in an attempt to cover every possible combination and permutation) (4-7) or many different conditional factors influencing performance (6). The level of complexity is inversely proportional to its adoption - the greater the complexity, the lower the rate of use (8-11). Complex guidelines may also hinder understanding and be less persuasive and hence difficult to implement (12), resulting in lower compliance and adherence (1, 13) and acceptance of guidelines (2). Simple and uncomplicated guidelines have higher compliance rates (14) and are more easily adopted (15, 16). To overcome the inherent complexity of guidelines (17), they should be supported by hierarchical nesting (18), categorized on a complexity-simplicity continuum (19), balance choices and options with need (20), and use the process of atomization (removing unnecessary words, and reducing decision variables to prototypic nouns with descriptors occupying the "value" element) (21). The use of conditional statements such as “If-then” or “If-then-else” formats can be used to write guideline rules with all of the parameters strictly defined using routinely collected clinical data (22, 23) can also help to reduce complexity. In terms of the complexity of numbers, the number “Three” is how we group digits in large numbers for increased readability, and should be used for items that need to be grasped rapidly and remembered easily (24). The number four can be used for casual rating scales, and is the same as years, so it is easily readable (though not as easy as the “number three”’) (24). The number five is the strict upper limit as it represents a handful or the number of fingers on a hand, but also our practical span of attention (24). The number six represents one above the “safe five”, and may work for some people or in some cases only, while the number seven is too many to be effective and too numerous to be numbered (24). In reducing complexity, the Error/Effort tradeoff also needs to be considered. In tasks taking more than a few seconds to complete (i.e., task complexity), people will monitor their effort expenditures and adjust their strategies accordingly (25). The desire to minimize effort may be stronger than the desire to minimize error (25), but excessive choice may cause confusion and be extremely de-motivating (20), so developers need to consider whether providing additional information and choice really contributes to improving decision making (26). In situations of great time pressure, overly elaborate guidelines that contain a multitude of decision trees in an attempt to cover every possible combination and permutation may be impractical. In these circumstances, clinicians may operate under a "take the best" paradigm in which they choose the first solution that matches their needs, without examining all solutions and integrating them (4). Simplicity can also be hampered by information overload (succinct), which occurs when information is overwhelming or oversupplied or when the quantity of information in which the internal and external requirements exceeds the available cognitive capability of individuals (27-30). Saturation of the information processing system can get saturated, thereby causing confusion, continuous partial attention and cognitive overload (30). This can complicate decision making (28), and result in lost or diminished interest in the information (31), postponement or abandonment of the information, a decline in the quality of choices (32), and resistance to novelty (28). When many alternatives are available, the inclination is to do nothing (33). The limit of working memory before information overload sets in is 5 +/- 2 chunks of information (34, 35) or a checklist of 5 to 9 items at a time (36). However, the 5 to 9 items depends upon the context, as the length should be dependent on how much time the user would have to look up that information (36). Furthermore, motivation plays an important role as it acts as a driving force determining the extent to which an individual is willing to use his or her maximum information capacities (37). The working memory can be optimized by narrowing the set of alternatives or decreasing the cognitive load (20, 23, 38) and limiting the number of new elements to 3 or 4 items or chunks (39-41). Applying rules of thumb or heuristics can also simplify medical decision making and help deal with information overload (42) by simplifying complex rules and information matrices into a smaller number of overriding truths (43). In complex and time-constrained scenarios, heuristics serve to condense relevant information and streamline decision-making processes (42). However, in situations where most frequent heuristics pertain to clinical decisions regarding areas well addressed by current published recommendations, heuristics can often conflict with the recommendations and can resemble the cognitive biases that distort clinical judgment like availability bias and base-rate fallacy (42). Furthermore, although the breadth of guideline applicability may be appropriate for an expert who can appreciate the nuances of different agents and patients, it is less suitable for novices, who might be better served by one safe choice instead of four options (44). Clear guidelines comprise recommendations that are actionable and written with effective language. When guidelines are unclear, physicians are left with little direction (45), and less likely to accept (2, 46) or comply (47) with guidelines. Guidelines can become unclear in high uncertainty situations, when the evidence is still evolving or recommendations are based on evidence not in common practice (45). This can also occur when the clinical decisions based on the results of the recommended investigations (or the names of recommended tests) are not precisely specified (46). To make clear, guidelines should define and specify the target population (48), the objective (49), key terms (50), specialized terminology (48), abbreviations (50) used in the recommendations aiming to be unambiguous (46, 48, 51). Actionable statements provide practical direction (52) using action-type (active) verbs (53-56) that specify the target behaviour: when (under what specific conditions), who, must/should or may (the level of obligation), do precisely what action (48, 53, 55). Using specific concrete statements increases the extent to which information is both understood and remembered (55) but overspecification (covering every conceivable point) should be avoided (36). Ambiguity can arise when guidelines do not clearly and consistently specify what to do or clarify the parameters on which decisions are based (14, 21), which can lead to vague and cautious recommendations that are unlikely to be applicable in particular situations (57) or guide practice in a meaningful way (58). Vague and underspecificed (weasel) words or phrases are open to broad interpretations (e.g., adequate, frequently, febrile, elderly) (22), and can lead to reduced adherence or to increased practice variation (59). Specificity can also be affected by the use of passive voice (a form of vagueness) because the essential “who” of the statement is missing (53); and the use of arbitrary numbers (months of treatment, intervals between tests) (60). However, there may occasionally be a need for deliberate vagueness or underspecificiation because of insufficient evidence (53, 59), in which case an explicit statement of the deliberate vagueness (and the reasons) should be provided (61). Clarity can also be improved through effective writing (direct style with active voice, good punctuation with short sentences, and devoid of abbreviations, redundant words or unnecessary jargon) (48, 62); and by keeping units of meaning together, hyphenation to a minimum, avoiding awkward breaks of sentences and words (63); using bulleted lists to simplify and clarify if recommendations convey a series of points, deal with repetition or complex paragraph structures (48, 64). The communication of guideline messages should be crisp and persuasive. This involves framing recommendations from a “gain” rather than “loss” stance (as people tend to be loss averse)(65), particularly in settings of uncertainty (66). Framing should also be grounded on clear and convincing arguments that are based on extensive clinical skills and experience (6) and which justify the need for change by comparison with existing approaches, norms and concerns (67). It is better to focus on omission of errors (not doing the right thing) rather than errors of commission (doing the wrong thing (21, 22). Poorly framed guidelines have little effect on individual or aggregate-practices patterns (68). Reminding people of a situation in which everything worked out for the best is a good way to increase confidence in a recommendation, while reminding people of a related incident in which things went wrong is a good way to increase fear of a bad outcome (65). Relative advantage the extent to which a potential adopter views a new care process as being better or offering an advantage over previous ways of performing the same task (9, 69-73). It is a dominant predictor of future intentions to use them (74) and is associated with clinician intention and behaviour to change (15). Thus, new processes with a clear, unambiguous advantage over the previous approach will be more easily adopted and implemented than those viewed with no relative advantage (9, 15, 75). The advantage may be conceptualized in terms of economic profitability, social prestige, or ease of use (76), and signifies the importance of having a clear understanding of existing resources when designing new information resources (15). 1.    Foy R, MacLennan G, Grimshaw J, Penney G, Campbell MK, Grol R. Attributes of clinical recommendations that influence change in practice following audit and feedback. Journal of Clinical Epidemiology. 2002;55(7):717-22. 2.    Milner KK, Valenstein M. A comparison of guidelines for the treatment of schizophrenia. Psychiatric Services. 2002;53(7):888-90. 3.    Essaihi A, Michel G, Shiffman RN, editors. 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Format

FORMAT: The consideration of format in guidelines allows a way to make explicit, the various elements of its purpose and content (1), and be influential in promoting guideline use in practice (2, 3) by making them concise, simple and easy to use (4-6). Formatting aspects of guidelines include the representation of multiple versions of guideline documents to optimize their uptake, the various components within a guideline document, and its presentation. Versions: Levels of guidelines typically progress from a research-based, information-gathering and analysis tool (which can be used to understand the basis of the recommendations in detail), to a briefer guide for clinical education, to a short version for actual clinical use, and finally to a lay-language version for patient education and discussion (7). Presenting guidelines in multiple formats or alternate versions (4, 5, 8, 9) can influence accessibility and ease of use, which may overcome attitudinal barriers of guideline adoption (10-12). For a guideline to be useful to physicians, it needs to be tailored to its intended end-users (13), and should be presented in formats that can be read and understood by non-physician reviewers, practitioners, and patients/consumers (11). Different groups of health professionals exhibit distinct preferences for different types of guidelines, which suggests a need for systems to produce, filter, target, and package the evidence in ways that reflect these preferences (14). As such, guidelines should be distributed or converted in a variety of formats (modalities) that are either non-electronic (i.e., paper or text-based) or electronic (i.e., computer-based) (15). Static electronic forms of guidelines refer to those that are computer generated but do not contain elements that are adaptable and change (i.e. pdfs). Guideline delivery forms that are electronic and dynamically generated which are adaptable to the specific expertise level of the user may be more effective at achieving a standard level of practice across providers with varying levels of expertise (16). Computerization of guidelines can improve their level of use, and their impact on clinical practice (15, 17), particularly if they become a component of an EMR (18). The majority of physicians prefer a guideline format that is short, concise, and easy to use, rather than a full text document (18). Components: Guidelines should specify their purpose, rationale, the participants in the development process, the targeted health problem, patient population and intended audience (1), include a general introductory section that explains the need for the guideline and the process by which they were developed (19) as well as a methods section (20). Other important components to include in guidelines are: overview material (structured abstract that includes the guideline's release date and print and electronic sources), name and institutional affiliation of adaptation panel; introduction and background; scope and purpose; target audience and target population; recommendations (including risks and benefits and specific circumstances under which to perform recommendations), strength of recommendations; supporting evidence and information for the recommendations (panel rationale behind the recommendations, presentation of additional evidence and/or the results of the updating process, how and why existing recommendations were modified; external review and consultation process (who was asked to review it, what process was followed, discussion of feedback and what was incorporated into the final document); plan for scheduled review and update; algorithm or summary document; implementation considerations; glossary; references; acknowledgement of source developers; list of panel members and their credentials, declaration of conflicts of interest; list of funding sources; and appendix describing adaptation process (13). Strategies to ensure recognizability of guidelines include abbreviated formats and a clear display of logos (21), which also avoids confusion between evidence-based and quasi guidelines or other information produced (21). To ensure that the most important recommendations of the guideline are being followed, key features should be highlighted such as recommendations that are essential to the whole guideline and to their ultimate goals (22), those that differentiate between major recommendations and other recommendations (23, 24) or is a central element in the guideline (25), and have the most significance in the care of patients (26). Short summaries or brief executive summaries should be easily read (27) and highlight principal or key management recommendations for busy clinicians who may not have the time to review the traditionally lengthy, full guideline document (3, 28). Brief summaries or algorithms with links to more extensive explications of guidelines could present the most pertinent information concisely, while not compromising comprehensiveness (18, 20), which can also help to create more clarity for patients (29). Presentation: The presentation of guidelines consists of factors that affect its layout and structure, and the way information is visualized. Document layout is about the placement or arrangement of visual elements and the length of documents, and for the information to be laid out spaciously and consistently so they are easier and quickly understood (30, 31). To maximize recall, pictorial elements such as product photography should be positioned on the left-hand side of documents, and text on the right (30). Given the time constraints on physicians and the potential for information overload, guidelines should be short and as succinct as possible (9, 18, 32-35). Structure relates to the high-level categorization of the components of a recommendation and how recommendations relate to each other (36), and represent the suggested template for major sections within a guideline (37). Matching the system to the real world and using grouping/ordering (sequential arrangement or bundling) facilitates the structure of guidelines to enhance their uptake. When guidelines are structured in a sequence that mimics the real patient encounter using real-world conventions, physicians will follow a more natural mapping process and thus assimilate information better (38). Beginning with the initial evaluation or presenting complaint is thus the best approach for clinical practice guidelines (7). Grouping (bundling) is a technique to help physicians remember a list of recommendations with less effort given the limit in the span of immediate memory (i.e., three bundles of three items is easier to process than a single series of nine items (39). Encapsulating knowledge (i.e., clinical knowledge) tends to be used preferentially and more readily assessed by doctors than biomedical knowledge (40). Bundling medical tests (and procedures) so that people remember to do them is far smarter than adhering to an erratic series of health commands that people are unwilling to follow (41). Information visualization is about presenting information in a visual form. It offers a way to shift cognitive load to the human perceptual system through graphics and animation, and involves the selection, transformation, and presentation of data (including spatial, abstract, physical, or textual) in a visual form that facilitates exploration and understanding (42); and can lead to better, faster, and more confident decisions (42). The simplest and most minimal design options are often the best for ensuring usability (38). Compared to words, which are better for representing procedural information, logical conditions, and abstract concepts, images are better for spatial structures, location and detail (43). Information visualization is made up of information display and information context. Information display can affect decision behaviour, and concerns how information is displayed such as with the use of tables, algorithms, pictures and graphical display. Tables can improve the clarity of guidelines if the information is most easily understood when tabulated (18, 20). An algorithm or flowchart of the clinical decision pathway can be useful tools for improving guideline utilization (44), but are most useful when the decision logic is complex and the temporal sequence of activities is unclear (37). However, algorithms can also be rigid and cannot provide all the information present in text-based guidelines because of its condensed nature or may be seen as ambiguous because there is no room for explanation of counter-intuitive advice (16). Graphical displays are short summaries of the guideline text (17) that enhance further interpretation and clarity of the recommendations (45) in an intuitive way (46). Stacked bar graphs are better at conveying absolute risk, simple bar graphs are better at conveying relative risk, while line graphs are typically the best choice when illustrating the effectiveness of a drug or trends over time (e.g., survival and mortality curves) (46). The bar chart format tends to be rated higher for clarity and interpreted the most consistently, but it may not be the most accurate way to convey outcomes information (47). Information context affects which information the decision maker attends to, and is determined by context variables that affect the framing, vividness, depth of field, and evaluability of information (42). By changing the presentation of a given problem (i.e., framing), visual representations may accentuate biases and heuristics in decision making (42). How to use colour appropriately is a key factor for vividness, which leads to pre-attentive processing and in turn attracts and holds our attention. Basic colours (green, red, yellow, blue) are easier to remember than non-basic colours (orange, lime green); and yellow and blue are the best for colour blindness (43). For ease of comprehension, colors of objects should have strong contrast with the background, as this helps people identify colours quickly (43). For ease of reading, text should have a reasonable luminance difference from its background (the finer the detail, the greater the contrast required) (43), while gray scales are an unreliable method for conveying quantitative information (43). Depth of field (the extent to which visual representations provide contextual overview vs. detailed information) enable end-users to keep both these levels in focus at the same time (42), while evaluability (the ease with which information can be assessed and compared) is likely to lead to increased acquisition, weighting, and processing of this information (42). 1.    Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA, the journal of the American Medical Association. 1999;281(20):1900-5.2.    Tong A. Clinical guidelines: can they be effective? Nursing Times. 2001;97(9):III-IV.3.    Grimshaw JM, Russell IT. Achieving health gain through clinical guidelines II: Ensuring guidelines change medical practice. Quality in Health Care. 1994;3(1):45.4.    Gagliardi A, Brouwers MC, Palda VA, Lemieux-Charles I, Grimshaw JM. How can we improve guideline use? A conceptual framework of implementability. Implementation Science. 2011;6(26).5.    Stone TT, Schweikhart SB, Mantese A, Sonnad SS. Guideline attribute and implementation preferences among physicians in multiple health systems. Quality Management in Health Care. 2005;14(3):177-87.6.    Carlsen B, Glenton C, Pope C. Thou shalt versus thou shat not: A meta-synthesis of GPs' attitudes to clinical practice guidelines. British Journal of General Practice. 2007;57(545):971-8.7.    Harris JS. Development, use, and evaluation of clinical practice guidelines. Journal of Occupational and Environmental Medicine. 1997;39(1):23-34.8.    Smith L, Walker A, Gilhooly K. Clinical guidelines of depression: a qualitative study of GPs' views. Journal of Family Practice. 2004;53(7):556-61.9.    Lugtenberg M, Zegers-van Schaick JM, Westert GP, Burgers JS. Why don't physicians adhere to guideline recommendations in practice? An analysis of barriers among Dutch general practitioners. Implementation Science. 2009;4(54).10.    Gagliardi AR, Brouwers MC, Palda VA, Lemieux-Charles L, Grimshaw JM. An exploration of how guideline developer capacity and guideline implementability influence implementation and adoption: study protocol. Implement Sci. 2009 /;4:36.11.    Institute of Medicine. Guidelines for clinical practice: from development to use. Washington, DC: National Academic Press; 1992.12.    Cabana MD, Ebel BE, Cooper-Patrick L, Powe NR, Rubin HR, Rand CS. Barriers pediatricians face when using asthma practice guidelines. Archives of Pediatrics and Adolescent Medicine. 2000;154(7):685-93.13.    The ADAPTE Collaboration. The ADAPTE Process: Resource Toolkit for Guideline Adaptation. Version 2.0: Guideline International Network; 2009.14.    Coleman P, Nicholl J. Influence of evidence-based guidance on health policy and clinical practice in England. Quality in Health Care. 2001;10(4):229-37.15.    Dufour JC, Bouvenot J, Ambrosi P, Fieschi D, Fieschi M. Textual guidelines versus computable guidelines: a comparative study in the framework of the PRESGUID project in order to appreciate the impact of guideline format on physician compliance. AMIA Annual Symposium Proceedings. 2006:219-23.16.    Patel VL, Arocha JF, Diermeier M, How J, Mottur-Pilson C. Cognitive psychological studies of representation and use of clinical practice guidelines. International Journal of Medical Informatics. 2001;63(3):147-67.17.    Quaglini S, Ciccarese P. Models for guideline representation. Neurological Sciences. 2006;27(Suppl 3):S240-S4.18.    Wolff M, Bower DJ, Marbella AM, Casanova JE. US family physicians' experiences with practice guidelines. Family Medicine. 1998;30(2):117-21.19.    American Psychological Association. Criteria for practice guideline development and evaluation. The American Psychologist. 2002;57(12):1048-51.20.    National Institute for Health and Clinical Excellence. The guidelines manual. London: National Institute for Health and Clinical Excellence, 2009.21.    McKinlay E, McLeod D, Dowell A, Marshall C. Clinical practice guidelines' development and use in New Zealand: an evolving process. The New Zealand Medical Journal. 2004;117(1199):U999.22.    Foy R, MacLennan G, Grimshaw J, Penney G, Campbell MK, Grol R. Attributes of clinical recommendations that influence change in practice following audit and feedback. Journal of Clinical Epidemiology. 2002;55(7):717-22.23.    Vlayen J, Aertgeerts B, Hannes K, Sermeus W, Ramaekers D. A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit. International Journal for Quality in Health Care. 2005;17(3):235-42.24.    Maviglia SM, Zielstorff RD, Paterno M, Teich JM, Bates DW, Kuperman GJ. Automating complex guidelines for chronic disease: lessons learned. Journal of the American Medical Informatics Association. 2003;10(2):154-65.25.    Grol R, Dalhuijsen J, Thomas S, Veld C, Rutten G, Mokkink H. Attributes of clinical guidelines that influence use of guidelines in general practice: observational study. British Medical Journal. 1998;317(7162):858-61.26.    Keeley PW. Clinical guidelines. Palliative Medicine. 2003;17(4):368-74.27.    Powell CV. How to implement change in clinical practice. Paediatric Respiratory Review. 2003;4(4):340-6.28.    Flanders SA, Halm EA. Guidelines for Community-Acquired Pnemonia: Are they reflected in practice. Treatments in respiratory medicine. 2004;3(2):67-77.29.    Veldhuijzen W, Ram PM, van der Weijden T, Niemantsverdriet S, van der Vleuten CP. Characteristics of communication guidelines that facilitate or impede guideline use: a focus group study. BMC Family Practice. 2007;8(31).30.    Silayoi P, Speece M. The importance of packaging attributes: a conjoint analysis approach. European Journal of Marketing. 2007;41(11/12):1495-517.31.    Conroy M, Shannon W. Clinical guidelines: their implementation in general practice. British Journal of General Practice. 2005;45:371-5.32.    Moffat M, Cleland J, van der Molen T, Price D. Poor communication may impair optimal asthma care: a qualitative study. Family Practice. 2007;24(1):65-70.33.    Mazza D, Russell SJ. Are GPs using clinical practice guidelines? Australian Family Physician. 2001;30(8):817-21.34.    Ruecker S, Boessler B. Benchmarking design performance of selected Canadian academic detailing materials.: International Association of Societies of Design Research Conference; 2007.35.    Cabana MD, Rushton JL, Rush AJ. Implementing practice guidelines for depression: Applying a new framework to an old problem. General Hospital Psychiatry. 2002;24(1):35-42.36.    Tu SW, Campbell J, Musen MA. The Structure of Guideline Recommendations: A Synthesis. AMIA Annual Symposium Proceedings. 2003;2003:679-83.37.    Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: A quality driven approach for translating evidence into action. . Otolaryngology Head Neck Surg. 2009;140(6 Suppl 1):S1-S43.38.    Kushniruk AW, Patel VL. Cognitive and usability engineering methods for the evaluation of clinical information systems. Journal of Biomedical Informatics. 2004;37(1):56-76.39.    Doumont JL. Magical Numbers: The Seven-Plus-or-Minus-Two Myth. IEEE Transactions on Professional Communication. 2002;45(2):123-7.40.    Schmidt HG, Rikers RM. How expertise develops in medicine: knowledge encapsulation and illness script formation. Medical Education. 2007;41(12):1133-9.41.    Ariely D. Predictably Irrational: The Hidden Forces That Shape Our Decisions. New York: Harper Perennial; 2009.42.    Lurie NH, Mason C. Visual Representation: Implications for Decision Making. Journal of Marketing. 2007;71.43.    Ware C. Information Visualization. San Francisco: Morgan Kaufman; 2004.44.    Sackett D, Straus S, Richardson W, Rosenberg W, Haynes R. Evidence based medicine: how to practice and teach EBM. Edinburgh Churchill Livingstone; 2000.45.    Swiglo BA, Murad MH, Schunemann HJ, Kunz R, Vigersky RA, Guyatt G, et al. A case for clarity, consistency, and helpfulness: state-of-the-art clinical practice guidelines in endocrinology using the grading of recommendations, assessment, development, and evaluation system. Journal of clinical endocrinology and metabolism. 2008;93(3):666-73.46.    Reyna VF. A theory of medical decision making and health: fuzzy trace theory. Medical Decision Making. 2008;28(6):850-65.47.    Dolan JG, Qian F, Veazie PJ. How well do commonly used data presentation formats support comparative effectiveness evaluations? Medical Decision Making. 2012;32(6):840-50.

2. Creating Content

The creation of content for guidelines involves two domains of guideline implementability that are interrelated and can be considered iteratively during the guideline development process. “Creating Content” involves (i) Evidence Synthesis (i.e., HOW to develop the evidence base; WHAT to report in the guideline; and WHEN, in terms of updating, so as to ensure the currency of the evidence base); and the (ii) Deliberations and Contextualization of the evidence by the guideline development group in formulating the guideline recommendations (i.e., considering aspects of Clinical Applicability, Values, and Feasibility).

Evidence Synthesis

EVIDENCE SYNTHESIS: Evidence synthesis reflects the attributes necessary to enhance guideline validity and reproducibility and involves three things: 1) the execution of these elements, ensuring that guidelines are evidence-based (1-5), valid & reliable (6-8), and communicate their methods and decision making processes in a transparent manner (9, 10) by reporting any potential conflicts of interest (11), the type and quantity of evidence the recommendations are based on (9), and how the evidence was interpreted, assessed, and linked to recommendations by the guideline committee (5, 6, 10, 12-16). This work must be done with the involvement of the entire development committee(7) and clearly distinguish when recommendations were based less on evidence and more on expert judgment or group consensus (6, 17); 2) the consistent reporting of what is needed to be included in the guideline such as the scope of the guideline (patient population, disease, etc.)(18), the number of recommendations, any recommendations contingent on a patient’s history (19, 20), phases of the illness (e.g. diagnosis or treatment)(21), ethnic-specific data (22), resources for patients (8), and the role of patient preferences (21, 23); cost and resource requirements (19, 20), comorbid conditions (19, 20, 24), the healthcare burden (6), outcomes data (preferably those important to patients) (9, 25), a variety of treatment modalities and alternatives (and associated outcomes) (23), and harms and benefits associated with recommendations/alternatives (6, 9); and 3) the currency of this reporting, since guidelines should be updated when new clinical evidence or professional consensus changes (26-28). However, this should be balanced with competing interests as users have a desire for recommendations which reflect the most current practice knowledge. Users have reservations about using “old” guidelines (29), they become skeptical of their utility when guidelines are constantly changing or if updates are significantly different than the originals (28). Regardless of the approach, guidelines should include statements about when guidelines should be reviewed to determine whether revisions are warranted (30) and how they will monitor new evidence and update recommendations (11). 1.    Grimshaw JM, Hutchinson A. Clinical practice guidelines-do they enhance value for money in health care? British Medical Bulletin. 1995;51(4):927-40. 2.    Corner A, Hahn U. Message framing, normative advocacy and persuasive success. Argumentation. 2010;24:153-63. 3.    Parry G, Cape J, Pilling S. Clinical practice guidelines in clinical psychology and psychotherapy. Clinical Psychology and Psychotherapy. 2003;10:337-51. 4.    Dahm P, Yeung L, Gallucci M, Simone G, Schunemann HJ. How to use a clinical practice guideline. The Journal of Urology. 2009;181(2):472-9. 5.    Grol R, Dalhuijsen J, Thomas S, Veld C, Rutten G, Mokink H. Attributes of clinical guidelines that influence use of guidelines in general practice: Observational study. British Medical Journal. 1998;317:858-61. 6.    Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngology-Head and Neck Surgery. 2009;140(6 Suppl 1):S1-S43. 7.    Grimshaw J, Russell I. Achieving health gain through clinical guidelines. I: Developing scientifically valid guidelines. British Medical Journal. 1993;2(4):243. 8.    Vlayen J, Aertgeerts B, Hannes K, Sermeus W, Ramaekers D. A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit. International Journal for Quality in Health Care. 2005;17(3):235-42. 9.    Hayward RA. Users' guide to the medical literature: VII. How to use clinical practice guidelines. A. Are the recommendations valid? JAMA. 1995;27(7):570-4. 10.    McAllister FA, van Diepen S, Padwal RS, Johnson JA, Majumdar SR. How evidence-based are the recommendations in evidence-based guidelines? PLoS Medicine. 2007;4(8):e250. 11.    Chou R. Using evidence in pain practice: Part I: Assessing quality of systematic reviews and clinical practice guidelines. Pain Medicine. 2008;9(5):518-30. 12.    Burgers JS, Cluzeau FA, Hanna SE, Hunt C, Grol R. Characteristics of high-quality guidelines: evaluation of 86 clinical guidelines developed in ten European countries and Canada. IntJTechnolAssessHealth Care. 2003;19(1):148-57. 13.    Polosa R, Cacciola RR, Avanzi GC, Di Maria GU. Making, disseminating and using clincial guidelines. Monaldi Arch Chest Dis. 2002;57(1):44-7. 14.    Graham ID, Calder LA, bert PC, Carter AO, Tetroe JM. A Comparison of Clinical Practice Guideline Appraisal Instruments. International Journal of Technology Assessment in Health Care. 2000;16(04):1024-38. 15.    Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. British Medical Journal. 2001;323:334-6. 16.    Grimshaw J, Freemantle N, Wallace S, Russell I, Hurwitz B, Watt I, et al. Developing and implementing clinical practice guidelines. British Medical Journal. 1995;4(1):55. 17.    Watine J, Friedberg B, Nagy E, Onody R, Oosterhuis WP, Bunting PS, et al. Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners. Clinical Chemistry. 2006;52(1):65-72. 18.    AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Quality and Safety in Health Care. 2003;12(1):18-23. 19.    Milner KK, Valenstein M. A comparison of guidelines for the treatment of schizophrenia. Psychiatric Services. 2002;53(7):888-90. 20.    Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Obstetrical & Gynecological Survey. 1994;49(7):469. 21.    Hayward RA, Hofer TP, Kerr EA, Krein SL. Quality improvement initiatives: issues in moving from diabetes guidelines to policy. Diabetes Care. 2004;27 Suppl 2:B54-B60. 22.    Manna DR, Bruijnzeels MA, Mokkink HG, Berg M. Ethnic specific recommendations in clinical practice guidelines: a first exploratory comparison between guidelines from the USA, Canada, the UK, and the Netherlands. Quality and Safety in Health Care. 2003;12(5):353-8. 23.    Roberts RG, Rosof BM, Thompson RS. Practice guidelines: Coping with information overload. Patient Care. 1996;30(4):39. 24.    Tierney W, Overhage JM, Takesue BY, Harris LE, Murray MD, Vargo DL, et al. Computerizing guidelines to improve care and patient outcomes: the example of heart failure. Journal of the American Medical Informatics Association. 1995;2(5):316-22. 25.    Wolff M, Bower DJ, Marbella AM, Casanova JE. US Family Physicians' Experiences with Practice Guidelines. Fam Med. 1998;30(2):117-21. 26.    Baldwin DS. Evidence-based guidelines for anxiety disorders: Can they improve clinical outcomes? CNS Spectr. 2006;11(10 (Suppl 12)):34-9. 27.    Gravas S, Tzortzis V, Melekos MD. Translation of benign protatic hyperplasia guidelines into clinical practice. Curr Opin Urol. 2008;18(1):56-60. 28.    Rashidian A, Eccles MP, Russell I. Falling on stony ground? A qualitative study of implementation of clinical guidelines' prescribing recommendations in primary care. Health policy. 2008;85(2):148-61. 29.    Moffat M, Cleland J, van der Molen T, Price D. Poor communication may impair optimal asthma care: a qualitative study. Family Practice. 2007;24(1):65-70. 30.    Institute of Medicine. Guidelines for clinical practice: from development to use. Washington, DC: National Academic Press; 1992.

Deliberations and Contextualization

DELIBERATIONS AND CONTEXTUALIZATIONS: Guidelines are designed to assist practitioners and patients in making complex clinical judgments, with the recognition that no guideline can replace or supersede the role of clinical or professional judgment about the individual patient (1, 2). Developers must supplement evidentiary factors (quality, quantity and consistency) with considered judgment, which represents the complex trade-offs between competing benefits and harms, side effects, and risks of different options for managing the disease or condition (3), as well as the consideration of clinical applicability, and the values and preferences of patients, developers and providers (4-7). Clinical applicability is at least as relevant as its support with evidence to guarantee adherence (8), and is influenced by the clinical relevance of recommendations, the appropriateness of these recommendations to the patient population, and whether implementation has been considered. Sometimes, there is a lack of fit between physicians’ own experiences and the guideline recommendations (9), and even if guidelines appear valid, they may not be applicable to all patients or too rigid to apply to individual patients (10-13). To help interpret and apply the recommendations and ensure that correct inferences are made in most cases, guidelines should have a clear, specific clinical question, be applicable in the real world across different levels of expertise, be as inclusive of appropriately defined patient populations as evidence and expert judgment permit, explicitly state the population(s) to which statements apply, and reflect the appropriateness or applicability of the evidence to the clinical circumstances and setting (14-25). Lack of clinical autonomy can hinder physicians’ acceptance and utilization of guidelines, so they should also be developed as a support for practitioners, allowing for clinical freedom and space for flexibility and clinical autonomy rather than a set of constrained rules (10, 26, 27), specifying flexibility and adaptability in recommendations (28), and identify interventions for which the strategy is most appropriate (2). Ultimately, the best strategy depends on clinical judgment and patient preferences or values (e.g., hormone replacement therapy) (1, 14, 29). Translating evidence into action often involves value judgments, which include guiding principles, ethical considerations, or other beliefs and priorities (30), but formulating recommendations should also include the values and preferences of those for whom the recommendations are intended: providers, patients, and developers (31, 32). Statements about the underlying values and preferences refer to the relative worth or importance of a health state or its consequences, and serve to facilitate accurate interpretation (i.e., the relative weight people attribute to particular benefits, risks, burdens and costs to determine their balance) (31, 32). The formulation of recommendations is complex and affected by the contexts and values under which guideline development takes place, but the accurate and comprehensive documentation of these factors is a challenge (33), particularly in situations when the evidence is inconsistent, scarce, lacking or when the majority of recommendations are not supported by RCTs (3, 34). If the underlying evidence is low quality, weak or conflicting, no matter what degree of consensus or peer review, the clinicians' confidence in the validity of the guideline will be limited (35). In these situations, the guideline team should explicitly state the root of the problem and consider using a robust formal consensus method to identify current best practices (36). Even when the evidence is certain, recommendations for or against interventions will involve subjective value judgments when the benefits are weighed against the harms (37). As a consequence, it may be difficult to describe arguments beyond the evidence in a transparent way, and the composition of the guideline-development group as well as group dynamics can influence this process (3). As such, guideline development needs to involve an unbiased expert team using a transparent and well-documented process with explicit strategies documenting, describing, and dealing with dissent among those judging guidelines, or frank reports of the degree of consensus (35, 36). They should report values or value judgments that were used to influence recommendations along with the research evidence underlying the recommendations (or state if none were used), and allow for adaptation after incorporating local values (30, 38). Guidelines should also flag or reflect the strength of the recommendation when differences in values would lead to different decisions or if there is important uncertainty about values that are critical to a decision (32). Ultimately, to better understand their influence on interpreting objective evidence and in turn to clarify information for end users, guideline developers should state value judgments and list their considered judgments clearly, including who, by influencing recommendations, was explicitly and implicitly involved in assigning values to outcomes (including various health and economic outcomes), and to systematically consider these aspects at all phases of the guideline-development process (3, 19, 30, 35, 39). Feasibility involves the local applicability of guidelines (i.e., strategies for adapting national recommendations to local conditions, and the use of application tools and strategies to assist guideline implementation), the consideration of resource constraints (which takes into consideration the availability of resources and economic outcomes to make them more implementable), and the influence of novelty or familiarity with guidelines for their adoption (i.e., the degree to which the recommendation proposes behaviours considered unconventional by clinicians or patients). Feasible guidelines allow for flexibility in individual clinical decisions, are in agreement with users’ opinions and skills, and are suitable for routine use in intended settings. 1.    Berg AO, Atkins D, Tierney W. Clinical practice guidelines in practice and education. Journal of General Internal Medicine. 1997;12:25-33. 2.    Parry G, Cape J, Pilling S. Clinical practice guidelines in clinical psychology and psychotherapy. Clinical Psychology and Psychotherapy. 2003;10:337-51. 3.    Verkerk K, van Veenendaal H, Severens JL, Hendriks EJM, Burgers JS. Considered judgment in evidence-based guideline development. International Journal for Quality in Health Care. 2006;18(5):365-9. 4.    Oosterhuis WP, Bruns DE, Watine J, Sandberg S, Horvath AR. Evidence-based guidelines in laboratory medicine: principles and methods. Clinical Chemistry. 2004;50(5):806-18. 5.    Watine J, Friedberg B, Nagy E, Onody R, Oosterhuis WP, Bunting PS, et al. Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners. Clinical Chemistry. 2006;52(1):65-72. 6.    Hayward RA. Users' guide to the medical literature: VII. How to use clinical practice guidelines. A. Are the recommendations valid? JAMA. 1995;27(7):570-4. 7.    AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Quality and Safety in Health Care. 2003;12(1):18-23. 8.    Burgers JS, Cluzeau FA, Hanna SE, Hunt C, Grol R. Characteristics of high-quality guidelines: evaluation of 86 clinical guidelines developed in ten European countries and Canada. IntJTechnolAssessHealth Care. 2003;19(1):148-57. 9.    Carlsen B, Glenton C, Pope C. Thou shalt versus thou shalt not: a meta-synthesis of GP's attitudes to clinical practice guidelines. British Journal of General Practice. 2007;57(545):971-8. 10.    Lobach DF. A model for adapting clinical guidelines for electronic implementation in primary care. Proc Annu Symp Comput Appl Med Care. 1995:581-5. 11.    Chou R. Using evidence in pain practice: Part I: Assessing quality of systematic reviews and clinical practice guidelines. Pain Medicine. 2008;9(5):518-30. 12.    Brouwers MC, Graham ID, Hanna SE, Cameron DA, Browman GP. Clinicians' assessments of practice guidelines in oncology: the CAPGO survey. International Journal of Technology Assessment in Health Care. 2004;20(04):421-6. 13.    Corbett M, Foster N, Ong BN. GP attitudes and self-reported behaviour in primary care consultations for low back pain. Family Practice. 2009;26(5):359-64. 14.    Keeley PW. Clinical guidelines. Palliative Medicine. 2003;17:368-74. 15.    Polosa R, Cacciola RR, Avanzi GC, Di Maria GU. Making, disseminating and using clincial guidelines. Monaldi Arch Chest Dis. 2002;57(1):44-7. 16.    Connelly DP, Rich EC, Curley SP, Kelly JT. Knowledge resource preferences of family physicians. Journal of Family Practice. 1990;30(3):353-9. 17.    Moffat M, Cleland J, van der Molen T, Price D. Poor communication may impair optimal asthma care: a qualitative study. Family Practice. 2007;24(1):65-70. 18.    Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why Don't Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement. JAMA: The Journal of the American Medical Association. 1999;282(15):1458-65. 19.    Dahm P, Yeung LL, Gallucci M, Simone G, Schunemann HJ. How to use a clinical practice guideline. Journal of Urology. 2009;181(2):472-9. 20.    Graham ID, Calder LA, bert PC, Carter AO, Tetroe JM. A Comparison of Clinical Practice Guideline Appraisal Instruments. International Journal of Technology Assessment in Health Care. 2000;16(04):1024-38. 21.    Mason J, Eccles M, Freemantle N, Drummond M. A framework for incorporating cost-effectiveness in evidence-based clinical practice guidelines. Health policy. 1999;47(1):37-52. 22.    Tan KB. Clinical practice guidelines: a critical review. 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