Guideline Development Checklist Glossary

Guideline Development Checklist Glossary of Terms

The glossary includes definitions of terms and acronyms appearing throughout the GDC to help with interpretation of the items included. Related terms in the list are grouped into categories describing the various aspects of guideline development.

Term	Definition
*Groups, individuals, and organizations involved in the guideline development process*
Guideline development group	The entire group of healthcare and other professionals, stakeholders, patients and carers, research and technical staff who develop a guideline. The guideline development group may consist of several task-specific subgroups or committees such as the oversight committee, guideline panel, stakeholder and consumer consultants, and working group. Certain individuals may be members of more than one subgroup or committee (e.g. a clinician scientist as a member of the working group and guideline panel).^1,2
Oversight committee	A body overseeing the guideline development process, whose tasks include the priority setting, and selection of potential guidelines for development out of proposed topics, recruitment and appointment of members for the guideline panel, and approval of the final guideline for publication and dissemination. May also be referred to as an executive committee or guideline advisory board.²
Guideline panel	Decides on topics to be covered within the guideline, formulates questions, develops and agrees on the recommendations in the guideline using evidence summaries prepared by the working group, and endorses the final guideline document for approval by the oversight committee. Members of the guideline panel may often be referred to as 'panelists'.²
Chair (of the guideline panel)	The leading member of the guideline panel. This person is neutral and has an expertise in coordinating groups of healthcare professionals and patients and caregivers. Someone who is qualified and experienced in strategies and facilitation of optimal group processes, ensuring all members of the panel have equal opportunity to contribute and freely express their opinion without feeling intimidated. This individual is not necessarily an expert of any specific clinical domain.^3,4
Co-chair (of the guideline panel)	Should be appointed when the guideline panel is especially large or the task particularly complex. Co-chairs should also have experience leading groups but should represent a different discipline (clinical or methodological) than the Chair.^3,4
Working group	A group of individuals tasked with the preparation and technical aspects of guideline development such as assisting the guideline panel in formulating PICO questions, conducting systematic reviews, rating quality of evidence, preparing evidence summaries and background documents for guideline panel discussions, writing the guideline, and reviewing comments from stakeholders and public consultation. Works closely with the guideline panel to ensure the work to achieve goals and objectives for the guideline is completed.
Secretariat	A group of individuals tasked with supporting the guideline development group in preparing for the development and writing of the guideline. The Secretariat provides technical support as well as administrative support (e.g. scheduling meetings and teleconferences, distributing documents).²
Stakeholder	An individual, group or an organization that has an interest in the organization and delivery of health care and will have an interest in the content of or the outcome of a guideline. This may include health care providers, professional societies and colleges, experts in a disease or condition, research institutions, and policy makers.^1,2
Consumer	Consumers of healthcare include: (a) individual patients, (b) carers, including patients' family and friends, (c) members of the public (both as potential patients and as funders of healthcare through taxation, insurance or direct payments), (d) voluntary and community organizations that represent the interests of patients, carers and the public, (e) advocates representing the interests of patients, carers and other client groups. They are described collectively as 'consumers' (without implying consumerist assumptions about health services) and are distinct from other consumers of guidelines such as health professionals, commissioners and providers of services.⁵
Carer	Provide non-reimbursed care and/or support to patients (e.g. family members, friends) and have knowledge of the issues that are important to patients and carers. May also be referred to as caregivers.
Advocate	Someone who speaks on behalf of a patient, or a group of patients to help them make their wishes known.⁶
Sponsoring organization	The organization that funds the development of a guideline and will endorse it for publication and dissemination.
Professional societies	Not-for-profit organizations whose membership consists of healthcare professionals working in a specific field or specialty and whose work focuses on a specific area or topic in health care (e.g. American College of Chest Physicians, European Society of Cardiology). Professional societies are often involved in the development of guidelines for their members and often take policy stances on medical issues and health promotion. May also be referred to as professional organizations or medical societies or associations.
Third party organizations	Organizations or groups that wish to adopt or adapt a guideline for which they were not directly involved in its development. This may often include government departments or ministries of health that do not have sufficient resources to develop guidelines de novo, or whose populations and health care settings are similar to those covered in an existing guideline.
*Guidelines and topics*
Guideline	A document that focuses on a disease or condition and includes recommendations for appropriate management of patients with this disease or condition. The guideline should be based on the best available evidence and should help healthcare providers by supplementing their knowledge and skills. Guidelines can be tailored to clinical, health policy, health systems or public health settings, among others.²
Target audience	The specific group or range of health care provider for whom the clinical practice guidelines are intended, to inform their work in a health care setting. The target audience will have an influence on the breadth and depth of the guideline content.⁷ The *primary audience* consists of the intended end users of the guideline. For example, if the guideline is for primary care, then the target audience will comprise of primary care physicians and nurses. *Secondary audiences* may include any other groups to whom the guideline content will be applicable, such as health care managers, hospital administrators, and policy makers.⁸
Guideline topic	The guideline topic specifies the disease, condition or overall area that will be covered by the guideline (e.g. chronic obstructive pulmonary disease). Guideline developers must consider prioritizing the guideline topics with the greatest potential to improve health care and health outcomes.⁹
Topics within guidelines	Topics within the guideline encompass the content that the guideline will cover. For example, whether the guideline will cover diagnosis of a condition, treatment of a condition, or both, or whether it will focus on topics where there is most uncertainty or variation in practice. Guideline panels must consider and decide on the many issues that may be addressed within a guideline that will be important to the target audience. May also be referred to as the scope of the guideline, and will be interrelated with the PICO questions addressed in the guideline.⁹
*Steps and processes in guideline development*
Priority setting	Priority setting is the identification, balancing and ranking of priorities by stakeholders. It ensures that resources and attention are devoted to those general areas (e.g. chronic obstructive pulmonary disease, diabetes, cardiovascular disease, cancer, prevention) where health care recommendations will provide the greatest benefit to the population, a jurisdiction, or a country. A priority-setting approach needs to contribute to future plans while responding to existing potentially difficult circumstances.¹⁰
Peer review	A process of subjecting scholarly works, research, or ideas to the scrutiny of others. Peer review of a guideline and recommendations by those with similar interests and expertise to the people who produced it is intended to ensure the guideline is accurate and valid. Peer review may be internal, conducted by colleagues from the same organization not directly involved in the production of the guideline, or external, conducted by individuals fully independent and removed from the development of the guideline.^2,6
Dissemination	The active process of distributing information, such as guidelines, to the target end users to ensure maximum exposure, uptake, and implementation. Various methods for dissemination may be used such as a printed version of the full guideline, online version of the guideline, a quick reference guide, mobile application of the guideline, incorporation of guideline recommendations into clinical decision support systems, consumer version of the guideline, education materials detailing the recommendations, conference meetings with target end users, etc. Products other than the main guideline document that are developed are commonly referred to as *derivative products*.¹¹
Implementation	The uptake and incorporation of guideline recommendations into practice by the target end users. An implementation plan should include the identification of potential barriers, criteria and indicators for success, baseline data for the indicators, required resources, training and education needs, identification of existing mechanisms or networks, methods for monitoring the implementation process, reporting and feedback mechanisms, and milestones with timescales.^2,11
Guideline Adaptation	A systematic approach to using and adjusting existing guidelines produced in one setting for use in a new setting with a different cultural or organizational context. The process of adapting a guideline and its recommendations must ensure that the adapted guideline addresses specific health questions relevant to the context of use and that it is suited to the needs, priorities, legislation, policies, and resources in the new target setting.¹²
Group processes	Group processes encompass how and when members of a group interact. For example, the interaction of guideline panel members during a consensus meeting to formulate recommendations.³
Consensus methods	Techniques used in decision-making to reach agreement on a particular issue. Consensus may be informal or formal, with examples of formal consensus methods including the Delphi and nominal group techniques.¹
Quorum	The smallest number of group members that must be present to constitute a valid meeting or voting or consensus process.¹
Milestones	When major steps are achieved during the guideline development process. Examples include completing the systematic review, having recommendations developed, and publishing the guideline report.³
*Considerations in the development of a guideline*
Declaration of interest (or disclosure of interest)	A declaration of interest is the disclosure of any potential or actual conflicts of interest that include financial, professional, intellectual or other interests relevant to the subject of the work or meeting to determine possible conflicts of interest. The declaration of interest must also include any relevant interests of others who may, or may be perceived to, unduly influence the expert's judgment, such as immediate family members, employers, close professional associates, or any others with whom the expert has a substantial common personal, financial, or professional interest.²
Conflict of interest	A divergence between or individual's private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual's professional actions or decisions are motivated by personal gain, such as financial, academic advancement, clinical revenue streams or community standing. This definition includes a financial or intellectual relationship that may impact an organization's or individual's ability to approach a scientific question with an open mind.¹³
Commercial sponsorship	May apply to individuals or organizations, including funding for the development of a guideline. Of particular concern is the possibility that guideline developers will feel, or be perceived to be, beholden to or pressured by the commercial sponsor to make recommendations favorable to the sponsor's interests. Commercial sponsorship may be in the form of industry-sponsored research, clinical services from which a committee member derives a substantial proportion of his or her income, consulting, board membership for which compensation of any type is received.¹⁴
Barriers to change	Should be identified and considered prior to developing a guideline where recommendations suggest changes in health care practice(s). Barriers to change can exist at various levels of the health care system and include structural barriers (e.g. lack of resources, financial disincentives), organizational barriers (e.g. inappropriate skill mix, lack of facilities or equipment), peer group barriers (e.g. local standards of care not in line with desired practice), professional-patient interaction barriers (e.g., communication and information-processing issues), and competing priorities. There are diverse methods to identify barriers that vary in their formality. Barriers may vary for given resources, across settings, and for different guidelines.¹¹
Equity (in health)	Equity in health, or health equity, is a measure of the degree to which health policies are able to distribute well-being fairly. It is the absence of systematic or potentially remediable differences in health status, access to healthcare and health-enhancing environments, and treatment in one or more aspects of health across populations or population groups defined socially, economically, demographically or geographically. Health inequity results from a gap in health status and in access to health services between different social classes, ethnic groups, and between populations in different geographical areas. Guideline panels must consider whether and the extent to which recommendations will have an impact on health equity. May also be referred to as health inequality.^1,10,15
Values, preferences and utilities	These include patient and carer knowledge, attitudes, expectations, moral and ethical values and beliefs; patient goals for life and health; prior experience with the intervention and the condition; symptom experience (for example breathlessness, pain, dyspnoea, weight loss); preferences for and importance of desirable and undesirable outcomes; perceived impact of the condition or interventions on quality of life, well-being or satisfaction and interactions between the work of implementing the intervention, the intervention itself, and other contexts the patient may be experiencing; preferences for alternative courses of action; and preferences relating to communication content and styles, information and involvement in decision-making and care. This can be related to what in the economic literature is considered utilities. An intervention itself can be considered a consequence of a recommendation (e.g. the burden of taking a medication or undergoing surgery) and a level of importance or value is associated with that. The values and preferences of those who will be affected by the recommendations should be integrated into the process of developing the guideline.⁵
Transparency	Transparency involves clearly documenting and presenting details of the entirety of the methods and process that were used to develop a guideline, including the participants involved, the evidence and information reviewed, and judgements made during any decision-making, especially formulating the recommendations. Transparency would allow others to follow and arrive at the same guideline product if replicating the guideline development process.
Credibility of guidelines	The degree to which a guideline's conclusions and recommendations can be trusted. Determined by the methods and approaches used, including timing and editorial dependence such as described by the AGREE II tool, the Institute of Medicine's report on guidelines and the Guideline International Network. May also be referred to as trustworthiness or quality of guidelines.^4,16,17
*Evidence review and consideration of additional information*
Protocol	A document that outlines the plan or set of steps that defines how a guideline will be produced and the methodology that will be used. Before carrying out a guideline, for example, the protocol sets out what questions to be answered, how information will be collected and analyzed, and the framework and consensus methods to be used to formulate recommendations.
PICO question	Population/Patient-Intervention-Comparison-Outcome; a mnemonic used in developing specific health care questions to be answered in a guideline. A question generated using the PICO framework will guide which evidence is reviewed and is meant to elicit information about the patient and their condition, interventions of interest that have been undertaken or should be taken, any comparisons between the current intervention and possible alternatives, and outcomes to be desired or achieved.²
Population	A group of people with a common link, such as the same medical condition or living in the same area or sharing the same characteristics. The population identified for a guideline is all the people the recommendations are intended to apply to (e.g. adults with diabetes mellitus).¹⁸
Comorbidity	A disease or condition that exists in a patient in addition to the principal disease of interest being studied or treated (e.g. chronic obstructive pulmonary disease and diabetes mellitus). Comorbidities may influence the clinical manifestations and natural history of a disease. May also be referred to as concomitant conditions.^6,19
Clinical pathway (or care pathway)	The sequence of practices, procedures, tests, interventions and treatments that should be used to provide care for people with a particular clinical condition.⁶
Outcomes	The impact that a test, treatment, policy, program or other intervention has on a person, group or population. Outcomes from interventions to improve the public's health could include a change in people's health and wellbeing or health status. In clinical terms, outcomes could include the number of patients who fully recover from an illness or the number of hospital admissions, and an improvement or deterioration in someone's health, functional ability, symptoms or situation.⁶
Patient-important outcomes	An outcome defined by answering "yes" to the following question: "If one knew that this outcome was the only thing to change with treatment, would the patient consider receiving this treatment even if it was associated with adverse effects, inconvenience, or cost?" Such outcomes include mortality, morbidity, and outcomes reported by patients.^20,21
Health-related quality of life	A combination of a person's physical, mental and social well-being; not merely the absence of disease. An example of a patient-important outcome.¹
Surrogate outcomes	Outcomes that are not themselves important health outcomes but may be correlated with patient-important health outcomes (e.g. bone density as surrogate for fractures as the patient-important outcome). May be referred to as substitute or indirect outcomes.²¹
Importance of outcomes	Ranking the relative importance of desirable (e.g. reduced mortality, improvement in health-related quality of life) and undesirable outcomes (e.g. side effects, costs) for the intervention in question allows a guideline panel to determine how much influence the particular outcomes and the results/estimates of effect for those outcomes will have in formulating a recommendation. The relative importance of outcomes is likely to vary according to different values and preferences or when considered from the perspective of patients, clinicians or policy-makers. In the GRADE framework, outcomes are rated as critical for decision-making, important but not critical for decision-making, or low importance for decision-making.²¹
Magnitude of effect	A measure of the difference or relative effect of an intervention on the outcome in the intervention group compared with that in a control group. Also referred to as the effect size.⁶
Systematic review	A comprehensive review of the published literature that focuses on a healthcare topic and answers a specific question. An extensive literature search is conducted based on a search strategy to identify all studies. The studies are reviewed, their quality is assessed, and the results are summarized according to the review question.²
Evidence retrieval	In the context of systematic reviews, the process of systematically searching for all scientific studies relevant to a particular question, and obtaining them for review. The process also includes obtaining evidence from other sources that may be unpublished.²
Selection criteria	The criteria used to decide which studies and study types should be included and excluded from consideration as potential sources of evidence when retrieving evidence during the development of a guideline. Also referred to as inclusion and exclusion criteria.⁶
Expert opinion	An interpretation of evidence. Sometimes based on high quality evidence, such as from randomized controlled trials or well-done observational studies, and other times based on unsystematically collected information, ideally summarized in writing. Expert opinion is often confused with the notion of evidence that is either not available from systematic research or not systematically summarized. Also often used as excuse for not collecting evidence systematically.
Economic evaluation	A set of formal, quantitative methods used to asses one or more interventions, programs, or strategies with respect to their resource use and their expected outcomes. Economic evaluation may involve different study types such as cost-effectiveness analysis, cost-benefit analysis, and economic models.²
Quality of evidence	Describes the level of confidence or certainty in the estimates of the effect of an intervention on a specific outcome in a given population. Also called strength of evidence, confidence in estimates, certainty in evidence, levels of evidence.²²
Evidence table or profile or summary of findings table	A table summarizing the results/estimate of effect from studies for each outcome of interest and the associated quality of evidence. The table provides a concise summary of the key information that is needed by someone making a decision and, in the context of a guideline, provides a summary of the key information underlying a recommendation.^6,23
*Recommendations and formulation of recommendations*
Analytic framework	A framework outlining the criteria that guideline panels use to review the evidence and analyze relevant information to arrive at a recommendation. The analysis may focus on the balance between desirable and undesirable consequences, informed by the quality of evidence, magnitude of the difference between the benefits and harms, the certainty about or variability in values and preferences, resource use, equity and other factors (e.g. GRADE/DECIDE Evidence-to-Recommendation framework).²⁴
Recommendation	A course of action recommended by the guideline based on clinical questions, evidence retrieval, and consideration of other information in the analytic framework. Recommendations in guidelines may relate to clinical interventions, public health activities, or government policies.²
Conditional recommendation	A recommendation for which a guideline panel rested with more uncertainty about whether implementation of the recommended action leads to more desirable than undesirable consequences. Specific conditions may have to be described. Also known as weak recommendation in the GRADE framework.²⁵
Research recommendation	A recommendation resulting from a guideline process for use in the context of research only. Guideline panels should consider making research recommendations when there is important uncertainty about the desirable and undesirable effects of an intervention, further research could reduce that uncertainty, and the potential benefits and savings of reducing the uncertainty outweigh the potential harms of not making the research recommendation. The formulation of recommendations for additional research should be as precise and specific as possible. Defining the population, intervention, comparator and outcomes (PICO) explicitly will make research recommendations more helpful.^24,26
Strength of recommendation	The strength of a recommendation reflects the extent to which guideline developers are confident that the desirable effects of adherence to the recommendation outweigh the undesirable effects.^24,25
Performance measures	Performance measures are criteria that can be measured to assess the quality-of-care (e.g. a physician following a specific management option). Management options associated with strong recommendations are particularly good candidates for quality criteria.²⁴
*Acronyms used in the checklist*
AGREE II	Appraisal of Guidelines for Research and Evaluation II; A validated tool developed through international collaboration for evaluating the process of practice guideline development and the quality of reporting.¹⁶
GRADE	Grading of Recommendations Assessment, Development and Evaluation approach; Developed by a collaborative, international working group, GRADE is a system that provides a transparent approach to rating quality of evidence and strength of recommendations and is used by many international organizations. It tackles methodological and practical issues related to systematic reviews and development and dissemination of recommendations.²⁷
USPSTF	United States Preventive Services Task Force; A government organization that develops recommendations about clinical preventive services such as screening, counseling services, and preventive medications. The organization developed its own framework for rating quality of evidence and grading recommendations.²⁸

References:

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12. The ADAPTE Collaboration. The ADAPTE Process: Resource Toolkit for Guideline Adaptation. Version 2.0. 2009; http://www.g-i-n.net/document-store/working-groups-documents/adaptation/adapte-resource-toolkit-guideline-adaptation-2-0.pdf. Accessed July 5, 2013.

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16. AGREE Research Trust. The AGREE Enterprise Website. 2013; http://www.agreetrust.org. Accessed July 21, 2013.

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18. Wilt TJ, Guyatt G, Kunz R, et al. Deciding What Type of Evidence and Outcomes to Include in Guidelines: Article 5 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report. Proceedings of the American Thoracic Society. 2012;9(5):243-250.

19. Fabbri LM, Boyd C, Boschetto P, et al. How to Integrate Multiple Comorbidities in Guideline Development: Article 10 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report. Proceedings of the American Thoracic Society. 2012;9(5):274-281.

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22. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. Apr 2011;64(4):401-406.

23. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. Apr 2011;64(4):383-394.

24. Schunemann HJ, Oxman AD, Akl EA, et al. Moving from Evidence to Developing Recommendations in Guidelines: Article 11 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report. Proceedings of the American Thoracic Society. 2012;9(5):282-292.

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26. Brown P BK, Chalkidou K, Chalmers I, Clarke M, Fenton M, et al,. How to formulate research recommendations. BMJ. Oct 14 2006;333(7572):804-806.

27. The GRADE working group. GRADE Working Group. 2013; http://www.gradeworkinggroup.org. Accessed July 21, 2013.

28. U.S. Preventive Services Task Force. Methods and Processes. 2013; http://www.uspreventiveservicestaskforce.org/methods.htm. Accessed July 21, 2013.