Julie Makarski

AGREE II: advancing guideline development, reporting and evaluation in health care

Clinical practice guidelines, which are systematically developed statements aimed at helping people make clinical, policy-related and system-related decisions,[1][1],[2][2] frequently vary widely in quality.[3][3],[4][4] A strategy was needed to differentiate among guidelines and ensure that those

Development of the AGREE II, part 1: performance, usefulness and areas for improvement

Background: We undertook research to improve the AGREE instrument, a tool used to evaluate guidelines. We tested a new seven-point scale, evaluated the usefulness of the original items in the instrument, investigated evidence to support shorter, tailored versions of the tool, and identified areas for improvement. Method: We report on one component of a larger study that used a mixed design with four factors (user type, clinical topic, guideline and condition). For the analysis reported in this article, we asked participants to read a guideline and use the AGREE items to evaluate it based on a seven-point scale, to complete three outcome measures related to adoption of the guideline, and to provide feedback on the instrument’s usefulness and how to improve it. Results: Guideline developers gave lower-quality ratings than did clinicians or policy-makers. Five of six domains were significant predictors of participants’ outcome measures (p < 0.05). All domains and items were rated as useful by stakeholders (mean scores > 4.0) with no significant differences by user type (p > 0.05). Internal consistency ranged between 0.64 and 0.89. Inter-rater reliability was satisfactory. We received feedback on how to improve the instrument. Interpretation: Quality ratings of the AGREE domains were significant predictors of outcome measures associated with guideline adoption: guideline endorsements, overall intentions to use guidelines, and overall quality of guidelines. All AGREE items were assessed as useful in determining whether a participant would use a guideline. No clusters of items were found more useful by some users than others. The measurement properties of the seven-point scale were promising. These data contributed to the refinements and release of the AGREE II.

Development of the AGREE II, part 2: assessment of validity of items and tools to support application.

Background: We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user’s manual in the β version of the AGREE II. Methods: We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user’s manual and completed a survey assessing the manual. Results: In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved. Interpretation: The validity of the items was established and the user’s manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user’s manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation.

AGREE II: advancing guideline development, reporting and evaluation in health care.

From McMaster University (Brouwers, Kho, Hanna, Makarski); the Program in Evidence-based Care, Cancer Care Ontario (Brouwers), Hamilton, Ontario; British Columbia Cancer Agency (Browman), Victoria, BC; the Dutch Institute for Healthcare Improvement CBO and IQ Healthcare (Burgers), Radboud University Nijmegen Medical Centre, the Netherlands; St. George’s University of London (Cluzeau), London, UK; the University of Bristol (Feder), Bristol, UK; Unité Cancer et Environement (Fervers), Université de Lyon e Centre Léon Bérard, Université Lyon 1, EA 4129, Lyon, France; the Canadian Institutes of Health Research (Graham), Ottawa, Ontario; the Ottawa Hospital Research Institute (Grimshaw), Ottawa, Ontario; the National Institute for Health and Clinical Excellence (Littlejohns), London, UK; and the Canadian Partnership Against Cancer (Zitzelsberger), Ottawa, Ontario

Guideline uptake is influenced by six implementability domains for creating and communicating guidelines: a realist review

OBJECTIVES To identify factors associated with the implementability of clinical practice guidelines (CPGs) and to determine what characteristics improve their uptake. STUDY DESIGN AND SETTING We conducted a realist review, which involved searching multiple sources (eg, databases, experts) to determine what about guideline implementability works, for whom, and under what circumstances. Two sets of reviewers independently screened abstracts and extracted data from 278 included studies. Analysis involved the development of a codebook of definitions, validation of data, and development of hierarchical narratives to explain guideline implementability. RESULTS We found that guideline implementability is associated with two broad goals in guideline development: (1) creation of guideline content, which involves addressing the domains of stakeholder involvement in CPGs, evidence synthesis, considered judgment (eg, clinical applicability), and implementation feasibility and (2) the effective communication of this content, which involves domains related to fine-tuning the CPGs message (using simple, clear, and persuasive language) and format. CONCLUSION Our work represents a comprehensive and interdisciplinary effort toward better understanding, which attributes of guidelines have the potential to improve uptake in clinical practice. We also created codebooks and narratives of key concepts, which can be used to create tools for developing better guidelines to promote better care.

The landscape of knowledge translation interventions in cancer control: What do we know and where to next? A review of systematic reviews

BackgroundEffective implementation strategies are needed to optimize advancements in the fields of cancer diagnosis, treatment, survivorship, and end-of-life care. We conducted a review of systematic reviews to better understand the evidentiary base of implementation strategies in cancer control.MethodsUsing three databases, we conducted a search and identified English-language systematic reviews published between 2005 and 2010 that targeted consumer, professional, organizational, regulatory, or financial interventions, tested exclusively or partially in a cancer context (primary focus); generic or non-cancer-specific reviews were also considered. Data were extracted, appraised, and analyzed by members of the research team, and research ideas to advance the field were proposed.ResultsThirty-four systematic reviews providing 41 summaries of evidence on 19 unique interventions comprised the evidence base. AMSTAR quality ratings ranged between 2 and 10. Team members rated most of the interventions as promising and in need of further research, and 64 research ideas were identified.ConclusionsWhile many interventions show promise of effectiveness in the cancer-control context, few reviews were able to conclude definitively in favor of or against a specific intervention. We discuss the complexity of implementation research and offer suggestions to advance the science in this area.

The AGREE Enterprise: a decade of advancing clinical practice guidelines

BackgroundThe original AGREE (A ppraisal of G uidelines for RE search and E valuation) Instrument was published in 2003, and its revision, the AGREE II, in 2009. Together, they filled an important gap in the guideline and quality of care fields. Ten years later, the AGREE Enterprise reflects on a trajectory of projects and international collaboration that have contributed to advancing the science and quality of practice guidelines and the uptake of AGREE/AGREE II.FindingsThe AGREE Enterprise has undertaken activities to improve the tool and to develop resources to support its use. Since 2003, the uptake and adoption of AGREE by the international community has been swift and broad. A total of 33 language translations of the original AGREE Instrument and the current AGREE II are available and were initiated by the international community. A recent scan of the published literature identified over 600 articles that referenced the AGREE tools. The AGREE tools have been widely received and applied, with several organizations having incorporated the AGREE as part of their formal practice guideline programs. Since its redevelopment in 2010, the AGREE Enterprise website (www.agreetrust.org) continues to experience steady increases in visitors per month and currently has over 10,000 registered users.ConclusionsThe AGREE Enterprise has contributed to the advancements of guidelines through research activities and international participation by scientific and user communities. As we enter a new decade, we look forward to ongoing collaborations and contributing to further advancements to improve quality of care and health care systems.

Clinical Practice Guidelines and Consensus Statements in Oncology – An Assessment of Their Methodological Quality

Background Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine’s standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicines standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Findings Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal’s consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Conclusion Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor’s product to enhance transparency.

Making sense of complex data: a mapping process for analyzing findings of a realist review on guideline implementability

BackgroundRealist reviews offer a rigorous method to analyze heterogeneous data emerging from multiple disciplines as a means to develop new concepts, understand the relationships between them, and identify the evidentiary base underpinning them. However, emerging synthesis methods such as the Realist Review are not well operationalized and may be difficult for the novice researcher to grasp. The objective of this paper is to describe the development of an analytic process to organize and synthesize data from a realist review.MethodsClinical practice guidelines have had an inconsistent and modest impact on clinical practice, which may in part be due to limitations in their design. This study illustrates the development of a transparent method for organizing and analyzing a complex data set informed by a Realist Review on guideline implementability to better understand the characteristics of guidelines that affect their uptake in practice (e.g., clarity, format). The data organization method consisted of 4 levels of refinement: 1) extraction and 2) organization of data; 3) creation of a conceptual map of guideline implementability; and 4) the development of a codebook of definitions.ResultsThis new method is comprised of four steps: data extraction, data organization, development of a conceptual map, and operationalization vis-a-vis a codebook. Applying this method, we extracted 1736 guideline attributes from 278 articles into a consensus-based set of categories, and collapsed them into 5 core conceptual domains for our guideline implementability map: Language, Format, Rigor of development, Feasibility, Decision-making.ConclusionsThis study advances analysis methods by offering a systematic approach to analyzing complex data sets where the goals are to condense, organize and identify relationships.

The Guideline Implementability Decision Excellence Model (GUIDE-M): a mixed methods approach to create an international resource to advance the practice guideline field

BackgroundPractice guideline (PG) implementability refers to PG features that promote their use. While there are tools and resources to promote PG implementability, none are based on an evidence-informed and multidisciplinary perspective. Our objectives were to (i) create a comprehensive and evidence-informed model of PG implementability, (ii) seek support for the model from the international PG community, (iii) map existing implementability tools on to the model, (iv) prioritize areas for further investigation, and (v) describe how the model can be used by PG developers, users, and researchers.MethodsA mixed methods approach was used. Using our completed realist review of the literature of seven different disciplines as the foundation, an iterative consensus process was used to create the beta version of the model. This was followed by (i) a survey of international stakeholders (guideline developers and users) to gather feedback and to refine the model, (ii) a content analysis comparing the model to existing PG tools, and (iii) a strategy to prioritize areas of the model for further research by members of the research team.ResultsThe Guideline Implementability for Decision Excellence Model (GUIDE-M) is comprised of 3 core tactics, 7 domains, 9 subdomains, 44 attributes, and 40 subattributes and elements. Feedback on the beta version was received from 248 stakeholders from 34 countries. The model was rated as logical, relevant, and appropriate. Seven PG tools were selected and compared to the GUIDE-M: very few tools targeted the Contextualization and Deliberations domain. Also, fewer of the tools addressed PG appraisal than PG development and reporting functions. These findings informed the research priorities identified by the team.ConclusionsThe GUIDE-M provides an evidence-informed international and multidisciplinary conceptualization of PG implementability. The model can be used by PG developers to help them create more implementable recommendations, by clinicians and other users to help them be better consumers of PGs, and by the research community to identify priorities for further investigation.