Development of an international glossary for clinical guidelines collaboration.

OBJECTIVES: Clinical practice guidelines (CPGs) are often created through collaboration among organizations. The use of inconsistent terminology may cause poor communication and delays. This study aimed to develop a glossary of terms related to collaboration in guideline development. STUDY DESIGN AND SETTING: A literature review of collaborative guidelines was performed to develop an initial list of terms related to guideline collaboration. The list of terms was presented to the members of the Guideline International Network Guidelines Collaboration Working Group, who provided presumptive definitions for each term and proposed additional terms to be included. The revised list was subsequently reviewed by an international, multidisciplinary panel of expert stakeholders. Recommendations received during this pre-Delphi review were implemented to augment an initial draft glossary. The glossary was then critically evaluated and refined through two rounds of Delphi surveys and a virtual consensus meeting with all panel members as Delphi participants. RESULTS: Forty-nine experts participated in the pre-Delphi survey, and 44 participated in the two-round Delphi process. Consensus was reached for 37 terms and definitions. CONCLUSION: Uptake and utilization of this guideline collaboration glossary by key organizations and stakeholder groups may facilitate collaboration among guideline-producing organizations by improving communication, minimizing conflicts, and increasing guideline development efficiency.

Adaptive Evolution in Rapid Assessments: A 25-Year Perspective.

OBJECTIVES: This article retrospectively examines the evolution of rapid assessments (RAs) produced by the Health Technology Assessment (HTA) Program at the Institute of Health Economics over its 25-year relationship with a single requester, the Alberta Health Ministry (AHM). METHODS: The number, types, and methodological attributes of RAs produced over the past 25 years were reviewed. The reasons for developmental changes in RA processes and products over time were charted to document the push-pull tension between AHM needs and the HTA Program's drive to meet those needs while responding to changing methodological benchmarks. RESULTS: The review demonstrated the dynamic relationship required for HTA researchers to meet requester needs while adhering to good HTA practice. The longstanding symbiotic relationship between the HTA Program and the AHM initially led to increased diversity in RA types, followed by controlled extinction of the less fit (useful) "transition species." Adaptations in RA methodology were mainly driven by changes in best practice standards, requester needs, the healthcare environment, and staff expertise and technology. CONCLUSIONS: RAs are a useful component of HTA programs. To remain relevant and useful, RAs need to evolve according to need within the constraints of HTA best practice.

A principal component analysis is conducted for a case series quality appraisal checklist.

OBJECTIVE: Because of a lack of a control group, a case-series study is considered one of the weaker study designs from which to obtain evidence on treatment effectiveness. Under certain circumstances, however, this is the only available evidence to inform health-care decisions. This study's intent was to develop and validate a quality appraisal checklist specifically for case-series studies. STUDY DESIGN AND SETTING: A modified Delphi process was used to develop the checklist, which was then used by multiple researchers to appraise a random sample of 105 case-series studies. A principal component analysis of these appraisals was conducted to further refine the checklist. RESULTS: The modified Delphi process resulted in a 20-criterion checklist. The principal component analysis of the appraisals for the 105 case-series studies revealed two components. The first component (10 criteria) indicated the extent to which a case series presented traditional features of a statistical hypothesis-testing paradigm. The second component (seven criteria) indicated whether detailed descriptions of the subjects' characteristics that might feature in the experimental design were present, particularly in judgments about the likelihood of confounding. CONCLUSION: This quality appraisal checklist may be useful in assessing case-series studies, but further validation of the checklist is required.

Guideline for primary care management of headache in adults.

OBJECTIVE: To increase the use of evidence-informed approaches to diagnosis, investigation, and treatment of headache for patients in primary care. QUALITY OF EVIDENCE: A comprehensive search was conducted for relevant guidelines and systematic reviews published between January 2000 and May 2011. The guidelines were critically appraised using the AGREE (Appraisal of Guidelines for Research and Evaluation) tool, and the 6 highest-quality guidelines were used as seed guidelines for the guideline adaptation process. MAIN MESSAGE: A multidisciplinary guideline development group of primary care providers and other specialists crafted 91 specific recommendations using a consensus process. The recommendations cover diagnosis, investigation, and management of migraine, tension-type, medication-overuse, and cluster headache. CONCLUSION: A clinical practice guideline for the Canadian health care context was created using a guideline adaptation process to assist multidisciplinary primary care practitioners in providing evidence-informed care for patients with headache.

Adapting low back pain guidelines within a multidisciplinary context: a process evaluation.

RATIONALE, AIMS AND OBJECTIVES: The Alberta Ambassador Program (AAP) adapted seven clinical practice guidelines on low back pain (LBP) into a single guideline spanning the continuum of care from prevention and diagnosis through to treatment. The Ambassador adaptation process was evaluated to 1 Identify the major challenges encountered and successful strategies utilized; 2 Assess strengths and weaknesses by benchmarking it with the ADAPTE framework; and 3 Identify opportunities for improvement. METHOD: External consultants reviewed the Ambassador and ADAPTE materials and conducted semi-structured telephone interviews with 29 participants from the AAP committees. All participants were asked about the major challenges encountered and potential areas for improvement. RESULTS: The response rate was 83% (29/35). There was strong consensus that the Ambassador guideline adaptation process was sound and rigorous all respondents indicated willingness to participate in further iterations of the Program. Key elements of success were identified. The main steps and sequence of the process were closely aligned with the ADAPTE framework, although the AAP incorporated additional enhancements which augmented the process. The main divergences between the two frameworks centred on the organizational structure and the methods used to overcome methodological difficulties. CONCLUSION: The AAP successfully utilized existing stakeholder interest to create an overarching guideline for managing LBP across multiple primary care disciplines. The study highlighted the strengths and weaknesses of the Program, and identified practical strategies for improvement. Evaluating guideline adaptation processes is pivotal to ensuring that they continue to be an efficient, rigorous and practicable option for producing contextualized, clinically relevant guidelines.

Creating a multidisciplinary low back pain guideline: anatomy of a guideline adaptation process.

RATIONALE, AIMS AND OBJECTIVES: A collaborative, multidisciplinary guideline adaptation process was developed to construct a single overarching, evidence-based clinical practice guideline (CPG) for all primary care practitioners responsible for the management of low back pain (LBP) to curb the use of ineffective treatments and improve patient outcomes. METHODS: The adaptation strategy, which involved multiple committees and partnerships, leveraged existing knowledge transfer connections to recruit guideline development group (GDG) members and ensure that all stakeholders had a voice in the guideline development process. Videoconferencing was used to coordinate the large, geographically dispersed GDG. Information services and health technology assessment experts were used throughout the process to lighten the GDG's workload. RESULTS: The GDG reviewed seven seed guidelines and drafted an Alberta-specific guideline during 10 half-day meetings over a 12-month period. The use of ad hoc subcommittees to resolve uncertainties or disagreements regarding evidence interpretation expedited the process. Challenges were encountered in dealing with subjectivity, guideline appraisal tools, evidence source limitations and inconsistencies, and the lack of sophisticated evidence analysis inherent in guideline adaptation. Strategies for overcoming these difficulties are discussed. CONCLUSION: Guideline adaptation is useful when resources are limited and good-quality seed CPGs exist. The Ambassador Program successfully utilized existing stakeholder interest to create an overarching guideline that aligned guidance for LBP management across multiple primary care disciplines. Unforeseen challenges in guideline adaptation can be overcome with credible seed guidelines, a consistently applied and transparent methodology, and clear documentation of the subjective contextualization process. Multidisciplinary stakeholder input and an open, trusting relationship among all contributors will ensure that the end product is clinically meaningful.

Managing low back pain in the primary care setting: the know-do gap.

OBJECTIVE: To ascertain knowledge gaps in the diagnosis and treatment of acute and chronic low back pain (LBP) in the primary care setting to prepare a scoping survey for identifying knowledge gaps in LBP management among Alberta's primary care practitioners, and to identify potential barriers to implementing a multidisciplinary LBP guideline. METHODS: English language studies, published from 1996 to 2008, comparing the clinical practice patterns of primary care practitioners with guideline recommendations were identified by systematically searching literature databases, the websites of various health technology assessment agencies and libraries, and the Internet. Data were synthesized qualitatively. RESULTS: The literature search identified 14 relevant studies. Knowledge gaps were reported among various primary care practitioner groups in the assessment of red flags, use of diagnostic imaging, provision of advice regarding sick leave and continuing activity, administration of some medications (muscle relaxants, oral steroids and opioids) and recommendation of particular treatments (acupuncture, physiotherapy, spinal manipulation, traction, ultrasound, transcutaneous electrical nerve stimulation and spinal mobilization). CONCLUSIONS: A know-do gap clearly exists among primary care practitioners with respect to the diagnosis and treatment of LBP. The information on know-do gaps will be used to construct a survey tool for unearthing the local knowledge gaps extant among Alberta's primary care practitioners, and to develop a dissemination strategy for a locally produced multidisciplinary LBP guideline, with the aim of ensuring that the know-do gaps inherent within each primary practice discipline are specifically targeted.

Making the AGREE tool more user-friendly: the feasibility of a user guide based on Boolean operators.

Rationale, aims and objectives The Appraisal of Guidelines Research and Evaluation (AGREE) instrument is a generic tool for assessing guideline quality. This feasibility study aimed to reduce the ambiguity and subjectivity associated with AGREE item scoring, and to augment the tool's capacity to differentiate between good- and poor-quality guidelines. Methods A literature review was conducted to ascertain what AGREE instrument adjustments had been reported to date. The AGREE User Guide was then modified by: 1 constructing a detailed set of instructions, or dictionary, using Boolean operators, and 2 overlaying seven criteria to categorize guideline quality. The feasibility of the Boolean-based dictionary was tested by three appraisers using three randomly selected guidelines on low back pain management. The dictionary was then revised and re-tested. Results Of the 52 published studies identified, 14% had modified the instrument by adding or deleting items and 35% had adopted strategies, such as using a consensus approach, to overcome inconsistencies and ensure identical item scoring among appraisers. For the feasibility test, Pearson correlation coefficients ranged from 0.27 to 0.81. Revision and re-testing of the dictionary increased the level of agreement (range 0.41 to 0.94). Application of the revised dictionary not only decreased the variability of the domain scores, but also reduced the tool's reliability among inexperienced appraisers. Conclusion Appraisers found the Boolean-based AGREE User Guide easier to use than the original, which improved their confidence in the tool. Good reliability was achieved in the feasibility test, but the reliability and validity of some of the changes will require further evaluation.

Using health technology assessment to identify research gaps: an unexploited resource for increasing the value of clinical research.

Health technology assessments (HTAs) are an as yet unexploited source of comprehensive, systematically generated information that could be used by research funding agencies to formulate researchable questions that are relevant to decision-makers. We describe a process that was developed for distilling evidence gaps identified in HTAs into researchable questions that a provincial research funding agency can use to inform its research agenda. The challenges of moving forward with this initiative are discussed. Using HTA results to identify research gaps will allow funding agencies to reconcile the different agendas of researchers who conduct clinical trials and healthcare decision-makers, and will likely result in more balanced funding of pragmatic and explanatory trials. This initiative may require a significant cultural shift from the current, mostly reactive, funding environment based on an application-driven, competitive approach to allocating scarce research resources to a more collaborative, contractual one that is proactive, targeted and outcomes-based.

Creating clinically relevant knowledge from systematic reviews: the challenges of knowledge translation.

RATIONALE AND OBJECTIVE: A research translation strategy for chronic pain was developed that has significant potential to advance the usefulness of systematic reviews (SRs) in clinical practice. METHOD: The strategy used interactive case-based workshops that summarize current evidence on treatments for chronic non-cancer pain. Health technology assessment researchers and clinicians collaborated to translate SR evidence into education aids, but this proved far from straightforward. RESULTS: Sourcing and selecting the SR evidence required maintaining a credible balance between the diametrical concepts of comprehensiveness and efficiency, and relevance and validity. On examination of the collated evidence base, further challenges were encountered in dealing with the lack of consistency among the SRs in the quality of execution, the scales used to rate the quality of the evidence, and the conclusions on common topic areas. Strategies for overcoming these difficulties are discussed. CONCLUSIONS: The key elements for creating clinically relevant knowledge from SRs are: a flexible, consistent and transparent methodology; credible research; involvement of renowned content experts to translate the evidence into clinically meaningful guidance; and an open, trusting relationship among all contributors.

Mentoring a developing health technology assessment initiative in Romania: an example for countries with limited experience of assessing health technology.

OBJECTIVES: The aim of this study was to assist and facilitate introduction and development of a health technology assessment (HTA) program in Romania. METHODS: Mentoring of an initiative group in Romania was provided by an HTA program in Canada. Mentoring activities included provision of HTA materials, participation in local seminars, facilitating contact with HTA and funding organizations, and in-house training of a professional from Romania. RESULTS: Since 1998, when the relationship was initiated, the Romanian group has been successful in developing an understanding of HTA and awareness of its utility among various decision-makers in the health system. Currently, although the need for HTA in Romania exists and interest in developing this activity has been officially expressed, HTA is still early in its development phase. The mentoring support helped to identify and define the need for HTA in Romania. Continuation of the existing relationship can be expected to strengthen the expertise in this country. However, while mentoring has been a valuable activity, it is not, by itself, sufficient to ensure development of an HTA program in Romania. The actions and decisions that could lead to implementing HTA in Romania depend on the local context. CONCLUSIONS: Mentoring services assisted the initiative group in promoting HTA in Romania. The implementation of HTA in Romania has not happened yet, and efforts need to continue to sustain the existing momentum. However, success in implementing an HTA program will depend on essential factors such as local political, economical, and educational support for this initiative and others like it.