Abstract
Background
Pediatric concussion is considered a serious public health concern in Canada. 1 Between 2003 and 2013, there was a 4.4-fold increase in pediatric concussion visits in Ontario, with nearly 35,000 visits in 2013. 2 The identification, assessment and management of pediatric concussion have evolved rapidly over the past decade, yet emerging evidence is not always integrated into practice. 3 Thus, it is critical that the clinical community is provided with evidence informed clinical guidelines to ensure that their concussion practices reflect a high level of care and consistency.
Clinical practice guidelines (CPGs) are systematically developed statements that assist clinicians in making evidence informed decisions regarding patient care. CPGs cover an array of patient-related domains such as screening, diagnosis, and management, in addition to informing health policy. 4 The overall goal of a CPG is to reduce unnecessary variations in service delivery by informing the management of a certain health condition. 5 Unnecessary variations in service delivery may be due to a variety of demographic factors that influence if and how a CPG is used. For example, factors such as a healthcare professional’s discipline, experience, age, and even sex, have the potential to influence the management of concussion, but have yet to be investigated in the field of pediatric concussion. 6
Within pediatric concussion, the Ontario Neurotrauma Foundation (ONF) released the Guidelines for Diagnosing and Managing Pediatric Concussion in 2014 (herein referred to as the 2014 CPG) with the aim to clarify and standardize concussion recommendations, anchored in empirical evidence. At the outset, the ONF committed to update the guidelines (proposed for 2019). 7 The 2014 CPG is one of four CPGs specific to pediatric concussion available, with one study reporting that 71.4% of appraisers indicated that they would recommend the 2014 CPG with revisions. 8 To date, no research has examined the various barriers to the 2014 CPG.
Updating the 2014 CPG presented a unique opportunity to assess the guidelines to inform current development activities. Beyond reviewing new knowledge generated by empirical evidence, it was key to employ a structured and systematic approach to evaluate the 2014 CPG so its evolution aligned rigorously with CPG development methodology, and to facilitate optimal dissemination and uptake of updated versions. Therefore, the use of an integrated knowledge translation (iKT) approach, defined as a co-production of knowledge through a relationship between researchers and decision makers, 9 was integral to improving clinical uptake of the CPG given that uptake is influenced by a myriad of factors beyond the evidence alone.
Though CPGs have the potential to improve practice and support clinical decision-making, these benefits have not consistently been achieved due to barriers to use. In addition to demographic factors, limited impact of a guideline can be attributed to vagueness, 10 lack of awareness, complexity of the guidelines, accessibility to resources and tools, and the lack of end-user involvement in development. 11 For instance, it has been reported that 16–66% of pediatricians were aware of the existence of various pediatric CPGs, but only 19–28% reported a change in their practice behaviour. 12 This supports that guidelines that are clear to understand and do not require specific resources are more likely to be implemented. 13 Therefore, it is evident that an iKT approach is warranted to glean the barriers limiting clinical uptake from target users presumed to use CPGs in their daily clinical practice.
Evaluating previous CPGs can be an effective and inexpensive way to increase the impact a CPG will have on clinical practices. 14 The validated Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool by Brouwers et al., 15 the most commonly used guideline appraisal tool, 16 was developed to assess CPG quality and to provide a methodological framework for the development and/or revision of CPGs. 15 The original AGREE tool was developed in 2003 through a multi-staged process and was tested on 100 guidelines from 11 countries. 17 In 2010, the AGREE II tool replaced the original AGREE project with improvements to its measurement properties, usefulness to stakeholders, and ease of implementation. 15 The AGREE II tool evaluates CPGs through six domains: (1) scope and purpose; (2) stakeholder involvement; (3) rigour of development; (4) clarity of presentation; (5) applicability; and (6) editorial independence through a seven-point Likert scale. 18 According to Appenteng et al., 8 the highest quality CPGs are targeted guidelines for a specific population, developed by a group with clinical, research and methodological expertise, and have undergone iterations of previous editions. The process of evaluating and developing CPGs should be viewed as progressively adaptive where quality is informed by the composition and expertise of the guideline developers. 19
The current study is anchored in an iKT approach and uses clinical experts as appraisers of the 2014 CPG given their scope of responsibility to invoke practice change. The purpose of this study was to rigorously evaluate the 2014 CPG using the AGREE II tool and utilize the feedback collected from end users to inform quality improvements across content, format, development processes and dissemination to support the development of an updated CPG. The study objectives include: (1) describe the quality of the 2014 CPG through AGREE II domain scores and frequency analysis of knowledge translation (KT) questions; (2) evaluate whether AGREE II ratings of the 2014 CPG are impacted by demographic factors; and (3) interpret written responses/justifications to AGREE II scores to describe potential areas for improvement beyond frequency analysis.
Evaluating AGREE II ratings by demographic factors may inform whether the CPG meets the needs of its target users, its content is well disseminated to end users, and whether there are barriers to use for subgroups of target users. Further, engaging end users in a CPG evaluation is a valuable method to revising a CPG as all end users are aware of the updating process as appraisers, purpose of the CPG as guideline developers, and carry out the recommendations in their own practice. The outcomes of this study are critical to inform the development of an impactful and evidence-informed knowledge product that has been co-created by concussion and knowledge translation experts.
Methods
Context
The ONF was a health research organization focusing on the practical applications of research to improve the lives of individuals with acquired brain injury or spinal cord injury, and the prevention of neurotrauma injuries. 20 In 2014, the ONF funded and released the Guidelines for Diagnosing and Managing Pediatric Concussion, a CPG intended for use by healthcare professionals in diagnosing and managing pediatric concussion (5–18 years). The 2014 CPG presents evidence informed recommendations, with levels of evidence indicative of the strength of research to date. The guideline was housed on the ONF website as a downloadable 140-page PDF document. The 2014 CPG contained sections regarding using the guidelines; recommendations for primary users (i.e., healthcare providers), secondary/tertiary users (i.e., parents and/or caregivers, schools and/or community sports organizations), and by injury timeline; background on pediatric concussion, rationale for the guidelines and areas of further research; information about the project team; a rigorous description on the methodology of creating the guidelines; results of an external review; derivative products, costs, updates and audits; notices; and a list of tools. At its release, three external reviewers (two physicians, one researcher) provided an overall quality rating of 90% for the guideline using the AGREE II tool.
In January 2018, the ONF initiated the process to update the 2014 CPG as per their commitment. In October 2018, leaders in concussion research convened for a pediatric concussion guideline consensus meeting, where limitations of the 2014 version were discussed, and a consensus on the new guidelines and format were formed. Engaging end users in the evaluation and revision of the 2014 CPG was a critical component to the consensus meeting as end users could readily reflect on the 2014 CPG when proposing revisions (i.e., content, format, development, dissemination) for the 2019 CPG. Thus, this study served as an essential tool to the process and end product of revising the CPG, in line with an iKT framework.
Study design
This iKT study employed a mixed-methods design. Quantitative data was gathered though surveys. Qualitative data was gathered through written justifications of quantitative survey responses.
Participants
A purposive sample of participants was recruited via email from the list of invitees attending the October 2018 pediatric concussion guideline consensus meeting. The participants comprised researchers, physicians, allied health professionals (i.e., occupational therapy, physical therapy, and speech language pathology), policy makers, educators and knowledge translation (KT) experts. As this was a purposive sample, there were no explicit exclusion criteria, with the exception that participants would be excluded if they could not read or write in English.
Measures
Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool 18
The AGREE II tool is a 23-item questionnaire, spanning six domains: (1) scope and purpose; (2) stakeholder involvement; (3) rigour of development; (4) clarity of presentation; (5) applicability; and (6) editorial independence. A description of the assessment focus for each domain is provided in Table 1. AGREE II items are rated on a seven-point Likert scale (1 =
Assessment description for AGREE II domains. 18
The AGREE II tool is the most commonly used guideline appraisal tool, 16 and it is well suited for evaluating the 2014 CPG as it is able to target any step along the healthcare continuum (i.e., identification, assessment, management, intervention) and is intended for healthcare providers and guideline developers. The AGREE II user manual does not specify thresholds that distinguish a high-quality versus low-quality guideline at this time; however, higher scores indicate higher quality CPGs. 18
AGREE II score comments
Appraisers were asked to provide comments and/or justifications in response to their rating for each AGREE II item. This was an opportunity to share strengths and constructive criticism/areas of improvement to consider for the 2019 CPG.
Demographic information
Demographic information such as age, sex, discipline and years of experience were collected.
Knowledge translation appraisal
This brief survey, purposefully developed by the research team including clinicians and knowledge translation specialists included 11 knowledge translation questions, which included participant self-reported previous use and familiarity of the 2014 CPG; influence of the 2014 CPG on concussion identification, assessment and management; facilitators and barriers to the use of the 2014 CPG; and recommended tools to enhance future clinical uptake. These KT questions utilized Likert scale responses.
Procedure
The study was approved in concordance with the Research Ethics Board at Holland Bloorview Kids Rehabilitation Hospital in Toronto, Canada. Participants were recruited via email and informed of the option to consent to have their data be part of this research study or decline their participation in research (but agree to have the broader team utilize their data for the development of the updated version of the CPG). Participants completed an online survey containing the measures. An electronic version of the 2014 CPG for healthcare professionals was provided to all participants.
The survey was created, distributed and housed on REDCap™, a secure web application used to build and manage online surveys and databases.21,22
Analysis of data
Frequency analysis of the self-reported demographic factor data was conducted. To assess quality across the AGREE II domains in accordance with the AGREE II user manual, 18 scaled domain scores were derived by summing the scores of the individual items in a domain, and scaling the total as a percentage of the maximum possible score for that domain. Descriptive statistics (i.e., mean, median, frequency percentages and 95% confidence intervals) captured how the 2014 CPG was rated according to the AGREE II criteria. Scaled AGREE II domain scores were stratified by meaningful demographic factor groups.
Qualitative data (i.e., comments/scoring justifications) related to the AGREE II tool were evaluated using a conceptual content analysis, 23 a common method for analyzing written answers to open-ended questions. An inductive approach was taken with explicit terms coded to determine the occurrence of common themes within the data. Critiques or strengths of the 2014 CPG were of interest during the content analysis. One research team member, independent of the development of either pediatric concussion CPGs, conducted this analysis. Continuous reflection and self-criticism by the research team member was practiced.24–26 Frequencies of concepts were reported. Lines-of-argument (synthesizing arguments) were generated by integrating the results of the content analysis into the update of the CPG. For this study, an ONF guideline developer provided details regarding how the synthesizing arguments were addressed in the development of the updated CPG.
Results
Participants
A total of 31 participants (males = 13, females = 18) enrolled in this study. Thirteen participants had made a previous contribution to the development of the 2014 CPG. While an array of healthcare professionals were represented in this study, 13 participants were physicians. Participants were equipped with notable experience in their respective fields (Median = 25 years, IQR = 14–30 years) as well as pediatric concussion (Median = 12 years, IQR = 8–20 years).
Appraisal of the 2014 CPG Using the AGREE II Tool
The results of the AGREE II appraisal stratified by demographic variables and KT survey items are provided in Table 2. Table 3 contains a comprehensive overview of the AGREE II ratings by domain and item, a summary of the appraiser justifications, and CPG updates provided by an ONF guideline developer. Note that the
Mean scaled domain scores (as percentages) of the AGREE II tool, stratified by demographic factors.
aAllied health professional.
AGREE II score results (%), score comment summaries and improvements in updated CPG. If no
Domain 1: Scope and purpose
Participants provided a mean overall rating of 80.8% (95% CI, 53.5–100.0%) in Domain 1, reflective of the 2014 CPG’s ability to demonstrate adequate scope and purpose. Physicians and allied health professionals provided the highest ratings (83.4% and 84.3%; 95% CI, 51.3–100.0% and 70.1–98.4%, respectively), while other professions (psychologists/neuropsychologists, researchers, one nurse practitioner) provided ratings approximately 6–17% lower. Participants with less than 10 years of experience in their discipline provided a higher rating (90.7%; 95% CI, 64.8–100.0%) than those with more than 10 years of experience who provided mean domain ratings between 71.0–84.9%. Additionally, participants using the CPG in rehabilitation (69.1%; 95% CI, 30.6–100.0%) and education (76.2%; 95% CI, 50.7–100.0%) settings rated this domain lower compared to those in acute care, research and policy settings (range of mean scores, 87.0–88.9%). Many appraisers (n = 16) stated that the scope and purpose were well described although they noted that more assistance with persistent symptoms was necessary (i.e., concussion management) and that the health questions of all stakeholders were not met as there were too many stakeholders considered.
Domain 2: Stakeholder involvement
The mean
Domain 3: Rigour of development
The mean domain score for
Domain 4: Clarity of presentation
The mean
Domain 5: Applicability
The mean score across all participants for Domain 5 was 69.3% (95% CI, 40.2–98.4%). Males provided a higher rating (80.7%; 95% CI, 48.0–100.0%) compared to females (62.2%; 95% CI, 43.7–80.7%). Physicians and allied health professionals provided higher ratings compared to ratings by psychologists/neuropsychologists (59.4%; 95% CI, 26.0–92.8%), researchers (56.3%; 95% CI, 13.7–98.8%), and one nurse practitioner (37.5%; 95% CI, N/A). Participants with less than 10 years of experience in their primary discipline provided the highest applicability rating (86.1%; 95% CI, 64.0–100.0%), yet those with less than 10 years of pediatric concussion experience provided the lowest applicability rating (60.7%; 95% CI, 21.2–100.0%). Finally, participants from a rehabilitation setting provided the lowest rating of 61.7% (95% CI, 31.0–92.3%), compared to other settings, which provided higher mean ratings ranging between 70.4–81.9%. Appraisers reported that while the 2014 CPG describes the facilitators and barriers to use (n = 13), additional barriers such as the CPG’s length exists. Appraisers identified that while many tools were provided to support implementing the recommendations into practice, some content between tools conflicted. Additionally, who should use the tools and how to interpret the results of the tools was unclear.
Domain 6: Editorial independence
The mean score across all participants for Domain 6 was 88.9% (95% CI, 56.7–100.0%). Females provided a lower mean score (82.7%; 95% CI, 76.9–88.5%) compared to males (99.0%; 95% CI, 60.4–100.0%). Researchers and one nurse practitioner rated editorial independence (70.8% and 58.3%; 95% CI, 14.7–100.0% and N/A, respectively) lower than that of the remaining professions. Interestingly, those with less than 10 years of pediatric concussion experience provided the lowest rating of 79.8% (95% CI, 34.7–100.0%), while those with greater than 10 years of concussion experience provided higher mean ratings ranging between 86.9–100.0%. Most appraisers (n = 19) noted that there was no undue influence by the funding body and that any competing interests were clearly stated (n = 17).
Use and influence of CPG 2014
According to the Knowledge Translation Appraisal survey responses, participants reported minimal use of the 2014 CPG in their daily practice. More specifically, 41.9% (n = 23) of appraisers indicated that they never or rarely used the 2014 CPG compared to 51.6% (n = 16) that stated occasional use. More frequent use of the 2014 CPG did not translate into higher AGREE II domain ratings. Notably, those who reported rarely using the 2014 CPG rated both the
Participants revealed that the greatest barriers to using the 2014 CPG included lack of knowledge of the guideline (9.7%, n = 3), length of the guideline (12.9%, n = 4), and that the recommendations could not be applied in their practice setting (19.4%, n = 6). Those that reported that the recommendations could not be applied to their practice setting were neuropsychologists and researchers, who are not primary end users of the guideline. These results provide clear feedback to consider during CPG updates.
Participants also rated how influential they perceived the 2014 CPG to be on concussion identification, assessment, and management. Twenty-four (77.4%) participants reported the 2014 CPG to be slightly or somewhat influential in identifying concussions, 22 (71.0%) participants stated that the 2014 CPG was somewhat to very influential on concussion assessment, and 23 (74.2%) participants indicated that the 2014 CPG was somewhat to very influential on concussion management. The majority of physicians (76.9%, n = 10) rated the 2014 CPG as somewhat to very influential on concussion identification, assessment and management. Also, 85.7% (n = 6) of allied health professionals rated the 2014 CPG somewhat influential on concussion identification, assessment and management. However, most appraisers in other disciplines (i.e., research, neuropsychology/psychology, nursing) believed the 2014 CPG to be only slightly influential on concussion identification, assessment and management.
CPG updates based on appraisal outcomes
Guideline developers considered AGREE II scaled scores in combination with appraiser feedback (Table 3, Column 2) to identify limitations of the 2014 CPG and conceptualize improvements to enhance implementation of the updated CPG (Table 3, Column 3). Common feedback included that the level of evidence was lacking in some areas, the evidence and recommendations were difficult to interpret for secondary/tertiary users, and the guideline was too long and often repetitive. As the field of pediatric concussion research is relatively new and ever expanding, establishing “gold standard” evidence is ongoing. As such, areas of pediatric concussion rehabilitation remain vague/less directive, which poses a challenge to end users looking for guidance in their everyday clinical practice. 11 To align with the progression in the field, the new CPG will be a living guideline in a website format. Content will be updated as the evidence emerges to ensure recommendations are rigorously developed and current. The website will make content more accessible and increase clarity, with a filter function to streamline end user needs. Additionally, to increase uptake and improve clarity, the updated CPG was created for healthcare providers as the single, primary target user. Derivative products were created for parents, as well as the sports and education communities, containing relevant information from the updated CPG. All areas of the updated CPG and associated products have been created by a multi-disciplinary team bolstered by KT specialists and graphic designers for optimal content quality, clarity and dissemination.
Discussion
The primary objective of the study was to evaluate the ONF’s Guidelines for Diagnosing and Managing Pediatric Concussion using the AGREE II tool in order to inform its update. Overall, the findings revealed that the 2014 CPG was acceptable across domains, with variations within domain scores suggested to be accounted for by various demographic factors examined in this study. The findings not only support the use of the AGREE II tool to ensure standards for a high-quality CPG were being met through critical appraisal by end users, but also to inform the development of the updated CPG to optimize implementation of of the revised 2019 CPG. While evaluating CPGs using the AGREE II tool is a widespread practice, the engagement of end users within an iKT lens has not been carried out in the field of pediatric concussion. This study makes a notable contribution to understanding how end user demographic factors influence CPG use and acceptability. The iKT framework engaged end users in the evaluation of the 2014 CPG, which enabled maximum participation in both the conception and future implementation of the 2019 CPG. The implication of this work is to prompt clinical communities to expand how they appraise and revise a CPG. As evidenced in this study, a high external reviewer score does not necessarily reflect optimal clinical uptake or acceptability to end users. Thus, it behoves the pediatric concussion community to take a more systematic approach to investigate factors limiting CPG usage.
The AGREE II appraisal of the 2014 CPG was in line with other pediatric concussion CPGs across the world. A study by Appenteng et al.
8
reported mean domain AGREE II scores for
The KT appraisal survey identified some key areas to consider for the updated version of the CPG. Firstly, over 90% of appraisers reported that they did not regularly use the 2014 CPG, which is of concern but may be improved. For example, clinician adherence to CPGs in brain injury rehabilitation in a brain injury rehabilitation unit in Melbourne, Australia with no active KT interventions was approximately 39%. With a >12-month audit and feedback intervention, adherence increased to 84%. 3 Thus, removing identified barriers to use (i.e., knowledge of the guideline, length of the guideline, and relevance) and implementing active KT interventions may lead to more frequent use by healthcare professionals. For the updated ONF guidelines, the use of KT specialists with dissemination and implementation expertise will help with widespread distribution of the updated CPG. The length barrier will be removed as the updated CPG will be on a website with sub-sections, making the information more digestible and less repetitive. Relevance of recommendations in practice settings will be improved based on more explicitly defining the target population of healthcare professionals to have more specific and relevant recommendations. Further, from the KT appraisal survey, an important finding was that healthcare professionals (i.e., physicians and allied health professionals), the new target users of the updated CPG, reported that the 2014 CPG was highly influential in identifying, assessing and managing concussions. This suggests that the guideline developers are well positioned to create an impactful, evidence-informed CPG for their target audience.
The combined analysis of the quantitative AGREE II domain ratings and qualitative appraiser feedback informed necessary updates to the 2014 CPG as outlined previously through a systematic approach. The use of end users focussed and streamlined the process. The
In line with the literature, the
Unique to the field of pediatric concussion was the use of appraisers from various disciplines that were both guideline developers and end users, as well as the high number of appraisers engaged. The engagement of these stakeholders brings value of learning from the use and development of prior iterations. Results from this unique sample were stratified according to experts’ demographic factors and experience. Similar trends were found across domains. For example, physicians and allied health professionals consistently provided higher ratings across domains compared to other professions. This finding may be due to the recommendations in the 2014 CPG being aligned more explicitly with these professions compared to other professions (i.e., neuropsychologists, nurse practitioner, researchers), in which recommendations may have been perceived as ambiguous. Interestingly, less years of experience in an appraiser’s respective discipline revealed stronger ratings across the
As stated by Brouwers et al., 15 the potential benefits of CPGs are only as good as the quality of the guideline itself, which is why it is critical to not only appraise CPGs but to involve key stakeholders in an integrated approach. Engaging in an iKT approach to CPG appraisal, as done in this study, brings greater accountability and credibility to practice recommendations, especially given that primary users of the guideline play a role in its development. 9
Limitations
While the study provides a rigorous approach to revising a CPG, it is not without limitations. While the use of appraisers who were also end users was a unique strength of this study, some appraisers had contributed to the development of the 2014 CPG, which may enter bias into their scoring. Wilcoxon Rank-Sum tests were conducted for each domain between groups to investigate this bias, however no difference between the groups was measured. This study presented AGREE II domain ratings; however, the AGREE II user manual does not specify thresholds that distinguish a high-quality versus low-quality guideline, making it difficult to objectively confirm the quality of the evaluated CPG. 18 The main purpose of the AGREE II tool is to assess the quality of structure and content, 30 but it does not explicitly evaluate the clinical utility/appropriateness of the recommendations themselves. Thus, high quality CPG content and structure does not guarantee better health outcomes for the target clinical population, 30 although it acts as a useful tool to inform usability while adding context that unless used, better health outcomes cannot be achieved.
Conclusion
High-quality CPGs reflect the perspectives of end users and other relevant stakeholder groups, are based in empirical evidence, are critically reviewed, and reflect specific recommendations. 15 This study provided a foundational iKT framework to appraise a CPG, while honing in on key factors that make a strong CPG in the context of pediatric concussion. Poor uptake of CPGs continues to be a critical barrier to utilizing evidence informed information to make clinical decisions. Through an iKT approach, the critical appraisal of CPGs and subsequent KT strategies provide a foundation for which to revise and implement an updated CPG to more appropriately reach and be used by the target audience of healthcare providers. Further, CPG recommendations need to be simple and clear to minimize the cognitive load and increase uptake. This study supported that ease of access, succinct information presentation and a user-friendly approach are key to enabling target users to implement the CPG. Demographic factors within end users are important to consider given their impact on domain score ratings and CPG use. Thus, engaging end users in the CPG appraisal resulted in these important outcomes: (1) identified areas of the guidelines that may have affected the lack of previous clinical uptake through a mixed-methods, integrated knowledge translation study design while abiding by a clinical practice guideline development framework; (2) shared and informed decision making regarding content and format of revised clinical practice guidelines; and (3) targeted content, clinical questions and dissemination strategies, which are key to clinical uptake.
