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Unique Features of the INESSS-ONF Rehabilitation Guidelines for Moderate to Severe Traumatic Brain Injury: Responding to Users' Needs

Bayley, Mark Theodore, MD; Lamontagne, Marie-Eve, PhD; Kua, Ailene, MSc, PMP; Marshall, Shawn, MD, MSc (Epi), FRCPC; Marier-Deschênes, Pascale, BSW; Allaire, Anne-Sophie, MSc; Kagan, Corinne, BA, BPS Cert; Truchon, Catherine, PhD, MSc Adm; Janzen, Shannon, MSc; Teasell, Robert, MD, FRCPC; Swaine, Bonnie, PhD

Section Editor(s): Swaine, Bonnie R. PhD; Bayley, Mark T. MD

The Journal of Head Trauma Rehabilitation: September/October 2018 - Volume 33 - Issue 5 - p 296–305
doi: 10.1097/HTR.0000000000000428
Clinical Practice Guidelines for TBI: Meeting the Needs of Users

Objective: Traumatic brain injury (TBI) clinical practice guidelines are a potential solution to rapidly expanding literature. The project objective was to convene experts to develop a unique set of TBI rehabilitation recommendations incorporating users' priorities for format and implementation tools including indicators of adherence.

Methods: The Guidelines Adaptation & Development Cycle informed recommendation development. Published TBI recommendations were identified and tabulated. Experts convened to adapt or, where appropriate, develop new evidence-based recommendations. These draft recommendations were validated by systematically reviewing relevant literature. Surveys of experts and target users were triangulated with strength of evidence to identify priority topics.

Results: The final recommendation set included a rationale, implementation tools (algorithms/adherence indicators), key process indicators, and evidence summaries, and were divided in 2 sections: Section I: Components of the Optimal TBI Rehabilitation System (71 recommendations) and Section II: Assessment and Rehabilitation of Brain Injury Sequelae (195 recommendations). The recommendations address top priorities for the TBI rehabilitation system: (1) intensity/frequency of interventions; (2) rehabilitation models; (3) duration of interventions; and (4) continuity-of-care mechanisms. Key sequelae addressed (1) behavioral disorders; (2) cognitive dysfunction; (3) fatigue and sleep disturbances; and (4) mental health.

Conclusion: This TBI rehabilitation guideline used a robust development process to address users' priorities.

Brain and Spinal Cord Rehabilitation Program, Toronto Rehabilitation Institute/University Health Network, Toronto, Ontario, Canada (Dr Bayley); Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada (Dr Bayley); Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS), Department of Rehabilitation, Faculty of Medicine, Université Laval, Québec, Canada (Dr Lamontagne); Toronto Rehabilitation Institute/University Health Network, Toronto, Ontario, Canada (Ms Kua); Ottawa Hospital Research Institute (OHRI) and University of Ottawa, Ontario, Canada (Dr Marshall); Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS), Department of Rehabilitation, Faculty of Medicine, Université Laval, Québec, Canada (Ms Marier-Deschênes); Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS), Québec, Canada (Ms Allaire); Ontario Neurotrauma Foundation (ONF), Toronto, Ontario, Canada (Ms Kagan); Institut national d'excellence en santé et en services sociaux (INESSS), Québec, Canada (Dr Truchon); Lawson Health Research Institute, St Joseph's Health Care, London, Ontario, Canada (Ms Janzen); St Joseph's Health Care, University of Western Ontario, London, Ontario, Canada (Dr Teasell); and Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain (CRIR) and Université de Montréal, Québec, Canada (Dr Swaine).

Corresponding Author: Mark Theodore Bayley, MD, Brain and Spinal Cord Rehabilitation Program, Toronto Rehabilitation Institute/University Health Network, Room 3-131, 550 University Ave, Toronto, ON M5G2A2, Canada (mark.bayley@uhn.ca).

The authors gratefully acknowledge the Institut national d'excellence en santé et en services sociaux (INESSS) and the Ontario Neurotrauma Foundation (ONF) for their support of this project. They also thank the group facilitators: Nora Cullen, Scott McCullagh, and Diana Velikonja for their contributions to this project. The authors extend their particular gratitude to the entire expert panel for their expertise, dedication, and support of the INESSS-ONF clinical practice guideline for rehabilitation of moderate to severe traumatic brain injury.

The project described in this manuscript was funded through the Institut national d'excellence en santé et en services sociaux (INESSS) and the Ontario Neurotrauma Foundation (ONF). The authors declare that no competing financial interests exist.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal's Web site (www.headtraumarehab.com).

The authors declare no conflicts of interests.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

REHABILITATION CLINICIANS are having difficulty keeping up with the growing volume of neuroscience literature.1 Clinical practice guidelines (CPGs) or systematically developed statements to assist both practitioner and patients' decisions about appropriate healthcare for specific clinical circumstances have been proposed as a solution.2 The problem is that development of guidelines is insufficient to change practice.3 Many factors influence guideline implementation including the quality of the guideline itself, the nature of the adopters, and the challenges inherent in the practice environment such as time available, funding, team coordination.4

Evaluation of the quality of guidelines using standardized tools such as the Appraisal of Guidelines Research and Evidence (AGREE 2) Instrument5 has highlighted that most guidelines have reasonable scientific rigor or connection with underlying evidence but lower scores in the domains of broad stakeholder involvement, applicability (eg, tools for implementation), and editorial independence.6 Applicability refers to the provision of an assessment of the potential barriers and challenges to implementation and of tool kits to implement the evidence.6 Furthermore, most CPGs do not prioritize recommendations for implementation.

In a previous article (titled “Assessment of Users' Needs and Expectations Toward Clinical Practice Guidelines to Support the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury,” Lamontagne et al7 survey of users accepted), potential users were surveyed to identify their preferences for scope, content, format and structure, and implementation strategies of the Institut national d'excellence en santé et en services sociaux and Ontario Neurotrauma Foundation (INESSS-ONF) guideline for rehabilitation of persons with moderate to severe traumatic brain injury (MSTBI). The survey highlighted the need for recommendations that covered such topics as the ideal models of care, optimal intensity, and duration of therapy. The surveyed users also asked for guidance in management of neurobehavioral dysfunction, cognitive dysfunction, and psychiatric complications that are challenging in MSTBI care. In view of the challenges with previously published guidelines and the identified needs of the users, the objective of this project was to develop a guideline that responded to the needs of users. The target audience is the interprofessional rehabilitation team including physicians, physiotherapists, occupational therapists, speech-language pathologists, nurses, and psychologists who work in acute care and inpatient or outpatient traumatic brain injury (TBI) rehabilitation settings.

The objective of this article is to highlight the unique features of this new guideline for rehabilitation of persons with MSTBI and the key priority recommendations for implementation. This will include illustration of how user needs were integrated into the guidelines' scope, format, presentation, and process for developing and prioritizing recommendations.

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METHODS

The Guidelines Adaptation Cycle8 process informed the development of the INESSS-ONF guideline through the following steps (see overview in Figure 1):

  1. Review and evaluation of quality of existing CPGs–-To minimize duplication of effort, existing TBI guidelines relevant to MSTBI published in English or French within the last 14 years (2000-2014) were reviewed and relevant recommendations extracted. Clinical practice guidelines were excluded if they addressed only mild TBI, or only acute or pediatric care. Four appraisers independently evaluated the quality of the development process for these CPGs using the AGREE instrument across 6 domains including (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence. Eight CPGs met the inclusion criteria and were of adequate quality (ie, recommended for consideration by at least 3 reviewers out of 4) for the adaptation process (see Supplemental Digital Content Table 1, available at: http://links.lww.com/JHTR/A254).
  2. Validation of the end users' needs and expectations—A needs assessment survey was developed to obtain feedback from end users of the CPG to guide the development strategy, particularly the nature, scope, and format of the desired end product. See previous report.9
  3. Synthesis of all existing documentation and evidence—The project team used the results of the survey of target CPG users, previous guidelines, and their own clinical expertise to identify the range of topics to be covered in the guideline. A recommendations matrix was created to allow comparison by topic of the published recommendations and associated level of evidence. The Evidence-Based Review of Moderate to Severe ABI (ERABI)10 is a free online systematic review of the literature available at www.abiebr.ca that is also funded by the ONF. The ERABI uses rigorous search strategies and quality appraisal of research literature and full methods are described on the Web site. To ensure that the experts had access to the current evidence, the ERABI was made available online and its evidence summary statements were added to the relevant matrix topic to allow validation against current evidence and the formulation of “de novo” recommendations, if dictated by the evidence.
  4. Expert consensus conference—A 2-day consensus conference was held in Montreal, Canada, in November 2014 to draft the initial set of evidence-informed recommendations. There were 60 participants selected to ensure a range of clinical, research, policy, decision making, lived experience, and knowledge translation expertise (list of participants available at https://braininjuryguidelines.org/). The objectives of the consensus conference were to (a) review the findings and resources from steps 1 to 3 above, (b) develop evidence-informed practice recommendations, and (c) identify potential performance indicators to measure adherence to the recommendations. The work was organized into 2 themes: (1) organization of rehabilitation services and (2) rehabilitation of specific brain injury sequelae. Experts were assigned to working groups on the basis of their expertise and topic interest and then generated recommendations by adopting/rewording recommendations or generating new recommendations.
  5. Adaptation, revision, and prioritization of the recommendations—Postconference, the 60 experts refined (clarifications and wordsmithing) high-priority topics and reviewed wording through e-mail and teleconference communication. The project team compiled all of the feedback and made edits to the recommendations. Two rounds of online surveys were used to narrow the set: Round 1 asked “Which recommendations should be included in the CPG.” To be included, at least 80% of the expert panel must have agreed with the recommendation. Round 2 asked which recommendations were “key” or priority recommendations for improving quality of TBI care. The project team then considered feasibility of implementation, the results of expert panel surveys, the strength of the evidence, and the survey of target users reference to identify priorities for implementation.
  6. Updated evidence review and grading of all recommendations—To ensure the evidence for final set of recommendations, the ERABI team collaborated on a review of the evidence for all recommendations. If new evidence was found, the evidence grading was updated accordingly.
  7. Refinement of the guideline supplementary sections—The project team finalized the supplementary text accompanying each topic including (1) a brief rationale and associated system implications designed for busy health administrators and funders, (2) key structure and process indicators, (3) implementation resources/tools, and (4) summary of the evidence from the ERABI. The set of indicators from the consensus conference was refined to address prioritized topics. The expert panel ranked the top 5 indicators (for each recommendation section) considering which would likely result in changes in clinician/manager's practice and they were included in the relevant section.
  8. Translation into French of recommendations and supplementary text—Occurred once all materials were finalized in English.
  9. External review—A guideline draft was circulated to recognized international experts who had not participated in its development. A francophone expert reviewed the translated version. These reviewers provided feedback about the validity and relevance of the recommendations that was incorporated into the final version.
Figure 1

Figure 1

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RESULTS

The final recommendations and the associated level of evidence (see Table 1) including the rationale, implementation tools, key process indicators, limitations of use, and evidence summaries are available in desktop and mobile device format at www.braininjuryguidelines.org and are divided in 2 sections. Section I: Components of the Optimal TBI Rehabilitation System includes 35 new and 36 already existing recommendations, while Section II: Assessment and Rehabilitation of Brain Injury Sequelae includes 195 recommendations among which 91 are new and 104 existing. A total of 126 new, original recommendations were formulated. This guideline was issued in October 2016 and will be reviewed in 2020.

TABLE 1

TABLE 1

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Fundamental and priority recommendations

The experts highlighted 2 recommendation types: Fundamental Recommendations defined as the recommended elements that programs must have, in order to build the rest of the system properly. Priority Recommendations are clinical practices deemed most important to implement and that meet the following criteria, that is, the practice was (i) highlighted in the targeted user survey, (ii) supported by strong evidence, (iii) ranked by the experts among the most important within a specific topic area, (iv) deemed feasible to implement by the project team, and (v) likely to have measureable outcomes.

Note: The reader is strongly encouraged to review the whole set of recommendations (http://www.braininjuryguidelines.org); however, we highlight below some key recommendations that arose out of the unique development process and are current priorities for practice improvement. Unless otherwise indicated, the recommendations are new stemming from the expert panel. Those adapted from a previous guideline are to be indicated in brackets.

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DISCUSSION

The resulting guideline is a comprehensive set of recommendations for rehabilitation of MSTBI. There are many unique features that respond to the users' needs and weaknesses of previous guidelines. As requested by our end users, the guideline exists in desktop and mobile device format with the option to print. Key recommendations were identified by triangulating results of the user survey, the expert consensus process, and the strength of the evidence. The top 4 issues for rehabilitation services identified by users that were addressed in the guidelines include (1) intensity/frequency of interventions, (2) rehabilitation models, (3) duration of interventions, and (4) continuity-of-care mechanisms.

There is a lack of level A evidence to address all of these issues specifically. However, comparative effectiveness research, for example, practice-based evidence project by Horn et al12 provides important insights, such as the recommendation stipulating that individuals with TBI should engage in cognitively effortful activities. This contradicts some clinicians' concerns that effortful activities may result in frustration and increased behavioral dysfunction. Furthermore, individuals with memory dysfunction should have specific training in that area in the subacute phase of rehabilitation. While it was difficult to establish an exact degree of intensity, experts reviewed previous recommendations and stated that a minimum of 3 hours of therapy per day was reasonable. To address care coordination, the experts recommended a case coordinator to engage throughout the continuum. The expert panel also highlighted coordination with mental health and substance abuse services as key drivers of TBI outcomes. If all healthcare professionals had specialized training in behavioral change strategies, patient adherence can be improved and adverse events minimized. Traumatic brain injury results in frequent involvement of frontal lobe executive systems; therefore, a behavioral approach can be helpful in reducing challenging behavior and ensuring generalization of learned skills.

The recommendations also aim to guide management of key sequelae identified by more than 70% of users including (1) behavior disorders; (2) cognitive function impairments; (3) fatigue and sleep disturbances; and (4) mental health.7 The guideline provides an algorithm for management of agitation. There remains limited evidence for behavioral management; however, the project team and expert panel developed some recommendations based on existing evidences and consensus. There are a large number of cognitive rehabilitation research studies, and the greatest numbers of level A evidence recommendations are in this section. We have provided guidance for common sleep and fatigue, and mental health complications.

In summary, this new guideline used a robust development process that addressed important priorities from the user perspective. The guideline also provides insights into where the evidence is still lacking and where future research efforts should be focused.

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                              Keywords:

                              guidelines; knowledge translation; rehabilitation; therapeutic approaches for the treatment of CNS injury; traumatic brain injury

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