Methodology
This page provides an overview of the methods used to develop the ANZ Concussion Guidelines.
The guideline development process commenced with a Scoping Review to assess the potential of using existing national and international mTBI/concussion clinical practice guidelines as source guidelines to develop the ANZ Concussion Guidelines. To assess the suitability for use of the potential source guidelines, the scope, methods, transparency in reporting and applicability of the guidelines to the ANZ healthcare setting were explored.
The scoping review found there was no existing single clinical practice guideline whose coverage completely aligned with that proposed for the ANZ Concussion Guidelines. In addition, most guidelines were developed internationally with applicability concerns for the ANZ healthcare context. Therefore, using a single source guideline for the development of the ANZ Concussion Guidelines was not appropriate. The Scoping Review was also used to inform the scope of the ANZ Concussion Guidelines (in terms of the topics to be addressed). Read More
Guidelines Quick Access
Meta-Guideline Approach
Closely aligned to the ADAPTE approach
The meta-guideline approach used to develop recommendations consisted of the following steps:
- Identification of relevant guidelines.
- Assessing multiple potential source guidelines (for recency, relevance, and quality).
- Selecting acceptable source guidelines.
- Extracting potentially suitable source recommendations (including their grading and the evidence associated with the recommendations).
- Assessing potentially suitable source recommendations.
- Adopting, adapting or discarding source recommendations through a considered judgement process and developing new recommendations where appropriate.
- Grading the adopted, adapted or new recommendations.
Details on Meta-Guideline Approach
Identification of Relevant Guidelines
The scoping review focussed on six potential existing evidence-based concussion guidelines. This included the guidelines in Table 1, with the exception of the Concussion in Para Sport (CIPS) Group339 which was found later in the guideline development process. The Sports Medicine Australia Concussion in Sport Policy (2018) was also included in the scoping review. These guidelines were selected due to alignment with the proposed ANZ Concussion Guidelines scope, generalisability to the Australian and Aotearoa New Zealand health care context, and because they had been published within the last 5 years.
Assessing and Selecting Acceptable Source Guidelines
To assess the extent to which the potential source guidelines complied with internationally recognised standards for evidence-based guidelines, an appraisal using the Appraisal of Guidelines Research and Evaluation (AGREE II) tool342 was undertaken on the guidelines included in the Scoping Review. The tool assessed the methodological quality of development of the potential source guidelines.
Considering the recency, scope, setting, context, and methodological rigour of development, the guidelines listed in Table 4 were identified as acceptable source guidelines for recommendations in adults, children and sport-related concussion. The Sports Medicine Australia Concussion in Sport Policy (2018) was not included based on AGREE II assessment, particularly the rigour of development domain. The source guideline developers were contacted, and permission was granted to adapt recommendations from these guidelines.
The first position statement developed by the Concussion in Para Sport (CIPS) Group339 was identified later in the guideline development process. It was reviewed and accepted as a source guideline for recommendations in para-athletes (a sub-group of interest).
| Guideline developer/ID(reference) | Publication Date | Guideline title | Target population | Country | AGREE II overall score |
|---|---|---|---|---|---|
| Living Concussion Guidelines27 | Living Guideline | Living Concussion Guidelines: Guideline for Concussion & Prolonged Symptoms for Adults 18 years of Age or Older | Adults | Canada | 6/7 |
| PedsConcussion28 | Living Guideline | Living Guideline for Pediatric Concussion Care | Children/adolescents 5-18 years | Canada | 6/7 |
| PREDICT6 | 2021 | Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children | Children < 18 years | Australia and Aotearoa New Zealand | 6/7 |
| CDC29 | 2018 | CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children | Children ≤ 18 years | United States | 6/7 |
| Concussion in Sport Group30 | 2023 | Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport- Amsterdam, October 2022 |
Sport-related concussion | International | 4/7a |
| Concussion in Para Sport (CIPS) Group339 | 2021 | Concussion in para sport: the first position statement of the Concussion in Para Sport (CIPS) Group | Para athletes | International | ND |
a The AGREE II assessment was performed on the 5th Consensus statement on concussion in sport as the 6th statement was not published at the time of the scoping review.
Extraction of Recommendations
All recommendations from the Living Concussion Guidelines, PedsConcussion and PREDICT Guidelines that addressed topics within the scope of the ANZ Concussion Guidelines were extracted. Extracted recommendations were categorised into sections, topics and sub-topics and the following key information was summarised:
Considered Judgement Process
The Guideline Development Group (GDG) undertook a considered judgement process via virtual meetings held throughout 2023. During these GDG meetings, the extracted source guideline recommendations were assessed to determine whether they were suitable for adoption or adaptation in the ANZ Concussion Guidelines.
Sport-Related Concussion
The 2023 Consensus Statement on concussion in sport was considered the primary source of evidence for sport-related concussion recommendations due to its recency and the extensive systematic reviews performed to inform the statement. Sport-related concussion recommendations from other source guidelines were often informed by the prior consensus statement published in 2017, and were therefore considered less recent and not prioritised.
GRADE
GRADE is an internationally recognised systematic and transparent approach for developing and presenting summaries of evidence and deriving evidence-based recommendations. GRADE is designed to assess prespecified outcomes that are based on an underlying research question (usually developed in PICO format) (GRADE Working Group, 2013). Due to the breadth of topics to be addressed by the ANZ Concussion Guidelines, the traditional approach of developing research questions and associated PICO criteria was not feasible. In addition, application of the GRADE approach to adoption or adaptation of recommendations from source guidelines is limited because none of the source guidelines used a full GRADE approach, or they did not provide sufficient information to apply the GRADE approach.
GRADE methods were incorporated where possible, such as in the categorisation of recommendations according to GRADE guidance that a “recommendation should have one of two strengths (strong or conditional, also called weak) and one of two directions (for or against). The definitions for each category should be consistent with the definitions used by the GWG (although different terminology may be used, such as strong and discretionary)” (Schunemann et al. 2023).
Types of recommendations
The types of recommendations included in the ANZ Concussion Guidelines are outlined in Table 5.
Table 6: ANZ Concussion Guidelines types of recommendations
| Recommendation | Description |
|---|---|
| Recommended (Strong) | Benefits of a recommended course of action clearly outweigh the harms, and this is supported by high-quality evidence. |
| Not recommended (Strong) | Harms of a recommended course of action clearly outweigh the benefits, and this is supported by high-quality evidence. |
| Conditionally recommended | Denotes uncertainty over the balance of benefits, such as when the evidence quality is low or very low, or when personal preferences or costs are expected to impact the decision, and as such refer to decisions where consideration of personal preferences is essential for decision-making. |
| Generally not recommended | Denotes uncertainty over the balance of harms, such as when the evidence quality is low or very low, or when personal preferences or costs are expected to impact the decision, and as such refer to decisions where consideration of personal preferences is essential for decision-making |
| Consensus-based recommendation (CBR) | Recommendation formulated by the GDG in the absence of quality evidence, after a systematic review of the evidence was conducted and failed to identify sufficient admissible evidence on the clinical question. |
| Practice point (PP) | Used to address important aspects of care that are not addressed by relevant source guidelines, practical considerations or where evidence is lacking. These are developed by consensus of the GDG. |
CBR = consensus-based recommendation; EBR = evidence-based recommendation; PP = practice point.
While the GRADE Working Group advises that the strength of recommendations should be assessed using two categories (Strong or Conditional), for improved implementation across settings the recommended terminology was slightly modified for the ANZ Concussion Guidelines. The terms ‘Recommended’ or ‘Not Recommended’ were used to denote strong recommendations, and ‘Conditionally recommended’ or ‘Generally not recommended’ to denote conditional recommendations.
Consensus-based recommendations were made where an evidence review was conducted by the source guideline developers and no evidence-based recommendation/s could be made, but the committee was able to reach consensus.
Practice points were used to address important aspects of care that were not addressed by relevant source guidelines, to describe practical considerations or where evidence was lacking.
A set of decision-rules were developed to harmonise mapping the grade of source guideline recommendations to the ANZ Concussion Guidelines grading conventions.
Where the source recommendation was adapted but the intention of the recommendation did not change, the recommendation was mapped to the ANZ Concussion Guidelines grading as per the decision rules. If there were concerns regarding the directness of the source recommendation, or transparency in the decision-making process by the source guideline developers, then the GDG may have chosen to map the recommendation to a lower strength than the source recommendation. Downgrading may have also occurred when a source recommendation was adapted, with the adaptation being outside the evidence-based used to formulate the source recommendation. The rationale for any downgrading of the strength of a recommendation is documented in the rationale report to ensure transparency in decision making.
Where different elements of an ANZ Concussion Guidelines recommendation were derived from different source recommendations, the different grading is transparently reported alongside the recommendation.
There were instances where there were no source recommendations to address important topics in the guideline, or the evidence was insufficient (e.g. CTE). To address these topics, the GDG combined consensus deliberations followed by a formal Delphi voting process to achieve consensus.
De Novo Evidence Review Approach
De novo evidence reviews were undertaken to address critical areas within the agreed scope of the ANZ Concussion Guidelines that were not addressed in source guidelines.
Clinical Questions
The research questions addressed through de novo evidence review were:
- What specific considerations should be given to the diagnosis, assessment and management of mTBI in Aboriginal and Torres Strait Islander peoples?
- What specific considerations should be given to the diagnosis, assessment and management of mTBI in Māori people and Pasifika peoples of Aotearoa New Zealand?
Details on De-Novo Evidence Review Approach
Eligibility Criteria
The systematic evidence review aimed to identify any research that addressed the diagnosis, assessment, or management of mTBI in Aboriginal and/or Torres Strait Islander peoples, or Māori and/or Pasifika peoples of Aotearoa New Zealand). The study eligibility criteria were developed using PICo (Population; activity, process or event of Interest; Context) criteria, and were intentionally broad to capture all relevant evidence. Evidence was included if it met the PICo criteria outlined in Table 7 or Table 8.
| Question 1 | What specific considerations should be given to the diagnosis, assessment and management of mTBI in Aboriginal and/or Torres Strait Islander peoples? | |
| Population | – Aboriginal and/or Torres Strait Islander people of any age, with suspected or confirmed mTBI due to any cause – Health professionals working with Aboriginal and/or Torres Strait Islander peoples with suspected or confirmed mTBI |
|
| Interest | The diagnosis, assessment and management of confirmed or suspected mTBI | |
| Context | Australian healthcare settings | |
| Study types | – Peer-reviewed publications (quantitative and qualitative) of clinical studies – Systematic reviewsof the above – Targeted grey literature |
Exclusions: – Conference abstracts/presentations – Theses – Letters or commentaries – Editorials – Book chapters |
| Search date restrictions | December 2012 onwards | |
| Bibliographic databases | – MEDLINE – Embase |
|
| Other limits | English language only | |
Abbreviations: mTBI = mild traumatic brain injury.
| Question 2 | What specific considerations should be given to the diagnosis, assessment and management of mTBI in Māori people and/or Pasifika peoples of Aotearoa (New Zealand)? | |
| Population | Māori people and/or Pasifika peoples of Aotearoa (New Zealand) of any age, with suspected or confirmed mTBI due to any causeHealth professionals working with Māori people and/or Pasifika peoples of Aotearoa (New Zealand) with suspected or confirmed mTBI | |
| Interest | The diagnosis, assessment and management of confirmed or suspected mTBI | |
| Context | Aotearoa New Zealand healthcare settings | |
| Study types | – Peer-reviewed publications (quantitative and qualitative) of clinical studies – Systematic reviews of the above – Targeted grey literature |
Exclusions: – Conference abstracts/presentations – Theses – Letters or commentaries – Editorials – Book chapters |
| Search date restrictions | December 2012 onwards | |
| Bibliographic databases | – MEDLINE – Embase |
|
| Other limits | English language only | |
Abbreviations: mTBI = mild traumatic brain injury.
Literature Search
A literature search was undertaken on 22 November 2022 in MEDLINE and Embase (using EMBASE.com) to identify peer-reviewed publications meeting the pre-defined evidence selection criteria. Evidence published since the 01 January 2012 was included.
Peer-reviewed publications (including systematic reviews) of clinical studies (quantitative and qualitative) were eligible; conference abstracts/presentations, theses, letters, commentaries, editorials, and book chapters were excluded. Searches were restricted to English language articles.
In addition to the formal literature search, references identified by members of the GDG, or grey literature searching were also assessed against the evidence selection criteria to determine eligibility.
Deduplication of records and determination of study eligibility was performed in EndNote.
Study Eligibility
Evidence selection criteria were applied in two stages: first to the titles and abstracts, and then to the full publications of potentially included studies. Records were excluded for the following reasons:
- Wrong population
- Wrong activity, process, or event of interest
- Wrong context/setting
- Wrong publication type
- Wrong study type.
Studies that included a mixed population of participants with stroke and traumatic brain injury (TBI) and/or participants across the spectrum of TBI severity (mild, moderate, severe) were excluded unless the results were presented separately for participants with mTBI, or at least 75% of participants were categorised as having mTBI.
Assessment of the Evidence
Formal assessment of the evidence was not undertaken as no evidence was identified that met the eligibility criteria. A technical report was provided to the GDG outlining the methodology and results of the de novo evidence reviews. The report provided a narrative summary of key literature that was identified, including the reason for the literature not meeting the PICo criteria.
Abbreviations and Glossary
ADHD: attention deficit hyperactivity disorder
ANZ: Australia Aotearoa New Zealand
AUS: Australia
BPPV: Benign paroxysmal positional vertigo
CSF: cerebrospinal fluid
CT: computed tomography
CTE: Chronic Traumatic Encephalopathy
ENT: Ear nose throat (doctor)
GCS: Glasgow coma scale
GDG: guideline development group
GFAP: glial fibrillary acidic protein
GP: general practitioner
MRI: magnetic resonance imaging
mTBI: mild traumatic brain injury
NZ: New Zealand
ONF: Ontario Neurotrauma Foundation
PECARN: Pediatric Emergency Care Applied Research Network
PREDICT: Paediatric Research in Emergency Departments International Collaborative
S100B: S100 calcium binding protein B
SCAT: sport concussion assessment tool
SPECT: single photon emission computed tomography
TBI: Traumatic brain injury
TES: Traumatic encephalopathy syndrome
VOMS: Vestibular Ocular-Motor Screening
WA: Western Australia
Abusive head trauma
A head or neck injury from physical abuse. This includes trauma from transmitted force.
Anticoagulation
In the context of these guidelines, this refers to both anticoagulants and antiplatelet therapy.
Appropriately qualified health professional
Depending on the context, this includes medical and/or allied health professionals.
Clinically important traumatic brain injury
This is a traumatic brain injury where any of the following has occurred: death from traumatic brain injury, neurosurgical intervention for traumatic brain injury, intubation for more than 24 hours for traumatic brain injury, or hospital admission of 2 nights or more associated with traumatic brain injury on CT.
Concussion
A biomechanical alteration of brain function which includes one or more somatic, cognitive, or emotional symptoms, behavioural change, sleep disturbance, and/or transient physical signs (i.e. loss of consciousness, amnesia). Concussion is a form of mild traumatic brain injury.
Elderly adult/Older people
A person aged more than 65 years or more than 50 years in an Aboriginal and/or Torres Strait Islander person.
Exercise
A form of physical activity that is planned, structured, and repetitive and aims to improve physical fitness.
Interdisciplinary Concussion Team
A team of health professionals from different disciplines working together to treat and manage a patient. The team does not need to be co-located but should be experienced in managing people with concussion and typically consists of three or more of the following disciplines: medical doctor (e.g. rehabilitation specialist, neurologist, paediatrician, sport medicine doctor), physiotherapist, vestibular physiotherapist, paediatric physiotherapist, occupation therapist, nurse specialist, psychologist and/or neuropsychologist.
Mild traumatic brain injury
A traumatically induced alteration of brain function where loss of consciousness, if present, is less than 30 minutes, the length of post-traumatic amnesia is less than 24 hours, and the Glasgow Coma Score is between 13 and 15.
Persisting symptoms
Symptoms that have persisted for more than 1 month following mTBI/concussion.
Physical activity
Any bodily movement produced by skeletal muscles that requires energy expenditure.
Sport
A human activity involving physical exertion and skill as the primary focus of the activity, with elements of competition or social participation.
Structured Observation
Observation of a person in an outpatient, inpatient or emergency department setting, performed by a qualified medical doctor or nursing staff. This would take the form of repeated clinical assessments over a period of 4-6 hours.