Traumatic Brain Injury Clinical Guidelines

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Introduction

The momentum for evidence-based healthcare has been gaining ground rapidly, motivated by clinicians, and management concerned about quality, consistency and costs of healthcare intervention. The use of Clinical Guidelines, based on standardised best practice, have been shown to be capable of supporting improvements in quality and consistency in healthcare and is considered one of the main ways that evidence-based medicine can be implemented. Clinical Practice Guidelines was defined by Field and Lohr (1990) as "systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific circumstances".

According to Woolf et al (2012) Clinical Guidelines have become one of the foundation of efforts to improve healthcare and health care management. Methods of guideline development have progressed both in terms of process and necessary procedures and the context for guideline development has changed with the emergence of Guideline Clearinghouses and large scale guideline production organisations e.g National Institute for Health and Clinical Excellence.

Purpose

Clinical guidelines provide recommendations on how healthcare professionals should care for people with specific conditions. They can cover any aspect of a condition and may include recommendations about providing information and advice, prevention, diagnosis, treatment and longer-term management and are designed to support the decision-making processes in patient care. The content of a guideline is based on a systematic review of research literature and clinical evidence - the main source for evidence-based care.

"The aim of clinical guidelines is to improve quality of care by translating new research findings into practice. There is evidence that the following characteristics contribute to their use: inclusion of specific recommendations, sufficient supporting evidence, a clear structure and an attractive lay out. In the process of formulating recommendations, implicit norms of the target users should be taken into account. Guidelines should be developed within a structured and coordinated programme by a credible central organisation. To promote their implementation, guidelines could be used as a template for local protocols, clinical pathways and interprofessional agreements".

• To describe appropriate care based on the best available scientific evidence and broad consensus;
• To reduce inappropriate variation in practice;
• To provide a more rational basis for referral;
• To provide a focus for continuing professional education;
• To promote efficient use of resources;
• To act as focus for quality control, including audit;
• To highlight shortcomings of existing literature and suggest appropriate future research. 

Limitations and Controversy

Clinical Guidelines can have their limitations and there can be controversy surrounding some recommendations within some guidelines. Not every patient or situation fits neatly into a guideline. Guidelines to not always cover every eventuality and each patient's circumstance needs to be taken into consideration when a treatment is decided upon. Recommendations should be viewed as statements that inform the clinician, the patient and any other user, and not as rigid rules.

Research and resulting evidence-based recommendation in the acquired brain injury field impose great difficulties on best practice and clinical guideline development. According to “Rehabilitation following Brain Injury Guideline” the challenges for clinical guidelines for the management of traumatic brain injury include:

• the marked heterogeneity with respect to the patient group, the intervention and setting, and to the outcomes that are relevant at each stage of recovery
• the small numbers group, ethical considerations, due to many patients with traumatic brain injury lacking the mental capacity to give fully informed consent confounding the application of randomised controlled trial designs 
• the ethical problem with randomisation of patients to ‘no treatment’ or even ‘standard’ care since the expanding body of evidence of the effectiveness of multidisciplinary rehabilitation in other conditions, particularly stroke, become available
• the funding issues of long-term projects whilst length of time over which rehabilitation may have its effects (often months or years) is usually longer than any funded research.

Due to those limitations having a significant impact on the research design and quality, the guidelines also utilise significant degree of expert opinion and existing consensus-based documents. 

Level of Evidence	Type of Evidence	Grade of Recommendation
Ia	Meta-analysis of randomised controlled trials (RCTs)	A
Ib	At least one RCT	A
IIa	At least one well-designed controlled study, but without randomisation	B
IIb	At least one well-designed quasi-experimental design	B
III	At least one non-experimental descriptive study (eg. comparative, correlation or case study)	B
IV	Expert committee reports, opinions and/or experience of respected authorities	C

Table.1 Generally used classification of evidence and recommendations whilst developing clinical guideline 

Degrees of Recommendation
A	At least one meta-analysis, systematic review or clinical trail classified as 1++ and directly applicable to the target population of the guideline; or a volume of scientific evidence composed of studies classified as 1+ and with great consistency among them
B	A volume of scientific evidence composed of studies classified as 2++, directly applicable to the target population of the guideline and showing great consistency between them; or scientific evidence extrapolated from studies classified as 1++ or 1+
C	A volume of evidence composed of studies classified as 2+, directly applicable to the target population of the guideline and showing great consistency between them; or scientific evidence extrapolated from studies classified as 2++
D	Scientific evidence level 3 or 4 or scientific evidence extrapolated from studies classified as 2+
Good Clinical Practice
Recommended practice, based on clinical experience and consensus of the group of experts

Table. 2 Degrees of recommendation according to Scottish Intercollegiate Guidelines Network

Clinical guidelines are not always exhaustive form of evidence-based practice. Other sources like Cochrane Collaboration or evidence database like PEDro are recommended in sourcing clinically valuable assessment and treatment approaches and organisational principles, especially in such heterogeneous population like traumatic brain injury survivors. Therefore, synthesis of established guidelines’ knowledge with clinical findings about individual with traumatic brain injury and clinically reasoned judgment of treating therapist / clinician is the most effective approach to management of individual with traumatic brain injury. 

Traumatic Brain Injury Clinical Guidelines

While the evidence base for traumatic brain injury managament and rehabilitation is increasing, substantial gaps still remain with an ongoing need for more research to improve both service delivery and more importantly patient outcomes. Many of the Clinical Guidelines related to traumatic brain injury treatments are focused on medical management such as avoidance of secondary injury. Overall most guidelines during each phase of management recommend that all individuals with a traumatic brain injury should have access to specialised traumatic brain injury care.

Guidelines

Head Injury: Assessment and Early Management

This guideline contains recommendation of the assessment and early management of head injury in children, young people and adults and is for healthcare professions, people with brain injury and their families.  “It promotes effective clinical assessment so that people receive the right care for the severity of their head injury, including referral directly to specialist care if needed.” The guideline includes recommendations on:

• Pre-hospital assessment and advice, and immediate management at the scene
• Assessment in the emergency department
• Investigating clinically important brain injuries and injuries to the cervical spine
• Information and support for families and carers
• Transfer from hospital to a neuroscience unit
• Admission and observation
• Discharge and follow-up

The guideline demonstrates best practice in patient-centred care and key priorities for implementation in areas of transport to hospital, assessment in the emergency department, criteria for performing a CT Head Scan, investigating injuries to the cervical spine, discharge and follow-up.

Guidelines for the Management of Severe Traumatic Brain Injury (2016)

Type: International Brain Injury Guidelines by Brain Trauma Foundation, American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), AANS & CNS Joint Section of Neurotrauma and Critical Care.

The guideline contains set of evidence-based recommendations for acute medical and clinical care of adults with severe TBI to prevent complication and improve patients’ outcomes. It provides recommendations for treatment like hypothermia, decompressive craniectomy, use of anaesthetics or sedatives, but also prevention of medical complications like infections, seizures, deep vein thrombosis. The guideline informs local algorithms and care pathways development.  

Management of Concussion-mild Traumatic Brain Injury (2016)

Type: Clinical Guideline by Department of Veterans Affairs and Department of Defense

The guideline document supports the critical decision points in the Management of Concussion/mild Traumatic Brain Injury (mTBI) and provides comprehensive evidence based recommendations incorporating current information and practices for clinitians working with adults with mTBI and concusion. The guideline is intended to improve patient outcomes including symptoms and functioning, adherence to treatment, recovery, well-being, and quality of life. The recommnedations aim to minimize preventable complications and morbidity.

The guideline contains recommendations about diagnosis, assessent and treatment of symptoms inlduing headach, dizziness, balance problems, cognitive symptoms, fatigue, visual and hearing symptoms, sleep disturbance and pain.

Rehabilitation Following Acquired Brain Injury (2003)

Type: Guideline by British Society of Rehabilitation Medicine (BSRM) and supported by the Clinical Effectiveness and Evaluation Unit of the Royal College of Physicians (RCP).

The guideline has been developed by multidiciplinary and muliagency experts in volving BSRM, RCP, charities working with pople with acquired brain injury and individuals with ABI.  It provides robust framework for managemnt of adults with ABI and provides standards of care from post-acute long-term care aiming to reduce morbidity, facilitate function restoration and community reintegration. The guidline provides sets of recommendations addressing quality of life of patientients living with ABI but alos their relatives. 

With the “Head injury: assessment and early management” guideline the “Rehabilitation following acquired brain injury ” guideline provide comprehensive framework for ABI management from pre-hospital to long-term care at clinical care and service provision level. 

The guideline provides recommendations regarding:

• Principles and organisation of services
• Approaches to rehabilitation
• Carers and families
• Early discharge and transition to rehabilitation services
• Inpatient clinical care - preventing secondary complications in severe brain injury
• Rehabilitation setting and transition phases
• Rehabilitation interventions
• Continuing care and support
• The need for further research
• Algorithm for early discharge into the community and referral to rehabilitation

SIGN Guidance for Brain Injury Rehabilitation in Adults (2013)

Type: Guideline by Scottish Intercollegiate Guidelines Network (SIGN)

The guideline for healthcare professionals managing patients with brain injury across sectors (in primary, secondary, tertiary or independent health care or the voluntary sector) covering in detail thelonger-term rehabilitation of adults (16 years of age and over) with brain injury following the post-acute stage. The guideline provides evidence for cognitive, communicative, emotional, behavioural and physical rehabilitation interventions as well as patient outcomes in relation to optimal models and settings of care, the benefits of discharge planning and the applicability of telemedicine. The information provided is relevant to individuals with brain injury and their families.

Physical Rehabilitation and Management Recommendations include:

• Repetitive task-oriented activities are recommended for improving functional ability, such as sit-to-stand or fine motor control. Grade of recommendation B
• Casts, splints and passive stretching may be considered in cases where contracture and deformity are progressive. Grade of recommendation C
• Botulinum Neurotoxin Therapy (BoNT) may be considered to reduce tone and deformity in patients with focal spasticity. Grade of recommendation B
• Full assessment of bladder and bowel function should be undertaken over a period of days following admission. The physical, cognitive and emotional function of the patient should be considered and the multidisciplinary team should be involved to plan an individualised approach. [null Additional good practice recommendation]

Service Delivery Recommendations include:

• For optimal outcomes, higher intensity rehabilitation featuring early intervention should be delivered by specialist multidisciplinary teams. Grade of recommendation B
• Community rehabilitation services for patients with brain injuries should include a wide range of disciplines working within a coordinated interdisciplinary model/framework and direct access to generic services through patient pathways. Additional good practice recommendation

Clinical Practice Guideline for Rehabilitation of Adults Moderate to Severe Traumatic Brain Injury

Type: Guideline by the Québec Institut national d'excellence en santé et en services sociaux (INESSS) and the Ontario Neurotrauma Foundation (ONF)

The guidelines were developed by a collaborative effort of researchers, clinicians, and policymakers from Ontario and Quebec with focus on community based rehabilitation and end users’ needs “including providing prioritization of recommendations for implementation, implementation tools, indicators to measure uptake, system implications and background rationale and evidence supporting the recommendation”. 

The clinical practice guideline contains recommendations related to the components of the optimal TBI rehabilitation system as well as components of assessment and rehabilitation of the sequelae of brain injury like:

• the intensity / frequency of interventions
• Rehabilitation mechanisms
• Duration of interventions and mechanisms for promoting continuity of care
• Promoting reintegration and participation
• Brain injury education and awareness
• Capacity and consent
• Family
• Comprehensive assessment of the person with traumatic brain injury
• Medical and nursing management
• Motor function and control
• Sensory impairment
• Cognitive dysfunction and communication
• Fatigue and sleep disturbance
• Pain and headache
• Disorders of Consciousness
• Dysphagia and nutrition
• Psychosocial / adaptation issues
• Neurobehavior and mental health
• Substance misuse

Prolonged Disorders of Consciousness: National Clinical Guidelines (2015)

[null Type: Guideline] by Royal College of Physicians (RCP)

The National Clinical Guideline contributing to clinical and ethical standards of treating and looking after patients with disorder of consciousness (DoC) and prolonged disorder of consciousness (PDoC).

The guideline was developed by panel of experts and provides the information for clinicians, other healthcare professionals, service providers and commissioners what constitutes best practice and legal decisions making process tools. It helps decide where patients should be cared for, how to use the life-sustaining treatments appropriately, and provides principles of management at the end of life.

It contains the following sections:

• Defining Criteria and Terminology
• Assessment, Diagnosis and Monitoring
• Acute to Longer-Term Management
• Ethical and Medico-Legal Issues
• End-of-Life Issues
• Service Organisation and Commissioning

The guideline advocates strong role of families in care of patients with PDoC and emphasises their need for access to information, training and support.  ”Further systematic longitudinal data collection” and the development of a national register and dataset of cases with DoC and PDoC is championed.

Guidance on Clinically-Assisted Nutrition and Hydration (2018)

Type: Guideline by British Medical Association, Royal College of Physicians (RCP) and General Medical Council (GMC)

The Prolonged Disorders of Consciousness guideline is closely related Guidance on clinically-assisted nutrition and hydration guideline published in 2018 by Royal College of Physicians (RCP) and British Medical Association (BMA) and General Medical Council (GMC). This guidance covers decisions to start, re-start, continue, or stop CANH for adults in England and Wales who lack the capacity to make the decision for themselves. It includes information related to previously healthy patients sustaining sudden brain injury, but also those with complex comorbidities and neurodegenerative comorbidities.

Key topics covered in the guideline include:

• The Legal Context for decision-making
• Who is the decision-maker, and who must be consulted?
• Conscientious Objections
• Clinical Assessments
• Best Interests Assessments
• Second opinions
• Managing Disagreement and Uncertainty
• Record-Keeping
• Governance and Audit

Splinting for Prevention and Correction of Contractures in Adults with Neurological Dysfunction

Type: Practice Guideline by Royal College and Occupational Therapists (RCOT) and Association of Chartered Physiotherapists in Neurology (ACPIN) 

The guideline provides and evidence for clinical practice and decision-making process when providing splints for adults with neurological conditions, especially with TBI stroke and MS. It describes roles and responsibilities of health professionals in prevention and correction of contractures in patients who are at the risk of deformities. The guideline carefully weighs benefits and risks of splinting process in individuals with upper motor neuron syndrome. It demonstrates factors for caution and when splinting should not be advised.

The guideline recommends splinting to be considered “not in isolation but as one part of a comprehensive goal-directed rehabilitation or management programme” and demonstrates systematic key steps for consideration when splinting adults with contractures. It supports the clinical reasoning of patient selection, recommends agreeing action plan prior to splinting with MDT and patient and/or relatives and outcome measures for evaluation of the process. It does not give any practical tips with regards to manufacturing casts or splints. The online resource includes a Neurosplinting CPD session.

Spasticity in Adults: Management using Botulinum Toxin

Type: Guideline by Royal College of Physicians, British Society of Rehabilitation Medicine, The Chartered Society of Physiotherapy, Association of Chartered Physiotherapists in Neurology and the Royal College of Occupational Therapists

The guideline provides recommendations for treatment of spasticity with botulinum toxin (BoNT) in adults living with neurological conditions. It recommends the botulinum toxin treatment to be a part of a comprehensive goal-directed rehabilitation and management programme. The guideline highlight mainly upper and lower limb treatment, however some other use of botulinum toxin is mentioned like in neck or jaw muscles. It lines up common areas of intervention when using BoNT:

• Pain relief
• Reduction of involuntary movements (i.e.: associated reactions, spasms)
• Prevention of contractures and deformity
• Passive Function (making it easier to care for the affected limb)
• Active Function (using the affected limb)
• Mobility

The guidelines demonstrate an evidence for self-management, postural management, stretching, task practice, strength training, electrical stimulation and various pharmacological treatment in spasticity management before demonstrating the role of botulinum toxin in this process.

The guideline provides recommendations about prescribing, storing, administration as well as muscle selection, techniques of injection, evaluation of the treatment and post-injection management when treating neurological patients with BoNT. It also gives recommendations about service organisation.

Specialist Neuro-rehabilitation Services: Providing for Patients with Complex Rehabilitation Needs

Type: Service Standards by British Society of Rehabilitation Medicine (BSRM)

The two documents define a clear set of guidelines and targets, mapped on to the NSF-LTC, for the planning and delivery of rehabilitation services in the United Kingdom. The documents define specialist rehabilitation, different complexity levels in neurological conditions, patients’ groups categories and individual patient’s needs. 

The documents provide recommendations for neurorehabilitation services organization including staffing ration and funding streams to enhance the patients’ outcomes and functioning of clinical pathways and networks, i.e.: trauma, stroke, neuroscience.

References