Medical advances have resulted in increasing numbers of children surviving a brain injury. Acquired brain injury (ABI) is a broad term which includes injuries related to illness or medical conditions (e.g. meningitis, stroke, brain tumours, hypoxia) in addition to those caused by trauma (e.g. road traffic accidents, falls, assaults). ABI is defined as any injury to the brain which has occurred following birth (Teasdale 2007). While the aetiology of the injury may vary, the outcomes for children are dependent on a host of factors such as severity of injury (Barker-Collo 2007), injury site (Bates 2001), pre-injury status (McKinlay 2010), age (Corkin 1989), socioeconomic status (SES) (Yeates 2004) and family (Taylor 2001). Whilst data are available on the prevalence of traumatic brain injury (TBI) (Hawley 2003; Parslow 2005; McKinlay 2008; Rushworth 2008), no such reliable figures exist for the broader population of children with ABI. However, both groups face a similar range of deficits that can severely limit their ability to participate in their lives and reduce overall quality of life.
Description of the condition
Following brain injury, the child is at increased risk of significant functional difficulties in areas such as attention, memory, planning, affect and coordination. A large proportion of children will also experience fatigue, which impacts on their ability to focus on, and carry out, tasks (Hooper 2004). This also has the effect of reducing the amount of cognitive resources available for processes such as information processing, attention and memory. Tasks which may once have been accomplished with ease now require increased levels of mental effort, which in turn leads to fatigue and results in the child feeling frustrated.
These deficits may lead to children falling behind in their school work (Ewing-Cobbs 2004; Hawley 2004), having reduced social participation (Anderson 2013; Bedell 2004), and experiencing social difficulties (e.g. bullying) (Backhouse 1999; Boylan 2009). Research suggests that children who have poor peer interactions are at increased risk of dropping out of education and engaging in criminality (Parker 1993). Thus, the lack of a supportive peer network may result in childhood survivors of brain injury missing out on education, which has clear implications for their future career prospects. Children and young people who experience difficulties with impulsivity and control following injury may also be more likely to engage in behaviours which bring them into contact with the criminal justice system. A recent study has demonstrated a high prevalence (65% of 186 participants) of young male offenders who self-reported at least one incidence of TBI, with multiple injuries associated with increasingly violent crimes (Williams 2010).
There are no consistent indices of severity across the spectrum of ABI, however for TBI severity measures are well established. Such injury is initially classified as being either mild, moderate or severe, and can be described in terms of the duration of post-traumatic amnesia (PTA) (Marosszeky 1997), loss of consciousness (LOC) (WHO 2008), or the widely used Glasgow Coma Scale (GCS) (Teasdale 1974). Children with PTA of less than one hour or LOC of less than 30 minutes are described as having a mild injury. Those between 1 and 24 hours PTA, or less than 6 hours LOC, are classified as moderate, while those 1 to 7 days PTA, and more than 6 hours LOC, are described as severe. Higher scores on the GCS indicate less severe injury (13 to 15 = Mild, 9 to 12 = Moderate, 3 to 8 = Severe). However, only the severe injury category has consistently been shown to have predictive power in relation to severity and persistence of short- and long-term outcomes (Klonoff 1993).
Rehabilitation of cognitive functioning is traditionally undertaken by a team of healthcare professionals. Clinical psychologists, speech and language therapists, occupational therapists, and psychiatrists may work with the patient. A variety of interventions may be applied by these professionals depending on the individual deficits of the child. Approaches such as the cognitive remediation programme (CRP) (Butler 2002) or the ‘Pay Attention’ (Thomson 2001) technique may be used to address deficits in attention or to teach behavioural regulation, which among others, are associated with executive functioning. Compensatory approaches for memory deficits have included pencil and paper diaries (Ho 2011), calendars, wall charts and notebooks (Evans 2003).
Description of the intervention
Technological aids, used in the rehabilitation of child and adolescent survivors of brain injury, come in a variety of forms. These may include electronic organisers, pagers, mobile phones, web-based scheduling and voice recorders. For example, the NeuroPage system utilised a paging service which sent a reminder or cue to an individual at pre-determined points (Wilson 1997). This system removed the need for the individual to remember to use the device, did not require complicated instructions on its use, and was relatively discrete (Wilson 1997). Recently, the use of smart phones has introduced the possibility of creating Apps (or ‘applications’) that can target specific cognitive deficits, whilst being discreetly contained within an attractive and desirable piece of technology (Svoboda 2009; Russell 2011). This is an important consideration for adolescents, who may fear social ridicule if asked to use a conspicuous device that may draw attention to their deficits. An example is the ‘It’s Done’ App (It's Done! 2012), which enables individuals to ‘check-off’ tasks as they are accomplished, and review these to ensure they have been achieved. The App can also send a text message or email to a significant other to inform them that the individual has completed the specified task (e.g. take medication).
The distinction between strategies intended to restore cognitive functioning and those intended to compensate for a deficit are unclear, as both utilise learning and repetition (Sohlberg 2001). However, external aids used in a compensatory fashion are generally viewed as a means to reduce the cognitive load and enable the successful completion of a task. Those intended to restore functioning rely on the restructuring of neural pathways which are dependent on the site and extent of injury. This review will focus on aids which are used as a compensatory approach.
How the intervention might work
Technological aids are viewed as a method to compensate for, rather than restore, reduced memory or executive functions. They act as a means to reduce the load on compromised processes in order to allow a person to successfully conduct a task. It has been suggested that compensatory strategies: should be purposeful and goal-directed, used to compensate for a particular breakdown; should rely on pre-existing behaviours that are adapted to compensate for a deficit; should be employed flexibly to fit a given situation; are unique to the individual; and are spontaneous rather than trained (Simmons-Mackie 1997). Clinicians should attempt to build upon existing strategies, tailor these to the individual’s needs, and provide systematic direct training (Sohlberg 2001).
There are two possible systems which may be employed in teaching the use of a technological aid. These are the non-declarative learning system, and prospective memory (Sohlberg 2001). For many survivors of brain injury, functionality of the declarative system is impaired, and learning is supported by the non-declarative system, which requires greater time and effort. The declarative learning system represents the knowledge we possess, and includes the conscious information about our lives. It is said to be divided into semantic (i.e. facts and meaning) and episodic (i.e. autobiographical events) memory systems (Tulving 1972). Damage to episodic memory may leave semantic systems intact but would reduce functionality and compromise declarative learning (Tulving 1983). The non-declarative learning system, which allows us to learn systems and procedures without conscious awareness, is often preserved following brain injury (Sohlberg 2001). This system functions by the gradual acquisition of learning over time (Poldrack 2001) and may therefore be used by clinicians to train childhood survivors of brain injury to use external aids.
Prospective memory processes allow us to plan future behaviours and act on these at the appropriate time (Baddeley 2007). In order to accomplish such a task the individual must plan the behaviour, keep the steps required to accomplish this in mind, recall the task, and take action (Sohlberg 2001). Prospective memory processing is said to consist of five components: meta-knowledge, planning, monitoring, content recall and output monitoring (Dobbs 1996). A technological aid could be used to hold information concerning an intended action, for example, a reminder to take a particular medication for high blood pressure (i.e. meta-knowledge). The aid could then describe the steps necessary to obtain the medication (e.g. go to the pharmacy in two days to renew the prescription - planning), alert the individual that the prescription needs to be refilled (i.e. monitoring) and remind them that the medication is important for controlling blood pressure (i.e. content recall). The aid could also be used to check whether an action had been taken (e.g. the prescription had been renewed - output monitoring).
Why it is important to do this review
The long-term nature of paediatric brain injury means that it places a significant burden on the child, family and society (Linden 2010). The use of technological aids as interventions offers an opportunity to continue treatment in the post-acute phase, or even into adulthood, whilst potentially alleviating some of this burden. Effective and timely interventions which employ readily available technology could improve the lives of these children and reduce healthcare costs. However, the evidence for the effectiveness of such interventions has yet to be systematically reviewed.
To assess the effects of technology-based interventions compared to placebo intervention, no treatment or other types of intervention, on the executive functioning and memory of children and adolescents with acquired brain injury (ABI).
Criteria for considering studies for this review
Types of studies
We will include randomised controlled trials (RCTs). We will not include cross-over, or cluster randomised trials.
Types of participants
We will include children and adolescents (aged 0 to 19 years) who have sustained an acquired brain injury (ABI).
Types of interventions
We will include studies that evaluate the use of a technology-based intervention on the cognitive functioning of children and adolescents. Here we define ‘technology’ as the incorporation of a device which can store, retrieve or transmit information. The device may be used under the guidance of a third party (e.g. healthcare practitioner) or independently. Cognitive functioning here is defined as higher order processes such as memory and executive functions (i.e. planning, problem solving, the ability to inhibit or initiate actions). Many of these processes are interrelated and share similar neuroanatomy, but they are theoretically distinct, and deficits in one area may not result in problems with another.
The comparisons will be:
- intervention versus placebo,
- intervention versus no treatment,
- intervention versus other types of intervention.
Types of outcome measures
Cognitive processes are those which enable us to make decisions about our lives. Cognitive processes include memory, attention, perception, information processing and executive functioning. Those processes most likely targeted for intervention using a technological aid include memory and executive functioning. Memory has been defined as the process of encoding, storing and retrieving information. It enables us to hold information for short periods of time, but also to recall past events, places and people (Banich 2004). Executive functioning refers to a number of processes which include the ability to control impulses, plan for the future, evaluate performance, organise our personal environment and regulate behaviour (Stuss 1986).
Due to the compensatory nature of technological aids it would not be expected that changes in cognitive functioning would be apparent. This is because the aid takes over from damaged processes to support day-to-day functioning. As such, the most appropriate means to determine the success or failure of an aid would be the use of ecologically-valid tasks which assessed improvements in functioning, or increased usage of the aid itself.
The primary outcomes are 1) executive functioning and 2) memory, measured using a test. Tests usually require initiating actions to complete a task, organising and planning the necessary steps, and monitoring the success or failure of the outcome. Participants typically receive a numerical score which is dependent on the type (verbal prompts or physical assistance) and number of cues needed to complete the task.
a) Some of the most common tests are:
- The 'Children's Kitchen Task Assessment' (Rocke 2008)
- The 'School Assessment of Motor and Process Skills' (Fisher 1997)
- The 'Chocolate Cake Task' (Chevignard 2008)
- The Behavior Rating Inventory for Executive Functions (Gioia 2000)
- The Rivermead Behavioural Memory Test for Children (Aldrich 1991)
- Any other tools measuring executive functioning and memory
b) We will record the type of errors made by participants while completing the assessment tasks (e.g. control errors, omissions, purposeless actions), and
c) the duration of time required to complete the task.
The Children’s Kitchen Task Assessment (Rocke 2008) and the Chocolate Cake Task (Chevignard 2008) have been shown to respectively possess discriminant and concurrent validity, while the School Assessment of Motor and Process Skills (School AMPS) has demonstrable scale and person response validity (Atchison 1998).
- Use of the assigned technological aid
- Quality of life reported by the participant
- Psychological functioning, including mood, self-esteem, anxiety and self-efficacy
- Social functioning
- Academic achievement
- Any other benefits or harms identified by the studies. This information will be described through a narrative summary.
Outcomes will be classified and analysed by the time at which measurement was taken following initiation of the intervention. Time periods will be grouped as follows: short-term (one month), medium-term (over one month to six months), and long-term (over six months).
Search methods for identification of studies
In order to reduce publication and retrieval bias we will not restrict our search by language, date or publication status.
The Cochrane Injuries Review Group's Trials Search Co-ordinator will search the following:
- Cochrane Injuries Group Specialised Register (present version);
- Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) (latest issue);
- Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R) (1946 to present);
- Embase Classic + Embase (OvidSP) (1947 to present);
- PubMed (limited to references not indexed in MEDLINE) (to present);
- CINAHL Plus (1937 to present);
- PsycINFO (OvidSP) (1806 to most recent date available);
- ISI Web of Science: Science Citation Index Expanded (SCI EXPANDED) (1970 to present);
- ISI Web of Science: Social Sciences Citation Index (SSCI) (1970 to present);
- ISI Web of Science: Conference Proceedings Citation Index - Science (CPCI-S) (1990 to present);
- ISI Web of Science: Conference Proceedings Citation Index - Social Science & Humanities (CPCI-SSH) (1990 to present);
- ClinicalTrials.gov (www.clinicaltrials.gov);
- Current Controlled Trials (http://www.controlled-trials.com/);
- WHO International clinical trials platform (http://apps.who.int/trialsearch/).
The authors will search the following sources:
- Theses search (e.g. EThOS, DART, NDLDT);
- National Institute for Health Research (UK) (www.portal.nihr.ac.uk);
- UK Clinical Research Network (www.public.ukcrn.org.uk);
The search strategy for MEDLINE (Appendix 1) will be adapted for use in other sources.
Searching other resources
To ensure we have included all relevant trials on the topic we will take the following steps:
- Conduct an Internet search for any mention of trials published or unpublished on the topic. This search will include conference proceedings, presentations and reports;
- Screen the reference lists of published trials; and
- Contact the authors of all included trials to enquire about other published, unpublished, and ongoing trials.
Data collection and analysis
Selection of studies
The titles and abstracts of articles, and other publications identified by the search strategy, will be reviewed by one author (ML) who will remove any that are clearly irrelevant. The resulting list will then be reviewed independently by two authors (ML and CH) to determine whether the abstracts selected meet the inclusion criteria. Articles selected based on abstract review will then be retrieved in full-text for a comprehensive review. In the event that an agreement is not reached following full-text review, a third author (BB) will determine the publication’s inclusion.
Data extraction and management
Working independently, two authors (ML and CH) will extract the requisite information from the trials by means of a standardised data extraction tool. The effectiveness of this tool will be determined by a pilot extraction with any problems or shortfalls requiring further refinement identified. When the tool is deemed valid, ML and CH will independently extract the data. In the case of disagreement a third author (BB) will be brought into the review. Where possible we will seek to document:
- Characteristics of the study design
- Type of intervention
- Duration, intensity and frequency of intervention
- Participant characteristics (e.g. gender, socio-economic status, age at injury, Glasgow Coma Score, injury severity, description of deficits, age at intervention)
- Sample size
- Outcome measures, as described below, and a description of the scale used, range of possible scores, and clinical or practical meaning of scores on the scale
- Effect of the intervention compared to placebo, no treatment or other types of intervention
Assessment of risk of bias in included studies
Two authors (ML and BB or CH) will independently assess each included study for risk of bias. Domains of potential bias (e.g. sequence generation, allocation concealment, blinding of participants and personnel) will be assessed through use of the ‘RCT risk of bias assessment tool’ included in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Each domain in the tool will be judged as 'low risk of bias', 'high risk of bias', or 'unclear risk of bias'.
Measures of treatment effect
We will use Review Manager software to analyse data. For continuous data we will calculate the mean difference (MD) for outcomes measured on the same scale, or the standardised mean difference (SMD) for outcomes measured on different scales, with 95% confidence intervals (CI), using the standard error of the mean. If continuous data are skewed, the outcome results will instead be described narratively. The treatment effect for dichotomous data will be described using the risk ratio (RR) with 95% CI.
Unit of analysis issues
Cross-over and cluster trials will not be included in this review, hence unit of analysis issues from these designs will not be an issue.
A child is the unit of analysis. In the case of studies which use multiple follow-up points, we will use short-, medium- and long-term outcome measures with the studies being grouped according to these periods, hence most (or all) of the multiple measurements may be used.
Dealing with missing data
If there are missing data, we will contact the study authors with the hope of obtaining any additional information. In the discussion of results, consideration will be given to studies where data are missing.
If studies have a completion rate of less than 80%, reasons will be explored for a potential attrition bias effect.
Assessment of heterogeneity
We will assess clinical heterogeneity by only combining studies whose participants are sufficiently similar, such that combining data across studies leads to a meaningful result.
We will consider statistical heterogeneity between studies through visual inspection of forest plots and use of the I
Assessment of reporting biases
If a sufficient number of studies is identified (n > 10), we will investigate reporting biases through use of a funnel plot.
Data will be analysed and reported in accordance with chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 (Deeks 2011). If two or more studies are available for an outcome, their results will be combined in a meta-analysis using Review Manager on an intention-to-treat basis. If there is very high heterogeneity (i.e. > 90%) we will report results narratively. If there are data from only one study for an outcome, the results will be reported narratively. For continuous data we will use the inverse variance method, while the Mantel–Haenszel method will be employed for dichotomous data. If there are a small number of events, or no events, we will use the Peto's odds ratio.
Subgroup analysis and investigation of heterogeneity
We plan to conduct the following subgroup analyses to assess the impact of the intervention on cognitive processes, and explore possible sources of heterogeneity:
- Age of participants: children (≤10 years of age) and adolescents (10 to 19 years of age) (WHO 2009).
- Severity of injury, grouped as follows:
Any other scale used to classify severity of injury will be classified in a similar way to the groups listed above.
Sensitivity analyses will be performed according to:
- allocation concealment (low risk of bias versus unclear or high risk of bias)
- blinding of the outcome assessor (low risk of bias versus unclear or high risk of bias).
Appendix 1. Search strategy
Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R)
1. exp Craniocerebral Trauma/
2. exp Brain Edema/
3. exp Glasgow Coma Scale/
4. exp Glasgow Outcome Scale/
5. exp Unconsciousness/
6. exp Cerebrovascular Trauma/
7. exp Pneumocephalus/
8. exp Epilepsy, post traumatic/
9. ((head or crani* or cerebr* or capitis or brain* or forebrain* or skull* or hemispher* or intra?cran* or inter?cran* or intracran* or intercran*) adj3 (injur* or trauma* or damag* or lesion* or wound* or destruction* or oedema* or edema* or contusion* or concus* or fracture*)).ab,ti.
10. ((head or crani* or cerebr* or brain* or intra?cran* or inter?cran* or intracran* or intercran*) adj3 (haematoma* or hematoma* or haemorrhag* or hemorrhag* or bleed* or pressur*)).ti,ab.
11. (Glasgow adj (coma or outcome) adj (scale* or score*)).ab,ti.
12. "rancho los amigos scale".ti,ab.
13. ("diffuse axonal injury" or "diffuse axonal injuries").ti,ab.
14. ((brain or cerebral or intracranial) adj3 (oedema or edema or swell*)).ab,ti.
15. ((unconscious* or coma* or concuss* or 'persistent vegetative state') adj3 (injur* or trauma* or damag* or wound* or fracture* or contusion* or haematoma* or hematoma* or haemorrhag* or hemorrhag* or pressur*)).ti,ab.
16. exp Cerebral Hemorrhage/
17. exp coma/
18. (injur* or trauma* or damag* or wound* or fractur* or contusion* or haematoma* or hematoma* or haemorrhag* or hemorrhag* or pressur* or lesion* or destruction* or oedema* or edema* or contusion* or concus*).ti,ab.
19. 17 and 18
20. Brain Injuries/
21. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 19 or 20
22. Memory Disorders/
24. cognition/ or executive function/
25. executive dysfunction.mp.
26. reduced memory.mp.
27. Cognition Disorders/
28. Motor Skills/
29. working memory.mp.
32. ((reduced or working) adj1 memory).ab,ti.
33. ((executive function* or cognit* or attention or memory) adj3 (disorder* or dysfunction or impaired or impairment or difficult* or problem* or disability)).ab,ti.
34. ((organiz* or plan* or manag* or "problem solving" or "decision making") adj3 (disorder* or dysfunction or impaired or impairment or difficult* or problem* or disability)).ab,ti.
35. 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34
36. 21 and 35
37. Rehabilitation/mt [Methods]
39. Reminder Systems/
40. Self-Help Devices/
42. Computers, Handheld/
43. (external adj3 (aid* or system*)).ab,ti.
44. cognitive aid.mp.
45. (ipad* or tablet* or iphone*).ab,ti.
46. personal data assistant*.mp.
48. ((technical or technological or technology) adj3 (aid* or assist*)).ab,ti.
49. ((technical or technological or technology) adj1 (app* or application*)).ab,ti.
50. ((memory or electronic or assitive) adj3 (organiser* or device*)).ab,ti.
52. voice recorder*.ab,ti.
53. ((answer* or "neuro?page" or paging) adj3 (system* or service* or device*)).ab,ti.
54. ((smart or cellular or mobile) adj1 (phone* or telephone*)).ab,ti.
55. 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 53 or 54
56. 36 and 55
58. randomized controlled trial.pt.
59. controlled clinical trial.pt.
61. clinical trials as topic.sh.
64. Comparative Study/
65. 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64
66. (animals not (humans and animals)).sh.
67. 65 not 66
68. 56 and 67
Contributions of authors
All authors contributed to drafting the protocol.
Declarations of interest
One author (Jonathan Evans) has published research which may be eligible for inclusion in this review. JE will not be involved in study selection or data extraction.
All other authors: None known.
Sources of support
- No sources of support supplied
- Research and Development Office Northern Ireland, and Health Research Board, Ireland.Fellowship awarded to Mark A Linden