Cognitive rehabilitation for occupational outcomes after

traumatic brain injury (Protocol)

K SK, Kumar SK, Macaden AS

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009, Issue 3
http://www.thecochranelibrary.com

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
APPENDICES . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.
.

1
1
1
2
2
5
5
6
7
7
7

[Intervention Protocol]

Cognitive rehabilitation for occupational outcomes after

traumatic brain injury
Suresh Kumar K1 , Samuel Kamalesh Kumar2 , Ashish S Macaden1
1

Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, India. 2 Department of Occupational
Therapy, Christian Medical College, Vellore, India
Contact address: Suresh Kumar K, Department of Physical Medicine and Rehabilitation, Christian Medical College, Christian Medical
College and Hospital, Ida Scudder Road, Vellore, Tamil Nadu, 632001, India. igemisun@gmail.com.

Editorial group: Cochrane Injuries Group.

Publication status and date: New, published in Issue 3, 2009.
Citation: K SK, Kumar SK, Macaden AS. Cognitive rehabilitation for occupational outcomes after traumatic brain injury. Cochrane
Database of Systematic Reviews 2009, Issue 3. Art. No.: CD007935. DOI: 10.1002/14651858.CD007935.
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
Primary objective
To determine the effects of cognitive rehabilitation for people with traumatic brain injury (TBI) in enabling survivors of TBI to
return to their occupation (occupations refers to all the things that people do in their everyday life, not just paid employment).
Secondary objectives
To evaluate the effectiveness and impact of cognitive rehabilitation interventions aimed at improving cognitive functions for
people with TBI.
To examine whether there is a differential effect for the remediating and the compensatory intervention strategies used.
To evaluate the effectiveness and impact of cognitive rehabilitation interventions aimed at improving quality of life of persons
with TBI.

BACKGROUND
Traumatic brain injury (TBI) results from an external force to
the brain causing transient or permanent neurological dysfunction
(Fary 2003). It is a relatively high-prevalence injury. The incidence
is highest in people in the prime of their lives i.e. between 16 to 60
(Chesnut 1999), coinciding with important events such as completing education, developing a career and establishing a family,

and thus at a time when they are more likely to have financial
problems. Much of the disability associated with TBI is hidden, as
survivors may have no physical evidence of their injury (Rosenthal
1990). Despite this, the consequences of TBI can severely and permanently change a persons life, resulting in family disruption, loss
of income and earning potential and considerable expense over a
lifetime (Fary 2003).

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Description of the condition

Why it is important to do this review

Traumatic brain injury is defined as damage to the brain resulting

from external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile (Maas
2008). Brain function is temporarily or permanently impaired and
structural damage may or may not be detectable (Parikh 2007).
TBI is usually classified based on severity into mild, moderate,
and severe categories (Saatman 2008). The Glasgow Coma Scale
(GCS), a universal system for classifying TBI severity, grades a
persons level of consciousness on a scale of 3 to 15 based on verbal,
motor, and eye-opening reactions to stimuli (Teasdale 1974). It is
generally agreed that a TBI with a GCS of 13 or above is mild, 912 is moderate, and 8 or below is severe (Valadka 2004). Permanent disability is thought to occur in 10% of mild injuries, 66% of
moderate injuries, and 100% of severe injuries (Frey 2003). Traumatic brain injury is a principal cause of death and disability in
young adults with consequences ranging from physical disabilities
to long-term cognitive, social and behavioural deficits. Individuals
who sustain brain injuries frequently have difficulties in arousal, attention, concentration, memory, problem solving, decision making, insight and other areas of cognition that impede their ability
to perform their occupation in everyday life. (Occupation refers
to all the things that people do with the use of time in their everyday life for a purpose, not just paid employment.) Alterations in
perception, motor control, balance, emotional functioning, social
interaction and control of behaviour are also common after brain
injury and are closely linked with cognitive issues (Bell 1998).

Cognitive rehabilitation is central to traumatic brain injury rehabilitation; however, there is still debate about what treatment
works best for which condition and for which patients. Therefore
we feel that it is appropriate and timely to explore the evidence
for cognitive rehabilitation not just to enhance cognitive function
but also to enable functional independence of an individual with
traumatic brain injury in everyday life under all contexts. This
review seeks to clarify the effectiveness of cognitive rehabilitation
for occupational outcomes after traumatic brain injury with special interest to return to occupations (school, work, home management activities), specific cognitive domains (attention, concentration, visuospatial, executive functions and metacognitive functions), community reintegration and quality of life.

To determine the effects of cognitive rehabilitation for

people with traumatic brain injury (TBI) in enabling survivors of
TBI to return to their occupation (occupations refers to all the
things that people do in their everyday life, not just paid
employment).

Description of the intervention

Secondary objectives

At its basic level, we regard cognitive rehabilitation as remediation or reduction of cognitive deficits following insult to the
brain. Cognitive rehabilitation refers to the therapeutic process
of increasing or improving an individuals capacity to process and
use information so as to allow increased functioning in everyday
life. This includes both methods to restore cognitive functions
and compensatory techniques (Sohlberg 1989). Cognitive rehabilitation applies to therapy methods that actually retrain or
alleviate problems caused by deficits in attention, visual processing, language, memory, reasoning/problem solving and executive
functions (Wilson 2002). Cognitive rehabilitation services are directed to achieve functional changes in an individual by reinforcing, strengthening or establishing previously learned patterns of
behavior and/or establishing new patterns of cognitive activity or
mechanisms to compensate for the impaired neurological systems
(Bergquist 1997). To enhance the independent everyday functioning of an individual with traumatic brain injury, cognitive rehabilitation must be considered in addressing all areas of occupational
functioning including mobility, self-care, social interaction, recreational pursuits, and productive activities such as school or work
and home management (Katz 2006).

To evaluate the effectiveness and impact of cognitive

rehabilitation interventions aimed at improving cognitive
functions for people with TBI.
To examine whether there is a differential effect for the
remediating and the compensatory intervention strategies used.
To evaluate the effectiveness and impact of cognitive
rehabilitation interventions aimed at improving quality of life of
persons with TBI.

OBJECTIVES

Primary objective

METHODS

Criteria for considering studies for this review

Types of studies
We will include all published and non-published randomised controlled trials.

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Types of participants

Electronic searches

We will consider trials where the participants have sustained a

clinically defined traumatic brain injury
of any severity and who are of working age (16 years and above),
irrespective of gender.

We will search the following electronic databases:

Cochrane Injuries Group Specialised Register (to latest
version);
Cochrane Depression Anxiety & Neurosis Group
Specialised Register (to latest version);
CENTRAL (The Cochrane Library, latest issue);
MEDLINE/PubMed (1950 to most recent date available);
EMBASE (1980 to most recent date available);
CINAHL (1982 to most recent date available);
PsycINFO (1806 to most recent date available);
ISI Web of Science: Science Citation Index Expanded (SCIEXPANDED) (1970 to most recent date available);
ISI Web of Science: Social Science Citation Index Expanded
(SCI-EXPANDED) (1970 to most recent date available);
ISI Web of Science: Conference Proceedings Citation
Index-Science (CPCI-S) (1990 to most recent date available);
ZETOC (to most recent date available);
www.clinicaltrials.gov;
Controlled Trials metaRegister (www.controlledtrials.com).

Types of interventions
1. Cognitive rehabilitation, a systematic, functionally
oriented service of therapeutic cognitive activities and an
understanding of persons brain behavioral deficits. Services are
directed to achieve functional changes by:
i) reinforcing, strengthening or establishing previously
learned patterns of behavior, or
ii) establishing new patterns of cognitive activity or
mechanism to compensate for impaired neurological systems
(Bergquist 1997).
2. Standard care that a person would receive if they are not
included in the research trial, with or without a placebo
cognitive rehabilitation. Placebo cognitive rehabilitation could
be some interaction that may provide similar contact between
patient and care giver to that encountered within the
experimental procedure outlined above, but that includes no
elements of cognitive rehabilitation.
3. Other interventions which will include any other
intervention, which could be biological, psychological or social,
such as medications, family therapy, psychological education.
We will not include studies combining cognitive rehabilitation
with other types of treatment in this review.

We will base the electronic database searches on the MEDLINE

strategy listed in Appendix 1 which will be adapted, as appropriate,
for other databases.

Searching other resources

Primary outcome

We will conduct an Internet search for relevant information. We

will also search the Internet for relevant conference proceedings
and presentation abstracts. We will seek further potential published and unpublished studies by checking references of relevant
papers and literature reviews and through communication with
trial authors. We will contact experts in the field for additional
published, unpublished and ongoing trials.

Occupational outcomes (occupations refers to all the things

that people do in their everyday life, not just paid employment)
in terms of schooling, work and home management tasks).

Data collection and analysis

Types of outcome measures

Secondary outcomes

Specific cognitive domain (memory, attention, speed of

processing, etc.).
Quality of life.
We will categorize outcomes into short term (less than three
months), medium term (3-12 months) and long term (more than
one year).

The authors will independently review the titles, abstracts, and

descriptor terms of all articles identified in the electronic searches
and will discard irrelevant articles. The authors will then independently apply the inclusion criteria to the full text version of each
citation. Where disagreement occurs, a third reviewer will contribute to the discussion until there is consensus. Reviewers will
have access to the journal name, the authors and their affiliated
institution for each publication, as hiding this information has
uncertain benefit in protecting against bias (Berlin 1997).

Selection of studies

Search methods for identification of studies

We will not restrict the searches by language or publication status.

Review authors will independently inspect the abstract of each

reference identified by the search to see if the study is likely to

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

be relevant. If it is unclear from an abstract whether a study is a

randomized trial, we will retrieve the full text of the study report
for further inspection. We will resolve disputes about the relevance
of potentially eligible study reports to the review by discussion.
Data extraction and management
Both the reviewers will independently extract the data from the
included trials. We will discuss any disagreement, will document
the decision, and, where necessary, contact the first authors of
the study for clarification. We will provide reasons for excluding
papers in the table Characteristics of excluded studies.
Assessment of risk of bias in included studies
We will assess randomized controlled trials (RCTs) using the risk
of bias assessment tool in section 8.5 of the Cochrane Handbook for
Systematic Reviews of Interventions (Higgins 2008). We will assess
specific sources, including: sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, incomplete outcome data, selective outcome reporting, and
other identified concerns about sources of bias such as baseline
imbalance and protection against contamination (Lundh 2008).
Review authors judgments regarding risk of bias will be either
Yes (low risk of bias), No (high risk of bias), or Unclear (if
insufficient information is available to make a judgment).
Assessment of heterogeneity
We will assess heterogeneity in the results of the trials by inspection
of graphical presentations and by the I2 and Chi2 statistic. We
will evaluate four possible reasons for heterogeneity for each trial:
(i) difference in the quality of the trial; (ii) the different types of
cognitive rehabilitation used; (iii) whether monetary incentives
were used; and (iv) the baseline levels of symptoms and cognitive
functioning of participants. Looking at separate subgroups of trials
will assess these issues.
Assessment of reporting biases
If sufficient trials are identified (more than five) we will enter data
from all selected trials into a funnel graph (trial effect versus trial
size) in an attempt to investigate the likelihood of overt publication
bias.
Data synthesis

Intention to treat analysis

Unless a study clearly reports the reasons for leaving the study
early, we will assume that participants who dropped out had no
change in level of cognitive function. When insufficient data were
provided to identify the original group size (prior to leaving the
study), we will contact the first authors . We will use the numbers
of patients who completed each study to test the sensitivity of the
results, by comparing trials that used intention-to-treat analysis
with those that did not.

Dichotomous outcomes

We will analyze dichotomous outcomes by calculating odds ratios (OR) for each trial with the uncertainty in each result being
expressed using 95% confidence intervals (CI). We will combine
the odds ratios from the different trials using the Mantel-Haenszel method of meta-analysis. When overall results are significant,
we will determine the number needed to treat (NNT) or number
needed to harm (NNH).

Continuous data

For continuous outcomes we will estimate a mean difference (MD)

between groups.

Normal distribution

Data on continuous outcomes are frequently skewed, the mean

not being the centre of the distribution. The statistics for metaanalysis are thought to be able to cope with some skew, but were
formulated for parametric data. To avoid this potential pitfall, we
will apply the following standards to all data before inclusion:
(i) we will report standard deviations and means or obtain them
from authors; and (ii) for data with finite limits, such as endpoint
scale data, the standard deviation (SD), when multiplied by two,
will be less than the mean. Otherwise the mean is unlikely to be
an appropriate measure of the center of the distribution (Altman
1996).
Where both change and endpoint data are available for the same
outcome category, we will present only endpoint data. We acknowledge that by doing this much of the published change data
may be excluded, but argue that endpoint data is more clinically
relevant and that if change data were to be presented along with
endpoint data it would be given undeserved, equal, prominence.
We will contact authors of studies reporting only change data for
endpoint figures.

Incomplete data

If, for a given outcome, more than 50% of participants were not
accounted for, we will not present the results, as we consider such
data impossible to interpret.

Scale data

A wide range of rating scales are available to measure outcomes

in brain injury trials. These scales vary in quality and many are

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

poorly validated. Before publication of an instrument, most scientific journals insist that both reliability and validity be demonstrated to the satisfaction of referees. We decided, as a minimum
standard, to exclude data from unpublished rating scales. In addition, the rating scale should have been either: (i) a self report; or
(ii) completed by an independent rater.
Continuous data may be presented from different scales, rating
the same outcome. Where possible, we will attempt to summate
results for similar scales using MD. If this is not possible, we

will synthesize data using the standardized mean difference. We

acknowledge that interpreting the clinical importance of changes
in SMD is more difficult than for MD but hope that we might
observe the direction of effect for pooled results with the former,
if scales used are dissimilar.
Where possible, we will enter data in such a way that the area to
the left of the line of no effect indicates a favorable outcome for
cognitive rehabilitation.

REFERENCES

Additional references
Altman 1996
Altman DG, Bland JM. Detecting skewness from summary
information. BMJ 1996;313:1200.
Bell 1998
Bell KR, Sandell ME. Brain injury rehabilitation. Post
acute rehabilitation and community integration. Archives of
Physical Medicine and Rehabilitation 1998;79:S215.
Bergquist 1997
Bergquist TF, Malec JF. Current practices and training issues
in treatment of cognitive dysfunctions. Neurorehabilitation
1997;8:4956.
Berlin 1997
Berlin JA. Does blinding of readers affect the results of
meta-analyses? University of Pennsylvania Meta-analysis
Blinding Study Group. Lancet 1997;350(9072):1856.
Chesnut 1999
Chesnut RM, Carney N, Maynard H, Patterson P, Mann
NC, Helfand M. Rehabilitation for traumatic brain injury.
Agency for Health Care Policy and Research. Evidence Report/
Technology Assessment 1999;2:1176.
Fary 2003
Khan F, Baguley IJ, Cameron ID. Rehabilitation after
traumatic brain injury. Medical Journal of Australia 2003;6
(178):2905.
Frey 2003
Frey LC. Epidemiology of posttraumatic epilepsy: A critical
review. Epilepsia 2003;10(44):117.
Higgins 2008
Higgins JPT, Green S. Cochrane Handbook for Systematic
Reviews of Interventions 5.0.0 [updated February
2008]. The Cochrane Collaboration, 2008, Available from
www.cochranehandbook.org.
Katz 2006
Katz DI, Ashley MJ, OShanick GJ, Connors SH. Cognitive
rehabilitation: the evidence, funding and case for advocacy
in brain injury. Brain Injury Association of America. 2006:
Available from www.biausa.org/.

Lundh 2008
Lundh A, Gotzsche C. Recommendations by Cochrane
Review Groups for assessment of the risk of bias in studies.
BMC Medical Research Methodology 2008;8:22.
Maas 2008
Maas AI, Stocchetti N, Bullock R. Moderate and severe
traumatic brain injury in adults. Lancet Neurology 2008;7
(8):72841.
Parikh 2007
Parikh S, Koch M, Narayan RK. Traumatic brain injury.
International Anesthesiology Clinics 2007;3(45):11935.
Rosenthal 1990
Rosenthal M, Griffith E, Bond M, Miller JD. In: Rosenthal
M, Griffith E, Bond M, Miller JD editor(s). Rehabilitation
of the adult and child with traumatic brain injury. 2nd
Edition. Philadelphia: FA Davis company, 1990:22.
Saatman 2008
Saatman KE, Duhaime AC. Classification of traumatic
brain injury for targeted therapies. Journal of Neurotrauma
2008;7(25):71938.
Sohlberg 1989
Sohlberg MM, Mateer CA. Cognitive rehabilitation, An
integrated neuropsychological approach. 1st Edition. Vol. 16,
United States of America: Guilford Press, 2001.
Teasdale 1974
Teasdale G, Jennett B. Assessment of coma and impaired
consciousness. A practical scale. Lancet 1974;2:814.
Valadka 2004
Valadka AB. Injury to the cranium. In: Moore E, Feliciano
D, Mattox K editor(s). Trauma. 1st Edition. Vol. 5, New
York: McGraw, 2004:385406.
Wilson 2002
Wilson B, Evans J. Does cognitive rehabilitation work?
Clinical and economic considerations and outcomes. In:
Prigatano GP, Pliskin NH editor(s). Clinical Neuropsychology
and Cost Outcome Research: A Beginning. 1st Edition. Vol.
16, New York: Psychology Press, 2002:32945.

Indicates the major publication for the study

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

APPENDICES

Appendix 1. Search strategy

MEDLINE (April 2007)
1.exp CRANIOCEREBRAL TRAUMA/
2.exp Cerebrovascular Trauma/
3.exp BRAIN EDEMA/
4.exp GLASGOW COMA SCALE/
5.exp GLASGOW OUTCOME SCALE/
6.exp UNCONSCIOUSNESS/
7.Glasgow coma scale$.ab,ti.
8.(Unconscious$ or coma$ or concuss$ or persistent vegetative state).ab,ti.
9.Rancho Los Amigos Scale.ab,ti.
10.((head or crani$ or cerebr$ or capitis or brain$ or forebrain$ or skull$ or hemispher$ or intra-cran$ or inter-cran$) adj3 (injur$ or
trauma$ or damag$ or wound$ or fracture$ or contusion$)).ab,ti.
11.Diffuse axonal injur$.ab,ti.
12.((head or crani$ or cerebr$ or brain$ or intra-cran$ or inter-cran$) adj3 (haematoma$ or hematoma$ or haemorrhag$ or hemorrhag$
or bleed$ or pressure)).ab,ti.
13.or/1-12
14.exp activities of daily living/ or exp occupational therapy/ or exp rehabilitation, vocational/
15.exp Cognition/
16.cognitive rehabilitation.ab,ti.
17.exp Quality of Life/
18.community integration.ab,ti.
19.(assessment adj3 cognition).ab,ti.
20.(return$ adj3 work$).ab,ti.
21.living skills.ab,ti.
22.((living or social) adj3 skill$).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
23.exp Karnofsky Performance Status/
24.Karnofsky Performance Status.ab,ti.
25.exp sickness impact profile/
26.sickness impact profile.ab,ti.
27.(limitation$ adj3 activit$).ab,ti.
28.(rehabilitat$ adj3 disabilit$).ab,ti.
29.or/14-28
30.13 and 29
31. randomized controlled trial.pt.
32. randomi?ed.ab,ti.
33. controlled clinical trial.pt.
34.randomized.ab.
35.placebo.ab.
36.clinical trials as topic.sh.
37.randomly.ab.
38.trial.ti.
39.31 or 32 or 33 or 34 or 35 or 36 or 37 or 38
40. animals.sh. not (humans.sh. and animals.sh.)
41. 39 NOT 40
42. 30 AND 41

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

HISTORY
Protocol first published: Issue 3, 2009

CONTRIBUTIONS OF AUTHORS
Suresh Kumar K: developed the idea and analyzed the rationale for the review, and developed the draft protocol with assistance from
co-reviewers.
Samuel Kamalesh Kumar: provided assistance in developing the draft protocol and search strategies.
Ashish Macaden: provided support and input regarding the methodology of the review, and developing outcomes for review.

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT

Internal sources
Christian Medical College, Vellore, Tamil Nadu, India.
SRM School of Public Health, India.

External sources
South Asian Cochrane Network, India.
Cochrane Injuries Group, UK.

Cognitive rehabilitation for occupational outcomes after traumatic brain injury (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.