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The family as a resource for improving patient and family functioning after traumatic brain injury: A descriptive nonrandomized feasibility study of a family-centered intervention

  • University of Oslo / Oslo University Hospital
  • Giunti Psychometrics


The aim of this study was to address feasibility aspects of a multidisciplinary, family-centered rehabilitation intervention for persons with traumatic brain injury and their family. The study was done in preparation of a full-scale RCT and conducted as a collaboration between specialist and municipal health-care service, with two municipal health professionals included as collaborating partners. By applying the intervention on six persons, two families, we evaluated the attendance rate, the appropriateness of the intervention’s topics, the collaboration with the municipal health professionals, and the data collection method. Predefined success-criteria were used to evaluate feasibility. The family intervention and study procedures were evaluated as feasible. Some challenges arose and were discussed prior to commencing the full-scale trial. They concerned the logistics regarding the delivery of the intervention and making appropriate adjustments to meet the families’ unique needs and facilitate participation. A pragmatic approach was considered necessary in the full-scale RCT.
The family as a resource for improving patient
and family functioning after traumatic brain
injury: A descriptive nonrandomized feasibility
study of a family-centered intervention
Mari S. Rasmussen
*, Nada Andelic
, Tonje H. Nordenmark
, Juan C. Arango-Lasprilla
Helene L. Soberg
Abstract: The aim of this study was to address feasibility aspects of
a multidisciplinary, family-centered rehabilitation intervention for persons with
traumatic brain injury and their family. The study was done in preparation of a full-
scale RCT and conducted as a collaboration between specialist and municipal
health-care service, with two municipal health professionals included as collabor-
ating partners. By applying the intervention on six persons, two families, we eval-
uated the attendance rate, the appropriateness of the interventions topics, the
collaboration with the municipal health professionals, and the data collection
method. Predefined success-criteria were used to evaluate feasibility. The family
intervention and study procedures were evaluated as feasible. Some challenges
arose and were discussed prior to commencing the full-scale trial. They concerned
the logistics regarding the delivery of the intervention and making appropriate
adjustments to meet the familiesunique needs and facilitate participation.
A pragmatic approach was considered necessary in the full-scale RCT.
All authors do their research in the field of
rehabilitation after traumatic brain injury. This
study is linked to the research group
Rehabilitation after traumaat Oslo University
Hospital in Oslo, Norway. The research group is
multidisciplinary and aims to generate knowl-
edge of the mechanisms and consequences of
traumas, especially traumatic brain injury, as
well as trends and challenges in treatment and
rehabilitation. The aim of this study was to
address feasibility aspects of conducting
a family intervention for families facing trau-
matic brain injury, and was part of the prepara-
tion of a full-scale randomized controlled trial.
The results add important knowledge for others
planning family intervention research, which can
apply to other patient groups as well. The
research is done as a collaboration between the
Department of Physical Medicine and
Rehabilitation at Oslo University Hospital, muni-
cipal health care, and the TBI research group at
the BioCruces Health Research Institute, Bilbao,
From a family system perspective, sustaining
a traumatic brain injury has an impact on all
members of the family and the family as a whole.
As the family members constitute the most
important support for those injured, it is impor-
tant that health and rehabilitation professionals
know how to meet the familys needs. As the
rehabilitation following a traumatic brain injury
often is oriented toward the injured person, more
research investigating the effectiveness of family
interventions improving functioning and well-
being of all family members is needed. In this
study, we evaluated the feasibility of an eight-
session family intervention as part of planning
a larger full-scale trial. The results showed that
the family intervention was feasible. However,
some challenges arose. They concerned the
logistics regarding the delivery of the intervention
and making appropriate adjustments to meet the
participantsunique needs. Evaluating feasibility is
an important step in determining whether an
intervention is suited to be tested for
Rasmussen et al., Cogent Medicine (2019), : 1607433
© 2019 The Author(s). This open access article is distributed under a Creative Commons
Attribution (CC-BY) 4.0 license.
Received: 06 January 2019
Accepted: 09 April 2019
*Corresponding author: Mari
S. Rasmussen, Physical Medicine and
Rehabilitation, Oslo University
Hospital (Oslo Universitetssykehus),
E-mail: m.s.rasmussen@studmed.uio.
Reviewing editor:
Omid Khaiyat, Liverpool Hope
University, Liverpool, UK
Additional information is available at
the end of the article
Page 1 of 14
Subjects: Health Psychology; Family Therapy; Rehabilitation Medicine; Primary Health Care
& Family Practice; Allied Health
Keywords: traumatic brain injury; adults; feasibility; family intervention; health related
quality of life; caregiver burden
1. Introduction
Traumatic brain injury (TBI), defined as an alteration in brain function or other evidence of brain
pathology caused by an external force, is a leading cause of chronic disability worldwide (Menon,
Schwab, Wright, & Maas, 2010). The disabilities following TBI tend to be multidimensional and include
physical, cognitive, behavioral, and emotional problems, which can persist for years after the onset of
injury (Forslund et al., 2017). Research studies have consistently demonstrated a poorer quality of life
in individuals with TBI compared with healthy controls in both the short term (Arango-Lasprilla, Krch,
Drew, De Los Reyes Aragon, & Stevens, 2012) and the long term (Soberg et al., 2013).
As rehabilitation services become less available in the chronic phase of recovery, the family
often becomes the primary support system for those injured (Oddy & Herbert, 2003). Family
members and caregivers have reported increased levels of anxiety and depression (Ennis,
Rosenbloom, Canzian, & Topolovec-Vranic, 2013; Ponsford, Olver, Ponsford, & Nelms, 2003) and
caregiver burden is frequently reported in the TBI literature (Baker, Barker, Sampson, & Martin,
2017). High levels of caregiver burden persist years after the injury (Bayen et al., 2016; Doser &
Norup, 2016) and correlate negatively with life satisfaction in caregivers after severe TBI (Manskow
et al., 2017). Moreover, the patientsand family membersfunctioning is interlinked. The behavioral
changes often seen in persons with TBI seem to predict unhealthy family functioning and distress
in relatives (Anderson, Simpson, & Morey, 2013; Schonberger, Ponsford, Olver, & Ponsford, 2010),
and the injured persons neuropsychological status has shown to be reciprocally connected to the
caregiver burden (Lehan, Arango-Lasprilla, de Los Reyes, & Quijano, 2012).
In studies evaluating the needs of families facing TBI, family members report to have unmet
needs, especially within the area of emotional support (Kreutzer et al., 2018; Norup et al., 2015).
Despite this, the family members and the family as a whole seldom seem to be the target for
rehabilitation efforts (Qadeer et al., 2017), and health professionals often lack knowledge about
how they could intervene to improve both patientsand family memberswell-being (Lefebvre,
Pelchat, & Levert, 2007). Moreover, caregiver and dyad intervention studies often are limited due to
the low sample size and poor fidelity (Kreitzer et al., 2018).
A two-armed randomized controlled trial (RCT) titled The family as a resource for improving
patient and family functioning after traumatic brain injury: a randomized controlled trial of
a family-centered interventionwill be conducted at Oslo University Hospital. The main aim of
this trial is to determine the effectiveness of a multidisciplinary, family-centered intervention for
TBI patients and their family members in improving family functioning and dynamics, including
health-related quality of life (HRQL) and self-efficacy, and to reduce the family membersperceived
caregiver burden over time.
Evaluating feasibility of interventions prior to larger-scale RCTs is in accordance with the com-
plex intervention framework presented by the Medical Research Council (MRC) (Craig et al., 2008).
Eldridge et al. (2016) proposed a conceptual framework defining feasibility as an overarching
concept in which pilot and feasibility studies are included (Eldridge et al., 2016). In such studies,
any part of the planned research can be performed to evaluate the feasibility of the process,
resources, management, and science (Morris & Rosenbloom, 2017).
In the current study, we conducted the intervention arm of the planned RCT to evaluate
feasibility aspects of a family intervention, the Traumatic Brain Injury (TBI)/Spinal Cord Injury
Rasmussen et al., Cogent Medicine (2019), : 1607433
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(SCI) Family Intervention. This is an eight-session intervention building on cognitive behavioral
therapy and a family system perspective (Stevens, Lehan, Duran, Plaza, & Arango-Lasprilla, 2016).
A previously published pilot study of this intervention on four Latin-American families facing SCI,
compared with a control group, showed promising results, with improvements in psychosocial
function (Stevens et al., 2016). However, these results are preliminary, and further investigation of
its effectiveness is warranted. In this study, we were especially interested in the following aspects
of feasibility:
(1) The familieswillingness and ability to attend the sessions of the intervention.
(2) The appropriateness of the interventions topics, including the need for cultural adjustments.
(3) The leadership structure of the sessions in the intervention and the collaborating mode with
the municipal health professionals.
(4) The appropriateness of the data collection method, including the participants' understand-
ing of and response to the selected outcome measures.
2. Methods
This nonrandomized feasibility study of the intervention arm of a planned full-scale RCT was
conducted in the south-eastern region of Norway. The full-scale RCT is registered at with the identifier NCT03000400, and the Medical Ethics Committee in Norway
has approved the study (#2016/1215).
2.1. Setting and procedures
The current study was done in a municipal health-care service in Southeastern Norway in collabora-
tion with health professionals working in this health service. The first author (MSR), with nearly 10
years of clinical experience as a physiotherapist, had the primary responsibility as the group facil-
itator in the family intervention. A nurse and an occupational therapist working in a municipal
health-care service were group facilitators together with the author MSR. Both municipal health
professionals had more than 15 years of clinical experience. All facilitators received a 2-day in-
person training for the intervention from one of the developers of the intervention (co-author JCA-L),
followed by two workshops conducted by the principal investigator (HLS).
Three individuals attending a community-based rehabilitation service for persons with an
acquired brain injury in the collaborating municipality at the time of the study were invited to
participate by receiving oral and written information about the study. The persons with TBI
nominated their respective family members for participation in the intervention, and eight persons
were ultimately invited to participate. Six persons agreed to participate, whereas a married couple,
declined to participate due to a lack of time to attend the eight sessions of the intervention for the
spouse. Informed written consent was obtained for all participants.
Assessment of eligibility was based on the following inclusion criteria: Patients that had been
diagnosed with a TBI that (a) were between 16 and 65 years of age, (b) lived at home, and (c)
received or had received rehabilitation from the municipal health-care service. Individuals nomi-
nated by the patients were eligible if they were (a) related to the patient with TBI by blood or
marriage, (b) lived in the same household and/or were regarded as significant others, and (c) were
between 16 and 65 years of age. Exclusion criteria for all participants were (a) inability to speak/
read Norwegian, (b) learning difficulties, (c) ICD-10 diagnosis of severe psychiatric or degenerative
neurological illness, (d) ongoing substance abuse, and (e) families in which other family members
required extensive/professional care.
Even though the feasibility of the intervention was the scope of this article, a comment
regarding sample size in the current study, is considered pertinent. In pilot studies a sample
size of 0.03-times the planned sample size of the future study is recommended (Stallard,
2012). With respect to the intervention arm of the full-scale RCT, the six included participants
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in the current study corresponded to 6% of the calculated sample size. We also took into
account a shortage of the research timeline and scarce human and financial resources as
recommended by (Feeley et al., 2009). Therefore, we considered six persons from two families
to be sufficient for this feasibility study because making statistical inferences was not an aim.
2.2. The Traumatic Brain Injury/Spinal Cord Injury Family Intervention
The multicomponent, individually delivered family intervention is developed by co-author JCA-L
and colleagues and aims to improve individual and family functioning (Stevens et al., 2016). By
giving the family members knowledge about specific topics and training in practical strategies, it is
expected that they can increase their understanding of each others experiences and be able to
manage family problems in a more functional way (Stevens et al., 2016). The intervention manual
has been published as supplementary material to the previously published pilot study on the
intervention (Stevens et al., 2016).
The intervention consists of eight 90-min sessions, preferably one session per week, with each
session focusing on a specific topic, see Table 1(Stevens et al., 2016). The sessions have a fixed
structure containing both theoretical and practical components. Additionally, families are given
between-session tasks. The intervention is described in a manual that provides text that can be
used to explain the topics and handouts and work tasks assigned to the participants. Although
the intervention is manualized, each family should be given the opportunity to share and discuss
the challenges that are relevant to their situation so that the intervention is individually adjusted
to meet each familys needs. Different health professionals and rehabilitation workers with
clinical experience and training in the intervention can lead the sessions as group facilitators
(Stevens et al., 2016).
The intervention was translated into Norwegian by a professional translator and was care-
fullyreviewedbyauthorsMSRandHLS.Minoradjustments of the sentence structure, changes
in some of the myths and misconceptions about TBI covered in session 2, and updates of
some of the references used in the handouts were made prior to conducting the current
study. The adjustments were done in collaboration with a Danish research group, translating
the intervention within a similar cultural context present in the Scandinavian countries.
Table 1. Overview and description of the sessions in the intervention (Stevens et al., 2016)
No Topic Description
1 Introduction Overview of expectations, structure of the sessions, and purpose of
the intervention. Completion of baseline questionnaires.
2 Making meaning of TBI/SCI Normalize and validate the family membersexperiences with TBI
and overcome misconceptions about TBI.
3 Shifting focus Shifting focus from negative to positive aspects of the situation and
recognizing the relationships among thoughts, mood, and
4 Managing emotions Identify warning-signsindicating an escalation of emotions and
strategies for managing emotions.
5 Communicating effectively Recognizing warning signs for communication and providing
techniques for communicating effectively.
6 Finding solutions Moving from a problem-oriented perspective to a solution-oriented
perspective, formulating goals, and tracking the progression toward
achieving those goals.
7 Boundary making Externalizations of problems, education of healthy vs. unhealthy
family dynamics, and the importance of self-care.
8 Farewell Summary of skills learned and how changes can be lasting and
consistent, provision of feedback on the intervention, and
completion of post-intervention questionnaires.
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2.3. Objectives and success criteria
The results of this study are based on quantitative measures, such as attendance rate and
between-session task compliance, by the qualitative feedback given by the participants, and
the health professionalsdiscussion and notes as group facilitators regarding obstacles,
difficulties, and benefits experienced during the delivery of the intervention. Prior to the
study we defined some success criteria of the feasibility aspects, see Table 2.Thethree
health professionals used 30 min after each session to discuss their experiences and to
write down the feedback given by the participants during the sessions.
2.4. Data collection and outcome measures
Independent variables were collected through a short questionnaire developed by the
authors MSR and HLS. From all participants, we collected sex, age, marital status (partner,
married/cohabitant, single), education (elementary school, high school/vocational school, and
college/university), current employment status (employed vs. unemployed), and type of work.
From the patients, we collected: Number of persons living in the household, employment
status pre- and post-injury, time since the injury (months/years), and the current amount of
rehabilitation services received (hours per week). Additionally, from the medical records we
collected injury-related data, including the date of injury, injury mechanism (traffic accident,
fall, violence, other), and Glasgow Coma Scale Score (GCS) upon admission to the emergency
room/trauma center, with 38 indicating severe TBI, 912 indicating moderate TBI, and
1315 indicating mild TBI (Prasad, 1996). From the family members, we collected the type
of kinship to the injured individual and whether they lived in the same household as the
person with TBI.
The outcome measures were assessed through self-report questionnaires, which the parti-
cipants completed during the first introductory session and in the last session of the inter-
vention. In the full-scale RCT, the participants will also complete the questionnaires at the
insufficient to capture the effects of the intervention on TBIs and the family system (Mayo &
Scott, 2011). Health-related quality of life (HRQL) and caregiver burden were the primary
outcomes. HRQL was measured by the Medical Outcomes 36-items Short Form Health Survey
(SF-36), which assesses eight dimensions of functioning: physical functioning (PT), role-
physical function (RP), bodily pain (BD), general health (GH), vitality (VT), social functioning
(SF), role-emotional function (RE), and mental health (MH) (Ware & Gandek, 1994). In the
current study, we used the SF-36 version 1 and report the mental scales median scores: VT,
Table 2. Study objectives and success criteria
Objectives Success criteria
The participantswillingness and ability to attend the
The participants attend all sessions and complete the
given between-session tasks.
The appropriateness of the topics covered in the
intervention, including the need for cultural
Participants and health professionals experience the
topics and strategies in the intervention as relevant
and recognizable.
The leadership structure of the sessions and
collaboration form with the municipal health
(a) The municipal health professionals have the
opportunity to attend all sessions and have
sufficient training in the intervention.
(b) The participants are satisfied with the leadership
structure and collaboration form through all
The appropriateness of data collection method,
including the participants' understanding of and
response to the selected outcome measures
The participants answer the self-reported
questionnaires within a given timeframe (70 minutes)
with less than 10 % missing variables.
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possibility to calculate the Mental Component Summary which is not available for version 1.
The SF-36 has been shown to be a valid and reliable measurement for use in TBI populations
(Findler, Cantor, Haddad, Gordon, & Ashman, 2001). Caregiver burden was assessed using the
Caregiver Burden Scale (Elmståhl, Malmberg, & Annerstedt, 1996), which captures five dimen-
sions of caregiverssubjective burden: general strain, isolation, disappointment, emotional
involvement, and environment (Elmståhl et al., 1996). The CBS has previously been used for
Norwegian caregivers after TBI (Manskow et al., 2015), and the questionnaire has shown good
validity and internal consistency when tested in studies involving stroke and dementia
(Elmståhl et al., 1996).
The secondary outcome measures included the Quality of Life after Brain Injury (QOLIBRI) (von
Steinbuchel et al., 2010) and The Family Adaptability and Cohesion Evaluation Scale, fourth edition
(FACES IV) (Olson, 2011). QOLIBRI has been used in Norwegian TBI populations and has shown good
psychometric properties (Soberg, Roe, Brunborg, von Steinbuchel, & Andelic, 2017). The FACES IV
assesses the participantsperceptions of family cohesion and flexibility. Additionally, how the
participants perceive their family communication and how satisfied they are with the family
dynamic are assessed by the Family Communication Scale (FCS) and the Family Satisfaction Scale
(FSS), which are embedded in FACES IV (Olson, 2011). For additional measurements, see Table 3.
(Andenaes, Bentsen, Hvinden, Fagermoen, & Lerdal, 2014; Friborg, Hjemdal, Rosenvinge, &
Martinussen, 2003; Huckans et al., 2010; Kroenke, Spitzer, & Williams, 2001; Spitzer, Kroenke,
Williams, & Löwe, 2006)
3. Results
3.1. Patient and family information
Patient and family characteristics are presented in Table 4.
3.2. Feasibility of the study
The evaluation of the predetermined success criteria in the current study was based on the
participantsfeedback of the acceptability of the intervention and the health professionals
discussion and notes of obstacles, difficulties, and benefits experienced in the sessions.
Table 3. Outcome measures
Outcome measure Scale range Patient Family
SF36 Mental Health Scales 0100 (worstbest) X X
Caregiver burden scale 2288 (bestworst) X
QOLIBRI 0100 (worstbest) X
FACES IV ratio score 010 (worstbest) X X
Family communication scale 1050 (worstbest) X X
Family satisfaction scale 1050 (worstbest) X X
Additional measures
Generalized Self-Efficacy Scale (GSE) 1040 (worstbest) X X
TBI Self-Efficacy Scale (TBI SE) 066 (worstbest) X
Patient Health Questionnaire-9 (PHQ-9) 027 (bestworst) X X
Generalized Anxiety Disorder-7 (GAD-7) 021 (bestworst) X X
Resilience Scale for Adults (RSA) 33165 (worstbest) X X
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3.2.1. The familieswillingness and ability to attend the sessions
The patients nominated two family members each for participation. Although there were other
potential family members that could have participated, the families expressed that the reason
for not including them was that they lived too far away, and that they were not actively
involved in the patientsdaily life. The health professionals experienced the participating family
members to willingly share thoughts, experiences, and concerns. With an attendance rate of
98%, the families appeared motivated to attend all sessions of the intervention. One family
member missed session number 4. All between-session tasks were completed. Some logistic
challenges when scheduling the sessions evolved due to other responsibilities that the partici-
pants had, such as work and school obligations. The health professionals experienced that
being flexible when scheduling the sessions was necessary to succeed with completion of the
intervention within 8 to 10 weeks.
3.2.2. The appropriateness of the interventions topics, including the need for cultural
Overall, the participantsperceived the topics and strategies as relevant and recognizable.
This was also the health professionalsimpression, as most of the participants showed
a good understanding of the background knowledge. However, there were different opinions
by the participants regarding the relevance of the myths and misconceptions about TBI,
covered in session 2. The family who had lived with the consequences of a severe TBI for five
years expressed that some of the myths and misconceptions were not relevant, whereas the
other family pointed out that the myths and misconceptions were consistent with concerns
theyhadatthatpoint.Someparticipantsperceived the language used in some of the
examples as sharper in tone than what was considered normal for them, i.e. an example
illustrating danger-signs in communication. Additionally, one of the injured participants
found parts of the intervention difficult to understand due to impaired ability in abstract
thinking and memorizing. This was also observed by the health professionals. The youngest
participant, aged 16, stated he found the intervention to be more relevant to couples and
less relevant for him at that point in life. This was also the health professionalsimpression,
as we experienced him to be less engaged in some of the sessions.
Table 4. Patient and family characteristics
Family A Family B
Patient (age) Male with TBI (50) Female with TBI (24)
Injury severity (GCS) Severe (3) Mild (15)
Time since injury 5 years 1 year
Main symptoms and concerns Impaired memory, lack of taking
initiative, problems with decision
Fatigue, sensitivity to light and
sound, and headache
Municipal rehabilitation service None 2 hours per week
Employment status patient Part time Sick-leave
Education patient University High School
Family members (age) Wife (50)
Child (16)
Partner (46)
Mother (56)
Living in the household (yes/no) Wife (yes)
Child (yes)
Partner (yes)
Mother (no)
Education family members Wife (University)
Child (Elementary School)
Partner (University)
Mother (University)
Employment status family
Wife (full-time)
Child (student)
Partner (full-time)
Mother (disability pension)
Family members are described by their relation to the individual with TBI.
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3.2.3. The leadership structure of the sessions and collaboration mode with the municipal
health professionals
One family highlighted the importance of havingthesamegroupfacilitatorsinallsessions
to build a trusting relationship between the participants and facilitators and to make the
sessions a safe place to openly express thoughts and concerns. The health professionals
evaluated the leadership structure of the sessionsaswellasfunctioning.However,itwas
important to have clarified role expectation in advance of the intervention to improve the
group dynamic and make sure we covered each session according to the manual and within
the given time frame. The participation represented an extra workload for the municipal
health professionals, as they also had ordinary work responsibilities to fulfill which made it
more challenging for them to show flexibility regarding scheduling of the sessions.
3.2.4. The appropriateness of the data collection method, including the participants'
understanding of and response to the selected outcome measures
The participants answered within the timeframe of 70 min, with less than 10% missing data
variables. The participant with a mild TBI reported some brief symptoms of headache and fatigue
immediately after answering the questionnaires, but recovered fast, and was otherwise satisfied
with the process.
A visual comparison of pre- and post-median scores on the primary and secondary out-
come measures showed primarily unchanged or slightly improved scores (see Table 5). The
Social Functioning Scale of the SF-36 had increased by >10 points, which can be viewed as
an important clinical change (Loge & Kaasa, 1998). The family membersscores on the CBS
had decreased slightly after intervention and were in a range of a low level of burden
(1.001.99) (Elmståhl et al., 1996). Of the secondary outcome measures, the median score
for the two individuals with TBI on the QOLIBRI had increased by 6.4 points indicating
a better quality of life post-intervention. All participants in the current study reported scores
on the FACES IV above 1 both at baseline and after completing the family intervention
indicating healthy family systems (Olson, 2011). Particularly, the median scores of the
Family Communication Scale and the Family Satisfaction Scale had increased with 5.4 and
4.0 points, respectively.
Table 5. Median scores and interquartile range (IQR) of the primary and secondary outcome
measures at baseline (T1) and post-intervention (T2)
Median T1 IQR Median T2 IQR
SF-36 Role
66.7 33.3 to 100 66.7 0 to 100
SF-36 Social
56.3 31.3 to 100 68.8 46.9 to 100
SF-36 Vitality 52.5 35.0 to 60.0 52.5 42.5 to 65.0
SF-36 Mental Health 66.0 44.0 to 84.0 68.0 58.0 to 79.0
Caregiver Burden
45.0 37.5 to 47.3 38.5 31.0 to 46.3
3.0 2.3 to 3.2 3.2 2.3 to 3.9
39.5 37.8 to 43.0 44.9 41,3 to 47.3
Family Satisfaction 40.5 36.3 to 41.3 44.5 40.8 to 47.0
QOLIBRI 35.5 41.9
Interquartile range is reported. The QOLIBRI (Quality of life after brain injury) was only answered by the patients (n =
2) and the IQR could not be estimated.
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4. Discussion
In summary, this article provides a rationale for commencing a full-scale RCT aiming to evaluate
the effectiveness of a family-centered intervention for families facing TBI. We aimed to evaluate
aspects of feasibility related to benefits, obstacles, and challenges when conducting the interven-
tion. Based on the participantsresponses and health professionalsobservations as group facil-
itators, the intervention was evaluated as feasible. However, some obstacles and challenges
became evident and were discussed prior to commencing the full-scale RCT.
4.1. Interpretation of the results
4.1.1. The familieswillingness and ability to participate in the sessions
The participants were perceived as actively engaged in the sessions by the health professionals, and
these observations are supported by the high attendance rate and the completion of all between-
session tasks. However, eight 90-min sessions posed some logistic challenges for the families due to
work and study obligations. Factors such as time demands may affect familiesopportunity and
willingness to participate in intervention studies (Wade & Kurowski, 2017). The health professionals
tried to minimize the burden of participation for the families by showing flexibility when scheduling the
sessions. We believe this flexibility will be crucial in succeeding with the recruitment of families in the
full-scale RCT, and we also determined that delivery of the intervention in the familieshomes, if
desired, should be an option in the full-scale RCT to minimize the burden of participation for the
In the intervention manual, it is recommended that families receive the intervention from 6
months to 1 year after the patient's discharge from post-acute rehabilitation (Stevens et al., 2016).
In the feasibility study, we included one family 1 year after injury and one family 5 years after
injury. However, as the research supports the notion of early intervention after brain injuries
(Ponsford, 2005; Ponsford et al., 2002), we have decided to include patients 6 to 18 months post-
TBI in the full-scale RCT. By increasing the inclusion period from 12 to 18 months post-injury, the
likelihood of succeeding with recruitment and reach the estimated sample size in the RCT will be
enhanced. Inclusion often can be challenging in many clinical trials (McDonald et al., 2006; Nichol,
Bailey, & Cooper, 2010), and the incidence of hospital-admitted patients with TBI is lower in
Norway than in other countries (Andelic, Sigurdardottir, Brunborg, & Roe, 2008).
There is no defined upper limit for how many family members that could participate in the
intervention (Stevens et al., 2016). Both patients nominated two of their closest family members
each. In Norway, the immediate families usually are small, and the average household in Oslo
consists of 1.98 people (Families and households,2016). Additionally, Norway has a welfare
system ensuring that all inhabitants have equal rights to health services. These factors might
influence to what extent the family is involved in the rehabilitation process and the amount of
informal care they provide for the injured family member, as opposed to other cultures and
countries where the familial sense is stronger and formal health services are limited. As we
could potentially have larger groups in the intervention, we determined that significant others,
such as close friends, can be included in the full-scale RCT.
4.1.2. The appropriateness of the topics covered in the intervention, including the need for
cultural adjustments
The family intervention is culturally sensitive and need for adjustments should be considered
before applying the intervention in other cultures (Stevens et al., 2016). The family intervention
is developed by integrating elements and strategies from several evidence-based cognitive and
psychological techniques. However, some of the examples used in the intervention were perceived
as culturally different from what were considered normal in the families. For instance, the lan-
guage used in some examples was sharper in tone than what was considered normal in the
families. Despite this, the examples clearly function well to illustrate what they intended to and we
decided to keep them as is with just minor changes in wording.
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There were also different opinions between the families regarding the myths and misconcep-
tions about TBI covered in session 2. This might relate to differences between LatinAmerica and
Norway regarding the amount of available information about TBI and the consequences of such
injury, but the observed differences between how they perceived the myths and misconceptions
might also be explained by what stage in the recovery process the families were when the
intervention was delivered. It is likely that families facing a severe TBI receive more health services
and get more information compared to families who initially believed their family member had
sustained a mild TBI with symptoms resolving in weeks. In the full-scale RCT, we will include
patients with all severities of TBI, and consequently, we will need to adjust the myths and
misconceptions according to severity and phase of recovery to make it relevant for each family.
The need for individual adjustment became evident in the current study, as one of the individuals with
TBI found parts of the intervention somewhat difficult to understand. If the participants do not
experience a sense of mastery, the intervention could potentially be a reminder for the family of the
problems caused by TBI. Considering common cognitive problems often experienced by people with TBI,
such as slowed information-processing and impaired memory and attention (Azouvi, Arnould, Dromer, &
Vallat-Azouvi, 2017), it is important that the group facilitators have the knowledge and skills to recognize
these problems when they occur and adaptthecontenttosuitanindividualsuniqueneeds.
In the previously published pilot study of the intervention by Stevens et al. (2016), licensed
psychologists were group facilitators, whereas the allied health professionals in the current study
had more limited psychological expertise. However, as the intervention was developed as a multi-
professional approach, it is important to evaluate the intervention when conducted by other than
psychologists. This is also in accordance with a pragmatic approach in research, where interven-
tions should be tested under circumstances closer to regular clinical practice and to ensure the
external validity for which the intervention was intended (Zwarenstein & Treweek, 2009).
The youngest participant stated he found parts of the intervention less relevant for him and more
suited for couples, which was in accordance with the health professionalsobservations as we observed
that he was less engaged in some of the sessions. In the intervention manual, it is recommended that
family members are at least 18 years, and our experience supports this recommendation. However,
due to the small sample size, one cannot make a conclusion based on this single experience.
Nonetheless, we decided to follow the manual recommendation with an age limit of 18 years for
family members in the full-scale RCT even if this might result in a loss of adult family members as
children often move out to pursue further education or to submit to initial compulsory military services.
4.1.3. The leadership structure of the sessions and collaboration mode with the municipal
health professionals
The municipal health-care service was motivated to be involved in the research; however, the
health professionals did not receive any allowances for their ordinary work responsibilities and
participation therefore represented an extra workload and some logistic challenges. This is in line
with what other researchers have identified to be challenges for clinicians involved in research, as
limited time and resources often restrict their possibility for participation (Di Bona et al., 2017;
Wusthoff, Waal, & Grawe, 2012). Likely, the logistic challenges will increase when we include more
families in the RCT study. It had already been determined that the municipal health professionals
should be co group-facilitators for a total of 10 out of 33 families in the RCT intervention arm,
which might be realistic based on our experience in the current study.
4.1.4. The appropriateness of data collection method, including the participants' understanding
of and response to the selected outcome measures
The family-centered intervention aims to give the families new and extended knowledge about
topics concerning interactions and relationships within the family after TBI, coping and self-
efficacy, and practical skills to manage challenges and problems in more functional ways.
Achieving this, the families can recognize and change inexpedient behaviors and patterns to
Rasmussen et al., Cogent Medicine (2019), : 1607433
Page 10 of 14
improve family function and dynamics. Behavioral changes are difficult to achieve for everyone
and might even be more complicated for persons who have sustained a TBI. Hence, the 6-month
follow-up in the full-scale RCT will provide important information about the effectiveness of the
family-centered intervention.
The participants managed to answer all questionnaires within the given timeframe. One
participant reported a brief increase in symptoms of pain and fatigue immediately after
completing the questionnaires. However, we evaluated the selected outcome measures as
feasible as this participant otherwise expressed being very satisfied with the process. An option
intheRCTwouldbetogivepatientsextendedtime to answer the questionnaires if needed.
Making statistical inferences regarding the effectiveness of the intervention was not the aim of
this study, but a visual comparison of the baseline and post-intervention median scores on the
primary and secondary outcome measures showed primarily unchanged or slightly improved
scores. However, we cannot make any suggestions of trends regarding the effectiveness of the
interventions based on these results. Strengths and limitations. A strength of this study was that all aspects of the intervention
arm were thoroughly tested, which resulted in some adjustments that will increase the validity of
the full-scale RCT. However, a major limitation of this study was the small sample size, six persons
in two families. This is a consequence of a shortage of research timeline and limited human
resources. Thus, we obtained limited information regarding the larger target groups willingness
to participate in the intervention and we could not determine recruitment rates based on the
sample in the current study.
In addition, we did not evaluate the feasibility of delivering the intervention to individuals other
than immediate family members, due to the fact that many Norwegian families are small, and the
extended family is less involved in the rehabilitation process. On the other hand, the study might
be of international interest because Norway is a welfare state with a long tradition of organizing
and allocating resources to comprehensive rehabilitation of patients with long-term disabilities,
including TBI. Furthermore, it can be considered a limitation that the a priori success criteria were
not systematically assessed, as this would have given us more accurate data when evaluating the
feasibility and potential changes in the study protocol.
4.2. Conclusion
The Traumatic Brain Injury/Spinal Cord Injury Family Interventionwas feasible when evaluating
the objectives and success criteria of this study based on a high attendance rate and between-
session task compliance, and feedback and observations from the participants and the health
professionals. A pragmatic approach was considered necessary in the full-scale RCT to minimize
the burden of participation and succeeding with the recruitment of families. Further investigation
of the effectiveness of the family-centered intervention and the results of the full-scale RCT will
form a basis for evaluating the effectiveness and the possibility of implementing the intervention
in routine clinical practice.
TBI Traumatic Brain Injury
RCT Randomized Controlled Trial
HRQL Health-related Quality of Life
GCS Glasgow Coma Scale
SF-36 Short Form 36 Health Survey
CBS Caregiver Burden Scale
QOLIBRI Quality of Life after Traumatic Brain
FACES IV Family Adaptability and Cohesion
FCS Family Communication Scale
FSS Family Satisfaction Scale
GSE Generalized Self-Efficacy Scale
Rasmussen et al., Cogent Medicine (2019), : 1607433
Page 11 of 14
TBI SE Traumatic Brain Injury Self-Efficacy
RSA Resilience Scale for Adults
SCI Spinal Cord Injury
PHQ-9 Patient Health Questionnaire-9
GAD-7 Generalized Anxiety Disorder 7-
item scale.
Not applicable.
This study and the future full-scale RCT have been made
possible through grants from the Norwegian
ExtraFoundation for Health and Rehabilitation [2016/
FO77196]. The trial funders played no role in the study
design, data collection, analysis or interpretation, manu-
script writing, or decision to submit the article for
Competing Interests
The authors declare that they have no competing
Author details
Mari S. Rasmussen
Nada Andelic
Tonje H. Nordenmark
Juan C. Arango-Lasprilla
Helene L. Soberg
Oslo University Hospital, Ulleval, Oslo, Norway.
Institute of Health and Society, Research Centre for
Habilitation and Rehabilitation Models & Services
(CHARM), Faculty of Medicine, University of Oslo, Oslo,
BioCruces Health Research Institute, Cruces University
Hospital, Barakaldo, Spain.
IKERBASQUE. Basque Foundation for Science, Bilbao,
Faculty of Health Sciences, Department of
Physiotherapy, Oslo Metropolitan University, Oslo,
Availability of data and materials
All data upon which the conclusion of this paper relies
upon are published in the article. The datasets generated
from the self-reported questionnaires are not publicly
available, due to privacy concerns and to ensure the
anonymity of the participants. De-identified responses to
the self-reported questionnaires are available from the
corresponding author, upon reasonable request.
Ethics approval and consent to participate
Ethics approval of the full-scale RCT was granted by the
Regional Committees for Medical and Health Research
Ethics in southeast Norway (#2016/1215) and the Data
Privacy Officer at Oslo University Hospital. Potential parti-
cipants were provided with written information sheets
about the project. In the first session of the intervention,
the rationale and purpose of the study were discussed
with the participants, and they were given the opportunity
to ask questions before signing the written consent form.
Citation information
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... 16 Based on the results of the pilot study by Stevens et al., we conducted a feasibility study prior to the current study. 17 The objective of the present study was to determine the effectiveness of this family intervention for patients with traumatic brain injury and their family members. We hypothesised that there would be significant improvements in the family intervention group for mental health-related quality of life, family functioning, communication and satisfaction in patients and family members as well as reduced caregiver burden over time for the family members when compared to the control group. ...
... 16 Some minor cultural adjustments to fit the Norwegian context were made in advance of the randomised controlled trial and are described in a previous publication. 17 To each family separately, the main-group facilitator (author MSR, physical therapist) delivered the sessions according to the instruction manual, with approximately one session per week. The sessions comprised both theoretical and practical components and had a fixed structure but were individually tailored to accommodate each family's unique needs. ...
... All group-facilitators had received training in the intervention, and they participated in a feasibility study of the family intervention. 17 Furthermore, elements from a publication by Winter et al. 29 were used to assess the main group-facilitator's adherence to the intervention manual and administration of the family intervention. The elements measuring task completion included the following: (a) explained purpose of each session clearly; (b) used appropriate pace and language; (c) showed sensitivity to the participant responses; (d) responded clearly to participants' questions, (e) demonstrated overall fidelity to the Traumatic Brain Injury/ Spinal Cord Injury Family System Intervention manual; and (f) explained next step of intervention. ...
Full-text available
Objectives: To determine the effectiveness of a family-centred intervention for patients with traumatic brain injury and family members. Design: Open-labelled, two-armed randomised controlled trial. Settings: Outpatient clinic and family residences. Participants: Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention (n = 30 families) and control group (n = 31 families). Intervention: An eight-session single-family intervention to improve individual and family functioning. Outcome measures: Self-reported questionnaires at start-of-treatment, median (IQR) 11.4 (8.4, 15.9) months post-injury, and at two follow-ups, 2.7 (2.3, 3.8) and 9.2 (8.2, 9.9) months after start-of-treatment. Primary outcome measures were the SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB). Secondary outcome measures were the Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI). Group differences were analysed with linear mixed-model analysis for repeated measurements. Results: No significant between-group differences were found. The intervention group significantly improved on the MCS, the CGB and FACES in the treatment period, whereas the controls did not. The mean (SD) MCS change in the treatment period was 2.4 (1.1) points P = 0.028 in the intervention group. Mean (SE) MCS scores were 47.9 (1.26) and 47.3 (1.27) in the intervention and control group at last follow-up. Conclusions: Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.
... The intervention was originally developed based on experiences from TBI rehabilitation services in Latin America. Adaptations of the intervention into a Norwegian setting have been published by our group [25]. This study was approved by the Regional Committee for Medical and Health Research Ethics, South-East Norway (approval no. ...
Full-text available
Traumatic brain injury (TBI) affects the family as a whole. This study aimed to describe and compare mental health and family functioning in TBI patients and their family members, and to identify individual and family-related factors that were associated with mental health. It was conducted at an urban, specialized, TBI outpatient clinic and included 61 patients with mild to severe TBI and 63 family members. Baseline demographics and injury-related data were collected, and the participants answered standardized, self-reported questionnaires 6-18 months post-injury that assessed mental health; general health; family functioning, communication, and satisfaction; depression and anxiety; self-efficacy; resilience; and condition-specific quality of life. The patients reported significantly worse mental health, depression, resilience, self-efficacy, and general health compared with the family members. Patients and family members had similar perceptions, showing balanced family functioning, high family communication levels, and moderate family satisfaction. Factors significantly associated with mental health in patients and family members were depression, anxiety, and resilience, explaining 56% of the variance (p < 0.001). Family-related factors were not associated with mental health. The disease burden was mainly on the patients; however, the family members also reported emotional distress. Family-targeted interventions across the TBI continuum should be considered.
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Introduction/Background Disability following traumatic brain injury (TBI) is multidimensional, affecting those injured and their family members. The family as a whole is seldom recognized as an arena for rehabilitation efforts. The aim of this study was to evaluate the feasibility of an eight-session, manualized multidisciplinary family-centred rehabilitation intervention for families facing TBI, aimed at improving individual and family functioning. We evaluated the families’ willingness to participate; the appropriateness of inclusion criteria; the need for cultural adjustment of the intervention; the collaboration with municipal health care service and the leadership structure of the sessions; and the appropriateness of the selected self-reported questionnaires for data collection. Material and method Two families, six people, participated in this non-randomized feasibility study of the intervention arm of a full-scale RCT, conducted at the University Hospital in Oslo, Norway ( #NCT03000400). The study was performed in close collaboration with a municipal health care service. Pre-defined success criteria were determined prior to conducting the feasibility study. The evaluation of these criteria was based on the families’ feedback regarding acceptability of the intervention, the self-report measures and the experiences of the group facilitators conducting the intervention. Results The pre-defined succes criteria were fulfilled. Both families completed all eight sessions of the intervention. Minor cultural differences were detected, however, the topics and strategies covered in the intervention were perceived as relevant and recognizable. Some challenges emerged and were discussed before commencing the full-scale RCT. The challenges were related to the logistics regarding the delivery of the intervention. This pertained to keeping an acceptable level of burden of participation for the families and the collaborating municipal health professionals, and making the necessary adjustments of the intervention to suit the families’ unique needs. Conclusion The family-centred intervention and trial procedures were feasible. A pragmatic approach is considered necessary when commencing the full-scale RCT.
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Insufficient attention towards caregivers has resulted in the emergence of psychological and health complaints. Affliction tethers more towards spouses as compared to parents and females as compared to males. The role of sibling care givers was found to be no different from parents or spouses. Marital relationships were found to suffer the most, with the caregiver leaving the traumatic brain injury (TBI) patient in his time of need. The Brief Symptom Inventory (BSI) and family assessment device (FAD) predicted a correlation between patient variables and caregiver discontent. The Blacks/Hispanics proved to cope better with stress and their caregiver roles as compared to Whites. Time elapsed since the injury was found to relieve distress, while the surprising severity of the injury has no recorded impact. Social support or rather a lack of it has been seen to have an impact on family homeostasis, which can further be deteriorated by substance abuse by the patient. The therapeutic intervention found to be most advantageous was the D'Zurilla and Nezu social problem-solving model. Current evidence suggests that emphasis should be given on proper education and encouragement of caregivers before discharge of TBI patients from hospital to reduce the incidence of stressors. Additionally, counseling sessions should be led by professionally led support groups for dealing with psychological symptoms and peer-led group to eliminate social insecurities of caregivers.
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Introduction To develop occupational therapy’s evidence base and improve its clinical outcomes, occupational therapists must increase their research involvement. Barriers to research consumption and leadership are well documented, but those relating to delivering research interventions, less so. Yet, interventions need to be researched within practice to demonstrate their clinical effectiveness. This study aims to improve understanding of challenges and enablers experienced by occupational therapists who deliver interventions within research programmes. Method Twenty-eight occupational therapists who participated in the Valuing Active Life in Dementia (VALID) research programme reported their experiences in five focus groups. Data were analysed thematically to identify key and subthemes. Results Occupational therapists reported that overwhelming paperwork, use of videos, recruitment and introducing a new intervention challenged their research involvement, whereas support, protected time and a positive attitude enabled it. The impact of these challenges and enablers varied between therapists and organisations. Conclusion Challenges and enablers to research involvement can be identified but must be addressed within individual and organisational contexts. Multifaceted collective action to minimise challenges and maximise enablers can facilitate clinicians’ involvement in research. Using this approach should enable occupational therapists to increase their research involvement, thus demonstrating the clinical effectiveness of their interventions.
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Background Consequences after Traumatic brain injury (TBI) affect the injured person’s self-image and quality of life. The purpose was to assess the health related quality of life (HRQoL) at 12 months after a TBI in patients admitted to regional trauma centres, and to evaluate the metric properties of the Norwegian version of the Quality of Life After Brain Injury (QOLIBRI) questionnaire. Methods Two hundred four patients with TBI of all severities were included. HRQoL at 12 months post-injury was measured by the QOLIBRI. It has a total scale and 6 subscales (satisfied with Cognition, Self, Daily Life and Autonomy and Social Relationships, and bothered by Emotions and Physical Problems). Demographic and injury related data were registered. Disability was registered by Glasgow Outcome Scale Extended (GOSE) and Rivermead Post-Concussion Questionnaire, and mental health by Hospital Anxiety and Depression Scale. Descriptive statistics, internal consistency by Cronbach’s alpha and Corrected Item-Total Correlations were calculated. Rasch analysis, Principal Component Analysis (PCA) and Structural Equation Modelling (SEM) were applied. Results Mean age was 37.6 (SD 15.4) years; 72% were men, and 41% had higher education. Over 60% were severely injured. Mean Glasgow Coma Scale score was 9.3 (SD 4.5). According to the GOSE 5.9% had severe disability, 45.5% had moderate disability, and 48.5% had good recovery at 12 months post-injury. The QOLIBRI scales had a high internal consistency (α = 0.75–0.96), and only Physical Problems had an α < 0.85. In the Rasch analysis all subscales and their items fit the Rasch model, except for the depression item in the Emotion subscale. PCA and SEM analyses supported a six-factor structure in a second-order latent model. The QOLIBRI supports an underlying unidimensional HRQoL model. The SEM model fit statistics of the second-order model indicated a moderate fit to the observed data (CFI = 0.86, TLI = 0.85, RMSEA = 0.076, SRMR = 0.061, χ² = 1315.76, df = 623, p-value < 0.001). Conclusion The Norwegian QOLIBRI has favourable psychometric properties, but there were some weaknesses related to its measurement properties of the total score when tested on a TBI population where many had severe TBI, and many had good recovery.
Objective: To describe and synthesize the existing literature of published adult TBI family caregiver and dyad intervention studies. Traumatic brain injuries (TBIs) are common and have a significant long-term impact, with some characterizing TBI as a chronic condition. Informal family caregivers of adults with TBI suffer from high rates of burnout, depression, fatigue, anxiety, lower subjective well-being, and poorer levels of physical health compared to non-caregivers. There is a critical gap in the understanding of interventions designed to address the impact of TBI on adult patients and their family caregivers. Data sources: PubMed and Medline STUDY SELECTION: Studies were selected using the following criteria: 1) English language 2) quasi-experimental or experimental design 3) subjects were TBI caregivers, survivors with heavy involvement of caregivers, or caregiver dyads 4) moderate and severe TBIs and 5) described an intervention that was implemented during some portion of the TBI care continuum. Data extraction: The search identified 2171 total articles. After duplicates were removed, additional screening, and application of inclusion and exclusion criteria, we identified 14 studies that met criteria for inclusion. 10 were randomized clinical trials and 4 were non randomized quasi-experimental studies. A secondary search to describe studies that included individuals with other forms of acquired brain injury in addition to TBI resulted in 852 additional titles, of which 5 met inclusion for review. Data synthesis: Interventions that targeted the caregiver primarily were more likely to provide benefit than those that targeted caregiver/survivor dyad or the survivor only. Many of the studies were limited by poor fidelity, low sample sizes, and high risk for bias based on randomization techniques. Conclusions: Future studies should enroll a more generalizable number of participants, and ensure adequate fidelity to properly compare interventions.
Objective: To examine the needs of family members in an inpatient setting and factors predicting extent to which needs are perceived as met. Setting: University health system inpatient rehabilitation unit. Participants: Adult survivors of traumatic brain injury and family members (n = 85). Design: Prospective, cross-sectional. Main measure: Family Needs Questionnaire-Revised (FNQ-R). Results: Needs related to the Health Information subscale were most frequently rated as met, whereas needs related to the Instrumental Support and Emotional Support subscales were most frequently rated as unmet. Predictors related to the FNQ-R included family income, gender, and ethnicity. For 4 of 6 subscales, white family members were more likely to rate needs as unmet than minority members. For 3 subscales, females were more likely to rate needs as unmet than males. Greater household income was associated with fewer met needs for 2 subscales. Conclusions: The ranking of met and unmet needs in the present study was remarkably similar to previous studies within and outside the United States. Clinicians should not assume that families with relatively higher incomes will experience fewer unmet needs. Through structured assessment, clinicians can reveal perceived needs that might have otherwise been unrecognized and facilitate appropriate supports. Findings provide direction for inpatient program development.
Traumatic brain injury (TBI) is a serious healthcare problem, and this report is a selective review of recent findings on the epidemiology, pathophysiology and neuropsychological impairments following TBI. Patients who survive moderate-to-severe TBI frequently suffer from a wide range of cognitive deficits and behavioral changes due to diffuse axonal injury. These deficits include slowed information-processing and impaired long-term memory, attention, working memory, executive function, social cognition and self-awareness. Mental fatigue is frequently also associated and can exacerbate the consequences of neuropsychological deficits. Personality and behavioral changes can include combinations of impulsivity and apathy. Even mild TBI raises specific problems: while most patients recover within a few weeks or months, a minority of patients may suffer from long-lasting symptoms (post-concussion syndrome). The pathophysiology of such persistent problems remains a subject of debate, but seems to be due to both injury-related and non-injury-related factors.
The purpose of this commentary is to outline the challenges encountered when conducting clinical trials of interventions for pediatric traumatic brain injury (TBI) and share potential solutions for surmounting these issues. This commentary grows out of our experience implementing 8 randomized clinical trials (RCTs) of family-centered interventions to reduce child behavior problems and caregiver/parent distress following pediatric brain injury. These studies, involving more than 600 participants from 8 clinical centers, support the feasibility of conducting RCTs with children who have sustained TBIs while highlighting potential challenges and threats to validity. The challenges of behavioral trials for pediatric TBI are apparent but not insurmountable. Careful consideration of the clinical trial issues outlined in this commentary can inform design choices and analyses when planning a clinical trial. It is critically important that investigators share their failures as well their successes to move the field of pediatric TBI intervention research forward.
Nurses are becoming increasingly involved in conducting clinical research in which feasibility studies are often the first steps. Understanding why and how these studies are conducted may encourage clinical nurses to engage with researchers and take advantage of opportunities to participate in advancing nursing science. This article provides an overview of feasibility studies, including pilot studies, and explains the type of preliminary data they seek to provide in order to make larger, future studies more efficient and successful. By way of example, the authors discuss a feasibility study they conducted that illustrates the key components and necessary steps involved in such work.
Primary objectives: To assess longitudinal trajectories of overall disability after moderate-to-severe traumatic brain injury (TBI) and to examine whether those trajectories could be predicted by socio-demographic and injury characteristics. Methods: Demographics and injury characteristics of 105 individuals with moderate-to-severe TBI were extracted from medical records. At the 1-, 2-, and 5-year follow-ups, TBI-related disability was assessed by the GOSE. A hierarchical linear model (HLM) was used to examine functional outcomes up to 5 years following injury and whether those outcomes could be predicted by: time, gender, age, relationship, education, employment pre-injury, occupation, GCS, cause of injury, length of post-traumatic amnesia (PTA), CT findings and injury severity score, as well as the interactions between each of these predictors and time. Results: Higher GOSE trajectories (lower disability) were predicted by younger age at injury and shorter PTA, as well as by the interaction terms of time*PTA and time*employment. Those who had been employed at injury decreased in disability over time, while those who had been unemployed increased in disability. Conclusion: The study results support the view that individual factors generally outweigh injury-related factors as predictors of disability after TBI, except for PTA.