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17. Assessment of Outcomes Following Acquired Brain Injury

Abbreviations

ABI Acquired Brain Injury
ABS Agitated Behavior Scale
ADL Activities of Daily Living
BBS Berg Balance Scale
BDI Beck Depression Inventory
BI Barthel Index
CBMS Community Balance and Mobility Scale
CHART Craig Handicap Assessment and Reporting Technique
CIQ Community Integration Questionnaire
DRS Disability Rating Scale
FAM Functional Assessment Measure
FIM Functional Independence Measure
FSS Fatigue Severity Scale
GCS Glasgow Coma Scale
GOS Glasgow Outcome Scale
GOSE Glasgow Outcome Scale – Extended
GOAT Galveston Orientation and Amnesia Test
HADS Hospital Anxiety and Depression Scale
HRQoL Health-Related Quality of Life
ICC Intra-Class Correlation Coefficient
LCFS Rancho Los Amigos Levels of Cognitive Functioning Scale
LHS London Handicap Scale
MADRS Montgomery-Asberg Depression Rating Scale
MCS Mental Component Scale of the Medical Outcomes Survey SF-36
MFIS Modified Fatigue Impact Scale
MMSE Mini Mental State Examination
MOS SF-36 Medical Outcome Survey Short Form 36
3MS Modified Mini Mental State Examination
MPAI Mayo Portland Adaptability Inventory
NFI Neurobehavioural Functioning Inventory
OPCS The Office of Population Consensus and Survey
PCS Physical Component Scale
PTA Post Traumatic Amnesia
QOLIBRI Quality of Life After Brain Injury
SWLS Satisfaction With Life Scale
TBI Traumatic Brain Injury
WAIS Wechsler Adult Intelligence Scale

Key Points

No Key Points in this Module

Introduction

The following chapter is a review of measurement tools used to assess individuals after a brain injury. The list of tools appearing here was derived by a consensus of experts working on the Evidence-Based Review of Acquired Brain Injury (ABI) literature.

The tools were chosen based on a 3-step process. The first was the development of an inventory of current outcome measures based on both the literature and discussions held with rehabilitation team members who actually use the tools. The second was a consensus agreement among a panel of experts as to which tools are most important. Finally, there had to be sufficient research on the outcome measure in ABI populations to allow a meaningful analysis of the psychometric qualities of the tools. Those outcome measures that made it through this process were selected for review. An exhaustive list of outcome tools is not listed here as there are over 700 measures related to function following TBI (Tate et al., 2013).

17.1.1 Evaluation Criteria for Outcome Measures

It is necessary to have a set of criteria to guide the selection of outcomes measures. Reliability, validity and responsiveness have widespread use and are discussed as being essential to the evaluation of outcome measures (Duncan et al., 2002; Law, 2002; Roberts & Counsell, 1998; van der Putten et al., 1999). Finch et al. (2002) provide a good tutorial on issues for outcome measure selection.

The Health Technology Assessment programme (Fitzpatrick et al., 1998) examined 413 articles focusing on methodological aspects of the use and development of patient-based outcome measures. In their report, they recommend the use of eight evaluation criteria (Table 17.2).  These criteria, including some additional considerations described below, were applied to each of the outcome measures reviewed in this chapter.

17.2 Agitated Behavior Scale

The Agitated Behavior Scale (ABS) was designed to assess agitation in patients who had sustained a TBI (Corrigan, 1989). According to Levy et al. (2005), despite the availability of the scale, agitation remains unmeasured by most who work with the TBI population. The scale, which began as a 39-item scale, was reduced to 14 items, with each item scored from 1 (absent) to 4 (present to an extreme degree). The scale which was originally tested by nurses, occupational therapists, physiotherapists, and other hospital staff was designed to be used by allied health professionals (Corrigan, 1989). The total score, which is considered the best overall measure of the degree of agitation, is calculated by adding the ratings (from one to four) on each of the 14 items. The scale can also be divided into three subscales. The Disinhibition subscale includes items 1, 2, 3, 6, 7, 8, 9, and 10; the Aggression subscale includes items 3, 4, 5 and 14; and the Lability subscale includes items 11, 12, and 13 (Corrigan & Bogner, 1994). Individual scores of ≥22 on the ABS indicate high agitation, conversely scores of ≤21 indicate low agitation (Corrigan & Mysiw, 1988).

Advantages

This scale was designed to be used specifically with those who had sustained a TBI (Corrigan, 1989). The ABS has also been tested with a group of individuals living in a long term care facility and has demonstrated strong internal consistency and inter-rater reliability (Bogner et al., 1999). Bogner et al. (2001) found that there was a strong relationship between cognition and agitation. Higher scores on the MMSE and the Functional Independence Measure (FIM) cognitive subscales were significantly related to lower scores on the ABS (Bogner et al., 2001; Corrigan & Bogner, 1994). Administering the scale requires little time and can be completed in less than 30 minutes. Agitation is considered to be present if the score is >21 (Corrigan & Bogner, 1995). The scale is free of cost and readily available at www.tbims.org/combi/abs/abs.pdf.

Limitations

The ABS has yet to be validated throughout a wider range of rehabilitation facilities (Corrigan & Bogner, 1995). As well, one of the more significant limitations of the ABI is the risk of over-diagnosing agitation (Corrigan & Mysiw, 1988).

Summary-ABS

  • Interpretability: Scores on the ABS are easy to interpret: severely agitated ≥36, moderately agitated 29-35, mildly agitated 22-28, and not agitated <22 (Bogner et al., 2000).
  • Acceptability: The scale is available free of charge and requires little time for training and administration.
  • Feasibility: The ABS requires little time to complete and can be completed by all health professionals working with the patient.

17.3 Berg Balance Scale

The Berg Balance Scale (BBS) provides a quantitative assessment of balance in older adults (Berg et al., 1989). It was intended for use in monitoring the clinical status of patients for effectiveness of treatment interventions over time (Berg et al., 1995).

The scale consists of 14 items requiring subjects to maintain positions or complete movement tasks of varying levels of difficulty. All items on the test are common to everyday life. Administration of the scale requires a ruler, stopwatch, chair, step or stool, space to turn 360° and 10-15 minutes. It is administered via direct observation of task completion and items are scored 0-4 based on the ability of the individual to meet the specific time and distance requirements of the test (Berg et al., 1995; Juneja et al., 1998).  A score of zero represents the inability to complete the item and a score of 4 represents the ability to complete the task independently. It is generally accepted that total scores below 45 indicate balance impairment (Berg et al., 1992b; Zwick et al., 2000). Despite the use of this scale, all but one study (Feld et al., 2001) examined psychometric properties among a stroke or older adult population. Therefore, caution is advised when making generalizations to an ABI population.

Limitations

The BBS has been thoroughly evaluated for use among populations of individuals who have experienced stroke. At present, information regarding the reliability and validity of the BBS when used among patients with TBI/ABI is severely limited.

No common interpretation exists for BBS scores, their relationship to mobility status, and the use of mobility aides (Wee et al., 2003). The rating scales associated with each item, while numerically identical, have different operational definitions for each number or score. A score of 2, for example, is defined differently and has a different associated level of difficulty from item to item (Kornetti et al., 2004). There is also no common score associated with successful item completion (Kornetti et al., 2004). Use of an overall score that adds ratings with different meanings having no common reference point may not be appropriate as interpretation is difficult and very little functional information is provided about the individual patient (Kornetti et al., 2004). The BBS requires a minimal detectable change of 6 points at a 90% confidence interval (Stevenson, 2001).

A recent Rasch analysis of the BBS revealed that some item ratings were not used at all or were underutilized, and others were unable to distinguish between individuals with different levels of ability (Kornetti et al., 2004). Collapsing rating scales to eliminate infrequently endorsed categories and creating a common pass/fail point for each item resulted in changes to the ordering of item difficulty, reduced tendencies for ceiling effects and an improved functional definition of the 45/56 cut-off point (Kornetti et al., 2004).

Summary-Berg Balance Scale

  • Interpretability: There are no common standards for the interpretation of BBS scores, though there is an accepted cut-off point for the presence of balance impairment.
  • Acceptability: This direct observation test would not be suited for severely affected patients as it assesses only one item relative to balance while sitting. Active individuals would find it too simple. The scale is not suited for use by proxy.

Feasibility: The BBS requires no specialized training to administer and relatively little equipment or space.

17.4 Community Balance and Mobility Scale

The Community Balance and Mobility Scale (CBMS) is a performance-based measure intended to evaluate balance and mobility skills in individuals who have experienced mild to moderate traumatic brain injury (TBI) (Inness, 1999). The scale is comprised of 13 items, each of which are rated on a 6-point scale from 0 to 5, where 5 represents the most successful completion of the scale item (Butcher et al., 2004; Inness, 1999).

Advantages

The CBMS is a measure developed specifically for use in assessment of individuals who have sustained mild to moderate TBI. It may have increased sensitivity to change when used within this population when compared to more established measures such as the Berg Balance Scale (Inness et al., 2011).

Limitations

The scale may be assessing a construct more similar to “dynamic mobility” rather than balance per se (Inness et al., 2011). The information available in the literature with regard to the reliability, validity or practical application of this scale is extremely limited and arises from the original authors only. Additional evaluation of the CBMS’ psychometric properties is required. The CBMS is not appropriate for use on individuals with severe ABIs in which ambulation is affected because the CBMS was developed for people who are ambulatory (Innes et al. 1999).

Summary-Community Balance and Mobility Scale

  • Interpretability: Not enough information available.
  • Acceptability: Not enough information available.
  • Feasibility: Not enough information available.

17.5 Community Integration Questionnaire

The Community Integration Questionnaire (CIQ) (Willer et al., 1993) was intended as a brief assessment of community integration or the degree to which an individual after a TBI is able to perform appropriate roles within the home and community. To achieve higher levels of reliability, the CIQ uses behavioural indicators of integration and does not include items focused on feelings or emotional status (Dijkers, 1997; Willer et al., 1994). The CIQ was developed for inclusion in the National Institute on Disability and Rehabilitation Research TBI model systems National Data Base in the United States (Dijkers, 1997).

The CIQ assesses handicap, which is viewed by the scale authors as the opposite of integration in three domains: home Integration (i.e. active participation in the operation of the home or household), social Integration (i.e. participation in social activities outside the home) and productivity (i.e. regular performance of work, school and/or volunteer activities) (Willer et al., 1993). The scale is comprised of 15 items in three corresponding subscales each of which has a different number of items and sub-scores (Sander et al., 1999; Willer et al., 1994). The Home Integration subscale consists of 5 items each scored on a scale from 0-2, where 2 represents the greatest degree of integration. The Social Integration subscale is comprised of 6 items rated in the same manner as Home Integration whereas the Productivity subscale consists of 4 questions with responses weighted to provide a total of 7 points. Scores from each of the subscales are summed to provide an overall CIQ score. The maximum possible score is 29, which reflects complete community integration (K. Hall et al., 1996a).

The CIQ may be completed individually, face-to-face, or through telephone interviews (K. Hall et al., 1996a). If the individual with TBI is unable to complete the assessment, the questionnaire may be completed by proxy (Willer et al., 1994). There are two versions of the questionnaire available, one for completion by the person with TBI and one for completion by a suitable proxy (family member, close friend, significant other) (Sander et al., 1999). The CIQ requires approximately 15 minutes to complete (K. Hall et al., 1996a; Zhang et al., 2002).

Advantages

The CIQ has become one of the most widely used tools in the assessment of community integration for people who have experienced TBI. The scale was originally developed via an expert panel that included individuals with TBI, suggesting that items have face validity (Willer et al., 1994; Willer et al., 1993). The scale can be completed quickly and easily by most individuals with TBI or by an appropriate proxy. The scale focuses more on behaviour than emotional states, which promotes better agreement between patient and proxy ratings (Cusick et al., 2000; Dijkers, 1997).

Limitations

While the CIQ was developed to assess handicap (as defined by WHO under the International Classification of Impairments, Disabilities and Handicaps), the CIQ does not appear to assess all of the domains included in the definition (Dijkers, 1997). Under the current definitions provided by the International Classification of Functioning, Disability and Health (WHO, 2001), CIQ items may reflect activities more than participation (Kuipers et al., 2004). The reduction of items from 47 to 15 based on factor analysis excluded items not loading onto one of the three predetermined factors that might have provided a more comprehensive assessment of handicap and/or participation. It should be noted that the factor analysis used to eliminate scale items was based on scale scores from an extremely small sample (n=49) of individuals with severe TBI (Dijkers, 1997; Willer et al., 1993). Lequerica et al. (2013) discovered that the CIQ is most effective when used to assess Caucasians in comparison to Black and Hispanic populations.

The CIQ does not measure integration skills, the success of integration activities from the point of view of the individual with TBI, nor the feelings or meaning associated with integration activities (Willer et al., 1993; Zhang et al., 2002). What the CIQ measures appears to be somewhat inconsistent. Some items measure the frequency with which activities are performed, while others measure the assistance or supervision required in order to perform an activity (Dijkers, 1997; Zhang et al., 2002). In addition, the CIQ social integration subscale does not relate to other measures of social integration in the expected way. The CIQ social integration subscale appears inconsistently related to the CHART social interaction subscale (Willer et al., 1993; Zhang et al., 2002) and only weakly related to the FIM social interaction item (Sander et al., 1999). It has been suggested that all three may be measuring slightly different constructs. The FIM examines appropriateness of interaction while CHART assesses the size and composition of social networks. The CIQ does not assess either of these aspects of social integration (Sander et al., 1999).

Age, gender and level of education have all been reported to have an effect on CIQ scores. Dijkers (1997) reviewed four studies that reported the effects of age and it generally appeared as though scores for women indicated greater integration into the home, while male scores typically suggested more integration into the productivity domain. Kaplan (2001) demonstrated similar effects of gender around home integration in a sample of individuals with malignant brain tumours. It has been suggested that a lack of more traditional, male household tasks may account for some of the reported differences in home integration (Dijkers 1997). The CIQ separates the activities of running a household from other productive activity. Therefore it may penalize individuals who were and continue to be homemakers.  It may also penalize those individuals with family members who have always shared in home-making activities (Kaplan, 2001). It has been suggested that this bias could be ameliorated by conducting a retrospective, pre-morbid assessment to provide a basis for comparison (Sander et al. 1999).

In his 1997 review, (Dijkers) reported a tendency for younger age to be associated with greater integration on the CIQ. Kaplan (2001) reported that older age was significantly related to poorer community integration both for the total CIQ and for each subscale. In addition to age and gender, amount of education appears to have an effect on community integration as assessed by the CIQ. More education is associated with better integration in all three dimensions ((Heinemann & Whiteneck, 1995; Kaplan, 2001). Gender roles, age and education differences all impact the CIQ differently. These differences need to be reflected in the scale through the development of age-appropriate norms stratified by education, gender and marital status (Dijkers, 1997; Kaplan, 2001; Sander et al., 1999).

In an assessment of the factor structure and validity of the CIQ, Sander et al. (1999)Sander et al. (1999) identified two items that appeared problematic. It was recommended that the childcare item and the frequency of shopping item both be removed. The childcare item is frequently not applicable and appears to penalize people who have no children in the home while the shopping item loaded significantly on two of the three identified factors and did not contribute any unique information to the sale (Sander et al. 1999).

Summary-Community Integration Questionnaire

  • Interpretability: The CIQ is widely used. However, no norms are currently available. There is no basis for determining that an individual’s level of integration on the CIQ is or is not normal (Dijkers, 1997).
  • Acceptability: The scale is short and simple and represents little patient burden. It has been used successfully with proxy respondents.
  • Feasibility: No special training is required to administer the CIQ. The scale is free, but should be requested from the scale author. It has been used in longitudinal studies to show change over time.

17.6 Disability Rating Scale

The Disability Rating Scale (DRS) was developed to provide quantitative information regarding the progress of individuals with severe head injury from “coma to community” (Rappaport et al., 1982). The DRS was designed to reflect changes in the following areas: arousal and awareness, cognitive ability to deal with problems around self-care, degree of physical dependence, and psychosocial adaptability as reflected in the ability to do useful work (Rappaport et al., 1982). The DRS was developed and tested in a rehabilitation setting among individuals who had experienced moderate to severe TBI (Hall, 1997).

The DRS is comprised of eight items in four categories: i) level of consciousness; ii) cognitive abilities; iii) dependence on others; and iv) employability (Rappaport et al., 1982). Each item has its own rating scale ranging from 0-3 to 0-5 and are either in ½-point or 1-point increments. Rating forms are available for download at http://tbims.org/combi/drs/drsrat.htm. The total or composite score is calculated by summing the ratings for all 8 items, so that lower scores are associated with less disability. The overall score can be used to assign the individual to one of 10 disability outcome categories ranging from no disability (DRS score=0) to extreme vegetative state (DRS score=29) and death (DRS=30) ((Fleming & Maas, 1994; K. M. Hall et al., 1996)

The DRS is available at no cost and is free to copy. It may be downloaded from http://tbims.org/combi. Training materials are also provided on the same website and a training video is available for a modest fee. Administration of the scale may be via direct observation or interview(Hall et al., 1993)  (Hall et al., 1993). When necessary, collateral sources of information may be used to complete the ratings (Rappaport et al., 1982). The DRS is simple to administer and requires approximately 5 minutes to complete (Hall et al., 1993; Hall, 1997).

Advantages

The DRS is a single assessment comprised of items spanning all major dimensions of impairment, disability and handicap (K. Hall et al., 1996b; Rappaport et al., 1982). It is a brief and simple tool that allows for the ongoing assessment of recovery from injury to community re-integration. In addition, the ability to assign scores to outcome category with relatively little loss of information (Gouvier et al., 1987) provides a quick snapshot of the individual’s overall disability status (Hall et al., 1993). The DRS appears to be more reliable and valid than the Level of Cognitive Functioning Scale (LCFS) and may be more sensitive to change than categorical rankings such as the Glasgow Outcome Scale (GOS) (Hall et al., 1985). In addition, Glasgow Coma scores can be obtained from the DRS (Hall, 1997).

Limitations

Descriptions of what corresponds to successful item performance at each rating level are not precise and subscales do not clearly identify areas for intervention (Brazil, 1992). The sequelae of head injury that are included for assessment are limited and do not include formal cognitive assessment (Brazil, 1992). The DRS assesses only general rather than specific function or functional change (Hall & Johnston, 1994). It may be most useful as a means to characterize sample severity and provide the means for comparison to other groups, but it is not particularly sensitive to the effects of treatments designed to ameliorate specific functional limitations or social participation (Hall et al., 1993). In inpatient rehabilitation settings, the FIM is a more sensitive instrument with which to monitor change (Hall & Johnston, 1994).

The DRS is not well suited to patients with mild TBI or very severe impairments (Hall et al., 1993; K. Hall et al., 1996b; Wilson et al., 2000). It has been recommended that ½ point scoring increments rather than whole points should be employed in order to increase the precision and sensitivity of the instrument when assessing higher functioning individuals (Hall et al., 1993). When subjects do not fit whole-point definitions for cognitive ability for self-care items, dependence on others and employability, ½ points can be awarded; total scores with ½ points are rounded down for the purposes of assignment to outcome category (Hammond et al., 2001). The rating form available for download has included the ½ point scoring option. When using the ½ point scoring option, the DRS does appear to be sensitive to change between discharge and one-year and even 5-year follow-ups. However, year-by-year change is not captured by DRS ratings more than one year post-injury (Hammond et al., 2001).

Summary-DRS

  • Interpretability: The DRS is widely used and is part of the TBI Model Systems Database. It provides a quick, accessible snapshot of outcomes of disability in terms of general function.
  • Acceptability: The simplicity and brevity associated with the DRS would suggest little to no patient burden associated with its administration. Ratings provided by family members are strongly correlated with those completed by healthcare team members.
  • Feasibility: The DRS is free to use and copy. Training materials are also provided free of charge and a training video is available for a modest fee. The DRS seems to be able to detect significant change over time and may be well suited for group comparisons.

17.7 Fatigue Severity Scale

Fatigue is essentially a subjective experience and often hard to measure even though it can be a major source of disablement (Belmont et al., 2006; Dittner et al., 2004). Individuals who sustain a TBI, regardless of the level of injury, often report fatigue as a constant or recurrent problem post injury (Belmont et al., 2006; Borgaro et al., 2005). Ziino and Ponsford (2005) found activities that required mental or physical effort often resulted in increased levels of fatigue.

Fatigue Severity Scale (FSS) is a self-report questionnaire designed to assess disabling fatigue in all individuals (Krupp et al., 1989). The scale was designed to investigate fatigue/function measures, that is, the connection between fatigue intensity and functional disability (Dittner et al., 2004; Taylor et al., 2000).The FSS, which consists of nine questions, uses a 7-point Likert scale ranging from strongly disagrees to strongly agree (see below). The scores from each question are totalled with lower scores indicating less fatigue in everyday life. The total score for the FSS is calculated as the average of the individual item responses. Although the FSS was originally designed to assess fatigue in individuals with multiple sclerosis, it has been found to be sensitive to fatigue in those with a TBI (Ziino & Ponsford, 2005).

Advantages

The FSS scale is a self-report scale that is easy to administer and can be completed quickly with minimal effort (Burger et al., 2010; LaChapelle & Finlayson, 1998). The scale can be accessed and downloaded for free from www.saintalphonsus.org/documents/boise/sleep-Fatigue-Severity-Scale.pdf.

Limitations

Although the overall score of the FSS is beneficial in comparing between groups, the individual questions are not able to do so (LaChapelle & Finlayson, 1998). Because no two fatigue scales measure the same construct, it is strongly recommended that the user understand what aspect of fatigue they want to assess and why, whether or not a unidimensional or multidimensional scale should be used, and whether the scale would be beneficial to the population of interest (Dittner et al., 2004). Another major concern with the scale is the use of a 7-point Likert scale (completely disagree to completely agree). It is believed that ≥6 categories on any rating scale obscures the distinction between the categories. The collapsing of the options to three (i.e., disagree, neutral, agree) may improve the measure (Burger et al., 2010). The FSS has not been found to be a good instrument for measuring cognitive levels of fatigue (Amtmann et al., 2012).

Summary-FSS

  • Interpretability: The FSS has been shown to be a valid and reliable scale for several populations including the ABI population (Ziino & Ponsford, 2005). Regardless, the scores on the FSS are easy to interpret and are used to assess patients for fatigue post injury. Items on the scale can be open to interpretation as the word fatigue may mean something different to each individual (Burger et al., 2010).
  • Acceptability: The scale has been shown to be both valid and reliable with a variety of populations. It has been shown to have good internal consistency and is sensitive to change in fatigue levels over time.
  • Feasibility: The FSS is a self-administered scale that does not require any training to use and is available in several languages.

17.8 Functional Independence Measure

Developed in 1987, in part as a response to criticism of the Barthel Index, the Functional Independence Measure (FIM) was intended to address issues of sensitivity and comprehensiveness as well as provide a uniform measurement system for disability for use in the medical remuneration system in the United States (McDowell & Newell, 1996). Rather than independence or dependence, the FIM assesses physical and cognitive disability in terms of burden of care, meaning the FIM score is intended to represent the burden of caring for that individual.

The FIM is a composite measure consisting of 18 items assessing six areas of function (i.e. self-care, sphincter control, mobility, locomotion, communication and social cognition). These fall into two basic domains: 1) physical (13 items) and 2) cognitive (5 items). The 13 physical items are based on those found on the Barthel Index (BI), while the cognitive items are intended to assess social interaction, problem-solving and memory. The physical items are collectively referred to as the motor-FIM while the remaining 5 items are referred to as the cognitive-FIM. The scale has not been found to fit with the Rasch model with MS patients (Mills et al., 2009).

Each item is scored on a 7-point Likert scale indicative of the amount of assistance required to perform each item (1=total assistance, 7=total independence). A simple summed score of 18-126 is obtained where 18 represents complete dependence/total assistance and 126 represents complete independence. Subscale scores for the physical and cognitive domains may also be used and may yield more useful information than combining them into a single FIM score (Linacre et al., 1994).

Administration of the FIM requires training and certification. The most common approach to administration is direct observation and the FIM takes approximately 30 minutes to administer and score. The developers of the FIM further recommend that the rating be derived by consensus opinion of a multi-disciplinary team after a period of observation.

Advantages

The FIM is a widely used, well-accepted, generic measure of burden of care used in inpatient rehabilitation settings. In clinical assessment, the greater number of items and wider choice of responses per item may yield more detailed information on an individual basis than assessments, such as the Barthel Index, with fewer items and response options (Hobart et al., 2001).

Limitations

The reliability of the FIM is dependent upon the individual conducting the assessment. Training and education in administration of the test is a pre-requisite for good levels of inter-rater reliability (Cavanagh et al., 2000) (stroke). Length of time and amount of training required to arrive at a consensus score, as recommended by the developers of the FIM, may have significant implications for the practical application of the FIM in clinical practice.

The use of a single summed raw score may be misleading as it gives the appearance of a continuous scale. Steps between scores, however, are not equal in terms of level of difficulty and cannot provide more than ordinal level information (Linacre et al., 1994). Kidd et al. (1995) (varying etiologies) suggested that one may use the summed scores as though on an interval level scale while the individual items remain ordinal.

Kidd et al. (1995) suggest that the inclusion of items related to communication and cognition as well as the ranking of 7 levels of severity for each item make the FIM more sensitive and inclusive. However, the contribution of the cognitive subscale to the scale as a whole is questionable. It has been shown to have less reliability and responsiveness than either the motor FIM or the total FIM (Hobart et al., 2001; Ottenbacher et al., 1996; van der Putten et al., 1999).

In an evaluation of responsiveness, FIM, motor FIM and the BI were all found to have similar effect sizes. The total-FIM was reported to exhibit no ceiling effect, 0% as compared to the BI’s 7% (van der Putten et al., 1999). This would suggest that the FIM might have no real advantage in terms of responsiveness to change despite having more items and a more precise scoring range for each item.

The FIM includes only five items to assess cognition. This limited cognitive assessment may be inadequate for the assessment of individuals who have experienced TBI (Hall & Johnston, 1994). In addition, the FIM is intended to be used in an inpatient rehabilitation setting and is not well suited to ongoing, long-term assessment in community-based settings ((Gurka et al., 1999); TBI).

Summary-Functional Independence Measure

  • Interpretability: The FIM has been well studied for its validity and reliability. It is widely used and has one scoring system, increasing the opportunity for comparison. It is important to remember when interpreting FIM scores that it is an ordinal level scale, not continuous.
  • Acceptability: Multiple modes in which this measure could be administration have been assessed, including through telephone interviews. The FIM has also been studied for use by proxy respondent.
  • Feasibility: Training and education of persons to administer the FIM, in addition to the price of the scale itself, may represent significant cost. Use of interview formats may make the FIM more feasible for longitudinal assessment.

17.9 Functional Assessment Measure

The Functional Assessment Measure (FAM) was created specifically for use with patients who have sustained a brain injury, in an attempt to enhance the appropriateness of the FIM for this specific population (Alcott et al., 1997; Hall et al., 1993; Hobart et al., 2001). The FIM contains only five cognitive items, which may limit its content validity in TBI populations (Hall & Johnston, 1994). The FAM does not stand alone as an assessment tool, but rather consists of 12 items that are added to the 18 FIM items. The 12 additional items were developed by a team of clinicians representing each of the disciplines in a rehabilitation model (Hall et al., 1993) and are intended to emphasize cognitive, communicative and psychosocial function (McPherson et al., 1996).

The 12 FAM items include swallowing, car transfer, community access, reading, writing, speech intelligibility, emotional status, adjustment to limitations, employability, orientation, attention, and safety judgement. Each item is rated using the same 7-point scale used on the FIM. Like the FIM, the FIM+FAM also consists of two subscales, one representing physical or motor functioning and one representing cognitive/psychosocial function. The total score for the FIM+FAM is 210, 112 for the motor FIM+FAM and 98 for the cognitive subscale (Gurka et al., 1999). Higher scores signify greater independence.

The FIM must be purchased from UDS and use of the FIM requires training and certification. The FAM items are in the public domain and can be downloaded from http://tbims.org/combi. A FIM+FAM rating form is available along with decision trees, training and testing vignettes specific to the FAM items from the website. The FIM+FAM requires approximately 35 minutes to administer (Hall & Johnston, 1994).

Advantages

The FIM was intended specifically for assessment during inpatient rehabilitation. The FAM items are better suited to evaluation post discharge from inpatient rehabilitation and may extend the applicability of the scale beyond the timeframe of the original FIM (Gurka et al., 1999). Addition of the FAM items to the FIM appeared to expand the range of abilities assessed (Hall et al., 1993).

Limitations

Use of the FIM+FAM still requires the use of trained raters who ideally complete ratings after a period of observation and contribute to a team consensus process (Hobart et al., 2001). The use of untrained raters may result in lower scale reliability (Hall et al., 1993).

Many of the FAM items have been identified as difficult to score (adjustment to limitations, emotion, employability, community mobility, safety judgement, attention and speech intelligibility) (Turner-Stokes et al., 1999). Items in the expanded psychosocial/cognitive subscale seem to include more abstract concepts requiring raters to make more subjective assessments than was necessary for the more objective and observable behavioural items included on the original FIM (Hall et al., 1993; McPherson et al., 1996). The abstract nature of items could have a deleterious effect on the reliability of those items (Alcott et al., 1997). Additional training together with more explicit definitions and/or content modification of the most abstract items could assist raters in the provision of reliable evaluations (Alcott et al., 1997; McPherson et al., 1996).

While the FAM items were intended to provide additional assessment of the psychosocial aspects of disability following brain injury (Hall et al., 1993), the validity of the assessment has not been clearly established (Hobart et al., 2001). The psychosocial/cognitive FIM+FAM does not correlate well with measures of handicap, such as the LHS or as strongly as one might expect with the mental component summary of the MOS SF36 (Hobart et al., 2001). Overall, the added length and increased training requirements associated with the FIM+FAM do not seem to offer any substantial advantage over the FIM (Hobart et al., 2001; McPherson & Pentland, 1997). While the FIM+FAM appears to evaluate a somewhat broader range of abilities (Hall et al., 1993), reports of ceiling effects associated with the FIM+FAM are varied and reported effect sizes are approximately the same as those reported for the FIM  (Hobart et al., 2001).

Summary-FIM+FAM

  • Interpretability: The 18-FIM items are widely used and recognized. However, the FAM items are more difficult to rate reliably and the validity of FAM is not well established.
  • Acceptability: Alternate modes of administration have not been examined and FAM items have not been evaluated for use in assessment by proxy.
  • Feasibility: The addition of FAM items to the FIM creates a longer assessment requiring the involvement of additional raters in team consensus and more training for these raters. While the FAM items are freely available, use of the FIM items requires purchase of the scale, training and certification.

17.10 Galveston Orientation and Amnesia Test

The Galveston Orientation and Amnesia test (GOAT) was intended to evaluate orientation to time, place and person and to provide an estimation of the intervals prior to and following a brain injury for which there is no recall (Levin et al., 1979). It is a brief and simple mental status examination developed for use by health professionals at the bedside or in the Emergency Department (Levin et al., 1979; van Baalen et al., 2003).

Assessment consists of 10 items regarding orientation to person (name, address, and birthdate), place (city/town and building they are in) and time (current time, date, month, year & date of hospital admission) as well as memory of events both after and prior to the injury (Bode et al., 2000). Oral questions are posed directly to the patient who may respond either orally or in writing (Jain et al., 2000; Levin et al., 1979). Error points are awarded for each incorrect response, summed and deducted from 100 to arrive at the total score. Both the scale and instructions for assigning error points are available in Levin et al. (1979).

The duration of post traumatic amnesia (PTA) is defined as the period following coma in which the GOAT score is<75 (Levin et al., 1979). PTA is considered to have ended if a score ≥75 is achieved on three consecutive administrations (Novack et al., 2000; Wade, 1992; Zafonte et al., 1997). In the initial standardization study of Levin et al. (1979) using patients with mild head injury as a reference group, it was determined that a score of 75 represented a level achieved by 92% of the standardization group. No patients with mild head injury scored less than 65 on the GOAT. Scores between 66 and 75 are considered borderline-abnormal while scores above 75 fall into the range considered normal within the reference group (Levin et al., 1979; van Baalen et al., 2003).

Advantages

The GOAT provides an objective rating of early cognitive recovery eliminating the need for sometimes ambiguous terminology used to describe mental status, such as “confused” (Levin et al., 1979). Rasch analysis demonstrated that items on the GOAT represent a wide range of difficulty suggesting that the scale is useful for assessing patients with a wide range of cognitive impairments (Bode et al., 2000).

Limitations

The standard GOAT response format makes administration difficult with nonverbal patients (Novack et al., 2000). The requirement for oral or written expression may result in penalizing patients who are experiencing deficits of expression but not in orientation or in the retrieval or consolidation of memory (Jain et al., 2000). An aphasia-specific version of the GOAT has been created, although it requires further evaluation.

For items in which partial credit is used, Rasch analysis revealed step disorder (Bode et al., 2000). Collapsing these response categories to a simple dichotomy (right versus wrong) eliminated the disorder and allowed the construction of an equal interval measure from the GOAT (Bode et al., 2000). While the GOAT does contain items intended to provide an assessment of memory, it is primarily a measure of disorientation. Eight of the 10 GOAT items evaluate orientation while only two examine memory (Forrester et al., 1994).

Summary-GOAT

  • Interpretability: The GOAT provides an objective assessment with a standardized cut-off for the presence of PTA.
  • Acceptability: In its original form, the GOAT is not well suited to the assessment of patients with aphasia.
  • Feasibility: The GOAT may be too lengthy for a simple, repeated bedside assessment of mental status. However, it is freely available and can be used by any healthcare professional.

17.11 Glasgow Coma Scale

The Glasgow Coma Scale (GCS) was developed as a simple, objective assessment of impaired consciousness and coma, and is based on eye opening, verbal and motor responsiveness (Teasdale & Jennett, 1974, 1976; Teasdale et al., 1978). It has become the most widely known and widely used scale in the assessment of level of consciousness (Foundation, 2000; Hall, 1997; Wade, 1992) .

The GCS is an observer rating scale consisting of 15 items in three basic categories: 1) motor response (6 items), 2) verbal response (5 items), and 3) eye opening (4 items). Points are awarded for the best response in each category and category scores are summed to provide a global GCS score (Sternbach, 2000; Wade, 1992). Total summed scores range from 3 (totally un-responsiveness) to 15 (alert, fully responsive). A total of ≤8 is used to separate coma from non-coma (Wade, 1992).

Additional categorical divisions are used to differentiate patients in terms of initial severity of head injury such that GCS scores 13-15 represent mild injury, scores 9-12 represent moderate injury, and scores ≤8 represent severe injury (Sternbach, 2000). The GCS is freely available, takes approximately 1 minute to administer and can be performed by all medical personnel (Oppenheim & Camins, 1992). The test can be obtained at no cost at ww.trauma.org/archive/scores/gcs.html.

Advantages

The Glasgow Coma Scale is a simple, straightforward and very brief bedside assessment. It is the most widely used instrument in the assessment of level of consciousness. GCS scores are a significant predictor of outcome following head injury. However, the prognostic value of the GCS is increased by taking other variables into account as well, such as mechanism of injury, age, CT findings, papillary abnormalities and episodes of hypoxia and hypotension (Balestreri et al., 2004; Demetriades et al., 2004; Zafonte et al., 1996).

Limitations

The GCS is based on the assumption that evaluation of eye opening is sufficient to represent brainstem arousal systems activity. While other assessments have been developed to provide a more comprehensive evaluation of brainstem responses, the resulting tools are substantially more complex than the GCS (Sternbach, 2000).

The GCS has been reported to be reliable when used by various groups of healthcare professionals regardless of the level of education or intensive care unit experience (Juarez & Lyons, 1995). Nurses and general surgeons have been reported to be as consistent in their ratings as neurosurgeons (Teasdale et al., 1978). However, it has also been demonstrated that consistent ratings among inexperienced raters may also be inaccurate.  Rowley and Fielding (1991)reported that the percentage agreement between inexperienced individuals and expert raters ranged from 58.3% to 83.3%. Lower levels of accuracy were most notable in the middle ranges of the scale. Training and the implementation of standard assessment procedures are important to maintain both high levels of reliability and accuracy of evaluation. The administration of a painful stimulus appears to be somewhat controversial and there is a great deal of variability in the means and location of its application (Edwards, 2001; Lowry, 1999).

The GCS is most often reported as a single overall score, although the scale authors did not recommend the summary score for use in clinical practice. While the single, global score may be a convenient way to summarize data, the use of a global score may result in a loss of information that adversely affects the predictive accuracy of the GCS (Healey et al., 2003; Teasdale et al., 1983; Teoh et al., 2000). The use of a global summary score assumes that each category is equally weighted (Teasdale et al., 1983). However, it has been reported that motor response has the greatest influence on the summary score and results are skewed toward this component (Bhatty & Kapoor, 1993). Healey et al. (2003) demonstrated that the ability of the GCS score to predict survival was derived mostly from the motor response category. In addition, the summary score represents a potential 120 combinations of scores from the three GCS components collapsed into only 13 possibilities. Different combinations of motor responsiveness, verbal responsiveness and eye-opening may have different associated outcomes. Teoh et al. (2000)reported significant differences in mortality outcomes between 4 of 11 scores with multiple permutations demonstrating that individuals with the same GCS scores in varying permutations can have significantly different risks for mortality.

Perhaps the most frequently encountered limitation of the GCS is untestable components in various patient groups. Pastorek et al. (2004) reported that the ability of the patient to be evaluated on the entire GCS contributed to the prediction of global outcome measures at 6 months (Pastorek et al., 2004). Unfortunately, patients who have been intubated or sedated, those with paralysis or facial swelling, patients with hypotension, hypoxia, alcohol or illicit drug intoxication may not be able to provide responses to all categories of GCS items for reasons unrelated to head trauma (Demetriades et al., 2004; Oppenheim & Camins, 1992; Rutledge et al., 1996). Murray et al. (1999), as cited in Teasdale and Murray (2000)) reported that in a study of head injury patients in European centres, total assessment was possible in 61% of patients before hospital, in 77% on arrival at hospital and in 56% of patients arriving at a neurosurgical unit. It has been suggested that inability to assess using the GCS may reflect the increased and more aggressive use of intubation, ventilation and sedation (Balestreri et al., 2004; Teasdale & Murray, 2000). When the GCS was developed, the initial assessment was to be undertaken approximately 6 hours after injury to allow time for stabilization of systemic problems, but prior to the initiation of interventions such as neuromuscular paralyzing agents or sedatives (Bakay & Ward, 1983; Marion & Carlier, 1994). Increasingly, GCS assessment is performed upon arrival at the Emergency Department and some patients may be already intubated and/or sedated by that time (Marion & Carlier, 1994; Waxman et al., 1991).

Summary-GCS

  • Interpretability: The GCS is the most familiar, most widely-used early assessment of level of consciousness. It has established categories related to the presence of coma and severity of injury.
  • Acceptability: A very brief, simple observer rater scale. The application of painful stimulus is controversial. Assessment of all components is compromised by aggressive, early interventions such as intubation and sedation.
  • Feasibility: The scale is simple to administer and designed for use by any health profession. Lack of experience and variability in assessment may result in inaccurate assessment. Training and standardized procedures are recommended.

17.12 Glasgow Outcome Scale/Extended Glasgow Coma Scale

The Glasgow Outcome Scale (GOS) is a practical index of social outcome following head injury designed to complement the Glasgow Coma Scale as the basis of a predictive system (Jennett & Bond, 1975). It is a simple, hierarchical rating scale with a limited number of broad categories. The scale focuses on how head injury had affected function in major life areas and is not intended to provide detailed information on specific deficits (Wilson et al., 1998). Individuals within any single outcome category represent a range of abilities (Jennett & Bond, 1975).

Patients are assigned to one of five possible outcome categories: 1) death, 2) persistent vegetative state, 3) severe disability, 4) moderate disability, and 5) good recovery (Jennett & Bond, 1975). In 1981, a revision to the scale was proposed to better classify patients who had regained consciousness (Jennett et al., 1981). In the Extended Glasgow Outcome Scale (GOSE), each of the three categories applicable to conscious patients are subdivided into an upper and lower band resulting in eight possible categories. GOS ratings can be derived from the GOSE by collapsing these subdivisions (Wilson et al., 2000).

The assignment of an individual to an outcome category should be based on the results of a structured interview focused on social and personal functional ability (Jennett et al., 1981). The final rating is based on the lowest category of outcome indication in the interview (Wilson et al., 2000). The GOS and GOSE can be accessed for no cost at
www.tbi-impact.org/cde/mod_templates/12_F_01_GOSE.pdf.

Advantages

The GOS is the most widely used and accepted measure of outcome following head injury (Wade, 1992). It has been adopted widely for use in clinical trials (Hellawell et al., 2000; Wade, 1992; Wilson et al., 2000). It is a simple, reliable means of describing recovery (Jennett et al., 1981) that is quick to administer, broadly applicable and has clinically relevant categories (Wilson et al., 2000).

Structured interviews and guidelines for their administration are available for the GOS and GOSE (Wilson et al., 1998). Each interview incorporates a way to include information regarding pre-injury status, thereby providing a means for determining the effect of the sequelae of head injury on outcome, separate from the effects of pre-existing conditions or circumstances (Pettigrew et al., 1998; Wilson et al., 1998). While use of the structured interview has increased the reliability of postal and telephone administration, face-to face interview remain the preferred method to determine a GOS rating (Wilson et al., 2002).

Limitations

The GOS provides an overall assessment of outcome and does not provide detailed information with regard to specific disabilities or handicaps. Categories are broad and the scale does not reflect subtle improvements in functional status of an individual (Pettigrew et al., 1998). Individuals may achieve considerable improvement in ability, but not change outcome category (Brooks et al., 1986). The GOS rating was intended primarily to provide an overall summary of outcome and facilitate comparison not to describe specific areas of dysfunction (Pettigrew et al., 1998). In addition, GOS outcome categories are often expressed as a dichotomy: poor or unfavourable outcome versus independence or favourable outcome. This results in a loss of information and low sensitivity (Teasdale et al., 1998).

Originally, GOS categories were described according to a range of features, but specific criteria were not defined for each of the different outcomes. This lack of clarity may have had a negative impact on scale reliability by introducing an element of subjectivity on the part of the rater (Maas et al., 1983; Teasdale et al., 1998). In addition, attempts to increase the sensitivity of the GOS by subdividing the upper three categories in an upper and lower band was associated with decreased consistency in category assignments (Maas et al., 1983). However, the structured interview and guidelines created by Wilson et al. (1998) have alleviated much of the difficulty surrounding ambiguous assignment criteria.

Summary-Glasgow Outcome Scale

  • Interpretability: The GOS is widely used and accepted. The GOS provides an overall assessment suitable for the comparison of outcomes at the group level.
  • Acceptability: The brevity and simplicity of the GOS facilitates patient compliance. The GOS has been studied for use by telephone and mail administration. Structured interviews improve the reliability of administration by these methods.
  • Feasibility: The GOS can be used by professionals from various backgrounds and does not require any physical, psychiatric or neurologic examination. It is well-suited to busy clinical settings and large scale research trials.

17.13 Hospital Anxiety and Depression Scale

The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems (Zigmond & Snaith, 1983). The scale was not designed to be a clinically diagnostic tool (Whelan-Goodinson et al., 2009). Originally the scale consisted of eight questions relating to depression and eight relating to anxiety. Initial findings indicated that one of the items on the depressions scale was weak (r=0.11), so it was removed. Remaining items on the scale had correlations ranging from +0.60 to +0.30, with a significance of p<0.02. Anxiety items had correlations ranging from +0.76 to +0.41 (p<0.01), but to keep the items in each scale equal, the weakest item on the anxiety portion of the scale was removed. Thus the final scale has a total of 14 items, with responses being scored on a scale of 0-3 (3 indicates higher symptom frequencies; (Whelan-Goodinson et al., 2009). Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. Prior to completing the scale patients are asked to “fill it completely in order to reflect how they have been feeling during the past week” ((Zigmond & Snaith, 1983); p. 366).

While many measures are used in the TBI population to assess depression and anxiety post injury, unfortunately none of these measures have been evaluated for use with this population (Schonberger & Ponsford, 2010; Whelan-Goodinson et al., 2009). Recently the HADS has been tested with those who have sustained an ABI. However, due to the mixed aetiology problems were found with some of the questions which could be related to the injury itself, the level of cognitive impairment or the decreased speed at which information is processed (Dawkins et al., 2006; Johnston et al., 2000).

Advantages

The HADS is brief and simple to use and although it was originally designed to be used with hospital populations it has been found to perform well with non-hospital groups (McDowell, 2006). It takes on average 2-5 minutes to complete and is completed by the patients themselves (Snaith, 2003). The HADS requires the individual to respond to the question in relation to how they felt in the past week, so it is reasonable to re-administer the test again but only at weekly intervals. It has been found to perform as well as the Beck Depression Inventory (BDI) and the General Health Questionnaire instruments. Overall, Mykletun et al. (2001)found the HADS scale possessed good “psychometric properties in terms of factor structure, intercorrelation, homogeneity and internal consistency” (p 543).

Limitations

When using the HADS to diagnosis depression or depressive symptoms post ABI, the sequelae of TBI may confound the test scores (Whelan-Goodinson et al., 2009). Caution is recommended when interpreting the results of these scales. Even though the HADS has been shown to be a reliable measure of emotional distress post ABI, the cut-off scores and categories have not been shown to be useful in predicting probable presence or “caseness” of depression or anxiety (Whelan-Goodinson et al., 2009).

Summary-HADS

  • Interpretability: The results are easy to interpret with higher scores on each individual scale or the entire scale indicating greater anxiety, depression or mood disorders.
  • Acceptability: The HADS is widely accepted and used with most patient populations including those with a TBI.
  • Feasibility: It takes only a few minutes to complete, no specialized training is need to administer the test and may be completed by the patients themselves.

17.14 Mayo-Portland Adaptability Inventory

The Mayo-Portland Adaptability Inventory (MPAI-4) is based on an earlier scale, the Portland Adaptability Inventory (Lezak, 1987). Specifically designed for the evaluation of individuals during the post-acute period following ABI, the scale was developed to provide a representation of the sequelae of ABI through the use of key indicators of abilities, activities and social participation (Malec, 2004b). Assessment with the MPAI is intended to yield information applicable to the development and ongoing evaluation of rehabilitation services within this population (J. L. Malec, MD., 2003)

The original version of the MPAI consisted of six subscales: physical/medical, cognition, emotion, everyday activities, social behaviours and behaviours (Bohac et al., 1997). Items were rated to reflect distinctions between impairment, disability and handicap as defined by the World Health Organization’s (International Classification of Impairments Disabilities and Handicaps) (Malec & Lezak, 2003; Malec et al., 2000b). The MPAI has undergone successive revisions based on ongoing Rasch and multivariate analyses. The most current version is the MPAI-4, which evaluates the general dimension of sequelae of ABI in 3 sub-dimensions: ability, adjustment and participation (Malec, 2004b).

The MPAI-4 consists of 29 items in 3 subscales (the Ability Index, the Adjustment Index and the Participation Index) plus an additional 6 items that are not included in the MPAI-4 score. The first 29 scale items are intended to reflect the current status of the individual with brain injury without attempting to determine whether their status might be influenced by factors other than ABI. The additional six, unscored items are intended to identify the presence of other factors that may be contributing to the individual’s current status (Malec & Lezak, 2003).

In general, items are rated on a 5-point scale from 0 to 4 where 0 represents the most favourable outcome, no problem or independence, and 4 represents the presence of severe problems. A worksheet is provided that guides the user through the scoring and re-scoring of items. Following any necessary re-scoring, item scores are summed for each subscale to provide a raw score for that index. After making adjustment for items appearing in more than one index, subscale raw scores are summed to provide an overall adaptability index score. Raw scores for the indices and total scale may be converted to T-scores with a mean of 50 and a standard deviation of 10 using the tables provided in the manual (Malec & Lezak, 2003). T-scores provided are based on data sets from two populations of individuals with ABI. They have not been referenced to non-ABI samples. In general, when compared to the reference populations with ABI, total T-scores less than 30 are indicative of good outcome, 30-40 of mild limitations, 40-50 of mild to moderate limitations, 50-60 of moderate to severe difficulties, and>60 of severe limitations (Malec & Lezak, 2003).

The MPAI-4 was designed to be completed by professional staff, individuals who have experienced brain injury and/or their significant others. Ratings provided by any two or more of these groups can be combined to provide a more comprehensive composite score (Malec & Lezak, 2003).When administered by professional staff, the ratings should be completed by team consensus. The MPAI-4 is free of charge. The manual and rating forms may be downloaded from the COMBI website (http://tbims.org/combi/mpai). A French translation of the rating form is also available from the website.

Advantages

The MPAI is a readily available assessment of the post-acute sequelae of ABI. The Participation Index may be administered independently to provide a quick evaluation of participation outcomes. Differences in ratings between staff member consensus and individual with ABI or between SO and individual with ABI may provide a measure of impaired self-awareness (Malec, 2004a; Malec & Degiorgio, 2002).

Limitations

The authors do not recommend the MPAI-4 for use in the assessment of individuals with very severe ABI (Malec et al., 2003).

The authors reported that the placement of items in the 3 scale indices is based on a rational process in keeping with clinical observation and the results of ongoing analyses  (Malec et al., 2003). However, the placement of some items appears odd. Self-care, for instance, is part of the participation index. In an earlier analysis, it was stated that it was more conceptually sound to place the self-care items with other basic skills such as use of hands, mobility and speech (Bohac et al., 1997). These basic items are currently part of the MPAI-4 abilities index. Other items, such as initiation, social contact and leisure skills/recreation were assigned to more than one index suggesting significant overlap between the subscales of adjustment and participation.

There are no published validation or reliability studies of the Mayo-Portland Adaptability that did not originate from the group responsible for the development of the scale.

Summary-MPAI

  • Interpretability: Tables are provided and raw scores are converted to standardized T-scores based on a national sample (n=386) or regional sample (n=134). No truly normative data is available for the purpose of comparison.
  • Acceptability: May be completed by patients and significant others with trained professionals available to provide assistance.
  • Feasibility: The MPAI-4 is free to download and copy. Administration, scoring and interpretation should be undertaken by trained professionals. The manual also contains a recommendation that a person capable in advanced psychometrics should be available. To maintain high levels of reliability, assessment should be completed by team consensus.

17.15 Medical Outcomes Study Short Form 36

The Medical Outcomes Study Short Form 36 (SF-36) is a generic health survey created to assess health status in the general population as part of the Medical Outcomes Study (Ware & Sherbourne, 1992). It is comprised of 36 items drawn from the original 245 items generated by that study (McHorney et al., 1993; Ware & Sherbourne, 1992).

Items are organized into eight dimensions or subscales which include physical functioning, role limitations: physical, emotional, bodily pain, social functioning, general mental health, and general health perceptions. It also includes two questions intended to estimate change in health status over the past year. These two questions remain separate from the eight subscales and are not scored. With the exception of the general change in health status questions, subjects are asked to respond with reference to the past four weeks. An acute version of the SF-36 refers to problems in the past week only (McDowell & Newell, 1996).

The recommended scoring system uses a weighted Likert system for each item. Items within subscales are summed to provide a total score for each subscale or dimension. Each of the eight summed scores is linearly transformed onto a scale from 0 to 100 to provide a score for each scale. In addition, a physical component and mental component score can be derived from the scale items. Standardized population data for several countries are available for the SF-36 (McDowell & Newell, 1996). The component scores have also been standardized with a mean of 50 and standard deviation of 10 (Finch et al., 2002)

The SF-36 questionnaire can be self-completed or administered in person or over the telephone by a trained interviewer. It is considered simple to administer and takes less than 10 minutes to complete (Andresen & Meyers, 2000). Permission to use the instrument should be obtained from the Medical Outcomes Trust who oversee the standardized administration of the SF-36 and will provide updates on administration and scoring (McDowell & Newell, 1996). Various computer applications are available to assist in scoring the SF-36 including free Excel templates that can be downloaded from the internet (Callahan et al., 2005).

Advantages

The SF-36 is simple to administer. Both forms (i.e., self-completed or interview) take less than 10 minutes to complete (Hartley et al., 1995). As a self-completed, mailed questionnaire, it has been shown to have reasonably high response rates: 83% has been reported by Brazier et al. (1992); O’Mahony and Rodgers H (1998), 75%-83% reported by Dorman et al. (1998). Dorman et al. (1999) reported a response rate of 85% and Walters et al. (2001) reported 82% overall and 69% for those over age 85.

Callahan et al. (2005)found that the SF-36 was appropriate for longitudinal serial assessment of recovery in a mixed group of patients suffering from a cerebrovascular accident, TBI, or spinal cord dysfunction. The instrument has been shown to be valid and reliable in the adult TBI population and appears to be sensitive to the wide spectrum of health issues faced by this group (Emanuelson et al., 2003; Findler et al., 2001).

Limitations

Higher rates of missing data have been reported among older patients when using a self-completed form of administration (Brazier et al., 1992; Brazier et al., 1996; Hayes et al., 1995). O’Mahony et al. (1998) found item completion rates to range from 66% to 96%. At the scale level, complete data collection (amount required to compute a scale score) ranged from 67% (role limitations-emotional) to 97% (social functioning). Walters et al. (2001) reported scale completion rates among community dwelling older adults ranging from 86.4% to 97.7% with all eight scales being calculable for 72% of respondents. Dorman et al. (1999) reported a proportion of missing data on the scale level ranging from 2% (social functioning) to 16% (role functioning-emotional). Given the lack of data completeness found, postal administration of the SF-36 may not be appropriate for use among older adults. However, low completion rates may not be limited to self-completion or postal administration. Andresen et al. (1999) administered the SF-36 to nursing home residents by face-to-face interview and reported that only 1 in 5 residents were able to complete it.

It has been suggested that data completeness may be indicative of respondent acceptance and understanding of the survey as relevant to them (Andresen et al., 1999; O’Mahony & Rodgers H, 1998). Hayes et al. (1995) noted that the most common items missing on the self-completed questionnaire referred to work or vigorous activity. Older respondents identified these questions as pertinent for much younger people and not relevant to their own situation. The authors suggested modifications to some of the questions, which may increase acceptability to older populations. In a qualitative assessment of the physical functioning and general health perceptions dimensions of the SF-36, Mallinson (2002) noted that the participants, who were all over the age of 65, tended to display signs of disengagement from the interview process and some participants expressed concern relating to the relevance of the questions. There was also considerable variation noted in subjective interpretation of items and most subjects used qualifying, contextual information to clarify their responses to the interviewer. As Mallinson (2002) pointed out, individual issues of subjective meaning and context are lost when the questionnaire is scored.

The SF-36 does not lend itself to the generation of an overall summary score. In scales using summed Likert scales, information contained within individual responses is lost in the total scale score , in that any given total score can be achieved in a variety of ways from individual item responses (Dorman et al., 1999). Hobart et al. (2002) examined the use of the 2-dimensional model, which consists of a mental health component (MCS) and physical health component (PCS). These two scales can account for only 60% of the variance in SF-36 scores suggesting a significant loss of information when the 2-component model is used.

It has been suggested that the SF-36 may be more sensitive to the health difficulties of mild TBI than of moderate/severe TBI patients as it was unable to differentiate between the severity levels (Emanuelson et al., 2003). One study found initial differences between these groups, but once depression was controlled for, these differences were less visible, suggesting that depression may account for the differences between TBI groups on the SF-36 (Findler et al., 2001). MacKenzie et al. (2002) suggest that adding a cognitive component to the SF-36 would make the instrument a more useful outcome measure in a head trauma population, as the tool is likely to underestimate the extent of disability in this group.

The level of test re-test reliability reported in stroke populations indicate that the SF-36 may not be adequate for serial comparisons of individual patients, but rather should be used for large group comparisons only (Dorman et al., 1998). Weinberger et al. (1996) also questioned the usefulness of the SF-36 in serial evaluation of individuals given large reported absolute differences in SF-36 scores obtained via common modes of administration (face-to-face interview, self-administration and telephone interview) over short testing intervals.

Dikmen et al. (2001) emphasized that the SF-36 was designed to be self-administered, thus its disadvantage is the inability to use the SF-36 to assess patients who are too impaired to complete the questionnaire on their own. While the use of a proxy may be the only means by which to include data from more severely affected TBI patients, reported disagreement between patient and proxy assessments has been considerable. In an adolescent TBI population, moderate rates of agreement were reported between proxy and patient respondent ratings for items related to physical health. However, on more subjective items, agreement was very low (Ocampo et al., 1997). It has been suggested that clinicians do not substitute proxy data for patient responses due to the subjective nature of many SF-36 items (Ocampo et al., 1997).

Summary-MOS-SF36

  • Interpretability: Use of scale scores and summary component scores represents a loss of information and decreases potential clinical interpretability. Standardized norms for several countries are available for the SF-36.
  • Acceptability: Completion times are approximately 10 minutes for either self-completed or interview administered questionnaires. Some items have been questioned for their relevance to elderly populations. The SF-36 has been studied for use by proxy, but agreement rates are low and reliability of the test decreased when proxy respondents completed assessments.
  • Feasibility: The SF-36 questionnaire can be administered through a self-completion questionnaire or by interview (either on the telephone or in-person). It has been used as a mail survey with reasonably high completion rates reported. However, data obtained is more complete when interview administration is used. Permission to use the instrument and additional information regarding its administration and scoring should be obtained from the Medical Outcomes Trust.

17.16 Mini Mental Status Examination

The Mini-Mental State Examination (MMSE) was developed as a brief screening tool to provide a quantitative assessment of cognitive impairment and to record cognitive changes over time (Folstein et al., 1975). While the tool’s original application was the detection of dementia within a psychiatric setting, its use has become widespread.

The MMSE consists of 11 simple questions or tasks. Typically, these are grouped into seven cognitive domains including orientation to time, orientation to place, registration of three words, attention and calculation, recall of three words, language, and visual construction. Administration by a trained interviewer takes approximately 10 minutes. The test yields a total score of 30 and provides a picture of a subject’s present cognitive performance based on direct observation of completion of test items/tasks. A score of 23 out of 24 is the generally accepted cut-off point indicating the presence of cognitive impairment (Dick et al., 1984). Levels of impairment have also been classified as none (24-30), mild (18-24), and severe (0-17) (Tombaugh & McIntyre, 1992).

An expanded version of the MMSE, the modified mini-mental state examination (3MS) was developed by Teng & Chui (1987) increasing the content, number, and difficulty of items included in the assessment. The score of the 3MS ranges from 0 to 100 with a standardized cut-off point of 79/80 for the presence of cognitive impairment. This expanded assessment takes approximately 5 minutes more to administer than the original MMSE. The MMSE is available for purchase at http://www4.parinc.com/Products/Product.aspx?ProductID=MMSE#Items.

Advantages

The Mini-mental State Examination is brief, inexpensive, and simple to administer. Its widespread use and accepted cut-off scores increase its interpretability.

Limitations

It has been suggested that the MMSE may attempt to assess too many functions in one brief test. An individual’s performance on individual items or within a single domain may be more useful than interpretation of a single score (Tombaugh & McIntyre, 1992; Wade, 1992). However, an acceptable cut-off for the identification of the presence of an impairment may be possible only when the test is used as a measure of “cognitive impairment” (Blake et al., 2002). Blake et al. (2002) reported that when the test is used to screen for problems of visual or verbal memory, orientation or attention acceptable cut-off scores could not be identified.

MMSE scores have been shown to be affected by age, level of education and sociocultural background (Bleecker et al., 1988; Lorentz et al., 2002; Tombaugh & McIntyre, 1992). These variables may introduce bias leading to the misclassification of individuals, and such biases have not always been reported. For instance, Agrell & Dehlin (2000) found neither age nor education to influence scores. Lorentz et al. (2002) expressed concern that adjustments made for these biases may limit the general utility of the MMSE.

Perhaps the greatest limitation of the MMSE is its low reported levels of sensitivity, particularly among individuals with mild cognitive impairment (de Koning et al., 1998; Tombaugh & McIntyre, 1992), in patients with focal lesions (particularly those in the right hemisphere) (Tombaugh & McIntyre, 1992), within a general neurological patient population (Dick et al., 1984) and within a stroke population (Blake et al., 2002; Suhr & Grace, 1999). It has been suggested that its low level of sensitivity derives from the emphasis placed on language items and a paucity of visual-spatial items (de Koning et al., 2000; de Koning et al., 1998; Grace et al., 1995; Suhr & Grace, 1999; Tombaugh & McIntyre, 1992). Various solutions have been proposed to the problem of the MMSE’s poor sensitivity including the use of age-specific norms (Bleecker et al., 1988) and the addition of a clock-drawing task to the test (Suhr & Grace, 1999). Clock-drawing tests themselves have been assessed as acceptable to patients, easily scored and less affected by education, age and other non-dementia variables than other very brief measures of cognitive impairment (Lorentz et al., 2002) and would have little effect on the simplicity and accessibility of the test. The MMSE has been evaluated for use among a variety of neurological populations.

At present, information regarding the reliability and validity of the MMSE when used among patients with TBI/ABI is extremely limited.

Summary-MMSE

  • Interpretability: The MMSE is widely used and has generally accepted cut-off scores indicative of the presence of cognitive impairment. Documented age and education effects have led to the development of stratified norms (Ruchinskas & Curyto, 2003).
  • Acceptability: The test is brief, requiring approximately 10 minutes to complete. It may be affected by patient variables such as age, level of education and sociocultural background. As it is administered via direct observation of task completion, it is not suitable for use with a proxy respondent.
  • Feasibility: The test requires no specialized equipment and little time, making it inexpensive and portable. A survey conducted by Lorentz et al. (2002) revealed participant physicians found the MMSE too lengthy and unable to contribute much useful information.

17.17 Neurobehavioral Functioning Inventory

The Neurobehavioral Functioning Inventory (NFI) was originally developed as part of the General Health and History Questionnaire, which was used to collect a variety of information on individuals who had experienced a TBI (Kreutzer  et al., 1987). The NFI is intended to assess a wide spectrum of behaviours and symptoms encountered in everyday life in order to evaluate the neurological, behavioural and psychological effects of head injury (Kreutzer et al., 1996; Seel et al., 1997; Weinfurt et al., 1999).

The NFI consists of 70 items representing behaviours or symptoms. These are grouped into six functional domains or subscales derived from principal components and factor analytic methodologies (Hart et al., 2003; Seel et al., 1997). The six domains include depression (13 items), somatic (11 items), memory/attention (19 items), communication (10 items), aggression (9 items) and motor (8 items) (Hart et al., 2003; Kreutzer et al., 1996). Six additional, critical items relating to patient safety and community integration have been added to the scale (Kreutzer et al., 1999) to be used in the identification of areas requiring immediate attention (Awad, 2002).

Items are rated for frequency of occurrence on a 5-point Likert scale from 1 (never) to 5 (always). While the NFI is a self-rating inventory, it provides for the inclusion of information obtained from suitable proxy sources. The test contains forms for ratings by self and by a significant other. The test takes approximately 20 minutes to complete (Awad, 2002).

The NFI is a proprietary scale that must be purchased from The Psychological Corporation (Harcourt Assessment, Inc.).

Advantages

The NFI allows information from collateral sources to be collected, allowing for a more comprehensive picture of both the difficulties experienced by the patient and the impact of problems on the home environment (Witol et al., 1999). Multiple sources of information can improve reliability of information provided through self-report from individuals with TBI who, due to impaired self-awareness, may supply unreliable information (Hart et al., 2003).

Limitations

Awad (2002) was unable to establish construct validity for the NFI. The author cited poor fit indices, a large number of items with poor/weak relation to their latent construct (20 items with squared multiple correlations <0.40), strong correlations between subscales and an inability to distinguish a group of individuals with TBI from non-clinical controls as the basis for this assertion. It is suggested that the NFI may be measuring aspects of a single large construct rather than six discrete constructs.

Weinfurt et al. (1999) reported very low endorsement rates for many of the items resulting in skewed distributions. Low rates of endorsement might indicate that these items are not meaningful discriminators for the head injury population.

While the authors do provide data for comparison, it is not truly normative. The data set used for standardization was derived from a population of individuals with TBI. There is no normative data available based on non-clinical populations (Awad, 2002; Witol et al., 1999).

Although the NFI is widely used, there is relatively little information available in the literature with regard to its reliability, validity and responsiveness. The information that is available pertains to older versions of the NFI and, at present, there are no validity or reliability data available for the 76-item version (Awad, 2002).

Summary-NFI

  • Interpretability: Comparative data is provided in the manual stratified by patient age and injury severity. The NFI has been translated into Spanish, German and French.
  • Acceptability: The NFI is a lengthy self-report inventory requiring approximately 20 minutes to complete. Forms are provided for assessment by self or by proxy.
  • Feasibility: The NFI is a proprietary scale and must be purchased.

17.18 Rancho Los Amigos Levels of Cognitive Functioning Scale

The Rancho Los Amigos Levels of Cognitive Functioning Scale (LCFS) was intended to provide a description of eight stages of cognitive function through which individuals with brain injuries typically progress during their stay in hospital and acute rehabilitative care (Hagen, 1982; Hagen et al., 1972). It was not developed as a scale and is not considered to be an outcome measure. Rather, it is a global index used to describe awareness, environmental interaction and behavioural competence (Timmons et al., 1987; Zafonte et al., 1996). It is used to monitor recovery and classify outcome in patients with brain injury (Gouvier et al., 1987). LCFS rating forms for the original 8-level LCFS are available for download from http://tbims.org/combi. Detailed item descriptions are also available from the website.

Advantages

The LCFS is a quick and simple way to present an individual’s level of recovery. It is also useful for making quick comparisons between groups (Johnston et al., 1991). Its simplicity and utility have contributed to its widespread use within the United States (Hall, 1997; Hall & Johnston, 1994).

Limitations

At present there is no standardized method to derive an LCFS rating. Variable interobserver agreement has been reported suggesting that standardized rating methods might serve to improve reliability (Beauchamp et al., 2001).

The LCFS provides a quick and simple description of global behaviour from which level of cognitive functioning is inferred. It focuses on the impact of cognitive dysfunction on arousal and overall behaviour, but does not provide information regarding specific domains of cognitive impairment (Labi et al., 1998). There is relatively little published evidence to support the reliability or validity of the LCFS.

Summary-RLA-CFS

  • Interpretability: The LCFS is used widely in the United States and provides a quick, global presentation of level of recovery.
  • Acceptability: Ratings are derived from observation and represent little or no patient burden. Use of collateral information to derive ratings has not been evaluated.
  • Feasibility: The LCFS is short and simple. It is available free of charge. The LCFS has been evaluated for use in longitudinal assessments.

17.19 Satisfaction with Life Scale (SWLS)

Life satisfaction may be defined as a conscious, cognitive, global judgement of one’s own life. It is not an assessment based on externally imposed objective standards, but rather depends upon a comparison of one’s life circumstances to one’s own internal standards or criteria (Diener et al., 1985; W.  Pavot & E. Diener, 1993; Pavot et al., 1991). The SWLS was created to assess a person’s global judgment of life satisfaction (Diener et al., 1985).

Diener et al. (1985) generated 48 self-report items related to satisfaction with life including items assessing positive and negative affect. Factor analyses were used to identify three factors including life satisfaction, negative affect and positive affect. All affect items were eliminated as were items with factor loadings of less than 0.60. The remaining 10 items were reduced to five on the basis of “semantic similarity” (Diener et al., 1985).

Respondents are instructed to rate each item using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Item ratings are summed to provide a total score ranging from 5 to 35 where higher scores are indicative of greater life satisfaction. The SWLS takes a global approach to assessment. Because no specific domains are named within the scale and items are not specific in nature, the respondent is free to consider the life domains or affective components that he or she believes to contribute the most to their subjective experience of happiness (Arrindell et al., 1999; Diener et al., 1985; W.  Pavot & E. Diener, 1993).

The scale is short and simple to administer and score. It can easily be added to assessments using multiple measures with no significant increase in time (Pavot et al., 1991). The Satisfaction with Life Scale can be accessed for no cost at www.ppc.sas.upenn.edu/lifesatisfactionscale.pdf.

Advantages

The scale is available freely and is simple to administer and score. With only five items, it takes very little time to complete. The scale has been evaluated for use in populations of varying ages (e.g., adolescent, young adult and senior). The original scale was tested in both college students and geriatric populations (Diener et al., 1985). Scale items are at the 6th to 10th grade reading level, which makes it comprehensible to most adults (W.  Pavot & E. Diener, 1993) The scale has been evaluated in several cultures and has been translated into several languages including Dutch, Taiwanese, Spanish, French, Russian, Korean, Hebrew, Mandarin Chinese, Spanish, and Portuguese.

It has been suggested that social desirability may account for a large proportion of variance in the assessment of subjective well-being and may, in fact be an important component of well-being (W.  Pavot & E. Diener, 1993). However, Diener et al. (1985) reported a very weak association between SWLS scores and the Marlowe-Crowne scale of social desirability (r=0.02).

Limitations

While the SWLS is a simple scale, interpretation of scores is not clear. The SWLS was not intended to provide an assessment of subjective well-being (SWB), only a single aspect of well-being. One cannot assume that SWLS scores provide a direct assessment of emotional well-being. In order to assess the broader construct of subjective well-being, assessment of negative and positive affect should be included (W.  Pavot & E.  Diener, 1993). Furthermore, no published normative data for the SWLS could be located. Pavot and Diener (1993) identified numerous studies providing means and standard deviations for SWLS scores in a variety of populations and note considerable variation within different population subsets. However, scores may be interpreted in absolute rather than relative terms. In this case, it has been suggested that a score of 20 is regarded as neutral, while scores in excess of 20 represent satisfaction (21-25=slightly satisfied and 26-30= satisfied), and scores of less than 20 represent dissatisfaction (15-19=slightly dissatisfied and 5-9=extremely dissatisfied) (W.  Pavot & E.  Diener, 1993).

The SWLS does not appear to be affected by gender or age (W.  Pavot & E.  Diener, 1993). Factor analyses focusing on factorial invariance across gender have demonstrated that the structure and measurement of life satisfaction are equivalent across groups. That is, the strength of relationships between items and the underlying construct is the same for men and women (Shevlin et al., 1998; Wu & Yao, 2006). However, factorial invariance was not demonstrated on evaluation of the Spanish version of the SWLS (Atienza et al., 2003; Pons et al., 2000). Westaway et al. (2003) reported that SWLS scores were not related to either gender or age, but rather to employment status and level of education. Similarly, Neto (1993) identified significant main effects associated with both gender and socioeconomic status such that higher status and male gender were associated with greater satisfaction with life as assessed on the SWLS.

Although the SWLS is used to evaluate satisfaction with life in populations of adults with ABI, no studies have specifically evaluated the use of this scale within the ABI population.

Summary-SWLS

  • Interpretability: Guidelines for absolute interpretation of scores are available. To our knowledge, no normative data is presently available for the SWLS.
  • Acceptability: Scale items are at a suitable reading level for most adults and it takes a minimal amount of time for the subject to complete the measure in its entirety.
  • Feasibility: This scale is brief, simple, and has a low-cost of administration.

17.20 Quality of Life after Traumatic Brain Injury

The quality of life after TBI (QOLIBRI) questionnaire was designed to specifically measure the quality of life of those who have sustained a TBI Prior to the creation of the scale, the following items were reviewed: Quality of Life of the TBI, The Profile de la Qualite de la View Subjective, The Brain Injury Community Rehabilitation Outcome scale, and the European Brain Injury Questionnaire. All items from each of the questionnaires were reviewed. Following a review of the items and an assessment of their psychometric properties, a preliminary QOLIBRI was developed which consisted of 49 items arranged into eight subscales (von Steinbuchel et al., 2010).

The final QOLIBRI consists of 37 items in six subscales including cognition (7 items), self (7 items), daily life and autonomy (7 items) and social relationships (6 items), emotions (5items) and physical problems (5 items). The first four subscales are coded on a 1 to 5 scale where 1 is not at all satisfied and 5 is very satisfied. The responses to the last two subscales (emotion and physical problems) are reverse scored to correspond with the satisfaction items. Here 1 is very bothered and 5 is not at all bothered. Responses for each subscale are summed to give a total, which is then divided by the number of responses to give the scale a mean score. The scale means have a maximum possible range of 1 to 5. The mean can be computed when there are some missing responses, but should not be calculated if more than one third of responses on the scale are missing. In a similar manner the QOLIBRI total score is calculated by summing all the responses, and then dividing by the actual number of responses. Again, a total score should not be calculated if more than one third of responses are missing (www.qolibrinet.com). The scales have also been translated into seven languages and have been tested with each language cohort. The test is available for no cost at http://www.qolibrinet.com/registration.htm.

Advantages

This scale was designed specifically for the ABI population and has been translated into six other languages. To date, this is the only scale designed specifically for those who have sustained either an ABI or a TBI. The composite measure has the advantage of covering both functional outcomes post ABI and Health-Related QoL (HRQoL) post ABI.

Limitations

Like so many other scales measuring quality of life, the important limitation is the complexity of HRQoL, as it remains virtually impossible to capture and define an individual’s view of the future, the concept of individuality, and the experience of intimacy (Truelle et al., 2010). The conclusions of the study are based on the approach to recruitment. Subjects where subjects were chosen at various times across a multitude of settings (convenience sampling), and therefore the sample was scale orientated, not patient focused (Truelle et al., 2010).

Summary-QOLIBRI

  • Interpretability: Results are easy to interpret, with lower scores indicating a better QoL.
  • Acceptability: The scale, available in seven languages, is a self-report based on each individual’s perception of how he or she is doing.
  • Feasibility: The scale is now available and ready for more regular use. It is easy to use, available in a variety of languages and there is no fee for its use.

Summary

No Summary in this Module

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