A Systematic Review of Functional and Quality of Life Assessment after Major Lower Extremity Amputation Alexander T. Hawkins,1,2,3 Antonia J. Henry,2 David M. Crandell,4,5 and Louis L. Nguyen,1,2,5 Boston and Charlestown, Massachusetts

Background: When judging the success or failure of major lower extremity (MLE) amputation, the assessment of appropriate functional and quality of life (QOL) outcomes is paramount. The heterogeneity of the scales and tests in the current literature is confusing and makes it difficult to compare results. We provide a primer for outcome assessment after amputation and assess the need for the additional development of novel instruments. Methods: MEDLINE, EMBASE, and Google Scholar were searched for all studies using functional and QOL instruments after MLE amputation. Assessment instruments were divided into functional and QOL categories. Within each category, they were subdivided into global and amputation-specific instruments. An overall assessment of instrument quality was obtained. Results: The initial search revealed 746 potential studies. After a review of abstracts, 102 were selected for full review, and 40 studies were then included in this review. From the studies, 21 different assessment instruments were used 63 times. There were 14 (67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3 (43%) of the QOL measures were specific for MLE amputees. Sixteen instruments were used >1 time, but only 5 instruments were used >3 times. An additional 5 instruments were included that were deemed important by expert opinion. The 26 assessment instruments were rated. Fourteen of the best-rated instruments were then described. Conclusions: The heterogeneity of instruments used to measure both functional and QOL outcomes make it difficult to compare MLE amputation outcome studies. Future researchers should seek to use high-quality instruments. Clinical and research societies should endorse the best validated instruments for future use in order to strengthen overall research in the field.

INTRODUCTION Supported by the Arthur Tracy Cabot Fellowship though the Brigham & Women’s Hospital Center for Surgery and Public Health and the Harvard-Longwood T-32 Vascular Training Grant (to A.T.H.; NIH 5T32HL007734). 1 Center for Surgery and Public Health, Boston, Massachusetts. 2

Brigham & Women’s Hospital, Boston, Massachusetts.

3

Massachusetts General Hospital, Boston, Massachusetts.

4

Spaulding Rehabilitation Hospital, Charlestown, Massachusetts.

5

Harvard Medical School, Boston, Massachusetts.

Correspondence to: Louis L. Nguyen, MD, MBA, MPH, Division of Vascular and Endovascular Surgery, Brigham & Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA; E-mail: llnguyen@ partners.org Ann Vasc Surg 2014; 28: 763e780 http://dx.doi.org/10.1016/j.avsg.2013.07.011 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: April 9, 2013; manuscript accepted: July 18, 2013; published online: February 2, 2014.

Amputation is widely regarded as the end stage for peripheral vascular disease, but life does go on for these patients. Major lower extremity (MLE) amputation remains an extremely prevalent procedure that represents a significant cost to the US health care system. In the United States, there are approximately 1.7 million people living with limb loss.1 Significant research is undertaken in the MLE amputee population, and the past decade has seen a shift in metrics used to evaluate outcomes after vascular surgery. Amputation research is transitioning to examining patient-oriented outcomes as opposed to traditional surgeon-oriented or technically oriented outcomes.2 This will become increasingly topical as our health care system moves toward pay for performance systems. Section 3022 of the Affordable 763

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Care Act (ACA) establishes the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) to reduce health care costs and promote quality.3 One of the main sections, ‘‘Patient and Caregiver Experience,’’ includes health and functional status as a key measure for reimbursement. It is paramount for the vascular specialist to understand how outcomes are assessed. Unfortunately, the assessment instruments used to define outcomes are varied and often confusing.4 This review describes the current assessment instruments available for the clinician and identifies areas for improvement. Because outcomes measure is a broad topic, this review focuses on functional and quality of life (QOL) instruments that are most important to the vascular specialist. Assessment of function is integral to understanding the effects of amputation and rehabilitation. QOL is a broader measure that seeks to provide a singular assessment of multiple aspects of how a patient views their current health state. For pre-, peri-, and postoperative planning, it is important for the vascular specialist to understand the functional and QOL instruments used to assess amputees in both the clinical and research realms. Understanding the instruments used in the literature and selecting the correct instrument to use in a research project are daunting tasks. Compounding this is the lack of consensus regarding the criterion standard measures for both function and QOL.5 We sought to systematically review the current instruments and perform a needs assessment for the development of new outcomes instruments.

METHODS Search A comprehensive search of MEDLINE, EMBASE, and Google Scholar was performed with customized search terms in April 2012. Databases were searched for clinical studies examining outcome after amputation from January 2001 to March 2012. Key terms were used, such as lower extremity amputation, treatment outcomes, assessment instruments, mobility, and quality of life (Appendix I). References of methodologic studies, existing reviews, and bibliographies of journal articles were also selectively hand-searched. Full inclusion and exclusion criteria are available in Appendix II. The focus was on full-length papers that used outcome measures to assess an adult, nononcologic amputee population. Studies were not assessed for quality of the work, because our primary focus was to determine which assessment

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instruments were being used. In addition to instruments identified in the studies, expert opinion was sought for any other instruments that warranted discussion. Existing Reviews Five previous review articles were identified. Rommers et al.6 focused on scales and questionnaires regarding patients with MLE amputation. Gautier-Gagnon and Grise7 developed a handbook for LEA outcome but did not include walk tests. Condie et al.5 performed a systematic review of all instruments to assess lower extremity prosthetics outcome between 1995 and 2005. Deathe et al.8 reviewed and classified outcome measures according to the World Health Organization (WHO) International Classification of Functioning, Disability and Health. They focused only on functional outcome measures. Finally, Sinha and Van Den Heuvel9 performed a systematic review of QOL in lower limb amputees, focusing on instruments that measure QOL.9 None of the previous reviews focused on both function and QOL, and none were written for an audience of vascular specialists. Classification and Assessment Assessment instruments were divided into those measuring function and QOL. In each category, instruments were again categorized into general and amputation-specific instruments.10 An overall assessment of instrument quality was performed using the guidelines suggested by Johnston and Graves.11 Originally designed for use in spinal cord injury, the guidelines have been previously adapted by Deathe et al.8 to make them relevant to amputation. Studies were scored on a 4-point scale for an overall assessment of quality as follows: 4 points (++++) indicated that the scale was extensively validated, with excellent reliability and validity (i.e., it was very well established as valid for MLE amputees); 3 points (+++) indicated that the scale showed content and metric reliability and validity (i.e., it was adequately/reasonably valid for the main defined purpose and could be used in studies, although checking of assumptions or small improvements may be desirable to further improve the measure); 2 points (++) indicated that the scale had minimal validity (i.e., it had apparently applicable content with good validity/reliability in another group but little use in MLE amputees, or it was used in MLE amputees but some limitations were evident with little reliability/validity information)din these scales, additional development was desirable, and the scale could be used if there were no alternatives,

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but firm conclusions are not possible given the preliminary and modest degrees of validity evidence; and 1 point (+) indicated that the scale was questionable or insufficient (i.e., there was little or no formal validity or reliability evidence and possibly questionable content for MLE amputees)din these scales, development would be required in order for the scale to be applicable to MLE amputees. Quality was judged independently by all authors, with group consensus reached only when there was a discrepancy between evaluators.

RESULTS The initial search revealed 746 potential studies. After a review of abstracts, 102 were selected for full review. Of these, another 62 were excluded according to the above exclusion criteria. Forty studies were then included in this review (Appendix III). From the studies, 21 different assessment instruments were used 63 times (Table 1). There were 14 (67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3 (43%) of the QOL measures were specific for MLE amputees. Sixteen instruments were used >1 time, including the Short Form-36 General Health Status Survey (SF-36)/Short Form12 General Health Status Survey (SF-12; 13 times), the Prosthetic Evaluation Questionnaire (5 times), the 6-Minute Walk Test/2-Minute Walk Test (6MWT/2MWT; 5 times), the Timed Up and Go (TUG; 4 times), the Functional Independence Measure (4 times), the modified Barthel Index (3 times), the Frenchay Activity Index (FAI; 3 times), the Locomotor Capabilities Index (3 times), the Houghton Scale (3 times), the WHOQOL-100/short version of the WHOQOL (WHOQOL-BREF; 3 times), the Simple Walking test (2 times), the Sickness Impact Profile (2 times), the Special Interest Group in Amputee Medicine assessment (SIGAM; 2 times), the Nottingham Health Profile (2 times), the European QOL scale (EQ5D; 2 times), and the Trinity Amputation and Prosthesis Experiences Scales (2 times). A number of studies not included in this review used original, nonvalidated assessment instruments. The examination of previous review papers and discussions with expert consultants resulted in an additional 5 instruments included for description, for a total of 26 instruments (Table II). After rating, 14 instruments were graded as +++ or above. They are described below, along with studies that exemplify their usage. Descriptions of the remaining 12 instruments can be found in Appendix IV.

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Instruments of Function: Walking Tests A collection of instruments measure function by assessing a patient’s ability to walk. All allow use of a prosthesis. Two tests (the TUG and 10-meter walk tests [10MWT]) set a fixed distance, while the 6MWT sets a fixed time. The TUG test (+++) assesses the ability of an amputee to rise from a seated position, walk 3 meters, and then return to a seated position. Total time is measured.12 Schoppen et al.13 used the TUG test to show that functional outcome could be predicted 2 weeks after amputation by age at amputation, 1-leg balance on the unaffected limb, and cognitive impairment. The 10MWT (+++) records the time it takes a patient to walk 10 meters. The purpose of the test is to use usual walking speed as a measure of mobility.14 This simple test has been modified and used for distances up to 500 meters. One well described downside to both the TUG test and the 10MWT is a significant ceiling effect. Munin et al.15 used a modified version of the 10MWT to show that early prosthetic rehabilitation resulted in greater ambulation at rehabilitation discharge. The 6MWT and the similar 2MWT (+++) both have a patient walk a 100-foot course for 6 min (or 2 min) at their usual pace.16 Because it evaluates the global and integrated responses of all the major body systems, it can be confounded by comorbidities (i.e., cardiopulmonary, musculoskeletal, and neurologic), and these must be taken into account when judging a patient’s performance on these tests.17 Overall, walk tests have been shown to have excellent reliability and adequate to excellent validity.14,16,18,19 Rau et al.20 used the 6MWT to show that physiotherapy is effective in improving functional performance of lower limb amputees in a resource poor setting. Instruments of Function: Activities of Daily Living The FAI (+++) assesses a broad range of activities of daily living (ADL) and beyond in patients.21 It is comprised of 15 questions and scored as 1e4, where a score of 1 represents the lowest level of activity. The scale provides a summed score ranging from 15e60. A modified 0e3 scoring system introduced by Wade et al.22 yields a score of 0e3 for each item, and a summed score from 0e45. The FAI has been extensively validated in stroke populations23e25 and has shown excellent reliability in a MLE amputation group.26 Asano et al.27 used the FAI to show that depression, perceived prosthetic mobility, social support, comorbidity, prosthesis

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Table I. List of instruments by function versus quality of life and then by general versus amputee-specific Instrument

Rating

Tests of function General tests Walking tests Six-minute Walk Test (6MWT) Timed Up and Go (TUG) 10 m Walk Simple Walking General function Activities of daily living Frenchay Activity Index (FAI) Modified Barthel Index (BI) Functional Independence Measure (FIM) International Physical Activity Questionnaire (IPAQ) Sickness Impact Profile (SIP) Mobility Rivermead Mobility Index (RMI) Amputee-specific Special Interest Group in Amputee Medicine (SIGAM) Houghton Scale Locomotor Capabilities Index (LCI-5) Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) Prosthetic Profile of the Amputee (PPA) Day’s Amputee Activity Score (AAS) Amputee Mobility Predictor (AMP) Functional Measure for Amputees (FMA) Test of quality of life General Short Form 36- General Health Status Survey (SF-36) Short Form 12- General Health Status Survey (SF-12) World Health Organization Quality of Life Assessment Instrument 100 (WHOQOL-100) European Quality of Life (EQ5D) Nottingham Health Profile (NHP) Satisfaction with Life Scale (SWLS) Amputee-specific Prosthesis Evaluation Questionnaire (PEQ) Trinity Amputation and Prosthesis Experiences Scales (TAPES) Attitude to Artificial Limb Questionnaire (AALQ)

problems, age, and social activity participation predict perceived QOL.27

+++ +++ +++ +

+++ ++ ++ ++ ++ +++ +++ +++ +++ ++ ++ ++ ++ ++

++++ +++ ++++ ++++ +++ ++ +++ ++ +

Though reliable and responsive to longitudinal change, the RMI is noted to have mild ceiling effects after analysis in amputees.30

Tests of Function: Mobility The Rivermead Mobility Index (RMI; +++) was initially developed to measure mobility for patients with brain injuries and has since been expanded to assess mobility in other disease processes, including amputees.28 A range of activities is covered, from turning over in bed to running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility).29

Instruments of Function: Amputee-Specific The SIGAM (+++) test is a single-item scale comprising 6 clinical grades (AeF) of amputee mobility.30 Grades range from A (nonlimb user) to F (normal or near normal walking). SIGAM was based on the Harald Wood Stanmore observer rated measure.31 The test is a self-report questionnaire answered yes/no that then uses an algorithm to facilitate grade assignment. Reliability is excellent, but there are sparse data to determine validity.32

Test

First author

Year of publication Domains

Items

Time to perform (min)

Functiondgeneral 6MWT/2MWT TUG 10-m walk FAI

d d d Holbrook

d d d 1983

d d d 3

d d d 15

10/5 1e10 0eN min 5

RMI

Franchignoni 2003

d

14 questions 10 plus standing

Yes

Free

Validated in amputee? Cost

Yes Yes Yes No

Free Free Free Free

Scoring range

0eN m 0eN min 0eN min 15e60, with 60 representing the highest level of activity 0 (poor mobility) to 15 (excellent mobility)

Functiondamputee-specific SIGAM Ryall

2003

6

21

2

Yes

Free

Houghton scale

Houghton

1992

4

6

5

Yes

Free

LCI-5

Franchignoni 2004

1

14

5

Yes

Free

Requires license 0e100 (100 is best possible score) Requires license 0e100 (100 is best possible score) Free with 0e1, with 1 representing registration perfect health state Free Scores available for domains, facets, and overall; higher scores indicate lower quality of life 0e100, with higher scores Requires representing greater health administrative problems fee

1992

8

36

10e15

No

SF-12

Ware

1996

8

12

2e3

No

EQ5D

Euro QOL

1990

5 + VAS 5 + VAS

3

No

WHOQOL-100/BREF WHOQOL Group

1994

6/4

100/26

20e30/10 No

NHP

1990

7

45

5e10

No

1998

9

82

10

Yes

Hunt

Quality of lifedamputee-specific PEQ Legro

Free

+++ +++ +++ +++ +++

+++ AeF (ranging from A [nonlimb user] to F [normal or near normal walking]) 0e12 (12 represents excellent +++ performance) 0e56, with 56 being the best +++ possible

0e100, with 100 being the best possible

++++ +++ ++++ ++++/+++

+++

+++

6MWT/2MWT, 6-min walk test/2-min walk test; EQ5D, European Quality of Life; FAI, Frenchay Activity Index; MET, metabolic equivalent; NHP, Nottingham Health Profile; LCI-5, Locomotor Capabilities Index; PEQ, Prosthesis Evaluation Questionnaire; RMI, Rivermead Mobility Index; SF-12, Short-Form 12; SF-36, Short-Form 36; SIGAM, Special Interest Group in Amputee Medicine; TUG, Timed Up and Go; VAS, Visual Analog Scale; WHOQOL-100, World Health Organization Quality of Life Assessment 100.

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Quality of lifedgeneral SF-36 Ware

Overall quality (adapted from Johnston and Graves11)

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Table II. Summary including test, first author, domains, items, time to perform, and scoring range

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Met et al.33 used the SIGAM to show that it is preferable to perform a straight above the knee amputation (AKA) instead of a through the knee amputation if the correct amputation level is in doubt in high-risk patients. The Houghton Scale (+++) was originally described in a vascular amputee population.34,35 It is a self-reported assessment of performance comprised of 4 sections. The test quantifies prosthetic use by time, context, ambulatory aids, and confidence over variable terrain. It is designed to assess activities that are independent of age, sex, gait quality, and comorbidities. The first 3 categories are measured on a 4-point scale, and the last has 3 questions with yes/no answers. The total score is on a 12-point scale; a higher score indicates better performance. The Houghton Scale has high reliability and is appropriately responsive to change in prosthetic use in individuals with lower-limb amputation after rehabilitation.36 The Houghton Scale has been used by Bhangu et al.37 to show that the overall functional outcome of individuals with a combination of below the knee amputation (BKA) and AKA because of dysvascular causes is poor, with a low level of ambulation, activity, and prosthetic use. The Locomotor Capabilities Index (LCI; +++) is a stand-alone subset of the Prosthetic Profile of the Amputee (PPA). It was designed to trace a comprehensive profile of ambulatory skills of the lower limb amputee with the prosthesis and to evaluate their level of independence while performing these activities.38 Like the PPA, it is self-reported and comprised of 4-point ordinal scales and provides an aggregated score for the 14 items. Franchignoni et al.39 transformed the original scale of the LCI into a 5-level version, the LCI-5. The upper ordinal level of each LCI item ‘‘Yes, alone‘‘ was split into 2 levels: ‘‘Yes, alone, with ambulation aids‘‘ (score: 3 points) and ‘‘Yes, alone, without ambulation aids‘‘ (score: 4 points). Therefore, the total score of the index is 56, with maximum subscores of 26. The test is widely used, with good consistency, reliability, and validity.40e42 Ceiling effects have been reduced by 50% in the LCI-5.40 Traballesi et al.43 used the LCI-5 to show that age reduced the possibility of improving the level of autonomy and that good stump quality is one of the major determinants of mobility outcome. Instruments of Quality of Life: General The SF-36 (also known as the MOS-36; ++++) was developed by the medical outcomes study as an instrument for both clinical assessment and research.44 It contains 8 domains: physical, role and

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social functioning, mental health, patient health perceptions, vitality, body pain, and change in health. The SF-36 has seen wide adoption and has broad use across languages and disease states. It is scored on a scale between 0e100, with 100 being the best possible score. The SF-12 (+++) was designed to be a simpler and quicker version of the SF-36.45 It selects items from all domains of SF-36 and shortens the test to 12 questions. Both the SF36 and the SF-12 have been translated into >140 languages. Both have been extensively validated, including in the MLE amputee population. PennBarwel et al.46 used the SF-36 to show that patients with a through the knee amputation have a better physical QOL than those with an AKA. The EQ5D (++++) is a widely used instrument that assesses QOL over 5 dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and depression/anxiety), with scoring standardized for the population.47 The EQ5D also uses a 100-point visual analog scale (VAS) to generate a health state based on the weighted time trade-off methodda value state suitable for cost effectiveness analysis.48 The EQ5D has been extensively validated across cultures and disease states and is a popular test worldwide.49 The EQ5D was also used by Asano et al.27 in their study to show that depression, perceived prosthetic mobility, social support, comorbidity, prosthesis problems, age, and social activity participation predict perceived QOL.27 The WHOQOL-100 (++++) is a generic, patientcompleted measure of health-related QOL that was simultaneously developed in 15 sites worldwide.50 It is focused around the definition of QOL advanced by the WHO, which includes the culture and context that influence an individual’s perception of health. The WHOQOL-BREF (+++) is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF instrument comprises 26 items that measure the following broad domains: physical health, psychological health, social relationships, and environment. Both are available in >20 languages. Deans et al.51 used the WHOQOL-100 to show that education about the importance of increasing and maintaining a level of physical activity conducive to health benefits should be implemented within a supportive sociable environment for the patient with lower-limb amputation. The Nottingham Health Profile (NHP; +++) is a questionnaire that assesses function and healthrelated QOL.52,53 It is made up of 2 sections; the first contains 38 yes/no questions over 6 domains (i.e., sleep, energy, emotional reactions, social isolation,

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physical mobility, and pain). The second session addresses difficulty with ADLs with 7 yes/no questions (i.e., employment, housework, family relationships, social life, sex life, hobbies, and vacations). Scores range from 0e100, with a higher score indicating a poorer level of health. The test has been translated into many languages. The original papers describe high reliability and validity. The NHP was used by Demet et al.54 to show that young age at the time of amputation, traumatic origin, and upper limb amputation were independently associated with better QOL. Instruments of Quality of Life: Amputee Specific The Prosthetics Evaluation Questionnaire (PEQ; +++) was developed from 1995e1997 to fill the need for a comprehensive self-report instrument for individuals with lower limb loss who use a prosthesis.55 The PEQ is a self-administered questionnaire consisting of 82 items with a linear analog scale response format. Nine scales are computed from 42 items (i.e., ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, and well-being). Scales are reported with a range from 0e100, with 100 representing the best score possible. The PEQ has good reliability and good to excellent construct validity.55,56 Pinzur et al.57 used the PEQ to show that patients with bone bridging had scores better than or comparable to those of a selected group of highly functional traditional BKAs.

DISCUSSION While there is no criterion standard available for outcome measures, there are a number of validated instruments that are of high quality and are widely used. We found that a wide range of outcome assessment instruments are available to both the researcher and clinician. While the large choice of potential instruments to fit to the particular study question is useful, the heterogeneity of the tests means that it is difficult to compare results from study to study. Identifying the perfect universal functional and QOL instrument is difficult for 2 reasons. First, each instrument has its strengths and weakness. Some trade brevity for comprehensiveness; others aim for generalizability across disease states rather than amputee specificity. Second, each research study or clinical practice has its own specific goals and needs. However, there are certain instruments in each category that are easy to administer, have

Functional and QOL assessment after MLE amputation 769

been better validated, and appear appropriate for use in the amputee population. Researchers should be cautioned against creating their own questionnaires and instead opt for a validated, reliable, and widely used metric. In the generic instruments of function group, the timed walk tests (6MWT and TUG) are widely used and well validated. While they require an administrator, they are simple to perform and could be seen as a criterion standard for mobility. The FAI has been widely used and appears to be appropriate for amputees. In the amputee-specific instrument of function, the SIGAM is simple and easy to use. The Houghton Scale tests well, but it is better suited for the clinical setting.42 For generic QOL instruments, the SF-36, SF-12, and the EQ5D are both widely used and extensively validated. The EQ5D has the ability to be converted into single index value for health status, which can then be used in the cost/utility analysis of health interventions and programs. Neither has been extensively tested in an amputee population, and more data would be useful. For amputee-specific QOL instruments, the PEQ has shown reliability and validity, but its length and scoring restrict it to research settings. Table III offers a guide for selection of appropriate instruments. Over the past 10 years, there has been an increase in the use of both functional and QOL assessment tools in the study of outcomes after amputation. This is clear evidence of the recognition by both vascular specialists and physical medicine and rehabilitation researchers of the importance of outcome measures in assessing the technical and functional success of amputation and rehabilitation. From the literature, vascular specialists tend to favor more dichotomous (walk versus no walk) functional tests and simpler tests of QOL than physical medicine and rehabilitation physicians. In examining the current state of assessment instruments after amputation, 3 needs become apparent. First, there needs to be additional research to move toward a consensus of what the best tests are for outcomes after amputation. National professional organizations should seek to standardize and make strong recommendations for the use of assessment instruments. Second, there needs to be additional research into assessment instrument use in the clinical setting. The use of assessment instruments by the clinician to evaluate an individual patient’s progress in response to treatment or aging is poorly understood. Finally, there needs to be additional investigation into amputee-specific instruments compared to instruments designed for the general population. Though amputee-specific

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Table III. A guide to the selection of functional and quality of life assessment instruments for amputees Time (min)

Setting

Use

Test

20 Clinic Inpatient Clinical Research Languages

Functiondgeneral 6MWT/2MWT TUG 10 M WALK FAI

  

RMI Functiondamputeespecific SIGAM Houghton scale LCI-5

   

   







  

  



Quality of lifedgeneral SF-36 SF-12  EQ5D  WHOQOL-100 NHP Quality of lifed amputee-specific PEQ





 



   

   

N/A N/A N/A English, Dutch, and Chinese English, Italian, and Dutch

Mode of administration

Observation Observation Observation Questionnaire Questionnaire/ observational



  



    

   

   

   

>50 >50 >150 >20 19

Questionnaire Questionnaire Questionnaire Questionnaire Questionnaire







English, French, and Arabic

Questionnaire

English Questionnaire English Questionnaire Dutch, English, French, Questionnaire Italian, Portuguese, Spanish, and Swedish

6MWT/2MWT, 6-min walk test/2-min walk test; EQ5D, European Quality of Life; FAI, Frenchay Activity Index; MET, metabolic equivalent; NHP, Nottingham Health Profile; LCI-5, Locomotor Capabilities Index; PEQ, Prosthesis Evaluation Questionnaire; RMI, Rivermead Mobility Index; SF-12, Short-Form 12; SF-36, Short-Form 36; SIGAM, Special Interest Group in Amputee Medicine; TUG, Timed Up and Go; VAS, Visual Analog Scale; WHOQOL-100, World Health Organization Quality of Life Assessment 100.

instruments may seem more appropriate a priori, there have been no studies that have shown superiority to general assessment instruments. In addition, general assessment instruments can be compared across disease states. This feature is increasingly important as the focus of health care reform turns to optimizing patient-centered outcomes and the allocation of limited health care resources.

2. 3. 4.

5.

CONCLUSION The heterogeneity of methods used to measure both functional and QOL outcomes makes it difficult to compare MLE amputation outcome studies. Future researchers should seek to use well-established instruments. Clinical and research societies should endorse the best validated instruments for future use to strengthen overall research in the field.

6.

7.

8.

REFERENCES 9. 1. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. Estimating the prevalence of limb loss in the United

States: 2005 to 2050. Arch Phys Med Rehabil 2008;89: 422e9. Landry GJ. Functional outcome of critical limb ischemia. J Vasc Surg 2007;45(Suppl A):A141e8. Patient Protection and Affordable Care Act of 2009, HR 3590, 111th Cong, 2nd session (2009). Brundage M, Bass B, Davidson J, et al. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res 2011;20:653e64. Condie E, Scott H, Treweek S. Lower limb prosthetic outcome measures: a review of the literature 1995-2005. J Prosthet Orthot 2006;18:13e45. Rommers GM, Vos LD, Groothoff JW, et al. Mobility of people with lower limb amputations: scales and questionnaires: a review. Clin Rehabil 2001;15:92e102. Gauthier-Gagnon C, Grise MC. Tools for outcome measurement in lower limb amputee rehabilitation. 10th World Congress of the International Society for Prosthetics and Orthotics, Glasgow Scotland, 2001, Institute de Readaption de Montreal, Quebec, Canada. Deathe AB, Wolfe DL, Devlin M, et al. Selection of outcome measures in lower extremity amputation rehabilitation: ICF activities. Disabil Rehabil 2009;31:1455e73. Sinha R, Van Den Heuvel WJ. A systematic literature review of quality of life in lower limb amputees. Disabil Rehabil 2011;33:883e99.

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10. Mays RJ, Casserly IP, Kohrt WM, et al. Assessment of functional status and quality of life in claudication. J Vasc Surg 2011;53:1410e21. 11. Johnston MV, Graves DE. Towards guidelines for evaluation of measures: an introduction with application to spinal cord injury. J Spinal Cord Med 2008;31:13e26. 12. Schoppen T, Boonstra A, Groothoff JW, et al. The timed ‘‘up and go‘‘ test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil 1999; 80:825e8. 13. Schoppen T, Boonstra A, Groothoff JW, et al. Physical, mental, and social predictors of functional outcome in unilateral lower-limb amputees. Arch Phys Med Rehabil 2003;84:803e11. 14. Boonstra AM, Fidler V, Eisma WH. Walking speed of normal subjects and amputees: aspects of validity of gait analysis. Prosthet Orthot Int 1993;17:78e82. 15. Munin MC, Espejo-De Guzman MC, Boninger ML, et al. Predictive factors for successful early prosthetic ambulation among lower-limb amputees. J Rehabil Res Dev 2001;38: 379e84. 16. Brooks D, Hunter JP, Parsons J, et al. Reliability of the twominute walk test in individuals with transtibial amputation. Arch Phys Med Rehabil 2002;83:1562e5. 17. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111e7. 18. Collin C, Wade D, Cochrane G. Functional outcome of lower limb amputees with peripheral vascular disease. Clin Rehabil 1992;6:13e21. 19. Datta D, Ariyararatnam R, Hilton S. Timed walking testdan all-embracing outcome measure for lower-limb amputees? Clin Rehabil 1996;10:227. 20. Rau B, Bonvin F, de Bie R. Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. Prosthet Orthot Int 2007;31:258e70. 21. Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing 1983;12:166e70. 22. Wade DT, Legh-Smith J, Langton Hewer R. Social activities after stroke: measurement and natural history using the Frenchay activities index. Int Rehabil Med 1985;7:176e81. 23. Schuling J, de Haan R, Limburg M, et al. The Frenchay Activities Index. Assessment of functional status in stroke patients. Stroke 1993;24:1173e7. 24. Schepers VP, Ketelaar M, Visser-Meily JM, et al. Responsiveness of functional health status measures frequently used in stroke research. Disabil Rehabil 2006;28:1035e40. 25. Green J, Forster A, Young J. A test-retest reliability study of the Barthel Index, the Rivermead Mobility Index, the Nottingham Extended Activities of Daily Living Scale and the Frenchay Activities Index in stroke patients. Disabil Rehabil 2001;23:670e6. 26. Miller WC, Deathe AB, Harris J. Measurement properties of the Frenchay Activities Index among individuals with a lower limb amputation. Clin Rehabil 2004;18:414e22. 27. Asano M, Rushton P, Miller WC, et al. Predictors of quality of life among individuals who have a lower limb amputation. Prosthet Orthot Int 2008;32:231e43. 28. Franchignoni F, Brunelli S, Orlandini D, et al. Is the Rivermead Mobility Index a suitable outcome measure in lower limb amputees?dA psychometric validation study. J Rehabil Med 2003;35:141e4. 29. Forlander DA, Bohannon RW. Rivermead mobility index: a brief review of research to date. Clin Rehabil 1999;13:97e100.

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30. Ryall NH, Eyres SB, Neumann VC, et al. The SIGAM mobility grades: a new population-specific measure for lower limb amputees. Disabil Rehabil 2003;25:833e44. 31. Hanspal RS, Newman WP. Mobility grades in amputee rehabilitation. Clin Rehabil 1991;5:344. 32. Gardiner MD, Faux S, Jones LE. Inter-observer reliability of clinical outcome measures in a lower limb amputee population. Disabil Rehabil 2002;24:219e25. 33. Met R, Janssen LI, Wille J, et al. Functional results after through-knee and above-knee amputations: does more length mean better outcome? Vasc Endovascular Surg 2008;42: 456e61. 34. Houghton A, Allen A, Luff R, et al. Rehabilitation after lower limb amputation: a comparative study of aboveknee, through-knee and Gritti-Stokes amputations. Br J Surg 1989;76:622e4. 35. Houghton AD, Taylor PR, Thurlow S, et al. Success rates for rehabilitation of vascular amputees: implications for preoperative assessment and amputation level. Br J Surg 1992; 79:753e5. 36. Devlin M, Pauley T, Head K, et al. Houghton scale of prosthetic use in people with lower-extremity amputations: reliability, validity, and responsiveness to change. Arch Phys Med Rehabil 2004;85:1339e44. 37. Bhangu S, Devlin M, Pauley T. Outcomes of individuals with transfemoral and contralateral transtibial amputation due to dysvascular etiologies. Prosthet Orthot Int 2009;33: 33e40. 38. Gauthier-Gagnon C, Grise MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil 1994;75:1309e14. 39. Streppel KR, de Vries J, van Harten WH. Functional status and prosthesis use in amputees, measured with the Prosthetic Profile of the Amputee (PPA) and the short version of the Sickness Impact Profile (SIP68). Int J Rehabil Res 2001;24:251e6. 40. Franchignoni F, Orlandini D, Ferriero G, et al. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil 2004;85:743e8. 41. Miller WC, Deathe AB, Speechley M. Lower extremity prosthetic mobility: a comparison of 3 self-report scales. Arch Phys Med Rehabil 2001;82:1432e40. 42. Gauthier-Gagnon C, Grise M, Lepage Y. The locomotor capabilities index: content validity. J Rehabil Outcomes Measurement 1998;4:40e6. 43. Traballesi M, Porcacchia P, Averna T, et al. Prognostic factors in prosthetic rehabilitation of bilateral dysvascular aboveknee amputee: Is the stump condition an influencing factor? Eura Medicophys 2007;43:1e6. 44. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 1992;30:473e83. 45. Ware J Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220e33. 46. Penn-Barwell JG. Outcomes in lower limb amputation following trauma: a systematic review and meta-analysis. Injury 2011;42:1474e9. 47. EuroQol Group. EuroQolda new facility for the measurement of health-related quality of life. Health Policy 1990; 16:199e208. 48. Chilcott J, McCabe C, Tappenden P, et al. Modelling the cost effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis. Commentary: evaluating

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49.

50. 51.

52. 53.

disease modifying treatments in multiple sclerosis. BMJ 2003;326:522. De Fretes A, Boonstra AM, Vos LD. Functional outcome of rehabilitated bilateral lower limb amputees. Prosthet Orthot Int 1994;18:18e24. WHOQOL Group. Development of the WHOQOL: rationale and current status. Int J Men Health 1994;23:24. Deans SA, McFadyen AK, Rowe PJ. Physical activity and quality of life: a study of a lower-limb amputee population. Prosthet Orthot Int 2008;32:186e200. Hunt SM, McEwen J. The development of a subjective health indicator. Sociol Health Illn 1980;2:231e46. Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract 1985;35:185e8.

APPENDIX I: SEARCH TERMS (‘‘Amputation’’ [Mesh] OR ‘‘Amputation Stumps’’ [Mesh] OR ‘‘Amputation, Traumatic’’ [Mesh] OR (amputable [Text Word] OR amputaciones [Text Word] OR amputaion [Text Word] OR amputaiton [Text Word] OR amputaled [Text Word] OR amputatatio [Text Word] OR amputate [Text Word] OR amputate’ [Text Word] OR amputated [Text Word] OR amputated/denervated [Text Word] OR amputated/dismembered [Text Word] OR amputated/inactive [Text Word] OR amputated/intact [Text Word] OR amputated/referent [Text Word] OR amputated’ [Text Word] OR amputatee [Text Word] OR amputates [Text Word] OR amputating [Text Word] OR amputatio [Text Word] OR amputatiointerthoraco [Text Word] OR amputation [Text Word] OR amputation/83 [Text Word] OR amputation/absorption [Text Word] OR amputation/avulsion [Text Word] OR amputation/bypass [Text Word] OR amputation/chest [Text Word] OR amputation/denervation [Text Word] OR amputation/devascularization [Text Word] OR amputation/disarticulation [Text Word] OR amputation/exarticulation [Text Word] OR amputation/fullness [Text Word] OR amputation/grafting [Text Word] OR amputation/hemisection [Text Word] OR amputation/injury [Text Word] OR amputation/neuropathy [Text Word] OR amputation/occlusion [Text Word] OR amputation/penetrating [Text Word] OR amputation/person [Text Word] OR amputation/plexus [Text Word] OR amputation/pulmonary [Text Word] OR amputation/radical [Text Word] OR amputation/readmission [Text Word] OR amputation/ regeneration [Text Word] OR amputation/replantation [Text Word] OR amputation/revision [Text Word] OR amputation/salvage [Text Word] OR amputation/sparing [Text Word] OR amputation/ trisection [Text Word] OR amputation/ulcer/

Annals of Vascular Surgery

54. Demet K, Martinet N, Guillemin F, et al. Health related quality of life and related factors in 539 persons with amputation of upper and lower limb. Disabil Rehabil 2003;25:480e6. 55. Legro MW, Reiber GD, Smith DG, et al. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil 1998;79:931e8. 56. Harness N, Pinzur MS. Health related quality of life in patients with dysvascular transtibial amputation. Clin Orthop Relat Res 2001;383:204e7. 57. Pinzur MS, Pinto MA, Saltzman M, et al. Health-related quality of life in patients with transtibial amputation and reconstruction with bone bridging of the distal tibia and fibula. Foot Ankle Int 2006;27:907e12.

neuropathic [Text Word] OR amputation/ulcers [Text Word] OR amputation’ [Text Word] OR amputation’’ [Text Word] OR amputational [Text Word] OR amputationes [Text Word] OR amputationplasty [Text Word] OR amputations [Text Word] OR amputations/crush [Text Word] OR amputations/ulcers [Text Word] OR amputations/ year/10,000 [Text Word] OR amputations’ [Text Word] OR amputative [Text Word] OR amputatrix [Text Word] OR amputatus [Text Word] OR amputed [Text Word] OR amputee [Text Word] OR amputee’ [Text Word] OR amputee’s [Text Word] OR amputees [Text Word] OR amputees/ 100 [Text Word] OR amputees/year/10,000 [Text Word] OR amputees’ [Text Word] OR amputeez [Text Word] OR amputer [Text Word] OR amputers [Text Word] OR amputes [Text Word] OR amputierten [Text Word] OR ampution [Text Word] OR amputive [Text Word] OR amputostypos [Text Word])) AND (‘‘Outcome Assessment (Health Care)’’ [Mesh] OR ‘‘Quality of Life’’ [Mesh] OR ‘‘Treatment Outcome’’ [Mesh]) AND (‘‘Leg’’ [Mesh] OR ‘‘Artificial Limbs’’ [Mesh] OR ‘‘Lower Extremity’’ [Mesh]) AND ((hasabstract [text] AND ‘‘loattrfull text’’ [sb]) AND ‘‘2002/07/23’’ [PDat]: ‘‘2012/07/19’’ [PDat] AND ‘‘humans’’ [MeSH Terms] AND English [lang] AND ‘‘adult’’ [MeSH Terms])

APPENDIX CRITERIA

II:

INCLUSION/EXCLUSION

Inclusion criteria  Major lower extremity amputee population  Full paper  Written in English

Sample size (amputees only) Country

Population (etiology)

Eijk et al (2012)29

Geriatric MLE Amputees

48

Netherlands BI

Cox et al (2011)30

MLE amputees because of diabetes

87

Jamaica

WHOQOL-BREF and FIM

Frlan-Vrgoc et al (2011)31

MLE amputees with prosthesis

50

Croatia

2MWT

da Silva et al (2011)32

MLE amputees

22

Brazil

Kark and Simmons (2011)33

MLE amputees

20

Australia

IPAQ and WHOQOLBREF PEQ, TUG, and 6MWT

Sinha et al (2011)34

MLE amputees

184

Penn-Barwell (2011)35

Lower limb (trauma)

Mazari et al (2010)36

BKA amputees

Stineman et al (2010)37

Raya et al (2010)38

Assessment instruments

Netherlands SF-36

3,105

UK

29

UK

SF-36, ability to walk 500 m SF-36

Veterans with a new lower 1,502 extremity amputation (DM, PVD, and trauma) MLE amputees 72

US

FIM

US

6MWT

Outcomes

DM and high premorbid BI were associated with discharge to an independent living situation; premorbid BI, admission BI, and 1-leg balance were independently associated to discharge BI BKA functioned better than those with AKA; womens were more likely to cope and function with disability than men Age, sex, level and cause of amputation, including the time from the first prosthetic supply, have an effect on the 2MWT Physical activity is not associated with QOL except for the psychological domain For high functioning MLE amputees, gait deviation was not associated with satisfaction; improving self-perceived functional ability and attitudes toward the prosthesis will improve patient satisfaction Amputees scored lower on SF-36 than general population Patients with a TKA have a better physical quality of life than those with an AKA No difference in clinical and QOL outcomes between 2 types of walking aides Patients who receive specialized rehabilitation make greater gains than patients who receive consultative services Impairments in hip strength and balance impact 6MWT scores; the findings of this study support the use of the 6MWT to underscore impairments of the musculoskeletal system that can affect ambulation ability in the amputee (Continued)

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First author (year)

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Table.

Sample size (amputees only) Country

First author (year)

Population (etiology)

Remes et al (2010)39

MLE amputees with PAD

59

Davidson et al (2010)40

MLE amputees

39

Taghipour et al (2009)41

Veterans with a war-related unilateral lower extremity amputation (trauma) Tibial trauma patients (trauma)

Giannoudis et al (2009)42

Assessment instruments

Outcomes

Finland

SF 36 and SWLS

Australia

SF-36

141

Iran

SF-36

Home-dwelling amputees had a relatively good QOL, whereas institutionalization was associated with depressive symptoms; in rehabilitation programs, QOL should be considered Upper limb amputees suffer postamputation pain more than MLE amputees and have reduced HR-QOL; the overall health status of amputees is lower than the Australian population norm Alleviation of pain, education, and employment are issues that should be addressed

22

UK

EQ5D

1,339

US

FIM

MLE amputees

Bhangu et al (2009)44

Bilteral MLE amputees because of dysvascular disease

31

Canada

2MWT, Houghton scale, and FAI

Boutoille et al (2008)45

Amputation after diabetic foot ulcer (DM) Bilateral transtibial amputees (DM, PVD)

25

France

SF-36

82

Canada

SF-12

415

Canada

FAI and EQ5D VAS

MacNeill et al (2008)46

Asano et al (2008)47

MLE amputation

Annals of Vascular Surgery

Kurichi et al (2009)43

Patients with tibial injuries report long-term health-related QOL problems of varying degrees Receipt of specialized compared with generalized rehabilitation during the acute postoperative inpatient period was associated with better outcomes Overall functional outcome of individuals with a combination of BKA and AKA amputation because of dysvascular causes is poor, with a low level of ambulation, activity, and prosthetic use No difference in QOL between patients with foot ulcers and amputees Patients undergoing rehabilitation for BTTA do well at long-term follow-up and to survive, on average, for >4 years after discharge Depression, perceived prosthetic mobility, social support, comorbidity, prosthesis problems, age, and social activity participation predict subjects’ perceived QOL

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Table. Continued

75

Desmond et al (2008)49

MLE amputation

89

Johannesson et al (2008)50

BKA for dysvascular disease

27

Met et al (2008)51

TKA and AKA (PVD, DM, and trauma)

50

Stasik et al (2008)52

Redo BKA (DM and PVD)

23

Yazicioglu et al (2007)53

Unilateral BKA fitted with prostheses Male unilateral lower limb amputees

24

49

Cannada and Jones (2006)56

BKA with distal tibial-fibular bone-bridge (DM, PVD, and trauma) Traumatic amputees

Traballesi et al (2006)57

Bilateral AKA for PVD

Rau et al (2007)54

Pinzur et al (2006)55

58

601

30

UK

TAPES and WHOQOLBREF

Education about the importance of increasing and maintaining a level of physical activity conducive to health benefits should be implemented within a supportive sociable environment for the patient with lower-limb amputation Ireland TAPES Important for clinicians to ascertain the type and level of pain and to separate the experiences of the pain from the experiences of the prosthetic limb Sweden LCI and TUG A vacuum-formed dressing appears to give results similar to those of the conventional dressing regarding time to prosthetic fitting and patient’s function with prosthesis Netherlands SIGAM Preferable to perform a straight AKA instead of a TKA if the correct amputation level is in doubt in high-risk patients Florida Ability to walk Redo BKA yields excellent functional outcomes; a history of minor stump trauma and a palpable popliteal pulse favor redo BKA compared with conversion to AKA Turkey Houhgton scale, LCI, Playing football (soccer) may have positive and SF-36 effects on balance and health-related QOL Myanmar 2MWT, TUG, and FMA Physiotherapy is effective in improving functional performance of lower limb amputees in a resource poor setting US PEQ Patients with bone-bridging had scores better than or comparable to those of a selected group of highly functional traditional BKA US SIP Factors other than the traditional variables, such as fracture healing, joint function, and ability to ambulate, have a profound effect on the patient’s estimation of improvement Italy BI and LCI Age reduced the possibility of improving the level of autonomy; good stump quality is one of the major determinants of mobility outcome (Continued)

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MLE amputees

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Deans et al (2008)48

Sample size (amputees only) Country

First author (year)

Population (etiology)

Gunawardena et al (2006)58

Unilateral, traumatic lower limb amputees

461

Sri Lanka

Wan Hazmy et al (2006)59

MLE amputation (DM, PVD, and trauma)

213

Malaysia

Meatherall et al (2005)60

MLE amputation because of DM

44

Van de Weg and Van der Windt (2005)61 Selles et al (2005)62

BKA amputees

Davies and Datta (2003)63

Unilateral BKA or AKA (DM, PVD, and trauma)

281

Schoppen et al (2003)64

Patients >60 years of age with MLE amputation because of PVD

46

Demet et al (2003)65

Major upper and lower extremity amputation

Unilateral BKA (DM, PVD, and trauma)

van der Schans et al (2002)66 MLE amputees

Canada

220

Netherlands

26

Netherlands

UK

Netherlands

539

France

437

Netherlands

MLE amputees

75

US

Hoogendoorn and van der Werken (2001)68

Grade III open tibial fractures (trauma)

43

Netherlands

Outcomes

SF-36

Amputees have comparatively poor functional outcomes, which could be improved by modifying stump length and problems with the stump and sound leg BI Most amputees had a good functional outcome; some were unhappy that they were insufficiently informed regarding postamputation expectation PEQ and PPA Major functional changes were noted after MLE amputation that had a large negative impact on QOL PEQ Liner prescription should not be employed as a matter of course for all BKA amputees FIM and PEQ Patients receiving an ICEX TSB socket and a conventional PTB socket had similar outcomes Harold Wood Stanmore Mobility rates 1 year after prosthetic mobility grade provision for unilateral BKA and AKA (precursor to SIGAM) worsen with increasing age and higher level of amputation SIP and TUG Functional outcome could be predicted 2 weeks after amputation by age at amputation, 1-leg balance on the unaffected limb, and cognitive impairment NHP Young age at the time of amputation, traumatic origin, and upper limb amputation were independently associated with better QOL SF-36 The most important amputation-specific determinants of health-related QOL were ‘‘walking distance’’ and ‘‘stump pain’’ 45-m walk test Early prosthetic rehabilitation resulted in greater ambulation at rehabilitation discharge NHP and SF-36 Amputees have greater impairment than those with successful limb salvage, but QOL is the same

AKA, Above-knee amputation; BKA, below-knee amputation; BTTA, bilateral trans tibial amputation; CLI, critical limb ischemia; DM, diabetes mellitus; MLE, major lower extremity; PVD, peripheral vascular disease; TKA, trans-knee amputation; UK, United Kingdom; US, United States. Dysvascular includes both PVD and DM.

Annals of Vascular Surgery

Munin et al (2001)67

Assessment instruments

776 Hawkins et al.

Table. Continued

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 The study must assess a population, not simply validate an assessment instrument  More than 20 patients  Major outcome must be either function or quality of life

Exclusion criteria  Amputations caused by oncologic or congenital etiologies  Pediatric populations  Review papers

APPENDIX III: TABLE OF STUDIES WITH AUTHOR, YEAR, SAMPLE SIZE, OUTCOMES INSTRUMENTS, AND OUTCOMES APPENDIX IV DESCRIPTION OF INSTRUMENTS SCORED D AND DD Instruments of Function: Activities of Daily Living The Barthel Index (++) assesses 10 activities, 8 of which are self-care and 2 are mobility.1 It was originally developed in 1965 with the intent of measuring what a patient is able to do with various neurologic conditions, but has been since used with amputees. It can be administered as either an interview questionnaire or by direct observation. The questionnaire method takes 5 min while the observation method takes 20 to 60 min. The 10 items are totaled to give a score out of 100 (total independence). The Barthel Index has been well studied in amputee populations and shows good validity and reliability, but is limited by ceiling effects.2 The Functional Independence Measure (FIM; ++) is a widely used test of function. It is comprised of motor and cognitive subscales.3,4 The motor portion has 13 components scored 1e7 for a summed score (range: 13e81) that indicates a patient’s physical ability to move about their environment and manage activities of daily living. The cognitive portion has 5 components, again scored 1e7 for a summed score (range: 5e35) that indicates a patient’s ability to perform basic cognitive functions and communicate. The FIM was developed by a consensus panel to both determine the burden of care and document progress in rehabilitation. The FIM has been proven to be reliable but with poor to moderate construct validity.5,6 In the amputee population, the FIM is hampered by ceiling effects and lack of responsiveness.7

Functional and QOL assessment after MLE amputation 777

The International Physical Activity Questionnaire (IPAQ; ++) is designed to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity.8 There are 2 versions of the questionnaire, and each has been translated into 22 languages. The short version (7 questions) is suitable for use in national and regional surveillance systems, whereas the long version (27 questions over 5 domains) provides more detailed information often required in research work or for evaluation purposes. Results are reported both as categorical (i.e., low, moderate, and high physical activity) and continuous (median metabolic equivalent of a task minutes). The IPAQ has been extensively validated among a number of different groups, but has seen little use in amputee populations.9e12 The Sickness Impact Profile (SIP; ++) is a 136-question, behaviorally based health status questionnaire.13,14 It assesses activities in 2 domains (physical and psychological health) and 12 everyday categories (i.e., sleep and rest, emotional behavior, body care and movement, home management, mobility, social interaction, ambulation, alertness behavior, communication, work, recreation and pastimes, and eating). The test is administered by either a questionnaire or by an interviewer (training is required). Scoring can be done at the level of domains and/or categories and at the total SIP level. Higher scores indicate more health-related behavioral problems (i.e., a poorer health state). The SIP has well documented reliability and validity.15,16 Scaled down versions are also available, most notably the SIP-68.17 Instruments of Function: Amputee-Specific The Questionnaire for Persons with a Transfemoral Amputation (Q-TFA; ++) is a self-reported, 70-question measure developed for nonelderly transfemoral amputees who use a prosthesis.18 The test generates a separate score (range: 0e100) for 4 categories: prosthetic use, mobility, problems, and global health. Scores of 100 indicate normal prosthesis wear, best possible mobility, more serious problems, and the best possible overall situation, respectively. The Q-TFA is a very specific survey for patients with an above the knee amputation who wear a prosthesis. The Prosthetic Profile of the Amputee (PPA; ++) is an instrument to evaluate prosthetic wear and active use of the prosthesis and to identify the factors that predispose to, enable, and reinforce prosthetic use.19,20 The PPA questionnaire consists of 44

778 Hawkins et al.

close-ended questions in which measurement scales are qualitative, nominal, and ordinal with a few quantitative ratios. The questions are grouped into 6 basic sections: the physical condition (4 questions; 20 items), the prosthesis (5 questions; 21 items), the prosthetic capabilities (7 questions; 23 items), the environment (10 questions; 22 items), the leisure activities (6 questions; 13 items), and demographic characteristics (5 questions; 5 items). In addition to the factors being evaluated, the questionnaire also includes questions pertaining to the behavior of prosthetic use (6 questions; 27 items). Two questions are specific to nonprosthetic users. The PPA has excellent reliability and validity, but issues have been reported with self-administration and understanding of the questions.7 The Day’s Amputee Activity Score (++) is an interview-based assessment instrument that rates the usual activity of the major lower extremity amputee living in the community.20 The 8 domains of activity include independence in dressing and undressing, regular walking habits, employment, domestic responsibilities, social activity, and wheelchair use. There are 20 questions and it takes 15 minutes in an interview setting. The individual section scores are summed to provide the overall activity score, which lies between 70 and 50, with the higher number representing better function. It has been validated and shown to be reliable.20 Because it can be difficult to interpret, it is best used in the community setting to monitor an amputee’s progress during rehabilitation. The Amputee Mobility Predictor (AMP; ++) was designed to measure an amputee patient’s functional capabilities without a prosthesis (AMPnoPRO) and to predict his/her ability to ambulate with a prosthesis (AMPPRO).21 It consists of 21 functional tasks rated by a clinician. The total score range for the AMP is 0e42 points, with higher numbers representing greater functional potential. Reliability and validity are described in the original article. It is specifically designed to assess amputee patients and is most useful in the clinical rehabilitation setting. The Functional Measure for Amputees (++) measures the function of amputees mainly in terms of prosthetic wear, use, and function with a prosthesis.22 It is modeled on a subset of the PPA questionnaire. It is comprised of 14 questions including the Locomotor Capabilities Index (mobility scale). Scores are calculated using a computerized guide and there is no overall score. Reliability was shown in the original paper. The instrument is probably best used in the clinical setting to assess how well a patient is using their prosthesis.

Annals of Vascular Surgery

Instruments of Quality of Life: General The Satisfaction with Life Scale (SWLS; ++) is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one’s life.23 The 5 questions are answered on a 7-point Likert scale. Strengths of the SWLS include its brevity and its ability to be used on a wide range of patients.24 Scores range from 5e35, with 20e24 representing average satisfaction with life. Instruments of Quality of Life: Amputee-Specific The Trinity Amputation and Prosthesis Experiences Scales (TAPES; ++) measures the healthrelated quality of life of major lower extremity amputees fitted with a prosthesis.25,26 It is made up of 9 subscales with a total of 38 items. Each item is rated on either a 3- or 5-point scale, with a greater score representing a greater degree of adjustment, restriction, and satisfaction. TAPES has good internal consistency, but further reliability and validity are unreported.25,26 A newer version, TAPES-R, has been recently developed with a simplified general structure. Additional studies are needed to confirm and further explore its measurement properties.26 The Attitude to Artificial Limb Questionnaire (+) was designed to measure quality of life in an amputee fitted with a prosthesis.27 It contains 10 items that measure satisfaction with prosthesis, restoration of body image, walking ability, and attitude of others toward them. Each item is scored on a 5-point ordinal scale from ‘‘not at all’’ to ‘‘completely.’’ The overall score ranges from 0e50, with a low score indicating a poorer quality of life. While internal consistency is good, other psychometric properties have yet to be assessed.28

Appendix References 1. Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. Md State Med J 1965;14:61e5. 2. Treweek SP, Condie ME. Three measures of functional outcome for lower limb amputees: a retrospective review. Prosthet Orthot Int 1998;22:178e85. 3. Keith RA, Granger CV, Hamilton BB, et al. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil 1987;1:6e18. 4. Granger CV, Hamilton BB, Keith RA, et al. Advances in functional assessment for medical rehabilitation. Top Geriatr Rehabil 1986;1:59e74. 5. Hamilton BB, Laughlin JA, Fiedler RC, et al. Interrater reliability of the 7-level functional independence measure (FIM). Scand J Rehabil Med 1994;26:115e9. 6. Stineman MG, Shea JA, Jette A, et al. The functional independence measure: tests of scaling assumptions, structure,

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and reliability across 20 diverse impairment categories. Arch Phys Med Rehabil 1996;77:1101e8. 7. Gauthier-Gagnon C, GM. Tools for outcome measurement in lower limb amputee rehabilitation 2001. 8. Craig CL, Marshall AL, Sjostrom M, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003;35:1381e95. 9. Brown WJ, Trost SG, Bauman A, et al. Test-retest reliability of four physical activity measures used in population surveys. J Sci Med Sport 2004;7:205e15. 10. Hallal PC, Victora CG. Reliability and validity of the international physical activity questionnaire (IPAQ). Med Sci Sports Exerc 2004;36:556. 11. Fogelholm M, Malmberg J, Suni J, et al. International physical activity questionnaire: validity against fitness. Med Sci Sports Exerc 2006;38:753e60. 12. Lee PH, Macfarlane DJ, Lam TH, et al. Validity of the international physical activity questionnaire short form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act 2011;8:115. 13. Gilson BS, Gilson JS, Bergner M, et al. The sickness impact profile. development of an outcome measure of health care. Am J Public Health 1975;65:1304e10. 14. Bergner M, Bobbitt RA, Pollard WE, et al. The sickness impact profile: validation of a health status measure. Med Care 1976;14:57e67. 15. Pollard WE, Bobbitt RA, Bergner M, et al. The sickness impact profile: reliability of a health status measure. Med Care 1976;14:146e55. 16. Carter WB, Bobbitt RA, Bergner M, et al. Validation of an interval scaling: the Sickness Impact Profile. Health Serv Res 1976;11:516e28. 17. de Bruin AF, Diederiks JP, de Witte LP, et al. The development of a short generic version of the sickness impact profile. J Clin Epidemiol 1994;47:407e18. 18. Hagberg K, Branemark R, Hagg O. Questionnaire for persons with a transfemoral amputation (Q-TFA): initial validity and reliability of a new outcome measure. J Rehabil Res Dev 2004;41:695e706. 19. Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil 1993;74:862e70. 20. Day HJ. The assessment and description of amputee activity. Prosthet Orthot Int 1981;5:23e8. 21. Gailey RS, Roach KE, Applegate EB, et al. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee’s ability to ambulate. Arch Phys Med Rehabil 2002;83:613e27. 22. Callaghan BG, Sockalingam S, Treweek SP, et al. A postdischarge functional outcome measure for lower limb amputees: test-retest reliability with trans-tibial amputees. Prosthet Orthot Int 2002;26:113e9. 23. Diener E, Emmons RA, Larsen RJ, et al. The satisfaction with life scale. J Pers Assess 1985;49:71e5. 24. Pavot W, Diener E, Colvin CR, et al. Further validation of the satisfaction with life scale: evidence for the crossmethod convergence of well-being measures. J Pers Assess 1991;57:149e61. 25. Gallagher P, Maclachlan M. Development and psychometric evaluation of the Trinity Amputation and Prosthesis Experience Scales (TAPES). Rehabil Psychol 2000;45:130e54. 26. Gallagher P, Maclachlan M. The Trinity Amputation and Prosthesis Experience Scales and quality of life in people with lower-limb amputation. Arch Phys Med Rehabil 2004;85:730e6.

Functional and QOL assessment after MLE amputation 779

27. Gallagher P, Franchignoni F, Giordano A, et al. Trinity Amputation and Prosthesis Experience Scales: a psychometric assessment using classical test theory and Rasch analysis. Am J Phys Med Rehabil 2010;89:487e96. 28. Fisher K, Hanspal R. Body image and patients with amputations: does the prosthesis maintain the balance? Int J Rehabil Res 1998;21:355e63. 29. Eijk MS, van der Linde H, Buijck BI, et al. Geriatric rehabilitation of lower limb amputees: a multicenter study. Disabil Rehabil 2012;34:145e50. 30. Cox PS, Williams SK, Weaver SR. Life after lower extremity amputation in diabetics. West Indian Med J 2011;60: 536e40. 31. Frlan-Vrgoc L, Vrbanic TS, Kraguljac D, et al. Functional outcome assessment of lower limb amputees and prosthetic users with a 2-minute walk test. Coll Antropol 2011;35: 1215e8. 32. da Silva R, Rizzo JG, Gutierres Filho PJ, et al. Physical activity and quality of life of amputees in southern Brazil. Prosthet Orthot Int 2011;35:432e8. 33. Kark L, Simmons A. Patient satisfaction following lowerlimb amputation: the role of gait deviation. Prosthet Orthot Int 2011;35:225e33. 34. Sinha R, van den Heuvel WJ, Arokiasamy P. Factors affecting quality of life in lower limb amputees. Prosthet Orthot Int 2011;35:90e6. 35. Penn-Barwell JG. Outcomes in lower limb amputation following trauma: a systematic review and meta-analysis. Injury 2011;42:1474e9. 36. Mazari FA, Mockford K, Barnett C, et al. Hull early walking aid for rehabilitation of transtibial amputeeserandomized controlled trial (HEART). J Vasc Surg 2010;52:1564e71. 37. Stineman MG, Kwong PL, Xie D, et al. Prognostic differences for functional recovery after major lower limb amputation: effects of the timing and type of inpatient rehabilitation services in the Veterans Health Administration. PM R 2010;2: 232e43. 38. Raya MA, Gailey RS, Fiebert IM, et al. Impairment variables predicting activity limitation in individuals with lower limb amputation. Prosthet Orthot Int 2010;34:73e84. 39. Remes L, Isoaho R, Vahlberg T, et al. Quality of life three years after major lower extremity amputation due to peripheral arterial disease. Aging Clin Exp Res 2010;22:395e405. 40. Davidson JH, Khor KE, Jones LE. A cross-sectional study of post-amputation pain in upper and lower limb amputees, experience of a tertiary referral amputee clinic. Disabil Rehabil 2010;32:1855e62. 41. Taghipour H, Moharamzad Y, Mafi AR, et al. Quality of life among veterans with war-related unilateral lower extremity amputation: a long-term survey in a prosthesis center in iran. J Orthop Trauma 2009;23:525e30. 42. Giannoudis PV, Harwood PJ, Kontakis G, et al. Long-term quality of life in trauma patients following the full spectrum of tibial injury (fasciotomy, closed fracture, grade IIIB/IIIC open fracture and amputation). Injury 2009;40:213e9. 43. Kurichi JE, Small DS, Bates BE, et al. Possible incremental benefits of specialized rehabilitation bed units among veterans after lower extremity amputation. Med Care 2009;47: 457e65. 44. Bhangu S, Devlin M, Pauley T. Outcomes of individuals with transfemoral and contralateral transtibial amputation due to dysvascular etiologies. Prosthet Orthot Int 2009;33: 33e40. 45. Boutoille D, Feraille A, Maulaz D, et al. Quality of life with diabetes-associated foot complications: comparison between

780 Hawkins et al.

46.

47.

48.

49.

50.

51.

52.

53.

54.

55.

56.

57.

lower-limb amputation and chronic foot ulceration. Foot Ankle Int 2008;29:1074e8. Mac Neill HL, Devlin M, Pauley T, et al. Long-term outcomes and survival of patients with bilateral transtibial amputations after rehabilitation. Am J Phys Med Rehabil 2008;87:189e96. Asano M, Rushton P, Miller WC, et al. Predictors of quality of life among individuals who have a lower limb amputation. Prosthet Orthot Int 2008;32:231e43. Deans SA, McFadyen AK, Rowe PJ. Physical activity and quality of life: a study of a lower-limb amputee population. Prosthet Orthot Int 2008;32:186e200. Desmond D, Gallagher P, Henderson-Slater D, et al. Pain and psychosocial adjustment to lower limb amputation amongst prosthesis users. Prosthet Orthot Int 2008;32: 244e52. Johannesson A, Larsson GU, Oberg T, et al. Comparison of vacuum-formed removable rigid dressing with conventional rigid dressing after transtibial amputation: similar outcome in a randomized controlled trial involving 27 patients. Acta Orthop 2008;79:361e9. Met R, Janssen LI, Wille J, et al. Functional results after through-knee and above-knee amputations: does more length mean better outcome? Vasc Endovascular Surg 2008;42: 456e61. Stasik CN, Berceli SA, Nelson PR, et al. Functional outcome after redo below-knee amputation. World J Surg 2008;32: 1823e6. Yazicioglu K, Taskaynatan MA, Guzelkucuk U, et al. Effect of playing football (soccer) on balance, strength, and quality of life in unilateral below-knee amputees. Am J Phys Med Rehabil 2007;86:800e5. Rau B, Bonvin F, de Bie R. Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. Prosthet Orthot Int 2007;31:258e70. Pinzur MS, Pinto MA, Saltzman M, et al. Health-related quality of life in patients with transtibial amputation and reconstruction with bone bridging of the distal tibia and fibula. Foot Ankle Int 2006;27:907e12. Cannada LK, Jones AL. Demographic, social and economic variables that affect lower extremity injury outcomes. Injury 2006;37:1109e16. Traballesi M, Porcacchia P, Averna T, et al. Prognostic factors in prosthetic rehabilitation of bilateral dysvascular above-

Annals of Vascular Surgery

58.

59.

60.

61.

62.

63.

64.

65.

66.

67.

68.

knee amputee: is the stump condition an influencing factor? Eura Medicophys 2007;43:1e6. Gunawardena NS, Seneviratne Rde A, Athauda T. Functional outcomes of unilateral lower limb amputee soldiers in two districts of Sri Lanka. Mil Med 2006;171:283e7. Wan Hazmy CH, Chia WY, Fong TS, et al. Functional outcome after major lower extremity amputation: s survey on lower extremity amputees. Med J Malaysia 2006; 61(Suppl A):3e9. Meatherall BL, Garrett MR, Kaufert J, et al. Disability and quality of life in Canadian aboriginal and non-aboriginal diabetic lower-extremity amputees. Arch Phys Med Rehabil 2005;86:1594e602. Van de Weg FB, Van der Windt DA. A questionnaire survey of the effect of different interface types on patient satisfaction and perceived problems among trans-tibial amputees. Prosthet Orthot Int 2005;29:231e9. Selles RW, Janssens PJ, Jongenengel CD, et al. A randomized controlled trial comparing functional outcome and cost efficiency of a total surface-bearing socket versus a conventional patellar tendon-bearing socket in transtibial amputees. Arch Phys Med Rehabil 2005;86:154e61. Davies B, Datta D. Mobility outcome following unilateral lower limb amputation. Prosthet Orthot Int 2003;27: 186e90. Schoppen T, Boonstra A, Groothoff JW, et al. Physical, mental, and social predictors of functional outcome in unilateral lower-limb amputees. Arch Phys Med Rehabil 2003;84: 803e11. Demet K, Martinet N, Guillemin F, et al. Health related quality of life and related factors in 539 persons with amputation of upper and lower limb. Disabil Rehabil 2003;25:480e6. van der Schans CP, Geertzen JH, Schoppen T, et al. Phantom pain and health-related quality of life in lower limb amputees. J Pain Symptom Manage 2002;24:429e36. Munin MC, Espejo-De Guzman MC, Boninger ML, et al. Predictive factors for successful early prosthetic ambulation among lower-limb amputees. J Rehabil Res Dev 2001;38: 379e84. Hoogendoorn JM, van der Werken C. Grade III open tibial fractures: functional outcome and quality of life in amputees versus patients with successful reconstruction. Injury 2001; 32:329e34.