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Psychometric Properties of Functional, Ambulatory, and Quality of Life Instruments in Lower Limb Amputees: A Systematic Review

Published:April 12, 2019DOI:https://doi.org/10.1016/j.apmr.2019.02.015

      Abstract

      Objective

      Summarize the psychometric properties of functional, ambulatory, and quality of life instruments among adult lower limb amputees, highlighting evidence deemed generalizable to the United States Medicare population.

      Data Sources

      Six databases and existing systematic reviews through October 30, 2017. Searches included terms for lower limb amputation or prostheses and outcome measures in humans, without language restriction.

      Study Selection

      We included peer-reviewed studies of at least 20 adults (≥18 years) with lower limb amputation. Eligible studies reported on psychometric properties of functional, ambulatory, or quality of life instruments. Fifty-three of 425 retrieved articles (12%) met criteria.

      Data Extraction

      Study characteristics and psychometric property data (validity, reliability, responsiveness, minimum detectable change, minimal important difference, or floor or ceiling effect) were extracted into a customized form based on standardized criteria. All extracted data were confirmed by 2 experts in systematic review and rehabilitation outcome measurement. Instruments were categorized regarding having been validated and found reliable. Other reported psychometric properties were recorded. Studies were also assessed for applicability to the Medicare population based on age and amputation etiology (dysvascular).

      Data Synthesis

      Fifty-six studies (in 53 articles) reported psychometric properties of 50 instruments. There is evidence for both validity and reliability for 30 instruments, 17 of which have evidence that was deemed generalizable to the Medicare population. Most of the remaining instruments have evidence of either validity or reliability, but not both. Twelve instruments have been assessed specifically among lower limb amputees prior to prosthesis prescription. Thirteen instruments have been assessed regarding their predictive properties for future outcomes.

      Conclusions

      Numerous instruments assessing ambulation, function, quality of life, and other patient-centered outcomes have evidence of validity and reliability for adults with lower limb amputations. Researchers and clinicians should use validated, reliable instruments when feasible. Many existing and new instruments require validation for use with lower limb amputees.

      Keywords

      List of abbreviations:

      2MWT (2-minute walk test), AHRQ (Agency for Healthcare Research and Quality), AMPnoPRO (Amputee Mobility Predictor without use of a prosthesis), AMPSIMM (Amputee Single Item Mobility Measure), CMS (Centers for Medicare & Medicaid Services), FAC (Functional Ambulation Categories), FAI (Frenchay Activities Index), FSST (Four Square Step Test), K-level (Medicare Functional Classification Level), LCI (Locomotor Capabilities Index), LCI-4 (LCI with a 4-point ordinal scale), LCI-5 (LCI with a 5-point ordinal scale), LEMOCOT (Lower-Extremity Motor Coordination Test), LLP (lower limb prosthesis), OMT (outcome measurement technique), OPCS (Office of Population Censuses and Surveys Scale), SF (Short Form Health Survey), SF-12 (SF 12 items), TUG (timed Up and Go Test)
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      References

        • Borrenpohl D.
        • Kaluf B.
        • Major M.J.
        Survey of U.S. practitioners on the validity of the Medicare Functional Classification Level System and utility of clinical outcome measures for aiding k-level assignment.
        Arch Phys Med Rehabil. 2016; 97: 1053-1063
        • Van Der Linde H.
        • Geertzen J.H.
        • Hofstad C.J.
        • Van Limbeek J.
        • Postema K.
        Prosthetic prescription in the Netherlands: an interview with clinical experts.
        Prosthet Orthot Int. 2004; 28: 98-104
        • Condie E.
        • Scott H.
        • Treweek S.
        Lower limb prosthetic outcome measures: a review of the literature 1995 to 2005.
        J Prosthet Orthot. 2006; 18: 13-45
        • Social Security Administration
        Disability evaluation under social security. Musculoskeletal system - adult.
        (Available at:)
        • Centers for Medicare & Medicaid Services
        Table 2.1 Medicare enrollment: hospital insurance and/or supplementary medical insurance programs for total, fee-for-service and managed care enrollees as of July 1, 2012: selected calendar years 1966-2012.
        (Available at:)
        • Ziegler-Graham K.
        • MacKenzie E.J.
        • Ephraim P.L.
        • Travison T.G.
        • Brookmeyer R.
        Estimating the prevalence of limb loss in the United States: 2005 to 2050.
        Arch Phys Med Rehabil. 2008; 89: 422-429
        • Centers for Medicare & Medicaid Services
        Lower limb prosthetic workgroup consensus document.
        (Available at:)
        • Balk E.M.
        • Gazula A.
        • Markozannes G.
        • et al.
        Lower limb prostheses: measurement instruments, comparison of component effects by subgroups, and long-term outcomes. Comparative Effectiveness Review No. 213.
        Agency for Healthcare Research and Quality, Rockville, MD2018
        • Agency for Healthcare Research and Quality
        Methods guide for effectiveness and comparative effectiveness reviews.
        Agency for Healthcare Research and Quality, Rockville2011
        • The World Bank
        World bank country and lending groups.
        (Available at:)
        • Jerosch-Herold C.
        An evidence-based approach to choosing outcome measures: a checklist for the critical appraisal of validity, reliability and responsiveness studies.
        Br J Occupat Ther. 2005; 68: 347-353
        • Resnik L.
        • Borgia M.
        • Silver B.
        Measuring community integration in persons with limb trauma and amputation: a systematic review.
        Arch Phys Med Rehabil. 2017; 98: 561-580
        • Tennant A.
        • Conaghan P.G.
        The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper?.
        Arthritis Rheum. 2007; 57: 1358-1362
        • Terwee C.B.
        • Bot S.D.
        • de Boer M.R.
        • et al.
        Quality criteria were proposed for measurement properties of health status questionnaires.
        J Clin Epidemiol. 2007; 60: 34-42
        • Veenhof C.
        • Bijlsma J.W.
        • van den Ende C.H.
        • van Dijk G.M.
        • Pisters M.F.
        • Dekker J.
        Psychometric evaluation of osteoarthritis questionnaires: a systematic review of the literature.
        Arthritis Rheum. 2006; 55: 480-492
        • Wright V.
        Prosthetic outcome measures for use with upper limb amputees: a systematic review of the peer-reviewed literature, 1970 to 2009.
        J Prosthet Orthot. 2009; 21: 3-63
        • Amtmann D.
        • Morgan S.J.
        • Kim J.
        • Hafner B.J.
        Health-related profiles of people with lower limb loss.
        Arch Phys Med Rehabil. 2015; 96: 1474-1483
        • Amtmann D.
        • Bamer A.M.
        • Kim J.
        • et al.
        A comparison of computerized adaptive testing and fixed-length short forms for the Prosthetic Limb Users Survey of Mobility (PLUS-M™).
        Prosthet Orthot Int. 2018; 42: 476-482
        • Brooks D.
        • Parsons J.
        • Hunter J.P.
        • Devlin M.
        • Walker J.
        The 2-minute walk test as a measure of functional improvement in persons with lower limb amputation.
        Arch Phys Med Rehabil. 2001; 82: 1478-1483
        • Brooks D.
        • Hunter J.P.
        • Parsons J.
        • Livsey E.
        • Quirt J.
        • Devlin M.
        Reliability of the two-minute walk test in individuals with transtibial amputation.
        Arch Phys Med Rehabil. 2002; 83: 1562-1565
        • Callaghan B.G.
        • Sockalingam S.
        • Treweek S.P.
        • Condie M.E.
        A post-discharge functional outcome measure for lower limb amputees: test-retest reliability with trans-tibial amputees.
        Prosthet Orthot Int. 2002; 26: 113-119
        • Callaghan B.G.
        • Condie M.E.
        A post-discharge quality of life outcome measure for lower limb amputees: test-retest reliability and construct validity.
        Clin Rehabil. 2003; 17: 858-864
        • Clemens S.M.
        • Gailey R.S.
        • Bennett C.L.
        • Pasquina P.F.
        • Kirk-Sanchez N.J.
        • Gaunaurd I.A.
        The component Timed-Up-and-Go Test: the utility and psychometric properties of using a mobile application to determine prosthetic mobility in people with lower limb amputations.
        Clin Rehabil. 2018; 32: 388-397
        • Condie M.E.
        • McFadyen A.K.
        • Treweek S.
        • Whitehead L.
        The trans-femoral fitting predictor: a functional measure to predict prosthetic fitting in transfemoral amputees--validity and reliability.
        Arch Phys Med Rehabil. 2011; 92: 1293-1297
        • Cyril J.K.
        Characterizing prosthetic device use and datisfaction, and evaluating measures of physical function among individuals with lower-extremity amputation secondary to trauma.
        Johns Hopkins University, Baltimore2002
        • de Laat F.A.
        • Rommers G.M.
        • Geertzen J.H.
        • Roorda L.D.
        Construct validity and test-retest reliability of the climbing stairs questionnaire in lower-limb amputees.
        Arch Phys Med Rehabil. 2010; 91: 1396-1401
        • de Laat F.A.
        • Rommers G.M.
        • Geertzen J.H.
        • Roorda L.D.
        Construct validity and test-retest reliability of the questionnaire rising and sitting down in lower-limb amputees.
        Arch Phys Med Rehabil. 2011; 92: 1305-1310
        • de Laat F.A.
        • Rommers G.M.
        • Geertzen J.H.
        • Roorda L.D.
        Construct validity and test-retest reliability of the walking questionnaire in people with a lower limb amputation.
        Arch Phys Med Rehabil. 2012; 93: 983-989
        • Deathe A.B.
        • Miller W.C.
        The L test of functional mobility: measurement properties of a modified version of the Timed “Up & Go” Test designed for people with lower-limb amputations.
        Phys Ther. 2005; 85: 626-635
        • Devlin M.
        • Pauley T.
        • Head K.
        • Garfinkel S.
        Houghton scale of prosthetic use in people with lower-extremity amputations: reliability, validity, and responsiveness to change.
        Arch Phys Med Rehabil. 2004; 85: 1339-1344
        • Dite W.
        • Connor H.J.
        • Curtis H.C.
        Clinical identification of multiple fall risk early after unilateral transtibial amputation.
        Arch Phys Med Rehabil. 2007; 88: 109-114
        • Eijk M.S.
        • van der Linde H.
        • Buijck B.I.
        • Zuidema S.U.
        • Koopmans R.T.
        Geriatric rehabilitation of lower limb amputees: a multicenter study.
        Disabil Rehabil. 2012; 34: 145-150
        • Fisher K.
        • Hanspal R.S.
        • Marks L.
        Return to work after lower limb amputation.
        Int J Rehabil Res. 2003; 26: 51-56
        • Franchignoni F.
        • Brunelli S.
        • Orlandini D.
        • Ferriero G.
        • Traballesi M.
        Is the Rivermead Mobility Index a suitable outcome measure in lower limb amputees?--A psychometric validation study.
        J Rehabil Med. 2003; 35: 141-144
        • Franchignoni F.
        • Orlandini D.
        • Ferriero G.
        • Moscato T.A.
        Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training.
        Arch Phys Med Rehabil. 2004; 85: 743-748
        • Franchignoni F.
        • Giordano A.
        • Ferriero G.
        • Munoz S.
        • Orlandini D.
        • Amoresano A.
        Rasch analysis of the locomotor capabilities index-5 in people with lower limb amputation.
        Prosthet Orthot Int. 2007; 31: 394-404
        • Franchignoni F.
        • Giordano A.
        • Ferriero G.
        • Orlandini D.
        • Amoresano A.
        • Perucca L.
        Measuring mobility in people with lower limb amputation: Rasch analysis of the mobility section of the prosthesis evaluation questionnaire.
        J Rehabil Med. 2007; 39: 138-144
        • Gailey R.S.
        • Roach K.E.
        • Applegate E.B.
        • 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: 613-627
        • Gallagher P.
        • MacLachlan M.
        Development and psychometric evaluation of the trinity amputation and prosthesis experience scales (TAPES).
        Rehabil Psychol. 2000; 45: 130
        • 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: 730-736
        • Gallagher P.
        • Franchignoni F.
        • Giordano A.
        • MacLachlan M.
        Trinity amputation and prosthesis experience scales: a psychometric assessment using classical test theory and Rasch analysis.
        Am J Phys Med Rehabil. 2010; 89: 487-496
        • Gauthier-Gagnon C.
        • Grise M.C.
        Prosthetic profile of the amputee questionnaire: validity and reliability.
        Arch Phys Med Rehabil. 1994; 75: 1309-1314
        • Gremeaux V.
        • Damak S.
        • Troisgros O.
        • et al.
        Selecting a test for the clinical assessment of balance and walking capacity at the definitive fitting state after unilateral amputation: a comparative study.
        Prosthet Orthot Int. 2012; 36: 415-422
        • Hafner B.J.
        • Morgan S.J.
        • Askew R.L.
        • Salem R.
        Psychometric evaluation of self-report outcome measures for prosthetic applications.
        J Rehabil Res Dev. 2016; 53: 797-812
        • Hafner B.J.
        • Gaunaurd I.A.
        • Morgan S.J.
        • Amtmann D.
        • Salem R.
        • Gailey R.S.
        Construct validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in adults with lower limb amputation.
        Arch Phys Med Rehabil. 2017; 98: 277-285
        • 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: 695-706
        • Hanspal R.S.
        • Fisher K.
        • Nieveen R.
        Prosthetic socket fit comfort score.
        Disabil Rehabil. 2003; 25: 1278-1280
        • Hart D.L.
        Orthotics and Prosthetics National Office Outcomes Tool (OPOT): initial reliability and validity assessment for lower extremity prosthetics.
        J Prosthet Orthot. 1999; 11: 101-111
        • Legro M.W.
        • Reiber G.D.
        • Smith D.G.
        • del Aguila M.
        • Larsen J.
        • Boone D.
        Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life.
        Arch Phys Med Rehabil. 1998; 79: 931-938
        • Leung E.C.
        • Rush P.J.
        • Devlin M.
        Predicting prosthetic rehabilitation outcome in lower limb amputee patients with the Functional Independence Measure.
        Arch Phys Med Rehabil. 1996; 77: 605-608
        • Major M.J.
        • Fatone S.
        • Roth E.J.
        Validity and reliability of the Berg Balance Scale for community-dwelling persons with lower-limb amputation.
        Arch Phys Med Rehabil. 2013; 94: 2194-2202
        • Miller W.C.
        • Deathe A.B.
        • Speechley M.
        Lower extremity prosthetic mobility: a comparison of 3 self-report scales.
        Arch Phys Med Rehabil. 2001; 82: 1432-1440
        • Miller W.C.
        • Deathe A.B.
        • Speechley M.
        Psychometric properties of the activities-specific balance confidence scale among individuals with a lower-limb amputation.
        Arch Phys Med Rehabil. 2003; 84: 656-661
        • Miller W.C.
        • Deathe A.B.
        • Harris J.
        Measurement properties of the Frenchay Activities Index among individuals with a lower limb amputation.
        Clin Rehabil. 2004; 18: 414-422
        • Newton K.L.
        • Evans C.
        • Osmotherly P.G.
        The Timed Up and Go and two-minute walk test: exploration of a method for establishing normative values for established lower limb prosthetic users.
        Eur J Physiother. 2016; 18: 161-166
        • Norvell D.C.
        • Williams R.M.
        • Turner A.P.
        • Czerniecki J.M.
        The development and validation of a novel outcome measure to quantify mobility in the dysvascular lower extremity amputee: the amputee single item mobility measure.
        Clin Rehabil. 2016; 30: 878-889
        • Panesar B.S.
        • Morrison P.
        • Hunter J.
        A comparison of three measures of progress in early lower limb amputee rehabilitation.
        Clin Rehabil. 2001; 15: 157-171
        • Ramstrand N.
        • Nilsson K.A.
        Validation of a patient activity monitor to quantify ambulatory activity in an amputee population.
        Prosthet Orthot Int. 2007; 31: 157-166
        • Reid L.
        • Thomson P.
        • Besemann M.
        • Dudek N.
        Going places: does the two-minute walk test predict the six-minute walk test in lower extremity amputees?.
        J Rehabil Med. 2015; 47: 256-261
        • Resnik L.
        • Borgia M.
        Reliability of outcome measures for people with lower-limb amputations: distinguishing true change from statistical error.
        Phys Ther. 2011; 91: 555-565
        • Rushton P.W.
        • Miller W.C.
        • Deathe A.B.
        Minimal clinically important difference of the L test for individuals with lower limb amputation: a pilot study.
        Prosthet Orthot Int. 2015; 39: 470-476
        • Ryall N.H.
        • Eyres S.B.
        • Neumann V.C.
        • Bhakta B.B.
        • Tennant A.
        The SIGAM mobility grades: a new population-specific measure for lower limb amputees.
        Disabil Rehabil. 2003; 25: 833-844
        • Ryall N.H.
        • Eyres S.B.
        • Neumann V.C.
        • Bhakta B.B.
        • Tennant A.
        Is the Rivermead Mobility Index appropriate to measure mobility in lower limb amputees?.
        Disabil Rehabil. 2003; 25: 143-153
        • Sakakibara B.M.
        • Miller W.C.
        • Backman C.L.
        Rasch analyses of the activities-specific balance confidence scale with individuals 50 years and older with lower-limb amputations.
        Arch Phys Med Rehabil. 2011; 92: 1257-1263
        • Sawers A.
        • Hafner B.J.
        A study to assess whether fixed-width beam walking provides sufficient challenge to assess balance ability across lower limb prosthesis users.
        Clin Rehabil. 2018; 32: 483-492
        • Schoppen T.
        • Boonstra A.
        • Groothoff J.W.
        • de Vries J.
        • Goeken L.N.
        • Eisma W.H.
        The Timed “Up and Go” test: reliability and validity in persons with unilateral lower limb amputation.
        Arch Phys Med Rehabil. 1999; 80: 825-828
        • Spaan M.H.
        • Vrieling A.H.
        • van de Berg P.
        • Dijkstra P.U.
        • van Keeken H.G.
        Predicting mobility outcome in lower limb amputees with motor ability tests used in early rehabilitation.
        Prosthet Orthot Int. 2017; 41: 171-177
        • Theeven P.
        • Hemmen B.
        • Stevens C.
        • Ilmer E.
        • Brink P.
        • Seelen H.
        Feasibility of a new concept for measuring actual functional performance in daily life of transfemoral amputees.
        J Rehabil Med. 2010; 42: 744-751
        • Wong C.K.
        • Gibbs W.
        • Chen E.S.
        Use of the Houghton scale to classify community and household walking ability in people with lower-limb amputation: criterion-related validity.
        Arch Phys Med Rehabil. 2016; 97: 1130-1136
        • Sansam K.
        • Neumann V.
        • O'Connor R.
        • Bhakta B.
        Predicting walking ability following lower limb amputation: a systematic review of the literature.
        J Rehabil Med. 2009; 41: 593-603
        • Kahle J.T.
        • Highsmith M.J.
        • Schaepper H.
        • Johannesson A.
        • Orendurff M.S.
        • Kaufman K.
        Predicting walking ability following lower limb amputation: an updated systematic literature review.
        Technol Innov. 2016; 18: 125-137
        • Ambler G.K.
        • Bosanquet D.C.
        • Brookes-Howell L.
        • et al.
        Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey.
        Trials. 2017; 18: 628
        • Kohler F.
        • Cieza A.
        • Stucki G.
        • et al.
        Developing core sets for persons following amputation based on the International Classification of Functioning, Disability and Health as a way to specify functioning.
        Prosthet Orthot Int. 2009; 33: 117-129
        • Williamson P.R.
        • Altman D.G.
        • Blazeby J.M.
        • et al.
        Developing core outcome sets for clinical trials: issues to consider.
        Trials. 2012; 13: 132