Patient-reported Outcome Instruments in Lower Extremity Trauma: A Systematic Review of the Literature

Lily R Mundy, A Jordan Grier, E Hope Weissler, Matthew J Carty, Andrea L Pusic, Scott T Hollenbeck, Mark J Gage, Lily R Mundy, A Jordan Grier, E Hope Weissler, Matthew J Carty, Andrea L Pusic, Scott T Hollenbeck, Mark J Gage

Abstract

Background: Advances in fracture fixation and soft tissue coverage continue to improve the care of patients after limb-threatening lower extremity (LE) trauma. However, debate continues regarding which treatment option-reconstruction or amputation-is most appropriate. Many authors have attempted to quantify the patient experience in this treatment paradigm; however, they have not used patient-reported outcome (PRO) instruments specific to this population. Our aim was to identify and evaluate PRO instruments developed specifically for LE trauma, applicable to reconstruction and amputation, using established PRO instrument development and validation guidelines.

Methods: A multidisciplinary team used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method to query PubMed, Medline Ovid, EMBASE, Cochrane, Medline Web of Science, and Psych Info databases from inception to November 2016. Publications were included that described the development and/or validation of a PRO instrument assessing satisfaction and/or quality of life in LE trauma, applicable to both amputation and reconstruction. Two authors independently reviewed each full-text citation.

Results: After removing duplicates, 6,290 abstracts were identified via the database query. Following a preliminary title and abstract screen, 657 full-text citations were reviewed. Of these references, none satisfied the previously established inclusion criteria.

Conclusions: No studies were identified that described a PRO instrument developed to assess outcomes in LE trauma patients applicable to both reconstruction and amputation. There is thus a need for a PRO instrument designed specifically for patients who have sustained limb-threatening LE trauma to guide treatment decisions.

Figures

Fig. 1.
Fig. 1.
Flow diagram of systematic review. *Publications with multiple instruments were counted in each associated group.

References

    1. Georgiadis GM, Behrens FF, Joyce MJ, et al. Open tibial fractures with severe soft-tissue loss. Limb salvage compared with below-the-knee amputation. J Bone Joint Surg Am. 1993;75:1431–1441.
    1. Gopal S, Majumder S, Batchelor AG, et al. Fix and flap: the radical orthopaedic and plastic treatment of severe open fractures of the tibia. J Bone Joint Surg Br. 2000;82:959–966.
    1. Naique SB, Pearse M, Nanchahal J. Management of severe open tibial fractures: the need for combined orthopaedic and plastic surgical treatment in specialist centres. J Bone Joint Surg Br. 2006;88:351–357.
    1. Penn-Barwell JG, Myatt RW, Bennett PM, et al. ; Severe Lower Extremity Combat Trauma (SeLECT) Study Group. Medium-term outcomes following limb salvage for severe open tibia fracture are similar to trans-tibial amputation. Injury. 2015;46:288–291.
    1. Saddawi-Konefka D, Kim HM, Chung KC. A systematic review of outcomes and complications of reconstruction and amputation for type IIIB and IIIC fractures of the tibia. Plast Reconstr Surg. 2008;122:1796–1805.
    1. Akula M, Gella S, Shaw CJ, et al. A meta-analysis of amputation versus limb salvage in mangled lower limb injuries—the patient perspective. Injury. 2011;42:1194–1197.
    1. Busse JW, Jacobs CL, Swiontkowski MF, et al. ; Evidence-based Orthopaedic Trauma Working Group. Complex limb salvage or early amputation for severe lower-limb injury: a meta-analysis of observational studies. J Orthop Trauma. 2007;21:70–76.
    1. Weber CD, Hildebrand F, Kobbe P, et al. Epidemiology of open tibia fractures in a population-based database: update on current risk factors and clinical implications. Eur J Trauma Emerg Surg. 2018.
    1. Economides JM, Patel KM, Evans KK, et al. Systematic review of patient-centered outcomes following lower extremity flap reconstruction in comorbid patients. J Reconstr Microsurg. 2013;29:307–316.
    1. Heinemann AW, Connelly L, Ehrlich-Jones L, et al. Outcome instruments for prosthetics: clinical applications. Phys Med Rehabil Clin N Am. 2014;25:179–198.
    1. Singh SJ, Sodergren SC, Hyland ME, et al. A comparison of three disease-specific and two generic health-status measures to evaluate the outcome of pulmonary rehabilitation in COPD. Respir Med. 2001;95:71–77.
    1. 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;79:931–938.
    1. O’Toole RV, Castillo RC, Pollak AN, et al. ; LEAP Study Group. Determinants of patient satisfaction after severe lower-extremity injuries. J Bone Joint Surg Am. 2008;90:1206–1211.
    1. 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;32:329–334.
    1. Chmell MJ, McAndrew MP, Thomas R, et al. Structural allografts for reconstruction of lower extremity open fractures with 10 centimeters or more of acute segmental defects. J Orthop Trauma. 1995;9:222–226.
    1. Aaronson N, Alonso J, Burnam A, et al. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11:193–205.
    1. Moher D, Liberati A, Tetzlaff J, et al. ; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:1006–1012.
    1. Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976;58:453–458.
    1. Court-Brown CM, McQueen MM, Quaba AA, et al. Locked intramedullary nailing of open tibial fractures. J Bone Joint Surg Br. 1991;73:959–964.
    1. Godina M. Early microsurgical reconstruction of complex trauma of the extremities. Plast Reconstr Surg. 1986;78:285–292.
    1. Dillingham TR, Pezzin LE, MacKenzie EJ, et al. Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study. Am J Phys Med Rehabil. 2001;80:563–571.
    1. Bosse MJ, MacKenzie EJ, Kellam JF, et al. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002;347:1924–1931.
    1. MacKenzie EJ, Bosse MJ, Kellam JF, et al. Characterization of patients with high-energy lower extremity trauma. J Orthop Trauma. 2000;14:455–466.
    1. Doukas WC, Hayda RA, Frisch HM, et al. The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am. 2013;95:138–145.
    1. Egeler SA, de Jong T, Luijsterburg AJM, et al. Long-term patient-reported outcomes following free flap lower extremity reconstruction for traumatic injuries. Plast Reconstr Surg. 2018;141:773–783.
    1. 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;65:1304–1310.
    1. Swiontkowski MF, Engelberg R, Martin DP, et al. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999;81:1245–1260.
    1. Aravind M, Shauver MJ, Chung KC. A qualitative analysis of the decision-making process for patients with severe lower leg trauma. Plast Reconstr Surg. 2010;126:2019–2029.
    1. Shauver MS, Aravind MS, Chung KC. A qualitative study of recovery from type III-B and III-C tibial fractures. Ann Plast Surg. 2011;66:73–79.
    1. Trickett RW, Mudge E, Price P, et al. A qualitative approach to recovery after open tibial fracture: the road to a novel, patient-derived recovery scale. Injury. 2012;43:1071–1078.
    1. Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305(6846):160–164.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483.
    1. 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;34:220–233.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370.
    1. EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.
    1. Skevington SM, Sartorius N, Amir M. Developing methods for assessing quality of life in different cultural settings. The history of the WHOQOL instruments. Soc Psychiatry Psychiatr Epidemiol. 2004;39:1–8.
    1. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol. 2005;23(5 Suppl 39):S14–S18.
    1. Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol. 2005;23(5 Suppl 39):S53–S57.
    1. Reeve BB, Hays RD, Bjorner JB, et al. ; PROMIS Cooperative Group. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007;45(5 Suppl 1):S22–S31.
    1. Kitaoka HB, Alexander IJ, Adelaar RS, et al. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994;15:349–353.
    1. Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) scale. J Gerontol A Biol Sci Med Sci. 1995;50A:M28–M34.
    1. Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–1840.
    1. Enneking WF, Dunham W, Gebhardt MC, et al. A system for the functional evaluation of reconstructive procedures after surgical treatment of tumors of the musculoskeletal system. Clin Orthop Relat Res. 1993:241–246.
    1. Heinemann AW, Bode RK, O’Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users’ Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003;27:191–206.
    1. Gauthier-Gagnon C, Grise M, Lepage Y. The locomotor capabilities index: content validity. J Rehabil Outcomes Meas. 1998;2:40–46.
    1. Binkley JM, Stratford PW, Lott SA, et al. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999;79:371–383.
    1. 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;85:1339–1344.
    1. 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;79:753–755.
    1. Gallagher P, Horgan O, Franchignoni F, et al. Body image in people with lower-limb amputation: a Rasch analysis of the Amputee Body Image Scale. Am J Phys Med Rehabil. 2007;86:205–215.
    1. Gallagher P, MacLachlan M. Development and psychometric evaluation of the Trinity Amputation and Prosthesis Experience Scales (TAPES). Rehabil Psychol. 2000;45:130.
    1. 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.
    1. Gauthier-Gagnon C, Grisé MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994;75:1309–1314.
    1. Grisé 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;74:862–870.
    1. Hagberg K, Brånemark R, Hägg 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.
    1. Wulterkens L, Aurégan JC, Letellier T, et al. A telephone questionnaire in order to assess functional outcome after post-traumatic limb salvage surgery: development and preliminary validation. Injury. 2015;46:2452–2456.
    1. Stalp M, Koch C, Ruchholtz S, et al. Standardized outcome evaluation after blunt multiple injuries by scoring systems: a clinical follow-up investigation 2 years after injury. J Trauma. 2002;52:1160–1168.
    1. Stalp M, Koch C, Regel G, et al. Development of a standardized instrument for quantitative and reproducible rehabilitation data assessment after polytrauma (HASPOC). Chirurg. 2001;72:312–318.
    1. Martin DP, Engelberg R, Agel J, et al. Development of a musculoskeletal extremity health status instrument: the musculoskeletal function assessment instrument. J Orthop Res. 1996;14:173–181.

Source: PubMed

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