Journal of NeuroEngineering and Rehabilitation

Background Candidacy for lower limb prostheses and especially access to advanced prosthetic technologies are the subject of in- creased scrutiny today. As healthcare costs continue to rise across the United States, regulatory positions have sought to establish policies that increase the collective confidence that the provision of a lower limb prosthesis will represent a sound investment in the health and well-being of the individual. Medicare ’ s current Local Coverage Determination (LCD) indicates that a determin- ation of the medical necessity is based on the beneficiary ’ s potential functional abilities, which are subsequently based on such factors as the beneficiaries ’ current condi- tion and the nature of any associated medical problems [ 1 ] . In a 2011 “ Dear Physician ” letter, Medicare Contrac- tors provided additional guidance on the desired contents of the medical record (Additional file 1 ) . Stipulating that “ physicians should tailor their history and examination to the individual patient ’ s condition, ” the letter suggests that evaluation should take into account “ past medical history, ” “ symptoms limiting ambulation, ” and “ other comorbidities impacting the use of a new prosthesis. ” Within this con- text, “ Cardiopulmonary examination ” is also included. While the need for an exhaustive, objective cardiopul- monary evaluation has been assigned to the discretion of the referring physician, there are instances when past medical history, symptoms and other comorbidities may suggest the need for an objective assessment of cardio- pulmonary capacity. Exercise testing or the measure- ment of the human body ’ s response to increased activity can be used to determine general cardiovascular fitness of an individual. It has also been utilized to assist in the determination of candidacy for successful utilization of a lower limb prosthesis among lower limb amputees [ 2 ] . Adequate physical fitness has also been identified as a correlate to increased function and successful ambula- tion with a prosthesis. However, these collective findings have never been compiled and assessed in a systematic way [ 3 – 6 ] . Further, there is no clear indication which modality of exercise testing is superior for use in the population with LEA and if exercise testing is best suited to determine general conditioning, prosthetic candidacy or ambulatory potential with a prosthesis. While guide- lines for prosthetic candidacy as it pertains to cardiopul- monary function have been suggested in individual clinical trials, aggregation and synthesis of these findings and suggestions have not occurred. These issues require consideration in their context of a healthcare climate moving toward evidence-based practice and the establishment of sound clinical practice recommendations, guidelines, and pathways [ 7 ] . These directives, to hold the most power and accuracy, must be based on the highest levels of research quality in sys- tematic literature reviews and meta-analyses (Fig. 1 ) . Therefore, the purpose of this project was to perform a systematic literature review regarding the use of exer- cise testing in the population of patients with history of lower extremity amputation and use the synthesis of that review to establish clinical practice recommenda- tion and present a clinical implementation pathway for future adoption. Methods A multidisciplinary team developed the methodology to be used in this systematic literature review and guideline development. All procedures were in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement and the Clinical Practice Guideline Development Manual [ 7 , 8 ] . The se- lected methodologies have been used in systematic re- views regarding prosthetic rehabilitation prior to this review as well as in the development of clinical practice guidelines and recommendations [ 9 – 13 ] . The multidis- ciplinary team consisted of a vascular surgeon, ortho- pedic surgeon, physical medicine and rehabilitation physician, research scientists, exercise physiologists, physical therapists, prosthetists, and epidemiologists from the private, Military, Veterans Affairs, and aca- demic sectors. Many of the authors have experience in systematic literature reviews and creation of clinical practice recommendations and all have experience work- ing directly with patients having a history of limb loss. Literature search Searches of four electronic medical research databases including (1) PubMed, (2) Google Scholar, (3) Web of Science, and (4) the Cochrane Library were used to compile possible articles and was conducted in January 2017. The range of article publication dates included December 2001 – December 2016. The searches were ex- ecuted independently by two authors who have experi- ence in performing literature database searches. The search terms were developed by the multi-disciplinary team and used for all searches per- formed. The search term set includes the following, where the use of an asterisk (*) indicates the use of a MeSH term or analogous input: amput* OR limb loss OR prosthe* AND function* OR capacity OR aerobic OR anaerobic OR cardio* OR vo2 maximum OR metabol* OR oxygen OR energy OR uptake OR consum* OR cost OR expend* OR fitness AND exercise OR stress OR ergomet* OR cycl* OR test* OR walk* OR ambulat* OR run* The resultant collection of manuscripts was compiled and screened independently by the same two authors who completed the searches. The screeners eliminated Klenow et al. Journal of NeuroEngineering and Rehabilitation 2018, 15 (Suppl 1):64 Page 12 of 72