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Structured Abstract
Background:
Lower limb prosthesis (LLP) candidates are a heterogeneous group. Many LLP options exist. How to best match an amputee with an LLP is unclear. Optimal selection of devices should be guided by evidence on which amputees would do best with which LLP component or configuration, and which evaluation instruments are valid and reliable in this population.
Methods:
We addressed questions pertaining to: assessing validity, reliability, and related psychometric properties for assessment techniques, predictor tools, and outcome measures in lower limb amputees; determining which patient and other characteristics may predict which LLP configuration or component would result in better clinical and patient-centered outcomes for different lower limb amputees (i.e., heterogeneity of treatment effect); determining whether patient expectations align with outcomes; evaluating whether patients are satisfied with the process of obtaining their LLPs; and describing long-term use of LLPs. The review does not evaluate overall comparative effectiveness among LLP components, nor does it include assessment of biomechanical outcomes. We searched six databases and other sources through October 2017 for eligible studies.
Results:
We found eligible studies that assessed the psychometric properties of 50 instruments (classified as assessment techniques, prediction tools, and outcome measures). Of these, 30 have evidence for both validity and reliability, but only 17 of these 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. Of 13 studies reporting data or analyses to allow assessment of heterogeneity of treatment effect, 7 used both predictor and outcome measures with evidence of validity. These studies mostly included younger men with unilateral transfemoral amputations due to trauma. Overall, studies did not identify participant characteristics that predict which lower limb amputees would benefit most or least from a given component (low strength of evidence); the studies were almost all underpowered to address this Key Question. Two studies provide low strength of evidence that people are satisfied with their encounters with their prosthetists. No eligible study addressed how study participants’ preprescription expectations of ambulation align with outcomes. Based on eight eligible studies, there is low strength of evidence that (1) about 11 to 22 percent of lower limb amputees who receive an LLP prescription stop using the prosthesis at about 1 year and (2) people with unilateral transfemoral amputations are about twice as likely to abandon their LLP than those with transtibial amputations. There is low strength of evidence that 24 to 29 percent of LLP recipients use their prostheses only indoors at 1 year.
Conclusions:
Numerous instruments assessing ambulation, function, quality of life, and other patient-centered outcomes have evidence of validity and reliability for people with lower limb amputations. The literature does not provide adequate evidence regarding whether specific characteristics or preprescription instruments are predictive of which specific LLP component individuals should receive to maximize ambulation, function, and quality of life, or to minimize abandonment or limited use. Further high-quality research in representative samples of people with LLPs is needed to inform optimal matching of prosthetic components to patients and to assess patient expectations and satisfaction with care.
Contents
- Key Messages
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Evidence Summary
- Introduction
- Methods
- Results
- Summary of Studies
- Key Questions 1 to 3. Assessment Techniques, Prediction Tools, Functional Outcome Measurement Tools
- Key Question 1. Assessment Techniques
- Key Question 2. Prediction Tools
- Key Question 3. Functional Outcome Measurement Tools
- Key Question 4. LLP Comparative Effectiveness by Subgroup
- Key Question 5. Expectations of Ambulation
- Key Question 6. Patient Satisfaction With Process
- Key Question 7. Long-Term Outcomes
- Discussion
- References
- Abbreviations and Acronyms
- Appendix A. Search Strategy
- Appendix B. Excluded Studies
- Appendix C. Study Results Key Questions 1 to 3
- Appendix D. Study Results Key Question 4
Suggested citation:
Balk EM, Gazula A, Markozannes G, Kimmel HJ, Saldanha IJ, Resnik LJ, Trikalinos TA. Lower Limb Prostheses: Measurement Instruments, Comparison of Component Effects by Subgroups, and Long-Term Outcomes. Comparative Effectiveness Review No. 213. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I.) AHRQ Publication No.18-EHC017-EF. Rockville, MD: Agency for Healthcare Research and Quality; September 2018. Posted final reports are located on the Effective Health Care Program search page. DOI: https://doi.org/10.23970/AHRQEPCCER213.
This report is based on research conducted by the Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00002-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
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