ABSTRACT
Introduction: The patient's voice in shared decision-making has progressed from physician's office to regulatory decision-making for medical devices with FDA's Patient Preference Initiative. A discrete-choice preference measure for upper limb prosthetic devices was developed to investigate patient's risk/benefit preference choices for regulatory decision making. Methods: Rapid ethnographic procedures were used to design a discrete-choice measure describing risk and benefits of osseointegration with myoelectric control and test in a pilot preference study in adults with upper limb loss. Primary outcome is utility of each choice based conjoint (CBC) attribute using mixed-effects regression. Utilities with and without video, and between genders were compared. Results: Strongest negative preference was for avoiding infection risk (B = -1.77, p < 0.001) and chance of daily pain (B = -1.22, p, 0.001). Strongest positive preference was for attaining complete independence when cooking dinner (B = 1.62, p < 0.001) and smooth grip patterns at all levels (B = 1.62, B = 1.28, B = 1.26, p < 0.001). Trade-offs showed a 1% increase in risk of serious/treatable infection resulted in a 1.77 decrease in relative preference. There were gender differences, and where video was used, preferences were stronger. Conclusions: Strongest preferences were for attributes of functionality and independence versus connectedness and sensation but showed willingness to make risk-benefit trade-offs. Findings provide valuable information for regulatory benefit-risk decisions for prosthetic device innovations. Trial Registration: This study is not a clinical trial reporting results of a health care intervention so is not registered.
ABSTRACT
INTRODUCTION: Fit and alignment are observable objectives of the prosthesis rendering process for individuals with lower limb amputation. Nevertheless, there is a dearth of validated measures to directly assess the quality of this clinical procedure. OBJECTIVES: The objectives of this scoping review are to evaluate existing measurement parameters and clinical outcomes used in investigations of transtibial socket fit or prosthetic alignment and to identify gaps in the literature regarding tools for evaluation of prosthetic fitting. STUDY DESIGN: Scoping literature review. METHODS: A comprehensive search was conducted in the following databases: MEDLINE (through PubMed), Embase (through Elsevier), Scopus (through Elsevier), and Engineering Village (through Elsevier), resulting in 6107 studies to be screened. RESULTS: Sixty-three studies were included in the review. When measuring fit, studies most frequently reported on patient-reported comfort (n = 22) and socket size compared with the residual limb volume (n = 9). Alignment was most frequently measured by the prosthetists' judgment and/or use of an alignment jig (n = 34). The measurement parameters used to determine alignment or fit varied greatly among the included studies. CONCLUSION: This review demonstrated that most measures of socket fit rely on a patient's self-report and may vary with biopsychosocial factors unrelated to the socket fitting process. Meanwhile, alignment is determined mostly by the prosthetist's judgment, paired with objective measurements, such as alignment jigs and gait analysis. Efforts to standardize and validate measures of these parameters of prosthetic fitting are vital to improving clinical practice and reporting outcomes.
