Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products

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Fältnamn	Indikatorer	Metadata
000		03243naa a2200277 4500
001		oai:gup.ub.gu.se/313111
003		SwePub
008		240910s2021 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://gup.ub.gu.se/publication/3131112 URI
024	7	a https://doi.org/10.1097/PXR.00000000000000082 DOI
040		a (SwePub)gu
041		a eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Hagberg, Kerstin,d 1957u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för ortopedi,Institute of Clinical Sciences, Department of Orthopaedics4 aut0 (Swepub:gu)xhagbk
245	1 0	a Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products
264	1	c 2021
520		a BACKGROUND: The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20 is a novel instrument aiming to address general benefits of medical devices. OBJECTIVE: To describe general patient-reported benefits of BAPs measured with MedTech20. STUDY DESIGN: This is a cross-sectional descriptive survey. METHODS: Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20 Questionnaire. Responses to each attribute were described, and the MedTech20 Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device). RESULTS: The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20 Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables. CONCLUSIONS: By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses. Copyright © 2021 International Society for Prosthetics and Orthotics.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Ortopedi0 (SwePub)302112 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Orthopaedics0 (SwePub)302112 hsv//eng
700	1	a Brodtkorb, T. H.4 aut
710	2	a Göteborgs universitetb Institutionen för kliniska vetenskaper, Avdelningen för ortopedi4 org
773	0	t Prosthetics and orthotics internationalg 45:4, s. 355-361q 45:4<355-361x 1746-1553
856	4 8	u https://gup.ub.gu.se/publication/313111
856	4 8	u https://doi.org/10.1097/PXR.0000000000000008

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