| 1. |
- Ernstsson, O., et al.
(author)
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Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry
- 2022
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In: Disability and Rehabilitation. - : Informa UK Limited. - 0963-8288 .- 1464-5165. ; 44:26, s. 8471-8479
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Journal article (peer-reviewed)abstract
- Purpose To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). Methods This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. Results The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. Conclusion The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.
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| 2. |
- Hagberg, Kerstin, 1957, et al.
(author)
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A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses. Mechanical complications and patient-reported outcomes
- 2020
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In: Bone & Joint Journal. - 2049-4394. ; 102B:1, s. 55-63
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Journal article (peer-reviewed)abstract
- Aims The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. Patients and Methods In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years' follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. Results The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. Conclusion Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required.
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| 3. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Daily Activity of Individuals With an Amputation Above the Knee as Recorded From the Nonamputated Limb and the Prosthetic Limb
- 2023
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In: Journal for the Measurement of Physical Behaviour. - 2575-6605 .- 2575-6613. ; 6:3, s. 223-232
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Journal article (peer-reviewed)abstract
- Introduction: Mobility restriction following limb loss might lead to a sedentary lifestyle, impacting health. Daily activity monitoring of amputees has focused on prosthetic steps, neglecting overall activity. Purpose: Toassessdailyactivityinindividualswithan established amputation and to explore the amount of activity recorded from the prosthesis as compared to the overall activity. Methods: Individuals with a unilateral transfemoral amputation or knee disarticulation who had used a prosthesis in daily life for >1 yearand could walk 100 m (unsupported or single aided) were recruited. Descriptive information and prosthetic mobility were collected. Two activPAL™ accelerometers were attached to the nonamputated thigh and the prosthesis, respectively. The mean daily activity over 7 days was compared between the nonamputated limb and the prosthesis. Results: Thirty-nine participants (22 men/17 women; mean age 54 [14.5] years) with amputation mainly due to trauma (59%) or tumor (28%) were included. Overall, participants took 6,125 steps and spent 10.2 hr sedentary, 5.0 hr upright, and 8.7 hr laying per day. Compared to recordings from the nonamputated limb, 85% of sit-to-stand transitions (32/38), 73% of steps (4,449/6,125), and 68% of walking time (1.0/1.5 hr) were recorded from the prosthesis. Recordings seemed to be less adequate for incidental prosthetic steps than for walks. Conclusions: Sedentary behavior accounted for most of the day demonstrating the importance to encourage physical activity among established prosthetic users. The prosthesis is used for daily activity to a great extent. However, noted pitfalls in the recordings call for further refinement of the measurements.
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| 4. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications
- 2023
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In: Journal of Orthopaedic Translation. - : Elsevier BV. - 2214-031X. ; 38, s. 56-64
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Journal article (peer-reviewed)abstract
- Background: Osseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient -reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes. Methods: In a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n = 51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0-100) and the Short Form 36 Health Survey (SF-36, ten scores 0-100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan-Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spear -man's correlation analysis was used for analyses of associations between adverse events. Results: PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (-28) and global score (+38) (all p < 0.001), and the SF-36 physical functioning score (+26, p < 0.001) and physical component score (+6, p < 0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%-91%), 65% (CI: 49%-77%) and 17% (CI: 7%-29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2-5.1) consti-tuted the most common serious adverse event and were more common during the last five years than during the first five years (p < 0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1-0.5) vs. 0.3 per person-years (CI: 0.1-0.5) (p = 0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p < 0.001) and between mechanical complications and adverse events (0.65, p < 0.001). Conclusion: Improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.
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| 5. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products
- 2021
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In: Prosthetics and orthotics international. - 1746-1553. ; 45:4, s. 355-361
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Journal article (peer-reviewed)abstract
- 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.
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| 6. |
- Kamrad, Ilka, et al.
(author)
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SwedeAmp—the Swedish Amputation and Prosthetics Registry : 8-year data on 5762 patients with lower limb amputation show sex differences in amputation level and in patient-reported outcome
- 2020
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In: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 91:4, s. 464-470
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Journal article (peer-reviewed)abstract
- Background and purpose — For want of national guidelines for lower limb amputation (LLA) the quality registry SwedeAmp was started in 2011 to increase knowledge around LLA and prosthetic rehabilitation. We now present data from the first 8 years of registration. Patients and methods — We present descriptive data from the first 8 years (2011–2018) of registration. Patient-reported outcome was collected at baseline and at follow-up 12 and 24 months after surgery for patients with prosthetic supply and included generic (EQ-5D-5L) and amputee-specific (e.g., LCI-5L and Prosthetic Use Score) measures. Sex differences were investigated. Results — As at December 31, 2018, 5,762 patients, 7,776 amputations, 2,658 prosthetic supplies, 1,848 baselines, and 2,006 follow-ups were registered. 61% of the patients were male, and mean age by the time of the first registered amputation was 74 years (SD 14). Women were older, more frequently had vascular disease without diabetes and more often underwent amputation at a higher level compared with men (p < 0.001). Time from amputation to fitting of first individual prosthesis was median 69 days (6–500) after transtibial amputation (TTA) and 97 days (19–484) after transfemoral amputation (TFA). The outcomes were lower after TFA than after TTA. Interpretation — SwedeAmp shows sex differences concerning amputation level, diagnosis, and age, leading to the conclusion that women have worse preconditions for successful prosthetic mobility after LLA. With increasing coverage, SwedeAmp can provide deeper knowledge with regard to patients undergoing LLA in Sweden.
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| 7. |
- Kohler, Friedbert, et al.
(author)
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Categorization and recommendations for outcome measures for lower limb absence by an expert panel
- 2023
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In: Prosthetics and Orthotics International. - 0309-3646 .- 1746-1553. ; 47:6, s. 565-574
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Journal article (peer-reviewed)abstract
- Background: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process. Methods: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend). Panelists were asked to individually categorize measures based on results of a systematic review of identified measures’ psychometric properties. Each measure’s final categorization was based on $70% agreement by all panelists. Results: No outcome measure attained the $70% consensus threshold needed to achieve a rating of “recommend.” Hence, panelists suggested combining “recommend” and “recommend with qualifications” into a single category of “recommend with qualifications.” Using this approach, consensus was reached for 59 of 60 measures. Consensus could not be reached on 1 outcome measure (socket comfort score). Thirty-six outcome measures were categorized as “unable to recommend” based on available evidence; however, 23 (12 patient-reported measures and 11 performance-based measures) demonstrated adequate psychometric properties in LLA samples and were thus rated as “recommend with qualification” by the expert panel. The panel of experts were able to recommend 23 measures for inclusion in the subsequent stakeholder review. A key strength of this process was bringing together international researchers with extensive experience in developing and/or using LLA outcome measures who could assist in identifying psychometrically sound measures to include in a subsequent stakeholder consensus process. Conclusion: The above categorizations represent the current state of psychometric evidence on outcome measures for people with LLA and hence may change over time as additional research becomes available. The results will be used to achieve wider consensus from clinicians, health policymakers, health clinic managers, researchers, and end users (i.e., individuals with LLA) on outcome measures for the International Society of Prosthetics and Orthotics lower limb Consensus Outcome Measures for Prosthetic and Amputation ServiceS.
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| 8. |
- Kuhlmann, A., et al.
(author)
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The Kenevo microprocessor-controlled prosthetic knee compared with non-microprocessor-controlled knees in individuals older than 65 years in Sweden : A cost-effectiveness and budget-impact analysis
- 2022
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In: Prosthetics and Orthotics International. - : Wolters Kluwer. - 0309-3646 .- 1746-1553. ; 46:5, s. 414-424
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Journal article (peer-reviewed)abstract
- BACKGROUND: Growing evidence suggests that individuals with transfemoral amputation or knee disarticulation using a prosthesis equipped with a microprocessor-controlled knee (MPK) benefit from enhanced mobility and safety, including less falls. In elderly individuals, high mortality rates are assumed to reduce the expected useful life of MPKs, and this raises concerns regarding their economic effectiveness. OBJECTIVE: To investigate the cost-effectiveness and budget impact of the Kenevo/MPK (Ottobock, Germany) compared with non-microprocessor-controlled knees (NMPKs) in people older than 65 years at the time of transfemoral amputation/knee disarticulation, from a Swedish payer's perspective. METHODS: A decision-analytic model was developed to conduct the economic analysis of the Kenevo/MPK. Model parameters were derived from Swedish databases and published literature. Univariate and probabilistic sensitivity analyses were performed to explore parameter uncertainty. RESULTS: Compared with NMPKs, the Kenevo/MPK reduced the frequency of hospitalizations by 137 per 1,000 person years while the frequency of fatal falls was reduced by 19 per 1,000 person-years in the simulation. Over a 25-year time horizon, the incremental cost-effectiveness ratio was EUR11,369 per quality-adjusted life year. The probability of the MPK being cost-effective at a threshold of EUR40,000 per quality-adjusted life year was 99%. The 5-year budget impact model predicted an increase in payer expenditure of EUR1.76 million if all new patients received a Kenevo/MPK, and 50% of current NMPK users switched to the MPK. CONCLUSIONS: Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls.
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| 9. |
- Möller, Saffran, et al.
(author)
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Cortical brain activity in transfemoral or knee-disarticulation prosthesis users performing single- and dual-task walking activities
- 2020
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In: Journal of Rehabilitation and Assistive Technologies Engineering. - : SAGE Publications. - 2055-6683. ; 7
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Journal article (peer-reviewed)abstract
- Introduction: Walking with a prosthesis while performing secondary tasks increases demand on cognitive resources, compromising balance and gait. This study investigated effects of a secondary task on patterns of brain activity and temporospatial gait parameters in individuals using a prosthesis with or without a microprocessor-controlled prosthetic knee(MPK) and controls. Methods: A cross-sectional study with repeated measures was performed. Twenty-nine individuals with amputations and 16 controls were recruited. Functional near-infrared spectroscopy was used to evaluate changes in oxygenated and de-oxygenated haemoglobin in the prefrontal cortex and temporospatial variables during single-and dual-task walking. Results: Differences in brain activity were observed within the MPK-group and controls without changes in temporospatial parameters. The Trail-Walking test was associated with highest levels of brain activity in both groups. No differences were observed between single- and dual-task walking in the non-MPK-group (p > 0.05). The Non-MPK and the MPK-group recorded higher levels of brain activity than controls during single-task walking and poorer results on temporospatial variables compared to controls. Conclusions: For the MPK-group and controls, introduction of a secondary task led to an increase in brain activity. This was not seen in the Non-MPK-group. Significant differences in brain activity were observed in the absence of changes in temporospatial parameters.
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| 10. |
- Thesleff, Alexander, 1986, et al.
(author)
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Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation
- 2021
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In: Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS. - 1557-170X. ; , s. 4600-4604
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Conference paper (peer-reviewed)abstract
- In research on lower limb prostheses, safety during testing and training is paramount. Lower limb prosthesis users risk unintentional loss of balance that can result in injury, fear of falling, and overall decreased confidence in their prosthetic leg. Here, we present a protocol for managing the risks during evaluation of active prosthetic legs with modifiable control systems. We propose graded safety levels, each of which must be achieved before advancing to the next one, from laboratory bench testing to independent ambulation in real-world environments.
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| 11. |
- Wentz, Kerstin, 1958, et al.
(author)
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Need for recovery in relation to effort from work and health in four occupations
- 2020
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In: International Archives of Occupational and Environmental Health. - : Springer Science and Business Media LLC. - 0340-0131 .- 1432-1246.
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Journal article (peer-reviewed)abstract
- Objective To examine three levels of need for recovery (NFR) after work in relation to effort from work demands, demand compensatory strategies, effort-moderating or -reversing resources, and health including health behaviors. A further purpose was to examine occupational characteristics determining NFR. Methods 5000 engineers, carpenters, nurses, and home care nurses were invited to participate. NFR k-means clusters were calculated from 1289 participants. The effect from three levels of NFR regarding demands, compensatory strategies, resources at work, health, and health behaviors was examined using analysis of variance (ANOVA) and post hoc analysis. Prevalence ratios (PRs) of suboptimal health for three levels of NFR were calculated using Poisson regression. Linear stepwise multiple regression predictors explaining NFR were examined also occupation wise. Results NFR centroids at 5.8/33, 13.1/33, and 21.0/33 points were identified. ANOVA showed corresponding effects from NFR levels on work demands and compensatory strategies. The inversed proportion concerned levels of resources at work. Only the low NFR cluster negated regular health effects. The other two cluster groups also repeatedly worked while ill and presented PRs concerning health effects from 1.9 to 3.9 when compared to the low NFR group. Making good quality work, recovery opportunities, and thinking of work when off work were the most important predictors of NFR among 1289 participants with also occupation-wise interpretable profiles. Conclusions Three levels of NFR meant corresponding levels of work demands, work-demand compensatory strategies, and unfavorable health behaviors. An inversed proportion of resources related to the same levels of NFR. Low NFR meant no regular health effects which could guide limit values regarding salutary NFR. Important predictors of NFR were resources making a good quality work, recovery opportunities, and reversely effort from rumination when off work. Occupation-wise predictors could guide interventions.
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