Gustav Jarl

Validity evidence for a modified version of the Orthotics and Prosthetics Users’ Survey

Purpose: To evaluate the validity of a modified version of the Orthotics and Prosthetics Users’ Survey (OPUS) with persons using different prosthetic and orthotic (P&O) devices.Method: Two-hundred-and-eighty-two adults using prosthesis, orthosis, shoe insoles or orthopaedic shoes completed OPUS. OPUS comprises five modules - Lower and Upper Extremity Functional Status, respectively (LEFS and UEFS), Client Satisfaction with Device and Services, respectively (CSD and CSS), and, Health-Related Quality of Life (HRQoL). Eight new items were added to LEFS and six to UEFS. Rasch analysis was used for data analyses.Results: Rating scales functioned satisfactory after some modifications. All modules demonstrated a ceiling effect. Unidimensionality was satisfactory after deleting some items and dividing HRQoL into two subscales, although somewhat weak on CSD and CSS. Item reliability was excellent for all modules and person reliability good for all but CSD and CSS. Some items demonstrated differential item functioning related to sex and age, but the impact on person measures was small.Conclusions: This study supports the validity of a modified version of OPUS for persons using different P&O devices, but also reveals limitations to be addressed in future studies. OPUS could be useful in clinical rehabilitation and research to evaluate P&O outcomes. Implications for Rehabilitation The rehabilitation of individuals with musculoskeletal dysfunction often includes prosthetic or orthotic devices. There is a need for validated instruments to assess the outcomes of prosthetic and orthotic (P&O) interventions. This study provides validity evidence in support of using the Orthotics and Prosthetics Users’ Survey (OPUS) as an outcome measure for P&O interventions.

Test-retest reliability of the Swedish version of the Orthotics and Prosthetics Users' Survey

Background: The Orthotics and Prosthetics Users’ Survey consists of five modules to assess outcomes of orthotic and prosthetic interventions: lower extremity functional status, upper extremity functional status, client satisfaction with device, client satisfaction with services and health-related quality of life. Objectives: To investigate the test–retest reliability and calculate the smallest detectable difference for all modules of the Swedish Orthotics and Prosthetics Users’ Survey. Study design: Test–retest reliability study design. Methods: A total of 69 patients at a Department of Prosthetics and Orthotics completed Orthotics and Prosthetics Users’ Survey on two occasions separated by a 2-week interval, giving 18 answers on lower extremity functional status, 41 on upper extremity functional status, 53 on client satisfaction with device, 12 on client satisfaction with services and 67 answers on health-related quality of life. Raw scores were converted into Orthotics and Prosthetics Users’ Survey units on a 0–100 scale. Intra-class correlation coefficients, Bland–Altman plots, common person linking plots and t-tests of person mean measures were used to investigate the reliability. The 95% confidence level smallest detectable differences were calculated. Results: The intra-class correlation coefficients ranged from 0.77 to 0.96 for the modules, and no systematic differences were detected between the response occasions. The smallest detectable differences ranged from 7.4 to 16.6 units. Conclusions: The test–retest reliability was satisfactory for all Orthotics and Prosthetics Users’ Survey modules. The smallest detectable difference was large on all modules except the health-related quality of life module. Clinical relevance The Orthotics and Prosthetics Users’ Survey modules are reliable and, thus, can be recommended for repeated measurements of patients over time. Relatively large changes are needed to achieve statistical significance when assessing individual patients.

The effect of insoles on foot pain and daily activities.

Background: Foot pain decreases individuals’ ability to perform daily activities. Insoles are often prescribed to reduce the pain which, in turn, may promote return to normal activities. Objectives: To evaluate the effects of insoles on foot pain and daily activities, and to investigate the relationship between individuals’ satisfaction with insoles and actual use of them. Study design: A 4-week pre–post intervention follow-up. Methods: Brief Pain Inventory, International Physical Activity Questionnaire and Lower Extremities Functional Status were used as outcome measures. Client Satisfaction with Device was used in the follow-up. Results: A total of 67 participants answered the questionnaires (81% women). Overall, a reduction in Pain Severity (p = 0.002) and Pain Interference (p = 0.008) was shown. Secondary analyses revealed a significant effect only in women. No changes in daily activities (Walking, p = 0.867; Total Physical Activity, p = 0.842; Lower Extremities Functional Status, p = 0.939) could be seen. There was no relation between Client Satisfaction with Device measures and duration of insole use. A difference in sex was shown; women scored higher than men on Pain Severity. Conclusion: Insoles reduce pain and pain interference with daily activities for women with foot pain. Satisfaction with the insoles is not a predictor of actual insole use. The effect of insoles on activity performance needs further study. Clinical relevance This study provides evidence for prescribing insoles to people with foot pain. Nonetheless, insoles are not enough to increase their physical activity level in the short term. Satisfaction with insoles and duration of use are not correlated and cannot be inferred from each other.

A modified walk-in system versus scheduled appointments in a secondary-care prosthetic and orthotic clinic:

Background: Waiting is common in health care, delays intervention, and has negative effects on satisfaction with services. Objectives: To evaluate effects of a modified walk-in system, where patients were invited consecutively from the waiting list to attend the clinic on a walk-in basis, on waiting times, services, and work environment. Study design: Parallel-group trial. Methods: In all, 1286 consecutive patients in need of shoe insoles were randomized to waiting lists for modified walk-in (n = 655) or a scheduled appointment (n = 631). Seven staff members also participated. Results: The median indirect waiting time to first appointment was 40 days shorter for modified walk-in (135 days) than for scheduled appointment (175 days; p < 0.001); 17% of those randomized to modified walk-in did not attend the clinic compared to 6% for scheduled appointment (p < 0.001). Mean direct waiting time in the waiting room was 9.9 min longer for modified walk-in than for scheduled appointment (p < 0.001). Patients attending modified walk-in or a scheduled appointment reported similar levels of satisfaction with services. Staff reported more support from co-workers with modified walk-in than with scheduled appointment (p = 0.041). Conclusion: The modified walk-in can reduce indirect waiting times without any substantial worsening of direct waiting times, service quality, or work environment. Studies are needed to investigate why many patients drop out from modified walk-in. Clinical relevance A modified walk-in system can cut the queues and create more timely interventions by reducing indirect waiting times. This system can therefore be recommended in secondary-care prosthetic and orthotic clinics to reduce patients’ suffering from their health condition.

An innovative sealed shoe to off-load and heal diabetic forefoot ulcers - a feasibility study

ABSTRACT Background: Non-removable knee-high devices are the gold standard to treat diabetic foot ulcers located on the plantar forefoot, but they immobilize the ankle, which restricts daily life activities and has negative effects on joint functioning. Objective: To investigate the feasibility of sealing a therapeutic shoe to off-load and heal diabetic forefoot ulcers. Design: A case series of seven men with type 2 diabetes and a metatarsal head ulcer were prescribed therapeutic shoes and custom-made insoles. The shoe was sealed with a plastic band. Off-loading was assessed with the F-scan pressure measurement system. Adherence to wearing the shoe was assessed with a temperature sensor and by documenting the status of the seal. Results: The off-loading was effective and all ulcers healed. Median time to healing was 56 days (range 8–160). Complications were secondary ulcer (n = 1) and plantar hematoma (n = 1). Five of seven participants did not disturb the seal. Conclusions: Sealing a therapeutic shoe is a feasible way to off-load and heal forefoot ulcers. A controlled trial is needed to compare the effectiveness and safety of a sealed shoe to other non-removable devices.

Adherence to wearing therapeutic shoes among people with diabetes : a systematic review and reflections

Introduction Therapeutic shoes are prescribed to prevent diabetic foot ulcers, but adherence to wearing the shoes is often poor. Aim The aim of this study was to review the literature on factors that are associated with adherence to wearing therapeutic shoes and construct a model of adherence to aid future research and development in the field. Methods We conducted a systematic search in PubMed, CINAHL, and PsycINFO for quantitative studies on factors associated with adherence to wearing therapeutic shoes among people with diabetes. Results Six studies were included in the review. The studies focused mainly on patient-, therapy-, and condition-related adherence factors. There is some evidence (three to five studies) that sex, diabetes duration, and ulcer history are not associated with adherence. The evidence for or against the other factors was weak (only one or two studies) or conflicting. Conclusion There is no conclusive evidence for using any factor to predict adherence to wearing therapeutic shoes, but there is some evidence against using certain factors for predicting adherence. Future studies should include a broader range of factors, including health system and social/economic factors, and they should investigate perceived costs and benefits of wearing therapeutic shoes in comparison with other shoes or no shoes. A seesaw model is presented illustrating the complex phenomenon of adherence. Further research is needed to identify factors associated with adherence to wearing therapeutic shoes, to enable the development of interventions to improve adherence and thereby reduce ulceration rates among people with diabetic foot complications.

A model to facilitate implementation of the International Classification of Functioning, Disability and Health into prosthetics and orthotics

Background: The International Classification of Functioning, Disability and Health is a classification of human functioning and disability and is based on a biopsychosocial model of health. As such, International Classification of Functioning, Disability and Health seems suitable as a basis for constructing models defining the clinical P&O process. The aim was to use International Classification of Functioning, Disability and Health to facilitate development of such a model. Proposed model: A model, the Prosthetic and Orthotic Process (POP) model, is proposed. The Prosthetic and Orthotic Process model is based on the concepts of the International Classification of Functioning, Disability and Health and comprises four steps in a cycle: (1) Assessment, including the medical history and physical examination of the patient. (2) Goals, specified on four levels including those related to participation, activity, body functions and structures and technical requirements of the device. (3) Intervention, in which the appropriate course of action is determined based on the specified goal and evidence-based practice. (4) Evaluation of outcomes, where the outcomes are assessed and compared to the corresponding goals. After the evaluation of goal fulfilment, the first cycle in the process is complete, and a broad evaluation is now made including overriding questions about the patient’s satisfaction with the outcomes and the process. This evaluation will determine if the process should be ended or if another cycle in the process should be initiated. Conclusion: The Prosthetic and Orthotic Process model can provide a common understanding of the P&O process. Concepts of International Classification of Functioning, Disability and Health have been incorporated into the model to facilitate communication with other rehabilitation professionals and encourage a holistic and patient-centred approach in clinical practice. Clinical relevance The Prosthetic and Orthotic Process model can support the implementation of International Classification of Functioning, Disability and Health in P&O practice, thereby providing a common understanding of the P&O process and a common language to facilitate communication with other rehabilitation professionals.

An alternative perspective on assistive technology: the Person–Environment–Tool (PET) model

ABSTRACT The medical and social models of disability categorize people as ablebodied or disabled. In contrast, the biopsychosocial model, which forms the basis for the International Classification of Functioning, Disability and Health (ICF), suggests a universalistic perspective on human functioning, encompassing all human beings. In this article, we argue that the artificial separation of function-enhancing technology into assistive technology (AT) and mainstream technology (MST) might be one of the barriers to a universalistic view of human functioning. Thus, an alternative view of AT is needed. The aim of this article was to construct a conceptual model to demonstrate how all human activities and participation depend on factors related to the person, environment, and tools, emphasizing a universalistic perspective on human functioning. In the person–environment–tool (PET) model, a person’s activity and participation are described as a function of factors related to the person, environment, and tool, drawing on various ICF components. Importantly, the PET model makes no distinction between people of different ability levels, between environmental modifications intended for people of different ability levels, or between different function-enhancing technologies (AT and MST). The PET model supports a universalistic view of technology use, environmental adapMcNeill tations, and variations in human functioning.

Beyond dichotomous thinking: a process perspective on diabetic foot disease

ABSTRACT Background: Diabetic foot (DF) disease causes severe suffering around the world, and appropriate self-care activities are needed to prevent and treat this condition. However, all too often, self-care activities are less than optimal and clinicians find themselves unable to influence them in a positive direction. Clinicians’ and researchers’ mental models of the DF tend to be dichotomous: either the patient has or does not have an active ulcer or other DF disease. This mode of thinking hides the long-term perspective of DF disease, where patients’ previous experiences and expectations for the future influence their current behavior. Thus, there is a need for a different perspective on DF disease to better understand patients’ perspectives and thereby improve self-care, leading to more effective prevention and treatment. Objective: To present a novel framework, the process perspective on the DF, which can explain inadequate self-care behaviors not easily understood with a dichotomous perspective, and how they can be changed. Results: Three fictive clinical examples are used to illustrate how the process perspective on the DF can be used to understand how patients’ previous experiences and expectations for the future influence their current behavior. In particular, this process perspective is used to understand how patients’ beliefs and behaviors are sometimes self-reinforcing, resulting in stable behavior patterns, here referred to as ‘DF cycles’. These cycles are quite common in clinical practice but are difficult to analyze using a dichotomous perspective on DF disease. The process perspective on the DF is used to analyze specific ‘vicious’ DF cycles of inadequate patient behavior and to find ways to transform them into ‘virtuous’ DF cycles, resulting in effective prevention and treatment. Conclusions: The process perspective on the DF seems suitable for understanding inadequate patient behaviors not easily understood with a dichotomous perspective on DF disease, opening up new avenues for clinical practice and research to help patients live a life with long remission phases, few relapses, and a high quality of life.