OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy.METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed.CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.
Background: Rising healthcare costs, an increasing general practitioner shortage and an aging population have made healthcare organization transformation a priority. To meet these challenges, traditional roles of non-medical members have been reconsidered. Within the domain of physiotherapy, there has been significant interest in Extended Scope Physiotherapy (ESP). Although studies have focused on the perceptions of different stakeholders in relation to ESP, there is a large variety in the interpretation of ESP. Aim: To identify a paradigm of ESP incorporating goals, roles and tasks, to provide a consistent approach for the implementation of ESP in primary care. Methods: An exploratory, qualitative multi-step design was used containing a scoping review, focus groups and semi-structured interviews. The study population consisted of patients, physiotherapists, general practitioners and indirect stakeholders such as lecturers, health insurers and policymakers related to primary care physiotherapy. The main topics discussed in the focus groups and semi-structured interviews were the goals, skills and roles affiliated with ESP. The ‘framework’ method, developed by Ritchie & Spencer, was used as analytical approach to refine the framework. Results: Two focus groups and twelve semi-structured interviews were conducted to explore stakeholder perspectives on ESP in Dutch primary care. A total of 11 physiotherapists, six general practitioners, five patients and four indirect stakeholders participated in the study. There was a lot of support for ‘decreasing healthcare costs’, ‘tackling increased health demand’ and ‘improving healthcare effectiveness’ as main goals of ESP. The most agreement was reached on ‘triaging’, ‘referring to specialists’ and ‘ordering diagnostic imaging’ as tasks fitting for ESP. Most stakeholders also supported ‘working in a multidisciplinary team’, ‘working as a consultant’ and ‘an ESP role separated from a physiotherapist role’ as roles of ESP. Conclusions: Based on the scoping review, focus groups and interviews with direct and indirect stakeholders, it appears that there is sufficient support for ESP in the Netherlands. This study provides a clear presentation of how ESP can be conceptualized in primary care. A pilot focused on determining the feasibility of ESP in Dutch primary care will be the next step.
Objective: The aim of this study was to obtain insight in specific elements influencing the use, non-use, satisfaction, and dissatisfaction of ankle foot orthoses (AFOs) and the presence of underexposed problems with respect to AFOs. Methods: A questionnaire was composed to obtain information from AFO users to investigate the variables associated with satisfaction and the relation between these variables. A specific feature of this study was the systematic analysis of the remarks made by the respondents about their AFO. Quantitative data analyses were used for analysing the satisfaction and qualitative analyses were used analysing the remarks of the respondents. A total of 211 users completed the questionnaire. Results: Our survey showed that 1 out of 15 AFOs were not used at all. About three quarters of the AFO users were satisfied and about one quarter was dissatisfied. Females and users living alone reported relatively high levels of dissatisfaction, especially in the field of dimensions, comfort, weight, safety and effectiveness. Dissatisfaction with respect to off-the-shelf AFOs for the item durability was higher than that for custom-made AFOs. In the delivery and maintenance process the items ‘maintenance’, ‘professionalism’ and ‘delivery follow-up’ were judged to be unsatisfactory. A large number of comments were made by the respondents to improve the device or process, mainly by the satisfied AFO users. These comments show that even satisfied users experience many problems and that a lot of problems of AFO users are ‘underexposed’. Conclusion: To improve user satisfaction, the user practice has to be identified as an important sub-process of the whole orthopaedic chain especially in the diagnosis and prescription, delivery tuning and maintenance, and evaluation phase.
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In Europe nearly 10% of the population suffers from diabetes and almost 1% from Rheumatoid Arthritis which can lead to serious problems with mobility and active participation, especially in the ageing population. Pedorthists deliver personalised designed and manufactured orthopaedic footwear or insoles for these patients. However, despite their often laborious efforts upfront, the industry has very little means to quantify how successful the fitting and function of a shoe is. They have to rely on subjective, qualitative measures such as client satisfaction and diminishing of complaints. Although valuable, the need for objective quantitative data in this field is growing. Foot plantar pressure and shear forces are considered major indicators of potential foot problems. Devices to measure plantar pressure slowly gain terrain as providers of objective quantitative data to guide orthotic design and manufacturing. For shear forces however, measuring devices are not yet commercial available. Although shear forces are considered as a major contributor to ulcer formation in diabetic feet, their exact role still requires elucidation and quantification. This project aims to develop a prototype of an in-shoe wearable device that measures both shear forces and pressure using state-of-the-art developments in sensor technologies, smart textiles and wireless data transfer. The collaboration of pedorthists’ small and medium-sized enterprises (SME)’s with medical device engineering companies, knowledge institutes,technical universities and universities of applied sciences in this project will bring together the different fields of expertise required to create an innovative device. It is expected that the tool will be beneficial to improve the quality of pedorthists’ services and potentially reduce health insurance costs. Furthermore, it can be used in new shear forces research and open new business potential. However, the eventual aim is to improve patient care and help maintain personal mobility and participation in society.
