State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy.

Supported by evidence-based guidelines, custom-made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom-made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate-to-high risk of developing a foot ulcer, for whom custom-made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face-to-face meetings to develop a footwear design algorithm and evidence-based pressure-relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe-specific and insole (orthosis)-specific features were defined. Most insole-related features and some shoe-related features were evidence based, whereas most shoe-related features were consensus based. The pressure-relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure-relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate-to-high-risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers.

The development of a multidisciplinary, evidence-based guideline for "HIV and employment".

The objective of this study was to develop a multidisciplinary guideline that supports the care and vocational rehabilitation of HIV-infected people with employment-related problems. The guideline was developed according to the "evidence-based guideline development" method developed by the Dutch Institute for Health Care Improvement. This method consists of the following steps: forming a multidisciplinary core group and an expert panel, formulating key questions, searching and appraising the available literature, formulating considerations and recommendations, peer reviewing the draft guideline, and authorizing the final guideline. All relevant professional associations were represented in the core group that was assembled to develop the guideline, i.e., HIV doctors, HIV nurses, general practitioners, occupational health physicians, psychologists, social workers, occupational health nurses, vocational experts, and insurance physicians. Five key questions for the guideline were formulated with the following themes: determinants of employment, disclosure and stigma, self-management, interventions, and the organization of care. In the literature review on these topics, 45 studies met the inclusion criteria. The methodological quality of the included articles was poor. Factors such as patient preferences and medical/ethical issues were considered. The recommendations in the guideline are a weighting of the scientific evidence and the considerations of the core group. The guideline, as well as its summary for daily practice, clarifies the most important barriers and facilitators to people with HIV either staying at work or returning to work, and it constitutes a clinical, easy-to-use guideline for health-care providers and how they can support people with HIV who want to work.

Development of a research agenda for medical grade footwear in the Netherlands: A multidisciplinary multiphase project to determine the key research questions to advance scientific knowledge in the field.

BACKGROUND: The field of medical grade footwear is dynamic. Originally, a field where individual knowledge, expertise and skills determined the footwear and its outcomes, now becoming a more evidence-based and data-driven field with protocols and systems in place to create appropriate footwear. However, scientific evidence concerning medical grade footwear is still limited. Evidently, all stakeholders, from patients to pedorthists to rehabilitation physicians, will profit from a larger evidence-base in this field. A widely supported research agenda is an essential first step to advance and facilitate new knowledge. METHODS: We formed a multidisciplinary team and followed the methodology from Dutch medical societies for the development of a research agenda on medical grade footwear. This consisted of seven steps: (1) inventory of relevant questions with users and professionals; (2) analyses of responses; (3) analyses of existing knowledge and evidence; (4) formulating research questions; (5) prioritising research questions by users and professionals; (6) finalising the research agenda and (7) implementing the research agenda. RESULTS: In phase 1, 109 participants completed a survey, including 50% pedorthists, 6% rehabilitation physicians and 3% users. Participants provided 228 potential research questions. In phases 2-4, these were condensed to 65 research questions. In phase 5, 152 participants prioritised these 65 research questions, including 50% pedorthists, 13% rehabilitation physicians and 9% users. In phase 6, the final research agenda was created, with 26 research questions, categorised based on the International Classification of Functioning Disability and Health 'process description assistive devices'. In phase 7, an implementation meeting was held with over 50 stakeholders (including users and professionals), resulting in seven applications for research projects based on one or more research questions from the research agenda. CONCLUSIONS: This research agenda structures and guides knowledge development within the field of medical grade footwear in the Netherlands and elsewhere. We expect that this will help to stimulate the field to tackle the research questions prioritised and with that to advance scientific knowledge in this field.

The contribution of adult attachment and perceived social support to depressive symptoms in patients with HIV.

The present study investigated the relationship between adult attachment style and depressive symptomatology in patients with HIV. Moreover, perceived social support was investigated as a potential mediator between adult attachment and depressive symptoms. A sample of 233 HIV-infected patients (90% male) completed questionnaires assessing adult attachment style (Relationship Questionnaire), depressive symptoms (Beck Depression Inventory), and perceived social support (Medical Outcomes Study Social Support Survey). After controlling for demographic and medical variables, an insecure adult attachment style was found to be strongly related with depressive symptoms. Half of the insecurely attached patients reported clinically elevated levels of distress, while one in nine securely attached patients reported elevated levels of distress (χ(2)=32.25, p=0.001). Moreover, the association between attachment style and depressive symptomatology was found to be partly mediated through perceived social support. This study strongly supports the notion that an insecure attachment style is a vulnerability factor for developing depressive symptoms that would warrant clinical attention when confronted with a chronic illness such as HIV. The clinical implications of these findings are discussed.

Delphi process yielded consensus on terminology and research agenda for therapeutic footwear for neuropathic foot.

OBJECTIVE: To investigate areas of consensus and disagreement among Dutch physiatrists concerning prescription of therapeutic footwear for the neuropathic foot and to develop a research agenda. STUDY DESIGN AND SETTING: Forty participants were physiatrists and experts in the field of orthopedic shoe techniques. Four postal Delphi rounds were followed by a final plenary session. RESULTS: Forty of the 44 invited experts participated in all postal Delphi rounds, with an overall response of 100%. They achieved consensus on the following. 1. (Dutch) Terminology for two sets of domains and dimensions for the various features of the neuropathic foot and for the shoe characteristics. 2. Application of specific shoe components: insole, shaft, outsole, tongue, and heel. In most features of the neuropathic foot, shaft and outsole domains were linked in the flexibility dimension. 3. Shoe prescriptions for various features of the neuropathic foot in at least four technical domains. Experts disagreed on application of rocker bar and shaft height. In a final conference, 31 experts agreed on a prioritized research agenda. CONCLUSION: An intensive Delphi process yielded consensus on terminology, and determined areas of consensus and disagreement for future research for the various features of the neuropathic foot and the shoe characteristics.

High satisfaction with an individualised stroke care programme after hospitalisation of patients with a TIA or minor stroke: a pilot study.

BACKGROUND: Many hospitalised patients with a transient ischaemic attack (TIA) or minor stroke develop subtle cognitive disorders and emotional problems a few weeks after discharge, and are dissatisfied with the care they have received, even with specialised stroke care programmes. Therefore, an individualised stroke care programme was developed to match the therapy with the personal care needs. In this pilot study we evaluated the feasibility of the rehabilitation programme, the satisfaction of stroke patients with this programme, and the factors associated with satisfaction. METHODS: Consecutive patients who were hospitalised with a TIA or minor stroke, with no apparent residual deficits, were eligible. Occupational and neuropsychological screening was applied 4-6 weeks after discharge, and therapy was provided when necessary. After 6 months, satisfaction with care (Satisfaction-With-Stroke-Care-19), was assessed as the primary outcome. Secondary outcomes were quality of life (QoL), disability, handicap, anxiety and depression. RESULTS: 42 patients with a TIA or minor stroke participated in the programme and the follow-up. Of all the participants, 71% were satisfied with the care they have received after discharge. Male patients were more satisfied than female patients. Dissatisfied patients were less able to perform the activities of daily living, had a lower QoL and more depressive symptoms. After regression analysis, only the Barthel Index was independently associated with satisfaction. CONCLUSIONS: In this pilot study, our individualised stroke care programme seems to have improved patient satisfaction. Ability to perform daily activities is associated with satisfaction. A randomised controlled trial is needed to confirm the effectiveness of this rehabilitation programme.

Evaluation of the wear-and-tear scale for therapeutic footwear, results of a generalizability study.

OBJECTIVE: Therapeutic footwear is often prescribed at considerable cost. Foot-care specialists normally assess the wear-and-tear of therapeutic footwear in order to monitor the adequacy of the prescribed footwear and to gain an indicator of its use. We developed a simple, rapid, easily applicable indicator of wear-and-tear of therapeutic footwear: the wear-and-tear scale. The aim of this study was to investigate the intra- and inter-rater reliability of the wear-and-tear scale. METHODS: A test set of 100 therapeutic shoes was assembled; 24 raters (6 inexperienced and 6 experienced physiatrists, and 6 inexperienced and 6 experienced orthopaedic shoe technicians) rated the degree of wear-and-tear of the shoes on the scale (range 0-100) twice on 1 day with a 4-h interval (short-term) and twice over a 4-week interval (long-term). Generalizability theory was applied for the analysis. RESULTS: Short-term, long-term and overall intra-rater reliability was excellent (coefficients 0.99, 0.99 and 0.98; standard error of measurement (SEM) 2.6, 2.9 and 3.9; smallest detectable changes (SDC) 7.3, 8.0 and 10.8, respectively). Inter-rater reliability between professions, experience and inexperienced raters, and overall was excellent (coefficients 0.97, 0.98 and 0.93; SEM 4.9, 4.5, and 8.1; SDC 13.7, 12.4 and 22.5, respectively). CONCLUSION: The wear-and-tear scale has excellent intra-rater, inter-rater, and overall reliability.

Use and effects of custom-made therapeutic footwear on lower-extremity-related pain and activity limitations in patients with rheumatoid arthritis: A prospective observational study of a cohort.

OBJECTIVES: An estimated 55-90% of patients with rheumatoid arthritis have foot problems. Therapeutic footwear is frequently prescribed as part of usual care, but data on its use and effect is incomplete. This study aimed to investigate the use and effects of therapeutic footwear. METHODS: Patients with rheumatoid arthritis receiving custom-made therapeutic footwear for the first time formed an inception cohort. Patients reported their therapeutic footwear use on 3 consecutive days in activity diaries 14 and 20 weeks after delivery of the footwear. The Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) was used as the primary outcome of lower-extremity-related pain and activity limitations, and the Health Assessment Questionnaire (HAQ) as a secondary outcome measure of activity limitations, both at baseline and 26 weeks after therapeutic footwear delivery. RESULTS: The cohort comprised 114 rheumatoid arthritis patients (median disease duration 10 years). Mean (standard deviation) therapeutic footwear use was 54 (25)% of the time patients were out of bed. The median (interquartile range) WOMAC score improved from 41 (27-59) to 31 (16-45) (p < 0.001). Secondary outcome measures improved significantly. CONCLUSION: Therapeutic footwear was used with moderate intensity by most rheumatoid arthritis patients and was associated with a substantial decrease in pain and activity limitations. Therapeutic footwear is a relevant treatment option for patients with rheumatoid arthritis and foot problems.

Foot-related health care use in patients with rheumatoid arthritis in an outpatient secondary care center for rheumatology and rehabilitation in The Netherlands: a cohort study with a maximum of fifteen years of followup.

OBJECTIVE: To describe foot-related health care use over time in a cohort of rheumatoid arthritis (RA) patients in an outpatient secondary care center for rheumatology and rehabilitation in The Netherlands. METHODS: A total of 1,087 patients with recent-onset RA from 1995 to September 2010 were included in the study. All foot-related visits to the podiatrist, rehabilitation physician, orthopedic surgeon, and the multidisciplinary foot-care clinic were registered and described. Logistic regression techniques for longitudinal data were used to analyze the course of foot-related health care use. RESULTS: A total of 32.9% of patients visited a podiatrist in secondary care during the course of their disease. For most patients, a visit to the podiatrist took place during the first year after diagnosis. This was followed by a significant decrease in visits in the ensuing years. Nine percent of patients visited the rehabilitation physician with foot symptoms, with peak prevalences between year 10 and 11 and during year 14 of followup. The orthopedic surgeon was visited by 5.3% of patients with foot symptoms, with a significant increase in visits over time. The multidisciplinary foot-care clinic was visited by 7.5% of patients. This was significantly associated with visits to the rehabilitation physician. CONCLUSION: In an outpatient secondary care center in The Netherlands, RA patients with foot symptoms visited the podiatrist in an early stage of the disease. When foot symptoms worsened, patients visited the rehabilitation physician, who subsequently referred patients to the multidisciplinary foot-care clinic for therapeutic footwear. The orthopedic surgeon was the final step in the management of foot symptoms.

Factors predicting the outcome of customised foot orthoses in patients with rheumatoid arthritis: a prospective cohort study.

BACKGROUND: Conservative management of foot problems in patients with rheumatoid arthritis (RA) may consist of the prescription of customised foot orthoses. Indications for foot orthoses are not clear and the effectiveness of the intervention is highly variable among patients. Knowledge on which patients benefit the most from foot orthoses can help to select patients eligible for this type of intervention. The objective of the present study was to determine clinical and demographic factors that predict the outcome of customised foot orthoses on pain and disability in patients with RA. METHODS: A total of 135 RA patients who were supplied with customised foot orthoses were included in this prospective cohort study. Pain and disability were measured before and after the intervention period using a Numeric Rating Scale (NRS) for foot pain, the Foot Function Index (FFI), the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) and a 10-meter walking test. The intervention period consisted of one or more appointments with the podiatrist during which the foot orthoses were customised.Swollen foot joint count, foot deformity scores, forefoot peak pressure, disease duration, age, gender, body mass index and baseline values of the outcome measures were selected as potential factors predicting outcome. Multivariate linear regression analyses were performed to determine factors associated with change in pain and disability (at P < 0.05). RESULTS: Disease duration was negatively associated with the change scores in NRS foot pain (P = 0.018), WOMAC pain (P = 0.001), FFI disability (P = 0.003) and WOMAC physical function (P = 0.002). Age was negatively associated with the change score in 10 meter walking time (P = 0.008). For all outcome measures baseline values were positively associated with the change scores (P < 0.001). CONCLUSIONS: Shorter disease duration predicted greater improvements in self-reported foot pain and disability, and younger age predicted greater improvements in walking time after intervention with foot orthoses. Also, higher baseline values of pain and disability predicted greater improvements. Referral for conservative management with foot orthoses in the early stage of RA seems important when aiming to achieve reduction in pain and improvement in daily activities.

Prediction of walking disability by disease-related factors in patients with rheumatoid arthritis.

OBJECTIVE: To investigate the relationship between disease-related factors and walking disability in different phases of rheumatoid arthritis; and to predict future walking disability in rheumatoid arthritis, using disease-related factors assessed 2 years after diagnosis. METHODS: A cohort of 848 newly diagnosed patients with rheumatoid arthritis was followed up for a maximum of 8 years. Walking disability and several disease-related and demographic factors were recorded during follow-up. A logistic regression model was used to study associations between walking disability and these factors at different time points. A multilevel logistic regression model for longitudinal data was used to predict walking disability during follow-up from potential predictors at year 2. RESULTS: Global pain and disease activity were consistently related to walking disability at almost every time point. Significant predictors of future walking disability were: walking disability, knee pain, global pain, the passage of time during follow-up, and age. CONCLUSION: Global pain and disease activity are related to walking disability during the first 8 years of RA. Walking disability, knee pain, and global pain at 2 years follow-up predict walking disability later in the disease. In addition, the risk for walking disability increases during the disease process and with higher age at diagnosis.

Prevalence and course of forefoot impairments and walking disability in the first eight years of rheumatoid arthritis.

OBJECTIVE: To evaluate the prevalence and 8-year course of forefoot impairments and walking disability in patients with rheumatoid arthritis (RA). METHODS: A total of 848 patients with recent-onset RA from 1995 through the present were included. The patients were assessed annually. Pain and swelling of the metatarsophalangeal (MTP) joints, erosions and joint space narrowing of the MTP joints and first interphalangeal joints, and the Health Assessment Questionnaire walking subscale were analyzed using descriptive and correlational techniques. RESULTS: Pain and swelling of > or = 1 MTP joint was present in 70% of patients at baseline, decreasing to approximately 40-50% after 2 years. The forefoot erosion score was > or = 1 in 19% of the patients at baseline, and the prevalence of forefoot erosion increased to approximately 60% after 8 years, during which the mean forefoot erosion score increased from 1.3 to 7.9. At least mild walking disability was present in 57% of patients at baseline, stabilizing at approximately 40% after 1 year. CONCLUSION: The prevalence rates for pain and swelling of the MTP joints and walking disability are initially high and then stabilize, but the prevalence and severity of forefoot joint damage increase during an 8-year course of RA. The findings of this study quantitatively emphasize the importance of forefoot involvement in patients with RA.