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Background/Objectives: This study aimed to develop a novel nanotechnological slow-release drug delivery platform based on hyaluronic acid Microsponge (MSP) for the subcutaneous administration of methotrexate (MTX) in the treatment of rheumatoid arthritis (RA). RA is a chronic autoimmune disease characterized by joint inflammation and damage, while MTX is a common disease-modifying antirheumatic drug (DMARD), the conventional use of which is limited by adverse effects and the lack of release control. Methods: MSP were synthesized as freeze-dried powder to increase their stability and allow for a facile reconstitution prior to administration and precise MTX dosing. Results: A highly stable and rounded-shaped micrometric MSP, characterized by an open porosity inner structure, achieved both a high MTX loading efficiency and a slow release of MTX after injection. Our drug release assays indeed demonstrated a characteristic drug release profile consisting of a very limited burst release in the first few hours, followed by a slow release of MTX sustained for over a month. By means of a preclinical rat model of RA, the administration of MTX-loaded MSP proved to nearly double the therapeutic efficacy compared to sole MTX, according to a steep reduction in arthritic score compared to control groups. The preclinical study was replicated twice to confirm this improvement in performance and the safety profile of the MSP. Conclusions: This study suggests that the MSP drug delivery platform holds significant potential for clinical use in improving RA therapy by enabling the sustained slow release of MTX, thereby enhancing therapeutic outcomes and minimizing side effects associated with conventional burst-release drug administration. [ABSTRACT FROM AUTHOR]

Background: In Italy, knee osteoarthritis (KOA) accounts for over 5 million prevalent cases and requires long-term multidisciplinary management. The most frequent KOA symptom is pain. The aim of the survey is to provide a national overview of the current management of moderate-to-severe pain associated with KOA from both clinicians' and patients' perspectives. Methods: An exploratory qualitative survey was conducted in Italy between July and October 2023. The survey participants were members of four national scientific societies and two patient associations who were invited to participate via email and given an online questionnaire. Questions included a mix of single and multiple responses and scalar items. Results: In total, 1473 clinicians and 150 patients with KOA completed the questionnaire. Patients rated knee pain as both the most burdensome symptom and the most frequent reason for treatment dissatisfaction and seeking consultation. One in two patients declared that they were unsatisfied/little satisfied with the current prescribed analgesic treatments. The clinicians surveyed preferentially prescribed intra-articular hyaluronic acid, oral non-steroidal anti-inflammatory drugs/paracetamol, non-pharmacological intervention, and intra-articular corticosteroids. The clinicians' selection of analgesic therapy often failed to adequately meet patients' expectations for pain relief. Conclusions: Our findings highlight the current unmet needs of patients with KOA in Italy and call for new approaches to effectively optimize the management of KOA-associated pain. [ABSTRACT FROM AUTHOR]

The global cases of knee osteoarthritis (KOA) are projected to increase by 74.9% by 2050. Currently, over half of patients remain dissatisfied with their pain relief. This review addresses unmet needs for moderate-to-severe KOA pain; it offers evidence and insights for improved management. Italian experts from the fields of rheumatology, physical medicine and rehabilitation, orthopedics, primary care, and pain therapy have identified several key issues. They emphasized the need for standardized care protocols to address inconsistencies in patient management across different specialties. Early diagnosis is crucial, as cartilage responds better to early protective and structural therapies. Faster access to physiatrist evaluation and reimbursement for physical, rehabilitative, and pharmacological treatments, including intra-articular (IA) therapy, could reduce access disparities. Concerns surround the adverse effects of oral pharmacological treatments, highlighting the need for safer alternatives. Patient satisfaction with corticosteroids and hyaluronic acid-based IA therapies reduces over time and there is no consensus on the optimal IA therapy protocol. Surgery should be reserved for severe symptoms and radiographic KOA evidence, as chronic pain post-surgery poses significant societal and economic burdens. The experts advocate for a multidisciplinary approach, promoting interaction and collaboration between specialists and general practitioners, to enhance KOA care and treatment consistency in Italy. [ABSTRACT FROM AUTHOR]

Meaningful progress in improving employment outcomes for people with intellectual and developmental disabilities continues to be elusive, despite 40 years of investment in research, policy, and supports. This article reviews the current state of employment for individuals with intellectual and developmental disabilities (IDD) and describes policy, practice, and individual factors that influence employment outcomes. Research suggests the need for a holistic approach to change that addresses systems-level strategy, policy, and fiscal investment while strengthening individual experiences with employment and related day services. Recommendations address strengthening the implementation of employment policy, developing pathways to employment, and engaging individuals with IDD and, in particular, individuals with diverse social characteristics in reflecting on the quality of their experiences and supports. [ABSTRACT FROM AUTHOR]

Osteoarthritis (OA) is a disease with systemic implications that go beyond joint problems. Its pathogenic mechanisms involve a variety of systemic conditions that contribute to joint damage. These include metabolic dysfunction, chronic low-grade inflammation, neuroplastic pain, and the influence of the central nervous system in the development of neuropathic pain. Besides, OA can negatively affect other aspects of health, such as quality of life, reduced physical activity, social isolation, depression, and anxiety. OA can be considered a complex system in which pathological interactions involve not only obesity and metabolic dysfunction, but also fragility syndrome, sarcopenia, neurological complications, and systemic energy redistribution. Complex systems are composed of multiple interacting and dynamic parts and exhibit emergent properties that cannot be fully explained by examining their individual components. Chronic low-grade inflammation is characteristic of OA, occurring both in the affected joint, and systemically, mainly due to adipose tissue inflammation in obese patients. Obesity is a key factor in the progression of OA, so primary treatment should focus on its control, while maintaining muscle health. The chronic inflammation could lead to changes in energy distribution among the affected joint tissues. Therefore, OA should be approached as a systemic disease, considering individual patient factors, such as genetics, inflammatory response, and lifestyle. Medical care should be more holistic and personalized. Consideration of a name change, such as "systemic OA", could help to move away from the perception of a disease focused only on the joints. [ABSTRACT FROM AUTHOR]

Background: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. Methods: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. Results: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. Conclusion: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA. [ABSTRACT FROM AUTHOR]

Implementing supported and customized employment in all their components is essential for supporting job seekers with disabilities to achieve their career goals. We asked 42 employment consultants in nine employment programs to respond daily to three quick questions about their employment support activities, for 6 months. Through monthly coaching, we helped the managers of these organizations engage their teams of employment consultants to interpret the data, reflect, set goals, and take action for quality improvement. Based on the positive results of this pilot, we recommend that employment consultants be provided with data-enabled feedback that supports decision making and helps them fully implement supported and customized employment as a necessary step toward improving job seekers' employment outcomes. [ABSTRACT FROM AUTHOR]

We investigated the extent to which employment consultants implemented job development practices recommended in the literature when assisting job seekers with intellectual or developmental disabilities. We contacted 83 employment consultants from 25 employment programs in Minnesota and Connecticut. Fifty-nine participants were eligible and completed surveys. We found inconsistencies between the employment consultants' practices and the job development literature in areas such as involvement of family members and acquaintances, observation of job seekers in work and nonwork environments, analyses of employers' needs, development of customized jobs, and assistance with work incentives planning. We recommend a system-wide effort for supporting employment consultants in implementing promising job development practices. This effort needs to involve funding agencies, employment programs, accreditation agencies, training programs, and researchers.

Using logistic and multiple regressions, the authors investigated predictors of employment and postsecondary education outcomes of youth with autism in the Vocational Rehabilitation Program. Data were obtained from the RSA911 data set, fiscal year 2008. Findings showed that the odds of gaining employment were greater for youth who received job placement services, yet only 48% of youth received this service. In addition, postsecondary education was among the strongest predictors of better earnings, yet only 10% of youth received college services. The authors recommended providing job placement services and college services to more youth with autism. At the same time, due to the relatively moderate effect sizes of these regression models, they recommend investigating additional variables currently not included in the RSA911 data set. (Contains 5 tables.)

This article describes a secondary analysis of variables from the National Longitudinal Transition Survey 2 (NLTS-2) database. Specifically, students with intellectual disability (ID) were compared to students with other disabilities regarding post-school transition goals listed on their IEPs/Transition Plans, contacts/referrals made to outside agencies during transition planning, participation of other agencies/organizations in transition planning (e.g., vocational rehabilitation and higher education representatives), and students' postsecondary education and employment outcomes. Students with ID were less likely to have postsecondary education or competitive employment goals and outcomes and more likely to have sheltered and supported employment goals and outcomes compared to students with other disabilities. Contacts with and participation of external professionals in IEP/Transition Plan meetings also differed between the two groups of students. (Contains 3 tables and 1 note.)

This study examined the extent to which employment specialists implemented the job development practices recommended in the research literature when assisting job seekers with intellectual or developmental disabilities. Self-reported data were collected through a Web-based survey from 163 employment specialists from 74 employment programs in 28 states. Questions focused on the following four clusters of activities: getting to know job seekers, finding job openings, engaging employers to hire, and facilitating transition to a job. Findings showed that some employment specialists self-reported practices conflicted with the practices advocated in the literature. On the basis of our findings, we recommended a greater emphasis on implementing job development activities recommended in the literature as well as furthering research on effective, evidence-based practices. (Contains 1 footnote and 3 tables.)

This article describes national trends in outcomes of the vocational rehabilitation (VR) program, with a focus on adults with developmental disabilities during the period of 1995 to 2005. Findings show that the VR program has made substantial progress in excluding extended employment from the array of possible employment closures. Efforts are needed, however, to increase the number of people placed in integrated employment and the earnings at closure while reducing the time frame from application to closure. The study suggests that to achieve these results, practices that lead to above-average outcomes should be identified and disseminated to agencies that show below-average outcomes; the Rehabilitation Act should be rigorously interpreted to prioritize self-sufficiency of VR recipients; and data management should be enhanced through better performance measurement and rapid reporting to state VR agencies. (Contains 2 figures and 1 table.)

BACKGROUND: Ensuring that job seekers with disabilities receive high-quality supported and customized employment services is key for increasing their chances of achieving their career aspirations. OBJECTIVE: To draw attention to the need for better support of employment consultants in the delivery of quality services. METHODS: Nine employment programs piloted ES-Coach, a tool designed to help employment consultants and managers visualize the implementation of supported and customized employment, reflect, set goals, and take action for continuous quality improvement. RESULTS: The nine employment programs invested an estimated 1:19 to 4:10 hours per day on getting to know job seekers, finding jobs, and any other support leading to hire combined. A large amount of their time was invested in administrative activities, ranging from 2:11 to 4:12 hour per day. ES-Coach helped the participants reflect on the quality of their employment support services and set goals for quality improvement. CONCLUSION: Supporting employment consultants with data-enabled feedback is key for improving the quality of supported and customized employment services, a key step toward improving job seekers' employment outcomes. [ABSTRACT FROM AUTHOR]

Background: Early stage of osteoarthritis (OA) is characterized by joint stiffness and pain as well as by subclinical structural changes that may affect cartilage, synovium, and bone. At the moment, the lack of a validated definition of early osteoarthritis (EOA) does not allow to make an early diagnosis and adopt a therapeutic strategy to slow disease progression. Also, no questionnaires are available to evaluate the early stage, and therefore this remains an unmet need. Objective: Therefore, the purpose of the technical experts panel (TEP) of 'International Symposium of intra-articular treatment' (ISIAT) was to create a specific questionnaire to evaluate and monitor the follow-up and clinical progress of patients affected by early knee OA. Design: The items for the Early Osteoarthritis Questionnaire (EOAQ) were identified according to the following steps: items generation, items reduction, and pre-test submission. Methods: During the first step, literature has been reviewed and a comprehensive list of items about pain and function in knee EOA was drafted. Then, during the ISIAT (5th edition 2019), the draft has been discussed by the board, which reformulated, deleted, or subdivided some of the items. After the ISIAT symposium, the draft was submitted to 24 subjects affected by knee OA. A score based on the importance and the frequency was created and the items with a score ⩾0.75 were selected. After intermediate evaluation made by a sample of patients, the second and final version of the questionnaire EOAQ was submitted to the whole board for final analysis and acceptance in a second meeting (29 January 2021). Results: After an exhaustive elaboration, the final version of the questionnaire contains two domains (Clinical Features and Patients Reported Outcome) with respectively 2 and 9 questions, for a total of 11 questions. Questions mainly explored the fields of early symptoms and patients reported outcomes. Marginally, the need of the symptoms treatment and the use of painkillers were investigated. Conclusions: Adoption of diagnostic criteria of early OA is strongly encouraged and a specific questionnaire for the whole management of the clinical features and patients' outcome might really improve the evolution of OA in the early stages of the disease, when the treatment is expected to be more effective. [ABSTRACT FROM AUTHOR]

Blocking pro-inflammation pathways by means of non-steroidal anti-inflammatory drugs (NSAIDs) is routinely used to manage pain and inflammation[2]. The natural combination medicine Traumeel (Tr14) improves resolution of inflammation by promoting the biosynthesis of specialized pro-resolving mediators. For patients with rheumatoid diseases, long-term treatment with disease-modifying anti-rheumatic drugs, such as methotrexate, hydroxychloroquine and sulphasalazine, helps relieve pain and inflammation by general suppression of the immune system. [Extracted from the article]

Hand osteoarthritis is the most common joint condition and is associated with significant morbidity. It is of paramount importance that patients are thoroughly assessed and examined when complaining of hand stiffness, pain, deformity or disability and that the patient's concerns and expectations are addressed by the healthcare professional. In 2019 the American College of Rheumatology and Arthritis Foundation (ACR/AF) produced guidelines which included recommendations for the treatment of hand osteoarthritis. An ESCEO expert working group (including patients) was convened and composed this paper with the aim to assess whether these guidelines were appropriate for the treatment of hand osteoarthritis therapy in Europe and whether they met with the ESCEO patient-centered approach. Indeed, patients are the key stakeholders in healthcare and eliciting the patient's preference is vital in the context of an individual consultation but also for informing research and policy-making. The patients involved in this working group emphasised the often-neglected area of aesthetic changes in hand osteoarthritis, importance of developing pharmacological therapies which can alleviate pain and disability and the need of the freedom to choose which approach (out of pharmacological, surgical or non-pharmacological) they wished to pursue. Following robust appraisal, it was recommended that the ACR/AF guidelines were suitable for a European context (as described within the body of the manuscript) and it was emphasised that patient preferences are key to the success of individual consultations, future research and future policy-making. [ABSTRACT FROM AUTHOR]

People with intellectual disability, autism, and other developmental disabilities have successfully demonstrated their ability to work in the general labor market. Yet, their employment rate remains substantially lower compared with the general population without disabilities. Scaling up the employment outcomes of this population requires improving the effectiveness and efficiency of employment support systems. To this end, this article recommends supporting employment providers rethink how they use their management information systems (MIS): from primary tools that automate billing and compliance to tools that track metrics for continuous quality improvement. As federal and state funding policies are the main factors shaping how MIS are currently used, this article recommends that federal and state policy guidelines be issued that enable employment providers to leverage their MIS to improve effectiveness and efficiency, and thus scale up employment outcomes of job seekers. [ABSTRACT FROM AUTHOR]

Viscosupplementation by intra-articular (i.a.) injection of the non-sulfated glycosaminoglycan (GAG) hyaluronic acid (HA) is a conservative therapy widely accepted in clinical practice for the management of osteoarthritis (OA) and joint diseases. The aim of viscosupplementation is to restore the rheological properties of the synovial fluid to relieve joint inflammation and pain and improve joint function through a chondroprotective effect. However, there is a range of hyaluronic acid products for OA that differ in preparation, molecular weight, rheological characteristics and concentration, and different i.a. formulations are more suited to particular patient populations and clinical situations, in part because of anatomical differences between joints. This paper focuses on innovative hybrid cooperative complexes of high and low molecular weight hyaluronic acid (HA-HL) and hyaluronic acid plus sodium chondroitin (HA-SC) that have been developed. Both products are formulated with pharmaceutical-grade, highly purified hyaluronic acid obtained with a multi-step biofermentation process, with properties that make them suitable across a range of degenerative joint diseases. They represent progress in building on the symptomatic and functional benefits of viscosupplementation in joint disease, with the additional beneficial effect of treating the patient with a high concentration of GAGs by a low number of injections. Here, we review the clinical evidence for the efficacy of a hybrid cooperative compound of HA-HL in various degenerative joint diseases, which suggests a synergistic effect of the different molecular weight hyaluronans that together more closely mimic the physiological composition of synovial fluid. Similarly, the evidence shows that HA-SC is safe, effective, and well tolerated in hip OA, with rapid and clinically significant improvements in pain symptoms and functionality. Such innovations in viscosupplementation expand the usefulness of the modality in the management of OA and other joint diseases, complemented by a lack of systemic or local side effects that allow the concurrent use of other drugs if needed. [ABSTRACT FROM AUTHOR]

BACKGROUND: Over the past decades, researchers have made tremendous progress in identifying standards of practice for supporting job seekers with disabilities achieve their career goals. However, little is known about the actual implementation of these standards, which may affect the quality of services, and thus put job seekers at a higher risk of not fully realizing their career goals. OBJECTIVE: To explore how electronic documentation software could be leveraged to monitor the implementation of national standards in employment supports for quality improvement. METHODS: A panel of three vendors of electronic documentation software shared their experiences at the 2021 Association of People Supporting Employment First (APSE) conference. RESULTS: Most employment programs use their electronic documentation software primarily for billing and compliance reporting. Lack of standard metrics and guidelines are a challenge to leverage technology for quality improvement. CONCLUSIONS: There is a need for standard metrics and guidelines so employment programs can leverage technology for quality improvement of employment services and outcomes. [ABSTRACT FROM AUTHOR]

The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition. The analysis aims to illustrate the peculiarities of the Italian cohort of patients compared with the whole population to provide a more real-life approach to the data for the Italian rheumatologists, ruling out possible local confounding factors. A prospective study for up to 6 months following transition was conducted. Outcome measures of interest include clinical characteristics at time of transition and disease activity scores (Disease Activity Score-28 [DAS28] for RA, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] for axSpA) over time and safety. One-hundred and eleven subjects (out of the 557 in total enrolled in the study) were derived from 8 Italian sites, including 79 with RA and 32 with axSpA. In both cohorts, the efficacy was maintained at 3 months and 6 months from the transition to the biosimilar with no significant change in mean DAS28 and BASDAI scores: at the end of the 6 months of observation the mean DAS28 and BASDAI was similar to baseline (confidence interval [CI] −0.22, 0.22), while the mean variation of the BASDAI was −0.14. Of note, 100.0% (95% CI 89.1, 100.0) in the axSpA and 90.8% (95% CI 81.5, 95.5) in the RA cohort of patients continued to receive SB4 at month 6 (binary variable with 95% Clopper-Pearson CI). Italian patients with stable RA or axSpA who transitioned from originator Etanercept to SB4 maintained clinical response at 6 months post-transition. Both the cohorts are representative of typical patients with long-standing established diagnoses. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition. [ABSTRACT FROM AUTHOR]

Osteoarthritis (OA) is a significant cause of disability. Considering the increasing diffusion of the viscosupplementation (VS) with hyaluronic acid (HA), the International Symposium Intra Articular Treatment (ISIAT) appointed a Technical Expert Panel (TEP) to identify the criteria for successful VS with a specific HA in OA; this through a systematic literature review (SLR), performed following the PRISMA guidelines interrogating Medline, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Grey Matters and American College of Rheumatology (ACR/EULAR) databases and the opinion of international experts. The research included only studies on adults and humans without limitations of language or time of publication. Researchers extracted both quantitative and qualitative data from each study. Mixed Methods Appraisal Tool (MMAT) was used to perform quality analysis for the level of evidence. The SLR retrieved 385 papers, 25 of which were suitable for the analysis. The TEP focused on the different formulations of the product Sinovial® [HA 0.8%, HA 1.6%, HA 2%, 800– 1200 kDa, HA 3.2% (1400– 2100 kDa/65– 110 kDa)]. The choice was due to the vast amount of evidence available. The TEP weighed the evidence in two rounds of a Delphi survey; the results, and any disagreement, were discussed in a final session. Three domains were considered: 1) the patients' characteristics associated with the best results; 2) the contraindications and the conditions linked to increased risk of failure; 3) the clinical conditions in which VS is considered appropriate. The TEP concluded that VS with HA is safe and effective in the treatment of knee and hip OA of grades I to III and that it is possible to undertake VS in other situations (eg grade IV Kellgren-Lawrence – KL); a comprehensive examination of the patient should be performed before the procedure. [ABSTRACT FROM AUTHOR]