Effects of a Single Intra-Articular Injection of a Microsphere-Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study

Background: Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. Methods: In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit. Results: The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: −3.12 versus −2.14; p < 0.0001) indicating ∼50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p < 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ≤ 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments. Conclusions: FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point)

Effects of methods of descending stairs forwards versus backwards on knee joint force in patients with osteoarthritis of the knee: a clinical controlled study

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to investigate the kinetic characteristics of compensatory backward descending movement performed by patients with osteoarthritis of the knee.</p> <p>Methods</p> <p>Using a three-dimensional motion analysis system, we investigated lower extremity joint angles, joint moments, joint force of the support leg in forward and backward descending movements on stairs, and joint force of the leading leg at landing in 7 female patients with osteoarthritis of the knee.</p> <p>Results</p> <p>Compared with the forward descending movement, knee joint angle, joint moment and joint force of the support leg all decreased in the backward descending movement. Joint force of the leading leg at landing was also reduced in the backward descending movement. In addition, we confirmed that the center of body mass was mainly controlled by the knee and ankle joints in the forward descending movement, and by the hip joint in the backward descending movement.</p> <p>Conclusions</p> <p>Since it has been reported that knee flexion angle and extensor muscle strength are decreased in patients with osteoarthritis of the knee, we believe that backward descending movement is an effective method to use the hip joint to compensate forthese functional defects. In addition, due to the decreased knee joint force both in the leading and support legs in backward descending movement, the effectiveness of compensatory motion for pain control and knee joint protection was also suggested.</p

Development of a patient-centred intervention to improve knowledge and understanding of antibiotic therapy in secondary care.

Background: We developed a personalised antimicrobial information module co-designed with patients. This study aimed to evaluate the potential impact of this patient-centred intervention on short-term knowledge and understanding of antimicrobial therapy in secondary care. Methods: Thirty previous patients who had received antibiotics in hospital within 12 months were recruited to co-design an intervention to promote patient engagement with infection management. Two workshops, containing five focus-groups were held. These were audio-recorded. Data were analysed using a thematic framework developed deductively based on previous work. Line-by-line coding was performed with new themes added to the framework by two researchers. This was used to inform the development of a patient information module, embedded within an electronic decision support tool (CDSS).The intervention was piloted over a four-week period at Imperial College Healthcare NHS Trust on 30 in-patients. Pre- and post-intervention questionnaires were developed and implemented to assess short term changes in patient knowledge and understanding and provide feedback on the intervention. Data were analysed using SPSS and NVIVO software. Results: Within the workshops, there was consistency in identified themes. The participants agreed upon and co-designed a personalised PDF document that could be integrated into an electronic CDSS to be used by healthcare professionals at the point-of-care. Their aim for the tool was to provide individualised practical information, signpost to reputable information sources, and enhance communication between patients and healthcare professionals.Eighteen out of thirty in-patients consented to participant in the pilot evaluation with 15/18(83%) completing the study. Median (range) age was 66(22-85) years. The majority were male (10/15;66%). Pre-intervention, patients reported desiring further information regarding their infections and antibiotic therapy, including side effects of treatment. Deployment of the intervention improved short term knowledge and understanding of individuals infections and antibiotic management with median (IQR) scores improving from 3(2-5)/13 to 10(6-11)/13. 13/15(87%) reported that they would use the intervention again. Conclusion: A personalised, patient-centred intervention improved understanding and short-term knowledge of infections and antibiotic therapy in participating patients'. Long term impact on attitudes and behaviours post discharge will be further investigated

Mapping the decision pathways of acute infection management in secondary care among UK medical physicians: a qualitative study.

BACKGROUND: The inappropriate use of antimicrobials drives antimicrobial resistance. We conducted a study to map physician decision-making processes for acute infection management in secondary care to identify potential targets for quality improvement interventions. METHODS: Physicians newly qualified to consultant level participated in semi-structured interviews. Interviews were audio recorded and transcribed verbatim for analysis using NVIVO11.0 software. Grounded theory methodology was applied. Analytical categories were created using constant comparison approach to the data and participants were recruited to the study until thematic saturation was reached. RESULTS: Twenty physicians were interviewed. The decision pathway for the management of acute infections follows a Bayesian-like step-wise approach, with information processed and systematically added to prior assumptions to guide management. The main emerging themes identified as determinants of the decision-making of individual physicians were (1) perceptions of providing 'optimal' care for the patient with infection by providing rapid and often intravenous therapy; (2) perceptions that stopping/de-escalating therapy was a senior doctor decision with junior trainees not expected to contribute; and (3) expectation of interactions with local guidelines and microbiology service advice. Feedback on review of junior doctor prescribing decisions was often lacking, causing frustration and confusion on appropriate practice within this cohort. CONCLUSION: Interventions to improve infection management must incorporate mechanisms to promote distribution of responsibility for decisions made. The disparity between expectations of prescribers to start but not review/stop therapy must be urgently addressed with mechanisms to improve communication and feedback to junior prescribers to facilitate their continued development as prudent antimicrobial prescribers

Current concept review: quality and process improvement in orthopedics

Stephen J Pinney,1 Alexandra E Page,2 David S Jevsevar,3 Kevin J Bozic4 1Department of Orthopaedic Surgery, St Mary&#39;s Medical Center, San Francisco, CA, USA; 2Orthopaedic Surgery, AAOS Health Care Systems Committee, San Diego, CA, USA; 3Department of Orthopaedics, Geisel School of Medicine, Dartmouth University, Hanover, NH, USA; 4Department of Surgery and Perioperative Care, Dell Medical School at the University of Texas, Austin, TX, USAAbstract: Multiple health care stakeholders are increasingly scrutinizing musculoskeletal care to optimize quality and cost efficiency. This has led to greater emphasis on quality and process improvement. There is a robust set of business strategies that are increasingly being applied to health care delivery. These quality and process improvement tools (QPITs) have specific applications to segments of, or the entire episode of, patient care. In the rapidly changing health care world, it will behoove all orthopedic surgeons to have an understanding of the manner in which care delivery processes can be evaluated and improved. Many of the commonly used QPITs, including checklist initiatives, standardized clinical care pathways, lean methodology, six sigma strategies, and total quality management, embrace basic principles of quality improvement. These principles include focusing on outcomes, optimizing communication among health care team members, increasing process standardization, and decreasing process variation. This review summarizes the common QPITs, including how and when they might be employed to improve care delivery. Keywords: clinical care pathway, musculoskeletal care, outcomes, quality management, six sigma, lean thinkin