Diabetic kidney disease (DKD) is a common complication of diabetes mellitus (DM) that may not be diagnosed until later stages of disease. Ways to improve non-invasive screening for DKD are desirable. Kidney cell exfoliation into urine is an active process, which may generate significant information regarding an individual's kidney status. Proximal tubule cell (PTC) exfoliation could also be useful within the DM context as glucose entry into PTCs is insulin independent, making PTCs particularly sensitive to hyperglycemia in diabetic conditions.
PURPOSE:There remains no standard of care for patients with recurrent and chemorefractory glioblastoma. Re-irradiation (reRT) provides an additional management option. However, published series predominantly focus on small reRT volumes utilizing stereotactic hypofractionated regimens. Concerns regarding toxicity have limited utilisation of reRT for larger recurrences, however this may be mitigated with use of bevacizumab (BEV). METHODS AND MATERIALS:A prospective database of patients managed with the EORTC-NCIC (Stupp) protocol 60 Gy chemoradiotherapy protocol for glioblastoma between 2007 and 2021 was reviewed for those patients receiving reRT for chemorefractory relapse. Serial MRI and PET were used to establish true progression and exclude patients with pseudoprogression or radionecrosis from reRT. The primary endpoint was overall survival (OS) from date of reRT. Prognostic factors were also assessed. RESULTS:447 patients managed for glioblastoma under the Stupp protocol were identified, of which 372 had relapsed and were thus eligible for reRT. 71 patients underwent reRT. Median relapse-free survival from diagnosis for the reRT and overall cohorts were similar at 11.6 months (95%CI:9.4-14.2) and 11.8 months (95%CI:9.4-14.2) respectively. 60/71 (85%) reRT patients had received BEV prior to reRT and continued concurrent BEV during reRT. Of the 11 patients not managed with BEV during reRT, 10 required subsequent salvage BEV. ReRT patients were younger (median 53 vs. 59 years, p < 0.001), had better performance status (86% vs. 69% ECOG 0-1, p = 0.002) and more commonly had MGMT promoter-methylated tumours (54% vs. 40%, p = 0.083) compared to non-reRT patients. Median reRT PTV volume was 135cm3 (IQR: 69-207cm3). Median OS from reRT to death was 7.1 months (95%CI:6.3-7.9). Patients aged < 50, 50-70 and > 70 years had post-reRT median OS of 7.7, 6.4 and 6.0 months respectively (p = 0.021). Median post-reRT survival was longer for patients with ECOG performance status 0-1 compared to 2-3 (8.1 vs. 6.3 months, p = 0.039). PTV volume, site of relapse, MGMT promoter-methylation status and extent of initial surgical resection were not associated with post-reRT survival. ReRT was well-tolerated. Out of the 6 patients (8%) admitted to hospital after reRT, only one was for reRT toxicity. This was a CTCAE grade 3 radiation necrosis event in a patient managed without prior BEV. CONCLUSION:Patients with recurrent glioblastoma who have been previously treated with 60 Gy radiotherapy have a meaningful survival benefit from large volume re-irradiation which is well tolerated. ReRT should not be ignored as a salvage treatment option in patients with chemorefractory progressive disease.
Introduction Knee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate sodium (PPS) is chondroprotective and could have anti-inflammatory effects in knee OA. This study aims to explore the efficacy and safety of oral PPS in symptomatic knee OA with dyslipidaemia.Methods and analysis MaRVeL is a phase II, single-centre, parallel, superiority trial which will be conducted at Royal North Shore Hospital, Sydney, Australia. 92 participants (46 per arm) aged 40 and over with painful knee OA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) will be recruited from the community and randomly allocated to receive two cycles of either oral PPS or placebo for 5 weeks starting at baseline and week 11. Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life and other structural changes. A biostatistician blinded to allocation groups will perform the statistical analysis according to the intention-to-treat principle.Ethics and dissemination The protocol has been approved by the NSLHD Human Research Ethics Committee (HREC) (2021/ETH00315). All participants will provide written informed consent online. Study results will be disseminated through conferences, social media and academic publications.Trial registration numbers Australian New Zealand Clinical Trial Registry (ACTRN12621000654853); U1111-1265-3750.
Forty-four of 50 immunology patients with primary or secondary immunodeficiency receiving intravenous immunoglobulin at a hospital in New South Wales, Australia, were rapidly enrolled in the subcutaneous immunoglobulin (SCIg) programme at the onset of the 2020 COVID-19 pandemic. Health and economic outcomes demonstrated that SCIg provides clinical efficacy as evidenced by the number of infections and maintenance of IgG levels, and also facilitates cost reduction in immunoglobulin maintenance programmes.
Background:Distal clavicle excision for acromioclavicular joint (ACJ) pathology is currently the mainstay of surgical management in patients with symptoms refractory to nonoperative treatment. There have been few high quality studies outlining the efficacy of arthroscopic excision of the distal clavicle as a single procedure in patients with isolated disease.Aim:To characterize function and pain outcomes in patients undergoing arthroscopic distal clavicle excision by utilizing stringent inclusion criteria to isolate ACJ pathology.Methods:Prospective data collection was undertaken with a minimum two year follow-up of 59 patients undergoing arthroscopic distal clavicle excision for ACJ osteoarthritis or distal clavicle osteolysis. Stringent eligibility criteria were applied to each patient. Data collection consisted of demographic data, clinical assessment of range of motion, and patient-reported outcome measures (PROMs), utilizing the standardized Shoulder Pain and Disability Index (SPADI) and the Visual Analogue (VAS) score to characterize pain. Furthermore, time to return to work and sport and a subjective measure of how 'normal' the shoulder felt were assessed. Data was recorded preoperatively, and at six, 12, and 24 months postoperatively. Statistical analysis was conducted utilizing institutional support.Results:Statistically significant improvements in range of motion measurements (abduction, forward elevation and external rotation), and PROMs (SPADI and VAS scores) were reported. VAS scores reduced from an average of 8.20 preoperatively to 3.39 (P < .001), 2.13 (P < .001) and 1.36 (P < .001) at 6, 12, and 24 month follow-up, respectively. Similarly, SPADI scores reduced from an average of 62.65 preoperatively to 19.96 (P < .001), 12.6 (P < .001), and 6.13 (P < .001) at 6, 12, and 24 months, respectively. The majority of patients were able to return to sport and work, within an average time of 1.72 and 3.02 months.Conclusion:In patients who presented with isolated ACJ pathology, arthroscopic distal clavicle excision, as a single procedure, results in statistically significant improvements in PROMs and functional outcomes.
Importance:Digital technology represents an opportunity to improve outcomes following total knee replacement (TKR). Digitally delivered interventions have been shown to be similar to face-to-face interventions and to increase participation levels in people with osteoarthritis. Objective:To assess the effect of a digital technology package in reducing pain compared with usual care following TKR. Design, Setting, and Participants:This randomized clinical trial recruited 102 adults after they received TKR in 3 rehabilitation hospitals in Sydney, Australia, between June 2020 and July 2021. Interventions:All participants underwent usual care. In addition to usual care, 51 participants received a digital technology package consisting of an exercise app, fitness tracker, and online health coaching. In the usual care group, 51 participants received a fitness tracker but with all notifications turned off and goals for step count, sleep, and active hours removed. Participants were followed up for 12 months (June 2021 to July 2022). Main Outcome and Measures:The primary outcome was mean knee pain during the past week assessed using a numerical rating scale (range, 0-10, with 10 indicating worst possible pain) at 3 months. In unadjusted analyses, considered primary and based on multiple imputations, independent t tests were used to compare means between groups. Secondary outcomes, including measures of function, activity participation, and quality of life, were analyzed using a generalized estimating equation model that accounted for repeated measurements. Results:Of 102 participants (mean [SD] age, 67.9 [7.2] years; 68 [67%] female; and 92 [90%] White) randomly assigned to intervention or usual care groups, 47 (92%) in each group completed the 3-month follow up. At 3 months, participants in the intervention group demonstrated small but not clinically meaningful improvements in pain compared with the usual care group in the unadjusted intention-to-treat analysis (mean difference, -0.84; 95% CI, -1.59 to -0.10; P = .03). Secondary outcomes indicated a statistically significant reduction in pain intensity, (mean difference, -0.94; 95% CI, -1.82 to -0.06), pain disability (mean difference, -5.42; 95% CI, -10.00 to -0.83), and sedentary behavior (mean difference, -9.76; 95% CI, -19.17 to -0.34) favoring the intervention from baseline to 3, 6, and 12 months. Conclusions and Relevance:In this randomized clinical trial, a combined digital technology program provided small but not clinically meaningful improvements in pain at 3 months and other longer-term favorable outcomes following TKR compared with usual care. Future studies should tailor digital interventions based on participants' abilities and preferences to ensure that the intervention is appropriate and fosters long-term self-management. Trial Registration:Anzctr.org.au Identifier: ACTRN12618001448235.
AIMS:To compare (a) the change in radiological bony morphology between participants with femoroacetabular impingement (FAI) syndrome who underwent arthroscopic hip surgery compared to physiotherapist-led non-surgical care and (b) the change in radiological bony morphology between participants with FAI syndrome who underwent arthroscopic hip surgery involving cam resection or acetabular rim trimming or combined cam resection and acetabular rim trimming.METHODS:Maximum alpha angle measurements on magnetic resonance imaging and Hip2 Norm standardized hip measurements on radiographs were recorded at baseline and at 12 months postoperatively. One-way analysis of covariance and independent T tests were conducted between participants who underwent arthroscopic hip surgery and physiotherapist-led non-surgical care. Independent T tests and analysis of variance were conducted between participants who underwent the 3 different arthroscopic hip procedures.RESULTS:Arthroscopic hip surgery resulted in significant improvements to mean alpha angle measurements (decreased from 70.8° to 62.1°) (P value < .001, 95% CI -11.776, -4.772), lateral center edge angle (LCEA) (P value = .030, 95% CI -3.403, -0.180) and extrusion index (P value = 0.002, 95% CI 0.882, 3.968) compared to physiotherapist-led management. Mean maximum 1-year postoperative alpha angle was 59.0° (P value = .003, 95% CI 4.845, 18.768) for participants who underwent isolated cam resection. Measurements comparing the 3 different arthroscopic hip procedures only differed in total femoral head coverage (F[2,37] = 3.470, P = .042).CONCLUSION:Arthroscopic hip surgery resulted in statistically significant improvements to LCEA, extrusion index and alpha angle as compared to physiotherapist-led management. Measured outcomes between participants who underwent cam resection and/or acetabular rim trimming only differed in total femoral head coverage.
OBJECTIVE:The objectives of this study are to ascertain the determinants of quality of life (QoL) and hand function among persons with hand osteoarthritis (OA) and to assess the influence of hand function on QoL among persons with OA.METHODOLOGY:Two hundred and four participants in a clinical trial completed the baseline assessment. Demographic, socioeconomic, QoL (AqoL-4D), hand function (Functional Index for Hand Osteoarthritis, FIHOA), pain assessment, radiographic and clinical characteristics of participants were measured using standard methods. Univariate and multivariate analyses were performed to evaluate potential associations.RESULTS:We studied 204 participants (76% female, age 65.63 ± 8.13 years, body mass index 28.7 ± 6.5 kg/m2 ) with hand OA. The mean pain score of the participants on a visual analog scale was 57.8 (SD ±13.6). There was a significant, negative moderate correlation between hand function and QoL scores except for the sense domain score. Global assessment, household income and serious illness were associated with QoL (P < .001) and explained 18% of the variance of the QoL. Pain scale, Patient Global Assessment, Mental Health Score, grip strength and cyst index were associated with hand function score and explained 26% of the variance of hand function.CONCLUSION:The results indicate increasing impairment in hand function decreases the QoL of persons with hand OA. Some determinants were significantly associated with hand function and QoL. Determinants related to hand functions may be modifiable. In future, appropriate intervention strategies should be implemented, and further studies should be conducted to identify the effectiveness of those interventions.