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ItemReview article: A primer for clinical researchers in the emergency department: Part XII. Sustainability of improvements in care: An introductionRamsden, V ; Middleton, S ; McInnes, E ; Babl, FE ; Tavender, E (WILEY, 2022-08-02)Despite an increased focus on ways to improve implementation of evidence and de-implementation of practices with no known benefit, there is limited guidance on how to sustain these improvements. This review provides an introduction to sustainability of improvements in care and sustainability research, discussing how to support sustainability in practice and detailing a sustainability research agenda for the emergency medicine setting.
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ItemCryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials)Reade, MC ; Marks, DC ; Howe, B ; McGuinness, S ; Parke, R ; Navarra, L ; Charlewood, R ; Johnson, L ; McQuilten, Z (BMJ PUBLISHING GROUP, 2022-12-01)INTRODUCTION: Cryopreservation at -80°C in dimethylsulphoxide extends platelet shelf-life from 7 days to 2 years. Only limited comparative trial data supports the safety and effectiveness of cryopreserved platelets as a treatment for surgical bleeding. Cryopreserved platelets are not currently registered for civilian use in most countries. METHODS AND ANALYSIS: CLIP-II and CLIPNZ-II are harmonised, blinded, multicentre, randomised, controlled clinical non-inferiority trials comparing bleeding, transfusion, safety and cost outcomes associated with cryopreserved platelets versus conventional liquid platelets as treatment for bleeding in cardiac surgery. CLIP-II is planning to enrol patients in 12 tertiary hospitals in Australia; CLIPNZ-II will recruit in five tertiary hospitals in New Zealand. The trials use near-identical protocols aside from details of cryopreserved platelet preparation. Patients identified preoperatively as being at high risk of requiring a platelet transfusion receive up to three units of study platelets if their treating doctor considers platelet transfusion is indicated. The primary endpoint is blood loss through the surgical drains in the 24 hours following intensive care unit (ICU) admission after surgery. Other endpoints are blood loss at other time points, potential complications, adverse reactions, transfusion and fluid requirement, requirement for procoagulant treatments, time to commencement of postoperative anticoagulants, delay between platelet order and commencement of infusion, need for reoperation, laboratory and point-of-care clotting indices, cost, length of mechanical ventilation, ICU and hospital stay, and mortality. Transfusing 202 (CLIP-II) or 228 (CLIPNZ-II) patients with study platelets will provide 90% power to exclude the possibility of greater than 20% inferiority in the primary endpoint. If cryopreserved platelets are not inferior to liquid-stored platelets, the advantages of longer shelf-life would justify rapid change in clinical practice. Cost-effectiveness analyses will be incorporated into each study such that, should clinical non-inferiority compared with standard care be demonstrated, the hospitals in each country that would benefit most from changing to a cryopreserved platelet blood bank will be known. ETHICS AND DISSEMINATION: CLIP-II was approved by the Austin Health Human Research Ethics Committee (HREC/54406/Austin-2019) and by the Australian Red Cross Lifeblood Ethics Committee (2019#23). CLIPNZ-II was approved by the New Zealand Southern Health and Disability Ethics Committee (21/STH/66). Eligible patients are approached for informed consent at least 1 day prior to surgery. There is no provision for consent provided by a substitute decision-maker. The results of the two trials will be submitted separately for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT03991481 and ACTRN12621000271808.
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ItemContinuous bladder urinary oxygen tension as a new tool to monitor medullary oxygenation in the critically illHu, RT ; Lankadeva, YR ; Yanase, F ; Osawa, EA ; Evans, RG ; Bellomo, R (BMC, 2022-12-16)Acute kidney injury (AKI) is common in the critically ill. Inadequate renal medullary tissue oxygenation has been linked to its pathogenesis. Moreover, renal medullary tissue hypoxia can be detected before biochemical evidence of AKI in large mammalian models of critical illness. This justifies medullary hypoxia as a pathophysiological biomarker for early detection of impending AKI, thereby providing an opportunity to avert its evolution. Evidence from both animal and human studies supports the view that non-invasively measured bladder urinary oxygen tension (PuO2) can provide a reliable estimate of renal medullary tissue oxygen tension (tPO2), which can only be measured invasively. Furthermore, therapies that modify medullary tPO2 produce corresponding changes in bladder PuO2. Clinical studies have shown that bladder PuO2 correlates with cardiac output, and that it increases in response to elevated cardiopulmonary bypass (CPB) flow and mean arterial pressure. Clinical observational studies in patients undergoing cardiac surgery involving CPB have shown that bladder PuO2 has prognostic value for subsequent AKI. Thus, continuous bladder PuO2 holds promise as a new clinical tool for monitoring the adequacy of renal medullary oxygenation, with its implications for the recognition and prevention of medullary hypoxia and thus AKI.
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ItemAustralian Donation and Transplantation Biobank: A Research Biobank Integrated Within a Deceased Organ and Tissue Donation ProgramSharma, VJ ; Starkey, G ; D'Costa, R ; James, F ; Mouhtouris, E ; Davis, L ; Wang, BZ ; Vago, A ; Raman, J ; Mackay, LK ; Opdam, H ; Jones, R ; Grayson, ML ; Martin, DE ; Gordon, CL (LIPPINCOTT WILLIAMS & WILKINS, 2023-01-01)UNLABELLED: We aimed to facilitate the donation of tissue samples for research by establishing a centralized system integrated in the organ donation program for collection, storage, and distribution of samples (the Australian Donation and Transplantation Biobank [ADTB]). METHODS: Feasibility of a research biobank integrated within the deceased organ and tissue donation program was assessed. DonateLife Victoria sought consent for ADTB donation after consent was received for organ donation for transplantation from the donor's senior available next of kin. ADTB samples were collected during donation surgery and distributed fresh to researchers or stored for future research. The main outcome measures were ADTB donation rates, ADTB sample collection, ADTB sample use, and to identify ethical considerations. RESULTS: Over 2 y, samples were collected for the ADTB from 69 donors (28% of 249 donors). Samples were obtained from the spleen (n = 59, 86%), colon (n = 57, 83%), ileum (n = 56, 82%), duodenum (n = 55, 80%), blood (n = 55, 80%), bone marrow (n = 55, 80%), skin (n = 54, 78%), mesenteric lymph nodes (n = 56, 81%), liver (n = 21, 30%), lung (n = 29, 42%), and lung-draining lymph node (n = 29, 42%). Heart (n = 20), breast (n = 1), and lower urinary tract (n = 1) samples were obtained in the second year. Five hundred fifty-six samples were used in 19 ethics-approved research projects spanning the fields of immunology, microbiology, oncology, anatomy, physiology, and surgery. CONCLUSIONS: The integration of routine deceased donation and transplantation activities with a coordinated system for retrieval and allocation of donor samples for use in a range of research projects is feasible and valuable.
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ItemRecently Acquired Blood-borne Virus Infections in Australian Deceased Organ Donors: Estimation of the Residual Risk of Unexpected Transmission.Dutch, MJ ; Seed, CR ; Cheng, A ; Kiely, P ; Patrick, CJ ; Opdam, HI ; Knott, JC (Ovid Technologies (Wolters Kluwer Health), 2023-03)UNLABELLED: Unexpected donor-derived infections of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV are rare but important potential complications of deceased organ transplantation. The prevalence of recently acquired (yield) infections has not been previously described in a national cohort of Australian deceased organ donors. Donor yield infections are of particularly significance, as they can be used to gain insights in the incidence of disease in the donor pool and in turn, estimate the risk of unexpected disease transmission to recipients. METHODS: We conducted a retrospective review of all patients who commenced workup for donation in Australia between 2014 and 2020. Yield cases were defined by having both unreactive serological screening for current or previous infection and reactive nucleic acid testing screening on initial and repeat testing. Incidence was calculated using a yield window estimate and residual risk using the incidence/window period model. RESULTS: The review identified only a single yield infection of HBV in 3724 persons who commenced donation workup. There were no yield cases of HIV or HCV. There were no yield infections in donors with increased viral risk behaviors. The prevalence of HBV, HCV, and HIV was 0.06% (0.01-0.22), 0.00% (0-0.11), and 0.00% (0-0.11), respectively. The residual risk of HBV was estimated to be 0.021% (0.001-0.119). CONCLUSIONS: The prevalence of recently acquired HBV, HCV, and HIV in Australians who commence workup for deceased donation is low. This novel application of yield-case-methodology has produced estimates of unexpected disease transmission which are modest, particularly when contrasted with local average waitlist mortality. Supplemental Visual Abstract; http://links.lww.com/TXD/A503.
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ItemFactors Associated with Long-Term Functional and Psychological Outcomes in Persons with Moderate to Severe Traumatic Brain InjuryKhan, F ; Amatya, B ; Judson, R ; Chung, P ; Truesdale, M ; Elmalik, A ; Galea, MP (Medical Journals Sweden, 2016-05-01)Objective: To examine factors impacting long-term functional and psychological outcomes in persons with moderate-severe traumatic brain injury. Methods: A prospective cross-sectional study (n = 103) assessed the long-term (up to 5 years) impact of traumatic brain injury on participants’ current activity and restriction in participation using validated questionnaires. Results: Participants’ median age was 49. 5 years (interquartile range (IQR) 20. 4–23. 8), the majority were male (77%), and 49% had some form of previous rehabilitation. The common causes of traumatic brain injury were falls (42%) and motor vehicle accidents (27%). Traumatic brain injury-related symptoms were: pain/headache (47%), dizziness (36%), bladder/bowel impairment (34%), and sensory-perceptual deficits (34%). Participants reported minimal change in their physical function and cognition (Functional Assessment Measure: motor (median 102, IQR 93–111) and cognition (median 89, IQR 78–95)). Participants were well-adjusted to community-living; however, they reported high levels of depression. Factors significantly associated with poorer current level of functioning/well-being included: older age (≥ 60 years), presence of traumatic brain injury-related symptoms, a lack of previous rehabilitation and those classified in “severe disability categories” at admission. Caregivers reported high levels of strain and burden (55%). Conclusion: Cognitive and psychosocial problems are more commonly reported than physical disability in the longer-term. A greater focus on participation and ageing with disability in these persons is needed.
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ItemChronic pain in multiple sclerosis: A 10-year longitudinal studyYoung, J ; Amatya, B ; Galea, M ; Khan, F (sevier B.V. on behalf of Scandinavian Association for the Study of Pain, 2017-07-01)BACKGROUND AND PURPOSE: Pain is a common symptom associated with multiple sclerosis (MS), and has lasting effects on an individual's functional capacity and quality of life. A wide range of prevalence rates of pain (between 23% and 90% )have been reported in MS and this is mainly due to the methodological differences amongst the studies such as variability in patient sources, method of sampling and the definition of pain used. Chronic pain in MS, defined as pain lasting for greater than 3-6 months, can have a significant impact on their biopsychosocial health, including negative impact on activities of daily living, relationships and social participation. The long-term course of MS-related pain and its impact in an Australian cohort over a 7-year period has been investigated earlier. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. METHODS: This was a prospective longitudinal study conducted at the Rehabilitation Department of Royal Melbourne Hospital (RMH), a tertiary referral hospital in Victoria and Australia. The source of participants was from the RMH MS database and contains detailed MS patient information including demographic data, diagnosis details (using McDonald's criteria), pain characteristics. Structured face-face interviews and validated measures were used, which include the visual analogue scale (VAS); chronic pain grade (CPG); the assessment of quality of life (AQoL) and the carer strain index (CSI). The mean age of the participants (n=70) was 55.3 years and majority (70%) were female. RESULTS: The mean age of the participants (n=70) was 55.3 years and majority (70%) were female. The findings show that over time (10 years), participants report having greater bilateral bodily pain and greater description of pain as 'worse as it could be'. Pain types were similar to 7-years follow-up but remained higher than baseline. There was a significant deterioration in quality of life in those with more severe CPG over time. Almost half of the participants 31 (44%) required care either from a private carer, institution or from a family member. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment over time and an increase in the use of healthcare services, mainly neurologists and general practitioners. CONCLUSIONS: The pain measures reported by the participants were similar to those at the 7-year follow-up except there was a greater representation of bilateral pain locations (limb, trunk and facial pain) compared to baseline and 7-year follow-up. At 10-year follow-up, more participants used medications compared to 7-year follow-up and there was an increase in the use of health professionals at the 10-year follow-up. At the 10-year follow up QoL of the participants deteriorated significantly and more participants had progressed to higher CPG III and CPG IV. This study demonstrates that chronic pain is a significant issue over time in MS, with clinical and health implications, impact on quality of life, disability and healthcare utilization. IMPLICATIONS: Greater awareness of chronic pain in pwMS, cognitive classifications and an interdisciplinary approach is required to improve long-term patient outcomes and well-being.
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ItemNo Preview AvailableChronic pain in persons with multiple sclerosisAmatya, B ; Young, J ; Galea, M ; Khan, F (Elsevier, 2018-07)Introduction/Background: Pain can be a significant long-term problem for a substantial proportion of persons with multiple sclerosis (pwMS). The aim of this study was to examine the course and impact of chronic pain over a span of 10-years. Material and method: A longitudinal, cross-sectional study assessed pwMS residing in the community at seven and ten years using validated measures: Visual Analogue Scale; Numerical Rating Scale; Chronic Pain Grade (CPG); Assessment of Quality of Life and the Carer Strain Index (CSI). Results: Mean age of the participants (n = 70) was 59.8 ± 9 years (range: 39–74 years) and majority (70%) were female. The findings show that over 10-year period, majority report bilateral lower limb dysesthesia (40%), mixed pain (35.2%) and widespread pain (17.1%). There was a significant deterioration in quality of life (QoL) in those with more severe CPG. Almost half of the participants (44%) required care either from a private carer/family or institution. The carers (n = 13) reported higher carer strain (mean CSI = 5.2), with over half reporting sleep disturbance, inconvenience, physical strains, family and personal constraints. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment and healthcare services, mainly neurologists and general practitioners over time. Conclusion: This study demonstrates that persistent chronic pain is a significant issue over time in pwMS, with clinical and health implications, poorer QoL, and increased healthcare utilisation. Greater awareness of chronic pain in pwMS and interdisciplinary approach is required to improve long-term patient outcomes and well-being.
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ItemInterdisciplinary management for chronic pain in central neurological disorders: a retrospective studyYoung, J ; Mantopoulos, S ; Blanchard, M ; Tardif, H ; Hogg, M ; Khan, F ; Galea, MP (Mark Allen Healthcare, 2020-01-02)Background/aims: Chronic pain in central neurological disorders is common and the current management of chronic pain is through an interdisciplinary approach. The aim of this study was to compare outpatient interdisciplinary-based treatment for chronic pain in patients with central neurological disorders to those without central neurological disorders. Methods: This was a retrospective study and pain-related outcome measures were collected from a clinical outcomes registry (electronic Persistent Pain Outcomes Collaboration). This registry contained data on people who attended a pain management service who, for the purpose of this study, were categorised into those with a central neurological disorder and those without a central neurological disorder. The two sample t-test was used to determine the significance of the difference between the groups and statistical significance was defined as P<0.05. Outcome measures compared included the Brief Pain Inventory, Depression, Anxiety and Stress Scale 21, Patient Self-efficacy Questionnaire and Patient Catastrophisation Scale. Results: There was a total of 1924 participants with a central neurological disorder. The electronic Persistent Pain Outcomes Collaboration registry shows that after engagement with an interdisciplinary pain management service, there was a reduction in pain severity scores, interference, mean depression, anxiety and stress in both groups at end of an episode of care compared to referral. There was a significant difference in mean changes for pain catastrophising between those with a central neurological disorder (−10.3) and those without (−7.8). Conclusions: This study shows that people with central neurological disorders can also benefit from interdisciplinary management and have similar results to those without these conditions.
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ItemThe Effect of Transcranial Direct Current Stimulation on Chronic Neuropathic Pain in Patients with Multiple Sclerosis: Randomized Controlled TrialYoung, J ; Zoghi, M ; Khan, F ; Galea, MP (OXFORD UNIV PRESS, 2020-12-01)OBJECTIVE: Chronic neuropathic pain is a common symptom in multiple sclerosis (MS). This randomized controlled single-blinded study investigated whether a new protocol involving five days of transcranial direct current stimulation (tDCS) with an interval period would be effective to reduce pain using the visual analog scale (VAS). Other secondary outcomes included the Neuropathic Pain Scale (NPS), Depression Anxiety Stress Score (DASS), Short Form McGill Pain Questionnaire (SFMPQ), and Multiple Sclerosis Quality of Life 54 (MSQOL54). DESIGN: A total of 30 participants were recruited for the study, with 15 participants randomized to a sham group or and 15 randomized to an active group. After a five-day course of a-tDCS, VAS and NPS scores were measured daily and then weekly after treatment up to four weeks after treatment. Secondary outcomes were measured pretreatment and then weekly up to four weeks. RESULTS: After a five-day course of a-tDCS, VAS scores were significantly reduced compared with sham tDCS and remained significantly low up to week 2 post-treatment. There were no statistically significant mean changes in MSQOL54, SFMPQ, NPS, or DASS for the sham or treatment group before treatment or at four-week follow-up. CONCLUSIONS: This study shows that repeated stimulation with a-tDCS for five days can reduce pain intensity for a prolonged period in patients with MS who have chronic neuropathic pain.