المؤلفون: Seng Khee Gan, Roslyn J. Francis, Gerald F. Watts, Joshua R. Lewis, William Macdonald, Alistair Vickery, Michael Phillips, Gerard T. Chew, Carl Schultz, Sing Ching Lee, Jamie W Bellinge

المصدر: Journal of Nuclear Cardiology. 29:1855-1866

مصطلحات موضوعية: medicine.medical_specialty, business.industry, Type 2 diabetes, 030204 cardiovascular system & hematology, medicine.disease, Placebo, Gastroenterology, 030218 nuclear medicine & medical imaging, law.invention, 03 medical and health sciences, chemistry.chemical_compound, Arterial calcification, 0302 clinical medicine, chemistry, Randomized controlled trial, law, Diabetes mellitus, Internal medicine, Medicine, Colchicine, Radiology, Nuclear Medicine and imaging, Cardiology and Cardiovascular Medicine, business, Adverse effect, Calcification

الوصف: There is currently no treatment for attenuating progression of arterial calcification. 18F-sodium fluoride positron emission tomography (18F-NaF PET) locates regions of calcification activity. We tested whether vitamin-K1 or colchicine affected arterial calcification activity. 154 patients with diabetes mellitus and coronary calcification, as detected using computed tomography (CT), were randomized to one of four treatment groups (placebo/placebo, vitamin-K1 [10 mg/day]/placebo, colchicine [0.5 mg/day]/placebo, vitamin-K1 [10 mg/day]/ colchicine [0.5 mg/day]) in a double-blind, placebo-controlled 2x2 factorial trial of three months duration. Change in coronary calcification activity was estimated as a change in coronary maximum tissue-to-background ratio (TBRmax) on 18F-NaF PET. 149 subjects completed follow-up (vitamin-K1: placebo = 73:76 and colchicine: placebo = 73:76). Neither vitamin-K1 nor colchicine had a statistically significant effect on the coronary TBRmax compared with placebo (mean difference for treatment groups 0·00 ± 0·16 and 0·01 ± 0·17, respectively, p > 0.05). There were no serious adverse effects reported with colchicine or vitamin-K1. In patients with type 2 diabetes, neither vitamin-K1 nor colchicine significantly decreases coronary calcification activity, as estimated by 18F-NaF PET, over a period of 3 months. Clinical trial registration: ACTRN12616000024448.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::42453e20b80449847ccbd8cfc20f7db0Test
https://doi.org/10.1007/s12350-021-02589-8Test

المؤلفون: David Whyatt, Mei Ruu Kok, Matthew Tuson, Berwin Turlach, M. J. Yap, Alistair Vickery, Bryan Boruff

المصدر: Emergency Medicine Australasia. 33:794-802

مصطلحات موضوعية: Multivariate statistics, Evidence-based practice, business.industry, Australia, Psychological intervention, 030208 emergency & critical care medicine, Western Australia, Emergency department, Unit (housing), 03 medical and health sciences, Modifiable areal unit problem, 0302 clinical medicine, Covariate, Statistics, Emergency Medicine, Humans, Medicine, 030212 general & internal medicine, Emergency Service, Hospital, business

الوصف: OBJECTIVE To examine the impact of the modifiable areal unit problem (MAUP) in an investigation of factors associated with ED demand in Perth, Western Australia, in 2016. Furthermore, to advocate a means of avoiding this impact. METHODS ED presentations were classified as: urgent medical, non-urgent medical, urgent trauma or non-urgent trauma. In each group, sex-stratified, age-adjusted multivariate associations with socio-economic status and distance to the nearest ED and general practitioner (GP) were estimated. Modelling was undertaken using different sets of spatial units: Australian Bureau of Statistics (ABS) Statistical Areas Level 1 (SA1s) and numerous aggregate-level zonations of SA1s (ABS SA2s and others). RESULTS Estimates obtained using the different units often varied widely: for seven (30%) of 24 strata defined by combinations of sex, ED type and covariate, the smallest and largest effect sizes differed in terms of direction; further, for 11 (65%) of the remaining 17 strata, the largest effect size was at least twice as high as the smallest. This demonstrates the MAUP's impact and that analyses based on a single set of spatial units are unreliable. To resolve the observed variation, we highlight the SA1-level estimates. CONCLUSIONS When formulating interventions targeting reduced ED utilisation, policy planners should be guided by evidence based on analysis of appropriate spatial units. This ideal is undermined by the widespread lack of acknowledgement of the MAUP in studies examining drivers of ED demand using spatially aggregated data. To avoid the MAUP, only estimates obtained through examining a minimal geographic unit should be relied upon.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c39fb7c78069f01871b94ccc51073e5Test
https://doi.org/10.1111/1742-6723.13727Test

المؤلفون: Phillip M. Finch, Alistair Vickery

المصدر: Internal Medicine Journal. 50:1326-1332

مصطلحات موضوعية: medicine.medical_specialty, Cannabinoid receptor, medicine.medical_treatment, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Internal Medicine, medicine, Cannabidiol, Humans, Dronabinol, 030212 general & internal medicine, Child, Adverse effect, Intensive care medicine, Cannabis, biology, Cannabinoids, business.industry, Australia, Chronic pain, medicine.disease, biology.organism_classification, Anxiety, Cannabinoid, Chronic Pain, medicine.symptom, business, medicine.drug, Chemotherapy-induced nausea and vomiting

الوصف: Cannabis has been used as a medicine for millennia. Prohibition in the mid-20th century precluded early scientific investigation. 'Cannabis' describes three separate forms - herbal cannabis, 'hemp' products, pharmaceutical-grade regulated cannabinoid-based medical products (CBMP). In Australia, CBMP became available for prescription in November 2016. Herbal cannabis with Δ9-tetrahydrocannabinol (THC), which is illegal, and cannabidiol (CBD) in herbal extracts, are both unregulated and unreliable sources of cannabinoids. The endocannabinoid system (ECS), delineated in the late 1990s, has increased the understanding and interest in research for appropriate clinical indications. The ubiquitous ECS has homeostatic and anti-inflammatory effects and comprises cannabinoid receptors, endocannabinoids and degrading enzymes. Phytocannabinoids are partial agonists of the ECS. In pre-clinical studies, THC and CBD produce beneficial effects in chronic pain, anxiety, sleep and inflammation. Systematic reviews often conflate herbal cannabis and CBMP, confusing the evidence. Currently large randomised controlled trials are unlikely to be achieved. Other methodologies with quality end-points are required. Rich, valuable high-quality real-world evidence for the safe and effective use of CBMP provides an opportunity to examine benefits and potential harms. Evidence demonstrates benefit of CBMP in multiple sclerosis, chronic neuropathic pain, chemotherapy induced nausea and vomiting, resistant paediatric epilepsy, anxiety and insomnia. CBMP are well tolerated with few serious adverse events. Additional clinical benefits are promising in many other resistant chronic conditions. Pharmaceutical grade prescribed CBMP has proven clinical benefits and provides another clinical option in the physician's pharmacopeia.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4beff1bde335dc5834f72c1c7bd3faf5Test
https://doi.org/10.1111/imj.15052Test

المؤلفون: David Mountain, Emma Haynes, Matthew Tuson, Alistair Vickery, David Whyatt, Yusuf Nagree

المصدر: Emergency Medicine Australasia. 31:780-786

مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Adolescent, Cross-sectional study, Primary health care, Psychological intervention, Primary care, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, General Practitioners, Humans, Medicine, 030212 general & internal medicine, Child, Health Services Needs and Demand, Primary Health Care, business.industry, Health services research, 030208 emergency & critical care medicine, Western Australia, Emergency department, Middle Aged, Cross-Sectional Studies, Family medicine, General practice, Cohort, Emergency Medicine, Female, Emergency Service, Hospital, business

الوصف: Objective To compare methods of assessment of the burden of primary care-type ED (PCTED) presentations against clinical assessment by general practitioners (GPs) in ED. Methods A cross-sectional study involving clinical assessment of patients presenting to four EDs in Western Australia. The GPs assessed patients who were likely to be discharged home from ED, and considered whether they could be managed in general practice. Patient presentations were defined by the GPs as: PCTED; PCTED if additional primary care resources were available; or not PCTED. Results GP researchers determined that 80% of patients assessed were PCTED presentations, with one-third of these considered PCTED presentations if additional resources were available. A high proportion of identified PCTED presentations included categories excluded by previous methods. Analysis of linked data found the cohort assessed to be of lower urgency, younger, and with a shorter length of stay than the average patient being discharged from ED. After accounting for potential bias, it is suggested that 20-40% of all ED presentations could be PCTED presentations. Conclusions Previous methods determining the burden of PCTED presentations have not been validated. Many presentations excluded by previous methods were identified as manageable in general practice by GPs clinically assessing patients in ED. Improved validation of criteria used to identify PCTED presentations will enable appropriately designed interventions to reduce such events.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5154c3d876277129e5c66f5e63a6b805Test
https://doi.org/10.1111/1742-6723.13255Test

المؤلفون: Tiew-Hwa Katherine Teng, Matthew Knuiman, Judith M. Katzenellenbogen, Joseph Hung, Frank M Sanfilippo, Alistair Vickery, Qun Mai, Sandra C. Thompson, Elizabeth Geelhoed, Anthony S. Gunnell

المصدر: International Journal for Equity in Health, Vol 17, Iss 1, Pp 1-11 (2018)
International Journal for Equity in Health

مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Native Hawaiian or Other Pacific Islander, Health care disparity, Population, Myocardial Ischemia, Aboriginal health, 030204 cardiovascular system & hematology, Medicare, Health Services Accessibility, 03 medical and health sciences, 0302 clinical medicine, Health care, medicine, Humans, 030212 general & internal medicine, education, Referral and Consultation, Health policy, Aged, Primary health care, education.field_of_study, Ischaemic heart disease, Shared care, business.industry, Health Policy, Public health, Research, lcsh:Public aspects of medicine, Public Health, Environmental and Occupational Health, Health services research, Australia, lcsh:RA1-1270, Emergency department, Middle Aged, medicine.disease, United States, 3. Good health, Administrative datasets, Hospitalization, Emergency medicine, Female, business, Kidney disease, Indigenous health services

الوصف: Background Ischaemic heart disease (IHD) remains the leading cause of morbidity and mortality for both Aboriginal and non-Aboriginal Australians. Patterns of primary and specialist care in patients leading up to the first hospitalisation for IHD potentially impact on prevention and subsequent outcomes. We investigated the differences in general practice (GP), specialist and emergency department (ED) consultations, and associated resource use in Aboriginal and non-Aboriginal people in the two years preceding hospitalisation for IHD. Methods Linked-data were used to identify first IHD admissions for Western Australians aged 25–74 years in 2002–2007. Person-linked GP, specialist and ED consultations were obtained from the Medicare Benefits Schedule (MBS) and ED records to assess health care access and costs for the preceding 2 years. Results Aboriginal people constituted 4.7% of 27,230 IHD patients, 3.5% of 1,348,238 MBS records, and 14% of 33,170 ED presentations. Aboriginal (vs. non-Aboriginal) people were younger (mean 50.2 vs 60.5 years), more commonly women (45.2% vs 28.4%), had more comorbidities [Charlson index≥1, 35.2% vs 26.3%], were more likely to have had GP visits (adjusted rate-ratio 1.07, 95% CI 1.02–1.12), long/prolonged (16.0% vs 11.9%) consults and non-vocationally registered GP consults (17.1% vs 3.2%), but less likely to received specialist consults (mean 1.0 vs 4.1). Mean number of urgent/semi-urgent ED presentations in the year preceding the IHD admission was higher in Aboriginal people (2.9 vs 1.9). Aboriginal people incurred 2.7% of total associated MBS expenditure (estimated at $59.7 million). Mean total cost per person was 43.3% lower in Aboriginal patients, with cost differentials being greatest in diabetic and chronic kidney disease patients. Conclusions Despite being over-represented in urgent/semi-urgent ED presentations and admissions for IHD, Aboriginal people were under-resourced compared with the rest of the population, particularly in terms of specialist care prior to first IHD hospitalisation. The findings underscore the need for better primary and specialist shared care delivery models particularly for Aboriginal people.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5f7cafb62ae78e73f75074b9110dea5Test
http://link.springer.com/article/10.1186/s12939-018-0826-9Test

المؤلفون: David R. Sullivan, Cristian Vargas-Garcia, Tom Brett, Gerald F. Watts, Carmen Condon, Jan Radford, Dick C. Chan, Clare Heal, Alistair Vickery, Gerard Gill, Charlotte Hespe, Ian Li, Jing Pang, Barbara Sheil, Diane Arnold-Reed

المصدر: Heart

مصطلحات موضوعية: medicine.medical_specialty, global burden of disease, Potential risk, business.industry, Medical record, hyperlipidemias, Electronic medical record, Disease, 030204 cardiovascular system & hematology, Cardiac Risk Factors and Prevention, 03 medical and health sciences, 0302 clinical medicine, Increased risk, electronic health records, Internal medicine, General practice, medicine, delivery of healthcare, 030212 general & internal medicine, atherosclerosis, Cardiology and Cardiovascular Medicine, business, Lipid clinic, Preventive healthcare

الوصف: ObjectiveFamilial hypercholesterolaemia (FH) is characterised by elevated low-density lipoprotein (LDL)-cholesterol and increased risk of cardiovascular disease. However, FH remains substantially underdiagnosed and undertreated. We employed a two-stage pragmatic approach to identify and manage patients with FH in primary healthcare.MethodsMedical records for 232 139 patients who attended 15 general practices at least once in the previous 2 years across five Australian States were first screened for potential risk of FH using an electronic tool (TARB-Ex) and confirmed by general practitioner (GP) clinical assessment based on phenotypic Dutch Lipid Clinic Network Criteria (DLCNC) score. Follow-up GP consultation and management was provided for patients with phenotypic FH.ResultsA total of 1843 patients were identified by TARB-Ex as at potential risk of FH (DLCNC score ≥5). After GP medical record review, 900 of these patients (49%) were confirmed with DLCNC score ≥5 and classified as high-risk of FH. From 556 patients subsequently clinically assessed by GPs, 147 (26%) were diagnosed with phenotypic FH (DLCNC score >6). Follow-up GP consultation and management for 77 patients resulted in a significant reduction in LDL-cholesterol (−16%, pConclusionsA pragmatic approach integrating electronic medical record tools and clinical GP follow-up consultation is a feasible method to identify and better manage patients with FH in the primary healthcare setting.Trial registration number12616000630415.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b10e49b08db20d99ae4b3a378bcf0b0Test
https://pubmed.ncbi.nlm.nih.gov/34016696Test

المؤلفون: Matthew Tuson, David Whyatt, Mei Ruu Kok, Alistair Vickery, Berwin A. Turlach, M. J. Yap, Kevin Murray, Bryan Boruff

المصدر: International Journal of Health Geographics, Vol 19, Iss 1, Pp 1-18 (2020)
International Journal of Health Geographics

مصطلحات موضوعية: General Computer Science, Computer science, Service delivery framework, Health geography, Acknowledgement, 0507 social and economic geography, Context (language use), lcsh:Computer applications to medicine. Medical informatics, Single-aggregation disease maps, Health informatics, Brain Ischemia, 03 medical and health sciences, 0302 clinical medicine, Humans, Computer Simulation, 030212 general & internal medicine, Set (psychology), business.industry, 05 social sciences, Methodology, Public Health, Environmental and Occupational Health, Modifiable areal unit problem, Western Australia, Zonation-dependence, General Business, Management and Accounting, Stroke, Risk analysis (engineering), Research Design, Disease mapping, lcsh:R858-859.7, Resource allocation, Resource allocation efficiency, business, 050703 geography

الوصف: Background In disease mapping, fine-resolution spatial health data are routinely aggregated for various reasons, for example to protect privacy. Usually, such aggregation occurs only once, resulting in ‘single-aggregation disease maps’ whose representation of the underlying data depends on the chosen set of aggregation units. This dependence is described by the modifiable areal unit problem (MAUP). Despite an extensive literature, in practice, the MAUP is rarely acknowledged, including in disease mapping. Further, despite single-aggregation disease maps being widely relied upon to guide distribution of healthcare resources, potential inefficiencies arising due to the impact of the MAUP on such maps have not previously been investigated. Results We introduce the overlay aggregation method (OAM) for disease mapping. This method avoids dependence on any single set of aggregate-level mapping units through incorporating information from many different sets. We characterise OAM as a novel smoothing technique and show how its use results in potentially dramatic improvements in resource allocation efficiency over single-aggregation maps. We demonstrate these findings in a simulation context and through applying OAM to a real-world dataset: ischaemic stroke hospital admissions in Perth, Western Australia, in 2016. Conclusions The ongoing, widespread lack of acknowledgement of the MAUP in disease mapping suggests that unawareness of its impact is extensive or that impact is underestimated. Routine implementation of OAM can help avoid resource allocation inefficiencies associated with this phenomenon. Our findings have immediate worldwide implications wherever single-aggregation disease maps are used to guide health policy planning and service delivery.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5a463f589fc57410876c985b4df8ec87Test
https://doi.org/10.1186/s12942-020-00236-yTest

المؤلفون: Caroline Bulsara, Amanda Timler, Jim Codde, Alistair Vickery, Max Bulsara, Jill Smith

المصدر: Trials
Trials, Vol 21, Iss 1, Pp 1-11 (2020)

مصطلحات موضوعية: Quality of life, Male, medicine.medical_specialty, Next of kin, Population, Medicine (miscellaneous), Pain, Medical Marijuana, 03 medical and health sciences, Study Protocol, 0302 clinical medicine, Double-Blind Method, Medicine, Dementia, Medicinal cannabis, Humans, Plant Oils, Pharmacology (medical), 030212 general & internal medicine, Functional ability, education, Aged, Pain Measurement, Randomized Controlled Trials as Topic, lcsh:R5-920, education.field_of_study, Cross-Over Studies, business.industry, Cannabinoids, Pain scale, medicine.disease, Crossover trial, Mental Status and Dementia Tests, Behavioural and neuropsychiatric symptoms of dementia (BPSD), Nursing Homes, Clinical trial, Treatment Outcome, Physical therapy, Female, lcsh:Medicine (General), business, 030217 neurology & neurosurgery, Neuropsychiatric Inventory Questionnaire

الوصف: Background Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability to inhibit some symptoms associated with dementia, and the adverse effects are often minimal; yet, little research has explored the use of CBM among this population. Aim To monitor the safety of a purified dose of CBM oil (3:2 delta-9-tetrahydrocannabinol:cannabidiol) on behaviour symptoms, quality of life and discomfort caused by pain. Methods/design We will carry out an 18-week, randomised, double-blind crossover trial that consists of a 2-week eligibility period, two 6-week treatment cycles, and two 2-week washout periods (between both cycles and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups and will receive a dose of either CBM oil or placebo for the first treatment cycle and the opposite medication for the second. Data will be collected using the Neuropsychiatric Inventory Questionnaire, the Cohen-Mansfield Agitation Inventory, the Quality of Life in Alzheimer’s Disease questionnaire, and the Abbey Pain Scale on seven occasions. These will be completed by the participants, aged-care staff, and nominated next of kin or family members. The participants’ heart rate and blood pressure will be monitored weekly, and their body composition and weight will be monitored fortnightly by a research nurse, to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions of CBM and to inform proposed focus groups consisting of the aged-care staff and next of kin. Discussion The study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12619000474156. Registered on 21 March 2019

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b5d1a0df1c6c5031614154c9cfda19d4Test
http://europepmc.org/articles/PMC7023743Test

المؤلفون: Alistair Vickery, Suzanna Allen, Thinh Nguyen, Yvonne Hauck, Jacqueline Frayne, Helena Liira

المساهمون: Department of General Practice and Primary Health Care, University Management, University of Helsinki

مصطلحات موضوعية: Adult, medicine.medical_specialty, Time Factors, PRETERM BIRTH, NEONATAL OUTCOMES, Population, Prenatal care, Antenatal care, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, 3123 Gynaecology and paediatrics, Severe mental illness, SCHIZOPHRENIA, Medicine, Humans, COHORT, education, Retrospective Studies, RISK, education.field_of_study, Pregnancy, COMPLICATIONS, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, Mental Disorders, Attendance, Obstetrics and Gynecology, Retrospective cohort study, General Medicine, medicine.disease, Delivery, Obstetric, Comorbidity, 3. Good health, Gestational diabetes, Pregnancy Complications, PRENATAL-CARE, PREGNANCY, 030220 oncology & carcinogenesis, Bipolar, Female, business, Psychosocial

الوصف: Purpose This study aims to describe 10 years of antenatal care and outcomes for women with a severe mental illness (SMI). Methods A retrospective cohort study of 420 completed pregnancy records over the last 10 years (2007-2017). Findings were compared to the Western Australian (WA) pregnancy data. Antenatal attendance, demographic, obstetric, neonatal and psychosocial variables were analysed using t tests, chi(2)(,) ANOVA and odds ratio (OR). Results Overall, women with a SMI had high rates of comorbidity (47%), antenatal complications, and preterm birth at 12.6% compared to WA mothers (p

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::942924ec279fba39743c63456e1a48f3Test
http://hdl.handle.net/10138/320959Test

المؤلفون: Kieran O'Sullivan, Alison H. McGregor, Alistair Vickery, Robert A. Laird, J. P. Caneiro, Anne Smith, Jan Hartvigsen, P. O'Sullivan, Stephanie Attwell, Mark J. Hancock, Peter Kent, Amity Campbell, Terry Haines, Robert Schütze

المصدر: BMJ Open, Vol 9, Iss 8 (2019)
BMJ Open
Kent, P, O'Sullivan, P, Smith, A, Haines, T, Campbell, A, McGregor, A H, Hartvigsen, J, O'Sullivan, K, Vickery, A, Caneiro, J P, Schütze, R, Laird, R A, Attwell, S & Hancock, M 2019, ' RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain : Study protocol for a randomised controlled trial ', BMJ Open, vol. 9, no. 8, e031133 . https://doi.org/10.1136/bmjopen-2019-031133Test

مصطلحات موضوعية: Activities of daily living, Cost-Benefit Analysis, medicine.medical_treatment, lcsh:Medicine, law.invention, Disability Evaluation, 0302 clinical medicine, Randomized controlled trial, law, Protocol, Multicenter Studies as Topic, 030212 general & internal medicine, low back pain, Pain Measurement, Randomized Controlled Trials as Topic, Rehabilitation, General Medicine, Low back pain, 3. Good health, Treatment Outcome, Roland Morris Disability Questionnaire, Quality-Adjusted Life Years, Chronic Pain, medicine.symptom, medicine.medical_specialty, Movement, Transducers, MEDLINE, Biofeedback, Rehabilitation Medicine, rehabilitation, 03 medical and health sciences, medicine, Humans, wearable electronic devices, Exercise, Physical Therapy Modalities, Cognitive Behavioral Therapy, business.industry, lcsh:R, Australia, Biofeedback, Psychology, Recovery of Function, clinical trial protocol, Clinical trial, Physical therapy, business, 030217 neurology & neurosurgery

الوصف: IntroductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.Methods and analysisPragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0–10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a ‘booster’ session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .Ethics and disseminationApproved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001396213).

وصف الملف: application/pdf

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4d257e9c4b5d2268b1d97932667ac72aTest
https://bmjopen.bmj.com/content/9/8/e031133.fullTest