human research ethic
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2021 ◽  
Author(s):  
Maíra Junkes-Cunha ◽  
Sofia Sieczkowska ◽  
Guilherme Torres Vilarino ◽  
Guilherme Guimarães Bevilacqua ◽  
Alexandro Andrade

BACKGROUND Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise as a treatment is beneficial for the improvement quality of life (QOL) in these patients and it widely accepted as well. OBJECTIVE To develop a protocol for a feasibility study designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors in patients with chronic LBP after 8 weeks of randomization. METHODS This is a study protocol for a randomized controlled trial that consists of individuals with chronic LBP aged between 18 and 65 years. Subjects will be allocated through block randomization in one of the following groups: Motor Control Exercises (MCE), Pain Education, MCE + Pain Education, and Usual Care. The primary outcome will be pain intensity, and secondary outcomes will be pressure pain threshold measured through digital algometer, LBP-related disability, fears and beliefs, fear of movement, QOL, mood states, levels of depression and anxiety. RESULTS This trial was funded in 2018 and it was approved by Human Research Ethic Committee in September 2018. We are starting the patient’s recruitment, as it involves patients on a public service waiting list and needs the health manager's permission to start the data collection considering the current health scenario. Results are expected to be achieved by April 2022. CONCLUSIONS This trial will provide preliminary data regarding the feasibility and safety of MCE and Pain Education in patients with low back pain. It will also provide preliminary outcome data used to identify the intervention more efficient and what level of health care should be implemented in public health services. CLINICALTRIAL RBR-2xx2r2


Author(s):  
Brian Stokes ◽  
Tim Albion ◽  
Nadine Wiggins

Background with rationaleIn recent years, rapid advancements in Geographic Information Systems (GIS) software has provided a range of users with an array of options to visually represent multiple digital data assets and for a range of purposes. The research community is increasingly able to represent complex data assets spatially to identify patterns in the population specific to burden of disease or for other reasons. Main AimTo develop a methodology and software solution to effectively attribute spatial coordinates at a unit record level to data held in the Tasmanian Data Linkage Units (TDLU) Master Linkage Map (MLM). A further requirement was to support an integrated process of clerical review to enable incorrect or missing address information to be corrected. Methods/Approach The Australian government makes available a geocoded address database for end users including Australian businesses, education and government. Known as the G-NAF (Geocoded National Address File), the database contains in excess of 30 tables for over 13 million principal Australian addresses. The TDLU developed software that extracts data held in its MLM and processes using the G-NAF to derive and store multiple spatial data elements. ResultsThe TDLU has achieved in excess of 92% automated geocoding to address level for all records held in its MLM. Extensive metadata is produced, analysed and stored and used for many reasons including quality assurance. The release of spatial information, together with linkage keys, is strictly managed in accordance with Human Research Ethic Committee and custodian approvals. ConclusionThe TDLU’s custom designed spatial information system has proven effective in both automatically allocating spatial coordinates for records held in its MLM, and for supporting review of missing or incorrect address information. Generating and storing spatial data at a unit record level enables the effective allocation of a range of geographic elements, population data and indices including measures of socio-economic disadvantage.


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