scholarly journals A Pathway to Precision Medicine for Aboriginal Australians: A Study Protocol

2021 ◽  
Vol 4 (2) ◽  
pp. 42
Author(s):  
Yeu-Yao Cheng ◽  
Jack Nunn ◽  
John Skinner ◽  
Boe Rambaldini ◽  
Tiffany Boughtwood ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Study Protocol ◽  
Torres Strait Islander ◽  
Genomic Data ◽  
Phase Iii ◽  
Community Members ◽  
Aboriginal Australians ◽  
Aboriginal Community ◽  
Potential Use ◽  
Fair Access

(1) Background: Genomic precision medicine (PM) utilises people’s genomic data to inform the delivery of preventive and therapeutic health care. PM has not been well-established for use with people of Aboriginal and Torres Strait Islander ancestry due to the paucity of genomic data from these communities. We report the development of a new protocol using co-design methods to enhance the potential use of PM for Aboriginal Australians. (2) Methods: This iterative qualitative study consists of five main phases. Phase-I will ensure appropriate governance of the project and establishment of a Project Advisory Committee. Following an initial consultation with the Aboriginal community, Phase-II will invite community members to participate in co-design workshops. In Phase-III, the Chief Investigators will participate in co-design workshops and document generated ideas. The notes shall be analysed thematically in Phase-IV with Aboriginal community representatives, and the summary will be disseminated to the communities. In Phase-V, we will evaluate the co-design process and adapt our protocol for the use in partnership with other communities. (3) Discussion: This study protocol represents a crucial first step to ensure that PM research is relevant and acceptable to Aboriginal Australians. Without fair access to PM, the gap in health outcome between Aboriginal and non-Aboriginal Australians will continue to widen.

A pathway to precision medicine for Aboriginal Australians: a study protocol

2021 ◽  
Vol 132 ◽  
pp. S331-S332
Author(s):  
Yeu-Yao (Kevin) Cheng ◽  
Jack Nunn ◽  
John Skinner ◽  
Boe Rambaldini ◽  
Tiffany Boughtwood ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Study Protocol ◽  
Aboriginal Australians

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

scholarly journals SAVER: sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia—a phase II randomised control trial study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Caroline McCarthy ◽  
Joseph Sacco ◽  
Stefano Fedele ◽  
Michael Ho ◽  
Stephen Porter ◽  
...  
Keyword(s):  
High Risk ◽  
Sodium Valproate ◽  
Study Protocol ◽  
Epigenetic Reprogramming ◽  
Epithelial Dysplasia ◽  
Phase Iii ◽  
Cancer Development ◽  
Randomised Control Trial ◽  
Oral Epithelial Dysplasia ◽  
Oral Epithelial

Abstract Background Sodium valproate (VPA) has been associated with a reduced risk of head and neck cancer development. The potential protective mechanism of action is believed to be via inhibition of histone deacetylase and subsequent epigenetic reprogramming. SAVER is a phase IIb open-label, randomised control trial of VPA as a chemopreventive agent in patients with high-risk oral epithelial dysplasia (OED). The aim of the trial is to gather preliminary evidence of the clinical and biological effects of VPA upon OED and assess the feasibility and acceptability of such a trial, with a view to inform a future definitive phase III study. Methods One hundred and ten patients with high-risk OED will be recruited from up to 10 secondary care sites in the UK and randomised into either VPA or observation only for 4 months. Women of childbearing potential will be excluded due to the teratogenic properties of VPA. Tissue and blood samples will be collected prior to randomisation and on the last day of the intervention/observation-only period (end of 4 months). Clinical measurement and additional safety bloods will be taken at multiple time points during the trial. The primary outcome will be a composite, surrogate endpoint of change in lesion size, change in grade of dysplasia and change in LOH profile at 8 key microsatellite regions. Feasibility outcomes will include recruitment targets, compliance with the study protocol and adverse effects. A qualitative sub-study will explore patient experience and perception of the trial. Discussion The current management options for patients with high-risk OED are limited and mostly include surgical resection and clinical surveillance. However, there remains little evidence whether surgery can effectively lead to a notable reduction in the risk of oral cancer development. Similarly, surveillance is associated with concerns regarding delayed diagnosis of OED progressing to malignancy. The SAVER trial provides an opportunity to investigate the effects of a repurposed, inexpensive and well-tolerated medication as a potential chemopreventive strategy for patients with high-risk OED. The clinical and biological findings of SAVER will inform the appropriateness, design and feasibility of a definitive phase III trial. Trial registration The trial is registered with the European Clinical Trials Database (Eudra-CT 2018-000197-30). (http://www.isrctn.com/ISRCTN12448611). The trial was prospectively registered on 24/04/2018.

Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial

2021 ◽  
Vol 30 (8) ◽  
pp. 105888
Author(s):  
Fred Stephen Sarfo ◽  
Albert Akpalu ◽  
Ansumana Bockarie ◽  
Lambert Appiah ◽  
Samuel Blay Nguah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Phase Iii

scholarly journals Poverty and mental health in Aboriginal Australia

1999 ◽  
Vol 23 (6) ◽  
pp. 364-366 ◽  
Author(s):  
Jonathan Laugharne
Keyword(s):  
Mental Health ◽  
Respiratory Diseases ◽  
Torres Strait Islander ◽  
Aboriginal People ◽  
Central Africa ◽  
Aboriginal Health ◽  
Aboriginal Australians ◽  
Death Rates ◽  
The World ◽  
Torres Strait

When the Australian Governor General, Sir William Deane, referred in a speech in 1996 to the “appalling problems relating to Aboriginal health” he was not exaggerating. The Australia Bureau of Statistics report on The Health and Welfare of Australia's Aboriginal and Torres Strait Islander Peoples (McLennan & Madden, 1997) outlines the following statistics. The life expectancy for Aboriginal Australians is 15 to 20 years lower than for non-Aboriginal Australians, and is lower than for most countries of the world with the exception of central Africa and India. Aboriginal babies are two to three times more likely to be of lower birth weight and two to four times more likely to die at birth than non-Aboriginal babies. Hospitalisation rates are two to three times higher for Aboriginal than non-Aboriginal Australians. Death rates from infectious diseases are 15 times higher among Aboriginal Australians than non-Aboriginal Australians. Rates for heart disease, diabetes, injury and respiratory diseases are also all higher among Aboriginals – and so the list goes on. It is fair to say that Aboriginal people have higher rates for almost every type of illness for which statistics are currently recorded.

scholarly journals Codeveloping a multibehavioural mobile phone app to enhance social and emotional well-being and reduce health risks among Aboriginal and Torres Strait Islander women during preconception and pregnancy: a three-phased mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052545
Author(s):  
Michelle Kennedy ◽  
Ratika Kumar ◽  
Nicole M Ryan ◽  
Jessica Bennett ◽  
Gina La Hera Fuentes ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Mobile Phone ◽  
Phase 1 ◽  
Qualitative Interviews ◽  
Mixed Methods Study ◽  
Phase 2 ◽  
Community Members ◽  
Phase 3 ◽  
Aboriginal Community ◽  
Aboriginal Women

ObjectiveDescribe the development and pretest of a prototype multibehavioural change app MAMA-EMPOWER.DesignMixed-methods study reporting three phases: (1) contextual enquiry included stakeholder engagement and qualitative interviews with Aboriginal women, (2) value specification included user-workshop with an Aboriginal researcher, community members and experts, (3) codesign with Aboriginal researchers and community members, followed by a pretest of the app with Aboriginal women, and feedback from qualitative interviews and the user-Mobile Application Rating Scale (U-MARS) survey tool.SettingsAboriginal women and communities in urban and regional New South Wales, Australia.ParticipantsPhase 1: interviews, 8 Aboriginal women. Phase 2: workshop, 6 Aboriginal women. Phase 3: app trial, 16 Aboriginal women. U-MARS, 5 Aboriginal women.ResultsPhase 1 interviews revealed three themes: current app use, desired app characteristics and implementation. Phase 2 workshop provided guidance for the user experience. Phase 3 app trial assessed all content areas. The highest ratings were for information (mean score of 3.80 out of 5, SD=0.77) and aesthetics (mean score of 3.87 with SD of 0.74), while functionality, engagement and subjective quality had lower scores. Qualitative interviews revealed the acceptability of the app, however, functionality was problematic.ConclusionsDeveloping a mobile phone app, particularly in an Aboriginal community setting, requires extensive consultation, negotiation and design work. Using a strong theoretical foundation of behavioural change technique’s coupled with the consultative approach has added rigour to this process. Using phone apps to implement behavioural interventions in Aboriginal community settings remains a new area for investigation. In the next iteration of the app, we aim to find better ways to personalise the content to women’s needs, then ensure full functionality before conducting a larger trial. We predict the process of development will be of interest to other health researchers and practitioners.

Treatment and secondary prevention of venous thrombo -embolism in cancer patients

2012 ◽  
Vol 32 (02) ◽  
pp. 139-144 ◽  
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Initial Period ◽  
Factor Xa ◽  
Secondary Prophylaxis ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancer-associated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3–6 months. New oral anti-coagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE also in cancer patients. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

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