scholarly journals Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017148 ◽  
Author(s):  
Frances Rapport ◽  
Patti Shih ◽  
Rebecca Mitchell ◽  
Armin Nikpour ◽  
Andrew Bleasel ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Services ◽  
Research Ethics ◽  
Surgical Intervention ◽  
Refractory Epilepsy ◽  
Ethics Committee ◽  
Local Health ◽  
Health Services Use ◽  
Research Ethics Committee ◽  
Resective Surgery

IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.

scholarly journals Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048395
Author(s):  
Morag E Taylor ◽  
Chris Todd ◽  
Sandra O'Rourke ◽  
Lindy M Clemson ◽  
Jacqueline CT Close ◽  
...  
Keyword(s):  
Older People ◽  
Research Ethics ◽  
Process Evaluation ◽  
Ethics Committee ◽  
Community Dwelling ◽  
Innovative Technology ◽  
Local Health ◽  
Research Ethics Committee ◽  
Personal Impact ◽  
The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

scholarly journals Protocol for the CONNECT project: a mixed methods study investigating patient preferences for communication technology use in orthopaedic rehabilitation consultations

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035210 ◽  
Author(s):  
Anthony William Gilbert ◽  
Jeremy Jones ◽  
Maria Stokes ◽  
Emmanouil Mentzakis ◽  
Carl R May
Keyword(s):  
Mixed Methods ◽  
Research Ethics ◽  
Phase Ii ◽  
Communication Technology ◽  
Patient Preferences ◽  
Technology Use ◽  
Ethics Committee ◽  
Phase Iii ◽  
Research Ethics Committee ◽  
Phase Iv

IntroductionTechnology has been placed at the centre of global health policy and has been cited as having the potential to increase efficiency and remove geographical boundaries for patients to access care. Communication technology may support patients with orthopaedic problems, which is one of the leading causes of disability worldwide. There are several examples of technology being used in clinical research, although uptake in practice remains low. An understanding of patient preferences will support the design of a communication technology supported treatment pathway for patients undergoing orthopaedic rehabilitation.Methods and analysisThis mixed methods project will be conducted in four phases. In phase I, a systematic review of qualitative studies reporting communication technology use for orthopaedic rehabilitation will be conducted to devise a taxonomy of tasks patients’ face when using these technologies to access their care. In phase II, qualitative interviews will investigate how the work of being a patient changes during face-to-face and communication technology consultations and how these changes influence preference. In phase III, a discrete choice experiment will investigate the factors that influence preferences for the use of communication technology for orthopaedic rehabilitation consultations. Phase IV will be a practical application of these results. We will design a ‘minimally disruptive’ communication technology supported pathway for patients undergoing orthopaedic rehabilitation.Ethics and disseminationThe design of a pathway and underpinning patient preference will assist in understanding factors that might influence technology implementation for clinical care. This study requires ethical approval for phases II, III and IV. Approvals have been received for phase II (approval received on 4 December 2016 from the South Central-Oxford C Research Ethics Committee (IRAS ID: 255172, REC Reference 18/SC/0663)) and phase III (approval received on 18 October 2019 from the London-Hampstead Research Ethics Committee (IRAS ID: 248064, REC Reference 19/LO/1586)) and will be sought for phase IV. All participants will provide informed written consent prior to being enrolled onto the study.PROSPERO registration numberCRD42018100896.

scholarly journals Understanding and responding to the cost and health impact of short-term health staffing in remote and rural Aboriginal and Torres Strait Islander community-controlled health services: a mixed methods study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e043902
Author(s):  
Michelle S Fitts ◽  
John Humphreys ◽  
Terry Dunbar ◽  
Lisa Bourke ◽  
Edward Mulholland ◽  
...  
Keyword(s):  
Health Services ◽  
Research Ethics ◽  
Primary Healthcare ◽  
Ethics Committee ◽  
Mixed Methods Study ◽  
Short Term ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
The Impact

IntroductionAccess to high-quality primary healthcare is limited for remote residents in Australia. Increasingly, remote health services are reliant on short-term or ‘fly-in, fly-out/drive-in, drive-out’ health workforce to deliver primary healthcare. A key strategy to achieving health service access equity, particularly evident in remote Australia, has been the development of Aboriginal Community Controlled Health Services (ACCHSs). This study aims to generate new knowledge about (1) the impact of short-term staffing in remote and rural ACCHSs on Aboriginal and Torres Strait Islander communities; (2) the potential mitigating effect of community control; and (3) effective, context-specific evidence-based retention strategies.Methods and analysisThis paper describes a 3-year, mixed methods study involving 12 ACCHSs across three states. The methods are situated within an evidence-based programme logic framework for rural and remote primary healthcare services. Quantitative data will be used to describe staffing stability and turnover, with multiple regression analyses to determine associations between independent variables (population size, geographical remoteness, resident staff turnover and socioeconomic status) and dependent variables related to patient care, service cost, quality and effectiveness. Qualitative assessment will include interviews and focus groups with clinical staff, clinic users, regionally-based retrieval staff and representatives of jurisdictional peak bodies for the ACCHS sector, to understand the impact of short-term staff on quality and continuity of patient care, as well as satisfaction and acceptability of services.Ethics and disseminationThe study has ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (project number DR03171), Central Australian Human Research Ethics Committee (CA-19-3493), Western Australian Aboriginal Health Ethics Committee (WAAHEC-938) and Far North Queensland Human Research Ethics Committee (HREC/2019/QCH/56393). Results will be disseminated through peer-reviewed journals, the project steering committee and community/stakeholder engagement activities to be determined by each ACCHS.

scholarly journals PRIME (Positive Transitions Through the Menopause) Study: a protocol for a mixed-methods study investigating the impact of the menopause on the health and well-being of women living with HIV in England

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025497 ◽  
Author(s):  
Shema Tariq ◽  
Fiona M Burns ◽  
Richard Gilson ◽  
Caroline Sabin
Keyword(s):  
Mixed Methods ◽  
Research Ethics ◽  
Well Being ◽  
Ethics Committee ◽  
Phase 2 ◽  
Research Ethics Committee ◽  
Women Living With Hiv ◽  
Living With Hiv ◽  
The Impact ◽  
Health And Well Being

IntroductionAdvances in antiretroviral therapy have transformed HIV into a long-term condition with near-normal life expectancy for those in whom viral replication is well controlled on treatment. This means that age-related events, including menopause, is of increasing importance in the care of people living with HIV. The PRIME (Positive Transitions Through the Menopause) Study aims to explore the impact of the menopause on the health and well-being of women living with HIV (WLHIV).Methods and analysisThe PRIME Study is a multicentre, mixed-methods observational study deploying a multiphase sequential design with explanatory and exploratory phases. Phase 1 comprised three focus group discussions with WLHIV. In phase 2 we aimed to administer questionnaires comprising detailed assessment of menopausal status and symptoms to 1500 WLHIV aged 45–60 attending HIV clinics in England. Phase 3 comprised semistructured interviews with a subsample of phase 2 participants. Ongoing quantitative follow-up of 100 participants is planned between October 2018 and September 2019. Qualitative and quantitative data will be kept analytically distinct and analysed using appropriate methods. We will integrate quantitative and qualitative findings using coding matrices.Ethics and disseminationThe PRIME Study has ethical approval from the South East Coast-Surrey Research Ethics Committee on behalf of all National Health Service (NHS) sites, and approval from University College London Research Ethics Committee for qualitative work conducted in non-NHS sites. In conjunction with the study Expert Advisory Group (which includes WLHIV), we have drafted a dissemination strategy that takes into account a wide range of stakeholders, including patients, policy makers and healthcare providers. This includes at least five empirical research papers to be submitted to peer-reviewed journals, as well as an accessible report aimed primarily at a non-technical audience (published in May 2018 and launched at a live-streamed event). Both quantitative and qualitative data are held by the PRIME Study team and are available by request.

scholarly journals Enabling Culturally Safe Sexual Health Services in Western Sydney: a Protocol to Improve Outcomes for Aboriginal Young People.

2020 ◽  
Author(s):  
Ashley John Ubrihien ◽  
Kylie Gwynne ◽  
David A. Lewis
Keyword(s):  
Young People ◽  
Health Services ◽  
Sexual Health ◽  
Research Ethics ◽  
Urban Areas ◽  
Aboriginal People ◽  
Ethics Committee ◽  
Local Health ◽  
Human Research Ethics ◽  
Aboriginal Elders

Abstract Aboriginal people face challenges on several fronts when it comes to the health and wellbeing of their community, compared to the rest of the Australian population. This is no different in urban areas such as Australia’s largest urban Aboriginal community located in Blacktown, NSW, where sexually transmitted infections remain an issue of concern. Across Australia, rates of Infectious Syphilis Human Immunodeficiency Virus (HIV) and Hepatitis C infection have increased by 400%, 260%, and 15% respectively while Gonorrhoea decreased 12% in the 5-year period from 2013 to 2017. This study explores how to address the barriers that prevent young Aboriginal people under 30 years of age accessing public Sexual Health Services.MethodsPurposeful qualitative sampling will be undertaken to recruit 20 male and 20 female health consumers, 10 Aboriginal Elders and 10 sexual health clinicians. This recruitment will be undertaken with the assistance of local Aboriginal organisations and Western Sydney Local Health District (WSLHD). Participants will be interviewed on a one on one basis using semi structured interviews and participants will be interviewed by someone of the same gender in order to address cultural preferences. Data collected will be analysed using NVivo and by conducting a thematic analysis.DiscussionThis study will seek to add to the literature that explores why young Aboriginal people do not access sexual health services. This study seeks to understand the experience of clinicians, Aboriginal Elders and Aboriginal young people to provide practical policy and clinical redesign evidence that can be used to improve the experience and cultural safety of sexual health services in urban areas of Australia. The results of the qualitative research will be disseminated with the assistance of participating local Aboriginal organisations and the findings will be published through peer-reviewed scientific journals and conference presentations.Trial registrationThe study is approved by Western Sydney Local Health District Human Research Ethics Committee (HREC/16/WMEAD/449) and the New South Wales Aboriginal Health and Medical Research Council’s Human Research Ethics Committee (1220/16).

Ethical issues in action-oriented research in Indonesia

2017 ◽  
Vol 24 (6) ◽  
pp. 686-693 ◽  
Author(s):  
Rini Rachmawaty
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committee ◽  
International Standards ◽  
Local Health ◽  
Human Subject Research ◽  
Research Ethics Committee ◽  
Oriented Research

Background: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. Objectives: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. Methods: A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Results: Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Discussion: Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Conclusion: Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies understand the research ethics on human subjects and apply it into their practice.

scholarly journals Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  
Keyword(s):  
At Risk ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
National Implementation ◽  
General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

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