International Mind, Activities and Urban Places (iMAP) study: methods of a cohort study on environmental and lifestyle influences on brain and cognitive health

IntroductionNumerous studies have found associations between characteristics of urban environments and risk factors for dementia and cognitive decline, such as physical inactivity and obesity. However, the contribution of urban environments to brain and cognitive health has been seldom examined directly. This cohort study investigates the extent to which and how a wide range of characteristics of urban environments influence brain and cognitive health via lifestyle behaviours in mid-aged and older adults in three cities across three continents.Methods and analysisParticipants aged 50–79 years and living in preselected areas stratified by walkability, air pollution and socioeconomic status are being recruited in Melbourne (Australia), Barcelona (Spain) and Hong Kong (China) (n=1800 total; 600 per site). Two assessments taken 24 months apart will capture changes in brain and cognitive health. Cognitive function is gauged with a battery of eight standardised tests. Brain health is assessed using MRI scans in a subset of participants. Information on participants’ visited locations is collected via an interactive web-based mapping application and smartphone geolocation data. Environmental characteristics of visited locations, including the built and natural environments and their by-products (e.g., air pollution), are assessed using geographical information systems, online environmental audits and self-reports. Data on travel and lifestyle behaviours (e.g., physical and social activities) and participants’ characteristics (e.g., sociodemographics) are collected using objective and/or self-report measures.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of the Australian Catholic University, the Institutional Review Board of the University of Hong Kong and the Parc de Salut Mar Clinical Research Ethics Committee of the Government of Catalonia. Results will be communicated through standard scientific channels. Methods will be made freely available via a study-dedicated website.Trial registration numberACTRN12619000817145.

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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 ◽

10.1136/bmjopen-2020-041695 ◽

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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Meniscal tear outcome Study (METRO Study): a study protocol for a multicentre prospective cohort study exploring the factors which affect outcomes in patients with a meniscal tear

BMJ Open ◽

10.1136/bmjopen-2020-038681 ◽

2020 ◽

Vol 10 (7) ◽

pp. e038681

Author(s):

Imran Ahmed ◽

Mike Bowes ◽

Charles E Hutchinson ◽

Nicholas Parsons ◽

Sophie Staniszewska ◽

...

Keyword(s):

Cohort Study ◽

Research Ethics ◽

Outcome Measures ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Meniscal Tear ◽

Ethics Committee ◽

Secondary Outcome ◽

Research Ethics Committee ◽

Baseline Characteristics

IntroductionThis study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail.Methods and analysisThis is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months.Ethics and disseminationThe study obtained approval from the National Research Ethics Committee West Midlands—Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication.Trial registration numberUHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18–19

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A study to evaluate the effectiveness of Best Beginnings’ Baby Buddy phone app in England: a protocol paper

Primary Health Care Research & Development ◽

10.1017/s1463423618000294 ◽

2018 ◽

Vol 20 ◽

Cited By ~ 3

Author(s):

Toity Deave ◽

Sally Kendal ◽

Raghu Lingam ◽

Crispin Day ◽

Trudy Goodenough ◽

...

Keyword(s):

Cohort Study ◽

Pregnant Women ◽

Research Ethics ◽

Health Professionals ◽

Self Efficacy ◽

Well Being ◽

Ethics Committee ◽

The West ◽

Research Ethics Committee ◽

The Impact

AbstractIntroductionDevelopments in information and communication technologies have enabled electronic health and seen a huge expansion over the last decade. This has increased the possibility of self-management of health issues.PurposeTo assess the effectiveness of the Baby Buddy app on maternal self-efficacy and mental well-being three months post-birth in a sample of mothers recruited antenatally. In addition, to explore when, why and how mothers use the app and consider any benefits the app may offer them in relation to their parenting, health, relationships or communication with their child, friends, family members or health professionals.MethodsWe will use a mixed-methods approach, a cohort study, a qualitative element and analysis of in-app data. Participants will be first-time pregnant women, aged 16 years and over, between 12 and 16 weeks of gestation and recruited from five English study sites.Evaluation planWe will compare maternal self-efficacy and mental health at three months post-delivery in mothers who have downloaded the Baby Buddy app compared with those that have not downloaded the app, controlling for confounding factors. Women will be recruited antenatally between 12 and 16 weeks of gestation. Further follow-ups will take place at 35 weeks of gestation and three months post-birth. Data from the cohort study will be supplemented by in-app data that will include, for example, patterns of usage. Qualitative data will assess the impact of the app on the lives of pregnant women and health professionals using both focus groups and interviews.EthicsApproval from the West Midlands-South Birmingham Research Ethics Committee (NRES) (16/WM/0029) and the University of the West of England, Bristol, Research Ethics Committee (HAS.16.08.001).DisseminationFindings of the study will be published in peer reviewed and professional journals, presented locally, nationally and at international conferences. Participants will receive a summary of the findings and the results will be published on Best Beginnings’ website.

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Recidivism, health and social functioning following release to the community of NSW prisoners with problematic drug use: study protocol of the population-based retrospective cohort study on the evaluation of the Connections Program

BMJ Open ◽

10.1136/bmjopen-2019-030546 ◽

2019 ◽

Vol 9 (7) ◽

pp. e030546 ◽

Cited By ~ 1

Author(s):

Elizabeth Sullivan ◽

Stephen Ward ◽

Reem Zeki ◽

Sarah Wayland ◽

Juanita Sherwood ◽

...

Keyword(s):

Cohort Study ◽

Drug Use ◽

Health Outcomes ◽

Research Ethics ◽

Retrospective Cohort ◽

Population Based ◽

Ethics Committee ◽

Research Ethics Committee ◽

Human Research Ethics ◽

Problematic Drug

IntroductionThe rising rate of incarceration in Australia, driven by high reoffending, is a major public health problem. Problematic drug use is associated with increasing rates of reoffending and return to custody of individuals. Throughcare provides support to individuals during imprisonment through to post-release, improving both the transition to community and health outcomes post-incarceration. The aim of this study is to evaluate the Connections Programme (CP) that utilises a throughcare approach for release planning of people in prison with a history of problematic drug use. The study protocol is described.Methods and analysisPopulation-based retrospective cohort study. The study will use record linkage of the Connections dataset with 10 other New South Wales (NSW) population datasets on offending, health service utilisation, opioid substitution therapy, pregnancy, birth and mortality. The study includes all patients who were eligible to participate in the CP between January 2008 and December 2015 stratified by patients who were offered CP and eligible patients who were not offered the programme (non-CP (NCP)). Propensity-score matching will be used to appropriately adjust for the observable differences between CP and NCP. The differences between two groups will be examined using appropriate univariate and multivariate analyses. A generalised estimating equation approach, which can deal with repeat outcomes for individuals will be used to examine recidivism, mortality and other health outcomes, including perinatal and infant outcomes. Survival analysis techniques will be used to examine the effect of the CP by sex and Indigenous status on the ‘time-to’ health-related outcomes after adjusting for potential confounders.Ethics and disseminationEthical approval was received from the NSW Population and Health Services Research Ethics Committee, the Justice Health and Forensic Mental Health Network Human Research Ethics Committee, the Aboriginal Health and Medical Research Council Ethics Committee, the Corrective Services NSW Ethics Committee and the University of Technology Sydney Human Research Ethics Committee.

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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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264621992214 ◽

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.

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

BMJ Open ◽

10.1136/bmjopen-2020-044628 ◽

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.

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A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

Ethics & Human Research ◽

10.1002/eahr.500104 ◽

2021 ◽

Vol 43 (5) ◽

pp. 42-44

Author(s):

Leonardo Tamariz ◽

Fred J. Hendler ◽

John M. Wells ◽

Annette Anderson ◽

Stephen Bartlett

Keyword(s):

Research Ethics ◽

Ethics Committee ◽

Research Ethics Committee

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

BMJ Open ◽

10.1136/bmjopen-2020-048395 ◽

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.

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