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

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.

Download Full-text

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

BMJ Open ◽

10.1136/bmjopen-2017-017148 ◽

2017 ◽

Vol 7 (8) ◽

pp. e017148 ◽

Cited By ~ 7

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.

Download Full-text

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 ◽

10.1136/bmjopen-2018-025497 ◽

2019 ◽

Vol 9 (6) ◽

pp. e025497 ◽

Cited By ~ 3

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.

Download Full-text

Perspectives of research ethics committee members on human challenge studies in the development of vaccines against COVID-19: a mixed methods study

Annals of Palliative Medicine ◽

10.21037/apm-20-2622 ◽

2021 ◽

Vol 10 (13) ◽

pp. 0-0

Author(s):

Zihan Pan ◽

Hongling Chu ◽

Yu Zhang ◽

Xue Hong ◽

Lijun Liang ◽

...

Keyword(s):

Mixed Methods ◽

Research Ethics ◽

Ethics Committee ◽

Mixed Methods Study ◽

Research Ethics Committee

Download Full-text

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.

Download Full-text

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.

Download Full-text

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.

Download Full-text

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

Download Full-text

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.

Download Full-text