Tagged / Health

Research transparency – HRA response to the Science and Technology Committee

Knowledge Exchange, NHS, Research Ethics

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

NIHR – Making a difference: Improving treatment for advanced prostate cancer

NHS

The NIHR have recently published an article on the STAMPEDE trial which is helping to improve the prognosis and quality of life of those diagnosed with prostate cancer.

This is a research study that’s supported by the NIHR, and has been up and running since 2005, with more than 10,000 men having taken part. 125 UK sites are conducting the research, with local NHS Trusts amongst those 125.

The trial is multi-arm, so compares different treatments amongst the participant group – it is also ‘randomised’, so participants are allocated their treatment at random, reducing any bias in allocation.

The results to date from the trial have also influenced the NHS treatment for men with high risk, locally advanced metastatic prostate cancer. More STAMPEDE related news can be found on their website.

You can read the article here, which contains a testimony from a trial participant whose condition and quality of life have been vastly improved.

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

HRA responds to paper outlining concerns over study set-up delays

NHS, Research assessment, Research Ethics, Research Integritiy

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

BU Systematic Review Masterclass starting tomorrow

Publishing, Research assessment, writing

Looking forward to our annual Systematic Review Masterclass at Bournemouth University which will be starting tomorrow February 14th.  This year for the first time we have renamed it a ‘Systematic Review to Inform Clinical Practice’ as it is not only a free-standing masterclass but also a level 7 unit of Continuing Professional Development and Training .  This year we aim to provide students with the opportunity to choose an area of interest and undertake an in-depth, independent study in the form of a systematic review, focusing on a negotiated aspect of clinical practice.  Prof. Vanora Hundley and I had published over twenty systematic reviews (or papers about systematic reviewing) over the past two decades. [1-21]  The unit will have input from BU’s Academic Liaison Librarian, Caspian Dugdale, and BU academics such as Dr. Bibha Simkhada, Lecturer in Nursing.

Professors Vanora Hundley and Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health (CMMPH)

 

References:

  1. van Teijlingen E, Wilson, B, Barry, N, Ralph, A, McNeill, G, Graham, W, Campbell, D. (eds.) (1998) Effectiveness of interventions to promote healthy eating in pregnant women & women of childbearing age: a review, London: Health Education Authority www.nice.org.uk/nicemedia/documents/effect_eatpregant.pdf  [ISBN: 0752110977].
  2. van Teijlingen ER, Bruce, J. (1999) Systematic reviews of health promotion initiatives: the Smokebusters experience, Health Education, 99: 76-83.
  3. Ryan M, Scott DA, Reeves C, Bate A., van Teijlingen E, Russell E, Napper M, Robb C (2001) Eliciting public preferences for healthcare: systematic review of techniques. Health Technology Assessment 5(5)
  4. Simkhada, B., van Teijlingen E., Porter, M., Simkhada, P. (2008) Factors affecting the utilisation of antenatal care in developing countries: a systematic review of the literature, Journal of Advanced Nursing 61(3): 244-260.
  5. Paul-Ebhohimhen, V.A., Poobalan, A., van Teijlingen E. (2008) Systematic review of effectiveness of school-based sexual health interventions in Sub-Saharan Africa, BMC Public Health, 8(4). www.biomedcentral.com/1471-2458/8/4
  6. Robertson L, Douglas F, Ludbrook A., Reid G., van Teijlingen E. (2008) What works with men? A systematic review of health promoting interventions targeting men, BMC Health Services Research 8(141). www.biomedcentral.com/1472-6963/8/141
  7. Acharya, D.R., Bhattarai, R, Poobalan, A, van Teijlingen E.R., Chapman, G. (2010) Factors associated with teenage pregnancy in South Asia: a systematic review. Health Sciences Journal 4(1): 3-14. www.hsj.gr/volume4/issue1/402.pdf
  8. Hundley V, Avan B, Braunholtz D, and Graham WJ (2012). Are birth kits a good idea? A systematic review of the evidence. Midwifery 28(2): 204-215
  9. Wasti, SP, van Teijlingen E., Simkhada, P., Randall, J., Baxter S, Kirkpatrick P, Vijay Singh Gc. (2012) Factors influencing adherence to antiretroviral treatment in Asian developing countries: a systematic review, Tropical Medicine & International Health 17(1): 71-81. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2011.02888.x/pdf
  10. VA Hundley, BI Avan, CJ Sullivan, WJ Graham. (2013) Should oral misoprostol be used to prevent postpartum haemorrhage in home-birth settings in low-resource countries? A systematic review of the evidence. BJOG: An International Journal of Obstetrics & Gynaecology, 120:277–287DOI: 10.1111/1471-0528.12049
  11. van Teijlingen, ER, Simkhada, B., Ireland J., Simkhada P., Bruce J. (2012) Evidence-based health care in Nepal: The importance of systematic reviews, Nepal Journal of Epidemiology 1(4): 114-118.
  12. Robertson, C, Archibald, D, Avenell, A, Douglas, F., Hoddinott, P., van Teijlingen E, et al. (2014) Systematic reviews of & integrated report on quantitative, qualitative & economic evidence base for the management of obesity in men. Health Technology Assessment 18(35): 1-424. http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0019/118180/FullReport-hta18350.pdf
  13. Stewart, F, Fraser, C, Robertson, C, Avenell, A, Archibald, D, Douglas, F, Hoddinott, P, van Teijlingen, E, Boyers, D. (2014) Are men difficult to find? Identifying male-specific studies in MEDLINE & Embase, Systematics Reviews 3,78
  14. Gyawali, B., Neupane, D., Sharma, R., Mishra, S.R., van Teijlingen, E., Kallestrup, P. (2015) Prevalence of type 2 diabetes in Nepal: Systematic review & meta-analysis from 2000 to 2014 Global Health Action 8: 29088 www.globalhealthaction.net/index.php/gha/article/view/29088/pdf_189
  15. Boyers, D, Stewart, F, Fraser, C, Robertson, C, Avenell, A, Archibald, D, Douglas, F, Hoddinott P, van Teijlingen E. (2015). A systematic review of the cost-effectiveness of non-surgical obesity interventions in men, Obesity Research & Clinical Practice 9(4), 310-327.
  16. Robertson, C, Avenell, A, Boachie, C., Stewart, F., Archibald D., Hoddinott, P, Douglas, F, van Teijlingen E, Boyers D. (2016) Should weight loss and maintenance programmes be designed differently for men? Systematic review of long-term RCTs presenting data for men & women: The ROMEO Project, Obesity Research & Clinical Practice 10: 70-84.
  17. Simkhada, P.P., Sharma, A., van Teijlingen, ER., Beanland, R,L. (2016) Factors influencing sexual behaviour between tourists and tourism employees: A systematic review. Nepal Journal of Epidemiology 6(1): 530-538. www.nepjol.info/index.php/NJE/article/view/14735/11952
  18. Symon, A., Pringle, J., Cheyne, H., Downe, S., Hundley, V., Lee, E., Lynn, F., McFadden, A., McNeill, J., Renfrew, M., Ross-Davie, M., van Teijlingen, E., Whitford, H, Alderdice, F. (2016) Midwifery-led antenatal care models: Mapping a systematic review to an evidence-based quality framework to identify key components & characteristics of care, BMC Pregnancy & Childbirth 16: 168 http://rdcu.be/uifu  
  19. Hanley GE, Munro S, Greyson D, Gross MM, Hundley V, Spiby H and Janssen PA (2016) Diagnosing onset of labor: A systematic review of definitions in the research literature. BMC Pregnancy and Childbirth 16: 71 http://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0857-4
  20. Robertson, C., Avenell, A., Stewart, F., Archibald, D., Douglas, F., Hoddinott, P., van Teijlingen, E., Boyers, D. (2017) Clinical effectiveness of weight loss & weight maintenance interventions for men: a systematic review of men-only randomised controlled trials (ROMEO Project), American Journal of Men’s Health 11(4): 1096-1123.
  21. Symon, A., Pringle, J., Downe, S., Hundley, V., Lee, E., Lynn, F., McFadden, A., McNeill, J., Renfrew, M., Ross-Davie, M., van Teijlingen, E., Whitford, H., Alderdice, F. (2017) Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models BMC Pregnancy & Childbirth 17:8 http://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-1186-3
  22. Pitchforth, E, Nolte, E, Corbett, J, Miani, C, Winpenny, E, van Teijlingen E, et al. (2017) Community hospitals and their services in the NHS: identifying transferable learning from international developments – scoping review, systematic review, country reports and case studies Health Services & Delivery Research 5(19): 1-248.
  23. Ochillo, M., van Teijlingen, E., Hind, M. (2017) Influence of faith-based organisations on HIV prevention strategies in Africa: a systematic review. African Health Sciences 17(3): 753-761.
  24. Mahato, P., van Teijlingen, E., Simkhada, P., Angell, C. (2017) Determinants of quality of care & access to Basic Emergency Obstetric & Neonatal Care facilities & midwife-led facilities in low & middle-income countries: A Systematic Review, Journal of Asian Midwives 4(2):25-51. https://ecommons.aku.edu/jam/vol4/iss2/4/
  25. Simkhada, P., van Teijlingen, E., Sharma, A., Bissell, P., Poobalan, A., Wasti, S.P. (2018) Health consequences of sex trafficking: A systematic review, Journal of Manmohan Memorial Institute of Health Sciences, 4(1): 130-149.

 

Medical research: articles/blogs of interest

Knowledge Exchange, NHS, Research Ethics

A medical ethicists explores the need to temper researchers’ enthusiasm when it comes to presenting the benefits of a treatment, and how important it is to distinguish research from a treatment.

Read the full article here.

Six project management tips for a PhD – Whatever kind of large research project you are doing, these tips from the private sector might be of some use.

Read the full article here.

#DataSavesLives—Patient participation ensures data are accurate and useful – In this blog, the author argues that we must not ignore the benefits that sharing patient data can have on quality in healthcare

Read the full blog post here.

New HRA guidance launched for public co-applicants in research

Guidance, NHS

‘Increasing numbers of public contributors are helping to shape and deliver health and social care research, and there has been a rise in the number of public co-applicants joining research teams.

Involving members of the public in research design and development has been shown to have a positive effect on projects by improving the quality and relevance of research. However, until now there has been no guidance, either for researchers or for people involved, about what it means to be a co-applicant.

Now new guidance co-developed by NIHR-INVOVLE, the NHS R&D Forum and the Health Research Authority, has been launched to help support members of the public who are co-applicants on research grants and ensure that their contribution is valuable and rewarding.’

See the HRA’s update here and remember that support is on offer at BU if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog.

New textbook for medical students

Centre for Excellence in Learning, international, Publishing, Training, writing

Experts from universities across the UK have contributed to a new edition of a best-selling textbook which is out this month.  This is the fourth edition of Psychology and Sociology Applied to Medicine which is a jargon-free 179-page introduction to psychology and sociology for medical students (and other health care students). The book is published by one of the largest academic publishers in the world, Elsevier in its series of Illustrated Colour Texts.

Seventy-three academics contributed chapters to the book which was edited by psychologist Prof. Gerry Humphris (University of St. Andrews) and sociologist Prof. Edwin van Teijlingen (Bournemouth University). The contributors are discipline and topic experts and come mainly from the UK but some are from further afield such as Ireland and Australia.   Compared to the third edition this latest edition has 45 new authors, who contribute the most up-to-date knowledge on classical psychological and sociological concepts and issues.  All chapters have been updated and several have been renamed and revamped to reflect changes in society, and three new ones have been added.  The editors are very grateful to Catherine Calderwood, Chief Medical Officer for Scotland, for writing the Foreword.

Teaching behavioural and social sciences to students is of vital importance for good health care in the future. This textbook covers topics across the life cycle from birth to death. A range of concepts and issues such as health screening, personality & health, quality of life, self-care, and anxiety are explained in an easy to understand fashion. This makes the textbook excellent introductory text as well as an essential revision tool for students. This textbook for medical students is Bournemouth University’s latest contribution to medical training.

 

Reference:

van Teijlingen, E. & Humphris, G. (Eds.) (2019)Psychology & Sociology Applied to Medicine: An Illustrated Colour Text (4th Edn), Edinburgh: Elsevier  The book is available as eBook [ISBN: 9780702062995] and as paperback [ISBN: 9780702062988].

HRA Update – Travel insurance and participation in clinical trials

NHS

Please see below for a message from the NIHR Workforce Development team –

‘We are pleased to inform you that the Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

If you are aware of instances when participation in a trial is given as a reason for not providing insurance or insurance being an obstacle to participation in clinical trials, please contact hrapublicinvolvement@nhs.net‘

Good Clinical Practice Refresher – Monday 4th February

NHS, Research Ethics, Training

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester on Monday 4th February, 9am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.

NIHR CRN – Principal Investigator Workshop

NHS, Research Ethics, Training

The above course is designed for those working as a Principal Investigator (PI) on clinical research projects, or those wishing to become a PI. It is particularly suited to those who have been in working in this role for less than 6 months.

The course will focus on the role and responsibilities of the PI, developing a greater understanding of the regulatory landscape in research, leadership, oversight and communication skills and the importance of building working relationships with local NHS Research & Development and Research & Innovation departments.

For further details of the course please email Kelly.Adams@nihr.ac.uk and to request the course agenda please email Research Ethics.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Good Clinical Practice Refresher – Monday 4th February

NHS, Research Ethics, Research Integritiy, Training

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester on Monday 4th February, 9am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.