Tagged / Health

Introduction to Good Clinical Practice – Tuesday 17th March at Dorset County Hospital

Are you interested in running your own research project within the NHS or healthcare? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Tuesday 17th March, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact 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 – Dorset County Hospital, Tuesday 18th February

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 Tuesday 18th February, 9:00am – 12:30pm.

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

New BU paper published on Plos One

Congratulation to Dr Francesco Ferraro, who published his latest paper on Plos One. 

The paper “Comparison of balance changes after inspiratory muscle or Otago exercise training” comes from Dr Ferraro`s PhD where, under the supervision of Professor McConnell, Dr Gavin and Associate Professor Wainwright, he looked at the effects of inspiratory muscle training on balance and physical performance with older adults.

This latest paper looks at the potential benefit of inspiratory muscle training as an alternative to standard balance training intervention.  The findings of this pragmatic parallel study support the hypothesis that 8 weeks of unsupervised, individual, home-based inspiratory muscle training, improves balance ability to a similar extent to supervised, group-based balance training in healthy older adults.

The article is now fully available as open access here

https://doi.org/10.1371/journal.pone.0227379

 

Dr Ferraro.

fferraro@bournemouth.ac.uk

www.ferrarotrainer.com

 

NIHR Podcast on Dementia Research

The NIHR have recently released another of their podcasts in their Health Research Futures series, this time from Professor Martin Rosser.

Professor Rosser founded Join Dementia Research, a national system for linking patients and public to research studies. He is also the Director of the NIHR Clinical Research Network for Dementia and Neurodegenerative diseases.

In this podcast he discusses dementia research and its importance in the clinical research landscape.

 

 

‘Research adrenaline junkie: how clinical research energised my career’

The Royal College of Physicians have recently published a set of articles that reflect the crucial role clinical research plays in the NHS.

This article comes from a Consultant Gastroenterologist at the Royal Wolverhampton NHS Trust in which he talks about the transformational effect that clinical research had on his career.

You can see the article here.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Happy reading!

The Schedule of Events Cost Attribution Tool (SoECAT)

SoECAT stands for the ‘Schedule of Events Cost Attribution Tool’ – either a SoECAT or a Schedule of Events (SoE) is required whenever you are conducting clinical research in the NHS or Social Care. Further information and clarification is provided below.

What is the purpose of the SoECAT?

  • The SoECAT is a way of providing clarity to participating NHS  organisations on the cost attributions associated with a study.
  • The template is designed to support correct cost attribution at application for Research Cost funding, to ensure that full site level Research Costs are recovered.

When is a SoECAT required?

  • A SoECAT is required by National Institute for Health Research (NIHR) and NIHR non-commercial partner research funders where the call relates to studies that may involve participants under an NHS or Health and Social Care duty of care.
  • In some cases, your study may be funded by an NIHR infrastructure award which does not cover Excess Treatment Costs (ETCs) – in these cases, a SoECAT would be required in order to access the ETC process for England. Further information on ETCs can be found here.
  • In cases where your study is not funded by the NIHR or a NIHR non-commercial partner, but you wish to make an application to the NIHR CRN Portfolio, you will need to complete a SoECAT.

How do I complete one?

  • The NIHR have recently released new guidance on how to complete a SoECAT which can be found here.

When is it completed and where does the SoECAT go when it is completed?

  • The SoECAT should be completed at the funding application stage.
  • The form must be authorised by an AcoRD Specialist prior to submission for Research Cost funding.
  • It should be submitted alongside your other supporting documents when applying through the IRAS system for NHS Ethics approval and/or Health Research Authority approval*.
  • The SoECAT/SoE is then sent to your participating NHS/HSC organisations as part of the Local Information Pack at the site study set-up stage.

*Where there is no external funding attached to a project, the Schedule of Events should be used instead of a SoECAT.

Where can I get further support and guidance?

  • Your research funder should have guidance you can follow if you are unsure about whether your application requires a SoECAT at the Research Cost funding application stage.
  • Get in touch with Suzy Wignall, the Clinical Governance Advisor, or your Funding Development Officer.
  • Further information about the SoECAT can be found here.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Guidance available to support researchers attending an NHS REC meeting

Two new links have been added to the Clinical Governance blog under the ‘Useful Links and Documents’ section which give further information and guidance as to attending an NHS Research Ethics Committee meeting for your project. The links are also provided below-

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

New midwifery paper CMMPH

Congratulations to Dr. Luisa Cescutti-Butler and Prof. Sue Way in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) on the publication of their latest research article.  This new paper called ‘The experience of student midwives being taught newborn infant physical examination (NIPE) as an extracurricular activity at a university in the UK: A descriptive survey study’ has been accepted by Nurse Education in Practice [1].  The paper went online pre-publication earlier this week.

Congratulations

Prof. Edwin van Teijlingen

CMMPH

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 4th February, Research Development & Support are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

By the end of this workshop you will have an understanding about:

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

If you’re interested in attending then reserve your place via Organisational Development.

NIHR resources – Patient and Public Involvement and Social Media Toolkit

Two resources are now available on the NIHR Learn website for researchers –

  • Patient and Public Involvement: Inspiring New Researchers – an online course developed by the Department of Health and NIHR. It is intended to help researchers to understand the benefits of good Patient and Public involvement into their research.
  • Social Media Toolkit – a combination of practical resources on how to get started and real case studies from how colleagues across the NIHR Clinical Research Network are currently using social media to support their work.

To access the above resources you will need to have access to the NIHR Learn website. Once you have an account select the tab ‘Health Research Innovations’ and then click on ‘NIHR Endorsed Learning’. Both courses are free and do not require an enrolment key.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Community-Based Research Event – register your interest

An exciting opportunity to attend a workshop, please see below for further details –

‘A team from the National Institute for Health Research (NIHR) are working on a project looking at how we recruit research study participants from commercial High Street health care providers (e.g. Boots, SpecSavers etc), or organisations that support health in some way (e.g. gyms, slimming clubs etc).

The project is titled Community-Based Research and we are looking to answer two specific questions:

  1. How can people with known health issues being seen only ‘on the high street’ access research?
  2. How can people with known health risk factors, who are pre-disease diagnosis, access research?

These two groups could miss out on research opportunities currently because they don’t come into the standard health system until they are either considered to be too severe for High Street treatment (in the case of group 1) or they already have a health problem (in the case of group 2).  We are looking to develop a process by which we can actively recruit participants at scale for trials before they need to access the health service, thus enabling better recruitment of milder disease and pre-disease phenotypes.  We are aware that research is happening in these two groups and would like to pull together researchers who have this experience in order to learn from their successes and challenges.

To support this ETI we are running a workshop on January 31st, 10.30-3.30, at The Wesley Euston Hotel & Conference Venue, London, which will bring together the research community to discuss:

a)      Examples of how we currently recruit from these settings, identifying successes and challenges

b)      Based on these, identifying the key elements of a recruitment strategy that the Clinical Research Network could use

We would like to invite researchers to attend if this would be of interest. Please could nominated representatives complete this Eventbrite registration page (https://www.eventbrite.co.uk/e/nihr-crn-community-based-research-event-tickets-83954384825) including indicating which Specialty they are representing.’

The last Christmas present

“On the twelfth day of Christmas ….” the editor  of the Journal of Health Research Ms Sunanta Wongchalee informed us that our paper ‘Silicone use in Nepali transgender women: The hazards of beauty’ has been accepted for publication [1].  That is nice belated Christmas present to receive on January 6th and a good start of the New Year.  The paper is written by FHSS’s Dr. Pramod Regmi and Prof. Edwin van Teijlingen with Sanjeev Raj Neupane in Nepal.  This is the second paper from this unique study on transgender women in Nepal, the first one was published last year in BMJ Open [2].

References:

  1. Regmi, P., van Teijlingen, E.,, Neupane, S. (2020) Silicone use in Nepali transgender women: The hazards of beauty, Journal of Health Research (accepted)
  2. Regmi, P., van Teijlingen, E., Neupane, S., Marahatta, S. (2019) Hormone use among Nepali transgender women: a qualitative study, BMJ Open 9: e030464. doi:10.1136/bmjopen-2019-030464.

 

Nepal’s migrant workers & risk at the workplace

For nearly a decade BU researchers have published widely about the hazards and risk of Nepali migrant workers in Asia and the Middle East [1-9].  Despite the fact that most migrant workers end up in semi-skilled and unskilled jobs in their host countries, only a minority report poor working environments.  For example, in Pratik Adhikary’s PhD study in FHSS only just over a fifth of migrant workers reported that their work environment in the Middle East or Malaysia was poor or very poor [4].  This relatively high level of satisfaction appears to seems contradict reports in local media on the risks associated with Nepali migrants working abroad, especially focusing on the football world cup in Qatar [7], official reports that many hundreds of bodies of dead Nepali migrants return home every year [10], and the fact that many of these Nepali migrant workers end up doing the jobs the local populations finds too dirty, dangerous and demeaning (colloquially referred to as 3D-jobs).  Why do so many who travel abroad take to do risky, dirty and otherwise undesirable jobs, but still assess their working environment as not too bad?

More theoretical papers on the drivers of migration have referred to many interconnected factors and links [11-12].  Local drivers in Nepal include poverty, lack of employment opportunities, having a history of work-related migration, a growing culture of migration (i.e. it becomes more or less an expectation) and many more.  One local element that is perhaps too easily ignored is that many Nepali migrant workers would have ended up in dirty, dangerous and demeaning jobs at home too.  And the risk, on for example building sites in Nepal might be even greater than that in Qatar or elsewhere in the Middle East as some of the photos below illustrate.  These photos of an accident involving an external building lift were taken today on a building site in Kathmandu.  

 

 

 

 

 

 

 

 

 

 

References:

  1. Adhikary P., Keen S., van Teijlingen E. (2011) Health Issues among Nepalese migrant workers in Middle East. Health Science Journal 5: 169-75. www.hsj.gr/volume5/issue3/532.pdf
  2. Adhikary, P, Sheppard, Z., Keen, S., van Teijlingen, E. (2017) Risky work: accidents among Nepalese migrant workers in Malaysia, Qatar & Saudi Arabia, Health Prospect 16(2): 3-10.
  3. Simkhada, P.P., Regmi, P.R.van Teijlingen, E., Aryal, N. (2017) Identifying the gaps in Nepalese migrant workers’ health and well-being: A review of the literature. Journal of Travel Medicine, 24 (4). https://doi.org/10.3126/nje.v9i3.25805
  4. Adhikary P, Sheppard, Z., Keen S., van Teijlingen E. (2018) Health and well-being of Nepalese migrant workers abroad, International Journal of Migration, Health & Social Care 14(1): 96-105 https://doi.org/10.1108/IJMHSC-12-2015-0052
  5. Regmi, P.van Teijlingen, E.Mahato, P.Aryal, N., Jadhav, N., Simkhada, P., Zahiruddin, Q.S., Gaidhane, A. (2019) The Health of Nepali Migrants in India: A Qualitative Study of Lifestyles and Risks. International Journal of Environmental Research and Public Health, 16 (19). https://doi.org/10.3390/ijerph16193655
  6. Aryal, N., Regmi, P.R., Faller, E.M., van Teijlingen, E., Khoon, C.C., Pereira, A., Simkhada, P. (2019) Sudden cardiac death and kidney health related problems among Nepali migrant workers in Malaysia. Nepal Journal of Epidemiology, 9 (3), 788-791. https://doi.org/10.3126/nje.v9i3.25805
  7. Adhikary P, van Teijlingen E., Keen S. (2019) Workplace accidents among Nepali male workers in the Middle East and Malaysia: A qualitative study, Journal of Immigrant & Minority Health 21(5): 1115–1122. https://link.springer.com/article/10.1007/s10903-018-0801-y
  8. Regmi, P., van Teijlingen, E., Mahato, P., Aryal, N., Jadhav, N., Simkhada, P., Syed Zahiruddin, Q., Gaidhane, A., (2019) The health of Nepali migrants in India: A qualitative study of lifestyles and risks, Journal of Environmental Research & Public Health 16(19), 3655; doi:10.3390/ijerph16193655.
  9. Regmi, P., Aryal, N., van Teijlingen, E., Adhikary, P. (2019) Nepali migrant workers and the need for pre-departure training on mental health: a qualitative study, Journal of Immigrant & Minority Health https://link.springer.com/content/pdf/10.1007/s10903-019-00960-z.pdf
  10. Ministry of Labour and Employment, Government of Nepal. (2018) Labour migration for employment: a status report for Nepal: 2015/2016 – 2016/2017. In. Kathmandu, Nepal: Ministry of Labour and Employment.
  11. Van Hear, N., Bakewell, O., Long. K. (2018) Push-pull plus: reconsidering the drivers of migration, Journal of Ethnic & Migration Studies, 44:6, 927-944, DOI: 10.1080/1369183X.2017.1384135
  12. Iqbal, M., Gusman, Y. (2015) Pull and Push Factors of Indonesian women migrant workers from Indramayu (West Java) to work abroad. Mediterranean Journal of Social Sciences, 6(5): 167   https://www.mcser.org/journal/index.php/mjss/article/view/7893

Community-Based Research Event – register your interest

An exciting opportunity to attend a workshop, please see below for further details –

‘A team from the National Institute for Health Research (NIHR) are working on a project looking at how we recruit research study participants from commercial High Street health care providers (e.g. Boots, SpecSavers etc), or organisations that support health in some way (e.g. gyms, slimming clubs etc).

The project is titled Community-Based Research and we are looking to answer two specific questions:

  1. How can people with known health issues being seen only ‘on the high street’ access research?
  2. How can people with known health risk factors, who are pre-disease diagnosis, access research?

These two groups could miss out on research opportunities currently because they don’t come into the standard health system until they are either considered to be too severe for High Street treatment (in the case of group 1) or they already have a health problem (in the case of group 2).  We are looking to develop a process by which we can actively recruit participants at scale for trials before they need to access the health service, thus enabling better recruitment of milder disease and pre-disease phenotypes.  We are aware that research is happening in these two groups and would like to pull together researchers who have this experience in order to learn from their successes and challenges.

To support this ETI we are running a workshop on January 31st, 10.30-3.30, at The Wesley Euston Hotel & Conference Venue, London, which will bring together the research community to discuss:

a)      Examples of how we currently recruit from these settings, identifying successes and challenges

b)      Based on these, identifying the key elements of a recruitment strategy that the Clinical Research Network could use

We would like to invite researchers to attend if this would be of interest. Please could nominated representatives complete this Eventbrite registration page (https://www.eventbrite.co.uk/e/nihr-crn-community-based-research-event-tickets-83954384825) including indicating which Specialty they are representing.’