Tagged / Health

Nepal reproductive health paper published yesterday

Congratulations on the latest paper published yesterday by Dr. Preeti Mahato in the Centre for Midwifery, Maternal & Reproductive Health (CMMPH) and colleagues.   This paper ‘Factors associated with contraceptive use in rural Nepal: Gender and decision-making’ [1], is freely available for the next 49 days through our personalized link: click here

 

This research paper in the journal Sexual and Reproductive Healthcare reports on a secondary analysis of pas a quantitative cross-sectional study in four villages of a hilly district in Nepal.  This authors found that gender was associated with current/ever use of contraceptives but decision-making was not found associated with current/eve use of contraceptives.  And, as perhaps was to be expected, socio-economic factors such as husband’s and wife’s education; and indicators showing sharing of childcare responsibilities were found to be associated with contraceptive use.   the paper concludes that educational, health promotional and family planning programmes involving husbands are needed to promote use of contraceptives.


Preeti’s co-authors are based at Dorset County Hospital in Dorchester, at CMMPH and at Singapore Clinical Research Institute/Duke-NUS Graduate Medical School, Singapore.

 

Reference:

  1. Mahato, P., van Teijlingen, E., De Souza, N., Sheppard, Z. (2020) Factors associated with contraceptive use in rural Nepal: gender and decision-making, Sexual & Reproductive Healthcare 24: 100507 https://doi.org/10.1016/j.srhc.2020.100507

 

Medical textbook translated into Spanish

This week saw the publication of Psicología y sociología aplicadas a la medicina [1].  This is a translated version of the fourth edition of Psychology & Sociology Applied to Medicine: An Illustrated Colour Text  [2] which was published last year by the international publishing house Elsevier.  This textbook for medical students is edited by Bournemouth University’s Prof. Edwin van Teijlingen, who is a Medical Sociologist and Prof. Gerry Humphries, who is Professor in Health Psychology at the School of Medicine, University of St Andrews.

Una sólida herramienta que aporta a los lectores valiosos conocimientos sobre los provesos psicológicos y sociológicos, fundamentales para proporcionar una atención personalizada.  Obra extremadamente relevatne para el currículo y la práctica médica actual, donde se hace cada vez más hincapié en el lugar que ocupa la medicina en la sociedad y en la enfermedad como producto de las circunstancias psicológicas y sociales, más que como un mero fenómeno biológico.   Los temas se presentan resumidos visualmente enuna doble página. Se acompañan con casos que refuerzan la comprensión de los conceptos fundamentales y con cuadros resumen y cuestiones para la reflexión.   Ayuda a apreciar el lado “no científico” de la medicina; lo importante que es entender de dónde viene el paciente, geográfica e ideológicamente. Además, aborda a la perfección temas tan actuales, como las dificultades sociales derivadas de las pruebas genéticas.

References:

  1. van Teijlingen, E. & Humphris, G. (Eds.) (2020) Psicología y sociología aplicadas a la medicina (Spanish translation), Madrid: Elsevier España [ISBN 978-84-9113-674-3/eISBN 978-84-9113-713-9].
  2. van Teijlingen, E. & Humphris, G. (Eds.) (2019) Psychology & Sociology Applied to Medicine: An Illustrated Colour Text (4th Edn), Edinburgh: Elsevier.

COVID-19 guidance for clinical researchers

The Health Research Authority have released guidance for clinical researchers, sponsors and sites with regard to COVID-19 (Coronavirus) – please read this guidance if you are currently conducting your project or are in the planning stages/set-up of the study (so you are aware of the current situation).

This guidance is subject to change and will be updated as and when required by the HRA.

You can read the guidance in the link provided above, but for convenience, these are the most likely situations BU clinical researchers may face. Please ensure that in planning amendments that these do not create additional burden to NHS staff or resources.

Amendments to existing studies impacted by wider COVID-19 response 

  • Example – Where changes to administrative arrangements are required to reduce burden or physical contact with sites – for example, changes to monitoring arrangements.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. Where the study involves the NHS, they will be marked by the sponsor as a category C amendment not requiring assessment, and sent directly to the sites. The site should implement the amendment on the date specified by the sponsor.

  • Example – Where changes are made to how or when patients are seen to avoid exposing patients or to reduce burden on clinical services – for example, changing site visits to phone calls or postal questionnaires.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as the first example should be followed.

  • Example – Where a temporary halt needs to be placed on some or all of the study, or the duration of the study needs to be extended.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as above should be followed.

  • Example – studies that need to be closed.

How this should be handled – for studies not involving provision of treatment to participants, a notification to the REC or study-wide review (for non-REC studies) should be provided, and an end of study report should subsequently be provided.
For any studies involving provision of treatment to participants, careful consideration should be given to post-study care. If this cannot be in line with the information provided in the participant-information sheet, a substantial amendment should be submitted.

To support sites in implementing the amendments it is important that:

  • The changes and local implications are made clear
  • Any changes to documentation are provided in tracked changes
  • In England and Wales All correspondence to sites should be copied to R&D/I department and the PI and delivery teams
  • Where indicated above, the sponsor should include the category and confirm that no assessment is required.

There may be some instances in which the site may raise issues or changes that need to be made. If they do, please inform the Sponsor as soon as possible.

What to do next

If you think that you may need to implement any changes or amendments to your study due to COVID-19 please get in touch with us as soon as possible. If you have any concerns or queries then please also get in touch to discuss these.

Latest NIHR-CRN podcast

The latest podcast in the Health Research Futures series comes from Professor Julie Lovegrove. Professor Lovegrove is from the University of Reading and talks about the challenges of conducting nutritional research and overcoming them.

 

Informed Consent training opportunities

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and at Wessex CRN’s office –

  • NIHR CRN Informed Consent training, Thursday 26th March, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN;
  • NIHR CRN Informed Consent training, Thursday 7th May, 8:30am – 12:30pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Thursday 7th May, 1:00pm – 5:00pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Friday 26th June, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

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.

A three-day Sandpit focused on Digital Technologies for Health and Care

UKRI have announced an opportunity to apply to attend a sandpit on Digital technologies for Health and Care.

This is the first sandpit in a series of three which will be advertised over the next three years.

The theme for this sandpit is novel digital technologies for improved self-monitoring and health management. The sandpit will run over three days starting mid-morning on Tuesday 30 June 2020 and finishing mid-afternoon on Thursday 02 July 2020.

Key dates:

  • Call announced: February 2020
  • Call close (expressions of interest): 04 May 2020
  • Participant Selection panel: May 2020
  • Sandpit: 30 June-02 July 2020
  • Funding Application Deadline: w/c 14 September 2020
  • Funding Announcement: Before 30 September 2020

For more details please visit EPSRC web page or contact your RDS Research Facilitator for further assistance.

New BU diabetes research

Congratulations to Dr. Sarah Collard in the Department of Psychology, Dr. Pramod Regmi in the Department of Nursing Science and FHSS Visiting Professor Katherine Barnard-Kelly on their publication: ‘Exercising with an automated insulin delivery system: qualitative insight into the hopes and expectations of people with type 1 diabetes’  [1]. This paper in Practical Diabetes is a joint publication with several North American scholars.

The authors of this qualitative paper distilled three themes related to the benefits of automated insulin delivery systems: (a) more freedom and spontaneity in the individual’s ability to exercise; (b) relief
from worry of hypoglycaemia as a result of exercise; (c) removing the ‘guesswork’ of adjusting insulin for exercise, as well as two further themes relating to potential concerns with regard to safely exercising while wearing an automated insulin delivery system.

Well done!

Prof. Edwin van Teijlingen

CMMPH

 

Reference:

  1. Collard, S.S., Regmi, P.R., Hood, K.K., Laffel, L., Weissberg-Benchell, J., Naranjo, D., Barnard-Kelly, K. (2020) Exercising with an automated insulin delivery system: qualitative insight into the hopes and expectations of people with type 1 diabetes, Practical Diabetes 2020; 37(1): 19–23

Health Research Authority email addresses are changing

All email addresses at the HRA are changing in the coming weeks and this change will be complete by March 2020.

HRA staff email addresses will be standardised as firstname.lastname@hra.nhs.uk. A full list of contact email addresses for the Research Ethics Committees is now available here.

If you use the HRA staff member’s @nhs.net email address to contact them after they have moved to their new email address, you will receive a response containing their new details but your email won’t be automatically forwarded.

If you are unsure which contact information to use for the individual or service you require, please contact the HRA mainline on 020 797 22545 or use their contact form.

Make sure to check your junk mail if you are expecting emails from the HRA or an NHS REC as they often are sent there instead. Please add them to your safe senders list if this is the case to make sure you don’t miss any important study emails!