Comment on NICE’s draft recommendations on the implantation of a duodenal-jejunal bypass sleeve (EndoBarrier) for the management of type 2 diabetes from 22 August


Public Involvement Programme

Commenting on an Interventional Procedures Consultation Document as a patient/carer or member of the public

This factsheet has been designed to help patients/carers and members of the public when commenting on provisional guidance produced by the National Institute for Health and Care Excellence (NICE) the implantation of a duodenal-jejunal bypass sleeve (EndoBarrier) for the management of type 2 diabetes (IP1196).


The sheet:

·        Describes who the Public Involvement Programme are and the support that they can provide

·        Describes what an interventional procedure is

·        Describes the Interventional Procedures consultation process

·        Defines Insertion of a magnetic-bead band for faecal incontinence

·        Suggests issues that patients/carers and members of the public might wish to consider when they comment on provisional guidance issued by NICE

 

Who are the Public Involvement Programme?

The Public Involvement Programme (PIP) are a team within NICE who are here to provide individual patients/carers and members of the public with advice on how they can get involved in the development of Interventional Procedures guidance, including how best to comment on the consultation document. Contact details can be found in the ‘Further Information’ section below.

What is an interventional procedure?

An interventional procedure is a procedure used for diagnosing an illness or treating a patient that involves:

·         making a cut or a hole to gain access to the inside of a patient's body - for example, when carrying out an operation or inserting a tube into a blood vessel

·         gaining access to a body cavity (such as the digestive system, lungs, womb or bladder) without cutting into the body - for example, examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth

·         using electromagnetic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light) - for example, using a laser to treat eye problems.

 

What is an Interventional Procedures Consultation?

The Interventional Procedure Advisory Committee (IPAC) has now met to look at and discuss the evidence, and formulate its draft recommendations. Once the committee has made its draft recommendations, NICE issues a consultation document. The main sections of the document are:

  • The draft recommendations
  • A short description of the procedure, along with what it is used to treat and any current treatment options available for this condition
  • A summary of the evidence (assessed by the committee) on how well the procedure works and how safe it is 

·         Any other comments the committee wishes to make about the procedure or the evidence presented.
 

What is ‘the implantation of a duodenal-jejunal bypass sleeve (EndoBarrier) for the management of type 2 diabetes’?

NICE is looking at a very specific type of procedure which we are calling ‘implantation of a duodenal-jejunal bypass sleeve (EndoBarrier) for the management of type 2 diabetes. In this procedure a plastic tube-like sleeve or liner is inserted through the mouth into the bowel to line the upper part of the bowel, using an endoscope. The sleeve is usually removed through the mouth, again using an endoscope, after about a year. It forms a barrier between food and the upper part of the bowel, thereby causing food to be absorbed further down in the bowel. The aim is to improve diabetes by altering digestion and reducing blood sugar levels.
 

NICE welcomes comments from the parents or carers of patients who have experience of this procedure, but also from any patient or carer who would like to comment on the guidance in general.

 

Practical information

Dates

The public consultation period will run for 4 weeks, and will start on the 22 August 2014, running until the 19 September 2014. During this period anyone is allowed to comment on the draft recommendations that are published on the NICE website.

How can I comment?

You can comment in a number of ways, including:

  • Using the online form on the NICE website (which you can access using the following link – and then clicking on the consultation link at the bottom): http://www.nice.org.uk/guidance/indevelopment/GID-IP1196
  • By email, please submit your comments to This e-mail address is being protected from spambots. You need JavaScript enabled to view it. , please make sure you use the name of the procedure in the email title
  • By post, please send your comments to: Interventional Procedures Team, NICE, 10 Spring Gardens, London, SW1A 2BU
  • By fax, please fax your comments to the following number: 0845 003 7784, please make sure you mark your fax for the attention of the IP team

 

NICE is committed to helping people to comment on their documents. If you have any special requirements that mean that you cannot comment in one of the above ways, please contact Heidi Livingstone in the PIP team ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it. ) who will try to arrange an alternative method.


Making your comments

If you choose to make comments on this consultation NICE would really like to hear the following information from patients/carers and members of the public with experience of this procedure or condition:

  • Your views on the provisional recommendations (these will be in section 1 of the consultation document)
  • Your views on how well the procedure works. This may include any benefits that you may have gained from having this procedure, or any negatives that you may have experienced from having this procedure, that have not been reported in the published literature.
  • Your views on how safe or unsafe the procedure is, including any side effects or complications that you may have experienced that have not been reported in the published literature.
  • New / additional evidence that the Interventional Procedures Committee may have missed when producing its provisional recommendation.  This should only include published evidence that is not already included in the evidence overview on how well the procedure works or on the safety of the procedure. The Interventional Procedures programme does not look at any evidence relating to cost or service provision.

 

When making your consultation comments you may wish to also consider the following points (if you have direct experience of this procedure):

  • The effect the procedure had on the progression of your condition
  • Any results that are really valued by patients/things that have made a big impact on your life, and why
  • The difference (positive or negative) the procedure has made to your
    • Physical wellbeing
    • Lifestyle
    • Mental health
    • Overall quality of life

There are also some issues, that although are important to patients, unfortunately fall outside of the remit of NICE Interventional Procedures Guidance. Comments on these issues are therefore considered less useful by the committee. NICE would encourage you not to comment on the following things:

  • The cost of the treatment, including the cost of private treatment, or comments about the cost savings this would mean to the NHS.
  • Comments about the consent process, this includes comments about your experience of being in hospital and the treatment that you received from the doctors and nurses.

When making a consultation comment you should bear in mind that your comments may be published on the NICE website. Although personal identifying data will removed from your comments before they are published, you should be mindful that your comments may be made public when discussing any sensitive information concerning your condition.

Further information

If you would like any further help or information when submitting your comments, or would like to be sent a link to the consultation document, please contact Heidi Livingstone in the Public Involvement Programme on This e-mail address is being protected from spambots. You need JavaScript enabled to view it. or 020 7045 2183.
 

Equalities

NICE is committed to promoting equality and eliminating unlawful discrimination in its activities.



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