Overview

NICE is issuing a call for evidence to support the development of public health guidance on ‘Vitamin D: implementation of existing guidance to prevent deficiency’. We are particularly interested in any relevant unpublished, commercial or other information that we would not be able to identify through a search of databases (for example, information about local interventions or processes to increase awareness and update of supplements containing vitamin D).  This will help support consideration of the key questions in the scope for this work:

Question 1: How effective and cost effective are interventions to increase awareness and implementation of existing guidance on vitamin D among health professionals or others working with at-risk populations? What are the implications for professional training and practice?

Question 2: How effective and cost effective are interventions to increase awareness and uptake of existing guidance on vitamin D among at-risk groups (with special consideration given to those eligible for the Healthy Start scheme)?

Question 3: What helps or hinders the implementation of existing guidance on vitamin D by commissioners, providers, practitioners, those working with at-risk groups and people in at-risk groups?

Question 4: What local provision is made to ensure vitamin D supplements are available for different at-risk groups (including Healthy Start, prescriptions and over-the-counter sales)?

The closing date for submissions is the 30 April 2013.

Background

Vitamin D is essential for skeletal growth and bone health. Dietary sources are limited. The major natural source of vitamin D is from skin synthesis following exposure to sunlight. In winter months, the UK population relies on body stores and dietary sources to maintain vitamin D levels (Scientific Advisory Committee on Nutrition 2007).

There have been reports that rickets is re-emerging in the UK (Pearce and Cheetham 2010). The national diet and nutrition survey of British adults (Ruston et al. 2004) also suggests that about a quarter of British women aged 19–24, and a sixth of those aged 25–34, are at risk of vitamin D deficiency.

Vitamin D deficiency can occur at any age but is more likely during periods of rapid growth (for example, during childhood), during pregnancy and while breastfeeding. People of South Asian, African, Caribbean and Middle Eastern descent, and those who remain covered when outside, are at particular risk. Older people are also at increased risk because their skin cannot synthesise vitamin D efficiently, they are likely to spend more time indoors and may not have enough dietary vitamin D. Limited sun exposure all year round – for example, because people are house bound or are in prison –also increases the risk (Scientific Advisory Committee on Nutrition 2007).

In 1991, the Committee on Medical Aspects of food policy (COMA) set reference nutrient intakes (RNI)for vitamin D (DH 1991). Some population groups can only achieve the RNI for vitamin D by taking a supplement.All UK health departments (Chief Medical Officers 2012) and NICE (see guidance on antenatal care and maternal and child nutrition) have issued evidence-based guidance on vitamin D supplements for various at-risk groups. They have also provided guidance on how to distribute free Healthy Start supplements (which contain vitamin D) to eligible families.

Evidence suggests implementation of these recommendations has been limited and there has been concern about how clear and consistent the recommendations are (Chief Medical Officers 2012; Feeding for Life Foundation 2012; DH: personal communication 2012). The cost effectiveness of implementing existing guidance on vitamin D also remains unclear.

Supplements containing vitamin D are available on prescription or for sale from pharmacies or shops. However, there is wide variation in the content and cost and some products may not be suitable for particular at risk groups. Healthy Start vitamins tend to be available from health clinics, children’s centres, Sure Start centres, outreach programmes or GP surgeries, although there have been local supply problems. Primary care spending on treatments for vitamin D deficiency rose from £28 million in 2004 to £76 million in 2011 (Robinson 2012; Health and Social Care Information Centre 2012).  

Introduction to call for evidence

This is the call for evidence for this guidance. The closing date for submissions is the 30^th April 2013. Any submitted evidence will contribute to the evidence reviews that are being commissioned as part of the development of this guidance. We are particularly interested in receiving unpublished, commercial or other data that we would not be able to identify through a search of databases. We are able to accept data in confidence (see below). Please note that for published data, we are interested in data published from 1995 onwards.

Key questions

We would like data that can contribute to any the key questions in the scope for this work, although we are particularly interested in information on the barriers and facilitators to implementation and process reports on local arrangements to increasing availability and uptake of vitamin D supplements (including healthy start).

The questions as stated in the scope are as follows:

Question 1: How effective and cost effective are interventions to increase awareness and implementation of existing guidance on vitamin D among health professionals or others working with at-risk populations? What are the implications for professional training and practice?

Question 2: How effective and cost effective are interventions to increase awareness and uptake of existing guidance on vitamin D among at-risk groups (with special consideration given to those eligible for the Healthy Start scheme)?

Question 3: What helps or hinders the implementation of existing guidance on vitamin D by commissioners, providers, practitioners, those working with at-risk groups and people in at-risk groups?

Question 4: What local provision is made to ensure vitamin D supplements are available for different at-risk groups (including Healthy Start, prescriptions and over-the-counter sales)? 

Information of interest

We are interested in a broad range of different types of information, including local process and evaluation reports, measures of service reach and sustainability and finance reports, alongside more traditional quantitative evidence (such as pilots or observational studies) and qualitative evidence (such as those which consider participant satisfaction or reasons for drop out). We are particularly interested in evidence that may help to better promote equality of opportunity relating to age, disability, gender, gender identity, ethnicity, religion and belief sexual orientation or socio-economic status.

With finance data, we are interested in the cost to individuals, the local authority or NHS of taking part in an intervention, including discounts by volume and for longer contracts. We are unlikely to be interested in the profits or losses to a commercial company.

Submitting evidence

If possible, it would be helpful if you could identify which (if any) of the questions above the information you are submitting relates to.

The only type of material we are not interested in is unsubstantiated opinion / discussion pieces or promotional material. Due to copyright restrictions please only forward the details of references for papers published in peer reviewed or other press. Please note that we are no long able to accept paper or electronic versions of evidence if it is published in the peer reviewed or other press.

The details and documents for this call for evidence can be found on the NICE website.

Please note that the following material is not eligible for consideration:

• Promotional material
• Opinion / discussion pieces
• Forms with electronic attachments of published material (eg journal articles), or hard copies of published material. For copyright reasons, we cannot accept these copies. However, if you give us the full citation, we will obtain our own copy. We are able to accept attachments of unpublished reports, local reports / documents.

Commercially or academically sensitive information

If you wish to submit relevant commercially sensitive information, unpublished information or research, please can you highlight which sections are confidential by using a highlighter pen or the highlighter function in word. Please see Annex 1 for further information on submissions of confidential material.

Please note that we will be holding individual meetings with commercial or other organisations who which to submit commercially or academically sensitive information. If you would like to arrange an individual meeting at NICE please contact Rukshana.Begum@nice.org.uk  

Forwarding relevant evidence

Please send details via the appropriate comments form (below) to: vitaminddeficiency@nice.org.uk

• Comments proforma (published material)
• Comments proforma (unpublished material)

Please send any relevant evidence by 30 April 2013.

Paper copies can be sent to:

Rukshana Begum
Co-ordinator for Centre for Public Health Excellence
National Institute for Health and Clinical Excellence
10 Spring Gardens
London SW1A 2BU

We look forward to receiving information on this and thank you in advance for your help

Annex 1

The use of 'commercial in confidence' and 'academic in confidence' data in the development of public health guidance: statement of principle

1. NICE is under obligations of transparency and fairness to all stakeholders, among others, in the development of its guidance

2. The rights of the owners of the data provided to NICE must be respected.

Definitions

3. Commercial in confidence information is information provided in confidence relating to the commercial interests of the owner of the information

4. Academic in confidence information is information provided in confidence in circumstances where disclosure could prejudice future publication of the information in a scientific publication. It would be expected that any information marked as academic in confidence is going to be published at some stage and that a timeline for publication can be given.

Submission of data

5. The amount of information submitted on an 'in confidence' basis should be kept to a minimum. The whole submission should not be marked as confidential. It is likely to be unacceptable to mark complete sections as confidential.

6. Only information that is genuinely confidential, such as actual numbers, should be marked as in confidence. NICE will only treat information in confidence if the material is in fact either 'commercial in confidence' or 'academic in confidence'.

7. When marking data as confidential, organisations should indicate if this status will apply at the time NICE anticipates publication/presentation of the data. The last opportunity for organisations to review the confidential status of information is during the consultation on the draft guidance and its supporting evidence.

8. For all unpublished data submitted as 'academic or commercial in confidence' the minimum that should be made available for release is that which normally would be included in a CONSORT (or PRISMA) compliant abstract (http://www.consort-statement.org/?o=1011) and be suitable for public disclosure. An equivalent approach is required for all data and studies which underpin and are included in economic analyses and models, and for the economic model included in the submission if that is marked 'academic or commercial in confidence'.

Presentation of data at PHAC or PDG meetings

9. Data that contributes to evidence of effectiveness and cost effectiveness can be presented to a PDG meeting or to a PHAC meeting provided the information is factual, accurate and not misleading.

10. 'Academic in confidence' information may be presented during the PDG and PHAC meetings, even if the meetings are conducted in public. However, the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain

11. The data owner retains the responsibility for the release of 'commercial in confidence' data into the public domain. With the exception of presentation of data at PDG or PHAC meetings, the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain.

Publication of data

12. In circumstances where NICE wishes to publish data regarded by the data owner as academic or commercial in confidence, both NICE and the data owner will negotiate in good faith to seek to find a mutually acceptable solution, recognising the need for NICE to support its recommendations with evidence and the data owner’s right to publication. However the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain.

Economic models

13. NICE will normally disclose in full economic models provided by manufacturers/sponsors to NICE as part of an submission of evidence, together with the data on which such models are based. Exceptionally, data within a model can be treated as confidential if they contain or make practical the reverse engineering of confidential data inputs which are credibly specified as confidential by the organisation or company.

14. Model structures will not be accepted as confidential information, and by submitting a model the manufacturers/sponsor will be taken to have agreed that the model structure may be put into the public domain.

Disclosure of confidential data

15. NICE is challenged that confidential information it has received should be released in the interests of fairness, during the guidance development process or otherwise, data owners must on request promptly reconsider whether it is in fact necessary to maintain confidentiality.

16. NICE does not intend to make repeated requests for a prima facie tenable claim of confidentiality to be abandoned or modified, and it will accept the data owner’s judgement in that regard.

17. NICE cannot 'second guess' the motives of a data owner. If a data owner would not agree to the specific request for disclosure made, but would agree to some more limited disclosure (for example to a "confidentiality club",) then it is asked itself to suggest the disclosure it would find acceptable, rather than wait for NICE to propose the specific formula it may have in mind and discuss and agree a potential solution with NICE.

18. If disclosure is not possible the data owner must be prepared to assert publicly that the information is considered to be confidential, and must submit evidence giving the justification for maintaining confidentiality in defence of NICE's maintenance of that confidentiality. In the absence of any such assertion and evidence, NICE shall be entitled to conclude that the information is no longer confidential.