Background

The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health to develop public health guidance onManaging overweight and obesity in adults - lifestyleweight management services.

The scope for this work can be found on the Managing overweight and obesity in adults webpage.

Since publication of the NICE guidance on obesity (2006), more evidence is available on the effectiveness of non-clinical, lifestyle-based weight management programmes for adults. As a result, it may be possible to refine and clarify best practice for both self-help and referral schemes. New evidence may also support the development of guidance on how to commission lifestyle weight management services. This might include, for example, whether a minimum number of sessions are required to ensure cost effectiveness, or the best ways to provide ongoing support. This guidance will provide recommendations for good practice, based on the best available evidence of effectiveness, including cost effectiveness. It is aimed at commissioners, health professionals and providers of weight management programmes. It will also be of interest to overweight and obese adults and other members of the public.

For the purpose of this guidance, multi-component lifestyle weight management approaches are defined as those which focus on adults who are overweight or obese and aim to change someone’s behaviour to reduce their energy intake and make them more physically active. It may include weight management programmes, courses or clubs that: 

• accept adults through self-referral or referral from a health practitioner
• are provided by the public, private or voluntary sector
• are based in the community, workplaces, primary care or online.

Call for evidence

We are now undertaking a call for evidence. Any submitted evidence will supplement 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 We are particularly interested in receiving unpublished, commercial or other data that we would not be able to identify through a search of databases.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.

We are interested in data that can contribute to any of the following key questions:

• How effective and cost effective are multi-component lifestyle weight management programmes for adults?
• How does effectiveness and cost effectiveness vary for different population groups (for example, men, black and minority ethnic or low-income groups)?
• What are the best practice principles for multi-component lifestyle weight management programmes for adults?
• What are the most effective and cost effective behavioural or psychological components of a lifestyle weight management programme for adults – and who might best deliver them?
• What are the views, perceptions and beliefs of adults in relation to lifestyle weight management programmes (whether or not they use such programmes)? How can overweight and obese adults from a diverse range of backgrounds be encouraged to join, and adhere to, these programmes?
• How can lifestyle changes and weight loss be sustained once the weight management programme has ended?
• What barriers and facilitators affect the delivery of effective weight-management programmes for adults and how do they vary for different population groups?
• What are the best practice principles for primary care when referring people to commercial, voluntary or community sector or self-help lifestyle weight management programmes?
• What are the best practice principles for commissioners of lifestyle weight management services for adults?
• What training is needed for professionals involved directly or indirectly with lifestyle weight management programmes for adults?
• How should lifestyle weight management programmes be monitored and evaluated locally?

We are interested in a broad range of different types of information, including local process and evaluation reports, finance reports, the pricing of weight management programmes and cost effectiveness data alongside more traditional quantitative evidence (such as experimental trials, pilots or observational studies) and qualitative evidence (such as those which consider or translational studies. 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.  The type of outcomes we are interested in include:

• Anthropometric measures, such as percentage weight loss, or changes in weight, BMI or waist circumference.
• Maintenance of weight loss in the short, medium and long term.
• Intermediate measures such as changes in diet or physical activity level.
• Psychological outcomes such as self-efficacy, motivation or mental wellbeing.
• Process measures such as participant satisfaction with weight management services, adherence (for example, percentage drop out rates), and measures of service reach and sustainability.

We are particularly interested in anonymised individual data (in order to link changes in weight, body mass index (BMI) or waist circumference  with the characteristics of the programme and of the individual), and would wish to discuss ensuring complete anonymity of the data with any supplier before it is sent to NICE.

With finance data, we are interested in the cost to individuals or the LA/NHS of taking part in a weight management programme, including discounts by volume and for longer contracts. We are unlikely to be interested in the profits or losses to a commercial company.  

We are interested in measuring the cost effectiveness of a weight management programme from the viewpoint of those paying for it. One way of doing this would be to divide the decrease in weight lost (or not gained) in total for all participants in the programme by the total amount paid on behalf of the people taking part in it. The weight lost (or not gained) could be measured over the length of the programme but may also be measured at a point of time (e.g. 12 months) after the end of the programme. The cost effectiveness analysis could also be carried out for subgroups (such as by gender, age, ethnicity or socioeconomic status).

Submitting evidence

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 Natalie.Bartle@nice.org.uk

Forwarding relevant evidence

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

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

Please send any relevant evidence by 27 July 2012.

Paper copies can be sent to:

Denise Jarrett
Co-ordinator for Centre for Public Health Excellence
National Institute for Health and Clinical Excellence
Level 1A
City Tower
Piccadilly Plaza
Manchester M1 4BD 

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.