2 How were these guidelines developed?
This chapter describes the process by which these guidelines were developed. It is worth reiterating that these guidelines have been developed in response to an action within the Hepatitis C Action Plan for Scotland, Phase II: May 2008 - March 2011, and the timescales for the process were set by the Action Plan. These timescales allowed seven months in total to produce a set of draft guidelines, which would then be put out to consultation among stakeholders across Scotland. The aim was to publish the final guidelines by July 2009. However, publication was postponed to allow a review to be undertaken by the Crown Office of the Lord Advocate's Guidelines on needle and syringe distribution in Scotland.
Organisations such as the Scottish Intercollegiate Guidelines Network ( SIGN) and the National Institute for Health and Clinical Excellence ( NICE) have formal processes which they follow in developing clinical guidelines. These processes invariably involve drawing up and agreeing a detailed specification for the guidelines; undertaking a systematic review and critical appraisal of the relevant literature; obtaining input from a range of experts in the field; and undertaking wider consultation. In general, this process from start to finish can take up to two or even three years.
The development of guidelines for IEP services in Scotland used a similar, but truncated process, to fit within the much shorter timescales available.
Specifying the scope of the guidelines
The initial specification for the scope of the guidelines came from the Hepatitis C Action Plan, Phase II. This stated that improvements should be made in services that provide injecting equipment in terms of:
- The quantity of injecting equipment distributed
- The quality of the service delivered, and
- The nature of service provision.
This was a very broad and general remit, and one of the first tasks was to set out a specific set of objectives for the guidelines. This was done in consultation with a multi-disciplinary expert group (the Guidelines Development Group), which was gathered for this purpose.
Reviewing the evidence
These guidelines have been informed by evidence of effectiveness in relation to the prevention of BBVs (and HCV in particular) and regarding the prevention and reduction of injection risk behaviour. Evidence related to improving access to and uptake of IEP services, and in relation to improving the quality of IEP services was also considered.
A systematic review of the evidence was not specifically undertaken for these guidelines. Rather, the guidelines have been informed by systematic reviews undertaken by other organisations, including NICE, 22 the World Health Organisation 8 and the Australian Government. 9,23 Reference has also been made to IEP guidelines and policies published in English-speaking countries including Australia, 24,25 Canada 26,27 and Wales. 28 Phase I of Scotland's Hepatitis C Action Plan (September 2006 to March 2008) involved a systematic gathering of evidence to inform the actions to be taken in Phase II and this evidence was also taken into account when developing the guidelines. 29
These guidelines, therefore, have been able to draw on a wealth of recent data on the nature and extent of current service provision and the needs for services in Scotland; review-level evidence on the impact of IEP services on a range of outcomes; as well as a substantial body of research which has been published by the Scottish Government since 2003 within its programme of research on HCV prevention. 17,18,19, 30, 31
Although there was a great deal of information available, it must be acknowledged that there was a dearth of systematic review-level evidence addressing the specific objectives set for these guidelines. Where review-level evidence existed, it has been used. However, where it was lacking, the guidelines have drawn on the findings of primary studies, some of which may have used less rigorous methods. In addition, where evidence was lacking altogether, the guidelines have drawn upon expert opinion.
Obtaining input from experts in the field
In addition to the information gathered through a review of evidence, a group of experts in the field were gathered to help assess the evidence and draft the guidelines. This group also had an important role in drafting guidelines on specific topics (for example, in relation to staff training) where it was felt a guideline was needed, but where evidence was generally lacking.
The members of the Guidelines Development Group comprised 18 experts from a range of disciplines. Members included representatives from IEP services; from NHS, voluntary and academic sectors; and from national bodies including the Scottish Government, the Scottish Prison Service, Health Protection Scotland, NHS Information Services Division, NHS Health Scotland and the Scottish Association of Alcohol and Drug Action Teams ( SAADAT). The group was chaired by Professor Avril Taylor from the University of the West of Scotland, a recognised international expert in the area of harm reduction. A small research advisory group was also established to manage and oversee the process.
The Guidelines Development Group met three times during the course of drafting the guidelines. The first meeting took place in July 2008 and had the aim of outlining the scope and remit of the group. The second meeting was a three-day residential meeting at the end of August 2008, which involved reviewing and assessing the evidence and formulating an initial draft of the guidelines.
A third meeting took place in November 2008 to review, discuss and make changes to the draft guidelines where necessary, resulting in a set of "interim guidelines".
Undertaking wider consultation
In Winter / Spring 2009, the interim guidelines were sent out for wide consultation to stakeholders in Scotland, including, inter alia, Drug and Alcohol Action Teams, HCV Executive Leads and HCV Prevention Teams in each NHS Board, public health consultants, IEP services in the NHS and voluntary sectors, and service user representatives. Service user representatives were also consulted at events held for that purpose. An analysis of consultation responses was undertaken and this is available upon request from the Scottish Government.
The guidelines will be reviewed after the end of the period covered by Phase II of Scotland's Hepatitis C Action Plan - after March 2011.