Information Generating Initiatives to Monitor the Performance of Actions
It is essential that the performance of actions to improve the prevention, diagnosis, treatment, care and support services to i) reduce the numbers of people becoming infected with Hepatitis C, ii) reduce the proportion of infected people who are undiagnosed and, iii) increase the numbers of infected people who clear their virus as a consequence of antiviral treatment, is monitored closely. All three Phase I Working Groups - the Prevention Group, the Testing, Treatment, Care and Support Group and the Education, Training and Awareness-raising Group - considered what Information Generating Initiatives ( IGIs) would be required in the context of their proposed actions; this was achieved by reviewing existing systems to identify if these needed further development or if completely new IGIs were required.
Clinical data to monitor the performance of actions 6 and 7 are required.
- Some sources of information such as the Scottish Hepatitis C Diagnosis Database - providing data on numbers and demographic/risk characteristics of persons diagnosed with Hepatitis C - are well established. 13
- The bulk of funding for Phase II of the Action Plan will be spent on improving treatment, care and support services so that the numbers of persons receiving antiviral therapy will increase from 450 in 2006 to 1,500 by 2010/11; the drug costs of a course of antiviral therapy are, on average, £8,000. It is essential that robust clinical data to monitor, for example, the numbers of persons offered, receiving and responding to therapy in all major treatment centres, are available.
- Since 2004, the Scottish Government has funded the development of local clinical databases, the data from some of which informed key Phase II actions. The current system, however, is relatively rudimentary. In the context of a very considerable increase in the numbers of infected persons to be managed in specialist treatment centres over the Phase II period and beyond, a Generic Clinical System for Hepatitis C - one that not only provides monitoring data but facilitates patients' management and conforms with Scotland's e-Health requirements - is needed.
- The further development of the National Hepatitis C Clinical Database, including the establishment of a Generic Clinical System for Hepatitis C, will be undertaken ( Action 19).
This action will ensure that measures to improve treatment, care and support services for Hepatitis C infected individuals, and thus reduce their chances of progressing to severe Hepatitis C-related disease, are evaluated effectively.
Data to monitor the performance of actions 10 and 11 are required.
- In 2009, public awareness campaigns to promote Hepatitis C testing among persons at risk of infection will be implemented. It is important that the performance of the campaigns regarding numbers of people undertaking a Hepatitis C test and the yield of detected infections is monitored as a measure of how appropriately testees have self-selected.
- A National Hepatitis C Diagnosis Database, involving the reporting of Hepatitis C positive diagnoses by laboratories to HPS, exists but, currently, data on all persons undergoing testing, regardless of test result, are unavailable. Accordingly, a system to capture such data is required.
- The development of a surveillance system to monitor Hepatitis C testing practice in Scotland will be undertaken ( Action 20).
This action will ensure that awareness campaigns aimed at reducing the proportion of infected persons who are undiagnosed are evaluated effectively.
Data to monitor the performance of actions 14-16 are required.
- A considerable amount of funding is being allocated for i) the improvement of services providing injection equipment to IDUs, ii) the education of this group and individuals at risk of starting to inject drugs and, iii) the generation of guidelines on injection equipment provision.
- Virtually no robust studies have been undertaken anywhere to ascertain the effectiveness of harm reduction interventions at preventing Hepatitis C transmission among IDUs. 34 The reasons for this are multiple and include: the complexity of designing such studies (particularly experimental ones involving intervention and control populations); the ethics of performing such studies in the context of the interventions already being fully or partially introduced; and, the expense of such studies.
- With the implementation of Phase II of the Action Plan there is a unique opportunity to gauge the impact of a package of major interventions on injection equipment uptake and sharing, and on Hepatitis C transmission among IDUs, by examining these measures before and after the implementation of the package in 2009. The interventions involve the generation of guidelines on injection equipment provision, the improvement of such provision in terms of quantity, quality and nature of service, and the development of more and better educational initiatives for IDUs and persons at risk of commencing injecting.
- Despite injection equipment having been made available to IDUs in Scotland over the last 20 years, no systematic approach to collecting data on the provision and uptake of such equipment exists.
- If the effectiveness of interventions is to be fully evaluated, it is essential that data on the incidence of Hepatitis C infection among IDUs throughout Scotland are collected.
- Studies, undertaken in Scotland 4 and elsewhere, demonstrate that measures of Hepatitis C incidence among IDUs can be generated through testing them for Hepatitis C and i) relating the result to the date of injecting drug use commencement and the age of the person and, ii) undertaking, on samples, laboratory tests which identify individuals who have just recently become infected.
- The development of a data collection system to monitor the provision of injection equipment in Scotland will be undertaken ( Action 21).
- Annual surveys of Hepatitis C prevalence and incidence among IDUs across Scotland will be performed ( Action 22).
These actions will ensure that the package of interventions designed to increase uptake and reduce sharing of injection equipment, and reduce Hepatitis C transmission, among IDUs is evaluated effectively.
If the performance of actions involving the development of prevention, diagnosis, treatment, care and support services in the prison setting is to be gauged, it is important that the proportion of Scotland's prison population who are Hepatitis C infected, the proportion of this group who are undiagnosed and the incidence of Hepatitis C transmission among prison inmates, is understood.
Also, if a sound understanding of the Hepatitis C diagnosis, treatment, care and support needs of i) children and ii) persons originating from Pakistan (and, possibly, other South Asian countries) - populations about whom little is known, apropos the proportions infected with Hepatitis C - is to be achieved, it is essential that prevalence studies on these groups are undertaken.
- The most recent series of Hepatitis C prevalence studies in Scotland's prisons were undertaken in the mid 1990s; inmates of five adult prisons were surveyed. Overall, Hepatitis C antibody prevalence was 24%. 21
- The only UK in-prison Hepatitis C incidence study was undertaken in Shotts Prison during 1999/2000; the incidence of Hepatitis C among inmates who had ever injected drugs was 12 per 100 person years of incarceration. 45
- Since the late 1990s, Scotland's prison population demographics have changed ( e.g. more prisoners) and large numbers of in-prison methadone therapy slots for drug users have become available.
- No major studies to determine the prevalence of Hepatitis C among children in the UK have been performed. A pilot study of children, averaging five years of age, who attended the General Anaesthetic Department of the Glasgow Dental Hospital and School in 2002, revealed that 2 of 70 were infected and that performing such a study in this setting was ethical and acceptable to parents and children. 47
- In Glasgow, where the great majority of Scotland's 32,000 Pakistani population reside, 48 Pakistani males, over the age of 50, have a tenfold greater chance of having been diagnosed Hepatitis C positive than other men belonging to the same age group. 49
- Studies to determine the prevalence of Hepatitis C among first generation Pakistani populations in England are being conducted.
- The interest in knowing the prevalence of Hepatitis C among first generation Pakistanis stems from knowledge that the prevalence of Hepatitis C in Pakistan (4-7%) 50-52 is one of the highest in the world and that around 320,000 Pakistani born individuals live in the UK. 53
- A survey of Hepatitis C prevalence and incidence among prisoners in Scotland will be undertaken ( Action 23).
- Surveys to estimate the prevalence of Hepatitis C among i) children in Scotland and, ii) people in Scotland who have lived in Pakistan (and, possibly, other South Asian countries) will be undertaken ( Action 24).
These actions will generate data to inform the needs of Hepatitis C infected prisoners, children and Pakistanis and will ascertain the effectiveness of measures to prevent the spread of Hepatitis C within the prison setting.