Global reporting system for hepatitis (GRSH) project description

Transcription

1 Global reporting system for hepatitis (GRSH) project description Contents 1. Background Target audience for this document Data to be reported through the Global Reporting System for Hepatitis Policy uptake indicators Service coverage indicators Impact indicators Implementing the Global Reporting System for Hepatitis Strengthening national reporting processes Future development of the Global Reporting System for Hepatitis References... 7 Annex 1. Policy uptake indicators for viral hepatitis... 8 Annex 2. Aggregated reporting form to monitor the cascade (outline for national reporting, to be expanded with meta-data) using 2017 as a reference year... 9 Annex 3. WHO template for a chronic hepatitis B and C patient management card

2 1. Background In May 2016, the World Health Assembly endorsed the global health sector strategy on viral hepatitis that proposes to eliminate viral hepatitis as a public health threat by 2030 (1). Five core interventions implemented with sufficient service coverage should lead to elimination, defined as a 90% reduction in people newly infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) and a 65% reduction in mortality (compared with the 2015 baseline (Table 1)). In addition, the 13 th WHO General Programme of Work, endorsed by the World Health Assembly in 2018, has integrated the global health sector strategy targets within the three billions and universal health coverage agenda (2). In 2016, WHO published two guidance documents for strategic information on viral hepatitis. Guidance on surveillance explains how to collect data on incidence, prevalence and mortality (3). A monitoring and evaluation framework describes indicators covering core interventions, including prevention, care and treatment (4). The monitoring and evaluation framework describes 10 core indicators, labelled from C1 to C10. Of these, a subset of these focuses on the service coverage of the core interventions and on the impact indicators that define elimination (Table 1). The Global hepatitis report, 2017 (5) documented baseline service coverage estimates for 2015 for these interventions, including testing and treatment (the cascade of care and cure). Since WHO Member States have pledged to eliminate viral hepatitis, they have mandated WHO to monitor progress towards elimination and to report back. WHO has therefore established the Global Reporting System for Hepatitis, to be run for the first time in 2018 (Member States will then report on data collected for 2017). The objectives of this project description document are: to outline the reporting required from Member States to WHO; and to describe the Global Reporting System for Hepatitis. 2. Target audience for this document National viral hepatitis programme managers WHO staff members and other international stakeholders providing technical assistance to countries 3. Data to be reported through the Global Reporting System for Hepatitis The Global Reporting System for Hepatitis will include indicators for (a) critical policy uptake, (b) service coverage and (c) impact. Indicators already collected by other systems will not be reported. 3.1 Policy uptake indicators WHO included a number of policy uptake indicators to monitor the adoption of WHO -recommended policy options (such as the existence of a national plan, testing and treatment poli cies and licensing of medicines). The policy uptake indicators selected for inclusion were extracted from the country profile survey conducted in 2017 (Annex 1). * * The results were presented at the World Hepatitis Summit in São Paulo, Brazil, 1 3 November

3 3.2 Service coverage indicators Prevention indicators Prevention indicators include (1) immunization, (2) prevention of mother -to-child transmission, (3) infection control and (4) harm reduction (Table 1). These indicators are reported through other programmes within WHO and therefore will not be reported in the Global Reporting System for Hepatitis. Table 1. Monitoring the coverage of the interventions that will lead to impact based on the global health sector strategy for viral hepatitis Service coverage Targets Indicators Reporting system 1. Hepatitis B vaccination: C.3.b: Coverage of third dose of WHO/UNICEF joint reporting form Give three doses to infants hepatitis B vaccine among infants Impact 2. Prevention of mother-tochild transmission of hepatitis B virus: Use birth-dose vaccination or other approach to preventing mother-to-child transmission 3. Infection control Administer safe health-care injections Reduce the rates of transmission of transfusiontransmissible infections 4. Harm reduction: Provide sterile needles and syringes for people who inject drugs 5. Testing and treatment: Diagnose people with HBV or HCV infection Treat people with chronic HBV or HCV infection Incidence: Reduce new chronic HBV and HCV infections Mortality: Reduce deaths from viral hepatitis B and C C.3.a: Coverage of timely hepatitis B vaccine birth dose (within 24 hours) and other interventions to prevent the mother-to-child transmission of HBV C.5: Facility-level injection safety A.17: Facility-level blood safety C.4: Needle and syringe distribution C.6.a/b: People with HCV and/or HBV diagnosed C.7.a/b: Treatment coverage and initiation for HBV (regardless of eligibility) and HCV infection C.8.a/b: Cure (HCV) or viral suppression (HBV) C.9.a: Cumulated incidence of HBV infection among children five years old C.9.b: Incidence of HCV infection C.10: Deaths from hepatocellular carcinoma, cirrhosis and chronic liver diseases attributable to HBV and HCV infections WHO/UNICEF joint reporting form National Demographic Health Surveys WHO s Global Database on Blood Safety WHO/UNAIDS Global AIDS Monitoring Global Reporting System for Hepatitis Ongoing systematic reviews of biomarker survey data Global Reporting System for Hepatitis Indicators of the cascade of care and treatment Indicators that focus on the cascade of care and treatment (Table 1) include the number of people (a) diagnosed, (b) placed on treatment and (c) cured (for HCV) or having suppressed viral loads (for HBV). These indicators will be This is a composite indicator built on data from different systems, according to the strategy chosen to prevent mother-to-child transmission. See the monitoring and evaluation framework (4) document for details. 3

4 reported through the Global Reporting System for Hepatitis. Analysis of this data generates the cascade of care for HBV and the cascade of cure for HCV (Fig. 1). Fig. 1. Cascade of care for HBV (left) and cascade of cure for HCV infection (right) by WHO region, Impact indicators Impact indicators include incidence and mortality (Table 1). These are the criteria that define elimination. Incidence The incidence of chronic infection is measured through the following. The prevalence of the surface antigen of HBV (HBsAg) among children five years old is measured. The prevalence of chronic infection at five years of age is a surrogate indicator of the cumulated incidence of chronic infections in the first five years of life: indicator C.9.a, Table 1. The data source is population-based biomarker surveys. The incidence of HCV infection is modelled using seroprevalence data and information from acute hepatitis surveillance: indicator C.9.b, Table 1 (4). 2 The data source is modelled based on (1) a population-based biomarker survey and (2) trends in new infections reported through enhanced case reporting. To estimate incidence, WHO will rely on ongoing systematic reviews of biomarker surveys conducted by WHO for HBV (6) and by partners for HCV (7). The Global Reporting System for Hepatitis will not capture the results of biomarker surveys. Other mechanisms to search published studies and reports on an ongoing basis are a more effective mechanism to obtain updated data on biomarker surveys and on prevalence than a ro utine reporting system. Mortality Mortality from HBV and HCV infection, indicator C10 (Table 1), is measured using two sources of data. One source is data on mortality from cirrhosis and hepatocellular carcinoma. WHO, including th e International Agency for Research on Cancer, already capture this information from vital registration and cancer registries. The fraction of cirrhosis and hepatocellular carcinoma that is attributable to HBV and HCV is measured (from sentinel surveillance for late-stage chronic liver diseases) (4). These indicators will be reported through the Global Reporting System for Hepatitis. 4

5 4. Implementing the Global Reporting System for Hepatitis Country reporting to WHO or other regional organizations will require political will to share official data and the technical capacity to collect, transmit, validate and analyse this data. Tool to be used for reporting To convey the data to the Global Reporting System for Hepatitis, WHO s Global Hepatitis Programme has developed a web-based District Health Information System (DHIS2) module located on the WHO integrated data platform, a collaboration managed by several WHO departments. The Department of Neglected Tropical Diseases coordinates this collaboration. National focal points who have login credentials can access the platform and enter data. Thus, even countries that do not use DHIS2 for national reporting can still use the Global Reporting System for Hepatitis for reporting to WHO. Annual reporting process The annual reporting process will be implemented as described in Fig. 2). Fig. 2. Proposed annual process of the Global Reporting System for Hepatitis WHO headquarters will send a request to report to Member States, via the WHO regional offices. WHO will coordinate brief training to facilitate data entry. Training will include data entry screens annotated with extracts from the strategic information guidance, a separate training package with short video tutorials and training webinars. WHO will open the online platform for reporting: - national focal points collating data (Annex 1 Annex 2); - the focal point receiving a unique login and password to access the online reporting tool; - the national focal point entering data online; and - the health ministry approving the data. The WHO country office, regional office and headquarters will be able to see the data to engage in a validation process. Responsibility for validation will lie with country office first and then the regional office. WHO headquarters will freeze the data for analysis when the validation phase is completed. WHO will analyse the data. Data from countries will be aggregated, and regional estimates will be pub lished in a WHO global report planned for publication in December The regional estimates will be sent for 5

6 WHO data clearance before publication. Certain country case studies may be used in the report following country validation. 5. Strengthening national reporting processes The data reported at the international level will be only as good as what get collated at the national level. Thus, WHO will work with partners such as the health data collaborative ( ) in the long term to build capacity in Member States for routine reporting of the viral hepatitis cascade data from health -care facilities to the national level. Individual or aggregated reporting from health care facilities The standardized viral hepatitis patient card (Annex 3) summarizes the data elements that are necessary to manage a person with chronic HBV or HCV infection and can be used in paper or electronic form. The patient card is primarily designed for clinicians to record key pieces of information to ensure appropriate care and was developed by WHO through consultation with key partners and experts. Data on the cascade can be reported by health-care facilities, both public and private, as individual records or as aggregated data. Encouraging private health-care facilities to report may require some innovative strategies such as public -private partnerships in the context of national viral hepatitis elimination goals. If the choice is to report individual records, several data elements from the patient card can be entered in a database (for paper records) or extracted from the database (for electronic medical records). A data cleaning stage may be needed for countries that would export data from electronic medical records. If the choice is to report aggregated data, health care facilities can report numbers that reflect the services delivered (such as the number of people tested and the number of people starting treatment) and the degree to which national guidelines are implemented at the facility level. This would generate a data flow from the health care facilities towards the subnational or national level. DHIS2 is one established tool that could be used to convey the information to the subnational or national level. DHIS2 is an open-source software platform for reporting, analysing and disseminating data for all health programmes. Other software may also be used to report aggregated data. Transmitting and compiling aggregated data Whether facilities initially report individual or aggregated data, the reporting requirements of the Global Reporting System for Hepatitis (Annex 2) can be used to report aggregated data up to the national level. 6. Future development of the Global Reporting System for Hepatitis Subsequent to the first year of reporting, WHO will review the Global Reporting System for Hepatitis. Subject to the outcome of this review and feedback received from countries, the Global Reporting System for Hepatitis will be refined and/or expanded. Possible developments include: greater levels of disaggregation; including data from national partners and nongovernmental organizations on the cascade of care and cure; including indicators that reflect the provisi on of and access to services for priority populations such as people who inject drugs, prisoners and pregnant women; and reporting on the proportion of people with HBV infection who are eligible for treatment. 6

7 7. References 1. Global health sector strategy on viral hepatitis, Geneva: World Health Organization; 2016 ( accessed 4 July 2018). 2. Draft thirteenth general programme of work , advance edited version. Geneva: World Health Organization; 2016 ( accessed 4 July 2018). 3. Technical considerations and case definitions to improve surveillance for viral hepatitis: surveillance document. Geneva: World Health Organization; 2016 ( accessed 4 July 2018). 4. Monitoring and evaluation for viral hepatitis B and C: recommended indicators and framework. Geneva: World Health Organization; 2016 ( accessed 4 July 2018). 5. Global hepatitis report, Geneva: World Health Organization; 2017 ( accessed 4 July 2018). 6. Global and country estimates of immunization coverage and chronic HBV infection. Geneva: World Health Organization; 2018 ( accessed 4 July 2018). 7. Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:

8 Annex 1. Policy uptake indicators for viral hepatitis Country Institution reporting In your country, is there a civil society representative involved in advising the government on their response to viral hepatitis? In your country, are funds allocated from the national budget to implement the national plan? In your country, is there official guidance on which test to use for diagnosing HBV and/or HCV? In your country, is tenofovir or entecavir considered the first line of treatment for people with chronic hepatitis B (not coinfected with hepatitis D virus)? Yes a member of the strategic technical advisory group or official working group Yes not a member of the strategic technical advisory group or official working group, but civil society has been consulted the plan is to involve civil society in the strategic technical advisory group or official working group no plan to involve civil society in the strategic technical advisory group or official working group Yes both HBV and HCV Yes only HBV Yes only HCV Yes both HBV and HCV Yes only HBV Yes only HCV Yes all patients Yes- but only for select patients according to the priorities set Name of the respondent address of the respondent Policy framework In your country, is there a national plan or strategy that covers the national response to viral hepatitis? In your country, are there policies or laws that address stigma and/or discrimination against people with hepatitis B or C? National guidelines In your country, are there official guidelines or protocols recommending that all people diagnosed with HBV and/or HCV be routinely referred for treatment and care? In your country, are interferon-free direct-acting antiviral regimens considered the first line of treatment for people with chronic hepatitis C? Yes published Yes drafted Yes there are policies or laws that specifically address stigma and/or discrimination against people with hepatitis B or C Yes there are anti-discrimination policies or laws, but they are not specific to hepatitis B or C Yes both HBV and HCV Yes only HBV Yes only HCV Yes all patients Yes- except for certain genotypes Yes but only for select people according to the priorities set 8

9 Annex 2. Aggregated reporting form to monitor the cascade (outline for national reporting, to be expanded with meta-data) using 2017 as a reference year Data from 1 January 2017 to 31 December 2017 Testing and diagnosis (C6) Treatment initiation and continuation (C7) Monitoring of treatment effectiveness (C8) Mortality from sequelae * (C10) infected people people tested with infected people newly diagnosed people continuing a people newly starting treatment in the selected year people completing people assessed for people with effective Proportion (%) of people dying Proportion (%) of people dying from already identified before the selected year (treated or not) serology (HBsAg or anti-hcv) in the selected year with infection in the selected year (HBsAg positive or HCV RNA or HCV core antigen positive, treated or not) treatment started before the year of reporting Total Among people who injected drugs in the past 12 months (among the total above) treatment ** treatment effectiveness treatment from cirrhosis who were positive for viral hepatitis infection hepatocellular carcinoma who were positive for viral hepatitis infection HBV Not applicable HCV Not applicable * Estimates from sentinel sites. Needs to include testing activities conducted with rapid diagnostic tests. Does not apply to HCV infection. Regardless of eligibility (HBV infection). ** Does not apply to HBV infection. Tested for viral suppression with ALT or HBV DNA (HBV) or tested for sustained viral response using HCV RNA or HCV core antigen (HCV). Normal ALT or viral suppression (HBV) or sustained viral response (HCV). 9

10 Annex 3. WHO template for a chronic hepatitis B and C patient management card Identification Unique identifier _ _ _ _ _ _ _ _ _ _ District: Health unit: District clinician or team: Name: First name: Patient clinic number: Sex: _ Female _ Male _ Other Date of birth (DD/MM/YYYY): / / Nationality: Address: District: Telephone: Infection status on enrolment Enrolment date: / / HBsAg: _ Positive _ Negative _ Not done HBV DNA (IU/mL): Value _ Negative _ Not done HBeAg: _ Positive _ Negative _ Not done Date of first diagnosis of HBV infection: / / HDV RNA (IU/mL): _ Positive _ Negative _ Not done Anti-HDV: _ Positive _ Negative _ Not done Anti-HCV: _ Positive _ Negative _ Not done HCV RNA (IU/mlL: _ Value _ Negative _ Not done HCV core antigen: _ Positive _ Negative _ Not done Date of first diagnosis of HCV infection: / / HCV genotype: _ Anti-HIV: _ Positive _ Negative _ Not done HIV treatment regimen: Date HIV treatment started: Latest HIV viral load (copies/ml): _ Not done CD4 count (cells/mm 3 ): _ Not done Tuberculosis: _ Active _ On treatment _ No Injection drug use: _ Active (last 12 months) _ Past history _ No Daily alcohol consumption: Metabolic syndrome: Staging Staging date: / / ALT: IU/mL AST: IU/mL PLT: /mm 3 Clinical diagnosis of cirrhosis: _ Yes _ No If yes, child Pugh score: APRI score: _ Not done FIB4: _ Not done Transient elastography (kpa): _ Not done Liver biopsy stage (F): _ Not done Bilirubin: Total μmol/l and direct: μmol/l Ultrasound scan: Prothrombin time/inr: Hepatitis B treatment Past experience with treatment: _ Yes _ No Past treatment regimen: HBV treatment regimen started (medicine): Date stated: / / Date stopped: / / First annual viral response assessment Date tested: / / HBV DNA (IU/mL): _ Positive _ Negative _ Not done ALT: IU/mL Hepatitis C treatment Past experience with treatment: _ Yes _ No Past treatment: HCV treatment regimen started: Date stated: / / Date completed: / / Sustained viral response assessment after treatment (usually at SVR12: 12 weeks after the treatment ends) Date tested: / / HCV RNA: _ Positive _ Negative _ Not done Follow-up visits 10

11 Unique identifier _ _ _ _ _ _ _ _ _ _ Name: First name: Patient clinic number: Date Clinical assessment ALT (IU/mL) Liver function test and staging AST (IU/mL) Platelets (number/ml) APRI Transient elastography (kpa) HBsAg (±) HBV tests HBeAg (±) HBV DNA (IU/mL) HCV tests HCV RNA (±) Renal function Creatinine (mg/dl) Screening for hepatocellular carcinoma Ultrasound AFP (ng/ml) Treatment regimen used Sideeffects and toxicity Observations 11

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