Appendix C. Detail on criteria for audit of the use of peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C
Possible objectives for an audit
An audit on the use of peginterferon alfa and ribavirin in the treatment of mild chronic hepatitis C could be carried out to ensure that the therapy is used appropriately.
Possible patients to be included in the audit
An audit could be carried out on a reasonable number of people being treated for mild chronic hepatitis C. Because there is insufficient evidence to recommend combination therapy or monotherapy with peginterferon alfa for people with mild chronic hepatitis C who are under the age of 18 years or who have had a liver transplant, these people should be excluded from this audit. Where a large number of people are being treated, a representative sampling strategy is suggested.
Measures that could be used as a basis for an audit
The measures that could be used in an audit of peginterferon alfa and ribavirin in the treatment of mild chronic hepatitis C are as follows.
|
Criterion |
Standard |
Exception |
Definition of terms |
|
1. A person with mild chronic hepatitis C is treated with combination therapy comprising peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin, within their licensed indications |
100% of people with mild chronic hepatitis C who present for treatment |
A. If a woman is pregnant or breastfeeding B. If ribavirin is contraindicated or is not tolerated (see criterion 2) |
For contraindications to ribavirin and symptoms of intolerance, see the summary of product characteristics. |
|
2. A person with mild chronic hepatitis C who is unable to tolerate or has a contraindication to ribavirin is treated with monotherapy with peginterferon alfa-2a or peginterferon alfa-2b, within their licensed indications |
100% of people with mild chronic hepatitis C who are unable to tolerate or have a contraindication to ribavirin and who present for treatment |
None |
For contraindications to ribavirin and symptoms of intolerance, see the summary of product characteristics. |
|
3. A person with mild chronic hepatitis C makes the decision on immediate treatment with combination therapy or monotherapy or waiting until the disease has reached a moderate stage after fully informed consultation with the responsible clinician |
100% of people with mild chronic hepatitis C who present for treatment |
None |
'Waiting until the disease has reached a moderate stage' can be referred to as 'watchful waiting.' Clinicians will need to agree on how the patient's decision and the fully informed consultation with the responsible clinician are documented, for audit purposes. The patient should understand that liver biopsy to determine the stage of the disease is not required if treatment is initiated immediately but biopsy may be recommended by the clinician for other reasons or if treatment is delayed. |
|
4. For a person with mild chronic hepatitis C who has been treated with a first course of either combination therapy or monotherapy with peginterferon alfa and who has not had an early response, second or subsequent courses of treatment are provided. |
0% of people with mild chronic hepatitis C who have had combination therapy or monotherapy with peginterferon alfa but who have not had an early response |
None |
'Early response' is as defined in the above measures, that is, the person's viral load has fallen to less than 1% of the initial level. |
Calculation of compliance
Compliance (%) with each measure described in the table above is calculated as follows.
|
Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed |
x 100 |
|
Number of patients to whom the measure applies |
Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.