Appendix C. Detail on criteria for audit of the use of imatinib for chronic myeloid leukaemia

Possible objectives for an audit

An audit could be carried out to ensure appropriate treatment with imatinib for patients with Philadelphia-chromosome-positive CML.

Possible patients to be included in the audit

An audit could be carried out on individuals being treated for Philadelphia-chromosome-positive CML, over a reasonable period for audit, for example, 1 year.

Measures that could be used as a basis for audit

The measures that could be used in an audit on the appropriateness of treating people who have Philadelphia-chromosome-positive CML with imatinib are as follows.

Criterion

Standard

Exception

Definition of terms

1. Imatinib is provided as first-line treatment for the management of an individual with Philadelphiachromosome-positive CML in the chronic phase

100% of patients in the chronic phase

None

If CML phases are not routinely coded, local specialists will have to agree on how to identify patients in the chronic phase for audit purposes Clinicians need to agree locally on any exceptions such as patient declining treatment

2. Imatinib is considered as an option for the treatment of an individual with Philadelphiachromosome-positive CML in the following circumstances.

a. The individual initially presents in the accelerated phase or blastcrisis or

b. The individual presents in the chronic phase and then progresses to the accelerated phase or blast crisis and has not received imatinib previously

100% of patients who present in accelerated or blast-crisis phase or who present in chronic phase and then progress to accelerated phase or blast crisis and who have not previously received imatinib

None

If CML phases are not routinely coded, local specialists will have to agree on how to identify patients in the accelerated or blast-crisis phase for audit purposes Clinicians need to agree locally on how consideration of treatment as an option will be documented for audit purposes and on any exceptions

3. For an individual in chronic-phase CML who is currently receiving IFN-α as first-line treatment, the decision about whether to change to imatinib is informed by the response of the disease to current treatment and the individual' tolerance of IFN-α, after informed discussion between the individual and the clinician responsible for treatment

100% of patients in the chronic phase who are currently receiving or have received IFN-α and are changing to imatinib as first-line treatment

None

Clinicians should agree locally on how informed discussion is recorded for audit purposes The informed discussion should take full account of the evidence on the risks and benefits of imatinib and the wishes of the patient

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.

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