Appendix C. Detail on criteria for audit of the use of human growth hormone (somatropin) in adults with growth hormone deficiency

Appendix C. Detail on criteria for audit of the use of human growth hormone (somatropin) in adults with growth hormone deficiency

Possible objectives for an audit

An audit on the appropriateness and effectiveness of the use of growth hormone (GH) treatment in adults with GH deficiency could be carried out to ensure the following.

  • GH treatment is given to an adult with GH deficiency only if he or she meets defined criteria.

  • An adult who is started on GH treatment is re-assessed and GH treatment is discontinued if there is an insufficient improvement in quality of life (QoL).

  • Continued GH treatment is given only in appropriate circumstances to an individual who has been treated for GH deficiency as a child and who has completed linear growth.

  • GH treatment is given to an adult who develops GH deficiency in early adulthood only in appropriate circumstances.

  • Initial treatment of adults with GH deficiency is done only by a qualified specialist and maintenance GH treatment is continued in primary care only when there is an agreed shared-care protocol.

Possible patients to be included in the audit

An audit could be carried out on all adults referred or seen for GH deficiency in a given time period, for example, 6 months or a year. Because the measures listed below refer to care provided after the start of GH treatment, it may be desirable to limit the audit to new patients or to agree on the specific time period of care that will apply to each of the measures.

Measures that could be used as a basis for audit

The measures that could be used in an audit of GH treatment are as follows.

Criterion

Standard

Exception

Definition of terms

1. An adult given recombinant human growth hormone meets all three of a–c or d as follows:

a. The individual has severe GH deficiency and

b. The individual has a perceived impairment of quality of life (QoL) as demonstrated by a reported score of at least 11 in the QoL-AGHDA questionnaire and

c. The individual is already receiving treatment for other pituitary hormone deficiencies as required or

d. The individual is receiving GH treatment at the date of publication of this guidance and, following reassessment, it is considered appropriate to continue the therapy

100% of the adults who are on recombinant human growth hormone

None

'Recombinant human growth hormone' means somatropin. 'Severe GH deficiency' means having a peak GH response of less than 9 mU/litre (less than 3 ng/ml) during an insulin tolerance test (ITT) or a cross-validated GH threshold in an equivalent test.

For b, see the individual's self-reported score on the QoL-AGHDA questionnaire.

For d, 're-assessment' means by the individual's consultant endocrinologist as part of routine follow-up.

For d, 'appropriate to continue' assumes that the consultant considers the criteria stated in 1a–1c.

Clinicians will have to agree locally on how consideration of the appropriateness of continuation of therapy, for patients on GH therapy at the date of publication of this guidance, is documented for audit purposes.

2. An adult who is started on GH treatment:

a. Is re-assessed for QoL status 9 months after the initiation of therapy

100% of the adults started on GH treatment within the time period agreed for audit purposes

None

Clinicians will have to agree locally how far back in time care is to be reviewed for this criterion, and on where QoL status at 9 months after initiation of therapy will be documented for audit purposes (that is, where the QoL–AGHDA questionnaire scores are ordinarily recorded).

b. Has GH treatment discontinued if the individual has a QoL improvement of less than 7 points in QoLAGHDA scor

100% of the adults started on GH treatment within the time period agreed for audit purposes who have insufficient QoL improvement

None

'9 months after the initiation of therapy' means after an initial 3-month period of GH dose titration followed by a 6-month therapeutic trial period.

3. The following are done for an individual who as a child was treated for GH deficiency and who has completed linear growth:

a. GH treatment is stopped for 2–3 months

and

b. The GH status of the individual is re-assessed

and

For 3 a and b: 100% of the individuals who have been treated for GH deficiency as a child and who have completed linear growth

For 3 a and b: None

'Completion of linear growth' means growth rate < 2cm/year.

c. GH treatment at an adult dose is re-started only if the individual meets criterion 1a above

and

d. GH treatment at an adult dose is continued until adult peak bone mass is achieved

and

For 3 c and d: 100% of the individuals who have been treated for GH deficiency as a child, who have completed linear growth and who have GH treatment restarted

For 3 c and d: None

'Re-assessed' means for GH status and QoL as defined in 1 above.

e. When adult peak bone mass is achieved, GH treatment is continued only if the individual meets criteria 1a–c above

For 3 e: 100% of the individuals who achieve adult peak bone mass and who have GH treatment continued

For 3 e: None

Adult peak bone mass is normally achieved by about 25 years of age.

4. The following are done for an individual who develops GH deficiency in early adulthood after linear growth is completed but before the age of 25:

a. GH treatment is given until adult peak bone mass is achieved if the individual meets criterion 1a above

and

b. When adult peak bone mass is achieved, GH treatment is continued only if the individual meets criteria 1a–1c above

100% of the individuals who develop GH deficiency in early adulthood after linear growth is completed but before the age of 25

See 1 above for definition of GH deficiency and see 3 above for definition of adult bone mass.

5. The following are carried out by a qualified specialist:

a. Initiation of GH treatment

and

b. Dose titration

and

c. Assessment of response during the trial period

100% of the individuals who are given GH therapy

None

A 'qualified specialist' is a consultant endocrinologist with a special interest in the management of GH disorders.

Clinicians will have to agree locally how far back in time care is to be reviewed for this criterion.

6. If an individual's maintenance GH treatment is prescribed in primary care, there is an agreed shared-care protocol

100% of individuals seen for maintenance prescription in primary care

None

Clinicians will have to agree locally on what constitutes agreement on a shared-care protocol.

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.