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Custom-made capsules and suppositories of methadone for patients on high-dose opioids for cancer pain |
Bruera E, Watanabe S, Fainsinger R L, Spachynski K, Suarez-Almazor M, Inturrisi C |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Using custom-made capsules and suppositories of methadone versus subcutaneous hydromorphone in cancer patients with poor pain control and receiving high doses of conventional opioids.
Economic study type Cost-effectiveness analysis.
Study population Patients with poor prognostic pain syndromes on high opioid doses.
Setting Primary care. The economic study was carried out in Edmonton, Alberta, Canada.
Dates to which data relate Effectiveness and resource data were recorded between December 1991 and May 1993. No date was reported for the prices used.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was undertaken prospectively on the same patient sample as that used for the effectiveness study.
Study sample Power calculations were not used to determine the sample size. The sample consisted of 37 patients, initially receiving hydromorphone, and who were eligible to be switched to methadone(21 were switched to oral methadone, and 16 to rectal methadone).
Study design This was a prospective cohort study, carried out in a single centre. The duration of follow-up was 6 days after initiation of the switch-over from subcutaneous injections of hydromorphone to methadone (oral or rectal). The rate of loss to follow up was 17%.
Analysis of effectiveness The analysis of effectiveness was based on intention to treat. Primary health outcomes used were pain intensity, cognitive function and side effects (toxicity). Pain intensity was evaluated by a visual analogue scale (VAS) (0 = no pain; 100 = worst pain). Cognitive function was assessed by means of a Mini-Mental State Questionnaire (MMSQ)(0.8, or 80% in a range of 0-1, being considered 'normal').
Effectiveness results Methadone presented a VAS value of 34 (+/- 21). The corresponding figure for hydromorphone was 51 (+/- 22), the difference being statistically significant (p<0.001). The MMSQ scores were 0.86 (+/-0.22) and 0.72 (+/- 0.1), respectively (p= 0.21). Only one patient discontinued methadone because of toxicity.
Clinical conclusions A slow switch-over to methadone is a safe, effective alternative in selected cancer patients receiving high doses of opioids for poor prognostic pain syndromes.
Measure of benefits used in the economic analysis No summary benefit measure was identified in the economic study, and only separate clinical outcomes were reported.
Direct costs For the intervention, quantities were measured as doses and times of administration for each patient,whereas for the comparator, it was assumed that the costs remained the same as the day before the switch to methadone. The cost items were not reported separately. The cost items considered in the costing of methadone were the drug cost, and the costs of the materials and time needed for it preparation. In the cost analysis of the comparator only the commercial parenteral preparation was considered. The perspective adopted in the cost analysis was not explicitly specified. The quantity of resources were measured between December 1991 and May 1993 for the intervention. No specific date was given for the prices.
Statistical analysis of costs ANOVA procedures were employed to evaluate the differences among the groups in terms of costs. Confidence intervals and p values were reported.
Sensitivity analysis No sensitivity analysis was reported.
Estimated benefits used in the economic analysis Cost results The total cost for methadone was Can$148 (+/- 201) whilst, for hydromorphone, the figure was Can$2,135 (+/- 472), (p<.001). The costs of adverse effects were included in the costing.
Synthesis of costs and benefits No synthesis was undertaken as the intervention was the dominant strategy.
Authors' conclusions Custom made capsules and suppositories of high-dose methadone are an effective, safe and low-cost alternative in patients receiving high doses of parenteral opioids.
CRD COMMENTARY - Selection of comparators A justification was given for the choice of the comparator, hydromorphone being chosen as it can be injected in smaller volumes because of its higher solubility.
Validity of estimate of measure of benefit The internal validity of the effectiveness results is open to doubt due to the lack of randomisation.
Validity of estimate of costs The resource utilisation and cost items included were not fully reported. The prices used to estimate costs were not reported (with one exception) and no price dates were given.
Other issues Given the lack of randomisation and sensitivity analysis, the results may need to be treated with some caution. As the authors pointed out, the results cannot be extendedto the ambulatory cancer population. The issue of generalisability to other settings or countries was not addressed.
Bibliographic details Bruera E, Watanabe S, Fainsinger R L, Spachynski K, Suarez-Almazor M, Inturrisi C. Custom-made capsules and suppositories of methadone for patients on high-dose opioids for cancer pain. Pain 1995; 62(2): 141-146 Indexing Status Subject indexing assigned by NLM MeSH Aged; Analgesics, Opioid /therapeutic use; Capsules; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Female; Humans; Hydromorphone /therapeutic use; Male; Methadone /administration & Middle Aged; Neoplasms /complications; Pain /drug therapy /etiology; Prospective Studies; Suppositories; dosage /adverse effects /economics AccessionNumber 21995001004 Date bibliographic record published 31/03/1999 Date abstract record published 31/03/1999 |
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