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Oral narcotic protocol to reduce narcotic injections in refractory migraine patients |
Von Seggern R L, Adelman J U |
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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 The use of an oral narcotic protocol (ONP) for the self-administration of drugs at home, to reduce narcotic injections in refractory migraine patients. The narcotics used were meperidine (300 mg) and hydromorphone (4 to 12 mg).
Economic study type Cost-effectiveness analysis.
Study population The study population comprised refractory migraine patients with severe headache that has been resistant to treatment.
Setting The setting was primary care and the community. The economic study was carried out in the United States.
Dates to which data relate The effectiveness and resource use data related to the period 1994 to 1995 for the intervention group, and up to one year earlier for the usual care. The unit cost data, although not explicitly stated, appear to relate to the end of the study.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was carried out prospectively on the same sample of patients as that used in the effectiveness analysis.
Study sample The study sample consisted of 11 patients from the authors' setting. These had all been resistant to treatment and had made significant use of health services for their condition over a period of several years. No power calculations were conducted to determine the sample size. The methods used to select the sample were not presented. The participants were suitable for the purpose of the study, but whether they were representative of the study population was not analysed.
Study design This was a single-centre, before-and-after study. The participants were followed for up to 1 year before and after the implementation of the ONP. Four patients received meperidine as the narcotic medication, whilst seven received hydromorphone. The patients' use of the medical service, in terms of visits to the primary care clinic or ED, was compared. No loss to follow-up was reported.
Analysis of effectiveness The analysis was conducted on an intention to treat basis. The clinical outcomes were proxied by the number of ED visits and the number of office visits before and after the introduction of ONP. The comparability of the patient groups, in terms of their clinical and demographic characteristics, was assured as a before-and-after study design was employed.
Effectiveness results After the introduction of ONP, the total number of ED visits dropped by 44.7%, from 47 to 26. The total office visits was reduced by 34.6%, from 81 to 53.
Clinical conclusions The use of an ONP with appropriate analgesic doses is an effective method of treating severe headache in refractory patients. It allows the patient to treat the headache in the comfort of their home, and avoids the environmental difficulties that may be present outside the patient's house, such as the waiting time in medical offices or in the ED. Both office visits and ED visits were reduced over the period of study following the introduction of the ONP, suggesting an improvement in the health outcomes for the patients.
Measure of benefits used in the economic analysis No summary measure of benefits was used in the economic analysis. The benefits are therefore associated with the effectiveness results reported. The costs were analysed separately for the ONP and usual care alternatives. Thus, the cost-effectiveness analysis was of a cost-consequences design.
Direct costs The direct costs included the costs for visits to the primary care centre and ED avoided. Discounting was irrelevant because the duration of the treatment was less than one year. The quantities were analysed using actual data from the participating patients. The quantities were reported separately from the costs. The total costs were derived using the charges for visits in the authors' setting, rather than the costs. The price year was not reported.
Indirect Costs No indirect costs were evaluated.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results Compared with the period before the intervention, the net cost-savings of introducing ONP were $4,592 for the study sample. For the sub-sample of 8 patients followed for a year before and after the administration of ONP, on average, two visits to the ED and three to the clinic were avoided annually. This resulted in an annual saving of $498 for each patient.
Synthesis of costs and benefits No synthesis of the costs and benefits was performed.
Authors' conclusions The oral narcotic protocol (ONP) was an effective and cost-effective method for treating severe headache in refractory patients. Its use in appropriate patients can provide a safe and effective therapy that will be greatly appreciated by the patients.
CRD COMMENTARY - Selection of comparators The authors justified their choice of usual care as a comparator. Since usual care could vary in different settings, you should consider whether the choice is appropriate in your own setting.
Validity of estimate of measure of effectiveness The effectiveness of the intervention was examined in the context of a before-and-after study design. This was appropriate, but it has some limitations since it does not account for unknown confounding factors. These may affect the effectiveness of the treatments. Th effectiveness was measured in terms of the number of office and ED visits avoided, which may be considered as a proxy for effectiveness (relief of pain and improved quality of life). It would, therefore, be useful in future studies to use health outcomes that reflect health improvements. Additionally, no power calculations were carried out to justify the sample size, which was small and unable to demonstrate statistically significant differences between the two alternatives examined.
Validity of estimate of measure of benefit No measure of health benefit was used. The analysis was conducted on the basis of the number of visits avoided, which acted as a proxy for health outcomes.
Validity of estimate of costs The costing demonstrated several weaknesses. First, the analysis of resource use could have been biased by the use of a before-and-after study design and small sample size. Second, the costs and the quantities were reported separately, but it is possible that cost categories relevant to the alternatives analysed could have been omitted (e.g. increased dose of drugs in the ONP, additional monitoring for dug-abuse). Third, the price year and the source of the unit price data were not reported. Finally, no statistical or sensitivity analyses were conducted on the costs. These features tend to limit the generalisability of the cost results to other settings.
Other issues The authors did not make comparisons with other studies looking at patients with refractory migraine. A convenience study sample was employed. The issues of generalisability were not explicitly addressed. The authors acknowledge that not all patients would be suitable for ONP, for example, those unable to retain oral medication during severe migraine.
Implications of the study The authors clearly state that the ONP is an effective, safe, and cost-saving alternative for treating suitable refractory migraine patients, who have severe headache that has been resistant to prior treatment. Attention is drawn to the possibility of drug abuse, and thus it is suggested that the drugs are prescribed in limited quantities and are monitored carefully. The study shows the potential of the proposed ONP but, as indicated in the commentary, the internal and external validity of this study needs to be explored and improved upon in further research.
Bibliographic details Von Seggern R L, Adelman J U. Oral narcotic protocol to reduce narcotic injections in refractory migraine patients. Headache 1997; 37(6): 341-345 Indexing Status Subject indexing assigned by NLM MeSH Administration, Oral; Clinical Protocols; Emergency Service, Hospital /utilization; Female; Health Care Costs; Humans; Hydromorphone /administration & Injections; Meperidine /administration & Migraine Disorders /drug therapy /economics; Narcotics /administration & Pain, Intractable /drug therapy; Self Administration; dosage /economics; dosage /economics; dosage /economics AccessionNumber 21997001005 Date bibliographic record published 31/08/2002 Date abstract record published 31/08/2002 |
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