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Treatment of moderate-to-severe pneumonia in elderly, long-term care facility residents |
Nicolle L E, Kirshen A, Boustcha E, Montgomery P |
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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 Broad-spectrum antimicrobials (Ceftriaxone) in the treatment of moderate-to-severe pneumonia in elderly residents of long-term care facilities.
Economic study type Cost-effectiveness analysis.
Study population Elderly long-term care facility patients with radiologically documented, moderate to severe pneumonia and requiring parenteral therapy. Patients were 65 years or older and had not received an effective antibiotic within 72 hours preceding study admission. The exclusion criteria consisted of allergy to any of the study drugs, required concomitant antimicrobial therapy, serum creatinine levels more than 200 (g
Setting The practice setting was long-term care facilities (nursing homes). The economics study was carried out in Winnipeg, Canada.
Dates to which data relate Dates were not given by the authors, but effectiveness, resource and price data were collected during the 2 year trial period before this paper was published in 1996.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data Costing was undertaken prospectively on the same patient sample as that used in the effectiveness study.
Study sample The study size was chosen based on power calculations. It aimed to recruit 40 patients to each arm so that a clinical difference of 25% could be detected with a power of 0.8. In total 37 patients were actually recruited to the trial: 20 to the ampicillin group and 17 to the ceftriaxone group. Forty patients were excluded for various reasons.
Study design The study was a randomised controlled trial conducted in four centres. The duration of follow-up was up to 10 to 15 days after cessation of therapy.
Analysis of effectiveness Analysis of the clinical study was based on intention-to-treat. The primary health outcomes were 'cure' and failure, where 'cure' was defined as improvement in clinical findings with no clinical evidence of residual or recurrent infection during follow-up, and 'failure' was defined as deterioration or no apparent response to therapy or deterioration after discontinuation of therapy. The two patient groups were shown to be similar for a list of characteristics (age, sex, number of medications, mean temperature, mean respiratory rate, and laboratory values) except for mean pre-therapy peripheral leukocyte count.
Effectiveness results According to the data, 70% (95% CI: 50 - 90%) of patients treated with ampicillin and 93% (95% CI: 83 - 100%) of patients treated with ceftriaxone were defined as cured of pneumonia (p<0.07). The differences in adverse effects between the two treatment groups were not statistically significant. Patients treated with ampicillin suffered diarrhoea (15%), rash (5%) and phlebitis (20%). Those treated with ceftriaxone suffered diarrhoea (12%) and phlebitis (41%). Power calculations were not designed to detect these differences. Three patients (8.1%) died during the study, 2 (10%) from the ampicillin group and 1 (6%) from the ceftriaxone group.
Clinical conclusions Treatment with ceftriaxone may be more effective than ampicillin in elderly patients in nursing homes who require parenteral therapy for pneumonia.
Measure of benefits used in the economic analysis Benefits are measured as the proportion of patients cured of pneumonia within the study period as defined by clinicians.
Direct costs Separate time and motion studies were conducted to derive quantities for costing. The costs measured were: nursing time for admixture and administration, acquisition costs and supply costs involved in administering drugs and maintaining intravenous access. The costs associated with treatment of relapses and failures were included in the estimates. These costs were from the hospital perspective. The source of acquisition and supply cost data was not stated, but is presumed to be based on the study hospital's financial estimations. The cost of nursing time was calculated based on a level 2 position (Can$19.9 per hour). Dates for the price data were not explicitly stated; presumably the price year is around the time of the 2 year trial ending in 1996. As patients were in, or awaiting, long-term care, no costs for additional length of stay were calculated for either group.
Sensitivity analysis No sensitivity analysis was performed.
Estimated benefits used in the economic analysis Initial empiric effectiveness was 70% for patients treated with ampicillin and 93% for patients treated with ceftriaxone (defined as cured of pneumonia). Duration of therapy was discretionary. Follow-up was 10-15 days after cessation of therapy. Adverse effects were observed to be similar between groups.
Cost results The total cost per case for the whole ampicillin treatment group, including those requiring additional antimicrobial therapy, was Can$284.08. It was estimated that, had those who failed to respond initially to ampicillin been treated with ceftriaxone as a second-line therapy, the total cost per case would have been Can$271.97. In any case, the total cost per case with ceftriaxone alone was Can$221.84.
Synthesis of costs and benefits Costs and befits were not combined as the intervention (ceftriaxone) was a dominant strategy over standard therapy (ampicillin): it was both more effective and had a lower total cost.
Authors' conclusions Ceftriaxone proved to be more effective in curing pneumonia in elderly long-term care residents than ampicillin. Initial therapy with ampicillin was less costly per case than with ceftriaxone, but, when labour costs and additional costs incurred by patients who were not cured by ampicillin, were considered ceftriaxone proved to be the least costly regimen.
CRD Commentary The authors' decision to use a prospective randomised controlled trial design was based on the lack of existing, relevant and comparative clinical trials to inform therapy strategy in this area. Sample size did not achieve that planned based on power calculations due to rigorous inclusion criteria. The study excluded patients thought to have a high likelihood of death within 72 hours, so results cannot be applied to this population. This study was performed at facilities where the use of extended-spectrum cephalosporins has been restricted, thus generalisability of results may be restricted especially where antimicrobial resistance is a problem.
This trial was an effectiveness study with a cost study conducted alongside it. The authors did not report any prior evidence of the resulting dominance in the study. Adverse effects were not costed as there was thought to be little difference between treatment groups, but the study lacked the power to detect these differences. The authors did not perform sensitivity analysis as variables were considered relatively certain within the study institutions. However, this means that results cannot easily be generalised to other settings where cost structures, for example, may be very different.
Source of funding Supported by a grant from Hoffman-LaRoche, Canada, Inc.
Bibliographic details Nicolle L E, Kirshen A, Boustcha E, Montgomery P. Treatment of moderate-to-severe pneumonia in elderly, long-term care facility residents. Infectious Diseases in Clinical Practice 1996; 5(2): 130-136 Indexing Status Subject indexing assigned by CRD MeSH Aged; Aged, 80 and over; Ampicillin /therapeutic use /economics; Anti-Bacterial Agents /administration & Ceftriaxone /therapeutic use /economics; Cost-Benefit Analysis; Homes for the Aged; Infusions, Parenteral; Nursing Homes; Pneumonia /economics; Pneumonia, Bacterial /diagnosis /drug therapy /economics; Survival Rate; Treatment Outcome; dosage /therapeutic use AccessionNumber 21996000355 Date bibliographic record published 28/02/1999 Date abstract record published 28/02/1999 |
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