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Clinical and economic impact of a pharmacist-intervention to promote sequential intravenous to oral clindamycin conversion |
Martinez M J, Freire A, Castro I, Inaraja M T, Ortega A, Del Campo V, Rodriguez I, Bardan B, Morano L E, Garcia J F |
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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 health technology examined in the study was a pharmacist-intervention (through an information sheet) for the promotion of sequential therapy with antibiotics (clindamycin), defined as the early change from intravenous (IV) to oral (PO) therapy.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients taking clindamycin for at least 72 hours. Patients were excluded if admitted to intensive care units and under 7 years of age.
Setting The setting of the study was a tertiary care teaching hospital. The economic study was carried out in Spain.
Dates to which data relate The dates during which the data concerning both effectiveness and resources used were collected were not reported. The price year was not reported.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was undertaken prospectively on the same patient sample as that used in the effectiveness analysis.
Study sample Power calculations were carried out in the planning phase and indicated that a sample of 190 evaluable patients per group would be required to demonstrate a reduction of 1.5 days in the IV treatment, with an alpha-error of 0.05 and a power of 90%. Patients were detected by the Pharmacy Department through a computerised unit-dose delivery system. A total sample of 473 patients participated in the study: 204 patients (mean age 57.5, 66.2% men) were included in the intervention group (IG) and 269 patients (mean age 59.7, 62.5% men) in the control group (CG).
Study design This was a prospective, non-randomised controlled study carried out in several centres (details were provided only for one hospital). Patients in the CG were selected in the first 6-month period (phase 1), during which no intervention to promote sequential therapy was used; while patients in the IG were identified in the last 6-month period (phase 2) during which the information sheet was distributed in the patient's chart 72 hours after the beginning of IV clindamycin, before the medical round on the fourth day of therapy. The length of follow-up was not reported.
Analysis of effectiveness It appears that the analysis was carried out on an intention to treat basis such that all patients included in the study were accounted for in the analysis. The primary health outcome was rate of clinical success, defined as the complete resolution of all clinical signs and symptoms related to the infection. Secondary outcome measures were number of patients with sequential therapy at 3rd day and after the 3rd day, total number of patients with sequential therapy, adverse effects (AE), number of treatment days, and length of hospitalisation. Groups were shown to be statistically comparable in terms of age, gender, infection severity, and clinical conditions.
Effectiveness results The effectiveness results were as follows:
Therapy success rate was 77.5% in the IG and 78.4% in the CG, (p=0.88). In particular, clinical success was 88% in sequential and 76.8% in non-sequential treatments, (p=0.09).
In terms of secondary outcomes, the number of patients with sequential therapy at 3rd day was 34 (16.7%) in the IG and 16 (5.9%) in the CG, (p<0.0005) and the number of patients with sequential therapy after the 3rd day was 73 (35.8%) in the IG and 41 (15.2%) in the CG, (p<0.0005), resulting in a total number of patients with sequential therapy of 107 (52.5%) in the IG and 57 (21.1%) in the CG.
A total of 52 patients (25.5%) in the IG and 87 (32.2%) in the CG reported AE related to the therapy, (p=0.1).
In terms of treatment duration, median (5 and 95 percentiles) therapy days were 8 (4-18) in the IG and 8 (4-19) in the CG, (p=0.7).
Length of hospital stay (median (5 and 95 percentiles)) was: 14.5 days (5-59 days) in the IG and 13 days (4-50 days) in the CG, (p=0.18).
However, a statistically significant decrease in hospital stay was observed when sequential treatments (9 days (3-31 days)) were compared with non-sequential treatments (14 days (3-59 days)), (p<0.001).
Clinical conclusions The success rate was not statistically different in the two groups; therefore the authors concluded that the pharmacist-intervention was as effective as the routine of no-intervention. Most of the secondary outcomes were also similar in the study groups.
Measure of benefits used in the economic analysis The primary health outcome was not statistically different between the study groups; therefore the authors stated that a cost-minimisation analysis was conducted.
Direct costs Discounting was not relevant as the time horizon of the study was one year. Quantities of resources used and unit costs were reported only for a few cost items such as drug consumption and hospital days. The cost/resource boundary adopted reflected the perspective of the hospital. The cost items analyses were IV and oral clindamycin, supplies, personnel, hospitalisation, and management of adverse events (AE) related to the treatment. Time spent in drug preparation and administration was not measured and was obtained from the literature. The remaining quantities of resources were estimated from the study reports. The estimation of costs was based on actual data, obtained from the Purchase and Pharmacy Services and from the Human Resources Department at the Meixoeiro Hospital. The period of collection of data regarding the resources used and the price year were not reported.
Statistical analysis of costs Statistical analyses of total costs were conducted to test for statistical significance of the results.
Indirect Costs Indirect costs were not included.
Currency Spanish pesetas (pta). 1 Euro = 166 pta.
Sensitivity analysis A sensitivity analysis was conducted to assess the impact of costs of IV preparation and administration on the final costs estimated in the study groups. Preparation/administration costs were varied by +/-50% of the estimation in the base case. The type of analysis was not reported.
Estimated benefits used in the economic analysis See effectiveness results above.
Cost results Average costs per patient were:
IG: drug, pta 15,181 (95% CI: 14,055 - 16,307); preparation/administration pta 6,901 (95% CI: 6,392 - 7,410);
CG: drug, pta 18,872 (95% CI: 17,586 - 20,159); preparation/administration pta 8,544 (95% CI: 7,964 -9,126), (p<0.001 for both cost items).
Costs for the management of AE were pta 291 (95% CI: 118 - 463) in the IG and pta 643 (95% CI: 423 - 862) in the CG, (p=0.025).
Costs for the pharmacist were incurred only in the IG and amounted to pta 650.
Total costs were pta 23,258 (95% CI: 21,541 - 24,976) in the IG and pta 28,504 (95% CI: 26,426 - 30,583) in the CG and the difference was pta 5,246 (95% CI: 2,556 - 7,935), (p<0.001).
Sensitivity analysis indicated that variations in the IV preparation/administration costs did not affect the savings achieved by the pharmacist-intervention.
Synthesis of costs and benefits Authors' conclusions The authors concluded that the introduction of an information sheet to enhance the conversion to oral therapy for patients undergoing intravenous treatment was a safe procedure and led to a significant reduction in overall intervention costs.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparator was clear. No intervention was selected because it represented the routine procedure in the case of patients using IV therapies. You, as a user of this database, should assess whether no intervention represents an actual alternative in your own setting.
Validity of estimate of measure of effectiveness The analysis of effectiveness was based on non-randomised, controlled study, which was appropriate for the study question, given that selection bias should have been minimal. In addition, power calculations were performed in the planning phase and a sequential distribution of patients in the study groups was conducted to avoid possible bias and confounding factors. However, as outcome data were gathered in two different study periods for the two groups, the authors, in order to ensure that the results were not affected by external factors outside the control of the investigator, had to assume that there were no procedural and management changes. This issue could have limited the internal validity of the study. Finally, details on the period of collection of the effectiveness evidence and the centres in which the study was conducted were not satisfactorily reported.
Validity of estimate of measure of benefit A summary benefit measure was not used, as the two interventions were considered similar in terms of the main outcome measure. However, it would have been helpful had the authors adopted a summary benefit measure, since there were some statistically significant differences in terms of secondary outcomes. In addition, patient preferences for the two different administration procedures could have been considered. Finally, although there was a lack of statistical significance, there was still uncertainty. Therefore, there might be occasions where effectiveness is greater for the control group. This might also be correlated with increased cost.
Validity of estimate of costs The perspective of the study was that of the hospital and it appears that all relevant categories of costs were included in the analysis. Although the estimation of some cost items was derived from the literature, appropriate sensitivity analyses were conducted to assess for the impact of these estimations on the results of the study. Quantities of resources used were only partially reported, and the period of collection of resources consumed was not reported. The price year was not indicated.
Other issues The issue of the generalisability of the study to other setting was only partially addressed by sensitivity analyses, which were conducted only on some specific cost items. As a result, the external validity of the study was somewhat low. However, the authors made several comparisons of their findings with those from other studies. Finally, results were generally fully reported, although with incomplete dating.
Implications of the study The authors noted that, despite the good results of the intervention, participation of the physicians involved was not as active as expected.
Source of funding Grant from The Spanish Society of Hospital Pharmacy. Support from Quimica Farmaceutica Bayer.
Bibliographic details Martinez M J, Freire A, Castro I, Inaraja M T, Ortega A, Del Campo V, Rodriguez I, Bardan B, Morano L E, Garcia J F. Clinical and economic impact of a pharmacist-intervention to promote sequential intravenous to oral clindamycin conversion. Pharmacy World and Science 2000; 22(2): 53-58 Indexing Status Subject indexing assigned by NLM MeSH Administration, Oral; Anti-Bacterial Agents /administration & Bacterial Infections /drug therapy /economics; Clindamycin /administration & Cost-Benefit Analysis; Costs and Cost Analysis; Female; Hospitalization; Hospitals, Public; Humans; Injections, Intravenous; Length of Stay; Male; Middle Aged; Patient Education as Topic; Pharmacists; Pharmacy Service, Hospital; Spain; dosage /economics /therapeutic use; dosage /economics /therapeutic use AccessionNumber 22000006464 Date bibliographic record published 30/09/2002 Date abstract record published 30/09/2002 |
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