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Effectiveness and cost-benefit analysis of intensive treatment and teaching programmes for Type 1 (insulin-dependent) diabetes mellitus in Moscow: blood glucose versus urine glucose self-monitoring |
Starostina E G, Antsiferov M, Galstyan G R, Trautner C, Jorgens V, Muhlhauser I, Berger M, Dedov I I |
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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 Diabetic treatment and teaching programme (DTTP).
Economic study type Cost-effectiveness analysis.
Study population Type 1 diabetes patients, aged 15-45. The study excluded patients with significant loss of vision, renal insufficiency and severe concomitant disorders unrelated to diabetes.
Setting Training took place in the hospital setting. The economic study was carried out in Moscow.
Dates to which data relate Effectiveness and resource data related to 1989-1992. 1992 prices were used.
Source of effectiveness data Link between effectiveness and cost data Some costs are based on data from the trial.
Study sample The study consisted of a sample of 121 consecutive patients. A "group randomisation protocol" was used which assigned the first consecutive 61 patients to urine glucose self-monitoring and the subsequent 60 patients to blood glucose self-monitoring. An additional 60 patients fulfilling the inclusion criteria were recruited as a control group. No power calculations were provided to determine the sample size.
Study design This was a randomised controlled trial using a "group randomisation protocol" which was conducted in a single centre study. Complete follow-up was available in 55 patients from the urine glucose self-monitoring group,52 from the blood glucose group and 58 from the control group. Duration of follow up was two years for the interventiongroups and one year for the control group.
Analysis of effectiveness It was not clear if the analysis was based on intention to treat. The groups appeared comparable in age and prognosis. Clinical outcomes were measured by glycated haemoglobin (HbA1) levels and cases of ketoacidosis, and diabetes related knowledge test scores were evaluated.
Effectiveness results Glycated haemoglobin levels decreased to a similar extent for both urine and blood glucose self-monitoring groups (9.2%, p<0.001), but remained unchanged for the control group (12.3%). The number of cases of severe hypoglycaemia was comparable between the intervention and the control groups. There was one case of ketoacidosis in the intervention groups. Diabetes-related knowledge test scores increased to a similar level in the intervention groups (25 and 26, p<0.001), but remained unchanged for the control group (11).
Clinical conclusions Both intervention programmes led to an improvement of metabolic control.
Measure of benefits used in the economic analysis HbA1 levels, cases of ketoacidosis, diabetes related knowledge test scores.
Direct costs Some costs and quantities were reported separately. Costs were discounted at 5%. 1992 prices were used. The direct costs were those ofhospitalisation (salaries, drugs, medical supplies, food, overheads) and the test strips. Data were based on actual data and the literature (unpublished study).
Statistical analysis of costs Mean values, standard errors and p-values for quantities were reported.
Indirect Costs Indirect costs included loss in productivity while patients were undergoing training for self-monitoring of glucose (based on 1992 average wage). Costs and quantities were reported separately. Costs were discounted at 5% and were based on actual data (derived from the study sample).
Currency German marks (DM) and Russian roubles.
Sensitivity analysis The authors considered one way and multiple way simple sensitivity analyses on quantity of resources used (test strips), price, and cost savings.
Estimated benefits used in the economic analysis Glycated haemoglobin levels decreased to a similar extent for both urine and blood glucose self-monitoring groups (p<0.001), but remained unchanged for the control group (9.2% and 12.3% respectively). The number of cases of severe hypoglycaemia was comparable between the intervention and the control groups. There was one case of ketoacidosis in the intervention group. Diabetes-related knowledge test scores increased to a similar level in the intervention groups (25 and 26, p<0.001), but remained unchanged for the control group (11).
Cost results The authors looked at two incremental cost analyses, one based on costs denominated in roubles, the other based on costs denominated in German marks. The former considered the costs of administering the treatment and was the same for blood and urine patients. The latter covered the cost of imported drugs, and varied for blood and urine testing. Both were based on a two year period. The cost analysis conducted in Russian roubles showed net savings of 14,400 roubles per patient overall. The cost analysis in German marks showed a net saving for the urine glucose self-monitoring of DM60per patient and a net cost of DM310 for blood glucose self-monitoring. The analysis was sensitive to savings from discontinuing drugs, the cost of test strips and the number of test strips used per day. There was a net saving as long as the price of test strips was below DM 0.27. Duration of costs was two years.
Synthesis of costs and benefits Intervention (DTTP) is the dominant strategy.
Authors' conclusions The authors stated that the intervention led to an improvement of metabolic control and saved resources. The use of urine glucose self-monitoring showed net benefits in comparison to blood glucose self-monitoring for Type 1 diabetes patients. However the authors admitted that the patient numbers may have been too small and follow-up period too short to be able to detect a true difference. Moreover, the incidence of severe hypoglycaemia may occur with lower levels of glycated haemoglobin.
CRD Commentary This is not a cost-benefit analysis as stated by the authors, but a cost-effectiveness analysis. Moreover, 1) Since they intended to address a societal point of view, other costs, such as patients' costs, should have been included; 2) the sensitivity analysis was under-reported ; 3) more information is needed about how the cost data was compiled;4) how relevant is the economic study outside the Eastern Block?
Source of funding Boehringer-Mannheim, Germany.
Bibliographic details Starostina E G, Antsiferov M, Galstyan G R, Trautner C, Jorgens V, Muhlhauser I, Berger M, Dedov I I. Effectiveness and cost-benefit analysis of intensive treatment and teaching programmes for Type 1 (insulin-dependent) diabetes mellitus in Moscow: blood glucose versus urine glucose self-monitoring. Diabetologia 1994; 37(2): 170-176 Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Analysis of Variance; Blood Glucose Self-Monitoring /economics; Cost-Benefit Analysis; Diabetes Mellitus, Type 1 /economics /rehabilitation /therapy; Female; Glycosuria; Health Knowledge, Attitudes, Practice; Humans; Insulin /therapeutic use; Male; Middle Aged; Moscow; Patient Education as Topic /economics; Self Care /economics; Socioeconomic Factors; Treatment Outcome AccessionNumber 21995007066 Date bibliographic record published 16/02/1996 Date abstract record published 16/02/1996 |
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