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A model educational program for people with type 2 diabetes: a cooperative Latin American implementation study (PEDNID-LA) |
Gagliardino J J, Etchegoyen G |
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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 intervention examined in the study was an educational programme for people with type 2 diabetes. The programme was based on four weekly teaching units (90-120 minutes each, providing general concepts about diabetes, self-monitoring, foot examinations, and booklets) and a reinforcement session at six months, involving also family members and spouses. All educators participated in an intensive 10-person, 2-day training seminar.
Type of intervention Other: education programme.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients aged under 65 years with type 2 diabetes, overweight or obese (BMI greater than 27), neither requiring insulin for metabolic control or ketonuria. The exclusion criteria were as follows: aged over 65 years, advanced chronic complications of diabetes (retinopathy, nephropathy with creatinine greater than 2 mg/dl, or neuropathy), other severe life-limiting illnesses, inability or unwillingness to participate in the diabetes education programme and/or the diagnostic procedures of the project, and participation in previous structured diabetes education courses.
Setting The setting was primary care. The economic study was carried out in ten Latin-American countries: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Mexico, Paraguay, and Uruguay.
Dates to which data relate Neither dates nor price year were reported.
Source of effectiveness data The 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 in the effectiveness analysis.
Study sample Power calculations were based on a published study enrolling similar patients and there was a 0.80 power and an alpha error of 0.05. Patients enrolled in the study were selected from eligible volunteers who periodically visited the study clinics for control of diabetes in the ten countries. Of 658 initially eligible patients, a final sample of 446 patients was considered: 64% were women with a mean age of 54.6+/-10.1 years and an average duration of diabetes since diagnosis of 8 +/-13 years; 92% of patients were either obese or overweight, 45% had systolic hypertension, 44% had diastolic hypertension, 62% had higher serum cholesterol, 53% had increased triglyceride levels, and 72% had HbA1c values greater than 6.5%. The authors stated that study participants were selected randomly from the patients presenting at the study clinics, but the method of randomisation was not reported. There was no statistically significant difference between those who participated in the study and those who were excluded.
Study design This was a before-after study carried out in several centres in ten Latin-American countries: the same sample of patients being evaluated before and after the implementation of the educational programme. Data were collected 6 months before participation in the programme (-6 months), on entry to the programme (time 0), and 4, 8, and 12 months after initiation of the programme. Attendance at 12 months was 76% and the main reason for dropouts was financial. No statistically significant difference was found between dropouts and those who remained in the study.
Analysis of effectiveness The basis for the clinical analysis appears to have been treatment completers only. The health outcomes assessed in the analysis were the variations in the levels of fasting blood glucose, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, cholesterol, and triglycerides. The intake of oral hypoglycaemic agents (such as glibenclamide), antihypertensive drugs (such as enalapril), and cholesterol-lowering drugs (such as simvastatin) was also estimated. No comparability of study groups was required as the same cohort of patients was used in the analysis.
Effectiveness results The effectiveness results were as follows:
The levels of fasting blood glucose (mmol/l) were 10.6+/-3.5 at -6 months, 10.2+/-3.3 at time 0, 8.8+/-3.1 at 4 months, 8.8+/-2.7 at 8 months, and 8.7+/-3.0 at 12 months.
The levels of HbA1c (%) were 9.0+/-2.0 at -6 months, 8.9+/-2.1 at time 0, 8.3+/-3.3 at 4 months, 7.9+/-1.7 at 8 months, and 7.8+/-1.6 at 12 months.
The levels of body weight (kg) were 84.6+/-14.7 at - 6 months, 83.2+/-14.9 at time 0, 81.4+/-14.5 at 4 months, 81.2+/-14.3 at 8 months, and 81.2+/-15.2 at 12 months.
The levels of systolic blood pressure (mmHg) were 149.6+/-33.6 at -6 months, 153.8+/-15.9 at time 0, 145.2+/-17.1 at 4 months, 141.9+/-17.8 at 8 months, and 142.9+/-18.8 at 12 months.
The levels of diastolic blood pressure (mmHg) were 91.9+/-11.5 at -6 months, 95.4+/-7.9 at time 0, 89.2+/-9.9 at 4 months, 87.4+/-10.7 at 8 months, and 87.4+/-11.0 at 12 months.
The levels of cholesterol (mmol/l) were 6.1+/-1.1 at -6 months, 6.2+/-0.8 at time 0, 5.7+/-1.0 at 4 months, 5.6+/-1.1 at 8 months, and 5.4+/-1.0 at 12 months.
The levels of triglycerides (mmol/l) were 2.7+/-1.8 at -6 months, 2.8+/-1.7 at time 0, 2.3+/-1.2 at 4 months, 2.1+/-1.0 at 8 months, and 2.1+/-1.2 at 12 months.
The differences between the levels at time 0 and those at months 4, 8, and 12 were statistically significant, while there were no statistically significant differences between levels at time 0 and -6 months, suggesting that the reported reductions resulted from the intervention.
Finally, the yearly intake of drugs was reduced from 247,470 tablets (76% of patients) at time 0 to 156,220 tablets (48% of patients) at 12 months for glibenclamide, from 71,540 (47% of patients) to 11,680 tablets (8% of patients) for enalapril, and from 20,440 tablets (10% of patients) to zero for simvastatin.
Clinical conclusions The educational programme had significant benefits on patients' health and reduced consumption of drugs.
Measure of benefits used in the economic analysis No summary benefit measure was used in the economic analysis, thus a cost-consequences analysis was carried out.
Direct costs Discounting was not carried out as costs were incurred over a period of 18 months. The economic analysis included drug acquisition costs and costs of daily urine-glucose strips. It was assumed that no patient used strips at time 0 and all patients were using them at 12 months. Unit costs and quantities of resources were reported. The cost/resource boundary was not stated. The estimation of costs was based on actual data derived from the average cost of the drugs in the Argentine market. The source of data on resource use was based on the trial, but the period of collection of data was not reported. No price year was given.
Statistical analysis of costs No statistical analysis of costs was carried out.
Indirect Costs Indirect costs were not included.
Sensitivity analysis No sensitivity analyses were carried out.
Estimated benefits used in the economic analysis Please refer to the effectiveness results reported earlier.
Cost results Total yearly drug costs were $107,939.99 ($59,640.27 for glibenclamide, $21,175.84 for enalapril, and $27,123.88 for simvastatin) at time 0, and $41,106.30 ($37,649.02 for glibenclamide, $3,457.28 for enalapril, and $0 for simvastatin) at 12 months.
Overall, there was a 62% reduction in total costs.
The yearly cost of urine-glucose stripes was $30,604.00. Subtracting this extra expense from the money saved by less drug use, the net cost savings were $32,229.69 per year, which represented a 34% reduction in costs at month 12 in comparison with time 0.
Synthesis of costs and benefits Authors' conclusions The authors concluded that the educational programme resulted in life-style modifications of patients with type 2 diabetes, leading to reduction in body weight and better control of glucose, blood pressure, and serum lipids. The intervention also proved to reduce the pharmacoeconomic costs of diabetes.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparator was clear. No educational programme was selected as this was the current situation. You, as a user of this database, should assess whether an educational programme is implemented in your own setting.
Validity of estimate of measure of effectiveness The analysis of effectiveness was based on a before-and-after study, thus a single sample of patients was used to estimate the variations in the main outcome measures. This removes any selection bias. There was a substantial rate of dropouts, but patients who remained in the study did not differ statistically significantly from those who dropped out. Power calculations were performed at the planning phase, based on a previous study. Randomisation to select the sample was carried out, although details were not provided. The authors stated that the population recruited might not have been representative of the general population in each participating country.
Validity of estimate of measure of benefit Health outcomes were left disaggregated and no summary benefit measure was used in the economic analysis. Although the use of a benefit measure would have been useful, the outcomes reported in the effectiveness analysis represent measures widely used in studies assessing the benefits of interventions for patients with diabetes.
Validity of estimate of costs The perspective adopted in the analysis was not stated. In fact, only drug and urine-glucose test costs were included in the analysis. However, unit costs and quantities of resources used were reported separately, thus increasing transparency and enhancing generalisability. Costs were treated deterministically and the period of collection of resources was not reported. No price year was given, making reflation exercises to other settings difficult.
Other issues The authors made several comparisons of their findings with those from other studies. The issue of the generalisability of the study results to other settings was addressed, although sensitivity analyses were not carried out. The authors stated that, due to variability in social environment and life-style habits in the Latin American region, the study results could be implemented in other countries with different socio-cultural settings. The study enrolled patients with type 2 diabetes and this was reflected in the conclusions of the analysis.
Implications of the study The main implication of the analysis was that patient education should be considered as a regular and essential part of diabetes care and as an effective means of reducing chronic complications of diabetes. The approach also has the potential of reducing the socioeconomic costs of diabetes.
Bibliographic details Gagliardino J J, Etchegoyen G. A model educational program for people with type 2 diabetes: a cooperative Latin American implementation study (PEDNID-LA) Diabetes Care 2001; 24(6): 1001-1007 Other publications of related interest Domenech M I, Assad D, Mazzei M E, Kronsbein P, Gagliardino J J. Evaluation of the effectiveness of an ambulatory teaching/treatment programme for non-insulin dependent (type 2) diabetic patients. Acta Diabetologica 1995;32:143-147.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Anticholesteremic Agents /therapeutic use; Antihypertensive Agents /therapeutic use; Blood Glucose /analysis; Blood Pressure; Cholesterol /blood; Curriculum; Diabetes Mellitus, Type 2 /blood /physiopathology /rehabilitation; Educational Measurement; Female; Follow-Up Studies; Hemoglobin A, Glycosylated /analysis; Humans; Hypercholesterolemia /complications /drug therapy; Hypertension /complications /drug therapy; Hypoglycemic Agents /therapeutic use; Latin America; Male; Middle Aged; Models, Educational; Patient Care Team; Patient Education as Topic; Patient Selection; Time Factors; Triglycerides /blood AccessionNumber 22001001202 Date bibliographic record published 31/01/2003 Date abstract record published 31/01/2003 |
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